ONE-YEAR FOLLOW-UP IN THE CORONARY ANGIOPLASTY VERSUS EXCISIONAL ATHERECTOMY TRIAL (CAVEAT-I)

Background Directional atherectomy is a frequently used percutaneous r evascularization strategy, but its long-term outcomes have not previou sly been compared with those of balloon angioplasty in a prospective t rial. Methods and Results The 1012 patients enrolled in the Coronary A ngioplasty Versus Excisional Atherectomy Trial (CAVEAT I) were followe d for at least 1 year after randomization. Analyses of predetermined e nd points were performed, including a detailed analysis of the 14 pati ents who died. At 1 year, 11 patients had died in the atherectomy grou p compared with 3 in the angioplasty group (2.2% versus 0.6%, P=.035), with an excess of out-of-hospital deaths (2.2% versus 0.2%, P=.01) an d late cardiac deaths (1.6% versus 0%, P=.01). Univariate predictors o f death included age, abrupt closure, periprocedural enzyme elevation, and peripheral vascular complications. There was no evidence that the excess of deaths after atherectomy was linked to perforation, ectasia , or deep resection. Cumulative rates of myocardial infarction were hi gher in those who had been randomized to atherectomy than in those ran domized to angioplasty (8.9% versus 4.4%, P=.005) with a trend toward excess Q-wave and non-Q-wave infarctions. By multivariate analysis, at herectomy was the only variable predictive of the combined end point o f death or myocardial infarction. No clinical or angiographic characte ristics added to this index. Rates of repeat percutaneous intervention at the target site (24.4% after atherectomy versus 25.9% after angiop lasty), coronary artery bypass surgery (9.3% versus 9.1%), hospitaliza tion (50% versus 47.1%), and stroke (1% in both groups) were not signi ficantly different. Conclusions Long-term follow-up of the 1012 patien ts randomized to atherectomy or angioplasty has revealed a statistical ly significant excess of deaths after directional atherectomy that was not evident at 6 months. This difference could be due to the chance o ccurrence of a low mortality rate in those randomized to angioplasty. The excess of myocardial infarctions after atherectomy remains statist ically significant at 1 year. Further investigation is warranted to im prove the safety of atherectomy.