Comparison of Angiographic and Clinical Outcome After Cutting Balloon and Conventional Balloon Angioplasty in Vessels Smaller than 3 mm in Diameter: A Randomized Trial.

ABSTRACT

OBJECTIVES: The purpose of the study was to evaluate and compare the immediate and six month follow-up angiographic and clinical outcome of cutting balloon angioplasty and conventional balloon angioplasty in small vessels (less than 3 mm in diameter). METHODS AND RESULTS: Between August 1995 and August 1996 a total of 71 eligible symptomatic patients with angiographically proven significant lesions in their coronary arteries smaller than 3 mm and requiring revascularization, were randomized to receive treatment by either cutting balloon angioplasty (CB) or conventional balloon angioplasty (BA). ÒStand-aloneÓ CB was performed on 51 lesions in 36 patients and BA on 47 lesions in 35 patients. Basic angiographic and clinical characteristics were similar in both groups. The overall procedural success rates for CB and BA groups were 92% and 97%, respectively. The immediate post-procedural minimal luminal diameter, residual stenosis and acute gain were similar in the CB and BA cohorts (1.93 +/- 0.36 mm, 24 +/- 12%, 1.18 +/- 0.45 mm vs. 2.01 +/- 0.34 mm, 22 +/- 9%, 1.26 +/- 0.35 mm, respectively). Total dissection rate and C-F dissections were fewer in the CB group (37%, 6% vs. 51%, 19%, respectively, p < 0.05). Six month follow-up angiographic restenosis rate was lower in the CB group (27% vs. 47%, p < 0.05). We also detected a significant difference of total number of all events at nine month clinical follow up (28% vs. 51%, p < 0.05). CONCLUSION: CB angioplasty can be performed with a comparable success rate to conventional BA in small vessels. Fewer bail-out procedures are needed as CB causes fewer and less severe dissections. There is also a significant reduction in six month restenosis rate. We suggest that CB might be a better option for revascularizing vessels smaller than 3 mm in diameter which are inherently more prone to immediate complications and late restenosis with BA.