LOCAL AND SYSTEMIC DELIVERY OF LOW-MOLECULAR-WEIGHT HEPARIN FOLLOWINGPTCA - ACUTE RESULTS AND 6-MONTH FOLLOW-UP OF THE INITIAL CLINICAL-EXPERIENCE WITH THE POROUS BALLOON (PILOT-STUDY)

The purpose of this study was to assess safety and feasibility of intr acoronary delivery of reviparin using a porous balloon following percu taneous transluminal coronary angioplasty. The 2.7 mm porous balloon u sed in this study had 35 holes arranged in a spiral pattern. Eighteen patients (male n = 10, female n = 8, age 63 +/- 9 years) undergoing su ccessful PTCA in coronary arteries with a vessel diameter of 2.5 to 3. 0 mm determined by online QCA (LAD = 11, RCX = 3, RCA = 4) were includ ed. They received a bolus of 7,000 anti-Xa-IU reviparin followed by lo cal delivery of 1,500 anti-Xa-IU in 4 mi with an injection pressure of 2 atm. The patients received additionally 10500 anti-Xa-units intrave nously during the following 24 hours and a daily dose of 7000 anti-Xa- units reviparin subcutaneously for the following 28 days. Angiograms w ere obtained before and after PTCA, directly after local delivery, at 24 hours postintervention and after 6 months. The primary success rate was 100%. Quantitative coronary angiography showed a minimum luminal diameter of 0.42 +/- 0.14 mm before PTCA, 1.87 +/- 0.45 after PTCA, 1. 67 +/- 0.43 after LDD, 1.63 +/- 0.46 after 24 hours, and 1.06 +/- 0.6 after 6 months. Angiographic follow-up was obtained in all patients. N o major complications occurred during the B-month follow-up period. Th e angiographic restenosis rate was 28% (5/18) at follow-up. This study demonstrates safety and feasibility of local intracoronary delivery o f reviparin with a porous balloon following PTCA even in smaller diame ter coronary arteries. (C) 1998 Wiley-Liss, Inc.