This Article Free upon publication Full Text Full Text (PDF) Data Supplement All Versions of this Article: 119/25/3198    most recent CIRCULATIONAHA.108.826479v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Google Scholar Articles by Kirtane, A. J. Articles by Stone, G. W. PubMed PubMed Citation Articles by Kirtane, A. J. Articles by Stone, G. W. Pubmed/NCBI databases Substance via MeSH Medline Plus Health Information Angioplasty Coronary Artery Disease Related Collections Catheter-based coronary interventions: stents Chronic ischemic heart disease Related Article

(Circulation. 2009;119:3198-3206.)
© 2009 American Heart Association, Inc.

Interventional Cardiology

Safety and Efficacy of Drug-Eluting and Bare Metal Stents

Comprehensive Meta-Analysis of Randomized Trials and Observational Studies

Ajay J. Kirtane, MD, SM; Anuj Gupta, MD; Srinivas Iyengar, MD; Jeffrey W. Moses, MD; Martin B. Leon, MD; Robert Applegate, MD; Bruce Brodie, MD; Edward Hannan, PhD; Kishore Harjai, MD; Lisette Okkels Jensen, MD; Seung-Jung Park, MD, PhD; Raphael Perry, MD; Michael Racz, PhD; Francesco Saia, MD, PhD; Jack V. Tu, MD, PhD; Ron Waksman, MD; Alexandra J. Lansky, MD; Roxana Mehran, MD; Gregg W. Stone, MD

From Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (A.J.K., A.G., S.I., J.W.M., M.B.L., A.J.L., R.M., G.W.S.); Wake Forest University Medical Center, Winston-Salem, NC (R.A.); Moses Cone Hospital, Greensboro, NC (B.B.); State University of New York, Albany (E.H.); Guthrie Health System, Sayre, Pa (K.H.); Odense University Hospital, Odense, Denmark (L.O.J.); Asan Medical Center, Korea (S.-J.P.); Cardiothoracic Centre National Health Service, Liverpool, UK (R.P.); New York State Department of Health, Albany (M.R.); University of Bologna, Bologna, Italy (F.S.); Institute for Clinical Evaluative Sciences, Toronto, Canada (J.V.T.); and Washington Hospital Center, Washington, DC (R.W.).

Correspondence to Gregg W. Stone, MD, Columbia University Medical Center, The Cardiovascular Research Foundation, 111 E 59th St, 11th Floor, New York, NY 10022.

Received October 7, 2008; accepted April 17, 2009.

Background— The safety and efficacy of drug-eluting stents (DES) among more generalized "real-world" patients than those enrolled in pivotal randomized controlled trials (RCTs) are controversial. We sought to perform a meta-analysis of DES studies to estimate the relative impact of DES versus bare metal stents (BMS) on safety and efficacy end points, particularly for non–Food and Drug Administration–labeled indications.

Methods and Results— Comparative DES versus BMS studies published or presented through February 2008 with 100 total patients and reporting mortality data with cumulative follow-up of 1 year were identified. Data were abstracted from studies comparing DES with BMS; original source data were used when available. Data from 9470 patients in 22 RCTs and from 182 901 patients in 34 observational studies were included. RCT and observational data were analyzed separately. In RCTs, DES (compared with BMS) were associated with no detectable differences in overall mortality (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.81 to 1.15; P=0.72) or myocardial infarction (HR, 0.95; 95% CI, 0.79 to 1.13; P=0.54), with a significant 55% reduction in target vessel revascularization (HR, 0.45; 95% CI, 0.37 to 0.54; P<0.0001); point estimates were slightly lower in off-label compared with on-label analyses. In observational studies, DES were associated with significant reductions in mortality (HR, 0.78; 95% CI, 0.71 to 0.86), myocardial infarction (HR, 0.87; 95% CI, 0.78 to 0.97), and target vessel revascularization (HR, 0.54; 95% CI, 0.48 to 0.61) compared with BMS.

Conclusions— In RCTs, no significant differences were observed in the long-term rates of death or myocardial infarction after DES or BMS use for either off-label or on-label indications. In real-world nonrandomized observational studies with greater numbers of patients but the admitted potential for selection bias and residual confounding, DES use was associated with reduced death and myocardial infarction. Both RCTs and observational studies demonstrated marked and comparable reductions in target vessel revascularization with DES compared with BMS. These data in aggregate suggest that DES are safe and efficacious in both on-label and off-label use but highlight differences between RCT and observational data comparing DES and BMS.

---

 

CLINICAL PERSPECTIVE

Related Article:

Clinical Summaries
Circulation 2009 119: 3163-3164. [Extract] [Full Text]

This article has been cited by other articles:

				R. A. Byrne, A. Kastrati, S. Kufner, S. Massberg, K. A. Birkmeier, K.-L. Laugwitz, S. Schulz, J. Pache, M. Fusaro, M. Seyfarth, et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial Eur. Heart J., October 2, 2009; 30(20): 2441 - 2449. [Abstract] [Full Text] [PDF]

				A. D. Kugelmass The quest for a 'better mousetrap' Eur. Heart J., October 2, 2009; 30(20): 2431 - 2432. [Full Text] [PDF]

				S. Cook and P. Wenaweser Off-Label Use and the Spectre of Drug-Eluting Stent Thrombosis Circ Cardiovasc Interv, August 1, 2009; 2(4): 273 - 276. [Full Text] [PDF]