PERIPHERAL VASCULAR COMPLICATIONS IN THE CORONARY ANGIOPLASTY VERSUS EXCISIONAL ATHERECTOMY TRIAL (CAVEAT-I)

Objectives. In-hospital peripheral vascular complications of balloon a ngioplasty were compared with those of directional atherectomy in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) to identify patients at risk and evaluate costs and outcomes. Background . The incidence, costs and outcomes of peripheral vascular complicatio ns after coronary intervention have not been fully characterized as a function of randomly assigned therapy. Methods. At 35 sites in the Uni ted States and Europe, 1,012 patients were randomized. Peripheral vasc ular complications were defined as the composite of pulse loss, pseudo aneurysm, hematoma >4 cm in diameter or groin hemorrhage necessitating blood transfusion. Logistic models were derived to 1) predict these c omplications from baseline and procedural characteristics, 2) test the relevance of randomization assignment, and 3) assess their impact on hospital costs and long-term outcomes. Results. Sixty-seven patients ( 6.6%) developed peripheral vascular complications, of whom 15 (22.4%) required a blood transfusion, 14 (20.9%) underwent vascular surgery, a nd 2 (3.0%) died. Both in-hospital deaths occurred in patients with pe ripheral vascular complications. There was no difference in composite peripheral vascular complication rates among patients randomized to an gioplasty or atherectomy. Greater age, female gender, postprocedural h eparin and intraaortic balloon counterpulsation were predictive of inc reased risk. In a representative 60% subset, mean hospital costs incre ased from $9,583 in patients without to $18,350 in those with peripher al vascular complications (p = 0.0001). The unadjusted mortality rate at 1 year was 7.5% for patients with peripheral vascular complications compared with 1.1% for all others (p = 0.0001). These complications i dentified patients at greater risk of death, myocardial infarction or repeat revascularization at 30 days and 1 year. The atherectomy group had a trend toward more frequent deaths and myocardial infarction. Con clusions. Directional atherectomy and balloon angioplasty had similar in-hospital peripheral vascular complication rates. Female gender, gre ater age, postprocedural heparin and intraaortic balloon counterpulsat ion were predictive of higher risk. The twofold increase in cost and s evenfold increase in long-term deaths highlight the need to prevent th ese periprocedural events and monitor patients closely.