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J Am Coll Cardiol, 2007; 49:1600-1606, doi:10.1016/j.jacc.2006.11.048
(Published online 30 March 2007). © 2007 by the American College of Cardiology Foundation |
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Manuscript received August 11, 2006; revised manuscript received November 20, 2006, accepted November 21, 2006.
* Reprint requests and correspondence: Dr. Maria Mori Brooks, The University of Pittsburgh, Graduate School of Public Health, 127 Parran Hall/130 DeSoto Street, Pittsburgh, Pennsylvania 15261. E-mail: mbrooks@pitt.edu
| Abstract |
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Background: Angioplasty and bypass surgery have been compared in numerous studies, but long-term clinical outcomes are limited.
Methods: Symptomatic patients with multivessel coronary artery disease (n = 1,829) were randomly assigned to initial treatment with PTCA or CABG and followed up for an average of 10.4 years. Analyses were conducted on an intention-to-treat basis.
Results: The 10-year survival was 71.0% for PTCA and 73.5% for CABG (p = 0.18). At 10 years, the PTCA group had substantially higher subsequent revascularization rates than the CABG group (76.8% vs. 20.3%, p < 0.001), but angina rates for the 2 groups were similar. In the subgroup of patients with no treated diabetes, survival rates were nearly identical by randomization (PTCA 77.0% vs. CABG 77.3%, p = 0.59). In the subgroup with treated diabetes, the CABG assigned group had higher survival than the PTCA assigned group (PTCA 45.5% vs. CABG 57.8%, p = 0.025).
Conclusions: There was no significant long-term disadvantage regarding mortality or myocardial infarction associated with an initial strategy of PTCA compared with CABG. Among patients with treated diabetes, CABG conferred long-term survival benefit, whereas the 2 initial strategies were equivalent regarding survival for patients without diabetes.
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An unexpected finding of the BARI trial was that among patients without treated diabetes, survival rates for the PTCA and CABG randomized groups were almost identical throughout the 7 years of follow-up, whereas among patients with treated diabetes, the CABG group had significantly better survival. The survival difference was attributable to reduced cardiac mortality (3).
This report describes the final 10-year results from the BARI randomized trial for the entire study group as well as for subgroups defined by treated diabetes status.
| Methods |
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The vital status of each patient was ascertained on March 31, 2000; patients who had not completed 10 years of follow-up by that date were followed up until they reached their 10-year visit. The BARI study ceased following up patients in 2002.
The primary end point was all-cause mortality, and secondary end points included death of cardiac cause, the composite end point of death or Q-wave myocardial infarction (MI), the composite end point of death of cardiac cause or any MI (Q-wave or nonQ-wave), subsequent revascularization procedures, and anginal status. All MI events were classified by the BARI central laboratory (St. Louis University) based on serial electrocardiographic analysis regardless of symptoms (4). The cause of death was classified by an independent review committee.
A priori subgroups specified by the BARI protocol included anginal status, number of diseased vessels, proximal left anterior descending coronary artery disease, left ventricular function, and lesion complexity. The BARI central radiographic laboratory (Stanford University) interpreted baseline coronary angiograms (5). Based on a request from the study Data and Safety Monitoring Board in 1992, patients were classified by treated diabetes status defined as treatment with either oral hypoglycemic medication or insulin at study entry.
Statistical methods. Kaplan-Meier estimates and log rank tests were used to compare death, cardiac events, and subsequent revascularization rates according to the intention-to-treat principle. The mean restricted life expectancy was estimated by the area under the survival curve between 0 and 10 years. The significance of statistical interactions between randomized treatment and subgroup variables were assessed with Cox regression. Generalized estimation equations were used to analyze presence of angina over time, and Nelson-Aalen methods were used to estimate the number of subsequent procedures. A value of p < 0.05 was considered statistically significant except for the treatment comparisons within identified subgroups, in which p < 0.01 was used to control for multiple comparisons.
| Results |
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Repeat revascularization. A significantly smaller proportion of patients assigned to CABG received subsequent revascularization (Table 3), and they had substantially fewer revascularization procedures over the 10 years of follow-up (Fig. 5).
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| Discussion |
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A comprehensive review of trials and registries comparing percutaneous coronary intervention with CABG is presented elsewhere (11). The BARI trial results are consistent with those of recent clinical trials such as ARTS (Arterial Revascularization Therapies Study) (12), which reported comparable 5-year mortality for coronary bare-metal stenting and CABG (8.0% stents vs. 7.6% CABG), but more subsequent revascularization (30.3% vs. 8.8%) and more angina (21.2% vs. 15.5%) in the stenting group. Meta-analyses (13) and registries (14) based on larger and more diverse populations have shown small but statistically significant survival advantages with CABG at 3 to 5 years. In the New York cardiac registry, 37,212 multivessel CAD patients undergoing CABG had better risk-adjusted survival than 22,102 undergoing stenting (14). Given the observed 10-year mortality rate in BARI, more than 7,200 patients would be required to have sufficient power to detect a 3% absolute difference in mortality, thus reflecting the challenge of conducting clinical trials.
In patients with type 2 diabetes, CABG conferred a consistent, clinically relevant, absolute survival benefit over balloon angioplasty that diminished somewhat over extended follow-up because patients in both groups had higher event rates. Five-year mortality results from ARTS (diabetes: 13.4% stents vs. 8.3% CABG, relative risk = 1.61, p = 0.27; no diabetes: 6.8% stents vs. 7.5% CABG, relative risk = 0.91, p = 0.71) (15) support the finding that CABG may have particular advantages for patients with diabetes. It remains to be seen whether advances in percutaneous procedures and medical management over the past decade will make contemporary angioplasty a reasonable option in this cohort.
The steady incidence of cardiac events over the 10 years of follow-up in both treatment groups emphasizes that coronary revascularization does not reverse the underlying pathophysiology of coronary disease. Underuse of evidence-based medical therapies is unfortunately common among patients with coronary disease. Clinical outcomes for all patients may be improved further by providing long-term aggressive medical management after revascularization.
| Appendix |
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This article was prepared by: Maria Mori Brooks, PhD, Edwin L. Alderman, MD, Eric Bates, MD, Martial Bourassa, MD, Robert M. Califf, MD, Bernard R. Chaitman, MD, Katherine M. Detre, MD, DrPH, Frederick Feit, MD, Robert L. Frye, MD, Raymond J. Gibbons, MD, Regina M. Hardison, MS, Mark A. Hlatky, MD, David R. Holmes, Jr., MD, Alice K. Jacobs, MD, Sheryl F. Kelsey, PhD, Mary Krauland, BS, William J. Rogers, MD, Hartzell V. Schaff, MD, Leonard Schwartz, MD, Kim Sutton-Tyrrell, DrPH, David O. Williams, MD, Patrick K. Whitlow, MD. Dr. Frye, as study chairman, assumes responsibility for overall content and integrity of this article.
From the University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania (M.M.B., K.M.D., R.M.H., S.F.K., M.K., K.S.-T.); Stanford University Medical Center, Stanford, California (E.L.A., M.A.H.); University of Michigan, Ann Arbor, Michigan (E.B.); Montreal Heart Institute, Montreal, Canada (M.B.); Duke University Medical Center, Durham, North Carolina (R.M.C.); St. Louis University Medical Center, St. Louis, Missouri (B.R.C.); New York University School of Medicine, New York, New York (F.R.); Mayo Clinic, Rochester, Minnesota (R.L.F., R.J.G., D.R.H., H.V.S.); Boston University Medical Center, Boston, Massachusetts (A.K.J.); University of Alabama at Birmingham, Birmingham, Alabama (W.J.R.); Toronto General Hospital, Toronto, Canada (L.S.); Brown University, Rhode Island Hospital, Providence, Rhode Island (D.O.W.); and the Cleveland Clinic Foundation, Cleveland, Ohio (P.L.W.).
| Acknowledgments |
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| Footnotes |
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* Please see the Appendix for a full list of the BARI Investigators. ![]()
| References |
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