Drug-eluting stents versus bare-metal stents for treatment of bare-metal in-stent restenosis.
OBJECTIVE
We compared the long-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) for treatment of bare-metal in-stent restenosis (ISR).


BACKGROUND
There are no randomized trials or observational studies directly comparing the safety and efficacy of DES versus BMS for treatment of bare-metal ISR.


METHODS
We examined data on all patients who underwent percutaneous coronary intervention (PCI) for ISR at Cleveland Clinic between 05/1999 and 06/2007. We compared the efficacy and safety of DES to BMS for treating bare-metal ISR. The primary end point was a composite of death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were individual components of the primary endpoint.


RESULTS
Of the 931 patients identified over 8 years, 706 had bare-metal ISR and met our study criteria. Of the 706 patients with bare-metal ISR, 362 were treated with DES and 344 with BMS. There were 230 cumulative events for a median follow-up of 3.2 years. After adjusting for 27 variables, DES were associated with lower primary endpoint compared to BMS for treatment of bare-metal ISR (21% vs. 45%, adjusted hazard ratio [HR] 0.63; 95% confidence interval [CI], 0.42-0.95; P = 0.03). The individual secondary endpoint of death (8% vs. 24%, P = 0.005) favored DES, but MI (3% vs. 8%, P = 0.31), and TLR (13% vs. 20%, P = 0.23) failed to reach statistical significance.


CONCLUSIONS
In our multivariate analysis of patients with bare-metal ISR, DES use was associated with significantly lower death, MI, or TLR when compared to BMS.
Singh
Inder M
IM
Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
Filby
Steven J
SJ
El Sakr
Fredy
F
Gorodeski
Eiran Z
EZ
Lincoff
A Michael
AM
Ellis
Stephen G
SG
Shishehbor
Mehdi H
MH
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D009820:Ohio; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D008670:Metals