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European Heart Journal Advance Access published online on April 25, 2008
European Heart Journal, doi:10.1093/eurheartj/ehn169
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org
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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

Petr Widimsky1,*, Zuzana Motovská1, Stanislav Simek2, Petr Kala4, Radek Pudil3, Frantisek Holm5, Robert Petr1, Dana Bílková1, Hana Skalická2, Petr Kuchynka2, Martin Poloczek4, Roman Miklík4, Marek Maly6, Michael Aschermann2 on behalf of the PRAGUE-8 trial Investigators

1 Third Medical Faculty and University Hospital Kralovske Vinohrady, Cardiocentre, Charles University, Srobárova 50, 100 34 Praha 10, Prague, Czech Republic
2 First Medical Faculty and General University Hospital, Cardiocentre, Charles University, Prague, Czech Republic
3 Medical Faculty and University Hospital Hradec Kralové, Cardiocentre, Charles University, Prague, Czech Republic
4 Masaryk University and University Hospital Brno, Brno, Czech Republic
5 Regional Hospital Liberec, Liberec, Czech Republic
6 National Institute of Public Health, Prague, Czech Republic

Received 11 October 2007; revised 12 March 2008; accepted 7 April 2008.

* Corresponding author. Tel: +420 267163159, Fax: +420 267162621, Email: widim{at}fnkv.cz

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 –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 –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.

Key Words: Elective percutaneous coronary intervention • Clopidogrel pre-treatment • Stable coronary artery disease • Bleeding complications • Periprocedural ischaemic complications


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