Efficacy of coronary heart disease stenting in small vessels versus balloon angioplasty study - CHIVAS Study Trial

This study enrolled 302 patients with angina or ischemic heart disease, in which elective stent placement could be performed, at 25 medical centers in Japan between April 1998 and July 2000. Patients were divided into diabetic and non-diabetic groups, and subsequently assigned to either a plain old balloon angioplasty (POBA) or a stent group by an envelope method. The subjects were assigned to stent (148 subjects) and POBA (154) groups. Acute gain in the stent group was better than that in the POBA group (1.08 mm vs. 0.84 mm). In contrast, there were no differences in late loss between the two groups. Binary restenosis in coronary angioplasty after 6 months in the stent group was 30.8%, significantly lower than that in the POBA group (43.5%). Major adverse cardiac events and TLR were not significantly different between the two groups. Restenosis in diabetes mellitus: In patients with diabetes mellitus, the rate of restenosis was significantly lower in the stent group compared to the POBA group (23.7% vs. 55.3%). We concluded that MULTI-LINK stents for small vessels (>3.0 mm) have better outcomes of 6 month restenosis rate rather than that of POBA, and especially in patients with diabetes mellitus.