Expert Review of Cardiovascular Therapy
ISSN: 1477-9072 (Print) 1744-8344 (Online) Journal homepage: http://www.tandfonline.com/loi/ierk20
Comparative effectiveness of revascularization strategies in stable ischemic heart disease: current perspective and literature review Zaher Fanari, Sandra A Weiss & William S Weintraub To cite this article: Zaher Fanari, Sandra A Weiss & William S Weintraub (2013) Comparative effectiveness of revascularization strategies in stable ischemic heart disease: current perspective and literature review, Expert Review of Cardiovascular Therapy, 11:10, 1321-1336 To link to this article: http://dx.doi.org/10.1586/14779072.2013.840136
Published online: 10 Jan 2014.
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Date: 05 November 2015, At: 15:16
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THEMED ARTICLE y Vascular Disease
Review
Comparative effectiveness of revascularization strategies in stable ischemic heart disease: current perspective and literature review Expert Rev. Cardiovasc. Ther. 11(10), 1321–1336 (2013)
Zaher Fanari, Sandra A Weiss and William S Weintraub* Christiana Care Health System, Newark, DE, USA *Author for correspondence: [email protected]
Percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) are established strategies for coronary revascularization in the setting of ischemic heart disease. Multiple randomized controlled trials and observational studies have compared the impact of the two modalities on the patients’ quality of life, mortality and morbidity, as well as the cost–effectiveness of these modalities in different clinical setting. CABG is the preferred strategy for revascularizations in patients with multi-vessel disease, especially in those with higher risk secondary to associated diabetes, left ventricular dysfunction or more complex lesions. PCI is a reasonable revascularization modality in patients with ischemia and single or low-risk multi-vessel disease and those with unprotected left main with low complexity anatomy. Compared with PCI, CABG is associated with less repeat revascularization, better quality of life and improved survival in high-risk patients. Although CABG is associated with higher cost, it is probably associated with a reasonable cost per quality-adjusted life-year gained in many patients. Therefore, CABG will often be a cost-effective strategy, especially in patients with high angiographic complexity and/or diabetes. KEYWORDS: coronary artery bypass grafting • drug-eluting stents • major adverse cardiovascular and cerebrovascular event • multi-vessel disease • percutaneous coronary intervention • unprotected left main disease
After the introduction of coronary artery bypass grafting (CABG) in 1968, it rapidly became part of standard management for symptomatic coronary artery disease (CAD), especially with consequent advances in surgical technology that reduced morbidity, mortality and rates of graft occlusion [1,2]. However, starting in 1977, percutaneous coronary intervention (PCI) emerged as a more convenient strategy of revascularization, and significant advances in technology coupled with increased experience made it possible to manage increasingly complicated angiographic disease in patients with co-morbidity and/or risk factors that limited surgical options [3]. This led to a continuing debate concerning the choice between these procedures, given the tremendous improvement in PCI, including the introduction of multiple generations of drugeluting stents (DES), new antiplatelet agents
www.expert-reviews.com
10.1586/14779072.2013.840136
and multiple enhanced modalities of evaluating coronary arteries on one side and the concomitant development of less invasive surgical techniques such as off-pump CABG (OPCABG) and minimally invasive keyhole techniques not requiring sternotomy (MIDCAB) on the other. Multiple randomized controlled trials (RCTs), meta-analysis and observational studies [4–24] have been conducted to compare these two modalities in different clinical setting, such as stable ischemic heart disease (SIHD) and anatomically challenging multi-vessel and unprotected left main (LM) disease. Additionally, they have been conducted to assess the impact of associated co-morbidities, especially diabetes and age. Studies have further evaluated the impact of the two strategies on patients’ quality of life, mortality and morbidity, and the relative cost–effectiveness of the two procedures, both short and long term.
Ó 2013 Informa UK Ltd
ISSN 1477-9072
1321
Review
Fanari, Weiss & Weintraub
Downloaded by [University of California Santa Barbara] at 15:16 05 November 2015
Despite the findings of RCTs, the application of these results to the general CAD patient population poses a real challenge, given that these trials often have limited power to evaluate subgroups, and the patients and centers in RCTs are often highly selected. Non-randomized, observational data from clinical databases can complement data from clinical trials, because observational data, if they are from a larger and more representative population, may better reflect real-world practice [21]. However, observational studies will suffer from treatment selection bias [21]. It is the purpose of this paper to review the studies comparing PCI and CABG for SIHD. PCI versus CABG: the early experience
Several early studies were performed comparing revascularization with balloon angioplasty alone or in conjunction with
bare metal stenting (BMS) to CABG. Although much of the medical therapy utilized during this era is suboptimal compared with current standards (i.e., statins and dual antiplatelet therapy), hard cardiovascular outcomes did not differ between groups, with an advantage seen in the CABG group for recurrent angina. Studies comparing CABG with PCI utilizing either balloon angioplasty alone or in conjunction with BMS are presented in TABLES 1 & 2, respectively. A meta-analysis of 10 trials (6 with plain old balloon angioplasty [POBA] and 4 with BMS) showed that over a median follow-up of 5·9 years, 575 (15%) out of 3889 patients assigned to CABG died compared with 628 (16%) of 3923 patients assigned to PCI (hazard ratio [HR] 0·91; 95% CI: 0.82–1.02; p = 0.12) [23]. In patients with diabetes (CABG, n = 615; PCI, n = 618), mortality was substantially
Table 1. Randomized controlled trial of percutaneous coronary intervention with plain old balloon angioplasty versus coronary artery bypass grafting. Study (year)
Patients (n)
Inclusion period
Follow-up (years)
Primary end points
Results
Revascularization
Stent use (%)
Ref.
BARI (2007)
1829
1988–1991
10.4
All-cause mortality
10-year survival: 71.0% PTCA vs 73.5% CABG (p = 0.18)
10-year freedom from revascularization: 33.2% PTCA vs 79.7% CABG (p < 0.001)
1
[4]
CABRI (1995)
1054
1988–1989
2.5
All-cause mortality
1-year death rate: 3.9% PTCA vs 2.7% CABG (RR: 1.42; 95% CI: 0.73–2.76)
1-year freedom from TVR: 66.4% PTCA vs 93.5% CABG (RR: 5.23; 95% CI: 3.90–7.03; p < 0.001)
0
[5]
EAST (2000)
392
1987–1990
8.2
All-cause mortality
8 years survival: 79.3% PTCA vs 82.7% CABG (p = 0.40)
8 years revascularization: 2.4% CABG vs 29.3% PTCA (p < 0.001)
0
[6]
RITA1 (1998)
1011
1988–1991
10.0
Composite of death and MI
The primary end point at 5 years:17% PTCA vs 16% CABG (p = 0.64)
26% of PTCA patients had subsequent CABG, and a further 19% required additional PTCA. In the CABG group, the reintervention rate averaged 2% per year
0
[7]
GABI (2005)
323
1986–1991
13.0
Freedom from angina pectoris (
ISSN: 1477-9072 (Print) 1744-8344 (Online) Journal homepage: http://www.tandfonline.com/loi/ierk20
Comparative effectiveness of revascularization strategies in stable ischemic heart disease: current perspective and literature review Zaher Fanari, Sandra A Weiss & William S Weintraub To cite this article: Zaher Fanari, Sandra A Weiss & William S Weintraub (2013) Comparative effectiveness of revascularization strategies in stable ischemic heart disease: current perspective and literature review, Expert Review of Cardiovascular Therapy, 11:10, 1321-1336 To link to this article: http://dx.doi.org/10.1586/14779072.2013.840136
Published online: 10 Jan 2014.
Submit your article to this journal
Article views: 36
View related articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ierk20 Download by: [University of California Santa Barbara]
Date: 05 November 2015, At: 15:16
Downloaded by [University of California Santa Barbara] at 15:16 05 November 2015
THEMED ARTICLE y Vascular Disease
Review
Comparative effectiveness of revascularization strategies in stable ischemic heart disease: current perspective and literature review Expert Rev. Cardiovasc. Ther. 11(10), 1321–1336 (2013)
Zaher Fanari, Sandra A Weiss and William S Weintraub* Christiana Care Health System, Newark, DE, USA *Author for correspondence: [email protected]
Percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) are established strategies for coronary revascularization in the setting of ischemic heart disease. Multiple randomized controlled trials and observational studies have compared the impact of the two modalities on the patients’ quality of life, mortality and morbidity, as well as the cost–effectiveness of these modalities in different clinical setting. CABG is the preferred strategy for revascularizations in patients with multi-vessel disease, especially in those with higher risk secondary to associated diabetes, left ventricular dysfunction or more complex lesions. PCI is a reasonable revascularization modality in patients with ischemia and single or low-risk multi-vessel disease and those with unprotected left main with low complexity anatomy. Compared with PCI, CABG is associated with less repeat revascularization, better quality of life and improved survival in high-risk patients. Although CABG is associated with higher cost, it is probably associated with a reasonable cost per quality-adjusted life-year gained in many patients. Therefore, CABG will often be a cost-effective strategy, especially in patients with high angiographic complexity and/or diabetes. KEYWORDS: coronary artery bypass grafting • drug-eluting stents • major adverse cardiovascular and cerebrovascular event • multi-vessel disease • percutaneous coronary intervention • unprotected left main disease
After the introduction of coronary artery bypass grafting (CABG) in 1968, it rapidly became part of standard management for symptomatic coronary artery disease (CAD), especially with consequent advances in surgical technology that reduced morbidity, mortality and rates of graft occlusion [1,2]. However, starting in 1977, percutaneous coronary intervention (PCI) emerged as a more convenient strategy of revascularization, and significant advances in technology coupled with increased experience made it possible to manage increasingly complicated angiographic disease in patients with co-morbidity and/or risk factors that limited surgical options [3]. This led to a continuing debate concerning the choice between these procedures, given the tremendous improvement in PCI, including the introduction of multiple generations of drugeluting stents (DES), new antiplatelet agents
www.expert-reviews.com
10.1586/14779072.2013.840136
and multiple enhanced modalities of evaluating coronary arteries on one side and the concomitant development of less invasive surgical techniques such as off-pump CABG (OPCABG) and minimally invasive keyhole techniques not requiring sternotomy (MIDCAB) on the other. Multiple randomized controlled trials (RCTs), meta-analysis and observational studies [4–24] have been conducted to compare these two modalities in different clinical setting, such as stable ischemic heart disease (SIHD) and anatomically challenging multi-vessel and unprotected left main (LM) disease. Additionally, they have been conducted to assess the impact of associated co-morbidities, especially diabetes and age. Studies have further evaluated the impact of the two strategies on patients’ quality of life, mortality and morbidity, and the relative cost–effectiveness of the two procedures, both short and long term.
Ó 2013 Informa UK Ltd
ISSN 1477-9072
1321
Review
Fanari, Weiss & Weintraub
Downloaded by [University of California Santa Barbara] at 15:16 05 November 2015
Despite the findings of RCTs, the application of these results to the general CAD patient population poses a real challenge, given that these trials often have limited power to evaluate subgroups, and the patients and centers in RCTs are often highly selected. Non-randomized, observational data from clinical databases can complement data from clinical trials, because observational data, if they are from a larger and more representative population, may better reflect real-world practice [21]. However, observational studies will suffer from treatment selection bias [21]. It is the purpose of this paper to review the studies comparing PCI and CABG for SIHD. PCI versus CABG: the early experience
Several early studies were performed comparing revascularization with balloon angioplasty alone or in conjunction with
bare metal stenting (BMS) to CABG. Although much of the medical therapy utilized during this era is suboptimal compared with current standards (i.e., statins and dual antiplatelet therapy), hard cardiovascular outcomes did not differ between groups, with an advantage seen in the CABG group for recurrent angina. Studies comparing CABG with PCI utilizing either balloon angioplasty alone or in conjunction with BMS are presented in TABLES 1 & 2, respectively. A meta-analysis of 10 trials (6 with plain old balloon angioplasty [POBA] and 4 with BMS) showed that over a median follow-up of 5·9 years, 575 (15%) out of 3889 patients assigned to CABG died compared with 628 (16%) of 3923 patients assigned to PCI (hazard ratio [HR] 0·91; 95% CI: 0.82–1.02; p = 0.12) [23]. In patients with diabetes (CABG, n = 615; PCI, n = 618), mortality was substantially
Table 1. Randomized controlled trial of percutaneous coronary intervention with plain old balloon angioplasty versus coronary artery bypass grafting. Study (year)
Patients (n)
Inclusion period
Follow-up (years)
Primary end points
Results
Revascularization
Stent use (%)
Ref.
BARI (2007)
1829
1988–1991
10.4
All-cause mortality
10-year survival: 71.0% PTCA vs 73.5% CABG (p = 0.18)
10-year freedom from revascularization: 33.2% PTCA vs 79.7% CABG (p < 0.001)
1
[4]
CABRI (1995)
1054
1988–1989
2.5
All-cause mortality
1-year death rate: 3.9% PTCA vs 2.7% CABG (RR: 1.42; 95% CI: 0.73–2.76)
1-year freedom from TVR: 66.4% PTCA vs 93.5% CABG (RR: 5.23; 95% CI: 3.90–7.03; p < 0.001)
0
[5]
EAST (2000)
392
1987–1990
8.2
All-cause mortality
8 years survival: 79.3% PTCA vs 82.7% CABG (p = 0.40)
8 years revascularization: 2.4% CABG vs 29.3% PTCA (p < 0.001)
0
[6]
RITA1 (1998)
1011
1988–1991
10.0
Composite of death and MI
The primary end point at 5 years:17% PTCA vs 16% CABG (p = 0.64)
26% of PTCA patients had subsequent CABG, and a further 19% required additional PTCA. In the CABG group, the reintervention rate averaged 2% per year
0
[7]
GABI (2005)
323
1986–1991
13.0
Freedom from angina pectoris (
