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.
OBJECTIVE
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.
Abbott
J Dawn
JD
Department of Cardiology, Rhode Island Hospital, Providence, Rhode Island, USA. jabbott@lifespan.org
Voss
Matthew R
MR
Nakamura
Mamoo
M
Cohen
Howard A
HA
Selzer
Faith
F
Kip
Kevin E
KE
Vlachos
Helen A
HA
Wilensky
Robert L
RL
Williams
David O
DO
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D003327:Coronary Disease / Q000628:therapy*; D054059:Coronary Occlusion / Q000628:therapy; D023903:Coronary Restenosis / Q000628:therapy; D003328:Coronary Thrombosis / Q000601:surgery / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D054555:National Heart, Lung, and Blood Institute (U.S.); D016896:Treatment Outcome; D014481:United States