Randomisation before planned PCI with DES (n=2500)

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Presentation transcript:

Randomisation before planned PCI with DES (n=2500) Assessment with a double Randomization of 1) a monitoring-adjusted antiplatelet treatment vs. a Common antiplatelet Treatment for DES implantation, and 2) Interruption vs. Continuation of double antiplatelet therapy one year after stenting Randomisation before planned PCI with DES (n=2500) Monitoring Treatment Arm -Systematic assessment of the pharmacodynamic response to clopidogrel and aspirin before DES placement and between D14-D30. 2-Adjustment of APT* dose regimen if high-on treatment platelet reactivity before DES placement** 3-Adjustment of APT* dose regimen if high-on treatment platelet reactivity during the maintenance phase (@ d14-30 )** Conventionnal Arm - No monitoring of pharmacodynamic platelet response - APT* strategy is left at the physician discretion according to routine practice Systematic Assessment of the biological response to both aspirin and clopidogrel beforre drug eluting stent placement and at day 7-14 Adjustment of the dose regimen of oral antiplatelet treatment in suboptimal responders VASP @ day 1 and before discharge Assessment of the primary endpoint at 1 year (minimal FU of 6 months for the last patients) All Cause Mortality Myocardial Infarction All Urgent Revascularization Stent Thrombosis requiring revascularization or not Ischemic Stroke requiring a new hospitalization *APT = Antiplatelet Therapy; **In the absence of high-on treatment platelet reactivity: DAPT dose regimen is 75mg of aspirin and 75mg of clopidogrel

ARU>550 %inh<15%/PRU>235 %inh>90% Planned PCI with DES, pretreated with aspirin and clopidogrel/prasugrel (local practice) and randomized to the Monitoring Treatment Arm VerifyNow before PCI : Aspirin & P2Y12 Thienopyridine ARU>550 (Aspirin cartridge) %inh<15% /PRU>235 (P2Y12 cartridge) Reload with 500 mg of IV aspirin GPIIb/IIIa inh. + clopidogrel (re)-loading (>or=600 mg) or prasugrel 60 mg and maintenance dose of 150 mg or prasugrel 10mg* VerifyNow @ day 14-30 Aspirin & P2Y12 thienopyridine for all patients ARU>550 %inh<15%/PRU>235 %inh>90% Doubling the aspirin dose ↗ Clopidogrel dose by at least 75 mg or switch to prasugrel 10mg* if clopidogrel 150mg, ↘ to 75mg or if on prasugrel switch to clopidogrel 75mg * Not indicated if previous stroke. Caution in patients >75 yo or <60kg. Indicated if Acute stent thrombosis or at least 2 of the following risk factors: (i) diabetes or overweight (BMI>30); (ii) High on-treatment platelet reacitivty; (iii) carriage of the 2C19*2 variant