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LATE-BREAKING CLINICAL TRIAL

Clinical Effectiveness of Coronary Stents in Elderly Persons

Results From 262,700 Medicare Patients in the American College of Cardiology-National Cardiovascular Data Registry

Pamela S. Douglas, MD^_*,_*, J. Matthew Brennan, MD^_*, Kevin J. Anstrom, PhD^_*, Art Sedrakyan, MD, PhD, Eric L. Eisenstein, DBA^_*, Ghazala Haque, MBBS, MHS^_*, David Dai, PhD^_*, David F. Kong, MD^_*, Bradley Hammill, PhD^_*, Lesley Curtis, PhD^_*, David Matchar, MD^_*, Ralph Brindis, MD^, and Eric D. Peterson, MD, MPH^_*

^_* Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
Agency for Healthcare Quality and Research, Rockville, Maryland
Kaiser Permanente, Oakland, California
American College of Cardiology, Washington, DC

Manuscript received February 13, 2009; revised manuscript received March 5, 2009, accepted March 9, 2009.

^_* Reprint requests and correspondence: Dr. Pamela S. Douglas, 7022 North Pavilion DUMC, P.O. Box 17969, Durham, North Carolina 27715 (Email: pamela.douglas{at}duke.edu).

Objectives: The aim of this study was to compare outcomes in older individuals receiving drug-eluting (DES) and bare-metal stents (BMS).

Background: Comparative effectiveness of DES relative to BMS remains unclear.

Methods: Outcomes were evaluated in 262,700 patients from 650 National Cardiovascular Data Registry sites during 2004 to 2006 with procedural registry data linked to Medicare claims for follow-up. Outcomes including death, myocardial infarction (MI), revascularization, major bleeding, stroke, death or MI, death or MI or revascularization, and death or MI or stroke were compared with estimated cumulative incidence rates with inverse probability weighted (IPW) estimators and Cox proportional hazards ratios.

Results: The DES were implanted in 217,675 patients and BMS were implanted in 45,025. At 30 months, DES patients had lower unadjusted rates of death (12.9% vs. 17.9%), MI (7.3 of 100 patients vs. 10.0 of 100 patients), and revascularization (23.0 of 100 patients vs. 24.5 of 100 patients) with no difference in stroke or bleeding. After adjustment, DES patients had lower rates of death (13.5% vs. 16.5%, hazard ratio [HR]: 0.75, 95% confidence interval [CI]: 0.72 to 0.79, p < 0.001) and MI (7.5 of 100 patients vs. 8.9 of 100 patients, HR: 0.77, 95% CI: 0.72 to 0.81, p < 0.001), with minimal difference in revascularization (23.5 of 100 patients vs. 23.4 of 100 patients; HR: 0.91, 95% CI: 0.87 to 0.96), stroke (3.1 of 100 patients vs. 2.7 of 100 patients, HR: 0.97, 95% CI: 0.88 to 1.07), or bleeding (3.4 of 100 patients vs. 3.6 of 100 patients, HR: 0.91, 95% CI: 0.84 to 1.00). The DES survival benefit was observed in all subgroups analyzed and persisted throughout 30 months of follow-up.

Conclusions: In this largest ever real-world study, patients receiving DES had significantly better clinical outcomes than their BMS counterparts, without an associated increase in bleeding or stroke, throughout 30 months of follow-up and across all pre-specified subgroups.

Key Words: comparative effectiveness • coronary revascularization • drug-eluting stent

Abbreviations and Acronyms   ACC = American College of Cardiology   BMS = bare-metal stent(s)   CABG = coronary artery bypass grafting   CI = confidence interval   DES = drug-eluting stent(s)   FDA = Food and Drug Administration   HR = hazard ratio   IPW = inverse propensity weighted scoring   MI = myocardial infarction   NCDR = National Cardiovascular Data Registry   NSTEMI = non–ST-segment elevation myocardial infarction   PCI = percutaneous coronary intervention   RCT = randomized controlled trial   STEMI = ST-segment elevation myocardial infarction

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