CURRENT OPINION
European Heart Journal (2014) 35, 313–320 doi:10.1093/eurheartj/eht550
The Year in Cardiology
The Year in Cardiology 2013: coronary intervention Raimund Erbel* and William Wijns Department of Cardiology, West-German Heart Center Essen, University Duisburg-Essen, Hufelandstr. 55, D-45122 Essen, Germany Received 13 November 2013; revised 26 November 2013; accepted 28 November 2013
----------------------------------------------------------------------------------------------------------------------------------------------------------Keywords
PCI † Intervention † Interventional cardiology † Coronary intervention
Appropriateness The year 2013 was rich of new developments in cardiology, and percutaneous coronary intervention (PCI) in particular, as summarized in this article.
Training for percutaneous coronary intervention, appropriateness, and indications Training Increasingly complex PCI procedures are performed in patients at higher risk with increasing impact of operator’s experience on clinical outcomes. In-hospital and up to 5-year safety outcomes of PCI undertaken either by trainees (working in a structured training environment) or by consultant operators were compared. Patients who have been treated by a consultant (n ¼ 7505) or a trainee (n ¼ 8502) had comparable in-hospital rates of stroke, emergency bypass surgery (CABG), and repeat PCI. The only independent outcome predictor for all-cause mortality was the clinical presentation of the patient himself.1 Use of a virtual catheterization laboratory reality simulator seems to offer a unique opportunity to complement training of young interventionalists by providing learning experience and feedback to the trainee that would otherwise require practice on patients.2
The appropriateness of indications of PCI has been challenged, particularly in the USA. Whereas only 1.1% of emergency procedures were regarded as inappropriate, up to 10-fold higher rates were reported for non-acute PCI.3 In addition to immediate technical success of PCI, the focus should be placed on long-term patient-oriented outcomes, quality metrics, and implementation of trial-based evidence.4
Indications Using the hyperaemic pressure-derived fractional flow reserve (FFR), the long-term outcomes of patients undergoing PCI with angiographic guidance only (n ¼ 6268) were compared with PCI with FFR guidance (n ¼ 1090) or deferred PCI (n ¼ 721). At 7 years, major adverse cardiac events (MACE) were 50% in patients with FFR-guided PCI, compared with 57% in patients treated with angiographic guidance (P ¼ 0.016). The defer strategy in patients with preserved FFR was independently associated with reduced rate of myocardial infarction (MI), hazard ratio (HR) 0.46, 95% confidence intervals (CI) 0.26– 0.82, P ¼ 0.008.5 The clinical impact of routine incorporation of FFR in real practice was tested in 5097 patients with death, MI, and repeat revascularization at 1 year as endpoints.6 With nearly half the stents implanted, primary endpoint (Figure 1) was significantly lower in patients treated after the routine use of FFR (FFR in 50.7% of all cases) vs. before (FFR in 1.9% of all cases): HR 0.55, CI 0.43–0.70 (P , 0.001). Implementation
The opinions expressed in this article are not necessarily those of the Editors of the European Heart Journal or of the European Society of Cardiology.
* Corresponding author. Tel: +49 2 01 723 4800, Fax: +49 2 01 723 5401, Email: [email protected] Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2014. For permissions please email: [email protected]
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The year 2013 was rich of new developments in cardiology, and percutaneous coronary intervention (PCI) in particular. This overview article will focus on contributions in the following areas: training for PCI, appropriateness and indications; access site selection, risk scores, peri-procedural myocardial infarction; trial results and long-term follow-up; PCI for specific patient and lesion subsets, including acute coronary syndrome and STsegment myocardial infarction; prevention of ischemic and reperfusion injury; stent thrombosis and new coronary stents and scaffolds.
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tional flow reserve in propensity-score matched patients. The primary endpoint of death from any causes, myocardial infarction, or any repeat revascularization (A); death from any causes (B); death from any causes or myocardial infarction (C); and any repeat revascularization (D). (Reprinted with kind permission from Reference 6, Eur Heart J 2013).
of FFR-based PCI strategies in daily practice is associated with improved clinical outcomes in both studies.5,6
Access site selection, risk scores, and peri-procedural myocardial infarction Access site selection The long-standing controversy on access site selection has evolved with an increasing worldwide use of the radial instead of the femoral approach, particularly following the presentation of the RIVAL trial.7 The benefit of radial access is to reduce bleeding complications, with some remaining concerns regarding prolonged fluoroscopy time. Radiation exposure, measured by median air kerma, was reduced with the femoral approach only in low volume radial centres, underlying the importance of proper training.8 Another potential advantage of radial access is the performance of PCI as an ambulatory procedure. Previously PCI without stenting was associated with high rates of (sub)acute coronary occlusion, requiring emergency angiography, followed by emergency repeat PCI or even CABG. Today predictability and stability of immediate PCI results allow same-day discharge in selected patients, already proposed by Kiemeneij et al.9 Consecutive patients (n ¼ 200) were discharged on the
same day without major bleeding or MACE at 24 h and at 7 days. Minor bleedings were noted in 4% of the patients, 2% were admitted to hospital, and only 1.5% had emergency revisits.10 The increasing use of radial access will provide an opportunity for further medical and economic evaluation of same-day PCI strategies.
Risk scores Multiple risk scores for the prediction of mortality after PCI have been validated and reviewed in ESC Practice Guideline recommendations.11 Most algorithms have identified the age, gender, cardiovascular risk factors, elevated creatinine, recent MI, and peripheral vascular disease as the strongest predictors of risk. The SYNTAX investigators calculated the 1-year risk for all cause death and MACE using the combination of SYNTAX score, age, ejection fraction, and creatinine clearance. The score provided excellent predictive accuracy12 and further enhanced the 5-year risk stratification either for PCI or CABG.13 Based on three angiographic and five clinical variables, this score provides an excellent tool for the heart team discussion in order to determine the optimal treatment strategy for each patient, from a personalized care perspective.
Peri-procedural myocardial infarction The Third Joint ESC/ACCF/AHA/WHF Task Force14 has issued new consensus definitions of peri-procedural MI (type 4a). The clinical significance of frequently observed peri-procedural elevations of
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Figure 1 Adjusted curves for the primary endpoint and selected secondary endpoint before and after the introduction of the routine use of frac-
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creatine kinase (CK), CK-MB, CK mass, and troponin continues to be evaluated. The frequency and predictive value of peri-PCI elevations of CK-MB mass was assessed from pooled analysis of individual data in 11 PCI studies. Mortality data at 1–5 years were prospectively collected in 23 604 patients showing peri-procedural MI in 7.1% (CI 6.8 –7.5%). The most common mechanism was side branch occlusion during PCI. Independent predictors of peri-procedural myonecrosis were old age, female gender, diabetes, hypertension, renal function, multivessel disease, left anterior descending coronary artery disease, left main disease, bifurcation lesions, long lesions, use of drug-eluting stent (DES), and the number of stents. After adjustment for baseline covariates, peri-procedural MI was associated with an increased risk of mortality at follow-up (HR 1.2; CI 1.04–1.39), calling for a systematic evaluation of pre- and post-PCI biomarker elevations.15
The final 5-year outcome results of SYNTAX trial have demonstrated better survival in patients with multivessel disease randomized to CABG implying that surgical revascularization should remain the standard of care for patients with complex lesions (high or intermediate SYNTAX scores). For less complex lesions (low SYNTAX score) or left main coronary disease (low or intermediate SYNTAX score), PCI is an acceptable alternative.16 Failure to prescribe aspirin after CABG or antiplatelet therapy after PCI were the strongest independent predictors of mortality in both surgery (HR 3.56, CI 2.04–6.21, P , 0.001) and PCI arm (HR 152.16, CI 53.57–432.22, P , 0.001).17 Long-term data after randomization for PCI, surgery, or medical treatment are rare. Of note, the 10-year follow-up results of the MASS II (Medical Angioplasty or Surgery Study) showed no difference between patients randomized to medical therapy, CABG, or PCI with respect to left ventricular ejection fraction, or its change between baseline and 10 years. This means that, in the absence of new MI, systolic ventricular function remained preserved after 10 years follow-up regardless of the initial therapeutic option,18 supporting the role for heart team decision making in patients with stable angina and complex coronary artery disease.11,19
Specific patient and lesion subsets Specific patient subsets Gender-related issues have become a topic of major interest in cardiology and other medical disciplines. A patient-level pooled analysis of 26 randomized trials involving 11 557 women looked at safety and efficiency of bare-metallic stent (BMS) and DES in women.20 At 3 years, the incidence of death and MI decreased dependent on the stent type from 12.8 to 10.9% and 9.2% comparing BMS to the first and newer DES generation (P ¼ 0.001). Definite or probable stent thrombosis occurred in 1.3, 2.1, and 1.1% women in the BMS, early-generation, new generation DES, respectively (P ¼ 0.01) combined with a significant reduction in TLR rates from 18.6 to 7.8%, and 6.3% (P , 0.0001). Newer generation DES should become the standard of care for PCI in women.
A major challenge in interventional cardiology is the percutaneous treatment of chronic total occlusions (CTO). Further to advanced techniques and novel equipment, improved results were shown in a meta-analysis of 18 061 patients from 65 studies demonstrating an overall angiographic success rate of 77% with low complication rates (MI 2.5%, coronary perforation 2.9%, cardiac tamponade 0.3%). Contrast-induced nephropathy occurred in 3.8%. Unsuccessful PCI in CTO had a higher mortality rate (1.5 vs. 0.4%, P , 0.0001).21
Percutaneous coronary intervention for acute coronary syndrome and STEMI While PCI for high-risk non-ST segment acute coronary syndrome (NSTE-ACS) and STEMI is recommended as a life-saving procedure, several recently reported trials are challenging current recommendations11,22 regarding important procedural strategies: the use of mechanical thrombus aspiration, deferred PCI of non-culprit stenosis in patients with multivessel disease, and the use of intra-aortic balloon pump (IABP) for haemodynamic support in patients with cardiogenic shock.
Thrombus aspiration In freshly occluded coronary vessels, the removal of thrombotic material and thrombus-related soluble substances prior to PCI was shown to reduce the thrombus burden, improve myocardial reperfusion, and provide clinical benefits.23 From prospectively collected data on 2567 consecutive STEMI patients treated with primary PCI and thrombectomy (mechanical thrombectomy in 42.7%) had a reduced in-hospital (4.5%) and longer-term (9.0%) mortality. Adjusted HR (after propensity weighing) was 0.43 (CI 0.19– 0.97, P ¼ 0.042).24 Reduction in long-term mortality was only significant when the total ischaemic time was ≤180 min. Of note, a detailed pilot randomized study using optical frequency domain imaging in primary PCI (141 patients) was not able to show differences between cases with and without thrombectomy in relation to minimal lumen area, plaque protrusion, intraluminal defects, complete and incomplete stent apposition.25 The TASTE study is the largest available randomized trial, nested in the SCAAR and SWEDEHEART nationwide registries, and involved 31 sites, all primary PCI centres in Sweden, 1 in Denmark and another in Iceland.26 The primary endpoint—all cause mortality—at 30 days was not different between 7244 patients randomized to either immediate PCI (n ¼ 3623) or manual thrombus aspiration plus PCI (n ¼ 3621): the HR was 0.94 (CI 0.72–1.22; P ¼ 0.63). The secondary endpoints mortality and re-MI rates at 30 days were 3.9 and 3.3%, respectively (P ¼ 0.23). Secondary endpoints of Re-MI (HR 0.61; CI 0.34–1.07) and stent thrombosis (HR 0.47; CI 0.20–1.02) were not significantly different, with low stent thrombosis rates at 1 month, 0.5 and 0.2%, respectively. None of the other variables showed an advantage of thrombus aspiration. At variance with results of prior smaller studies and meta-analyses, this large study shows no evidence of short-term mortality benefit for systematic thrombus aspiration prior to PCI for STEMI. Until longer
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Trial results and long-term follow-up
Specific lesion subsets
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follow-ups become available, TASTE challenges the level of the current recommendation to routinely perform mechanical thrombus aspiration prior to primary PCI. Pathophysiological studies have provided a better understanding of microvascular obstruction by embolization of debris and how it affects TIMI frame count and myocardial blush.27 Intramyocardial areas of microvascular obstruction, oedema, and haemorrhage can be identified using magnetic resonance imaging (Figure 2) by late gadolinium enhancement.28 Whether these sensitive metrics of reduced reperfusion injury will show advantage of prior thrombus aspiration over immediate primary PCI needs confirmation.29,30
Primary percutaneous coronary intervention and multivessel disease The recently presented PRAMI trial (Preventive Angioplasty in MI trial) involved 465 patients with multivessel disease who were
randomized 1:1 to PCI of the culprit stenosis only or to immediate PCI of all stenosis following successful primary PCI of the culprit occlusion.31 Primary endpoint of cardiac death, MI, or refractory angina with proven ischaemia was in favour of preventive angioplasty of non-culprit stenosis: 21 vs. 53% event rates, HR 0.35 (CI 0.21– 0.58; P , 0.001). There was no increased safety hazard, and increase in procedure duration and radiation exposure seems to be acceptable. Superiority of the more invasive approach remained highly significant with secondary combined endpoint of death and MI at 11 vs. 27%, respectively (HR 0.36, CI 0.18–0.73; P ¼ 0.004). Criteria that were used to identify suitable patients for inclusion in the trial as well as to identify which non-culprit lesions were suitable for immediate PCI need to be better understood before this approach can be generalized. These impressive results are calling for confirmation in a larger trial powered to confirm superiority of the ‘preventive’ angioplasty approach using a dual mortality and MI primary endpoint.
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Figure 2 Late gadolinium enhancement images (top row) compared with T2-weighed turbo-spinecho (T2w) images (bottom row) in one animal (1 and 2) and one PCI-treated STEMI patient (54-year-old male with anterior wall infarction). Cardiac magnetic resonance was performed 5 days after PCI. Late gadolinium enhancement imaging (3) shows microvascular obstruction (arrow), consistent with the hypo-intense area of haemorrhage on T2w-image (4). Intramyocardial haemorrhage and microvascular obstruction are very comparable in size and location and show a close relationship. (Reprinted with kind permission from Reference 28, Eur Heart J 2013).
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Balloon pump in cardiogenic shock The negative results of the trials testing the usefulness of intra-aortic balloon counterpulsation (IABP) for haemodynamic support in cardiogenic shock patients have surprised many physicians. Primary endpoint, mortality at 30 days, in the SHOCK-IABP trial was entirely neutral between patients presenting with STEMI and cardiogenic shock randomized 1:1 to best of care, with (n ¼ 301) or without (n ¼ 299) IABP. No evidence of benefit accrued up to 1 year. Mortality in cardiogenic shock patients remained very high at 52 and 51%, with and without IABP (relative risk 1.01). Quality of life metrics in survivors were good, yet superimposable between randomization groups. Outcomes following cardiogenic shock are dismal and IABP does not appear to sufficiently support the failing circulation. The unmet need remains and urges the evaluation of more powerful assist devices.32
Pre- and post-conditioning as well as remote ischaemic preconditioning strategies have suggested positive effects on endpoints based on biomarker release or magnetic resonance imaging. At variance, pharmacological approaches using adenosine, cariporide, nicorandil, PKC-delta inhibitors, erythropoietin, and cyclosporine A have showed mixed result.33 From a pooled analysis of 10 randomized trials, ischaemic post-conditioning reduced myocardial enzyme leaks and preserved left ventricular ejection fraction.34 Remote ischaemic conditioning was tested in 333 STEMI patients during transportation to the primary PCI centre.35 Conditioning entails intermittent arm ischaemia through four cycles of 5-min blood-pressure cuff inflation followed by 5-min deflation. At 3.8 years follow-up, the primary composite endpoint-all-cause mortality, MI, readmission for heart failure, and ischaemic stroke were 13.5% in patients with remote ischaemic conditioning and 25.6% in the control group (HR 0.49, CI 0.27– 0.89, P ¼ 0.018). Obviously, these results need to be confirmed in larger populations. When proven useful, such simple measures could be implemented during pre-hospitalcare through the emergence of increasingly efficacious and well-organized STEMI networks.
New-generation drug-eluting stents, stent thrombosis, and coronary scaffolds Drug-eluting stents Meanwhile coronary stent implantation using DES has become a default therapy during PCI, with an increasing number of approved DES becoming available, and few undergoing extensive trial-based evaluation in large study populations. Given the good results obtained with second-generation DES, recent trials are designed to test noninferiority, rather than superiority of the newer drug-polymer-device iteration.
Stent thrombosis A meta-analysis of four trials studied the clinical impact of extending dual antiplatelet therapy (DAPT) in 8231 randomized patients. The median DAPT time was 16.8 vs. 6.2 months for the control group. All-cause death, MI, stent thrombosis, or cardiovascular event rates were not reduced in the extended DAPT group.
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Prevention of ischaemic and reperfusion injury: role of pre- and post-conditioning
The TWENTE trial randomized patients 1:1 between zotarolimuseluting (ZES, Resolute) and everolimus-eluting stent (EES, Xience V). The primary endpoint was target vessel failure (TVF). At 1 year, the composite of cardiac death, TV-related MI, and clinically driven TV revascularization (TVR) reached 8.2% in the ZES and 8.1% in the EES arm, demonstrating non-inferiority.36 Meanwhile the 2-year results showed equal rates of TVF at 10.9 vs. 11.6% (P ¼ 0.65) and similar MACE rates.37 The Dutch PEERS study (TWENTE II) compared 1:1 the ZES (Resolute) with the EES (Promus Element platinum chromium DES) in 1811 all-comer patients (2371 lesions). The primary endpoint of TVF was a composite of safety (cardiac death or TV-related MI) and efficacy (TVR) at 12 months (with a noninferiority margin of 36%). The primary endpoint was met by 55 (6%) of 905 patients in the ZES and 47 (5%) of 905 in the EES stent group (absolute risk difference 0.88%, CI 21.24–3.01%; upper limit of one-sided 95% CI 2.69%; non-inferiority P ¼ 0.006).38 An additional multicentre study reported the 2-year results of a pooled analysis looking at ZES (Resolute) for in-stent restenosis. The restenosis rate was 12.7% compared with 4.3% (P ¼ 0.003) in patients with de novo stenosis. Cardiac death and TV-related MI did not differ significantly (6.9 vs. 6.1%).39 The final 5-year report for the LEADERS (Limus Eluted from A Durable vs. ERodable Stent coating) trial became available as well.40 Either a biodegradable polymer biolimus-eluting stent (BES) or a durable polymer sirolimus-eluting stent (SES, first generation Cypher, no longer available) was implanted in 2707 patients. Biolimus-eluting stent had a significant reduction of (very) late definite stent thrombosis from 1 to 5 years (0.6 vs. 2.2%, P ¼ 0.003). The risk reduction was 0.26 (CI 0.10–0.69, P ¼ 0.0034). Post-hoc comparison of cases with low and high SYNTAX scores showed similar reduction in definite stent thrombosis with BES. Biolimus-eluting stent (Nobori) and EES (Xience or Promus) were recently compared 2:1 in 2707 patients (4025 lesions). Cardiac death, non-fatal MI, and clinically indicated TVR at 12 months occurred in 93 (5.2%) patients in the BES group and 44 (4.8%) patients in the EES group (relative risk 1.07, CI 0.75– 1.52, P , 0.0001, non-inferiority).41 Similar findings were reported by the NEXT investigators, who randomized 3235 patients 1:1 to receive BES or EES.42 Given the limited availability of large direct comparative studies between each new DES, network meta-analysis has been proposed as an alternative evaluation method. A recent network analysis evaluating the relative merits of paclitaxel-eluting stent (PES), SES, EES, ZES, and BES identified EES and ZES as the devices with highest safety profile.43 Whether newer generation DES, especially when the drug is released from bioerodable polymers show clinical advantages over EES or ZES that use more biocompatible durable polymers than first-generation DES, especially in the long term, remains undecided.
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Drug-eluting coronary scaffolds The year 2013 has seen the emergence of clinical application of bioerodable coronary scaffolds, in particular with the use of the everolimus-eluting Absorb device (BVS).49 While results of randomized evaluations of this technology are pending, numerous case reports and small series reporting on the feasibility of BVS use in various lesions and patient subsets have been released, including PCI for (N)STEMI.50 – 52 Confidence in the clinical performance of BVS has grown following extensive analysis of limited observational series but involving sequential multimodality evaluations using angiography, intravascular ultrasound, optical coherence tomography imaging, coronary vasomotor testing, and multislice coronary computed tomography.53 In addition to this specific brand, other
bioerodable scaffolds may be entering the clinical scene.54,55 Because many announced that bioerodable scaffolds represent the future of coronary stenting, adoption of BVS by physicians and patients seems to have anticipated the available evidence, at least in areas with favourable regulatory environment. If the incremental value of bioerodable scaffolds over durable metallic stents stems primarily from their disappearance, clinically relevant benefit will only become apparent after long-term follow-up of large patient groups.
Conclusion This overview is necessarily subjective but demonstrates the vitality of the clinical research in the field of PCI, and stresses areas where further investigation remains very active. Significant advances in the synergy between novel antithrombotic drugs and coronary devices, especially in patients with ACS, were reported in 2013, but not discussed here. Disruptive innovative technologies continue to be developed, with potential changes in clinical treatment strategies ahead. It is expected that even stronger emphasis will be placed on life-saving indications of PCI in patients with NSTE-ACS or STEMI, optimization of adjunctive medical therapy as well on the costeffectiveness of PCI procedures in general. Conflict of interest: R.E.: Travel expenses from Biotronik paid directly to private account. W.W.: Institutional research grants from pharmaceutical (AstraZeneca, Therabel) and device (Abbott Vascular, Biosensors, Biotronik, Boston Scientific, Cordis, Medtronic, Orbus Neich, St Jude, Terumo, Tryton) companies; honoraria and fees on behalf of W.W. go to the Cardiovascular Research Center Aalst. Co-founder and stockholder of Argonauts, Genae Americas, and Cardio3BioSciences.
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However, extended DAPT increased the risk of major bleedings (HR 2.64, CI 1.1 –5.3, P ¼ 0.006).44 The PRODIGY (PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia study) trial studied the duration of DAPT (6–24 months) depending on type and potency of the implanted stent. In a randomized study, 2013 patients were treated with BMS, ZES, PES, or EES implantation. Patients receiving ZES showed a significantly higher rate of definite, probable, and possible stent thrombosis in the shorter DAPT group. No association was seen between stent potency for inhibition of intimal hyperplasia and greater vulnerability to shorter DAPT. The rate of death, MI, and cerebrovascular event were higher in the ZES group with longer DAPT therapy (HR 2.85, P ¼ 0.0018).45 In 3119 patients with stable coronary artery disease or low-risk ACS treated with ZES, 3 months of DAPT (clopidogrel plus aspirin) was non-inferior to 12 months for the composite of all-cause death, MI, stroke, or major bleeding, without significantly increasing the risk of stent thrombosis [6.0 vs. 5.8%, respectively; risk difference, 0.17 (95% CI, 21.52–1.86); P ¼ 0.002].46 A nation-wide retrospective cohort study of 29 268 patients was performed in Denmark in order to estimate the risk of stent thrombosis, when clopidogrel was discontinued after MI. All patients receiving clopidogrel after discharge from a first MI were included from 2004 to 2009.47 At 18 months follow-up, death and recurrent MI were observed in 3214 cases (11%). For those treated by PCI, the estimated incidence rate ratio of death or MI within the first 90 days following discontinuation was 1.59 (CI 1.11–2.30, P ¼ 0.013). There was no such risk in patients treated medically only. Thus, discontinuation of clopidogrel therapy 1 year after PCI for MI was associated with an increased risk of death of a recurrent MI during the first 90 days following clopidogrel interruption. The incidence and impact of DAPT cessation on adverse events following PCI was evaluated in the PARIS 5031-patients large real-world registry.48 The importance of the mode of cessation was evaluated, i.e. discontinuation (as recommended by the physician), interruption (a conscious decision guided by a physician), or disruption (patient stops because of bleeding or non-compliance). Rate of cessation of DAPT therapy was 2.9, 23.3, and 57.3% within 30 days, 1 year, and 2 years, respectively. Cardiac death, stent thrombosis, or MI were strongly associated with the mode of cessation with no increase risk in the case of discontinuation or interruption. Disruption, however, was associated with high risk of adverse events with significant HRs of 9.82 with DAPT cessation within 1 week, 2.98 with cessation within 30 days, and 1.71 beyond 30 days following PCI.
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Eur Heart J 2012;33:3054 –3061. Onuma Y, Thuesen L, van Geuns RJ, van der Ent M, Desch S, Fajadet J, Christiansen E, Smits P, Holm NR, Regar E, van Mieghem N, Borovicanin V, Paunovic D, Senshu K, van Es GA, Muramatsu T, Lee IS, Schuler G, Zijlstra F, Garcia-Garcia HM, Serruys PW, TROFI Investigators. Randomized study to assess the effect of thrombus aspiration on flow area in patients with ST-elevation myocardial infarction: an optical frequency domain imaging study—TROFI trial. Eur Heart J 2013;34: 1050 –1060. Fro¨bert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angera˚s O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Ka˚regren A, Nilsson J, Robertson L, Sandhall L, Sjo¨gren I, Ostlund O, Harnek J, James SK. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med 2013;369:1587 –1597. Porto I, Biasucci LM, De Maria GL, Leone AM, Niccoli G, Burzotta F, Trani C, Tritarelli A, Vergallo R, Liuzzo G, Crea F. Intracoronary microparticles and microvascular obstruction in patients with ST elevation myocardial infarction undergoing primary percutaneous intervention. Eur Heart J 2012;33:2928 –2938. Robbers LF, Eerenberg ES, Teunissen PF, Jansen MF, Hollander MR, Horrevoets AJ, Knaapen P, Nijveldt R, Heymans MW, Levi MM, van Rossum AC, Niessen HW, Marcu CB, Beek AM, van Royen N. Magnetic resonance imaging-defined areas of microvascular obstruction after acute myocardial infarction represent microvascular destruction and haemorrhage. Eur Heart J 2013;34:2346 – 2353. Heusch G, Kleinbongard P, Bo¨se D, Levkau B, Haude M, Schulz R, Erbel R. Coronary microembolization: from bedside to bench and back to bedside. Circulation 2009; 120:1822 –1836. Fro¨hlich GM, Meier P, White SK, Yellon DM, Hausenloy DJ. Myocardial reperfusion injury: looking beyond primary PCI. Eur Heart J 2013;34:1714 –1722. Wald DS, Morris JK, Wald NJ, Chase AJ, Edwards RJ, Hughes LO, Berry C, Oldroyd KG, PRAMI Investigators. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med 2013;369:1115 –1123. Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Bo¨hm M, Ebelt H, Schneider S, Werdan K, Schuler G, Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) Trial Investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet 2013;382:1638 –1645. Heusch G. Cardioprotection: chances and challenges of its translation to the clinic. Lancet 2013;381:166 – 175. Zhou C, Yao Y, Zheng Z, Gong J, Wang W, Hu S, Li L. Stenting technique, gender, and age are associated with cardioprotection by ischaemic postconditioning in primary coronary intervention: a systematic review of 10 randomized trials. Eur Heart J 2012; 33:3070 –3077. Sloth AD, Schmidt MR, Munk K, Kharbanda RK, Redington AN, Schmidt M, Pedersen L, Sørensen HT, Bøtker HE, CONDI Investigators. Improved long-term clinical outcomes in patients with ST-elevation myocardial infarction undergoing remote ischaemic conditioning as an adjunct to primary percutaneous coronary intervention. Eur Heart J 2013. [Epub ahead of print]. von Birgelen C, Basalus MW, Tandjung K, van Houwelingen KG, Stoel MG, Louwerenburg JH, Linssen GC, Saı¨d SA, Kleijne MA, Sen H, Lo¨wik MM, van der Palen J, Verhorst PM, de Man FH. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial. J Am Coll Cardiol 2012;59:1350 –1361. Tandjung K, Sen H, Lam MK, Basalus MW, Louwerenburg JH, Stoel MG, van Houwelingen KG, de Man FH, Linssen GC, Saı¨d SA, Nienhuis MB, Lo¨wik MM, Verhorst PM, van der Palen J, von Birgelen C. Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimuseluting Xience V stents: 2-year follow-up of the randomized TWENTE trial. J Am Coll Cardiol 2013;61:2406 –2416. von Birgelen C, Sen H, Lam MK, Danse PW, Jessurun GA, Hautvast RW, van Houwelingen GK, Schramm AR, Gin RM, Louwerenburg JW, de Man FH,
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substudy of the multicenter randomized RIVAL trial. JACC Cardiovasc Interv 2013;6: 258 –266. Kiemeneij F, Laarman GJ, Slagboom T, van der Wieken R. Outpatient coronary stent implantation. J Am Coll Cardiol 1997;29:323 –327. Muthusamy P, Busman DK, Davis AT, Wohns DH. Assessment of clinical outcomes related to early discharge after elective percutaneous coronary intervention: COED PCI. Catheter Cardiovasc Interv 2013;81:6 –13. Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI), Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur J Cardiothoracic Surg 2010;38(Suppl.):S1 –S52. Farooq V, Vergouwe Y, Ra¨ber L, Vranckx P, Garcia-Garcia H, Diletti R, Kappetein AP, Morel MA, de Vries T, Swart M, Valgimigli M, Dawkins KD, Windecker S, Steyerberg EW, Serruys PW. Combined anatomical and clinical factors for the longterm risk stratification of patients undergoing percutaneous coronary intervention: the Logistic Clinical SYNTAX score. Eur Heart J 2012;33:3098 –3104. Farooq V, van Klaveren D, Steyerberg EW, Meliga E, Vergouwe Y, Chieffo A, Kappetein AP, Colombo A, Holmes DR Jr, Mack M, Feldman T, Morice MC, Sta˚hle E, Onuma Y, Morel MA, Garcia-Garcia HM, van Es GA, Dawkins KD, Mohr FW, Serruys PW. Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. Lancet 2013;381:639–650. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Joint ESC/ ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche´ P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation 2012;126:2020 –2035. Park DW, Kim YH, Yun SC, Ahn JM, Lee JY, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Park SJ. Frequency, causes, predictors, and clinical significance of periprocedural myocardial infarction following percutaneous coronary intervention. Eur Heart J 2013;34:1662 –1669. Mohr FW, Morice MC, Kappetein AP, Feldman TE, Sta˚hle E, Colombo A, Mack MJ, Holmes DR Jr, Morel MA, Van Dyck N, Houle VM, Dawkins KD, Serruys PW. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet 2013;381:629 –638. Farooq V, Serruys PW, Bourantas C, Vranckx P, Diletti R, Garcia Garcia HM, Holmes DR, Kappetein AP, Mack M, Feldman T, Morice MC, Colombo A, Morel MA, de Vries T, van Es GA, Steyerberg EW, Dawkins KD, Mohr FW, James S, Sta˚hle E. Incidence and multivariable correlates of long-term mortality in patients treated with surgical or percutaneous revascularization in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial. Eur Heart J 2012;33:3105 –3113. Garzillo CL, Hueb W, Gersh BJ, Lima EG, Rezende PC, Hueb AC, Vieira RD, Favarato D, Pereira AC, Soares PR, Serrano CV Jr, Ramires JA, Kalil Filho R. Longterm analysis of left ventricular ejection fraction in patients with stable multivessel coronary disease undergoing medicine, angioplasty or surgery: 10-year follow-up of the MASS II trial. Eur Heart J 2013;34:3370 – 3377. Head SJ, Kaul S, Mack MJ, Serruys PW, Taggart DP, Holmes DR Jr, Leon MB, Marco J, Bogers AJ, Kappetein AP. The rationale for Heart Team decision-making for patients with stable, complex coronary artery disease. Eur Heart J 2013;34:2510 – 2518. Stefanini GG, Baber U, Windecker S, Morice MC, Sartori S, Leon MB, Stone GW, Serruys PW, Wijns W, Weisz G, Camenzind E, Steg PG, Smits PC, Kandzari D, Von Birgelen C, Galatius S, Jeger RV, Kimura T, Mikhail G, Itchhaporia D, Mehta L, Ortega R, Kim HS, Valgimigli M, Kastrati A, Chieffo A, Mehran R. Safety and efficacy of drug-eluting stents in women: a patient-level pooled analysis of randomised trials. Lancet 2013. [Epub ahead of print]. Patel VG, Brayton KM, Tamayo A, Mogabgab O, Michael TT, Lo N, Alomar M, Shorrock D, Cipher D, Abdullah S, Banerjee S, Brilakis ES. Angiographic success and procedural complications in patients undergoing percutaneous coronary chronic total occlusion interventions: a weighted meta-analysis of 18,061 patients from 65 studies. JACC Cardiovasc Interv 2013;6:128–136. Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology (ESC), Steg PG, James SK, Atar D,
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Nicolela EL Jr, Perin MA, Devito FS, Labrunie A, Salvadori D Jr, Gusma˜o M, Staico R, Costa JR Jr, de Castro JP, Abizaid AS, Bhatt DL, OPTIMIZE Trial Investigators. Three vs Twelve Months of Dual Antiplatelet Therapy After ZotarolimusEluting Stents: The OPTIMIZE Randomized Trial. JAMA 2013. [Epub ahead of print]. Charlot M, Nielsen LH, Lindhardsen J, Ahlehoff O, Olsen AM, Hansen ML, Hansen PR, Madsen JK, Køber L, Gislason GH, Torp-Pedersen C. Clopidogrel discontinuation after myocardial infarction and risk of thrombosis: a nationwide cohort study. Eur Heart J 2012;33:2527 – 2534. Mehran R, Baber U, Steg PG, Ariti C, Weisz G, Witzenbichler B, Henry TD, Kini AS, Stuckey T, Cohen DJ, Berger PB, Iakovou I, Dangas G, Waksman R, Antoniucci D, Sartori S, Krucoff MW, Hermiller JB, Shawl F, Gibson CM, Chieffo A, Alu M, Moliterno DJ, Colombo A, Pocock S. Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study. Lancet 2013. [Epub ahead of print]. Iqbal J, Onuma Y, Ormiston J, Abizaid A, Waksman R, Serruys PW. Bioresorbable Scaffolds: rationale, current status, challenges and future. Eur H J 2013. [Epub ahead of print]. Gori T, Schulz E, Hink U, Wenzel P, Post F, Jabs A, Mu¨nzel T. Early outcome after implantation of Absorb bioresorbable drug-eluting scaffolds in patients with acute coronary syndromes. EuroIntervention 2013. [Epub ahead of print]. Kocka V, Malyy M, Budesı´nskyy T, Lisa L, Prodanov P, Tousek P, Jarkovskyy J, Widimsky P. Bioresorbable vascular scaffolds in acute ST- segment elevation myocardial infarction. A prospective multicenter study: PRAGUE 19. Eur Heart J 2013. [Epub ahead of print]. Diletti R, Karanasos A, Muramatsu T, Nakatani S, Van Mieghem NM, Onuma Y, Nauta ST, Ishibashi Y, Lenzen MJ, Ligthart J, Schultz C, Regar E, de Jaegere PP, Serruys PW, Zijlstra F, van Geuns RJ. Everolimus eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction. BVS STEMI FIRST Study. Eur Heart J 2013. [Epub ahead of print]. Onuma Y, Dudek D, Thuesen L, Webster M, Nieman K, Garcia-Garcia HM, Ormiston JA, Serruys PW. Five-Year Clinical and Functional Multislice Computed Tomography Angiographic Results After Coronary Implantation of the Fully Resorbable Polymeric Everolimus-Eluting Scaffold in Patients With De Novo Coronary Artery Disease: The ABSORB Cohort A Trial. JACC Cardiovasc Interv 2013;6: 999 –1009. Haude M, Erbel R, Erne P, Verheye S, Degen H, Bo¨se D, Vermeersch P, Wijnbergen I, Weissman N, Prati F, Waksman R, Koolen J. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial. Lancet 2013;381:836 –844. Verheye S, Ormiston JA, Stewart J, Webster M, Sanidas E, Costa R, Costa JR Jr, Chamie D, Abizaid AS, Pinto I, Morrison L, Toyloy S, Bhat V, Yan J, Abizaid A. A NextGeneration Bioresorbable Coronary Scaffold System-From Bench to First Clinical Evaluation: Six- and 12-Month Clinical and Multimodality Imaging Results. JACC Cardiovasc Interv 2013. [Epub ahead of print].
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Stoel MG, Lo¨wik MM, Linssen GC, Saı¨d SA, Nienhuis MB, Verhorst PM, Basalus MW, Doggen CJ, Tandjung K. Third-generation zotarolimus-eluting and everolimuseluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial. Lancet 2013. [Epub ahead of print]. Richardt G, Leschke M, Abdel-Wahab M, Toelg R, El-Mawardy M, Serruys PW, Silber S, Windecker S, Belardi JA, Neumann FJ, Widimsky P. RESOLUTE All Comers; RESOLUTE International Investigators. Clinical outcomes of the resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis. JACC Cardiovasc Interv 2013;6:905 – 913. Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, Rademaker-Havinga T, van Es GA, Meier B, Ju¨ni P, Windecker S. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimuseluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv 2013;6:777 –789. Smits PC, Hofma S, Togni M, Va´zquez N, Valde´s M, Voudris V, Slagboom T, Goy JJ, Vuillomenet A, Serra A, Nouche RT, den Heijer P, van der Ent M. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimuseluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet 2013;381:651 –660. Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T, NEXT Investigators. Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial. J Am Coll Cardiol 2013;68:181 –190. Navarese EP, Tandjung K, Claessen B, Andreotti F, Kowalewski M, Kandzari DE, Kereiakes DJ, Waksman R, Mauri L, Meredith IT, Finn AV, Kim HS, Kubica J, Suryapranata H, Aprami TM, Di Pasquale G, von Birgelen C, Kedhi E. Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis. BMJ 2013. [Epub ahead of print]. Cassese S, Byrne RA, Tada T, King LA, Kastrati A. Clinical impact of extended dual antiplatelet therapy after percutaneous coronary interventions in the drug-eluting stent era: a meta-analysis of randomized trials. Eur Heart J 2012;33:3078 –3087. Valgimigli M, Borghesi M, Tebaldi M, Vranckx P, Parrinello G, Ferrari R. PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY Investigators. Should duration of dual antiplatelet therapy depend on the type and/or potency of implanted stent? A pre-specified analysis from the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY). Eur Heart J 2013;34:909 –919. Feres F, Costa RA, Abizaid A, Leon MB, Marin-Neto JA, Botelho RV, King SB 3rd, Negoita M, Liu M, de Paula JE, Mangione JA, Meireles GX, Castello HJ Jr,
R. Erbel and W. Wijns
European Heart Journal (2014) 35, 313–320 doi:10.1093/eurheartj/eht550
The Year in Cardiology
The Year in Cardiology 2013: coronary intervention Raimund Erbel* and William Wijns Department of Cardiology, West-German Heart Center Essen, University Duisburg-Essen, Hufelandstr. 55, D-45122 Essen, Germany Received 13 November 2013; revised 26 November 2013; accepted 28 November 2013
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PCI † Intervention † Interventional cardiology † Coronary intervention
Appropriateness The year 2013 was rich of new developments in cardiology, and percutaneous coronary intervention (PCI) in particular, as summarized in this article.
Training for percutaneous coronary intervention, appropriateness, and indications Training Increasingly complex PCI procedures are performed in patients at higher risk with increasing impact of operator’s experience on clinical outcomes. In-hospital and up to 5-year safety outcomes of PCI undertaken either by trainees (working in a structured training environment) or by consultant operators were compared. Patients who have been treated by a consultant (n ¼ 7505) or a trainee (n ¼ 8502) had comparable in-hospital rates of stroke, emergency bypass surgery (CABG), and repeat PCI. The only independent outcome predictor for all-cause mortality was the clinical presentation of the patient himself.1 Use of a virtual catheterization laboratory reality simulator seems to offer a unique opportunity to complement training of young interventionalists by providing learning experience and feedback to the trainee that would otherwise require practice on patients.2
The appropriateness of indications of PCI has been challenged, particularly in the USA. Whereas only 1.1% of emergency procedures were regarded as inappropriate, up to 10-fold higher rates were reported for non-acute PCI.3 In addition to immediate technical success of PCI, the focus should be placed on long-term patient-oriented outcomes, quality metrics, and implementation of trial-based evidence.4
Indications Using the hyperaemic pressure-derived fractional flow reserve (FFR), the long-term outcomes of patients undergoing PCI with angiographic guidance only (n ¼ 6268) were compared with PCI with FFR guidance (n ¼ 1090) or deferred PCI (n ¼ 721). At 7 years, major adverse cardiac events (MACE) were 50% in patients with FFR-guided PCI, compared with 57% in patients treated with angiographic guidance (P ¼ 0.016). The defer strategy in patients with preserved FFR was independently associated with reduced rate of myocardial infarction (MI), hazard ratio (HR) 0.46, 95% confidence intervals (CI) 0.26– 0.82, P ¼ 0.008.5 The clinical impact of routine incorporation of FFR in real practice was tested in 5097 patients with death, MI, and repeat revascularization at 1 year as endpoints.6 With nearly half the stents implanted, primary endpoint (Figure 1) was significantly lower in patients treated after the routine use of FFR (FFR in 50.7% of all cases) vs. before (FFR in 1.9% of all cases): HR 0.55, CI 0.43–0.70 (P , 0.001). Implementation
The opinions expressed in this article are not necessarily those of the Editors of the European Heart Journal or of the European Society of Cardiology.
* Corresponding author. Tel: +49 2 01 723 4800, Fax: +49 2 01 723 5401, Email: [email protected] Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2014. For permissions please email: [email protected]
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The year 2013 was rich of new developments in cardiology, and percutaneous coronary intervention (PCI) in particular. This overview article will focus on contributions in the following areas: training for PCI, appropriateness and indications; access site selection, risk scores, peri-procedural myocardial infarction; trial results and long-term follow-up; PCI for specific patient and lesion subsets, including acute coronary syndrome and STsegment myocardial infarction; prevention of ischemic and reperfusion injury; stent thrombosis and new coronary stents and scaffolds.
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tional flow reserve in propensity-score matched patients. The primary endpoint of death from any causes, myocardial infarction, or any repeat revascularization (A); death from any causes (B); death from any causes or myocardial infarction (C); and any repeat revascularization (D). (Reprinted with kind permission from Reference 6, Eur Heart J 2013).
of FFR-based PCI strategies in daily practice is associated with improved clinical outcomes in both studies.5,6
Access site selection, risk scores, and peri-procedural myocardial infarction Access site selection The long-standing controversy on access site selection has evolved with an increasing worldwide use of the radial instead of the femoral approach, particularly following the presentation of the RIVAL trial.7 The benefit of radial access is to reduce bleeding complications, with some remaining concerns regarding prolonged fluoroscopy time. Radiation exposure, measured by median air kerma, was reduced with the femoral approach only in low volume radial centres, underlying the importance of proper training.8 Another potential advantage of radial access is the performance of PCI as an ambulatory procedure. Previously PCI without stenting was associated with high rates of (sub)acute coronary occlusion, requiring emergency angiography, followed by emergency repeat PCI or even CABG. Today predictability and stability of immediate PCI results allow same-day discharge in selected patients, already proposed by Kiemeneij et al.9 Consecutive patients (n ¼ 200) were discharged on the
same day without major bleeding or MACE at 24 h and at 7 days. Minor bleedings were noted in 4% of the patients, 2% were admitted to hospital, and only 1.5% had emergency revisits.10 The increasing use of radial access will provide an opportunity for further medical and economic evaluation of same-day PCI strategies.
Risk scores Multiple risk scores for the prediction of mortality after PCI have been validated and reviewed in ESC Practice Guideline recommendations.11 Most algorithms have identified the age, gender, cardiovascular risk factors, elevated creatinine, recent MI, and peripheral vascular disease as the strongest predictors of risk. The SYNTAX investigators calculated the 1-year risk for all cause death and MACE using the combination of SYNTAX score, age, ejection fraction, and creatinine clearance. The score provided excellent predictive accuracy12 and further enhanced the 5-year risk stratification either for PCI or CABG.13 Based on three angiographic and five clinical variables, this score provides an excellent tool for the heart team discussion in order to determine the optimal treatment strategy for each patient, from a personalized care perspective.
Peri-procedural myocardial infarction The Third Joint ESC/ACCF/AHA/WHF Task Force14 has issued new consensus definitions of peri-procedural MI (type 4a). The clinical significance of frequently observed peri-procedural elevations of
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Figure 1 Adjusted curves for the primary endpoint and selected secondary endpoint before and after the introduction of the routine use of frac-
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creatine kinase (CK), CK-MB, CK mass, and troponin continues to be evaluated. The frequency and predictive value of peri-PCI elevations of CK-MB mass was assessed from pooled analysis of individual data in 11 PCI studies. Mortality data at 1–5 years were prospectively collected in 23 604 patients showing peri-procedural MI in 7.1% (CI 6.8 –7.5%). The most common mechanism was side branch occlusion during PCI. Independent predictors of peri-procedural myonecrosis were old age, female gender, diabetes, hypertension, renal function, multivessel disease, left anterior descending coronary artery disease, left main disease, bifurcation lesions, long lesions, use of drug-eluting stent (DES), and the number of stents. After adjustment for baseline covariates, peri-procedural MI was associated with an increased risk of mortality at follow-up (HR 1.2; CI 1.04–1.39), calling for a systematic evaluation of pre- and post-PCI biomarker elevations.15
The final 5-year outcome results of SYNTAX trial have demonstrated better survival in patients with multivessel disease randomized to CABG implying that surgical revascularization should remain the standard of care for patients with complex lesions (high or intermediate SYNTAX scores). For less complex lesions (low SYNTAX score) or left main coronary disease (low or intermediate SYNTAX score), PCI is an acceptable alternative.16 Failure to prescribe aspirin after CABG or antiplatelet therapy after PCI were the strongest independent predictors of mortality in both surgery (HR 3.56, CI 2.04–6.21, P , 0.001) and PCI arm (HR 152.16, CI 53.57–432.22, P , 0.001).17 Long-term data after randomization for PCI, surgery, or medical treatment are rare. Of note, the 10-year follow-up results of the MASS II (Medical Angioplasty or Surgery Study) showed no difference between patients randomized to medical therapy, CABG, or PCI with respect to left ventricular ejection fraction, or its change between baseline and 10 years. This means that, in the absence of new MI, systolic ventricular function remained preserved after 10 years follow-up regardless of the initial therapeutic option,18 supporting the role for heart team decision making in patients with stable angina and complex coronary artery disease.11,19
Specific patient and lesion subsets Specific patient subsets Gender-related issues have become a topic of major interest in cardiology and other medical disciplines. A patient-level pooled analysis of 26 randomized trials involving 11 557 women looked at safety and efficiency of bare-metallic stent (BMS) and DES in women.20 At 3 years, the incidence of death and MI decreased dependent on the stent type from 12.8 to 10.9% and 9.2% comparing BMS to the first and newer DES generation (P ¼ 0.001). Definite or probable stent thrombosis occurred in 1.3, 2.1, and 1.1% women in the BMS, early-generation, new generation DES, respectively (P ¼ 0.01) combined with a significant reduction in TLR rates from 18.6 to 7.8%, and 6.3% (P , 0.0001). Newer generation DES should become the standard of care for PCI in women.
A major challenge in interventional cardiology is the percutaneous treatment of chronic total occlusions (CTO). Further to advanced techniques and novel equipment, improved results were shown in a meta-analysis of 18 061 patients from 65 studies demonstrating an overall angiographic success rate of 77% with low complication rates (MI 2.5%, coronary perforation 2.9%, cardiac tamponade 0.3%). Contrast-induced nephropathy occurred in 3.8%. Unsuccessful PCI in CTO had a higher mortality rate (1.5 vs. 0.4%, P , 0.0001).21
Percutaneous coronary intervention for acute coronary syndrome and STEMI While PCI for high-risk non-ST segment acute coronary syndrome (NSTE-ACS) and STEMI is recommended as a life-saving procedure, several recently reported trials are challenging current recommendations11,22 regarding important procedural strategies: the use of mechanical thrombus aspiration, deferred PCI of non-culprit stenosis in patients with multivessel disease, and the use of intra-aortic balloon pump (IABP) for haemodynamic support in patients with cardiogenic shock.
Thrombus aspiration In freshly occluded coronary vessels, the removal of thrombotic material and thrombus-related soluble substances prior to PCI was shown to reduce the thrombus burden, improve myocardial reperfusion, and provide clinical benefits.23 From prospectively collected data on 2567 consecutive STEMI patients treated with primary PCI and thrombectomy (mechanical thrombectomy in 42.7%) had a reduced in-hospital (4.5%) and longer-term (9.0%) mortality. Adjusted HR (after propensity weighing) was 0.43 (CI 0.19– 0.97, P ¼ 0.042).24 Reduction in long-term mortality was only significant when the total ischaemic time was ≤180 min. Of note, a detailed pilot randomized study using optical frequency domain imaging in primary PCI (141 patients) was not able to show differences between cases with and without thrombectomy in relation to minimal lumen area, plaque protrusion, intraluminal defects, complete and incomplete stent apposition.25 The TASTE study is the largest available randomized trial, nested in the SCAAR and SWEDEHEART nationwide registries, and involved 31 sites, all primary PCI centres in Sweden, 1 in Denmark and another in Iceland.26 The primary endpoint—all cause mortality—at 30 days was not different between 7244 patients randomized to either immediate PCI (n ¼ 3623) or manual thrombus aspiration plus PCI (n ¼ 3621): the HR was 0.94 (CI 0.72–1.22; P ¼ 0.63). The secondary endpoints mortality and re-MI rates at 30 days were 3.9 and 3.3%, respectively (P ¼ 0.23). Secondary endpoints of Re-MI (HR 0.61; CI 0.34–1.07) and stent thrombosis (HR 0.47; CI 0.20–1.02) were not significantly different, with low stent thrombosis rates at 1 month, 0.5 and 0.2%, respectively. None of the other variables showed an advantage of thrombus aspiration. At variance with results of prior smaller studies and meta-analyses, this large study shows no evidence of short-term mortality benefit for systematic thrombus aspiration prior to PCI for STEMI. Until longer
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follow-ups become available, TASTE challenges the level of the current recommendation to routinely perform mechanical thrombus aspiration prior to primary PCI. Pathophysiological studies have provided a better understanding of microvascular obstruction by embolization of debris and how it affects TIMI frame count and myocardial blush.27 Intramyocardial areas of microvascular obstruction, oedema, and haemorrhage can be identified using magnetic resonance imaging (Figure 2) by late gadolinium enhancement.28 Whether these sensitive metrics of reduced reperfusion injury will show advantage of prior thrombus aspiration over immediate primary PCI needs confirmation.29,30
Primary percutaneous coronary intervention and multivessel disease The recently presented PRAMI trial (Preventive Angioplasty in MI trial) involved 465 patients with multivessel disease who were
randomized 1:1 to PCI of the culprit stenosis only or to immediate PCI of all stenosis following successful primary PCI of the culprit occlusion.31 Primary endpoint of cardiac death, MI, or refractory angina with proven ischaemia was in favour of preventive angioplasty of non-culprit stenosis: 21 vs. 53% event rates, HR 0.35 (CI 0.21– 0.58; P , 0.001). There was no increased safety hazard, and increase in procedure duration and radiation exposure seems to be acceptable. Superiority of the more invasive approach remained highly significant with secondary combined endpoint of death and MI at 11 vs. 27%, respectively (HR 0.36, CI 0.18–0.73; P ¼ 0.004). Criteria that were used to identify suitable patients for inclusion in the trial as well as to identify which non-culprit lesions were suitable for immediate PCI need to be better understood before this approach can be generalized. These impressive results are calling for confirmation in a larger trial powered to confirm superiority of the ‘preventive’ angioplasty approach using a dual mortality and MI primary endpoint.
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Figure 2 Late gadolinium enhancement images (top row) compared with T2-weighed turbo-spinecho (T2w) images (bottom row) in one animal (1 and 2) and one PCI-treated STEMI patient (54-year-old male with anterior wall infarction). Cardiac magnetic resonance was performed 5 days after PCI. Late gadolinium enhancement imaging (3) shows microvascular obstruction (arrow), consistent with the hypo-intense area of haemorrhage on T2w-image (4). Intramyocardial haemorrhage and microvascular obstruction are very comparable in size and location and show a close relationship. (Reprinted with kind permission from Reference 28, Eur Heart J 2013).
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Balloon pump in cardiogenic shock The negative results of the trials testing the usefulness of intra-aortic balloon counterpulsation (IABP) for haemodynamic support in cardiogenic shock patients have surprised many physicians. Primary endpoint, mortality at 30 days, in the SHOCK-IABP trial was entirely neutral between patients presenting with STEMI and cardiogenic shock randomized 1:1 to best of care, with (n ¼ 301) or without (n ¼ 299) IABP. No evidence of benefit accrued up to 1 year. Mortality in cardiogenic shock patients remained very high at 52 and 51%, with and without IABP (relative risk 1.01). Quality of life metrics in survivors were good, yet superimposable between randomization groups. Outcomes following cardiogenic shock are dismal and IABP does not appear to sufficiently support the failing circulation. The unmet need remains and urges the evaluation of more powerful assist devices.32
Pre- and post-conditioning as well as remote ischaemic preconditioning strategies have suggested positive effects on endpoints based on biomarker release or magnetic resonance imaging. At variance, pharmacological approaches using adenosine, cariporide, nicorandil, PKC-delta inhibitors, erythropoietin, and cyclosporine A have showed mixed result.33 From a pooled analysis of 10 randomized trials, ischaemic post-conditioning reduced myocardial enzyme leaks and preserved left ventricular ejection fraction.34 Remote ischaemic conditioning was tested in 333 STEMI patients during transportation to the primary PCI centre.35 Conditioning entails intermittent arm ischaemia through four cycles of 5-min blood-pressure cuff inflation followed by 5-min deflation. At 3.8 years follow-up, the primary composite endpoint-all-cause mortality, MI, readmission for heart failure, and ischaemic stroke were 13.5% in patients with remote ischaemic conditioning and 25.6% in the control group (HR 0.49, CI 0.27– 0.89, P ¼ 0.018). Obviously, these results need to be confirmed in larger populations. When proven useful, such simple measures could be implemented during pre-hospitalcare through the emergence of increasingly efficacious and well-organized STEMI networks.
New-generation drug-eluting stents, stent thrombosis, and coronary scaffolds Drug-eluting stents Meanwhile coronary stent implantation using DES has become a default therapy during PCI, with an increasing number of approved DES becoming available, and few undergoing extensive trial-based evaluation in large study populations. Given the good results obtained with second-generation DES, recent trials are designed to test noninferiority, rather than superiority of the newer drug-polymer-device iteration.
Stent thrombosis A meta-analysis of four trials studied the clinical impact of extending dual antiplatelet therapy (DAPT) in 8231 randomized patients. The median DAPT time was 16.8 vs. 6.2 months for the control group. All-cause death, MI, stent thrombosis, or cardiovascular event rates were not reduced in the extended DAPT group.
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Prevention of ischaemic and reperfusion injury: role of pre- and post-conditioning
The TWENTE trial randomized patients 1:1 between zotarolimuseluting (ZES, Resolute) and everolimus-eluting stent (EES, Xience V). The primary endpoint was target vessel failure (TVF). At 1 year, the composite of cardiac death, TV-related MI, and clinically driven TV revascularization (TVR) reached 8.2% in the ZES and 8.1% in the EES arm, demonstrating non-inferiority.36 Meanwhile the 2-year results showed equal rates of TVF at 10.9 vs. 11.6% (P ¼ 0.65) and similar MACE rates.37 The Dutch PEERS study (TWENTE II) compared 1:1 the ZES (Resolute) with the EES (Promus Element platinum chromium DES) in 1811 all-comer patients (2371 lesions). The primary endpoint of TVF was a composite of safety (cardiac death or TV-related MI) and efficacy (TVR) at 12 months (with a noninferiority margin of 36%). The primary endpoint was met by 55 (6%) of 905 patients in the ZES and 47 (5%) of 905 in the EES stent group (absolute risk difference 0.88%, CI 21.24–3.01%; upper limit of one-sided 95% CI 2.69%; non-inferiority P ¼ 0.006).38 An additional multicentre study reported the 2-year results of a pooled analysis looking at ZES (Resolute) for in-stent restenosis. The restenosis rate was 12.7% compared with 4.3% (P ¼ 0.003) in patients with de novo stenosis. Cardiac death and TV-related MI did not differ significantly (6.9 vs. 6.1%).39 The final 5-year report for the LEADERS (Limus Eluted from A Durable vs. ERodable Stent coating) trial became available as well.40 Either a biodegradable polymer biolimus-eluting stent (BES) or a durable polymer sirolimus-eluting stent (SES, first generation Cypher, no longer available) was implanted in 2707 patients. Biolimus-eluting stent had a significant reduction of (very) late definite stent thrombosis from 1 to 5 years (0.6 vs. 2.2%, P ¼ 0.003). The risk reduction was 0.26 (CI 0.10–0.69, P ¼ 0.0034). Post-hoc comparison of cases with low and high SYNTAX scores showed similar reduction in definite stent thrombosis with BES. Biolimus-eluting stent (Nobori) and EES (Xience or Promus) were recently compared 2:1 in 2707 patients (4025 lesions). Cardiac death, non-fatal MI, and clinically indicated TVR at 12 months occurred in 93 (5.2%) patients in the BES group and 44 (4.8%) patients in the EES group (relative risk 1.07, CI 0.75– 1.52, P , 0.0001, non-inferiority).41 Similar findings were reported by the NEXT investigators, who randomized 3235 patients 1:1 to receive BES or EES.42 Given the limited availability of large direct comparative studies between each new DES, network meta-analysis has been proposed as an alternative evaluation method. A recent network analysis evaluating the relative merits of paclitaxel-eluting stent (PES), SES, EES, ZES, and BES identified EES and ZES as the devices with highest safety profile.43 Whether newer generation DES, especially when the drug is released from bioerodable polymers show clinical advantages over EES or ZES that use more biocompatible durable polymers than first-generation DES, especially in the long term, remains undecided.
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Drug-eluting coronary scaffolds The year 2013 has seen the emergence of clinical application of bioerodable coronary scaffolds, in particular with the use of the everolimus-eluting Absorb device (BVS).49 While results of randomized evaluations of this technology are pending, numerous case reports and small series reporting on the feasibility of BVS use in various lesions and patient subsets have been released, including PCI for (N)STEMI.50 – 52 Confidence in the clinical performance of BVS has grown following extensive analysis of limited observational series but involving sequential multimodality evaluations using angiography, intravascular ultrasound, optical coherence tomography imaging, coronary vasomotor testing, and multislice coronary computed tomography.53 In addition to this specific brand, other
bioerodable scaffolds may be entering the clinical scene.54,55 Because many announced that bioerodable scaffolds represent the future of coronary stenting, adoption of BVS by physicians and patients seems to have anticipated the available evidence, at least in areas with favourable regulatory environment. If the incremental value of bioerodable scaffolds over durable metallic stents stems primarily from their disappearance, clinically relevant benefit will only become apparent after long-term follow-up of large patient groups.
Conclusion This overview is necessarily subjective but demonstrates the vitality of the clinical research in the field of PCI, and stresses areas where further investigation remains very active. Significant advances in the synergy between novel antithrombotic drugs and coronary devices, especially in patients with ACS, were reported in 2013, but not discussed here. Disruptive innovative technologies continue to be developed, with potential changes in clinical treatment strategies ahead. It is expected that even stronger emphasis will be placed on life-saving indications of PCI in patients with NSTE-ACS or STEMI, optimization of adjunctive medical therapy as well on the costeffectiveness of PCI procedures in general. Conflict of interest: R.E.: Travel expenses from Biotronik paid directly to private account. W.W.: Institutional research grants from pharmaceutical (AstraZeneca, Therabel) and device (Abbott Vascular, Biosensors, Biotronik, Boston Scientific, Cordis, Medtronic, Orbus Neich, St Jude, Terumo, Tryton) companies; honoraria and fees on behalf of W.W. go to the Cardiovascular Research Center Aalst. Co-founder and stockholder of Argonauts, Genae Americas, and Cardio3BioSciences.
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However, extended DAPT increased the risk of major bleedings (HR 2.64, CI 1.1 –5.3, P ¼ 0.006).44 The PRODIGY (PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia study) trial studied the duration of DAPT (6–24 months) depending on type and potency of the implanted stent. In a randomized study, 2013 patients were treated with BMS, ZES, PES, or EES implantation. Patients receiving ZES showed a significantly higher rate of definite, probable, and possible stent thrombosis in the shorter DAPT group. No association was seen between stent potency for inhibition of intimal hyperplasia and greater vulnerability to shorter DAPT. The rate of death, MI, and cerebrovascular event were higher in the ZES group with longer DAPT therapy (HR 2.85, P ¼ 0.0018).45 In 3119 patients with stable coronary artery disease or low-risk ACS treated with ZES, 3 months of DAPT (clopidogrel plus aspirin) was non-inferior to 12 months for the composite of all-cause death, MI, stroke, or major bleeding, without significantly increasing the risk of stent thrombosis [6.0 vs. 5.8%, respectively; risk difference, 0.17 (95% CI, 21.52–1.86); P ¼ 0.002].46 A nation-wide retrospective cohort study of 29 268 patients was performed in Denmark in order to estimate the risk of stent thrombosis, when clopidogrel was discontinued after MI. All patients receiving clopidogrel after discharge from a first MI were included from 2004 to 2009.47 At 18 months follow-up, death and recurrent MI were observed in 3214 cases (11%). For those treated by PCI, the estimated incidence rate ratio of death or MI within the first 90 days following discontinuation was 1.59 (CI 1.11–2.30, P ¼ 0.013). There was no such risk in patients treated medically only. Thus, discontinuation of clopidogrel therapy 1 year after PCI for MI was associated with an increased risk of death of a recurrent MI during the first 90 days following clopidogrel interruption. The incidence and impact of DAPT cessation on adverse events following PCI was evaluated in the PARIS 5031-patients large real-world registry.48 The importance of the mode of cessation was evaluated, i.e. discontinuation (as recommended by the physician), interruption (a conscious decision guided by a physician), or disruption (patient stops because of bleeding or non-compliance). Rate of cessation of DAPT therapy was 2.9, 23.3, and 57.3% within 30 days, 1 year, and 2 years, respectively. Cardiac death, stent thrombosis, or MI were strongly associated with the mode of cessation with no increase risk in the case of discontinuation or interruption. Disruption, however, was associated with high risk of adverse events with significant HRs of 9.82 with DAPT cessation within 1 week, 2.98 with cessation within 30 days, and 1.71 beyond 30 days following PCI.
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