Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention for ST-Segment–Elevation Myocardial Infarction: A Multicenter, Randomized, Double-Blind Trial,Circulation

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Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention for ST-Segment–Elevation Myocardial Infarction: A Multicenter, Randomized, Double-Blind Trial
Circulation ( IF 37.8 ) Pub Date : 2024-02-26 , DOI: 10.1161/circulationaha.123.067079
Yan Yan _{1,

2,

3} , Jincheng Guo ₄ , Xiao Wang _{1,

2,

3} , Guozhong Wang _{1,

2,

4} , Zeyuan Fan ₅ , Delu Yin ₆ , Zhifang Wang ₇ , Fuchun Zhang ₈ , Changming Tian ₉ , Wei Gong ₃ , Jiamin Liu ₁₀ , Jiapeng Lu ₁₁ , Yongjun Li ₁₂ , Changsheng Ma _{2,

3,

13} , Eric Vicaut ₁₄ , Gilles Montalescot ₁₅ , Shaoping Nie _{1,

2,

3} ,

Affiliation

Center for Coronary Artery Disease, Capital Medical University, Beijing, China. (Y.Y., X.W., W.G., S.N.)
National Clinical Research Center of Cardiovascular Diseases, Beijing, China (Y.Y., X.W., W.G., C.M., S.N.).
Beijing Institute of Heart, Lung, and Blood Vessel Diseases, China (Y.Y., X.W., W.G., C.M., S.N.).
Division of Cardiology, Beijing Anzhen Hospital, and Beijing Luhe Hospital, Capital Medical University, Beijing, China. (J.G., G.W.)
Civil Aviation General Hospital, Beijing, China (Z.F.).
The First People’s Hospital of Lianyungang, Jiangsu, China (D.Y.).
Xinxiang Central Hospital, Henan, China (Z.W.).
Beijing Haidian Hospital, Beijing, China (F.Z.).
The People’s Hospital of Yongcheng, Henan, China (C.T.).
NHC Key Laboratory of Clinical Research for Cardiovascular Medications (J. Liu)
National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Center for Cardiovascular Diseases, Beijing, China (J. Lu).
The Second Hospital of Hebei Medical University, Shijiazhuang, China (Y.L.).
Arrhythmia Center, Capital Medical University, Beijing, China. (C.M.)
ACTION Study Group, Epidemiology and Clinic Research Unit, Lariboisière University Hospital, Paris, France (E.V.).
Sorbonne Université, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France (G.M.).

BACKGROUND:Postprocedural anticoagulation (PPA) is frequently administered after primary percutaneous coronary intervention in ST-segment–elevation myocardial infarction, although no conclusive data support this practice.METHODS:The RIGHT trial (Comparison of Anticoagulation Prolongation vs no Anticoagulation in STEMI Patients After Primary PCI) was an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled, superiority trial conducted at 53 centers in China. Patients with ST-segment–elevation myocardial infarction undergoing primary percutaneous coronary intervention were randomly assigned by center to receive low-dose PPA or matching placebo for at least 48 hours. Before trial initiation, each center selected 1 of 3 PPA regimens (40 mg of enoxaparin once daily subcutaneously; 10 U·kg·h of unfractionated heparin intravenously, adjusted to maintain activated clotting time between 150 and 220 seconds; or 0.2 mg·kg·h of bivalirudin intravenously). The primary efficacy objective was to demonstrate superiority of PPA to reduce the primary efficacy end point of all-cause death, nonfatal myocardial infarction, nonfatal stroke, stent thrombosis (definite), or urgent revascularization (any vessel) within 30 days. The key secondary objective was to evaluate the effect of each specific anticoagulation regimen (enoxaparin, unfractionated heparin, or bivalirudin) on the primary efficacy end point. The primary safety end point was Bleeding Academic Research Consortium 3 to 5 bleeding at 30 days.RESULTS:Between January 10, 2019, and September 18, 2021, a total of 2989 patients were randomized. The primary efficacy end point occurred in 37 patients (2.5%) in both the PPA and placebo groups (hazard ratio, 1.00 [95% CI, 0.63 to 1.57]). The incidence of Bleeding Academic Research Consortium 3 to 5 bleeding did not differ between the PPA and placebo groups (8 [0.5%] vs 11 [0.7%] patients; hazard ratio, 0.74 [95% CI, 0.30 to 1.83]).CONCLUSIONS:Routine PPA after primary percutaneous coronary intervention was safe but did not reduce 30-day ischemic events.REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03664180.

更新日期：2024-02-26

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