PubMed · 10529320
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A Colombo. 1999. Different benefits, different risks, equal cost.. https://doi.org/10.1053/euhj.1999.1828
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Three platelet glycoprotein (GP) IIb/IIIa receptor antagonists have been evaluated in patients undergoing percutaneous coronary intervention (PCI). One of these agents, abciximab, is structurally and pharmacologically quite different from the other 2, eptifibatide and tirofiban. We conducted a meta-analysis to determine whether different antagonist types achieved different clinical outcomes, possibly related to their structural differences. Odds ratios (OR) were calculated and a random effects model was used to combine the outcomes of 14,644 patients enrolled in 8 prospective, randomized, placebo-controlled clinical trials assessing treatment with a GP IIb/IIIa inhibitor to prevent ischemic complications of PCI. Neither abciximab (OR 0.69; 95% confidence interval [CI] 0.4 to 1.9) nor eptifibatide or tirofiban treatment (OR 0.74; 95% CI 0.4 to 1.28) resulted in reductions in mortality. Only the abciximab-treated patients had reductions in myocardial infarction (4.3% vs 8.5%, OR 0.49; 95% CI 0.40 to 0.59). There was no effect of eptifibatide or tirofiban on myocardial infarction (OR 0.85; 95% CI 0.69 to 1.04). Urgent revascularization was reduced in both abciximab-treated (2.7% vs 6.2%, OR 0.42; 95% CI 0.34 to 0.53) and eptifibatide- and tirofiban-treated (4.2% vs 5.5%, OR 0.76; 95% CI 0.60 to 0.96) groups. Only abciximab-treated patients had increased major bleeding (5.8% vs 3.8%; OR 1.53; 95% CI 1.24 to 1.90). There was no effect of eptifibatide or tirofiban on major bleeding (5.0% vs 4.3%; OR 1.19; 95% CI 0.94 to 1.52). Thus, significant differences exist between clinical outcomes achieved by abciximab and those achieved by eptifibatide or tirofiban following PCl procedures.
BACKGROUND: Unfractionated heparin has been the primary anticoagulant therapy for percutaneous coronary intervention for >20 years. Despite the availability of rapid "point of care" testing, little clinical data defining the optimal level of anticoagulation are available. Furthermore, recent reports have advocated the use of low-dose heparin regimens in the absence of large-scale, well-conducted studies to support this practice. METHODS AND RESULTS: We pooled the data from 6 randomized, controlled trials of novel adjunctive antithrombotic regimens for percutaneous coronary interventions in which unfractionated heparin constituted the control arm. Patients were divided into 25-s intervals of activated clotting times (ACTs), from <275 s to >476 s. In a total of 5216 patients, the incidence of death, myocardial infarction, or any revascularization and major or minor bleeding at 7 days were calculated for each group and compared. An ACT in the range of 350 to 375 s provided the lowest composite ischemic event rate of 6.6%, or a 34% relative risk reduction in 7-day ischemic events compared with rates observed between 171 and 295 s by quartile analysis (P=0.001). CONCLUSIONS: Contrary to recent reports, the optimal suppression of ischemic events with unfractionated heparin therapy in patients undergoing percutaneous coronary intervention demands treatment to ACT levels that are substantially higher than currently appreciated. These data define a goal for heparin dosing within coronary interventions and establish a benchmark of optimal unfractionated heparin therapy against which future trials of novel antithrombotic regimens in percutaneous interventions can be compared.
Among 214 patients treated with abciximab within 24 hours of full-dose thrombolytic therapy, major bleeding occurred in 50 patients (23%; 95% confidence interval [CI] 18% to 30%) and intracranial hemorrhage occurred in 3 patients (1.4%; 95% CI 0.3% to 4%). The independent multivariate predictors of major bleeding were age (odds ratio [OR] 1.53/10 years, 95% CI 1.05 to 2.21, p = 0.03), time from thrombolytic to abciximab (OR 0.91/hour, 95% CI 0.83 to 0.99, p = 0.03), and intra-aortic balloon pump insertion (OR 4.42, 95% CI 2.00 to 9.72, p = 0.0002).