A Prospective, Randomized, Comparative Clinical Investigation of the Effects of Sulodexide on Restenosis after Percutaneous Transluminal Coronary Balloon Angioplasty

Kim, Jin Woo; Lee, Cheol Whan; Cheong, Sang Sig; Kang, Duk Hyun; Hong, Myeong Ki; Song, Jae Kwan; Kim, Jae Joong; Park, Seong Wook; Park, Seung Jung

Abstract

BACKGROUND
Restenosis remains as the major limitation of percutaneous translumainal coronary balloon angioplasty (PTCA). Although its mechanism remains incompletely understood, proliferative action of arterial smooth muscle cells has been found to play an important role on restenosis by neointimal formation after PTCA. Glycosaminoglycan-containing compounds, including Sulodexide (Vessel Due , ALFA, Wasserman, S.p.A, Italy), inhibit the proliferation and maigration of vascular smooth muscle cells in vitro.
OBJECTIVES
This study was performed to assess the efficacy of Sulodexide, a glycosaminoglycan compound with antithrombotic and antiproliferative properties, in preventing restenosis after PTCA. METHOD: Two hundred eighty-four patients with ischemic heart disease were randomized to receive either the standard PTCA without Sulodexide in 144 patients (control group, M : F = 99 : 45, Age = 58 +9 or -9), 160 lesions or the standard PTCA with Sulodexide in 140 patients (treated group, M : F = 89 : 51, age = 58 +10 or -10), 158 lesions. Successful angioplasties were performed in 258 atheromatous coronary lesions in 224 patients for whom follow-up angiographic data were obtained 6 month later. Quantitative coronary angiographic analysis (QCA) was performed before , immediate after PTCA and 6-month later. Angiographic restenosis (>50% diameter stenosis at follow-up) was the primary end point : miniamal luminal diameter at follow-up angiogram was the secondary end point. RESULT: Successful PTCA was 97.6% and 97.5% in the standard PTCA with Sulodexide and the standard PTCA without Sulodexide, respectively. Although reference vessel size and minimal luminal diamater after PTCA were larger in the control group than in the Sulodexide group(2.94+0.11 or-0.11 vs 2.83+0.13 or -0.13 mm and 2.26+0.12 or -0.12 vs 2.18+0.08 or -0.08 mm, respectively, p=NS), there was a increased tendency of minimal lumen diameter at 6 months angiogram in the Sulidexide group than in the control group (1.12+0.50 or -0.50 vs 1.07 + 0.53 or -0.53 mm, respectively, p=NS). Angiographic restenosis occured in 42% of lesions in the Sulodexide group and 52% of the control group (p=NS).
CONCLUSIONS
Sulodexide treatment had a tendency to reduce restenosis rate in 6 months after coronary angioplasty. However, further study is necessary to verify the antiproliferative effect of Sulodexide with much larger number of patients.