EXCIMER-LASER CORONARY ANGIOPLASTY OF AORTO-OSTIAL STENOSES - RESULTS OF THE EXCIMER-LASER CORONARY ANGIOPLASTY (ELCA) REGISTRY IN THE 1ST 200 PATIENTS

Background. Percutaneous transluminal coronary angioplasty (PTCA) of aorto-ostial stenosis has been associated with a lower rate of acute success, a high risk of vessel closure, and late restenosis. The purpose of this report is to document a prospective multicenter trial of excimer laser coronary angioplasty (ELCA) of aorto-ostial stenosis involving the coronary arteries and saphenous vein grafts. Methods and Results. Between December 1989 and May 1992, 206 aorto-ostial ELCA procedures were performed on 209 stenoses in 200 patients. Canadian Cardiovascular Society class III or IV angina was present in 76%. The distribution of stenosis locations was left main coronary (LM) in 26 (12%), right coronary (RCA) in 124 (59%), and vein grafts (VG) in 59 (28%). Adjunctive PTCA was performed in 72%. Procedure success defined as less than-or-equal-to 50% diameter stenosis without major complications was achieved in 90% (LM, 92%; RCA, 89%; VG, 90%). Quantitative angiographic analysis documented an improvement in stenosis diameter from 0.8+/-0.5 mm or 76+/-14% at baseline to 2.1+/-0.6 mm or 36+/-15% at completion (P<.01). The majority of the acute gain in diameter (1.0+/-0.6 mm) resulted from ELCA. A major complication during hospitalization occurred in 3.9% (death, 0%; Q-wave myocardial infarction, 0.5%; bypass surgery, 3.4%). The only logistic regression univariate and multivariate predictor of procedure failure was female gender. Six-month angiographic follow-up, available in 51% of eligible patients, documented an average lumen diameter of 1.7+/-1.0 mm and mean diameter stenosis of 46+/-26%. Restenosis (>50% diameter stenosis) occurred in 39% (LM, 64%; RCA, 35%; VG, 35%). Restenosis was less likely when residual stenosis was less-than-or-equal-to 35% (28% versus 53%, P<.05). Clinical events at follow-up were death, 2.7%; bypass surgery, 6.5%; myocardial infarction, 2.2%; and repeat angioplasty, 16.2%. Of the remainder, 78% were asymptomatic, class I or II for anginal symptoms. An adverse event during follow-up was more than twice as likely in the group with LM (50.0% versus 21.1%, P<.02). Conclusions. ELCA is acutely effective and safe therapy in patients with aorto-ostial stenosis. Six-month restenosis, adverse-event rates were higher and functional status was poorer in the group with LM stenosis. ELCA may be considered as an alternative to bypass surgery in carefully selected patients with isolated aorto-ostial stenosis of the RCA and saphenous vein grafts.