Randomized comparison of balloon angioplasty versus silicon carbon-coated stent implantation for de novo lesions in small coronary arteries.

The objectives of this study were to compare the short- and long-term clinical and angiographic outcomes of conventional balloon angioplasty versus elective silicon carbide-coated stent implantation in de novo lesions in small coronary arteries (<3.0 mm). Angioplasty of small coronary arteries is associated with high restenosis rates. The beneficial effects of stent implantation on restenosis rates and clinical outcomes have been suggested by observational studies. However, randomized trials comparing balloon angioplasty with stenting show conflicting results. A total of 496 patients with a de novo stenosis in a coronary artery, with a diameter between 2.0 and 3.0 mm, were randomly assigned to balloon angioplasty (n = 246) or stent implantation (n = 250). One-year clinical and 6-month angiographic follow-up were performed. Baseline characteristics were similar for the 2 groups, with 16% having diabetes and 77% complex lesions (type B or C). Crossover to stents occurred in 29% of patients randomized to balloon angioplasty. At 6 months, angiographic restenosis rates were 25% versus 21% for the angioplasty and stent groups, respectively (p = NS). One-year clinical follow-up showed no difference in occurrence of major adverse cardiac events. Elective silicon carbon-coated stent implantation in small coronary arteries is safe and effective, with no beneficial effect on angiographic or clinical outcome compared with balloon angioplasty with provisional stenting.