OPTIMAL DIRECTIONAL CORONARY ATHERECTOMY - FINAL RESULTS OF THE OPTIMAL ATHERECTOMY RESTENOSIS STUDY (OARS)

Background-Previous clinical trials of directional coronary atherectom y (DCA) have failed to show significant improvement in early or late o utcomes compared with balloon angioplasty (PTCA). The present study te sted the hypothesis that more aggressive ''optimal'' atherectomy could be performed safely to produce larger initial lumen diameters and a l ower late restenosis rate. Methods and Results-The present study was a prospective multicenter registry of consecutive patients undergoing o ptimal DCA of de novo or restenotic lesions in 3.0- to 4.5-mm native c oronary arteries. Optimal DCA was defined as using a 7F atherectomy de vice and adjunctive PTCA if necessary to achieve a <15% residual steno sis. Six-month angiographic and 1-year clinical follow-up was planned in all patients. A total of 199 patients with 213 lesions met eligibil ity criteria for enrollment. Short-term procedural success was achieve d in 97.5%, with a major complication rate (death, emergency bypass su rgery, or Q-wave myocardial infarction [MI]) of 2.5%. There were no ea rly deaths. Non-Q-wave MI (CK-MB >3 times normal) occurred in 14% of p atients. Mean reference vessel diameter was 3.28 mm, Mean diameter ste nosis was reduced from 63.5% to a final stenosis of 7%. Late 1-year cl inical follow-up revealed one cardiac death and a target lesion revasc ularization rate of 17.8%. The angiographic restenosis rate at 6 month s was 28.9%, with the major predictor oi restenosis being a smaller po stprocedure lumen diameter. Conclusions-Optimal DCA produced a low res idual percent diameter stenosis and a lower restenosis rate than seen in previous trials without an increase in early or late major adverse events.