CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Long-Term Outcome in Patients Treated With Sirolimus-Eluting Stents in Complex Coronary Artery Lesions3-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)
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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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