COMPARISON OF ANGIOGRAPHIC AND CLINICAL OUTCOME AFTER CUTTING BALLOONAND CONVENTIONAL BALLOON ANGIOPLASTY IN VESSELS SMALLER THAN 3 MM IN DIAMETER - A RANDOMIZED TRIAL

Objectives. The purpose of the study was to evaluate and compare the i mmediate and six month follow-up angiographic and clinical outcome of cutting balloon angioplasty and conventional balloon angioplasty in sm all vessels (less than 3 mm in diameter). Methods and Results. Between August 1995 and August 1996 a total of 71 eligible symptomatic patien ts with angiographically proven significant lesions in their coronary arteries smaller than 3 mm and requiring revascularization, were rando mized to receive treatment by either cutting balloon angioplasty (CB) or conventional balloon angioplasty (BA). ''Stand-alone'' CB was perfo rmed 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 lumi nal 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. 2.0 1 +/- 0.34 mm, 22 +/- 9%, 1.26 +/- 0.35 mm, respectively). Total disse ction rate and C-F dissections were fewer in the CB group (37%, 6% vs. 51%, 19%, respectively, p < 0.05). Sig month follow-up angiographic r estenosis rate was lower in the CB group (27% vs. 47%,p < 0.05). We al so detected a significant difference of total number of all events at nine month clinical follow up (28% vs. 51%,p < 0.05). Conclusion. CB a ngioplasty can be performed with a comparable success rate to conventi onal BA in small vessels. Fewer bail-out procedures are needed as CB c auses fewer and less severe dissections. There is also a significant r eduction in six month restenosis rate. We suggest that CB might be a b etter option for revascularizing vessels smaller than 3 mm in diameter which are inherently more prone to immediate complications and late r estenosis with BA.