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CLINICAL STUDY

Stenting in small coronary arteries (SISCA) trial

A randomized comparison between balloon angioplasty and the heparin-coated beStent

Rasmus Moer, MD^*,*, Yngvar Myreng, MD, PhD^*, Per Mølstad, MD, PhD^*, Per Albertsson, MD, PhD, P.ål Gunnes, MD, PhD, Bo Lindvall, MD, Rune Wiseth, MD, PhD^||, Kjetil Ytre-Arne, MD^*, John Kjekshus, MD, PhD^¶ and Svein Golf, MD, PhD^*

^* Department of Cardiology, The Feiring Heart Clinic, Feiring, Norway
Division of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
Department of Cardiology, Tromsø University Hospital, Tromsø, Norway
Department of Radiology/Cardiology, Huddinge University Hospital, Stockholm, Sweden
^|| Division of Cardiology, University Hospital of Trondheim, Norwegian University of Science and Technology, Trondheim, Norway
^¶ Department of Cardiology, National Hospital, Oslo, Norway

Manuscript received January 9, 2001; revised manuscript received June 5, 2001, accepted August 13, 2001.

^* Reprint requests and correspondence: Dr. Rasmus Moer, Department of Cardiology, The Feiring Heart Clinic, N-2093 Feiring, Norway
moer{at}online.no

OBJECTIVES

The purpose of this study was to assess the clinical and angiographic benefits of elective stenting in coronary arteries with a reference diameter of 2.1 to 3.0 mm, as compared with traditional percutaneous transluminal coronary angioplasty (PTCA).

BACKGROUND

The problems related to small-vessel stenting might be overcome using modern stents designed for small vessels, combined with effective antiplatelet therapy.

METHODS

In five centers, 145 patients with stable or unstable angina were randomly assigned to elective stenting treatment with the heparin (Hepamed)-coated beStent or PTCA. Control angiography was performed after six months. The primary end point was the minimal lumen diameter (MLD) at follow-up. Secondary end points were the restenosis rate, event-free survival and angina status.

RESULTS

At follow-up, there was a trend toward a larger MLD in the stent group (1.69 ± 0.52 mm vs. 1.57 ± 0.44 mm, p = 0.096). Event-free survival at follow-up was significantly higher in the stent group: 90.5% vs. 76.1% (p = 0.016). The restenosis rate was low in both groups (9.7% and 18.8% in the stent and PTCA groups, respectively; p = 0.15). Analyzed as treated, both the MLD and restenosis rate were significantly improved in patients who had stents as compared with PTCA.

CONCLUSIONS

In small coronary arteries, both PTCA and elective stenting are associated with good clinical and angiographic outcomes after six months. Compared with PTCA, elective treatment with the heparin-coated beStent improves the clinical outcome; however, there was only a nonsignificant trend toward angiographic improvement.

Abbreviations and Acronyms   BA = balloon/artery ratio   DS = diameter stenosis   MACE = major adverse cardiac event   MLD = minimal lumen diameter   PTCA = percutaneous transluminal coronary angioplasty   QCA = quantitative coronary angiography   RD = reference diameter   SISCA = Stenting In Small Coronary Arteries trial

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