Clopidogrel pre-treatment in stable angina: for all patients > 6 h before elective coronary angiography or only for angiographically selected patients a few minutes before PCI? A randomized multicentre trial PRAGUE-8
Abstract
Aims To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography (CAG)+-ad hoc percutaneous coronary intervention (PCI). Methods and results Open-trial randomized 1028 patients with stable angina to group A ('non-selective'-clopidogrel 600 mg >6 h before CAG; n = 513) or group B ('selective'-clopidogrel 600 mg in the cath-lab after CAG, only in case of PCI; n = 515).
Combined primary endpoint was death/periprocedural myocardial infarction (MI)/stroke/re-intervention within 7 days. Secondary endpoints were troponin elevation and bleeding complications.
Primary endpoint occurred in 0.8% group A patients vs. 1% group B (P = 0.749; 90% CI for the percentage difference MINUS SIGN 1.2-0.8). Periprocedural troponin elevation (>3x ULN) was detected in 2.6% group A vs. 3.3% group B (P = 0.475; 90% CI MINUS SIGN 2.5-1.0).
Bleeding complications occurred in 3.5% group A patients vs. 1.4% group B (P = 0.025). After adjustment for covariates and factors that may influence the bleeding risk, patients in group A were shown to have more likely bleeding complications when compared with group B (OR = 3.03; 95% CI 1.14-8.10; P = 0.027).
Conclusion High (600 mg) loading dose of clopidogrel before elective CAG increased the risk of minor bleeding complications, while the benefit on periprocedural infarction was not significant. Clopidogrel can be given safely in the catheterization laboratory between CAG and PCI in chronic stable angina patients.