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

https://doi.org/10.1016/j.jacc.2009.03.005Get rights and content
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Objectives

The aim of this study was to compare outcomes in older individuals receiving drug-eluting stents (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 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

Cited by (0)

This project was sponsored by the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services, Rockville, Maryland, as part of the Cardiovascular Consortium and funded under Project ID: 24-EHC-1 and Work Assignment Number: HHSAA290-2005-0032–TO4-WA1 as part of the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) program. The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services. Additional support was obtained from the National Cardiovascular Data Registry, American College of Cardiology, Washington, DC. Dr. Anstrom has received research support from AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Co., and Medtronic, and has served as a consultant for Johnson & Johnson and Pfizer. Dr. Eisenstein has received research support from Medtronic Vascular and Eli Lilly and Co. Dr. Curtis has received research support from Allergan, Eli Lilly and Co., GlaxoSmithKline, Medtronic, Merck & Co., Johnson & Johnson (Ortho Biotech), Novartis, OSI Eyetech, and Sanofi-Aventis. Dr. Peterson has received research support from BMS/Sanofi and Merck/Schering.