A randomized pilot trial for aggressive therapeutic approaches in aspirin-resistant patients undergoing percutaneous coronary intervention

J Invasive Cardiol. 2011 Jan;23(1):9-13.

Abstract

Background: There is great variability among individual patients in platelet inhibition after aspirin intake. Aspirin resistance has been associated with a higher incidence of ischemic events after percutaneous coronary intervention (PCI). The optimal antiplatelet therapy in aspirin-resistant patients undergoing PCI is unknown. The objective of this study was to evaluate whether aggressive antiplatelet therapy would reduce ischemic events in aspirin-resistant patients after PCI.

Methods: A total of 330 patients undergoing PCI (with bivalirudin) were screened for aspirin responsiveness. The resulting 36 aspirin-resistant patients were randomized into two arms: 1) conventional strategy patients received 325 mg aspirin orally and a loading dose of 600 mg clopidogrel at the time of the procedure; and 2) aggressive strategy patients received similar amounts of aspirin and clopidogrel, with the addition of an intravenous glycoprotein IIb/IIIa inhibitor bolus intraprocedurally. The primary outcome was an elevation of cardiac enzymes within 24 hours post procedure. The secondary outcome was a composite of major adverse cardiac events including death, myocardial infarction, stent thrombosis and urgent revascularization, and bleeding up to 30 days.

Results: Primary outcome occurred in 22% of the conventional strategy group and 11% of the aggressive strategy group (p = 0.36). The secondary outcome was reached in 27.8% of the conventional group and 5.5% of the aggressive strategy group (p = 0.17), which is suggestive of a statistical trend toward more ischemic events with conventional therapy. Importantly, there were 2 cases of definite stent thrombosis in the conventional strategy group.

Conclusion: In aspirin-resistant patients, aggressive antiplatelet therapy tended to show better outcomes after PCI, without an increase in bleeding. These findings need validation in a large, randomized study.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Angioplasty, Balloon, Coronary*
  • Antithrombins / administration & dosage
  • Antithrombins / therapeutic use*
  • Aspirin / pharmacology
  • Blood Platelets / drug effects*
  • Clopidogrel
  • Drug Resistance
  • Drug Therapy, Combination
  • Female
  • Hirudins / administration & dosage
  • Humans
  • Male
  • Middle Aged
  • Peptide Fragments / administration & dosage
  • Peptide Fragments / therapeutic use*
  • Pilot Projects
  • Platelet Aggregation / drug effects
  • Platelet Aggregation Inhibitors / administration & dosage*
  • Platelet Aggregation Inhibitors / pharmacology
  • Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors*
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / therapeutic use
  • Ticlopidine / administration & dosage
  • Ticlopidine / analogs & derivatives

Substances

  • Antithrombins
  • Hirudins
  • Peptide Fragments
  • Platelet Aggregation Inhibitors
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Recombinant Proteins
  • Clopidogrel
  • Ticlopidine
  • Aspirin
  • bivalirudin