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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Unrestricted Use of Drug-Eluting Stents Compared With Bare-Metal Stents in Routine Clinical Practice

Findings From the National Heart, Lung, and Blood Institute Dynamic Registry

J. Dawn Abbott, MD, FACC^_*,_*, Matthew R. Voss, MD^_*, Mamoo Nakamura, MD, Howard A. Cohen, MD, FACC, Faith Selzer, PhD, Kevin E. Kip, PhD,, Helen A. Vlachos, MSc, Robert L. Wilensky, MD, FACC and David O. Williams, MD, FACC^_*

^_* Department of Cardiology, Rhode Island Hospital, Providence, Rhode Island
Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania
Lenox Hill Heart and Vascular Institute, New York, New York
Cardiovascular Division, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania

Manuscript received February 16, 2007; revised manuscript received June 27, 2007, accepted July 2, 2007.

^_* Reprint requests and correspondence: Dr. J. Dawn Abbott, Rhode Island Hospital, 814 APC, 593 Eddy Street, Providence, Rhode Island 02903. (Email: jabbott{at}lifespan.org).

Objectives: We investigated the effectiveness and safety of drug-eluting stents (DES) as used in routine clinical practice.

Background: Randomized trials have shown that DES prevent target vessel revascularization in selected patients, but whether this translates into superior outcomes, compared with bare-metal stents (BMS), for the full spectrum of patients treated with DES in North America is unknown.

Methods: Patients in the National Heart, Lung, and Blood Institute Dynamic Registry enrolled in 2004 who received at least 1 DES (n = 1,460) were compared with 1,763 patients enrolled in the recruitment period immediately preceding the approval of DES (2001 to 2002) who received at least 1 BMS.

Results: Patients receiving DES more often had diabetes mellitus and less often presented with an acute myocardial infarction (MI). At 1 year, cumulative death and MI was 7.6% in DES- and 8.7% in BMS-treated patients (adjusted hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.68 to 1.15; p = 0.34). The 1-year rate of target vessel revascularization was 5.0% in DES and 9.2% in BMS patients (p < 0.001), and the risk of any repeat revascularization by percutaneous coronary intervention or coronary bypass was lower in DES patients (adjusted HR 0.38, 95% CI 0.25 to 0.60; p < 0.001). Patients with both simple and complex lesion characteristics benefited from DES with lower risk of repeat target vessel revascularization by percutaneous coronary intervention compared with BMS (any complex lesion: adjusted HR 0.57, 95% CI 0.39 to 0.83; absence of any complex lesion: adjusted HR 0.44, 95% CI 0.28 to 0.71). The 1-year incidence of stent thrombosis was 1.0% in DES patients.

Conclusions: The generalized use of DES resulted in better outcomes than BMS, with fewer clinically driven revascularization procedures and similar rates of death and MI at 1 year.

Abbreviations and Acronyms   BMS = bare metal stent(s)   DES = drug-eluting stent(s)   HR = hazard ratio   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention

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