posted by Borja
Journal of the American College of CardiologyVolume 41, Issue 6, 19 March 2003, Pages 969-973
A randomized comparison of clopidogrel and aspirin versus ticlopidine and aspirin after the placement of coronary artery stents
Abstract
Objectives
The aim of the present study was to compare clopidogrel and ticlopidine after coronary stenting with regard to cardiovascular death during long-term follow-up.
Background
Randomized trials comparing clopidogrel and ticlopidine with a restricted use of intravenous glycoprotein IIb/IIIa inhibition have reported a trend toward a higher incidence of thrombotic stent occlusion with clopidogrel at 30 days.
Methods
After successful coronary stent implantation, 700 patients with 899 lesions were randomly assigned to receive a four-week course of either 500 mg ticlopidine (n = 345) or 75 mg clopidogrel (n = 355) in addition to 100 mg aspirin. Cardiovascular death was the primary end point and was recorded during a median follow-up period of 28 months.
Results
Cardiovascular death occurred in eight patients with ticlopidine versus 26 patients with clopidogrel (hazard ratio with ticlopidine compared with clopidogrel, 0.30; 95% confidence interval [CI], 0.14 to 0.66; P = 0.003). After adjustment for co-variables, ticlopidine reduced the risk of cardiovascular death by 63% compared with clopidogrel. The combined end point of cardiovascular death or nonfatal myocardial infarction was present in 19 patients assigned ticlopidine, compared with 40 patients assigned clopidogrel (hazard ratio, 0.45; P = 0.005). The hazard ratio for all-cause mortality with ticlopidine as compared with clopidogrel was 0.30 (95% CI, 0.14 to 0.64; P = 0.002).
Conclusions
After the placement of coronary artery stents in unselected patients, ticlopidine was associated with a significantly lower mortality than clopidogrel. This raises concern about the current practice of substituting clopidogrel for ticlopidine after stenting and highlights the need for further long-term studies.
COMMENT: This paper received almost no attention in the literature. Important to note that clopidogrel was administered with no loading dose, while ticlopidine treatment was started by a 500 mg alodaing dose. However, in a table enclosed in the paper, it is clear that the events curve start to diverge quite late (more than 2 months after stent implantation). In this scenario, it seems highly unlikely that the absence of loading dose of clopidogrel has something to do.
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The fact that statins interfere with clopidogrel´s metabolism, and not with ticlopidine´s, may play an important role in its apparent inferiority to prevent CV events and death, since in the typical clinical scenario most patients also take statins. The ticlopidine loading dose may have also helped it to come out better in this study, since it is well known that proper periinterventional antiaggregation is vital to prevent stent occlusion, even in the long run, as is the case in this study. The issue is whether to give a rather safe drug, such as clopidogrel, or a drug with more adverse effects, but with probably more efficacy, as is ticlopidine.
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