Thromb Haemost. 2019;119(1):149-162.
Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy: Individual Patient Level Landmark Meta-Analysis from Seven RCTs.
제1저자 강지훈 · 교신저자 박경우, 김효수
소속 (13)
- Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
- Dipartimento Cardio-Toraco-Vascolare, University of Bologna, Bologna, Italy.
- Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York, United States.
- Division of Cardiology, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California, United States.
- San Raffaele Scientific Institute, Milan, Italy.
- Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
- Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts, United States.
- Swiss Cardiovascular Center, Bern University Hospital, Bern University, Bern, Switzerland.
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
- Department of Cardiology, Brest University, Brest, France.
- Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.
- The Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, University of Ulsan, Seoul, Republic of Korea.
- Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Changwon, Republic of Korea.
Abstract
BACKGROUND Prolonged dual anti-platelet therapy (DAPT) is intended to reduce ischaemic events, at the cost of an increased bleeding risk in patients undergoing percutaneous coronary intervention (PCI). In this study, we evaluated whether race influences the ischaemia/bleeding risk trade-off.
METHODS We searched for randomized clinical trials (RCTs) comparing DAPT duration after PCI. To compare the benefit or harm between DAPT duration by race, individual patient-level landmark meta-analysis was performed after discontinuation of the shorter duration DAPT group in each RCT. The primary ischaemic endpoint was major adverse cardiac events (MACEs), and the primary bleeding endpoint was major bleeding events (clinicaltrials.gov NCT03338335).
RESULTS Seven RCTs including 16,518 patients (8,605 East Asians, 7,913 non-East Asians) were pooled. MACE occurred more frequently in non-East Asians (0.8% vs. 1.8%, p < 0.001), while major bleeding events occurred more frequently in East Asians (0.6% vs. 0.3%, p = 0.001). In Cox proportional hazards model, prolonged DAPT significantly increased the risk of major bleeding in East Asians (hazard ratio [HR], 2.843, 95% confidence interval [CI], 1.474-5.152, p = 0.002), but not in non-East Asians (HR, 1.375, 95% CI, 0.523-3.616, p = 0.523). East Asians had a higher median probability risk ratio of bleeding to ischaemia (0.66 vs. 0.15), and the proportion of patients with higher probability of bleeding than ischaemia was significantly higher in East Asians (32.3% vs. 0.4%, p < 0.001).
CONCLUSION We suggest that the ischaemia/bleeding trade-off may be different between East Asians and non-East Asians. In East Asians, prolonged DAPT may have no effect in reducing the ischaemic risk, while significantly increases the bleeding risk.
Georg Thieme Verlag KG Stuttgart · New York.
Comment · 정정
Conflict of interest statement
Deepak L. Bhatt discloses the following relationships - Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Cleveland Clinic, Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Ironwood, Ischemix, Lilly, Medtronic, Pfizer, Roche, Sanofi Aventis, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, St. Jude Medical (now Abbott); Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, PLx Pharma, Takeda. Marco Valgimigli reports grants from AstraZeneca; personal fees from AstraZeneca, grants and personal fees from Terumo, personal fees from Abbott Vascular, personal fees from Bayer, personal fees from Amgen, personal fees from Cardinal health, personal fees from Biosensors, personal fees from Abbott Vascular, personal fees from Daiichi Sankyo, outside the submitted work. All the other authors report no conflict of interest.
그 밖의 정보
- 출판 형태
- Journal Article, Meta-Analysis
- 저널
- Thrombosis and haemostasis · eISSN 2567-689X
- 전자 출판
- 2018-12-31
- MeSH
- Asian People · Blood Platelets · Coronary Artery Disease / complications / ethnology / therapy · Drug-Eluting Stents · Ethnicity · Hemorrhage / drug therapy / ethnology · Humans · Ischemia / drug therapy / ethnology · Myocardial Infarction / complications / ethnology · Percutaneous Coronary Intervention / adverse effects · Platelet Aggregation Inhibitors / pharmacology · Probability · Randomized Controlled Trials as Topic · Risk Factors · Treatment Outcome
- Substances
- Platelet Aggregation Inhibitors
- 데이터
- ClinicalTrials.gov: NCT03338335