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Ioannis Iakovou, MD; Thomas Schmidt, MD; Erminio Bonizzoni, PhD; Lei Ge, MD; Giuseppe M. Sangiorgi, MD; Goran Stankovic, MD; Flavio Airoldi, MD; Alaide Chieffo, MD; Matteo Montorfano, MD; Mauro Carlino, MD; Iassen Michev, MD; Nicola Corvaja, MD; Carlo Briguori, MD; Ulrich Gerckens, MD; Eberhard Grube, MD; Antonio Colombo, MD

JAMA. 2005;293:2126-2130.

Context  Traditionally, stent thrombosis has been regarded as a complication of percutaneous coronary interventions during the first 30 postprocedural days. However, delayed endothelialization associated with the implantation of drug-eluting stents may extend the risk of thrombosis beyond 30 days. Data are limited regarding the risks and the impact of this phenomenon outside clinical trials.

Objective  To evaluate the incidence, predictors, and clinical outcome of stent thrombosis after implantation of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice.

Design, Setting, and Patients  Prospective observational cohort study conducted at 1 academic hospital and 2 community hospitals in Germany and Italy. A total of 2229 consecutive patients underwent successful implantation of sirolimus-eluting (1062 patients, 1996 lesions, 2272 stents) or paclitaxel-eluting (1167 patients, 1801 lesions, 2223 stents) stents between April 2002 and January 2004.

Interventions  Implantation of a drug-eluting stent (sirolimus or paclitaxel). All patients were pretreated with ticlopidine or clopidogrel and aspirin. Aspirin was continued indefinitely and clopidogrel or ticlopidine for at least 3 months after sirolimus-eluting and for at least 6 months after paclitaxel-eluting stent implantation.

Main Outcome Measures  Subacute thrombosis (from procedure end through 30 days), late thrombosis (>30 days), and cumulative stent thrombosis.

Results  At 9-month follow-up, 29 patients (1.3%) had stent thrombosis (9 [0.8%] with sirolimus and 20 [1.7%] with paclitaxel; P = .09). Fourteen patients had subacute thrombosis (0.6%) and 15 patients had late thrombosis (0.7%). Among these 29 patients, 13 died (case fatality rate, 45%). Independent predictors of stent thrombosis were premature antiplatelet therapy discontinuation (hazard ratio [HR],  89.78; 95% CI, 29.90-269.60; P<.001), renal failure (HR,  6.49; 95% CI, 2.60-16.15; P<.001), bifurcation lesions (HR,  6.42; 95% CI, 2.93-14.07; P<.001), diabetes (HR,  3.71; 95% CI, 1.74-7.89; P = .001), and a lower ejection fraction (HR,  1.09; 95% CI, 1.05-1.36; P<.001 for each 10% decrease).

Conclusions  The cumulative incidence of stent thrombosis 9 months after successful drug-eluting stent implantation in consecutive "real-world" patients was substantially higher than the rate reported in clinical trials. Premature antiplatelet therapy discontinuation, renal failure, bifurcation lesions, diabetes, and low ejection fraction were identified as predictors of thrombotic events.

Author Affiliations: Centro Cuore Columbus and San Raffaele Hospital, Milan, Italy (Drs Iakovou, Ge, Sangiorgi, Stankovic, Airoldi, Chieffo, Montorfano, Carlino, Michev, Corvaja, Briguori, and Colombo); Mediolanum Cardio Research, Milan, Italy (Dr Sangiorgi); Department of Cardiology, Klinikum Siegburg Rhein-Sieg GmbH, Siegburg, Germany (Drs Schmidt, Gerckens, and Grube); and Institute of Medical Statistics and Biometry, University of Milan, Milan, Italy (Dr Bonizzoni).

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