Incremental Value of Platelet Reactivity Over a Risk Score of Clinical and Procedural Variables in Predicting Bleeding After Percutaneous Coronary Intervention via the Femoral Approach: Development and Validation of a New Bleeding Risk Score.
BACKGROUND
Growing evidence suggests that platelet reactivity (PR) may predict bleeding. We investigate the incremental value of PR in predicting bleeding after percutaneous coronary intervention (PCI) via the femoral approach over a validated bleeding risk score (BRS) of clinical and procedural variables.


RESULTS
A total of 800 patients undergoing elective PCI via the femoral approach were included. PR was measured before PCI with the VerifyNow P2Y12 assay and low PR was defined as a P2Y12 reaction unit value ≤ 178. Calculation of the BRS included the following: age, sex, intra-aortic balloon pump, glycoprotein IIb/IIIa inhibitors, chronic kidney disease, anemia, and low-molecular-weight heparin within 48-hour pre-PCI. A new risk score including low PR (BRS-PR) was developed and validated in an independent cohort of patients (n = 310). Bleeding events at 30 days after PCI were defined according to the thrombolysis in myocardial infarction, Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2, and Bleeding Academic Research Consortium criteria. Both BRS and PR showed high discriminatory power for bleeding (area under the curve [AUC] > 0.7 for all definitions). Discriminatory power of BRS-PR (AUC = 0.809 for thrombolysis in myocardial infarction bleeding; AUC = 0.814 for Bleeding Academic Research Consortium class ≥ 2 bleeding; AUC = 0.708 for Bleeding Academic Research Consortium class ≥ 3 bleeding; and AUC = 0.813 for REPLACE-2 bleeding) was significantly higher than that of BRS alone (P < 0.001 for all bleeding definitions). In the validation set, BRS-PR showed higher discriminatory power for thrombolysis in myocardial infarction bleeding than BRS alone (AUC = 0.788 versus 0.709; P = 0.036).


CONCLUSIONS
PR has incremental predictive value on bleeding events after elective PCI via the femoral approach over a validated risk score of clinical and procedural variables. A risk score including PR yields significantly better prognostic performance compared with the original BRS.
From the Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy (F.M., E.R., C.D., G.P., V.V., G.D.S.); and Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium (E.B., A.P., B.D.B., W.W.). f.mangiacapra@unicampus.it g.disciascio@unicampus.it.
Fabio
F
Mangiacapra
From the Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy (F.M., E.R., C.D., G.P., V.V., G.D.S.); and Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium (E.B., A.P., B.D.B., W.W.).
Elisabetta
E
Ricottini
From the Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy (F.M., E.R., C.D., G.P., V.V., G.D.S.); and Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium (E.B., A.P., B.D.B., W.W.).
Emanuele
E
Barbato
From the Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy (F.M., E.R., C.D., G.P., V.V., G.D.S.); and Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium (E.B., A.P., B.D.B., W.W.).
Chiara
C
Demartini
From the Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy (F.M., E.R., C.D., G.P., V.V., G.D.S.); and Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium (E.B., A.P., B.D.B., W.W.).
Aaron
A
Peace
From the Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy (F.M., E.R., C.D., G.P., V.V., G.D.S.); and Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium (E.B., A.P., B.D.B., W.W.).
Giuseppe
G
Patti
From the Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy (F.M., E.R., C.D., G.P., V.V., G.D.S.); and Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium (E.B., A.P., B.D.B., W.W.).
Vincenzo
V
Vizzi
From the Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy (F.M., E.R., C.D., G.P., V.V., G.D.S.); and Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium (E.B., A.P., B.D.B., W.W.).
Bernard
B
De Bruyne
From the Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy (F.M., E.R., C.D., G.P., V.V., G.D.S.); and Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium (E.B., A.P., B.D.B., W.W.).
William
W
Wijns
From the Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy (F.M., E.R., C.D., G.P., V.V., G.D.S.); and Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium (E.B., A.P., B.D.B., W.W.). f.mangiacapra@unicampus.it g.disciascio@unicampus.it.
Germano
G
Di Sciascio
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects*; D001792:Blood Platelets / Q000502:physiology*; D003324:Coronary Artery Disease / Q000097:blood / Q000628:therapy*; D005260:Female; D005263:Femoral Artery; D006801:Humans; D008297:Male; D008875:Middle Aged; D010974:Platelet Aggregation; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D010979:Platelet Function Tests; D019106:Postoperative Hemorrhage / Q000175:diagnosis* / Q000209:etiology; D011446:Prospective Studies; D058925:Receptors, Purinergic P2Y12 / Q000097:blood; D012307:Risk Factors
D010975:Platelet Aggregation Inhibitors; D058925:Receptors, Purinergic P2Y12
hemorrhage; percutaneous coronary intervention; platelet reactivity