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PRAGUE-8 Study

PRAGUE-8 Study C lopidogrel > 6 hours before elective CAG vs. a few minutes before PCI in stable angina ? P Widimský, Z Mo ť ovská, S Šimek , P Kala & PRAGUE-8 trial Investigators

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PRAGUE-8 Study

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  1. PRAGUE-8 Study Clopidogrel > 6 hours before elective CAGvs. a few minutes before PCI in stable angina ?P Widimský, Z Moťovská, S Šimek, P Kala &PRAGUE-8 trial Investigators Charles University Prague (Third Medical Faculty, First Medical Faculty, Medical Faculty Hradec Kralové), University Hospital Brno and Regional Hospital Liberec. Open, randomized multicenter trial. Support: Research project MSM0021620817 Charles University Prague. Nothing else to disclose, no support from industry.

  2. The full list of investigators. • Charles University Prague - 3rd Medical Faculty and University Hospital Kralovske Vinohrady (442 pts. enrolled):Zuzana MOTOVSKA, Petr Widimský, Robert Petr, Dana Bílková, Václav Bufka, Pavel Gregor, Radovan Jirmář, Petr Ošťádal, Tomáš Buděšínský, Jaroslav Dvořák, Viktor Kočka, Libor Lisa. • Charles University Prague – 1st Medical Faculty and General University Hospital (334 pts. enrolled):Stanislav Šimek, Hana Skalická, Jan Horák, Petr Kuchynka, Aleš Linhart, Michael Aschermann. • Masaryk University & University Hospital Brno (204 pts. enrolled):Petr Kala, Martin Poloczek, Roman Miklík, Jindřich Špinar, Lenka Kubková, Jan Maňoušek. • Charles University Prague – Medical Faculty & University Hospital Hradec Kralove (24 pts. enrolled): Lucie Horáková, Radek Pudil, Jan Vojáček, Josef Šťásek, Josef Bis, Jaroslav Dušek, Pavel Polanský, Miroslav Brtko. • Regional Hospital Liberec (24 pts. enrolled):František Holm, Zdeněk Šembera, Jiri Maly.

  3. Background. • Clopidogrel pre-treatment before planned elective PCI reduces periprocedural complications. • Current practice:very few„planned“ PCI’s(i.e. separate procedures from CAG), but rather „ad-hoc“ PCI’s(unplanned, indicated and performed immediately afterplanned elective CAG). • ESC guidelines for PCI: Evidence is lacking. Expert consesnsus: clopidogrel pre-treatment to all elective CAG’s (to achieve therapeutic levels at the time of possible ad-hoc PCI). • Is this valid ??

  4. Group A „nonselective“ clopidogrel use (n = 513) clopidogrel 600 mg > 6 hours before each CAG (mean time interval between clopidogrel loading dose and CAG was 20,6 hours) Group B „selective“ clopidogrel use (n = 515) clopidogrel 600 mg in the cath-lab after CAG, only to patients, undergoing subsequent PCI Randomizationon the day before CAG

  5. Primary end-point(death / periprocedural MI / stroke or TIA / re-intervention within 7 days, %) n.s.

  6. Periprocedural troponin elevation(% of pts. with >3x ULN after intervention) n.s.

  7. Bleeding complications(clinically significant, major & minor, %) Definitions: Major: intracranial or clinically overt bleeding with a decrease in hemoglobin > 50 g/l Minor: clinically visible with a decrease in hemoglobin ≤ 50 g/l according to the TIMI criteria p = 0,02 p = 0,006

  8. Individual end-points [n]

  9. Clopidogrel and early CABG (n = 28)Only 2,7% of all CAG patients underwent early (within <7 days) CABG.

  10. Conclusion. • Routine clopidogrel pretreatment before elective CAG in stable coronary artery disease is not justified. • It increased the risk of bleeding complications, while the benefit on ischemic periprocedural complications was not significant. • Clopidogrel should be given only to patients with known CAG who undergo PCI and this can be done safely in the catheterization laboratory between the two procedures.

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