ROTATIONAL ATHERECTOMY MULTICENTER REGISTRY - ACUTE RESULTS, COMPLICATIONS AND 6-MONTH ANGIOGRAPHIC FOLLOW-UP IN 709 PATIENTS

Objectives. The purpose of this study was to describe data collected f or an industry-sponsored multicenter registry of rotational atherectom y. Background. Several new devices are in use or under development for coronary atherectomy. The clinical role for each is in part defined b y descriptive registry data. Methods. We describe results in 709 conse cutive patients undergoing 743 procedures representing 874 lesions. Th e majority of lesions were in the left anterior descending coronary ar tery. Lesion morphology was described as eccentric (61.1%), calcified (32%), tortuous (26.6%) and long (24.9%), with previous intervention i n 32.7%. Results. Overall procedural success rate, including lesions t reated with rotational atherectomy alone and with balloon angioplasty was 94.7% and did not vary between lesion type, location, characterist ics or severity. Previously treated lesions had a significantly higher success rate (97.4%, p = 0.04) than new lesions. Major complications, including death 0.8% (95% confidence interval [CI] O.3% to 1.7%), Q w ave myocardial infarction 0.9% (95% CI 0.4% to 1.9%) and emergent coro nary artery bypass surgery 1.7% (95% CI 0.9% to 3.0%), were similar to other reported devices and were associated with length and number of lesions treated. Non-Q wave myocardial infarction occurred in 3.8% of patients and was significantly associated with female gender and histo ry of previous myocardial infarction. Abrupt occlusion occurred in 3.1 % of patients and was significantly associated with bifurcated lesions and the use of adjunctive therapy. Angiographic evidence of dissectio n was seen in 10.5%(95% CI 8.3% to 12.7%) of patients and was signific antly associated with more complex lesions, such as eccentric, long, c alcified and American College of Cardiology/American Heart Association type C lesions. Overall restenosis rate was 37.7%, determined with 6- month angiography, representing 64% of treated lesions. Higher resteno sis rates were associated only with poorer initial treatment outcome, diabetes and lower follow-up angiographic rate per reporting center. C onclusions. Rotational atherectomy appears to be a safe method of trea tment with a high success rate in a broad spectrum of lesion types, wi th restenosis rates similar to other techniques. Further conclusions w ill require randomized trials.