מתוך TCMD , סקירת מאמר מלנצט:
The authors did a meta-analysis of all large randomized trials that studied the clinical efficacy and safety of glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes (ACS) who were not routinely scheduled for early coronary revascularization: PRISM, PRISM-PLUS, PARAGON-A, PURSUIT, PARAGON-B, and GUSTO-IV ACS.
The six trials altogether enrolled 31,402 patients in 41 countries. The primary efficacy endpoint was a composite of death or non-fatal myocardial infarction (MI). Major bleeding was the primary safety endpoint.
For practical reasons, the authors used the trial-specific definitions of MI and major bleeding.
There were no important differences in baseline characteristics between patients randomly assigned glycoprotein IIb/IIIa inhibitors (n=18,297) and those assigned placebo or control (n=13,105). 5 days after randomization, 389 (1B72%) patients had died.
The composite endpoint of death or MI was reached in 1943 (6.2%) patients at 5 days and 3530 (11.2%) patients at 30 days. At 30 days, 1116 (3.6%) patients had died. Glycoprotein IIb/IIIa inhibitors were associated with a highly significant 16% relative reduction in the odds of death or MI at 5 days (p=0.0003) and 9% at 30 days (p=0.015).
There was no statistical evidence of heterogeneity in treatment effect among the separate trials. The benefits of glycoprotein IIb/IIIa inhibitors were consistent across various subpopulations including age, diabetes mellitus, history of cardiac disease, and condition on admission. The treatment effect seemed larger in patients with ST-segment depression than in those without, but the difference did not reach significance.
Baseline cardiac troponin data were available in 69% of the patients enrolled in PRISM, 6% in PRISM-PLUS, 4% in PURSUIT, 23% in PARAGON-B, and 91% in GUSTO-IV. No cardiac troponin data were available in PARAGON-A. In the 45% of patients with positive troponin T or I, glycoprotein IIb/IIIa inhibitors were associated with a 15% reduction in the odds of 30-day death or MI. In patients with negative troponins, no risk reduction was seen. There was a highly significant interaction between gender and treatment. In men, glycoprotein IIb/IIIa inhibitors were associated with a 19% reduction in the odds of 30-day death or MI. Conversely, in women, the data showed a risk increase (from 10.4% to 11.5%).
There were important differences between men and women with regard to age (62 vs 66 years), diabetes mellitus (20% vs 26%), history of MI (37% vs 28%), history of heart failure (9% vs 12%), history of coronary revascularisation (23% vs 15%), admidssion ST-segment depression (54% vs 60%), and increased creatine kinase MB concentrations on admission (50% vs 38%). The gender difference in treatment effect remained (p<0.0001) after adjustment for these baseline characteristics. However, once patients were stratified according to troponin concentration, there was no evidence of a gender difference in treatment response, and a risk reduction was seen in men and women with elevated troponin concentrations.
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