A randomized comparison of balloon angioplasty and stent implantation in the percutaneous treatment of coronary bifurcations.

Objective: A prospective randomized multicentre pilot trial, comparing stenting with balloon angioplasty as a treatment for coronary lesions, located in a bifurcation was performed.

Methods And Results: After balloon dilatation, with a < 30% residual stenosis in the main vessel and < 50% residual stenosis in the side branch, patients were randomized to stay in a "balloon-only" group or to stenting. The stents used were the AVE S 670 for the main vessel and the Bestent, if needed, for the side branch. The primary end point was the incidence of major adverse cardiac events (MACE) at 6 months, secondary end points were in-hospital MACE, acute angiographic results, use of materials and duration of the procedure. One hundred eleven patients were randomized: 55 in the balloon group, 56 in the stent group. No differences in MACE-rates were found at 6 months (22% versus 20%, p = 0.78). The target vessel revascularization rate was 16% in the balloon group and 12.5% in the stent group (p = 0.56). The acute angiographic results were significantly better in the stent group (residual stenosis 8% versus 26% [p < 0.05]). More materials were used, with a near doubling of the duration of the procedure in the stent group (p < 0.05).

Conclusions: Although stenting resulted in better immediate angiographic results during percutaneous treatment of lesions located in a bifurcation, as compared to balloon angioplasty alone, clinical events were comparable in the two treatment arms.