The aim of this study was to assess the safety and effectiveness of > or =4 sirolimus-eluting stent (SES; Cypher, Cordis, Johnson and Johnson) implantation. The safety of implantation of > or =4 SESs in the same patient and setting has not been established. Furthermore, it has been hypothesized that sirolimus administration with the use of multiple stents may diminish the platelet inhibitory effects of clopidogrel and may trigger drug-drug interactions. We identified 96 consecutive patients (96 procedures) who underwent implantation of > or =4 SESs in 365 lesions (438 stents) during the same procedure. All patients received aspirin indefinitely and clopidogrel or ticlopidine for at least 1 year postprocedure; 57% and 47% of the patients were on calcium channel blocker and statin therapy, respectively. All stents were successfully deployed and glycoprotein IIb/IIIa inhibitors were used in 50% of the procedures. There were no in-hospital deaths, Q-wave myocardial infarction (MI), urgent bypass surgery, or repeat percutaneous coronary intervention; 18 patients (19%) suffered non-Q-wave MI (defined as CK-MB elevation >3 times the upper limit of normal). At 30-day follow-up, there was one (1%) subacute thrombosis resulting in target lesion revascularization. At mean follow-up time of 15.4 +/- 6.2 months, the frequency of target lesion revascularization, target vessel revascularization, and major adverse cardiac event rates were 12%, 16%, and 18%, respectively. No other notable clinical events that might have been attributed to the possible drug-drug interactions or discontinuation of concomitant antithrombotic, statin, or calcium channel blocker therapy were reported. Multiple (> or =4) SES implantation appears safe with no increase in major adverse cardiac events.
Copyright 2005 Wiley-Liss, Inc.