title: Validation of Three Platelet Function Tests for Bleeding Risk Stratification During Dual Antiplatelet Therapy Following Coronary Interventions.
abstract: BACKGROUND
  Although low platelet reactivity (LPR) is commonly detected during bleeding, a validated threshold for reliable DAPT bleeding risk stratification is lacking. We tested the diagnostic utility of 3 conventional platelet-activity assays to define the predictive value (if any) of LPR for bleeding.
  
  
  OBJECTIVE
  We hypothesized whether one of these tests be better than any others for predicting bleeding events.
  
  
  METHODS
  Patients (n = 800) following drug-eluting stent implantation received DAPT. Bleeding was assessed by Bleeding Academic Research Consortium (BARC) classification and events were collected for 1 year after stenting. Platelet reactivity was measured by light transmittance aggregometry (LTA), VerifyNow, and multiple electrode aggregometry (MEA). The LPR values for bleeding event stratification were defined as ≤15% for LTA, ≤139 PRU for VerifyNow, and ≤25 U for MEA.
  
  
  RESULTS
  Bleeding events occurred in 18 patients (2.3%). All tests distinguished LPR as an independent predictor for bleeding by univariate analysis ([HR]: 5.00, 95% [CI]: 1.8-14.0, P = 0.002 for LTA; HR: 21.3, 95% CI: 6.2-73.0, P < 0.0001 for VerifyNow; and HR: 7.4, 95% CI: 2.2-25.5, P = 0.002 for MEA). Multivariate analysis revealed that only VerifyNow (HR: 11.5, 95% CI: 2.9-45.7, P < 0.0004) remained an independent predictor for bleeding. However, the specificity (81.5%, 60.2%, and 81.7%, respectively) and sensitivity (61.1%, 83.3%, and 83.2%, respectively) of all 3 tests were quite low.
  
  
  CONCLUSIONS
  Among 3 conventional platelet-activity assays, VerifyNow was better than LTA or MEA for triaging future bleeding risks. However, all 3 tests failed to reliably predict future bleeding.
authors.affiliation: Clinical Trial Center, Dong-A University Hospital, Busan, South Korea.|Department of Cardiology, Dong-A University Hospital, Busan, South Korea.
authors.forename: Moo Hyun
authors.initials: MH
authors.lastname: Kim
authors.affiliation: Clinical Trial Center, Dong-A University Hospital, Busan, South Korea.
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Choi
authors.affiliation: Clinical Trial Center, Dong-A University Hospital, Busan, South Korea.
authors.forename: Soo Yeon
authors.initials: SY
authors.lastname: An
authors.affiliation: HeartDrug Research Laboratories, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Victor
authors.initials: V
authors.lastname: Serebruany
mesh_terms: D001792:Blood Platelets / Q000502:physiology*; D003324:Coronary Artery Disease / Q000097:blood / Q000628:therapy*; D003430:Cross-Sectional Studies; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D010974:Platelet Aggregation / Q000502:physiology; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D010979:Platelet Function Tests / Q000379:methods*; D011379:Prognosis; D011446:Prospective Studies; D056910:Republic of Korea / Q000453:epidemiology; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors
chemical_list: D010975:Platelet Aggregation Inhibitors