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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Long-Term Outcome in Patients Treated With Sirolimus-Eluting Stents in Complex Coronary Artery Lesions

3-Year Results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) Trial

Henning Kelbæk, MD^_*,_*, Lene Kløvgaard, RN^_*, Steffen Helqvist, MD^_*, Jens F. Lassen, MD, Lars R. Krusell, MD, Thomas Engstrøm, MD^_*, Hans E. Bøtker, MD, Erik Jørgensen, MD^_*, Kari Saunamäki, MD^_*, Samir Aljabbari, MD^_*, Per Thayssen, MD, Anders Galløe, MD, Gunnar V.H. Jensen, MD^¶ and Leif Thuesen, MD

^_* Rigshospitalet, Copenhagen, Denmark
Skejby Sygehus, Skejby, Denmark
Odense Universitetshospital, Odense, Denmark
Gentofte Hospital, Gentofte, Denmark
^¶ Roskilde Hospital, Roskilde, Denmark.

Manuscript received November 8, 2007; revised manuscript received January 4, 2008, accepted January 7, 2008.

^_* Reprint requests and correspondence: Dr. Henning Kelbæk, Cardiac Catheterization Laboratory, Rigshospitalet, DK–2100 Copenhagen Ø, Denmark. (Email: henning.kelbaek{at}rh.regionh.dk).

Objectives: Our purpose was to evaluate the long-term use of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with complex coronary artery lesions.

Background: Although the use of SES has proved to be effective in patients with simple coronary artery lesions, there are limited data of the long-term outcome of patients with complex coronary artery lesions.

Methods: We randomly assigned 322 patients with total coronary occlusions or lesions located in bifurcations, ostial, or angulated segments of the coronary arteries to have SES or BMS implanted.

Results: At 3 years, major adverse cardiac events had occurred in 20 patients (12%) in the SES group and in 59 patients (38%) in the BMS group (p < 0.001). Four versus 2 patients suffered a cardiac death (p = NS), and 5 versus 1 died of a noncardiac disease (p = NS) in the SES versus the BMS group. Six patients in the SES group versus 15 patients in the BMS group suffered a myocardial infarction (p < 0.05) during the 3-year observation period, and target lesion revascularization was performed in 8 patients (4.9%) versus 53 patients (33.8%), respectively (p < 0.001); of these, 4 in the SES versus 7 in the BMS group were performed between 1 and 3 years after the index treatment (p = NS). According to revised definitions, stent thrombosis occurred in 5 patients (3.1%) in the SES group and in 7 patients (4.4%) in the BMS group (p = NS); very late stent thrombosis was observed in 4 versus 1 patient.

Conclusions: A continued benefit was observed up to 3 years after implantation of SES in patients with complex coronary artery lesions. The rate of late adverse events was similar in the 2 groups, and stent thromboses occurred rarely after 1 year. (Sirolimus Eluting Stents in Complex Coronary Lesions [SCANDSTENT]; NCT00151658)

Abbreviations and Acronyms   BMS = bare-metal stent(s)   DES = drug-eluting stents   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization

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