Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry

• Definite Stent Thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"
• Any Bleeding Event [ Time Frame: 30days ] [ Designated as safety issue: Yes ]

  Bleeding classified by the TIMI hemorrhage classification scheme:

  Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin of 3 to < 5 g/dL

  Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL

• early definite stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  early (= acute and subacute) definite stent thrombosis according to ARC criteria
• any bleeding event [ Time Frame: 30days ] [ Designated as safety issue: Yes ]
  bleeding classified by the TIMI hemorrhage classification scheme

The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).

Depending on the clinical presentation patients are treated according to standard operating procedures in our department. The earliest, 12 hours after an initial clopidogrel-loading dose (600mg)"on-treatment" platelet reactivity will be determined by Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer), a point of care assay. In case of high residual platelet reactivity (i.e. ≥ 50U), patients are switched according to a therapeutic algorithm to either prasugrel (Efient®), or in case of contraindication (i.e. stroke) to ticagrelor (Brilique®), or in case of contraindication (intracranial hemorrhage) reloaded with clopidogrel.

• Platelet Inhibition
• Coronary Stent Implantation

• Drug: prasugrel or ticagrelor
  prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month
  Other Names:

  • Efient
  • Brilique
• Drug: Clopidogrel
  clopidogrel 75mg od for 12 month
  Other Name: Plavix

• Active Comparator: standard therapy
  standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
  Intervention: Drug: Clopidogrel
• Experimental: individualized therapy
  dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
  Intervention: Drug: prasugrel or ticagrelor

• Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schömig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56.
• Bonello L, Camoin-Jau L, Arques S, Boyer C, Panagides D, Wittenberg O, Simeoni MC, Barragan P, Dignat-George F, Paganelli F. Adjusted clopidogrel loading doses according to vasodilator-stimulated phosphoprotein phosphorylation index decrease rate of major adverse cardiovascular events in patients with clopidogrel resistance: a multicenter randomized prospective study. J Am Coll Cardiol. 2008 Apr 8;51(14):1404-11.
• Price MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, Puri S, Robbins M, Garratt KN, Bertrand OF, Stillablower ME, Aragon JR, Kandzari DE, Stinis CT, Lee MS, Manoukian SV, Cannon CP, Schork NJ, Topol EJ; GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011 Mar 16;305(11):1097-105.

Inclusion Criteria:

• all consecutive PCI patients with stent implantation of our institution

Exclusion Criteria:

• pregnancy