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Patients Treated with High-dose Certoparin for the Prevention
of Post-PTCA Restenosis |
| E Galbraith, L Wrona, F Leya,
E Grassman, D Hoppensteadt, A Fasanella,
B Lewis, H Wolf* |
| Cardiac Clinical Research,
Loyola University Medical Center, Maywood,
IL, USA and *Novartis/Sandoz AG, Nürnberg,
Germany |
| Low-molecular-weight heparins
(LMWHs) are currently undergoing several
clinical trials for both acute and chronic
cardiovascular indications. The high bioavailability
of these agents allows their administration
by subcutaneous (s.c.) injection. To determine
the efficacy of high-dose s.c. LMWH in
reducing the incidence of restenosis following
percutaneous transluminal coronary angioplasty
(PTCA), 118 patients were randomized into
two groups. All patients underwent angioplasty
with conventional heparinization. Following
PTCA, the LMWH group received certoparin
(Sandoz AG), 80 mg/o.d. s.c. for 90 days
(n = 59). The placebo group received saline
(n = 59). Blood samples to measure laboratory
parameters and to ensure compliance were
drawn at baseline, 2 weeks, 4-6 weeks,
3 months and 6 months. Of the patients
who completed the entire course (n = 102),
compliance in the LMWH group was 100%,
as measured by anti-Xa and Heptest methods.
Final analysis of the trial is still pending,
but trends indicate that patients in the
LMWH group had a reduced restenosis rate
compared with the placebo group. No patients
in the study developed thrombocytopenia,
although heparin-PF4-antibodies were found
in 21% of patients.
This study demonstrates that long-term
use of LMWH is safe and patients can
be taught to self- administer this drug.
It is therefore concluded that LMWHs
at an optimized dose can be used in
chronic cardiovascular indications with
periodic monitoring. It is stressed
that different LMWHs may exhibit distinct
safety profiles.
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