Stenting in small coronary arteries (SISCA) trial. A randomized comparison between balloon angioplasty and the heparin-coated beStent.
OBJECTIVE
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.
Moer
R
R
Department of Cardiology, The Feiring Heart Clinic, Feiring, Norway. moer@online.no
Myreng
Y
Y
Mølstad
P
P
Albertsson
P
P
Gunnes
P
P
Lindvall
B
B
Wiseth
R
R
Ytre-Arne
K
K
Kjekshus
J
J
Golf
S
S
D015906:Angioplasty, Balloon, Coronary; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control; D003331:Coronary Vessels / Q000473:pathology; D004867:Equipment Design; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D018709:Statistics, Nonparametric; D015607:Stents; D016019:Survival Analysis; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D010975:Platelet Aggregation Inhibitors; D006493:Heparin