A randomized trial of the low-molecular-weight heparin certoparin to prevent restenosis following coronary angioplasty

• Published in: The Journal of invasive cardiology 2001-11, Vol.13 (11), p.723-728
• Main Authors: Grassman, E D, Leya, F, Fareed, J, Lewis, B E, Bacher, P, Loeb, H S, Moran, J F
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Anticoagulants - therapeutic use; Coronary Artery Disease - complications; Coronary Artery Disease - therapy; Coronary Restenosis - etiology; Coronary Restenosis - prevention & control; Double-Blind Method; Female; Follow-Up Studies; Heparin, Low-Molecular-Weight - therapeutic use; Humans; Male; Middle Aged; Time Factors; Treatment Outcome; Treatment Refusal
• ISSN: 1042-3931

The objectives of this study were to evaluate the effectiveness and safety of the low-molecular-weight heparin (LMWH) certoparin in preventing restenosis following balloon coronary angioplasty. Restenosis following coronary angioplasty continues to limit the long-term efficacy of this procedure. Animal studies have indicated a potential role for LMWH in reducing restenosis by limiting smooth muscle proliferation. This study tested the effects of certoparin, self-administered for 3 months, in reducing restenosis following balloon coronary angioplasty. One hundred and eighteen patients with 158 lesions treated with angioplasty were enrolled in this randomized, placebo-controlled trial. One hundred and two patients completed the study. The endpoint was relative loss measured with quantitative coronary angiography. The relative loss for placebo was 0.19 +/- 0.23 compared to 0.14 +/- 0.21 for LMWH (p = NS). The minimum lumen diameter (MLD) was 1.47 +/- 0.66 for placebo and 1.40 +/- 0.57 for the LMWH (p = NS). There was a reduction (31% for LMWH; 49% for placebo PSDP) in the percent of patients having binary restenosis (MLD < 50% of reference diameter). At the end of the study 77% of the placebo patients and 76% of the LMWH group were asymptomatic (p = NS). There was a low rate of bleeding complications and these were minor. Bone density scans showed that there was no significant occurrence of osteoporosis with 3 months of LMWH. Administration of certoparin for 3 months is safe, but appears ineffective in reducing post-PTCA restenosis.