Curr Treat Options Cardio Med (2014) 16:301 DOI 10.1007/s11936-014-0301-x

Coronary Artery Disease (D Feldman, Section Editor)

Saphenous Vein Graft Interventions Emmanouil S. Brilakis, MD, PhD1,* Michael Lee, MD2 Julinda Mehilli, MD3 Konstantinos Marmagkiolis, MD4 Josep Rodes-Cabau, MD5 Rajesh Sachdeva, MD6 Anna Kotsia, MD1 George Christopoulos, MD1 Bavana V. Rangan, BDS, MPH1 Atif Mohammed, MD1 Subhash Banerjee, MD1 Address *,1VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas VA Medical Center (111A), 4500 South Lancaster Road, Dallas, TX 75216, USA Email: [email protected] 2 UCLA Medical Center, Los Angeles, CA, USA 3 Munich University Clinic, Campus Grosshadern and Innenstadt, Ludwig-Maximilian University, Munich, Germany 4 Citizens Memorial Hospital, Heart and Vascular Institute, Bolivar, MO, USA 5 Quebec Heart and Lung Institute, Quebec City, Quebec, Canada 6 Wellstar Cardiology, North Fulton Hospital, Roswell, GA, USA

Published online: 19 March 2014 * Springer Science+Business Media New York (outside the USA) 2014

This article is part of the Topical Collection on Coronary Artery Disease Keywords Percutaneous coronary intervention Internal mammary artery

I

Saphenous vein grafts

I

Outcomes

I

Drug eluting stent

I

Opinion statement Saphenous vein graft (SVG) percutaneous coronary intervention (PCI) currently accounts for approximately 6 % of all PCIs and is associated with increased risk for distal embolization and subsequent SVG failure compared with native coronary artery PCI. To minimize the risk for distal embolization, embolic protection devices should be used during SVG PCI when technically feasible. To minimize the risk for in-stent restenosis and the need for repeat PCI, drug eluting stents should be utilized in patients without contraindications to long-term antiplatelet therapy. Treating native coronary artery lesions is preferable to SVG PCI when technically feasible.

301, Page 2 of 12

Curr Treat Options Cardio Med (2014) 16:301

Introduction Saphenous vein grafts (SVGs) have high rates of failure, with up to 50 % of SVGs becoming occluded by 1 year after coronary artery bypass graft surgery (CABG) [1–3]. Moreover, the rate of SVG failure is accelerating with increasing time post-CABG [4, 5]. SVG percutaneous coronary interventions (PCIs) currently represent approximately 6.0 % of all PCI in the United States [4, 6]. SVG PCI can be challenging because of high rates of distal embolization and instent restenosis. In the present review, we will review the current status of SVG PCI and discuss strategies for optimizing acute and long-term outcomes.

Indications for SVG PCI Three treatment strategies are available for patients who present with SVG failure: medical therapy, PCI, and repeat CABG. Redo CABG is currently reserved for patients with multiconduit failure, good CABG target vessels, availability of vein grafts, and failed PCI of the native vessels. It is infrequently performed because it carries significantly increased risk (for in-hospital mortality, myocardial infarction, and prolonged ventilation) [7, 8]. Hence, the perioperative risk of redo CABG may obviate the potential benefits associated with complete coronary revascularization [9]. Redo CABG could also lead to injury of patent grafts, which is especially concerning for internal mammary grafts (IMAs). In the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) trial the risk for subsequent clinical events was similar after redo CABG and after PCI [10]. The 2011 American College of Cardiology/American Heart Association (ACC/AHA) PCI guidelines suggest the following factors to support redo CABG: vessels unsuitable for PCI, number of diseased bypass grafts, availability of the IMA for grafting chronically occluded coronary arteries, and good distal targets for bypass graft placement [11]. Factors favoring PCI over CABG include limited areas of ischemia causing symptoms, suitable PCI targets, a patent graft to the left anterior descending artery, poor CABG targets, and comorbid conditions [11]. PCI or medical therapy is, therefore, the main treatment modality for patients presenting with SVG lesions. If feasible, native coronary artery PCI is preferred over SVG PCI supplying the same territory, because of better short- [4] and long- [12–14] term

outcomes, especially in diffusely diseased and degenerated SVGs. However, some native coronary arteries supplied by a failing SVG may be chronically occluded, which may pose challenges to revascularization, as success rates of chronic total occlusion (CTO) PCI is lower among patients with prior CABG [15]. Use of a SVG as a retrograde conduit to the native vessel may facilitate revascularization [16]. Overall CTO PCI was attempted in 5.44 % of prior CABG patients included in the National Cardiovascular Data Registry (NCDR) [4].

Distal embolization and embolic protection devices Distal embolization is of particular importance for SVG PCI because SVG lesions are often friable. Distal embolization can present clinically with no reflow and acute ST-segment elevation or as asymptomatic cardiac biomarker elevation. CK-MB elevation post SVG PCI (especially if 95× upper limit of normal) has been associated with increased mortality [17], highlighting the importance of prevention and prompt treatment if distal embolization occurs. The only proven strategy for preventing distal embolization during SVG PCI is the use of an embolic protection device (EPD). These devices are designed to capture debris liberated during PCI before they enter the coronary microcirculation causing injury. Three EPDs are currently available in the US, the Filterwire, (Boston Scientific Natick MA), the Spider (ev3, Plymouth, MN) and the Guardwire (Medtronic Vascular, Santa Rosa, CA). A proximal occlusion device (Proxis, St Jude, Minneapolis, MN) was previously available, but production was discontinued in 2012. The first two devices are filters that capture debris, whereas the Guardwire is a 0.014’ guidewire with a distal balloon that when inflated stops antegrade flow; after completion of PCI any column of blood within the SVG is aspirated with a thrombectomy catheter before restoring antegrade flow. The Guardwire allows for “complete” protection (ie, capture of all released particles and humoral factors) in contrast to filters that only capture larger size particles. However, the Guardwire can be cumbersome to use and blood flow cessation may be poorly tolerated by some patients, especially those in whom the SVG supplies a large area of myocardium. The study that established the utility of EPDs in SVG PCI was the Saphenous vein graft Angioplasty Free of Emboli Randomized (SAFER) trial [18••], in

Curr Treat Options Cardio Med (2014) 16:301 which the primary endpoint (composite of death, myocardial infarction, emergency bypass, or target lesion revascularization by 30 days) occurred in 65 patients (16.5 %) assigned to control vs 39 patients (9.6 %) assigned to the Guardwire (P = 0.004). This 42 % relative reduction in the primary endpoint was driven by a reduction in the incidence of myocardial infarction (8.6 % vs 14.7 %, P = 0.008). No-reflow was also less common in the EPD group (3 % vs 9 %, P=0.02). Subsequent studies used a non-inferiority design to compare one EPD vs another (Table 1) [19–23]. The choice of EPD is based on several factors, such as SVG lesion location, device availability, local expertise in EPD use, and the potential hemodynamic consequences of SVG flow cessation. SVG body lesions can be protected by either a filter or

Page 3 of 12, 301 the Guardwire. Ostial SVG lesions should only be protected with a filter because the Guardwire could result in debris embolization in the aorta. Use of EPDs for ostial SVG lesions is poorly studied because ostial lesions were excluded from the pivotal SVG PCI trials. Abdel-Karim et al reported high success rates with EPD use in ostial lesions, however, difficulty with filter retrieval poststenting was encountered in 11 % of the lesions and led to stent thrombosis causing cardiac arrest in 1 % [24•]. Distal anastomotic lesions cannot be protected with any of the currently available EPDs. Most SVG lesions are located in SVG body (58.4 %), with 22.1 % of the lesions located in the proximal and 19.0 % in the distal anastomosis [6]. Routine use of EPDs in SVG in-restenotic lesions is not needed because such lesions are com-

Table 1. Trials of embolic protection devices in SVG PCI Author

Year n

Primary endpoint

EPD vs no EPD SAFER [18••]

2002 801 30-day composite of death, MI, emergency CABG, or TLR

One EPD vs another EPD FIRE [19] 2003 651 30-day composite of death, MI, or TVR SPIDER 2005 732 30-day composite of death, MI, urgent CABG, or TVR PRIDE [20] CAPTIVE [21] PROXIMAL [22]

AMETHYST [23]

2005 631 30-day composite of cardiac death, MI, or TLR 2006 652 30-day composite of death, or TVR 2007 594 30-day composite of death, MI, or TVR 2008 797 30-day composite of death, MI, or urgent repeat revascularization

P superiority

EPD event rate (%) (Guardwire) 9.6

Control group event rate (%) 16.5

Test EPD event rate (%) (Filterwire) 9.9

Control EPD P non-inferievent rate (%) ority (Guardwire) 11.6 % 0.0008

(Spider) 9.1

(Guardwire 24 % or 0.012 Filterwire 76 %) 8.4 (Filterwire) 10.1 % 0.02

(Triactiv) 11.2 % (Cardioshield) 11.4 % (Proxis) 9.2 %

(Interceptor Plus) 8.0 %

(Guardwire) 9.1 % (Guardwire Filterwire 10.0 % (Guardwire Filterwire 7.3 %

0.004

0.057

19 % or 0.006 81 %) 72 % or 0.025 18 %)

AMETHYST Assessment of the Medtronic AVE Interceptor Saphenous Vein Graft Filter System, CABG coronary artery bypass graft surgery, CAPTIVE CardioShield Application Protects during Transluminal Intervention of Vein grafts by reducing Emboli, EPD embolic protection device, FIRE FilterWire EX Randomized Evaluation, MI myocardial infarction, PRIDE Protection During Saphenous Vein Graft Intervention to Prevent Distal Embolization, PROXIMAL Proximal Protection During Saphenous Vein Graft Intervention, SAFER Saphenous vein graft Angioplasty Free of Emboli Randomized, SPIDER Saphenous Vein Graft Protection In a Distal Embolic Protection Randomized Trial, TLR target lesion revascularization, TVR target vessel revascularization. Guardwire; Medtronic Vascular, Santa Rosa, CA; Filterwire; Boston Scientific, Natick, MA; SPIDER; ev3, Plymouth, MN; Triactive, Kensey Nash Corp., Exton, PA; Cardioshield, MedNova, Galway; Proxis, St Jude Medical, Minneapolis, MN; Interceptor Plus; Medtronic Vascular, Santa Rosa, CA.

301, Page 4 of 12

Curr Treat Options Cardio Med (2014) 16:301

Table 2. Trials of SVG lesion stenting Study

Year

BMS vs balloon angioplasty SAVED [39] 1997 Venestent [40]

2003

BMS vs covered stents RECOVERS [41] 2003 STING [42]

2003

SYMBIOT III [43] 2006 BARRICADE [44] BMS vs. DES RRISC

SOS

ISAR-CABG [49••]

2011

n

220 6-month angiographic restenosis 150 6-month angiographic restenosis 301 6-month angiographic restenosis 211 6-month angiographic restenosis 700 8-month angiographic percent diameter stenosis 243 8-month angiographic restenosis

2006 (45) 75 2007 (46) 2009 (47) 80 2010 (48) 2011

Primary endpoint

6-month restenosis MACE at 32 months

12-month angiographic restenosis 80 Target vessel failure at 35 months 610 12-month composite of death, MI, and TLR

Bare metal stent event rate (%)

Other group event rate (%)

P

37

46

0.24

19.1

32.8

0.069

24.8

24.2

0.237

20

29

0.15

30.9

31.9

0.80

28.4

31.8

0.63

32.6 41

13.6 58

0.031 0.13

51

9

G0.001

72

34

0.001

22

15

0.02

BARRICADE Barrier Approach to Restenosis: Restrict Intima to Curtail Adverse Events Trial, BMS bare metal stent, DES drug-eluting stent, ISAR-CABG Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts Trial, MACE major adverse cardiac events, MI myocardial infarction, RECOVERS European multicenter Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts Trial, RRISC Reduction of Restenosis In Saphenous vein grafts with Cypher™ sirolimus-eluting stent Trial, TLR target lesion revascularization, SAVED Saphenous Vein De Novo Trial, SOS Stenting Of Saphenous vein grafts Trial, STING Stents IN Grafts Trial, SYMBIOT III A Prospective, Randomized Trial of a Self-Expanding PTFE Stent Graft During SVG Intervention.

monly due to neointimal proliferation, making distal embolization unlikely [25]. According to the 2011 ACC/AHA PCI guidelines “EPDs should be used during SVG PCI when technically feasible” (class I indication, level of evidence B) [11]. However, EPDs were only used in 23 % of SVG PCI between 2004 and 2009 in the NCDR registry [26], whereas some studies suggest that up to 77 % of SVG lesions are eligible [27]. There are various potential explanations for EPD underutilization. First, the study demonstrating the efficacy of protection devices in SVG lesions, (the SAFER trial) was performed before the era of potent ADP P2Y12-receptor inhibitors. In the ISAR-CABG trial all patients were

pretreated with 600 mg clopidogrel before PCI and, despite very infrequent EPD use (in G1 % of SVG PCIs), the incidence of myocardial infarction was 6 %. This is substantially lower than the incidence of myocardial infarction reported in the control EPD arm of the SAFER trial (14.7 % and 8.6 %, respectively). With the use of more potent P2Y12 receptor inhibitors such as prasugrel and ticagrelor, even better results are expected [28]. Thus, a new randomized trial to evaluate the efficacy of EPDs in degenerated SVG would require a very large sample size to achieve a measurable benefit. In addition lack of reimbursement and technical challenges associated with EPDs may limit their use [29]: for example no

Curr Treat Options Cardio Med (2014) 16:301 EPDs are currently available for distal anastomotic lesions, and many operators are not comfortable using EPDs. EPD use can also be associated with complications, such as device entrapment [30] and acute vessel occlusion [24•]. Alternative but unproven strategies to reduce distal embolization (or obviate its adverse consequences) include intragraft vasodilator administration (such as adenosine [31], nitroprusside [32], nicardipine [33], and verapamil [34] and implantation of slightly un-

Page 5 of 12, 301 dersized stents [35], which did not appear to be associated with worse clinical outcomes (such as increased in-stent restenosis) during 12 months of follow-up [35]. Direct stenting may be associated with less distal embolization in SVGs compared with a strategy of predilation followed by stenting [36]. Newer micromesh-coated stents are currently being developed in an effort to prevent distal embolization but have undergone limited clinical evaluation [37, 38].

SVG stenting Stent selection for SVG PCI has substantially evolved over the years, with bare metal stents (BMS) shown to superior to balloon angioplasty alone [39] and drug-eluting stents (DES) shown to be superior to BMS in most studies (Table 2). DES are currently preferred for SVG PCI and have been evaluated in three randomized-controlled clinical trials (Table 2) [39–45, 46•, 47, 48•, 49••]. The first DES study in SVGs was the Reduction of Restenosis In Saphenous vein grafts with Cypher Sirolimus-Eluting Stent Trial (RRISC), which compared the sirolimus-eluting stent (SES, Cypher; Cordis, Warren, NJ) with a BMS in 75 patients and reported less angiographic restenosis and target lesion revascularization at 6 months [45, 46•]. However, during longer followup the SES group had higher mortality (29 % vs 0 %, P=.001), whereas target vessel revascularization was similar in both groups [46•]. Most patients died because of non-cardiac causes or cardiac causes unrelated to the target SVG. The second study was the Stenting Of Saphenous Vein Grafts trial (SOS) trial that compared a paclitaxel-eluting stent (PES, Taxus; Boston Scientific, Natick, MA) to a similar BMS in 80 patients, showing less angiographic restenosis and lower incidence of clinical events (both repeat revascularization and myocardial infarction) with PES [47, 48•]. The largest trial that was powered for a clinical endpoint was the “Is DrugEluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts?” (ISAR-CABG) study that randomized 610 patients to a first generation DES (SES, PES, or sirolimus-eluting ISAR stent) or a BMS. At 12 months, DES use was associated with significantly lower incidence of target lesion revascularization (7 % vs 13 %, P=0.01) compared with BMS, with similar incidence of all-cause death (5 % vs 5 %, P=0.83), myocardial infarction (5 % vs 6 %, P=0.27) and definite of probable stent thrombosis (1 % vs 1 %, P= 0.99) [49••]. Based on the above studies, the 2011 ACC/AHA PCI guidelines state that “DES are generally preferred over BMS” in SVG lesions [11]. Whether second generation DES further improve outcomes compared with first generation DES remains controversial. In a pilot prospective study, use of the secondgeneration everolimus-eluting stent was associated with high rates of stent strut coverage but also high malapposition rates at 12 months postimplantation [50]. Two retrospective studies had conflicting results, with one showing better (less target vessel revascularization) [51] and one showing similar [52]

301, Page 6 of 12

Curr Treat Options Cardio Med (2014) 16:301 outcomes with second generation DES. On the other hand, all-comer trials comparing the first and second generation “limus”-eluting stents suggest a higher efficacy and safety with second generation DES, with 50 % reduction of the risk of late stent thrombosis with everolimus-eluting stent compared with other DES or BMS platforms [53– 55]. Total occlusion of a SVG is often silent without typical symptoms of acute coronary syndrome. In the ISAR-CABG trial, repeat follow-up angiography was performed in 72 % of the study population. The incidence of total occlusion of treated SVG was 6 % with DES and 12 % with BMS within the first year after PCI [49••]. It is difficult to differentiate between an occlusive restenosis (which is highly probable) progression of atherosclerosis within the SVG or a thrombotic occlusion of the SVG. However, the newer generation DES have the potential to reduce this complication.

Adjunctive pharmacotherapy Unfractionated heparin and bivalirudin can be used for anticoagulation during SVG PCI. Glycoprotein IIb/IIIa inhibitors are not beneficial [56•] and may be harmful [57] in SVG PCI, as reflected in the 2011 American Heart Association (AHA)/American College of Cardiology (ACC) PCI guidelines: “platelet GP IIb/IIIa inhibitors are not beneficial as adjunctive therapy during SVG PCI” (Class III, level of evidence B) [11]. In spite of this recommendation glycoprotein IIb/IIIa inhibitors were used in 40 % of SVG PCI in the US in the NCDR) between 2004 and 2009 [26]. Twelve months of antiplatelet therapy remains the standard of care after DES implantation in SVGs [58]. One study demonstrated high rates of death or myocardial infarction after clopidogrel discontinuation at 12 months after SVG PCI [59], suggesting that prolonged dual antiplatelet therapy might have some advantages in these patients. Optimizing the overall medical regimen and aggressively controlling coronary artery disease risk factors remains of paramount importance, given the high risk profile and poor risk factor control of patients undergoing SVG PCI [60].

Technical aspects of SVG PCI Intravascular imaging Intravascular imaging can be of great benefit in SVG PCI, especially when treating large SVGs, in which stent size selection can be challenging. Intravascular imaging can assist with selecting stent size and also the need for pretreatment, for example in SVGs containing thrombus [61•]. Stent undersizing could result in stent deformation upon advancement of equipment through the stent [62], however, in large, heavily diseased conduits slight undersizing and avoiding postdilation may prevent distal embolization [35].

SVG engagement Identifying and engaging the SVGs in each patient can be challenging, especially when the CABG anatomy is unknown [63]. SVG engagement is significantly easier when graft markers are present, yet such markers are very

Curr Treat Options Cardio Med (2014) 16:301

Page 7 of 12, 301

infrequently inserted at the time of CABG, in part because of concerns on their effect on SVG patency [64]. SVG engagement appears to be easier using femoral compared to radial access [65•] and can be significantly facilitated by guide catheter extensions [66•]. However, SVG PCI via radial access may also be associated with lower risk for vascular access complications and shorter duration of hospital stay [67]. In extremely challenging cases, retrograde SVG wiring could serve as a “last resort” technique for identifying the ostium and cannulating unusual aortocoronary bypass grafts [68].

Acutely occluded SVGs Acutely occluded SVGs often have a large amount of thrombus and even when they are successfully recanalized recurrent SVG failure is very common [69]. Combined use of thrombectomy and embolic protection devices may be the most effective strategy for treating such lesions [70] and laser also appears promising as an adjunctive modality [71]. Alternatively PCI can be performed with an undersized balloon restoring Thrombolysis In Myocardial Infarction (TIMI) 1-2 flow followed by anticoagulation for 1–2 weeks and the definite treatment with stent implantation [72]. Native coronary PCI, if feasible, may be preferred in such cases, but can also be challenging [16].

Chronically occluded SVGs PCI of SVG CTOs is associated with low success and high restenosis rates [73, 74] and as a result carries a class III recommendation (level of evidence C) in the 2011 PCI guidelines [11]. Similar to acutely occluded SVGs, native vessel PCI is preferred to PCI of SVG CTOs, but when such procedures are not feasible PCI of a SVG CTO remains a treatment option [75].

Intermediate SVG lesions SVG intermediate lesions can progress rapidly into significant lesions, often presenting with an acute coronary syndrome [76–78]. As a result fractional flow reserve (FFR) has limited role in intermediate SVG lesions, although it does appear to correlate with ischemia in small pilot study [79]. The Moderate VEin Graft LEsion Stenting With the Taxus Stent and Intravascular Ultrasound (VELETI) Pilot Trial demonstrated a lower rate of SVG disease progression and a trend toward a lower incidence of major adverse cardiac events at 1-year follow-up with intermediate SVG lesion stenting using PES compared with medical treatment alone [80••]. Another ongoing trial [VELETI II] is examining the role of prophylactic stenting of intermediate SVG lesions in a larger patient population using a clinical (rather than angiographic/intravascular ultrasonography) primary endpoint.

SVG PCI complications SVG perforation is a rare, but potentially catastrophic complication of SVG PCI. Although prior CABG patients have pericardial adhesions tamponade is still possible in case of perforation and can lead to rapid hemodynamic deterioration and death [81]. Moreover, perforated SVGs have very high subsequent occlusion rates [81].

301, Page 8 of 12

Curr Treat Options Cardio Med (2014) 16:301

Compliance with Ethics Guidelines Conflict of Interest Dr. Emmanouil S. Brilakis received research support from the department of Veterans Affairs (PI of the Drug Eluting Stents in Saphenous Vein Graft Angioplasty – DIVA trial and Merit grant – I01-CX00078701) and from the National Institutes of Health (1R01HL102442-01A1); consulting fees/speaker honoraria from St Jude Medical, Boston Scientific, Asahi, Janssen, Sanofi, and Terumo; research support from Guerbet; spouse is an employee of Medtronic. Dr. Michael Lee received honoraria from Medtronic, Boston Scientific, Abiomed, and St. Jude Medical. Dr. Julinda Mehilli received lecture fees from Lilly/Daiichi Sankyo, Abbott Vascular, Terumo, The Medicines Company, and Biotronik. Dr. Josep Rodes-Cabau received an unrestricted research grant from Boston Scientific. Dr. Subhash Banerjee received research support from the department of Veterans Affairs (PI of the—Plaque Regression and Progenitor Cell Mobilization with Intensive Lipid Elimination Regimen (PREMIER)) trial. Speaker honoraria from St. Jude Medical, Medtronic, and Johnson & Johnson, Boehinger, Sanofi, Mdcare Global; research support from Boston Scientific and The Medicines Company. Dr. Konstantinos Marmagkiolis, Dr. Rajesh Sachdeva, Dr. Anna Kotsia, Dr. George Christopoulos, Dr. Bavana V. Rangan, and Dr. Atif Mohammed each declare no potential conflicts of interest relevant to this article. Human and Animal Rights and Informed Consent This article does not contain any studies with human or animal subjects performed by any of the authors.

References and Recommended Reading Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance 1.

2.

3.

4.

Widimsky P, Straka Z, Stros P, et al. One-year coronary bypass graft patency: a randomized comparison between off-pump and on-pump surgery angiographic results of the PRAGUE-4 trial. Circulation. 2004;110:3418–23. Alexander JH, Hafley G, Harrington RA, et al. Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA. 2005;294:2446–54. Morice MC, Feldman TE, Mack MJ, et al. Angiographic outcomes following stenting or coronary artery bypass surgery of the left main coronary artery: fifteen-month outcomes from the synergy between PCI with TAXUS express and cardiac surgery left main angiographic substudy (SYNTAXLE MANS). EuroIntervention. 2011;7:670–9. Brilakis ES, Rao SV, Banerjee S, et al. Percutaneous coronary intervention in native arteries versus bypass grafts in prior coronary artery bypass grafting patients a report from the national cardiovascular

5.

6.

7.

8.

data registry. JACC Cardiovasc Interv. 2011;4:844– 50. Goldman S, Zadina K, Moritz T, et al. Long-term patency of saphenous vein and left internal mammary artery grafts after coronary artery bypass surgery. Results from a Department of Veterans Affairs Cooperative Study. J Am Coll Cardiol. 2004;44:2149–56. Dehmer GJ, Weaver D, Roe MT, et al. A contemporary view of diagnostic cardiac catheterization and percutaneous coronary intervention in the United States: a report from the CathPCI Registry of the National Cardiovascular Data Registry, 2010 through June 2011. J Am Coll Cardiol. 2012;60:2017–31. Yau TM, Borger MA, Weisel RD, Ivanov J. The changing pattern of reoperative coronary surgery: trends in 1230 consecutive reoperations. J Thorac Cardiovasc Surg. 2000;120:156–63. Yap CH, Sposato L, Akowuah E, et al. Contemporary results show repeat coronary artery bypass grafting remains a risk factor for operative mortality. Ann Thorac Surg. 2009;87:1386–91.

Curr Treat Options Cardio Med (2014) 16:301 9.

Garcia S, Sandoval Y, Roukoz H, et al. Outcomes after complete versus incomplete revascularization of patients with multivessel coronary artery disease: a meta-analysis of 89,883 patients enrolled in randomized clinical trials and observational studies. J Am Coll Cardiol. 2013;62:1421–31. 10. Morrison DA, Sethi G, Sacks J, et al. Percutaneous coronary intervention versus repeat bypass surgery for patients with medically refractory myocardial ischemia: AWESOME randomized trial and registry experience with post-CABG patients. J Am Coll Cardiol. 2002;40:1951–4. 11. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011;58:e44–122. 12. Varghese I, Samuel J, Banerjee S, Brilakis ES. Comparison of percutaneous coronary intervention in native coronary arteries vs bypass grafts in patients with prior coronary artery bypass graft surgery. Cardiovasc Revasc Med. 2009;10:103–9. 13. Bundhoo SS, Kalla M, Anantharaman R, et al. Outcomes following PCI in patients with previous CABG: a multicenter experience. Catheter Cardiovasc Interv. 2011;78:169–76. 14. Xanthopoulou I, Davlouros P, Tsigkas G, Panagiotou A, Hahalis G, Alexopoulos D. Long-term clinical outcome after percutaneous coronary intervention in grafts vs native vessels in patients with previous coronary artery bypass grafting. Can J Cardiol. 2011;27:716–24. 15. Michael TT, Karmpaliotis D, Brilakis ES, et al. Impact of prior coronary artery bypass graft surgery on chronic total occlusion revascularisation: insights from a multicentre US registry. Heart. 2013;99:1515–8. 16. Brilakis ES, Banerjee S, Lombardi WL. Retrograde recanalization of native coronary artery chronic occlusions via acutely occluded vein grafts. Catheter Cardiovasc Interv. 2010;75:109–13. 17. Hong MK, Mehran R, Dangas G, et al. Creatine kinase-MB enzyme elevation following successful saphenous vein graft intervention is associated with late mortality. Circulation. 1999;100:2400–5. 18.•• Baim DS, Wahr D, George B, et al. Randomized trial of a distal embolic protection device during percutaneous intervention of saphenous vein aorto-coronary bypass grafts. Circulation. 2002;105:1285–90. First (and only) randomized-controlled trial showing benefit with use of embolic protection devices in SVG lesions 19. Stone GW, Rogers C, Hermiller J, et al. Randomized comparison of distal protection with a filter-based catheter and a balloon occlusion and aspiration system during percutaneous intervention of diseased

Page 9 of 12, 301 saphenous vein aorto-coronary bypass grafts. Circulation. 2003;108:548–53. 20. Carrozza Jr JP, Mumma M, Breall JA, Fernandez A, Heyman E, Metzger C. Randomized evaluation of the TriActiv balloon-protection flush and extraction system for the treatment of saphenous vein graft disease. J Am Coll Cardiol. 2005;46:1677–83. 21. Holmes DR, Coolong A, O’Shaughnessy C, et al. Comparison of the CardioShield filter with the guardwire balloon in the prevention of embolisation during vein graft intervention: results from the CAPTIVE randomised trial. EuroIntervention. 2006;2:161–8. 22. Mauri L, Cox D, Hermiller J, et al. The PROXIMAL trial: proximal protection during saphenous vein graft intervention using the Proxis Embolic Protection System: a randomized, prospective, multicenter clinical trial. J Am Coll Cardiol. 2007;50:1442–9. 23. Kereiakes DJ, Turco MA, Breall J, et al. A novel filterbased distal embolic protection device for percutaneous intervention of saphenous vein graft lesions: results of the AMEthyst randomized controlled trial. JACC Cardiovasc Interv. 2008;1:248–57. 24.• Abdel-Karim AR, Papayannis AC, Mahmood A, et al. Role of embolic protection devices in ostial saphenous vein graft lesions. Catheter Cardiovasc Interv. 2012;80:1120–6. Only study examining use of EPDs in ostial SVG lesions 25. Ashby DT, Dangas G, Aymong EA, et al. Effect of percutaneous coronary interventions for in-stent restenosis in degenerated saphenous vein grafts without distal embolic protection. J Am Coll Cardiol. 2003;41:749–52. 26. Brilakis ES, Wang TY, Rao SV, et al. Frequency and predictors of drug-eluting stent use in saphenous vein bypass graft percutaneous coronary interventions: a report from the American College of Cardiology National Cardiovascular Data CathPCI registry. JACC Cardiovasc Interv. 2010;3:1068–73. 27. Webb LA, Dixon SR, Safian RD, O’Neill WW. Usefulness of embolic protection devices during saphenous vein graft intervention in a nonselected population. J Interv Cardiol. 2005;18:73–5. 28. Brilakis ES, Held C, Meier B, et al. Effect of ticagrelor on the outcomes of patients with prior coronary artery bypass graft surgery: insights from the platelet inhibition and patient outcomes (PLATO) trial. Am Heart J. 2013;166:474–80. 29. Mahmood A, Khair T, Abdel-Karim AR, et al. Contemporary approaches to saphenous vein graft interventions: a survey of 275 interventional cardiologists. Catheter Cardiovasc Interv. 2012;79:834–42. 30. Badhey N, Lichtenwalter C, de Lemos JA, et al. Contemporary use of embolic protection devices in

301, Page 10 of 12

31.

32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

saphenous vein graft interventions: insights from the stenting of saphenous vein grafts trial. Catheter Cardiovasc Interv. 2010;76:263–9. Sdringola S, Assali A, Ghani M, et al. Adenosine use during aortocoronary vein graft interventions reverses but does not prevent the slow-no reflow phenomenon. Catheter Cardiovasc Interv. 2000;51:394–9. Zoghbi GJ, Goyal M, Hage F, et al. Pretreatment with nitroprusside for microcirculatory protection in saphenous vein graft interventions. J Invasive Cardiol. 2009;21:34–9. Fischell TA, Subraya RG, Ashraf K, Perry B, Haller S. “Pharmacologic” distal protection using prophylactic, intragraft nicardipine to prevent no-reflow and non-Q-wave myocardial infarction during elective saphenous vein graft intervention. J Invasive Cardiol. 2007;19:58–62. Michaels AD, Appleby M, Otten MH, et al. Pretreatment with intragraft verapamil prior to percutaneous coronary intervention of saphenous vein graft lesions: results of the randomized, controlled vasodilator prevention on no-reflow (VAPOR) trial. J Invasive Cardiol. 2002;14:299–302. Hong YJ, Pichard AD, Mintz GS, et al. Outcome of undersized drug-eluting stents for percutaneous coronary intervention of saphenous vein graft lesions. Am J Cardiol. 2010;105:179–85. Okabe T, Lindsay J, Torguson R, et al. Can direct stenting in selected saphenous vein graft lesions be considered an alternative to percutaneous intervention with a distal protection device? Catheter Cardiovasc Interv. 2008;72:799–803. Maia F, Costa Jr JR, Abizaid A, et al. Preliminary results of the INSPIRE trial with the novel MGuard stent system containing a protection net to prevent distal embolization. Catheter Cardiovasc Interv. 2010;76:86–92. Abizaid A, Weiner B, Bailey SR, Londero H. Use of a self-expanding super-elastic all-metal endoprosthesis; to treat degenerated SVG lesions: the SESAME first in man trial. Catheter Cardiovasc Interv. 2010;76:781–6. Savage MP, Douglas Jr JS, Fischman DL, et al. Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts. Saphenous Vein De Novo Trial Investigators. N Engl J Med. 1997;337:740–7. Hanekamp CE, Koolen JJ, Den Heijer P, et al. Randomized study to compare balloon angioplasty and elective stent implantation in venous bypass grafts: the Venestent study. Catheter Cardiovasc Interv. 2003;60:452–7. Stankovic G, Colombo A, Presbitero P, et al. Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: the Randomized Evaluation of polytetrafluoroethylene COVERed

Curr Treat Options Cardio Med (2014) 16:301 stent in Saphenous vein grafts (RECOVERS) Trial. Circulation. 2003;108:37–42. 42. Schachinger V, Hamm CW, Munzel T, et al. A randomized trial of polytetrafluoroethylene-membranecovered stents compared with conventional stents in aortocoronary saphenous vein grafts. J Am Coll Cardiol. 2003;42:1360–9. 43. Turco MA, Buchbinder M, Popma JJ, et al. Pivotal, randomized U.S. study of the Symbiottrade mark covered stent system in patients with saphenous vein graft disease: eight-month angiographic and clinical results from the Symbiot III trial. Catheter Cardiovasc Interv. 2006;68:379–88. 44. Stone GW, Goldberg S, O’Shaughnessy C, et al. 5year follow-up of polytetrafluoroethylene-covered stents compared with bare-metal stents in aortocoronary saphenous vein grafts the randomized BARRICADE (barrier approach to restenosis: restrict intima to curtail adverse events) trial. JACC Cardiovasc Interv. 2011;4:300–9. 45. Vermeersch P, Agostoni P, Verheye S, et al. Randomized double-blind comparison of sirolimuseluting stent versus bare-metal stent implantation in diseased saphenous vein grafts: six-month angiographic, intravascular ultrasound, and clinical follow-up of the RRISC Trial. J Am Coll Cardiol. 2006;48:2423–31. 46.• Vermeersch P, Agostoni P, Verheye S, et al. Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC Trial. J Am Coll Cardiol. 2007;50:261–7. First trial of DES in SVGs raising concerns for increased mortality with DES during long-term follow-up 47. Brilakis ES, Lichtenwalter C, de Lemos JA, et al. A randomized controlled trial of a paclitaxel-eluting stent versus a similar bare-metal stent in saphenous vein graft lesions the SOS (Stenting of Saphenous Vein Grafts) trial. J Am Coll Cardiol. 2009;53:919–28. 48.• Brilakis ES, Lichtenwalter C, Abdel-Karim AR, et al. Continued benefit from paclitaxel-eluting compared with bare-metal stent implantation in saphenous vein graft lesions during long-term follow-up of the SOS (Stenting of Saphenous Vein Grafts) trial. JACC Cardiovasc Interv. 2011;4:176–82. Second trial of DES and the first one to show improved short- and long-term outcomes with DES compared to BMS 49.•• Mehilli J, Pache J, Abdel-Wahab M, et al. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet. 2011;378:1071–8. Third and largest clinical trial of DES in SVG showing reduction in the need of target vessel revascularization with DES with no difference in mortality or the incidence of myocardial infarction 50. Papayannis AC, Michael TT, Yangirova D, et al. Optical coherence tomography analysis of the stenting

Curr Treat Options Cardio Med (2014) 16:301 of saphenous vein graft (SOS) Xience V Study: use of the everolimus-eluting stent in saphenous vein graft lesions. J Invasive Cardiol. 2012;24:390–4. 51. Kitabata H, Loh JP, Pendyala LK, et al. Two-year follow-up of outcomes of second-generation everolimus-eluting stents versus first-generation drugeluting stents for stenosis of saphenous vein grafts used as aortocoronary conduits. Am J Cardiol. 2013;112:61–7. 52. Costopoulos C, Latib A, Naganuma T, et al. Comparison of first- and second-generation drug-eluting stents in saphenous vein grafts used as aorto-coronary conduits. Am J Cardiol. 2013;112:318–22. 53. Bangalore S, Kumar S, Fusaro M, et al. Short- and long-term outcomes with drug-eluting and baremetal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation. 2012;125:2873–91. 54. de Waha A, Cassese S, Park DW, et al. Everolimuseluting versus sirolimus-eluting stents: an updated meta-analysis of randomized trials. Clin Res Cardiol. 2012;101:461–7. 55. Palmerini T, Biondi-Zoccai G, Della Riva D, et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012;379:1393–402. 56.• Roffi M, Mukherjee D, Chew DP, et al. Lack of benefit from intravenous platelet glycoprotein IIb/ IIIa receptor inhibition as adjunctive treatment for percutaneous interventions of aortocoronary bypass grafts: a pooled analysis of five randomized clinical trials. Circulation. 2002;106:3063–7. Meta-analysis demonstrating lack of benefit with glycoprotein IIb/IIIa inhibitor administration in SVG interventions 57. Coolong A, Baim DS, Kuntz RE, et al. Saphenous vein graft stenting and major adverse cardiac events: a predictive model derived from a pooled analysis of 3958 patients. Circulation. 2008;117:790–7. 58. Brilakis ES, Patel VG, Banerjee S. Medical management after coronary stent implantation: a review. JAMA. 2013;310:189–98. 59. Sachdeva A, Bavisetty S, Beckham G, et al. Discontinuation of long-term clopidogrel therapy is associated with death and myocardial infarction after saphenous vein graft percutaneous coronary intervention. J Am Coll Cardiol. 2012;60:2357–63. 60. Boatman DM, Saeed B, Varghese I, et al. Prior coronary artery bypass graft surgery patients undergoing diagnostic coronary angiography have multiple uncontrolled coronary artery disease risk factors and high risk for cardiovascular events. Heart Vessels. 2009;24:241–6. 61.• Davlouros P, Damelou A, Karantalis V, et al. Evaluation of culprit saphenous vein graft lesions with optical coherence tomography in patients with acute

Page 11 of 12, 301 coronary syndromes. JACC Cardiovasc Interv. 2011;4:683–93. First study of optical coherence tomography in SVGs among patients presenting with acute coronary syndromes 62. Sachdeva R, Aleti S, Thai H. Radial stent deformation in saphenous vein graft. EuroIntervention. 2012;8:876–7. 63. Varghese I, Boatman DM, Peters CT, et al. Impact on contrast, fluoroscopy, and catheter utilization from knowing the coronary artery bypass graft anatomy before diagnostic coronary angiography. Am J Cardiol. 2008;101:1729–32. 64. Eisenhauer MD, Malik JA, Coyle LC, Arendt MA. Impact of aorto-coronary graft markers on subsequent graft patency: a retrospective review. Catheter Cardiovasc Diagn. 1997;42:259–61. 65.• Michael TT, Alomar M, Papayannis A, et al. A randomized comparison of transradial versus transfemoral approach for coronary artery bypass graft angiography and intervention (the RADIAL CABG trial). JACC Cardiovasc Interv. 2013;6:1138–44. First prospective randomized trial of radial vs femoral access for coronary angiography and PCI in patients with prior coronary bypass graft surgery showing high crossover rate and increased use of equipment and radiation in the radial group 66.• Farooq V, Mamas MA, Fath-Ordoubadi F, Fraser DG. The use of a guide catheter extension system as an aid during transradial percutaneous coronary intervention of coronary artery bypass grafts. Catheter Cardiovasc Interv. 2011;78:847–63. The first paper to systematically assess the utility of guide catheter extensions for SVG angiography and PCI 67. Bundhoo SS, Earp E, Ivanauskiene T, et al. Saphenous vein graft percutaneous coronary intervention via radial artery access: safe and effective with reduced hospital length of stay. Am Heart J. 2012;164:468–72. 68. Papayannis AC, Banerjee S, Brilakis ES. Retrograde wiring: a novel technique for identifying the origin of unusual saphenous vein grafts. Cardiovasc Revasc Med. 2012;13:298–300. 69. Abdel-Karim AR, Banerjee S, Brilakis ES. Percutaneous intervention of acutely occluded saphenous vein grafts: contemporary techniques and outcomes. J Invasive Cardiol. 2010;22:253–7. 70. Cook J, Uretsky BF, Sachdeva R. Intervention in the occluded vein graft: with high risk can come great reward. Review of techniques with case examples. J Invasive Cardiol. 2012;24:612–7. 71. Giugliano GR, Falcone MW, Mego D, et al. A prospective multicenter registry of laser therapy for degenerated saphenous vein graft stenosis: the COronary graft Results following Atherectomy with Laser (CORAL) trial. Cardiovasc Revasc Med. 2012;13:84–9. 72. Fiorina C, Meliga E, Chizzola G, et al. Early experience with a new approach for percutaneous inter-

301, Page 12 of 12

73.

74.

75. 76.

77.

vention of totally occluded saphenous vein graft: is the flow the best thrombolytic? EuroIntervention. 2010;6:461–6. Al-Lamee R, Ielasi A, Latib A, et al. Clinical and angiographic outcomes after percutaneous recanalization of chronic total saphenous vein graft occlusion using modern techniques. Am J Cardiol. 2010;106:1721–7. Jim MH, Ho HH, Ko RL, et al. Paclitaxel-eluting stents for chronically occluded saphenous vein grafts (EOS) study. J Interv Cardiol. 2010;23:40– 5. Mhatre A, Uretsky BF, Sachdeva R. Substrate for complications. J Invasive Cardiol. 2012;24:E153–6. Ellis SG, Brener SJ, DeLuca S, et al. Late myocardial ischemic events after saphenous vein graft intervention–importance of initially “nonsignificant” vein graft lesions. Am J Cardiol. 1997;79:1460–4. Abdel-Karim AR, Da Silva M, Lichtenwalter C, et al. Prevalence and outcomes of intermediate saphenous vein graft lesions: findings from the stenting of saphenous vein grafts randomized-controlled trial. Int J Cardiol. 2013.

Curr Treat Options Cardio Med (2014) 16:301 78.

Rodes-Cabau J, Facta A, Larose E, et al. Predictors of aorto-saphenous vein bypass narrowing late after coronary artery bypass grafting. Am J Cardiol. 2007;100:640–5. 79. Aqel R, Zoghbi GJ, Hage F, Dell’Italia L, Iskandrian AE. Hemodynamic evaluation of coronary artery bypass graft lesions using fractional flow reserve. Catheter Cardiovasc Interv. 2008;72:479–85. 80.•• Rodes-Cabau J, Bertrand OF, Larose E, et al. Comparison of plaque sealing with paclitaxel-eluting stents versus medical therapy for the treatment of moderate nonsignificant saphenous vein graft lesions. The moderate VEin Graft LEsion Stenting With the Taxus Stent and Intravascular Ultrasound (VELETI) pilot trial. Circulation. 2009;120:1978–86. First trial to demonstrate clinical benefit with prophylactic stenting of intermediate SVG lesions with DES 81. Marmagkiolis K, Brilakis ES, Hakeem A, Cilingiroglu M, Bilodeau L. Saphenous vein graft perforation during percutaneous coronary intervention: a case series. J Invasive Cardiol. 2013;25:157–61.