Development and Validation of an Ischemic and Bleeding Risk Evaluation Tool in East Asian Patients Receiving Percutaneous Coronary InterventionFunding None.
23 November 2018
03 April 2019
12 May 2019 (eFirst)
Background The ischemic/bleeding risk of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is still uncertain. We sought to develop a tool to predict ischemic and bleeding events in East Asians receiving 2nd generation drug-eluting stents (DESs) PCI.
Methods A pooled cohort of 13,172 East Asian patients receiving PCI with 2nd generation DES (the Grand DES cohort) was analyzed to develop a scoring system. A net score was calculated by subtracting the bleeding score from the ischemic score. External validation was performed in the HOST-ASSURE and NIPPON trials.
Results Among the total population, ischemic and bleeding events occurred in 195 patients (1.5%) and 166 patients (1.3%), respectively. The score to predict ischemic events included previous myocardial infarction (MI) or PCI, presentation as acute MI, anemia, stent diameter < 3 mm, and total stent length of ≥30 mm, while that for bleeding events included older age, low creatinine clearance, and anemia. C-statistics of the ischemic and bleeding model was 0.708 and 0.665, respectively. Patients with a net score of ≥1 had a higher ischemic risk compared with bleeding risk, and patients with a net score of ≤–1 had a higher bleeding risk compared with ischemic risk. The validation cohort showed a C-statistic of 0.647 for ischemic events and 0.633 for bleeding events.
Conclusion We developed a tool to predict ischemic and bleeding events in East Asian patients received PCI with 2nd generation DES. This system can be used to assess clinical event risks, and to determine the adequate duration of DAPT in East Asians.
Keywordsdual antiplatelet therapy - percutaneous coronary intervention - 2nd generation drug-eluting stents - East Asians - ischemic and bleeding risk - scoring system
- 1 Levine GN. Balancing ischemic and bleeding risks of prolonged dual antiplatelet therapy. JAMA 2017; 318 (02) 194-195
- 2 Levine GN, Bates ER, Bittl JA. , et al. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: an update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention, 2011 ACCF/AHA guideline for coronary artery bypass graft surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease, 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction, 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes, and 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery. Circulation 2016; 134 (10) e123-e155
- 3 Valgimigli M, Bueno H, Byrne RA. , et al; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: the Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2018; 39 (03) 213-260
- 4 Baber U, Mehran R, Giustino G. , et al. Coronary thrombosis and major bleeding after PCI with drug-eluting stents: risk scores from PARIS. J Am Coll Cardiol 2016; 67 (19) 2224-2234
- 5 Yeh RW, Secemsky EA, Kereiakes DJ. , et al; DAPT Study Investigators. Development and validation of a prediction rule for benefit and harm of dual antiplatelet therapy beyond 1 year after percutaneous coronary intervention. JAMA 2016; 315 (16) 1735-1749
- 6 Costa F, van Klaveren D, James S. , et al; PRECISE-DAPT Study Investigators. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet 2017; 389 (10073): 1025-1034
- 7 Levine GN, Jeong YH, Goto S. , et al. Expert consensus document: World Heart Federation expert consensus statement on antiplatelet therapy in East Asian patients with ACS or undergoing PCI. Nat Rev Cardiol 2014; 11 (10) 597-606
- 8 Kang J, Han JK, Ahn Y. , et al; investigators for Korea Acute Myocardial Infarction Registry-National Institute of Health (KAMIR-NIH). Third-generation P2Y12 inhibitors in East Asian acute myocardial infarction patients: a nationwide prospective multicentre study. Thromb Haemost 2018; 118 (03) 591-600
- 9 Pencina MJ, D'Agostino Sr RB, D'Agostino Jr RB, Vasan RS. Evaluating the added predictive ability of a new marker: from area under the ROC curve to reclassification and beyond. Stat Med 2008; 27 (02) 157-172
- 10 Navarese EP, Andreotti F, Schulze V. , et al. Optimal duration of dual antiplatelet therapy after percutaneous coronary intervention with drug eluting stents: meta-analysis of randomised controlled trials. BMJ 2015; 350: h1618
- 11 Patil RK, Swaminathan RV, Feldman DN. Continuation of dual-antiplatelet therapy following percutaneous revascularization with a drug-eluting stent: what duration is optimal?. Curr Atheroscler Rep 2015; 17 (11) 63
- 12 Capodanno D, Alfonso F, Levine GN, Valgimigli M, Angiolillo DJ. ACC/AHA versus ESC guidelines on dual antiplatelet therapy: JACC guideline comparison. J Am Coll Cardiol 2018; 72 (23 Pt A): 2915-2931
- 13 Mauri L, Kereiakes DJ, Yeh RW. , et al; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med 2014; 371 (23) 2155-2166
- 14 Ueda P, Jernberg T, James S. , et al. External validation of the DAPT score in a nationwide population. J Am Coll Cardiol 2018; 72 (10) 1069-1078
- 15 Park KW, Jeon KH, Kang SH. , et al. Clinical outcomes of high on-treatment platelet reactivity in Koreans receiving elective percutaneous coronary intervention (from results of the CROSS VERIFY study). Am J Cardiol 2011; 108 (11) 1556-1563
- 16 Park KW, Kang J, Park JJ. , et al. Amlodipine, clopidogrel and CYP3A5 genetic variability: effects on platelet reactivity and clinical outcomes after percutaneous coronary intervention. Heart 2012; 98 (18) 1366-1372
- 17 Kang J, Kim HS. The evolving concept of dual antiplatelet therapy after percutaneous coronary intervention: focus on unique feature of East Asian and “Asian Paradox”. Korean Circ J 2018; 48 (07) 537-551
- 18 Jeong YH. “East Asian paradox”: challenge for the current antiplatelet strategy of “one-guideline-fits-all races” in acute coronary syndrome. Curr Cardiol Rep 2014; 16 (05) 485
- 19 Goto S, Huang CH, Park SJ, Emanuelsson H, Kimura T. Ticagrelor vs. clopidogrel in Japanese, Korean and Taiwanese patients with acute coronary syndrome -- randomized, double-blind, phase III PHILO study. Circ J 2015; 79 (11) 2452-2460
- 20 Saito S, Isshiki T, Kimura T. , et al. Efficacy and safety of adjusted-dose prasugrel compared with clopidogrel in Japanese patients with acute coronary syndrome: the PRASFIT-ACS study. Circ J 2014; 78 (07) 1684-1692
- 21 Li P, Gu Y, Yang Y. , et al. Low-dose ticagrelor yields an antiplatelet efficacy similar to that of standard-dose ticagrelor in healthy subjects: an open-label randomized controlled trial. Sci Rep 2016; 6: 31838
- 22 Lee JM, Jung JH, Park KW. , et al. Harmonizing optimal strategy for treatment of coronary artery diseases--comparison of REDUCtion of prasugrEl dose or POLYmer TECHnology in ACS patients (HOST-REDUCE-POLYTECH-ACS RCT): study protocol for a randomized controlled trial. Trials 2015; 16: 409
- 23 Giustino G, Kirtane AJ, Baber U. , et al. Impact of anemia on platelet reactivity and ischemic and bleeding risk: from the assessment of dual antiplatelet therapy with drug-eluting stents study. Am J Cardiol 2016; 117 (12) 1877-1883
- 24 Wang X, Qiu M, Qi J. , et al. Impact of anemia on long-term ischemic events and bleeding events in patients undergoing percutaneous coronary intervention: a system review and meta-analysis. J Thorac Dis 2015; 7 (11) 2041-2052
- 25 Hébert PC, Van der Linden P, Biro G, Hu LQ. Physiologic aspects of anemia. Crit Care Clin 2004; 20 (02) 187-212