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TCT: Twelve-Month Results For ASPECT Demonstrate Maintenance Of Positive Results For The Paclitaxel-Eluting Stent By Maggie Schwarz Special to DG News WASHINGTON, DC -- September 27, 2002 -- A 12-month review of results in ASPECT (Asian Paclitaxel-Eluting Stent Clinical Trial) indicates that the effectiveness and safety profile of paclitaxel are maintained. S. Park, MD, of Asan Medical Center, Seoul, South Korea, and coinvestigators, reported results of their follow-up assessment at 14th Annual Transcatheter Cardiovascular Therapeutics symposium. ASPECT is a randomized, multicenter clinical study of three paclitaxel dose densities: 0.0 mg/mm2 (control), 1.3 mg/mm2 and 3.1 mg/mm2. The main efficacy endpoint was the percent diameter stenosis and late loss at 6 months . The primary safety endpoint was major adverse coronary events (MACE) at 1 and 6 months. Clinical follow-up was obtained at 12 months. The 177 patients in the study had lesions 2.25 to 3.5 mm in diameter and less than 15 mm long. The patients had an average age of 60 years and about three-fourths were male. The majority of lesions were types A (53 percent) and B1 (40 percent). Patients with severe calcification and tortuosity, angulation greater than 45 degrees, thrombus, total occlusion, myocardial infarction within 72 hours, or having staged procedures were excluded. Vessels treated included the left anterior descending coronary artery (51 percent), right coronary artery (26 percent), left circumflex (22 percent), and ramus (1 percent). Patients received 2.5, 3.0 or 3.5 x 15 mm paclitaxel-eluting Supra Gstents or uncoated control stents. Antiplatelet drugs (aspirin + ticlopidine or aspirin + cilostazol) were administered for 1 to 6 months post procedure. The MACE-free rate at 6 months for patients treated with aspirin and ticlopidine was 96 percent, 95 percent and 96 percent for the 3.1 mg/mm2, 1.3 mg/mm2 and control arms, respectively. Between 6 and 12 months, no late thrombosis, Q-wave myocardial infarction or death was reported in the paclitaxel-eluting stent goups. Dr. Park concluded that the effectiveness of paclitaxel-eluting stents in reducing restenosis relative to uncoated stents and reducing intimal hyperplasia was maintained at 12 months. E-mail this page to a friend or colleague! To print, use this version