- Levine G.N.
- Bates E.R.
- Blankenship J.C.
- et al.
- Pandey A.
- McGuire D.K.
- de Lemos J.A.
- et al.
What Is the Clinical Question?
What Does the Evidence Conclude?
Intervention | Quality of Evidence ∗ 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. | 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 |
What Are the Parameters for Our Evidence Search and Basis for Our Conclusions?
Population
Intervention
Comparator
Primary Outcomes
What Do the Clinical Guidelines Say?
- Levine G.N.
- Bates E.R.
- Blankenship J.C.
- et al.
- •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).
- Ryden L.
- Grant P.J.
- et al.
ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD).
- •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
- Sipahi I.
- Akay M.H.
- Dagdelen S.
- Blitz A.
- Alhan C.
NCT00326196. Coronary Artery Revascularization in Diabetes. 2006. Available at: https://clinicaltrials.gov/ct2/show/NCT00326196.
- Morice M.C.
- Serruys P.W.
- Kappetein A.P.
- et al.
- Soares P.R.
- Hueb W.A.
- Lemos P.A.
- et al.
- Flather M.
- Rhee J.W.
- Boothroyd D.B.
- et al.
- Ariyaratne T.V.
- Ademi Z.
- Yap C.H.
- et al.
- Athappan G.
- Chacko P.
- Patvardhan E.
- Gajulapalli R.D.
- Tuzcu E.M.
- Kapadia S.R.
- Fanari Z.
- Weiss S.A.
- Zhang W.
- Hadid M.
- Weintraub W.S.
- Hakeem A.
- Garg N.
- Bhatti S.
- Rajpurohit N.
- Ahmed Z.
- Uretsky B.F.
- Lang C.
- Shim H.G.
- Arora R.
- Verma S.
- Yanagawa B.
- Ahsan M.
- et al.
NCT00326196, Coronary artery revascularization in diabetes (VA CARDS), Available at: https://clinicaltrials.gov/ct2/show/NCT00326196?term=NCT00326196&rank=1.
NCT00006305. Bypass angioplasty revascularization investigation in type 2 diabetes. 2000. Available at: https://clinicaltrials.gov/ct2/show/NCT00006305?term=NCT00006305&rank=1.
NCT00086450. Comparison of two treatments for multivessel coronary artery disease in individuals with diabetes (FREEDOM). 2004. Available at: https://clinicaltrials.gov/ct2/show/NCT00086450?term=NCT00086450&rank=1.
- Flather M.
- Rhee J.W.
- Boothroyd D.B.
- et al.
Population: Adults with diabetes and multivessel CAD | ||||||
Settings: Inpatient | ||||||
Intervention: PCI with drug-eluting stents | ||||||
Comparator: CABG | ||||||
Outcome | Risk With Intervention Per 1000 | Risk With Comparator Per 1000 | Relative Measure of Association (95% CI) | No. of Participants (Studies) | Quality of Evidence (GRADE) | Comment |
---|---|---|---|---|---|---|
All-cause mortality, 1- to 5-y follow-up | 142 | 90 Attributable events per 1000 treated, 40 (8-73) | OR 1.4 (1.1-1.9) NNT 25 (14-125) | 3516 (7 RCTs) 4 , 5
Coronary artery bypass grafting vs percutaneous coronary intervention and long-term mortality and morbidity in multivessel disease: meta-analysis of randomized clinical trials of the arterial grafting and stenting era. JAMA Intern Med. 2014; 174: 223-230 | Low | Favors CABG |
All-cause mortality, 5-y follow-up | 169 | 112 Attributable events per 1000 treated, 63 (19-107) | RR 1.5 (1.1-2.1) NNT 16 (9-53) | 2588 (4 RCTs) 6 | Very low | Favors CABG |
Death/MI/stroke events | 214 | 165 Attributable events per 1000 treated, 49 (23-76) | HR 1.4 (1.2-1.7) NNT 20 (13-43) | 3443 (individual participant data meta-analysis of 3 RCTs) 7 , 8 , 9 , 10 | Moderate | Favors CABG |
Myocardial infarction, 1- to 5-y follow-up | 103 | 60 | OR 1.3 (0.9-2.0) | 3516 (7 RCTs) 4 | Very low | No difference |
Nonfatal myocardial infarction at 5-y follow-up | 125 | 67 | RR 1.5 (0.8-2.8) | 2620 (4 RCTs) 6 | Very low | No difference |
Need for subsequent revascularization, 1- to 5-y follow-up | 263 | 113 Attributable events per 1000 treated, 107 (41-174) | OR 2.4 (1.7-3.1) NNT 9 (6-24) | 3516 (7 RCTs) 4 | Low | Favors CABG |
Stroke, 1- to 5-y follow-up | 24 | 41 Attributable avoided events per 1000 treated, 15 (3-27) | RR 0.6 (0.4-0.8) NNTp 67 (37-333) | 3516 (7 RCTs) 4 | Low | Favors PCI |
Quality of life at 2-y follow-up, Seattle Angina Questionnaire, total score | NR | NR | MD −2.2 (−3.8 to −0.7) | 1900 (1 RCT) 11 | Very low | Favors CABG |
Total, nonserious adverse events | 69 | 690 Attributable avoided events per 1000 treated 621 (517-726) | RR 0.10 (0.05-0.21) NNTp 2 (1-2) | 198 (1 RCT) 12 NCT00326196. Coronary Artery Revascularization in Diabetes. 2006. Available at: https://clinicaltrials.gov/ct2/show/NCT00326196. | Very low | Favors PCI |
Total, serious adverse events | 227 | 474 Attributable avoided events per 1000 treated 247 (118-375) | RR 0.48 (0.32-0.73) NNTp 4 (3-8) | 198 (1 RCT) 12 NCT00326196. Coronary Artery Revascularization in Diabetes. 2006. Available at: https://clinicaltrials.gov/ct2/show/NCT00326196. | Very low | Favors PCI |
Population: Adults with diabetes and multivessel CAD | ||||||
Settings: Inpatient | ||||||
Intervention: PCI with bare-metal stents | ||||||
Comparator: CABG | ||||||
Outcome | Risk With Intervention Per 1000 | Risk With Comparator Per 1000 | Relative Measure of Association (95% CI) | No. of Participants (Studies) | Quality of Evidence (GRADE) | Comment |
---|---|---|---|---|---|---|
All-cause mortality, 5-y follow-up | 127 | 82 Attributable events per 1000 treated, 54 (5-102) | RR 1.4 (0.8-2.5) NNT 19 (10-200) | 543 (4 RCTs) 6 | Low | Favors CABG |
Nonfatal myocardial infarction, 5-y follow-up | 89 | 88 | RR 1.0 (0.4-2.5) | 350 (2 RCTs) 6 | Low | No difference |
Myocardial infarction, 1- to 5-y follow-up | 100 | 58 | OR 1.9 (1.2-2.9) | 752 (4 RCTs) 4 | Low | Favors CABG |
Need for subsequent revascularization, 1- to 5-y follow-up | 328 | 72 Attributable events per 1000 treated, 216 (144-287) | OR 5.2 (3.7-7.4) NNT 5 (3-7) | 896 (5 RCTs) 4 | Low | Favors CABG |
Need for subsequent revascularization, 5-y follow-up | 361 | 82 Attributable events per 1000 treated, 261 (135-387) | RR 4.2 (2.5-7.2) NNT 4 (3-7) | 350 (2 RCTs) 6 | Very low | Favors CABG |
Population: Adults with diabetes and multivessel CAD | ||||||
Settings: Inpatient | ||||||
Intervention: PCI with bare-metal stents | ||||||
Comparator: PCI with drug-eluting stents | ||||||
Outcome | Risk with Intervention per 1000 | Risk with Comparator per 1000 Attributable Events per 1000 Treated (95% CI) | Relative Measure of Association (95% CI) NNT (95% CI) | No. of Participants (RCTs) | Quality of Evidence (GRADE) | Comment |
---|---|---|---|---|---|---|
All-cause mortality, 1- to 5-y follow-up | 94 | 79 | OR 0.9 (0.7-1.2) | 3470 (14 RCTs) 4 | Low | No difference |
Myocardial infarction, 1- to 5-y follow-up | 94 | 57 Attributable events per 1000 treated, 26 (7-46) | OR 1.4 (1.0-2.0) NNT 38 (22-143) | 3131 (10 RCTs) 4 | Low | Favors PCI with drug-eluting stents |
Need for subsequent revascularization, 1- to 5-y follow-up | 329 | 190 Attributable events per 1000 treated, 151 (101-202) | OR 2.2 (1.7-3.0) NNT 7 (5-10) | 2444 (6 RCTs) 4 | Moderate | Favors PCI with drug-eluting stents |
- Hakeem A.
- Garg N.
- Bhatti S.
- Rajpurohit N.
- Ahmed Z.
- Uretsky B.F.
- Levine G.N.
- Bates E.R.
- Blankenship J.C.
- et al.
- Ryden L.
- Grant P.J.
- et al.
ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD).
Acknowledgment
Appendix
Population: Adults with diabetes and multivessel CAD | ||||||
Settings: Inpatient | ||||||
Intervention: PCI | ||||||
Comparator: CABG | ||||||
Outcome | Risk With Intervention Per 1000 | Risk With Comparator Per 1000 | Adjusted Relative Measure of Association (95% CI) | No. of Participants (Studies) | Quality of Evidence (GRADE) | Comment |
---|---|---|---|---|---|---|
Registry of 8 community hospitals, US | ||||||
Mortality, 5-8 y | NR | NR | OR 1.67 (1.08-2.56) | 1082 (1 study) 17 | Very low | Favors CABG |
MACE (mortality, nonfatal myocardial infarction, or revascularization), 5-8 y | NR | NR | OR 1.75 (1.43-3.23) | 1082 (1 study) 17 | Very low | Favors CABG |
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) | 1998 (1 study) 16 | Very low | Favors CABG |
Cardiac death, 5 y | NR | NR | HR 1.45 (1.00-2.51) | 1998 (1 study) 16 | Very low | Favors CABG |
MI, 5 y | NR | NR | HR 2.31 (1.31-4.08) | 1998 (1 study) 16 | Very low | Favors CABG |
Any coronary revascularization), 5 y | NR | NR | HR 3.70 (2.91-4.69) | 1998 (1 study) 16 | Very low | Favors CABG |
Stroke, 5 y | NR | NR | HR 1.07 (0.72-1.59) | 1998 (1 study) 16 | Very low | No difference |
Elderly in a single center in Japan | ||||||
Mortality, 3.5 y | NR | NR | HR 1.37 (0.72-2.50) | 483 (1 study) 15 | Very low | No difference |
Single-center study in China | ||||||
All-cause death, 3 y | NR | NR | HR 1.10 (0.70-1.75) | 1154 (1 study) 13 | Very low | No difference |
Death, MI, and stroke, 3 y | NR | NR | HR 0.66 (0.51-0.87) | 1154 (1 study) 13 | Very low | Favors PCI |
Repeat revascularization, 3 y | NR | NR | HR 6.74 (4.38-10.37) | 1154 (1 study) 13 | Very low | Favors CABG |
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Article info
Publication history
Footnotes
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.