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


BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
Administration of certoparin for 3 months is safe, but appears ineffective in reducing post-PTCA restenosis.
Grassman
E D
ED
Loyola University Medical Center, 2160 South First Avenue, Maywood, IL 60153, USA. egrassm@wpo.it.luc.edu
Leya
F
F
Fareed
J
J
Lewis
B E
BE
Bacher
P
P
Loeb
H S
HS
Moran
J F
JF
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000150:complications / Q000628:therapy; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D016312:Treatment Refusal
D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; C403769:certoparin