CABG or PCI: Patients with Diabetes – CABG Rein Supreme
Reporter: Aviva Lev-Ari, PhD, RN
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Compelling Evidence for Coronary-Bypass Surgery in Patients with Diabetes
Mark A. Hlatky, M.D.
November 4, 2012DOI: 10.1056/NEJMe1212278
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Seventeen years ago, the National Heart, Lung, and Blood Institute issued a clinical alert1 that coronary-artery bypass grafting (CABG) had better rates of survival than percutaneous coronary intervention (PCI) in patients with diabetes. The alert was based on the results of the Bypass Angioplasty Revascularization Investigation (BARI) trial,2 in which patients with multivessel coronary artery disease were randomly assigned to undergo either CABG or PCI.
This recommendation has been controversial ever since, largely because subsequent trials comparing CABG and PCI have enrolled only small numbers of patients with diabetes. A pooled analysis of 10 randomized trials involving 1233 patients with diabetes confirmed that such patients had a particular survival advantage after CABG, as compared with PCI.3 But this evidence was discounted because drug-eluting stents were not used in PCI procedures in the earlier trials, and more recent trials in which drug-eluting stents were used4,5 enrolled relatively few patients with diabetes. Settling this controversy would require a trial with a large number of patients with both diabetes and multivessel coronary artery disease in whom CABG or PCI would be performed with the use of contemporary methods.
Farkouh et al.6 now report in the Journal the results of the definitive Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM) trial, in which 1900 patients with diabetes (about as many patients with diabetes as in all previous trials combined) were randomly assigned to undergo either CABG or PCI with drug-eluting stents.
As a cardiologist who does not perform either procedure, I find that the FREEDOM trial provides compelling evidence of the comparative effectiveness of CABG versus PCI in patients with diabetes and multivessel coronary artery disease. After 5 years of follow-up, the 947 patients assigned to undergo CABG had significantly lower mortality (10.9% vs. 16.3%) and fewer myocardial infarctions (6.0% vs. 13.9%) than the 953 patients assigned to undergo PCI. However, patients in the CABG group had significantly more strokes (5.2% vs. 2.4%), mostly because of strokes that occurred within 30 days after revascularization. In the CABG group, the primary composite outcome of death, myocardial infarction, or stroke over 5 years was reduced by 7.9 percentage points, or a relative decrease of 30%, as compared with PCI (18.7% vs. 26.6%, P=0.005). These results are consistent with the findings of multiple previous trials comparing CABG and PCI in patients with diabetes,3 as well as the most recent trials in which drug-eluting stents were used during PCI.4,5
Despite the results of BARI and other trials, over time more and more patients with diabetes have undergone PCI rather than CABG to treat multivessel coronary disease.7,8 The reasons for this trend are uncertain, yet there are two broad potential explanations. First, because PCI technology continues to evolve, many cardiologists simply have dismissed the results of earlier randomized studies as outdated because they used earlier techniques. This is a catch-22, since long-term studies are needed to compare hard outcomes, but evidence from long-term studies may be ignored if therapies are evolving. The results of the FREEDOM trial suggest that the comparative effectiveness of CABG and PCI on hard outcomes remains similar whether PCI is performed without stents, with bare-metal stents, or with drug-eluting stents. Mortality has been consistently reduced by CABG, as compared with PCI, in more than 4000 patients with diabetes who have been evaluated in 13 clinical trials. The controversy should finally be settled.
Another potential reason for the increasing use of PCI in patients with multivessel coronary disease is that the clinical-decision pathway leads patients toward PCI over alternative treatments. Many PCIs today are ad hoc procedures, performed at the time of diagnostic coronary angiography, with the same physician making the diagnosis, recommending the treatment, and performing the procedure. There is little time for informed discussion about alternative treatment options, either medical therapy on the one hand or CABG on the other. Well-informed patients might choose any of those options on the basis of their concerns about the various outcomes of treatment, such as survival, stroke, myocardial infarction, angina, and recovery time. This is a complicated decision, and clinical guidelines in the United States9 and Europe10 now emphasize the importance of more deliberate decision making about coronary revascularization, including discussions with a multidisciplinary heart team.
The results of the FREEDOM trial suggest that patients with diabetes ought to be informed about the potential survival benefit from CABG for the treatment of multivessel disease. These discussions should begin before coronary angiography in order to provide enough time for the patient to digest the information, discuss it with family members and members of the heart team, and come to an informed decision.
Disclosure forms provided by the author are available with the full text of this article at NEJM.org.
This article was published on November 4, 2012, at NEJM.org.
SOURCE INFORMATION
From Stanford University School of Medicine, Stanford, CA.
REFERENCES:
REFERENCES
- National Heart, Lung, and Blood Institute (NHLBI). Clinical alert: bypass over angioplasty for patients with diabetes. US National Library of Medicine, National Institutes of Health, September 21, 1995 (http://www.nlm.nih.gov/databases/alerts/bypass_diabetes.html).
- The Bypass Angioplasty Revascularization Investigation (BARI) Investigators. Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease. N Engl J Med 1996;335:217-225[Erratum, N Engl J Med 1997;336:147.]Full Text | Web of Science
- Hlatky MA, Boothroyd DB, Bravata DM, et al. Coronary artery bypass surgery compared with percutaneous coronary interventions for multivessel disease: a collaborative analysis of individual patient data from ten randomised trials. Lancet 2009;373:1190-1197CrossRef | Web of Science | Medline
- 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;32:2125-2134CrossRef | Web of Science
- Hall R. Coronary Artery Revascularisation in Diabetes trial: five year follow-up data. ESC Clinical Trial and Registry update, Munich, August 27, 2012 (http://www.escardio.org/congresses/esc-2012/congress-reports/Pages/710-5-CARDia.aspx).
- Farkouh ME, Domanski M, Sleeper LA, et al. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med 2012. DOI: 10.1056/NEJMoa1211585.
- Hassan A, Newman A, Ko DT, et al. Increasing rates of angioplasty versus bypass surgery in Canada, 1994-2005. Am Heart J 2010;160:958-965CrossRef | Web of Science
- Frutkin AD, Lindsey JB, Mehta SK, et al. Drug-eluting stents and the use of percutaneous coronary intervention among patients with class I indications for coronary artery bypass surgery undergoing index revascularization: analysis from the NCDR (National Cardiovascular Data Registry). JACC Cardiovasc Interv 2009;2:614-621CrossRef | Web of Science
- Hillis LD, Smith PK, Anderson JL, et al. 2011 ACCF/AHA guideline for coronary artery bypass graft surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists and Society of Thoracic Surgeons. J Am Coll Cardiol 2011;58:e123-e210CrossRef | Web of Science
- Wijns W, Kolh P, Danchin N, et al. Guidelines on myocardial revascularization. Eur Heart J2010;31:2501-2555CrossRef | Web of Science | Medline
SOURCE:
http://www.nejm.org/doi/full/10.1056/NEJMe1212278?query=OF
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Many thanks,Annette
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Many thanks,Annette
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Many thanks,Annette
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Many thanks,Annette