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 for an industry-sponsored multicenter registry of rotational atherectomy.

BACKGROUND

Several new devices are in use or under development for coronary atherectomy. The clinical role for each is in part defined by descriptive registry data.

METHODS

We describe results in 709 consecutive patients undergoing 743 procedures representing 874 lesions. The majority of lesions were in the left anterior descending coronary artery. Lesion morphology was described as eccentric (61.1%), calcified (32%), tortuous (26.6%) and long (24.9%), with previous intervention in 32.7%.

RESULTS

Overall procedural success rate, including lesions treated with rotational atherectomy alone and with balloon angioplasty was 94.7% and did not vary between lesion type, location, characteristics 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] 0.3% to 1.7%), Q wave myocardial infarction 0.9% (95% CI 0.4% to 1.9%) and emergent coronary 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 history 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 dissection was seen in 10.5% (95% CI 8.3% to 12.7%) of patients and was significantly associated with more complex lesions, such as eccentric, long, calcified 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 restenosis rates were associated only with poorer initial treatment outcome, diabetes and lower follow-up angiographic rate per reporting center.

CONCLUSIONS

Rotational atherectomy appears to be a safe method of treatment with a high success rate in a broad spectrum of lesion types, with restenosis rates similar to other techniques. Further conclusions will require randomized trials.