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Coronary Artery Bypass Surgery and Percutaneous Coronary Intervention in Patients with Diabetes
CONCISE ADVICE FOR CLINICIANS
Coronary Artery Bypass Surgery and Percutaneous Coronary Intervention in Patients with Diabetes Wilbert S. Aronow, MD,a Tatyana A. Shamliyan, MD, MSb a
Westchester Medical Center and New York Medical College, Valhalla; bEvidence-Based Medicine Center, Elsevier, Philadelphia, Pa.
Existing American guidelines developed more than 5 years ago recommend coronary artery bypass grafting over percutaneous coronary intervention in patients with diabetes, particularly for multivessel disease.1 Despite these recommendations, one third of patients with diabetes and multivessel coronary artery disease undergoing revascularization received coronary artery bypass grafting.2 We conducted a rapid review according to a protocol developed a priori to examine the most current evidence on the comparative effectiveness and safety of coronary artery bypass grafting and percutaneous coronary intervention for revascularization in patients with diabetes and multivessel coronary artery disease.
WHAT IS THE CLINICAL QUESTION? What are the comparative effectiveness and safety of coronary artery bypass grafting and percutaneous coronary intervention for revascularization in patients with diabetes and multivessel coronary artery disease?
WHAT DOES THE EVIDENCE CONCLUDE?
WHAT ARE THE PARAMETERS FOR OUR EVIDENCE SEARCH AND BASIS FOR OUR CONCLUSIONS? Population The patient population included adults with diabetes and multivessel coronary artery disease (angiographic diagnosis). Patient characteristics contributing to treatment effect included demographics; risk factors for coronary artery disease, including hypertension, smoking and hyperlipidemia; duration of coronary artery disease; duration of diabetes; type of diabetes; and hemoglobin A1c.
Intervention Intervention was percutaneous coronary intervention, including the number and type of stents.
Comparator The comparator was coronary artery bypass grafting.
Primary Outcomes The primary outcomes were mortality, all-cause mortality, disease-specific mortality, quality of life, incident myocardial
Intervention
Quality of Evidence*
Balance Between Benefits and Harms†
Percutaneous coronary intervention vs coronary artery bypass grafting
Low
Trade-off between benefits and harms coronary artery bypass grafting improves mortality and quality of life, and reduces the risk of revascularization but increases the risk of stroke, specifically in patients with high baseline risk for stroke and renal insufficiency
*Quality of Evidence scale (Grading of Recommendations, Assessment, Development and Evaluations): high, moderate, low, and very low. For more information on the Grading of Recommendations, Assessment, Development, and Evaluations rating system, see http://gdt.guidelinedevelopment.org/app/ handbook/handbook.html. †The Guideline Elements Model: http://gem.med.yale.edu/default.htm.
Funding: Elsevier Evidence-Based Medicine Center. Conflict of Interest: TAS is employed by Elsevier. Authorship: Both authors had access to the data and played a role in writing this manuscript. Requests for reprints should be addressed to Tatyana A. Shamliyan, MD, MS, Evidence-Based Medicine Center, Elsevier, 1600 JFK Blvd, Philadelphia, PA 19103. E-mail address: [email protected]
0002-9343/$ -see front matter http://dx.doi.org/10.1016/j.amjmed.2017.03.034
infarction, incident stroke, and need for subsequent revascularization.
WHAT DO THE CLINICAL GUIDELINES SAY? American College of Cardiology Foundation/American Heart Association/Society for Cardiovascular Angiography
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Table 1 Disease
GRADE Summary—Percutaneous Coronary Intervention With Drug-Eluting Stents Versus Coronary Artery Bypass Grafting for Adults With Diabetes and Multivessel Coronary Artery
Population: Adults with diabetes and multivessel CAD Settings: Inpatient Intervention: PCI with drug-eluting stents Comparator: CABG
All-cause mortality, 5-y follow-up
169
Death/MI/stroke events
214
Myocardial infarction, 1- to 5-y follow-up Nonfatal myocardial infarction at 5-y follow-up Need for subsequent revascularization, 1- to 5-y follow-up
103 125
Stroke, 1- to 5-y follow-up
263
24
Quality of life at 2-y follow-up, Seattle Angina Questionnaire, total score Total, nonserious adverse events
NR
Total, serious adverse events
227
69
Risk With Comparator Per 1000 90 Attributable events per 1000 treated, 40 (8-73) 112 Attributable events per 1000 treated, 63 (19-107) 165 Attributable events per 1000 treated, 49 (23-76) 60 67 113 Attributable events per 1000 treated, 107 (41-174) 41 Attributable avoided events per 1000 treated, 15 (3-27) NR 690 Attributable avoided events per 1000 treated 621 (517-726) 474 Attributable avoided events per 1000 treated 247 (118-375)
Relative Measure of Association (95% CI) OR* 1.4 (1.1-1.9) NNT 25 (14-125)
No. of Participants (Studies) 3516 (7 RCTs)4,5
Quality of Evidence (GRADE) Low
Comment Favors CABG
RR 1.5 (1.1-2.1) NNT 16 (9-53)
2588 (4 RCTs)6
Very low
Favors CABG
HR 1.4 (1.2-1.7) NNT 20 (13-43)
3443 (individual participant data meta-analysis of 3 RCTs)7-10
Moderate
Favors CABG
OR* 1.3 (0.9-2.0) RR 1.5 (0.8-2.8)
3516 (7 RCTs)4 2620 (4 RCTs)6
Very low Very low
No difference No difference
OR* 2.4 (1.7-3.1) NNT 9 (6-24)
3516 (7 RCTs)4
Low
Favors CABG
RR 0.6 (0.4-0.8) NNTp 67 (37-333)
3516 (7 RCTs)4
Low
Favors PCI
MD 2.2 (3.8 to 0.7)
1900 (1 RCT)11
Very low
Favors CABG
RR 0.10 (0.05-0.21) NNTp 2 (1-2)
198 (1 RCT)12
Very low
Favors PCI
RR 0.48 (0.32-0.73) NNTp 4 (3-8)
198 (1 RCT)12
Very low
Favors PCI
CABG ¼ coronary artery bypass grafting; CAD ¼ coronary artery disease; CI ¼ confidence interval; GRADE ¼ Grading of Recommendations Assessment, Development, and Evaluation; MD ¼ mean difference; NNT ¼ number needed to treat; NNTp ¼ number needed to treat to prevent 1 event; NR ¼ not reported; OR ¼ odds ratio; PCI ¼ percutaneous coronary intervention; RCT ¼ randomized controlled trial; RR ¼ relative risk. *ORs from Bayesian network meta-analysis with 95% Credible Intervals.
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Outcome All-cause mortality, 1- to 5-y follow-up
Risk With Intervention Per 1000 142
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Aronow and Shamliyan GRADE Summary—Percutaneous Coronary Intervention With Bare-Metal Stents Versus Coronary Artery Bypass Grafting for Adults With Diabetes and Multivessel Coronary Artery Disease
Population: Adults with diabetes and multivessel CAD Settings: Inpatient Intervention: PCI with bare-metal stents Comparator: CABG Outcome All-cause mortality, 5-y follow-up
Nonfatal myocardial infarction, 5-y follow-up Myocardial infarction, 1- to 5-y follow-up Need for subsequent revascularization, 1- to 5-y follow-up Need for subsequent revascularization, 5-y follow-up
Risk With Intervention Per 1000 127
Risk With Comparator Per 1000 82 Attributable events per 1000 treated, 54 (5-102) 88
Relative Measure of Association (95% CI) RR 1.4 (0.8-2.5) NNT 19 (10-200)
No. of Participants (Studies) 543 (4 RCTs)6
Quality of Evidence (GRADE) Low
Comment Favors CABG
RR 1.0 (0.4-2.5)
350 (2 RCTs)6
Low
No difference
100
58
OR* 1.9 (1.2-2.9)
752 (4 RCTs)4
Low
Favors CABG
328
72 Attributable events per 1000 treated, 216 (144-287) 82 Attributable events per 1000 treated, 261 (135-387)
OR* 5.2 (3.7-7.4) NNT 5 (3-7)
896 (5 RCTs)4
Low
Favors CABG
RR 4.2 (2.5-7.2) NNT 4 (3-7)
350 (2 RCTs)6
Very low
Favors CABG
89
361
CABG Versus PCI in People With Diabetes
Table 2
CABG ¼ coronary artery bypass grafting; CAD ¼ coronary artery disease; CI ¼ confidence interval; GRADE ¼ Grading of Recommendations Assessment, Development, and Evaluation; NNT ¼ number needed to treat; OR ¼ odds ratio; PCI ¼ percutaneous coronary intervention; RCT ¼ randomized controlled trial; RR ¼ relative risk. *ORs from Bayesian network meta-analysis with 95% Credible Intervals.
3
329 Need for subsequent revascularization, 1- to 5-y follow-up
CAD ¼ coronary artery disease; CI ¼ confidence interval; GRADE ¼ Grading of Recommendations Assessment, Development, and Evaluation; NNT ¼ number needed to treat; OR ¼ odds ratio; PCI ¼ percutaneous coronary intervention; RCT ¼ randomized controlled trial. *ORs from Bayesian network meta-analysis with 95% Credible Intervals.
Favors PCI with drug-eluting stents Moderate 2444 (6 RCTs)4 OR* 2.2 (1.7-3.0) NNT 7 (5-10)
Quality of Evidence (GRADE) Low Low Outcome All-cause mortality, 1- to 5-y follow-up Myocardial infarction, 1- to 5-y follow-up
Risk with Intervention per 1000 94 94
Risk with Comparator per 1000 Attributable Events per 1000 Treated (95% CI) 79 57 Attributable events per 1000 treated, 26 (7-46) 190 Attributable events per 1000 treated, 151 (101-202)
Relative Measure of Association (95% CI) NNT (95% CI) OR* 0.9 (0.7-1.2) OR* 1.4 (1.0-2.0) NNT 38 (22-143)
No. of Participants (RCTs) 3470 (14 RCTs)4 3131 (10 RCTs)4
Comment No difference Favors PCI with drug-eluting stents
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Population: Adults with diabetes and multivessel CAD Settings: Inpatient Intervention: PCI with bare-metal stents Comparator: PCI with drug-eluting stents
Table 3
GRADE Summary—Percutaneous Coronary Intervention With Bare-Metal Stents Versus Drug-Eluting Stents for Adults With Diabetes and Multivessel Coronary Artery Disease
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and Interventions guideline for percutaneous coronary intervention. A report of the American College of Cardiology Foundation, the American Heart Association Task Force on Practice Guidelines, and the Society for Cardiovascular Angiography and Interventions, 2011 (Appraisal of Guidelines for Research and Evaluation II score: 74%).1 This guideline states that coronary artery bypass grafting probably is recommended in preference to percutaneous coronary intervention to improve survival in patients with multivessel coronary artery disease and diabetes mellitus, particularly if a left internal mammary artery graft can be anastomosed to the left anterior descending artery (level of evidence: B, limited population evaluated in single randomized controlled trials [RCTs] or nonrandomized studies). European Society of Cardiology guidelines on diabetes, prediabetes, and cardiovascular diseases, developed in collaboration with the European Association for the Study of Diabetes. The Task Force on Diabetes, Prediabetes, and Cardiovascular Diseases of the European Society of Cardiology in collaboration with the European Association for the Study of Diabetes, 2013 (Appraisal of Guidelines for Research and Evaluation II score: 53%).3 This guideline recommends coronary artery bypass grafting in patients with diabetes mellitus and multivessel or complex (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery score >22) coronary artery disease to improve survival free from major cardiovascular events (level of evidence: A, strong recommendation based on high-quality evidence from RCTs). This guideline recommends that in patients with diabetes mellitus who received percutaneous coronary intervention, drug-eluting stents rather than bare-metal stents are recommended to reduce the risk of target vessel revascularization (level of evidence: A, strong recommendation based on high-quality evidence from RCTs).
AUTHOR COMMENTARY Our comprehensive search in PubMed, Cochrane Library, EMBASE, and clinicaltrials.gov identified 2 individual patient data and 24 aggregate data meta-analyses of RCTs, unpublished data from 3 RCTs, 2 post hoc analyses of 2 RCTs, and 5 observational studies.4-87 We graded the quality of evidence according to the criteria from the Grading of Recommendations, Assessment, Development, and Evaluations Working Group. Low-quality evidence suggests that when compared with percutaneous coronary intervention with drug-eluting stents, coronary artery bypass grafting reduces mortality and the need for subsequent revascularizations and improves quality of life but increases the risk for stroke (Table 1). Reduction in mortality after coronary artery bypass grafting versus percutaneous coronary intervention was largest in people with diabetes aged more than 59 years of age in a
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CABG Versus PCI in People With Diabetes
meta-analysis of individual patient data from 10 RCTs (adjusted relative risk, 0.61; 95% confidence interval [CI], 0.44-0.85).53 Observational studies confirmed better survival after coronary artery bypass grafting but rarely reported stroke as an outcome in adults with diabetes undergoing revascularization for coronary artery disease (Appendix Table 1, available online). Only 1 observational study examining the risk of stroke did not find a statistically significant association between coronary artery bypass grafting and the risk of stroke in Japanese adults with diabetes (Appendix Table 1, available online).16 Low-quality evidence suggests that when compared with percutaneous coronary intervention with bare-metal stents, coronary artery bypass grafting reduces mortality and the need for subsequent revascularization (Table 2). Low-quality evidence suggests that percutaneous coronary intervention with drug-eluting stents, when compared with percutaneous coronary intervention with bare-metal stents, reduces the risk for myocardial infarction and revascularization (Table 3). A single observational study reported that people with diabetes with prior percutaneous coronary intervention had poorer long-term outcomes after coronary artery bypass grafting revascularization compared with those who had no prior percutaneous coronary intervention.14 All published meta-analyses reported better survival after coronary artery bypass grafting but a higher risk for stroke when compared with percutaneous coronary intervention.55,58,61-63,65,67-69,74 Post hoc analysis of the largest RCTs of diabetic patients revealed that levels of low-density lipoprotein >105 mg/dL (adjusted hazard ratio [HR], 3.28; 95% CI, 1.19-9.02) and renal insufficiency (adjusted HR, 3.57; 95% CI, 1.01-12.64) were associated with more than a 200% increase in relative risk for later stroke.78 In contrast, and for unclear reasons, each 1 mm Hg increase in diastolic blood pressure was associated with a 5% relative reduction in the risk for stroke (adjusted HR, 0.95; 95% CI, 0.91-0.99).78 We downgraded the quality of evidence because of risk of bias in the body of evidence, small number of events, and inconsistency in treatment effects. We also downgraded the quality of evidence from indirect comparisons in the network meta-analysis.4 Current clinical practice guidelines recommend coronary artery bypass grafting over percutaneous coronary intervention for diabetic patients with multivessel disease.1,3 However, the choice of treatment always should be individualized depending on the baseline risk for stroke, renal function, and anticoagulant use. Future research is needed to examine the role of patient characteristics and provider skills and the quality of provided care on patient survival and quality of life in patients undergoing these procedures.
ACKNOWLEDGMENT The authors thank David Goldmann, MD, for his contribution to the development of the clinical question, review protocol, and preliminary analysis of the evidence.
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83.
7 grafting in patients with diabetes. Conference abstract, American Heart Association 2013 Scientific Sessions and Resuscitation Science Symposium, Dallas, TX, United States. Circulation. 2013;22(Suppl 1):128. Li X, Kong M, Jiang D, Dong A. Comparing coronary artery bypass grafting with drug-eluting stenting in patients with diabetes mellitus and multivessel coronary artery disease: a meta-analysis. Interact Cardiovasc Thorac Surg. 2014;18:347-354. Lim JY, Deo SV, Kim WS, Altarabsheh SE, Erwin PJ, Park SJ. Drug-eluting stents versus coronary artery bypass grafting in diabetic patients with multivessel disease: a meta-analysis. Heart Lung Circ. 2014;23:717-725. Qi X, Xu M, Yang H, et al. Comparing mortality and myocardial infarction between coronary artery bypass grafting and drug-eluting stenting in patients with diabetes mellitus and multivessel coronary artery disease: a meta-analysis. Arch Med Sci. 2014;10:411-418. Smit Y, Vlayen J, Koppenaal H, Eefting F, Kappetein AP, Mariani MA. Percutaneous coronary intervention versus coronary artery bypass grafting: a meta-analysis. J Thorac Cardiovasc Surg. 2015;149:831-838.e813. Verma S, Yanagawa B, Ahsan M, et al. CABG versus PCI in patients with diabetes: a metaanalysis of randomized controlled trials in the era of DES. Can J Cardiol. 2013;29:S254-S255. Verma S, Yanagawa B, Ahsan M, et al. CABG versus PCI in patients with diabetes: a metaanalysis of randomized controlled trials in the era of stents. Meeting abstract: American Heart Association 2013 Scientific Sessions and Resuscitation Science Symposium, Dallas, TX, United States. Circulation. 2013;22(Suppl 1):128. Wu YC, Su TW, Zhang JF, Shen WF, Ning G, Kong Y. Coronary artery bypass grafting versus drug-eluting stents in patients with severe coronary artery disease and diabetes mellitus: systematic review and meta-analysis. J Diabetes. 2015;7:192-201. Zhang F, Yang Y, Hu D, Lei H, Wang Y. Percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in the treatment of diabetic patients with multi-vessel coronary disease: a meta-analysis. Diabetes Res Clin Pract. 2012;97:178-184. Banning AP, Westaby S, Mohr FW, et al. Revascularization with cardiac surgery versus paclitaxel-eluting stents in patients with diabetes and metabolic syndrome: 1-year results from the SYNTAX study. J Am Coll Cardiol. 2009;53:A3-A4. Booth J, Clayton T, Pepper J, et al. Randomized, controlled trial of coronary artery bypass surgery versus percutaneous coronary intervention in patients with multivessel coronary artery disease: six-year follow-up from the Stent or Surgery Trial (SoS). Circulation. 2008;118:381-388. NCT00326196, Coronary artery revascularization in diabetes (VA CARDS), Available at: https://clinicaltrials.gov/ct2/show/NCT0032 6196?term¼NCT00326196&rank¼1. Domanski MJ, Farkouh ME, Zak V, et al. Predictors of stroke associated with coronary artery bypass grafting in patients with diabetes mellitus and multivessel coronary artery disease. Am J Cardiol. 2015;115:1382-1388. Hueb W, Lopes NH, Gersh BJ, et al. Five-year follow-up of the Medicine, Angioplasty, or Surgery Study (MASS II): a randomized controlled clinical trial of 3 therapeutic strategies for multivessel coronary artery disease. Circulation. 2007;115:1082-1089. Kappetein AP, Feldman TE, MacK MJ, et al. Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year follow-up of the SYNTAX trial. Eur Heart J. 2011;32:2125-2134. Kapur A, Hall RJ, Malik IS, et al. Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. 1-year results of the CARDia (Coronary Artery Revascularization in Diabetes) Trial. J Am Coll Cardiol. 2010;55: 432-440. NCT00006305. Bypass angioplasty revascularization investigation in type 2 diabetes. 2000. Available at: https://clinicaltrials.gov/ct2/show/ NCT00006305?term¼NCT00006305&rank¼1. NCT00086450. Comparison of two treatments for multivessel coronary artery disease in individuals with diabetes (FREEDOM). 2004.
8 Available at: https://clinicaltrials.gov/ct2/show/NCT00086450? term¼NCT00086450&rank¼1. 84. Serruvs PW, Morice MC, Kappetein AP, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009;360:961-972. 85. Serruys PW, Ong ATL, Van Herwerden LA, et al. Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial. J Am Coll Cardiol. 2005;46:575-581. 86. Serruys PW, Unger F, Sousa JE, et al. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med. 2001;344:1117-1124.
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87. Stables RH. Coronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent or Surgery trial): a randomised controlled trial. Lancet (London, England). 2002;360: 965-970.
SUPPLEMENTARY DATA Supplementary table accompanying this article can be found in the online version at http://dx.doi.org/10.1016/j.amjmed. 2017.03.034.
Risk With Intervention Risk With Adjusted Relative Measure Outcome Per 1000 Comparator Per 1000 of Association (95% CI) Registry of 8 community hospitals, US Mortality, 5-8 y NR NR OR 1.67 (1.08-2.56) NR NR OR 1.75 (1.43-3.23) MACE (mortality, nonfatal myocardial infarction, or revascularization), 5-8 y Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI/CABG Registry Cohort-2, Japan Mortality, 5 y NR NR HR 1.31 (1.01-1.70) Cardiac death, 5 y NR NR HR 1.45 (1.00-2.51) MI, 5 y NR NR HR 2.31 (1.31-4.08) Any coronary NR NR HR 3.70 (2.91-4.69) revascularization), 5 y Stroke, 5 y NR NR HR 1.07 (0.72-1.59) Elderly in a single center in Japan Mortality, 3.5 y NR NR HR 1.37 (0.72-2.50) Single-center study in China All-cause death, 3 y NR NR HR 1.10 (0.70-1.75) Death, MI, and stroke, 3 y NR NR HR 0.66 (0.51-0.87) Repeat revascularization, 3 y NR NR HR 6.74 (4.38-10.37)
No. of Participants (Studies)
Quality of Evidence (GRADE)
Comment
1082 (1 study)17 1082 (1 study)17
Very low Very low
Favors CABG Favors CABG
Very Very Very Very
Favors Favors Favors Favors
1998 1998 1998 1998
(1 (1 (1 (1
study)16 study)16 study)16 study)16
low low low low
CABG CABG CABG CABG
1998 (1 study)16
Very low
No difference
483 (1 study)15
Very low
No difference
1154 (1 study)13 1154 (1 study)13 1154 (1 study)13
Very low Very low Very low
No difference Favors PCI Favors CABG
CABG Versus PCI in People With Diabetes
Population: Adults with diabetes and multivessel CAD Settings: Inpatient Intervention: PCI Comparator: CABG
Aronow and Shamliyan
Appendix Table 1 GRADE Summary—Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting for Adults With Diabetes and Multivessel Coronary Artery Disease: Results From Observational Studies
CABG ¼ coronary artery bypass grafting; CAD ¼ coronary artery disease; CI ¼ confidence interval; GRADE ¼ Grading of Recommendations Assessment, Development, and Evaluation; HR ¼ hazard ratio; NR ¼ not reported; OR ¼ odds ratio; MACE ¼ major adverse cardiac events; MI ¼ myocardial infarction; PCI ¼ percutaneous coronary intervention.
8.e1
Coronary Artery Bypass Surgery and Percutaneous Coronary Intervention in Patients with Diabetes Wilbert S. Aronow, MD,a Tatyana A. Shamliyan, MD, MSb a
Westchester Medical Center and New York Medical College, Valhalla; bEvidence-Based Medicine Center, Elsevier, Philadelphia, Pa.
Existing American guidelines developed more than 5 years ago recommend coronary artery bypass grafting over percutaneous coronary intervention in patients with diabetes, particularly for multivessel disease.1 Despite these recommendations, one third of patients with diabetes and multivessel coronary artery disease undergoing revascularization received coronary artery bypass grafting.2 We conducted a rapid review according to a protocol developed a priori to examine the most current evidence on the comparative effectiveness and safety of coronary artery bypass grafting and percutaneous coronary intervention for revascularization in patients with diabetes and multivessel coronary artery disease.
WHAT IS THE CLINICAL QUESTION? What are the comparative effectiveness and safety of coronary artery bypass grafting and percutaneous coronary intervention for revascularization in patients with diabetes and multivessel coronary artery disease?
WHAT DOES THE EVIDENCE CONCLUDE?
WHAT ARE THE PARAMETERS FOR OUR EVIDENCE SEARCH AND BASIS FOR OUR CONCLUSIONS? Population The patient population included adults with diabetes and multivessel coronary artery disease (angiographic diagnosis). Patient characteristics contributing to treatment effect included demographics; risk factors for coronary artery disease, including hypertension, smoking and hyperlipidemia; duration of coronary artery disease; duration of diabetes; type of diabetes; and hemoglobin A1c.
Intervention Intervention was percutaneous coronary intervention, including the number and type of stents.
Comparator The comparator was coronary artery bypass grafting.
Primary Outcomes The primary outcomes were mortality, all-cause mortality, disease-specific mortality, quality of life, incident myocardial
Intervention
Quality of Evidence*
Balance Between Benefits and Harms†
Percutaneous coronary intervention vs coronary artery bypass grafting
Low
Trade-off between benefits and harms coronary artery bypass grafting improves mortality and quality of life, and reduces the risk of revascularization but increases the risk of stroke, specifically in patients with high baseline risk for stroke and renal insufficiency
*Quality of Evidence scale (Grading of Recommendations, Assessment, Development and Evaluations): high, moderate, low, and very low. For more information on the Grading of Recommendations, Assessment, Development, and Evaluations rating system, see http://gdt.guidelinedevelopment.org/app/ handbook/handbook.html. †The Guideline Elements Model: http://gem.med.yale.edu/default.htm.
Funding: Elsevier Evidence-Based Medicine Center. Conflict of Interest: TAS is employed by Elsevier. Authorship: Both authors had access to the data and played a role in writing this manuscript. Requests for reprints should be addressed to Tatyana A. Shamliyan, MD, MS, Evidence-Based Medicine Center, Elsevier, 1600 JFK Blvd, Philadelphia, PA 19103. E-mail address: [email protected]
0002-9343/$ -see front matter http://dx.doi.org/10.1016/j.amjmed.2017.03.034
infarction, incident stroke, and need for subsequent revascularization.
WHAT DO THE CLINICAL GUIDELINES SAY? American College of Cardiology Foundation/American Heart Association/Society for Cardiovascular Angiography
2
Table 1 Disease
GRADE Summary—Percutaneous Coronary Intervention With Drug-Eluting Stents Versus Coronary Artery Bypass Grafting for Adults With Diabetes and Multivessel Coronary Artery
Population: Adults with diabetes and multivessel CAD Settings: Inpatient Intervention: PCI with drug-eluting stents Comparator: CABG
All-cause mortality, 5-y follow-up
169
Death/MI/stroke events
214
Myocardial infarction, 1- to 5-y follow-up Nonfatal myocardial infarction at 5-y follow-up Need for subsequent revascularization, 1- to 5-y follow-up
103 125
Stroke, 1- to 5-y follow-up
263
24
Quality of life at 2-y follow-up, Seattle Angina Questionnaire, total score Total, nonserious adverse events
NR
Total, serious adverse events
227
69
Risk With Comparator Per 1000 90 Attributable events per 1000 treated, 40 (8-73) 112 Attributable events per 1000 treated, 63 (19-107) 165 Attributable events per 1000 treated, 49 (23-76) 60 67 113 Attributable events per 1000 treated, 107 (41-174) 41 Attributable avoided events per 1000 treated, 15 (3-27) NR 690 Attributable avoided events per 1000 treated 621 (517-726) 474 Attributable avoided events per 1000 treated 247 (118-375)
Relative Measure of Association (95% CI) OR* 1.4 (1.1-1.9) NNT 25 (14-125)
No. of Participants (Studies) 3516 (7 RCTs)4,5
Quality of Evidence (GRADE) Low
Comment Favors CABG
RR 1.5 (1.1-2.1) NNT 16 (9-53)
2588 (4 RCTs)6
Very low
Favors CABG
HR 1.4 (1.2-1.7) NNT 20 (13-43)
3443 (individual participant data meta-analysis of 3 RCTs)7-10
Moderate
Favors CABG
OR* 1.3 (0.9-2.0) RR 1.5 (0.8-2.8)
3516 (7 RCTs)4 2620 (4 RCTs)6
Very low Very low
No difference No difference
OR* 2.4 (1.7-3.1) NNT 9 (6-24)
3516 (7 RCTs)4
Low
Favors CABG
RR 0.6 (0.4-0.8) NNTp 67 (37-333)
3516 (7 RCTs)4
Low
Favors PCI
MD 2.2 (3.8 to 0.7)
1900 (1 RCT)11
Very low
Favors CABG
RR 0.10 (0.05-0.21) NNTp 2 (1-2)
198 (1 RCT)12
Very low
Favors PCI
RR 0.48 (0.32-0.73) NNTp 4 (3-8)
198 (1 RCT)12
Very low
Favors PCI
CABG ¼ coronary artery bypass grafting; CAD ¼ coronary artery disease; CI ¼ confidence interval; GRADE ¼ Grading of Recommendations Assessment, Development, and Evaluation; MD ¼ mean difference; NNT ¼ number needed to treat; NNTp ¼ number needed to treat to prevent 1 event; NR ¼ not reported; OR ¼ odds ratio; PCI ¼ percutaneous coronary intervention; RCT ¼ randomized controlled trial; RR ¼ relative risk. *ORs from Bayesian network meta-analysis with 95% Credible Intervals.
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Outcome All-cause mortality, 1- to 5-y follow-up
Risk With Intervention Per 1000 142
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2017
Aronow and Shamliyan GRADE Summary—Percutaneous Coronary Intervention With Bare-Metal Stents Versus Coronary Artery Bypass Grafting for Adults With Diabetes and Multivessel Coronary Artery Disease
Population: Adults with diabetes and multivessel CAD Settings: Inpatient Intervention: PCI with bare-metal stents Comparator: CABG Outcome All-cause mortality, 5-y follow-up
Nonfatal myocardial infarction, 5-y follow-up Myocardial infarction, 1- to 5-y follow-up Need for subsequent revascularization, 1- to 5-y follow-up Need for subsequent revascularization, 5-y follow-up
Risk With Intervention Per 1000 127
Risk With Comparator Per 1000 82 Attributable events per 1000 treated, 54 (5-102) 88
Relative Measure of Association (95% CI) RR 1.4 (0.8-2.5) NNT 19 (10-200)
No. of Participants (Studies) 543 (4 RCTs)6
Quality of Evidence (GRADE) Low
Comment Favors CABG
RR 1.0 (0.4-2.5)
350 (2 RCTs)6
Low
No difference
100
58
OR* 1.9 (1.2-2.9)
752 (4 RCTs)4
Low
Favors CABG
328
72 Attributable events per 1000 treated, 216 (144-287) 82 Attributable events per 1000 treated, 261 (135-387)
OR* 5.2 (3.7-7.4) NNT 5 (3-7)
896 (5 RCTs)4
Low
Favors CABG
RR 4.2 (2.5-7.2) NNT 4 (3-7)
350 (2 RCTs)6
Very low
Favors CABG
89
361
CABG Versus PCI in People With Diabetes
Table 2
CABG ¼ coronary artery bypass grafting; CAD ¼ coronary artery disease; CI ¼ confidence interval; GRADE ¼ Grading of Recommendations Assessment, Development, and Evaluation; NNT ¼ number needed to treat; OR ¼ odds ratio; PCI ¼ percutaneous coronary intervention; RCT ¼ randomized controlled trial; RR ¼ relative risk. *ORs from Bayesian network meta-analysis with 95% Credible Intervals.
3
329 Need for subsequent revascularization, 1- to 5-y follow-up
CAD ¼ coronary artery disease; CI ¼ confidence interval; GRADE ¼ Grading of Recommendations Assessment, Development, and Evaluation; NNT ¼ number needed to treat; OR ¼ odds ratio; PCI ¼ percutaneous coronary intervention; RCT ¼ randomized controlled trial. *ORs from Bayesian network meta-analysis with 95% Credible Intervals.
Favors PCI with drug-eluting stents Moderate 2444 (6 RCTs)4 OR* 2.2 (1.7-3.0) NNT 7 (5-10)
Quality of Evidence (GRADE) Low Low Outcome All-cause mortality, 1- to 5-y follow-up Myocardial infarction, 1- to 5-y follow-up
Risk with Intervention per 1000 94 94
Risk with Comparator per 1000 Attributable Events per 1000 Treated (95% CI) 79 57 Attributable events per 1000 treated, 26 (7-46) 190 Attributable events per 1000 treated, 151 (101-202)
Relative Measure of Association (95% CI) NNT (95% CI) OR* 0.9 (0.7-1.2) OR* 1.4 (1.0-2.0) NNT 38 (22-143)
No. of Participants (RCTs) 3470 (14 RCTs)4 3131 (10 RCTs)4
Comment No difference Favors PCI with drug-eluting stents
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Population: Adults with diabetes and multivessel CAD Settings: Inpatient Intervention: PCI with bare-metal stents Comparator: PCI with drug-eluting stents
Table 3
GRADE Summary—Percutaneous Coronary Intervention With Bare-Metal Stents Versus Drug-Eluting Stents for Adults With Diabetes and Multivessel Coronary Artery Disease
4
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and Interventions guideline for percutaneous coronary intervention. A report of the American College of Cardiology Foundation, the American Heart Association Task Force on Practice Guidelines, and the Society for Cardiovascular Angiography and Interventions, 2011 (Appraisal of Guidelines for Research and Evaluation II score: 74%).1 This guideline states that coronary artery bypass grafting probably is recommended in preference to percutaneous coronary intervention to improve survival in patients with multivessel coronary artery disease and diabetes mellitus, particularly if a left internal mammary artery graft can be anastomosed to the left anterior descending artery (level of evidence: B, limited population evaluated in single randomized controlled trials [RCTs] or nonrandomized studies). European Society of Cardiology guidelines on diabetes, prediabetes, and cardiovascular diseases, developed in collaboration with the European Association for the Study of Diabetes. The Task Force on Diabetes, Prediabetes, and Cardiovascular Diseases of the European Society of Cardiology in collaboration with the European Association for the Study of Diabetes, 2013 (Appraisal of Guidelines for Research and Evaluation II score: 53%).3 This guideline recommends coronary artery bypass grafting in patients with diabetes mellitus and multivessel or complex (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery score >22) coronary artery disease to improve survival free from major cardiovascular events (level of evidence: A, strong recommendation based on high-quality evidence from RCTs). This guideline recommends that in patients with diabetes mellitus who received percutaneous coronary intervention, drug-eluting stents rather than bare-metal stents are recommended to reduce the risk of target vessel revascularization (level of evidence: A, strong recommendation based on high-quality evidence from RCTs).
AUTHOR COMMENTARY Our comprehensive search in PubMed, Cochrane Library, EMBASE, and clinicaltrials.gov identified 2 individual patient data and 24 aggregate data meta-analyses of RCTs, unpublished data from 3 RCTs, 2 post hoc analyses of 2 RCTs, and 5 observational studies.4-87 We graded the quality of evidence according to the criteria from the Grading of Recommendations, Assessment, Development, and Evaluations Working Group. Low-quality evidence suggests that when compared with percutaneous coronary intervention with drug-eluting stents, coronary artery bypass grafting reduces mortality and the need for subsequent revascularizations and improves quality of life but increases the risk for stroke (Table 1). Reduction in mortality after coronary artery bypass grafting versus percutaneous coronary intervention was largest in people with diabetes aged more than 59 years of age in a
Aronow and Shamliyan
CABG Versus PCI in People With Diabetes
meta-analysis of individual patient data from 10 RCTs (adjusted relative risk, 0.61; 95% confidence interval [CI], 0.44-0.85).53 Observational studies confirmed better survival after coronary artery bypass grafting but rarely reported stroke as an outcome in adults with diabetes undergoing revascularization for coronary artery disease (Appendix Table 1, available online). Only 1 observational study examining the risk of stroke did not find a statistically significant association between coronary artery bypass grafting and the risk of stroke in Japanese adults with diabetes (Appendix Table 1, available online).16 Low-quality evidence suggests that when compared with percutaneous coronary intervention with bare-metal stents, coronary artery bypass grafting reduces mortality and the need for subsequent revascularization (Table 2). Low-quality evidence suggests that percutaneous coronary intervention with drug-eluting stents, when compared with percutaneous coronary intervention with bare-metal stents, reduces the risk for myocardial infarction and revascularization (Table 3). A single observational study reported that people with diabetes with prior percutaneous coronary intervention had poorer long-term outcomes after coronary artery bypass grafting revascularization compared with those who had no prior percutaneous coronary intervention.14 All published meta-analyses reported better survival after coronary artery bypass grafting but a higher risk for stroke when compared with percutaneous coronary intervention.55,58,61-63,65,67-69,74 Post hoc analysis of the largest RCTs of diabetic patients revealed that levels of low-density lipoprotein >105 mg/dL (adjusted hazard ratio [HR], 3.28; 95% CI, 1.19-9.02) and renal insufficiency (adjusted HR, 3.57; 95% CI, 1.01-12.64) were associated with more than a 200% increase in relative risk for later stroke.78 In contrast, and for unclear reasons, each 1 mm Hg increase in diastolic blood pressure was associated with a 5% relative reduction in the risk for stroke (adjusted HR, 0.95; 95% CI, 0.91-0.99).78 We downgraded the quality of evidence because of risk of bias in the body of evidence, small number of events, and inconsistency in treatment effects. We also downgraded the quality of evidence from indirect comparisons in the network meta-analysis.4 Current clinical practice guidelines recommend coronary artery bypass grafting over percutaneous coronary intervention for diabetic patients with multivessel disease.1,3 However, the choice of treatment always should be individualized depending on the baseline risk for stroke, renal function, and anticoagulant use. Future research is needed to examine the role of patient characteristics and provider skills and the quality of provided care on patient survival and quality of life in patients undergoing these procedures.
ACKNOWLEDGMENT The authors thank David Goldmann, MD, for his contribution to the development of the clinical question, review protocol, and preliminary analysis of the evidence.
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SUPPLEMENTARY DATA Supplementary table accompanying this article can be found in the online version at http://dx.doi.org/10.1016/j.amjmed. 2017.03.034.
Risk With Intervention Risk With Adjusted Relative Measure Outcome Per 1000 Comparator Per 1000 of Association (95% CI) Registry of 8 community hospitals, US Mortality, 5-8 y NR NR OR 1.67 (1.08-2.56) NR NR OR 1.75 (1.43-3.23) MACE (mortality, nonfatal myocardial infarction, or revascularization), 5-8 y Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI/CABG Registry Cohort-2, Japan Mortality, 5 y NR NR HR 1.31 (1.01-1.70) Cardiac death, 5 y NR NR HR 1.45 (1.00-2.51) MI, 5 y NR NR HR 2.31 (1.31-4.08) Any coronary NR NR HR 3.70 (2.91-4.69) revascularization), 5 y Stroke, 5 y NR NR HR 1.07 (0.72-1.59) Elderly in a single center in Japan Mortality, 3.5 y NR NR HR 1.37 (0.72-2.50) Single-center study in China All-cause death, 3 y NR NR HR 1.10 (0.70-1.75) Death, MI, and stroke, 3 y NR NR HR 0.66 (0.51-0.87) Repeat revascularization, 3 y NR NR HR 6.74 (4.38-10.37)
No. of Participants (Studies)
Quality of Evidence (GRADE)
Comment
1082 (1 study)17 1082 (1 study)17
Very low Very low
Favors CABG Favors CABG
Very Very Very Very
Favors Favors Favors Favors
1998 1998 1998 1998
(1 (1 (1 (1
study)16 study)16 study)16 study)16
low low low low
CABG CABG CABG CABG
1998 (1 study)16
Very low
No difference
483 (1 study)15
Very low
No difference
1154 (1 study)13 1154 (1 study)13 1154 (1 study)13
Very low Very low Very low
No difference Favors PCI Favors CABG
CABG Versus PCI in People With Diabetes
Population: Adults with diabetes and multivessel CAD Settings: Inpatient Intervention: PCI Comparator: CABG
Aronow and Shamliyan
Appendix Table 1 GRADE Summary—Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting for Adults With Diabetes and Multivessel Coronary Artery Disease: Results From Observational Studies
CABG ¼ coronary artery bypass grafting; CAD ¼ coronary artery disease; CI ¼ confidence interval; GRADE ¼ Grading of Recommendations Assessment, Development, and Evaluation; HR ¼ hazard ratio; NR ¼ not reported; OR ¼ odds ratio; MACE ¼ major adverse cardiac events; MI ¼ myocardial infarction; PCI ¼ percutaneous coronary intervention.
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