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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Treatment of multivessel coronary artery disease with sirolimus-eluting stent implantation: immediate and mid-term results

Dejan Orlic, MD^*, Erminio Bonizzoni, PhD, Goran Stankovic, MD^*, Flavio Airoldi, MD, Alaide Chieffo, MD, Nicola Corvaja, MD^*, Giuseppe Sangiorgi, MD^*, Massimo Ferraro, RN^*, Carlo Briguori, MD, Matteo Montorfano, MD, Mauro Carlino, MD and Antonio Colombo, MD, FACC^*,*

^* EMO, Centro Cuore Columbus Hospital, Milan, Italy
San Raffaele Hospital, Milan, Italy
Institute of Medical Statistics and Biometry, University of Milan, Milan, Italy

Manuscript received June 16, 2003; revised manuscript received October 17, 2003, accepted October 20, 2003.

^* Reprint requests and correspondence: Dr. Antonio Colombo, EMO Centro Cuore Columbus, Via Buonarroti 48, Milan, Italy.
info{at}emocolumbus.it

OBJECTIVES: This study evaluated clinical outcome after multivessel stenting with sirolimus-eluting stents (SES) in unselected lesions.

BACKGROUND: Safety and effectiveness of multivessel SES implantation is currently unknown.

METHODS: Major adverse cardiac events (MACE) (death, myocardial infarction [MI], and repeat revascularization) were analyzed at 30 days and at 6 months after multivessel SES implantation.

RESULTS: In 155 consecutive patients, 573 SES were implanted in 3.3 ± 1.3 lesions per patient. At 30 days, the cumulative MACE rate was 10.3%: 7.1% patients developed a non–Q-wave MI, 1.9% developed a Q-wave MI, 0.6% died for non-cardiac reasons, and 0.6% had a repeat revascularization. Clinical follow-up was obtained in all 112 eligible patients treated for 359 lesions at a mean time of 6.5 ± 2.2 months. The cumulative MACE rate was 22.3%: 3 (2.7%) deaths (1 for cardiac reasons), 4 (3.6%) MIs, target lesion revascularization (TLR) in 16 (14.3%) patients with 24 (6.7%) lesions. Target vessel revascularization was required in 18 (16.1%) patients due to TLR of lesions treated with SES or to disease progression (1.8% of patients). Cox regression analysis revealed total stent length per patient as the most powerful independent predictor of MACE. Overall stent thrombosis occurred in three (1.9%) patients.

CONCLUSIONS: Multivessel SES implantation can be safely performed on patients with complex coronary artery disease. The need for revascularization increases because of the cumulative effect of TLR on patients with multiple lesions.

Abbreviations and Acronyms   BMS = bare metal stent   CABG = coronary artery bypass grafting   CK = creatine kinase   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention   PTCA = percutaneous transluminal coronary angioplasty   SES = sirolimus-eluting stent   SIRIUS = U.S. Multicenter, Randomized, Double-Blind Study of the Sirolimus- Eluting Stent in De Novo Native Coronary Lesions   TLR = target lesion revascularization   TVR = target vessel revascularization

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