title: A randomized pilot trial for aggressive therapeutic approaches in aspirin-resistant patients undergoing percutaneous coronary intervention.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Mount Sinai Hospital, One Gustave L. Levy Place, New York, NY 10029, USA.
authors.forename: Fadi
authors.initials: F
authors.lastname: El-Atat
authors.forename: Kunal
authors.initials: K
authors.lastname: Sarkar
authors.forename: Visali
authors.initials: V
authors.lastname: Kodali
authors.forename: Rucha
authors.initials: R
authors.lastname: Karajgikar
authors.forename: Madhavi
authors.initials: M
authors.lastname: Jakkulla
authors.forename: Angelica
authors.initials: A
authors.lastname: Mares
authors.forename: Samin
authors.initials: S
authors.lastname: Sharma
authors.forename: Annapoorna
authors.initials: A
authors.lastname: Kini
mesh_terms: D000328:Adult; D015906:Angioplasty, Balloon, Coronary; D000991:Antithrombins / Q000008:administration & dosage / Q000627:therapeutic use*; D001241:Aspirin / Q000494:pharmacology; D001792:Blood Platelets / Q000187:drug effects*; D000077144:Clopidogrel; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D006629:Hirudins / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000008:administration & dosage / Q000627:therapeutic use*; D010865:Pilot Projects; D010974:Platelet Aggregation / Q000187:drug effects; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000494:pharmacology; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin; C074619:bivalirudin