Incidence and Predictors of Target Vessel Revascularization and Clinical Event Rates of the Sirolimus-Eluting Coronary Stent (Results from the Prospective Multicenter German Cypher Stent Registry)

Randomized trials have demonstrated the ability of drug-eluting stents to decrease the risk of restenosis after coronary stent implantation. However, the incidences of major cardiovascular/cerebral adverse events (MACCEs) and target vessel revascularization (TVR) during follow-up in a routine clinical setting remain to be determined. We analyzed data of the multicenter German Cypher Stent Registry. From April 2002 to March 2003, 1,726 patients at 93 hospitals who received ≥1 sirolimus-eluting coronary stent were included. Median follow-up was 6.7 months. During follow-up, death occurred in 1.2% of patients (20 of 1,726), nonfatal myocardial infarction in 2.5% (43 of 1,706), and nonfatal stroke in 0.5% (7 of 1,469). TVR was performed in 8.6% of patients, with percutaneous coronary intervention in 7.3% and coronary artery bypass grafting in 1.5%. The overall rate of MACCEs or TVR was 10.8% (186 of 1,726). Independent predictors of TVR were the target vessel being a bypass graft (odds ratio [OR] 2.43, 95% confidence interval [CI] 1.41 to 4.18, p = 0.001), management of >1 lesion during the same intervention (OR 1.75, 95% CI 1.04 to 2.96, p = 0.035), 2- or 3-vessel disease (OR 1.69, 95% CI 1.05 to 2.72, p = 0.030), and age (per decade; OR 0.82, 95% CI 0.69 to 0.98, p = 0.025). These data confirm the safety and effectiveness of using the sirolimus-eluting stent in daily clinical practice. The management of bypass grafts and multiple lesions in 1 session and the presence of multivessel disease were predictors of MACCEs or TVR.