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J Am Coll Cardiol, 2006; 47:449-455, doi:10.1016/j.jacc.2005.10.045
(Published online 13 December 2005). © 2006 by the American College of Cardiology Foundation |
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* Rigshospitalet, Copenhagen, Denmark
Skejby Sygehus, Skejby, Denmark
Roskilde Amtssygehus, Roskilde, Denmark
Odense Universitets hospital, Odense, Denmark
|| Gentofte Amtssygehus, Gentofte, Denmark
¶ Heart Core, Leiden, the Netherlands
Manuscript received September 6, 2005; revised manuscript received September 27, 2005, accepted October 11, 2005.
* Reprint requests and correspondence: Dr. Henning Kelbæk, Cardiac Catheterization Laboratory 2013, Rigshospitalet, DK2100, Copenhagen, Denmark (Email: henning.kelbaek{at}rh.hosp.dk).
OBJECTIVES: The purpose of the SCANDSTENT study was to evaluate the use of sirolimus-eluting stents (SES) in complex coronary lesions.
BACKGROUND: The use of SES improves angiographic and clinical outcomes compared with bare-metal stents (BMS) in simple coronary artery lesions, but there is limited evidence of their safety and efficacy when implanted in complex lesions.
METHODS: We randomly assigned 322 patients with symptomatic complex coronary artery disease to receive either SES or BMS. The lesions were occluded (36%), bifurcational (34%), ostial (22%), or angulated (8%) in morphology. The primary end point was the difference in minimal lumen diameter six months after stent implantation.
RESULTS: The patients were well matched in terms of demographic and angiographic baseline characteristics; 18% had diabetes. The reference vessel diameter was 2.86 mm in mean, and the lesion length 18.0 mm. At follow-up, patients who received SES had a minimal lumen diameter of 2.48 mm compared with 1.65 mm in those who received BMS (p < 0.001), a diameter stenosis of 19.3% versus 43.8% (p < 0.001), and 2.0% versus 31.9% developed restenosis (p < 0.001). The rate of major adverse cardiac events was 4.3% with SES versus 29.3% with BMS (p < 0.001), and stent thrombosis was observed in 0.6% in the SES group versus 3.1% in the BMS group (p = 0.15).
CONCLUSIONS: The use of SES markedly reduced restenosis and the occurrence of major adverse cardiac events in patients with complex coronary artery lesions without increasing the risk of stent thrombosis.
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