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EXPEDITED REVIEW

The Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) Trial

Henning Kelbæk, MD^_*,_*, Leif Thuesen, MD, Steffen Helqvist, MD^_*, Lene Kløvgaard, RN^_*, Erik Jørgensen, MD^_*, Samir Aljabbari, MD^_*, Kari Saunamäki, MD^_*, Lars R. Krusell, MD, Gunnar V.H. Jensen, MD, Hans E. Bøtker, MD, Jens F. Lassen, MD, Henning R. Andersen, MD, Per Thayssen, MD, Anders Galløe, MD^||, Anton van Weert, PhD^¶ SCANDSTENT Investigators

^_* 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, DK–2100, 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.

Abbreviations and Acronyms   BMS = bare-metal stent   LL = late (lumen) loss   MLD = minimal lumen diameter   SES = sirolimus-eluting stent   TLR = target lesion revascularization