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STrategies for antithrombotic tRreatment following transcatheter edge-to-edge repair in patients with severe mitral regurgitation: Rationale and design of STAR-TEER trial.

期刊: American heart journal 日期: 2026-06-01 PMID: 41616808 浏览: 49
作者: Wang C, Liu Z, Li Z, Yan X, Wang C, Zhou N, Zhang F, Ouyang W, Zhao G, Ma J, Wang S, Pan X
C, W., Z, L., Z, L., X, Y., C, W., N, Z., F, Z., W, O., G, Z., J, M., S, W., & X, P. (2026). STrategies for antithrombotic tRreatment following transcatheter edge-to-edge repair in patients with severe mitral regurgitation: Rationale and design of STAR-TEER trial.. American heart journal.
C W, Z L, Z L, X Y, C W, N Z, et al. STrategies for antithrombotic tRreatment following transcatheter edge-to-edge repair in patients with severe mitral regurgitation: Rationale and design of STAR-TEER trial.. American heart journal. 2026; PMID: 41616808
C W, Z L, Z L, et al. STrategies for antithrombotic tRreatment following transcatheter edge-to-edge repair in patients with severe mitral regurgitation: Rationale and design of STAR-TEER trial.[J]. American heart journal. 2026.
@article{c2026,
  author = {Wang C and Liu Z and Li Z and Yan X and Wang C and Zhou N and Zhang F and Ouyang W and Zhao G and Ma J and Wang S and Pan X},
  title = {STrategies for antithrombotic tRreatment following transcatheter edge-to-edge repair in patients with severe mitral regurgitation: Rationale and design of STAR-TEER trial.},
  journal = {American heart journal},
  year = {2026},
  note = {PMID: 41616808},
}
TY  - JOUR
AU  - Wang C
AU  - Liu Z
AU  - Li Z
AU  - Yan X
AU  - Wang C
AU  - Zhou N
AU  - Zhang F
AU  - Ouyang W
AU  - Zhao G
AU  - Ma J
AU  - Wang S
AU  - Pan X
TI  - STrategies for antithrombotic tRreatment following transcatheter edge-to-edge repair in patients with severe mitral regurgitation: Rationale and design of STAR-TEER trial.
T2  - American heart journal
PY  - 2026
AN  - PMID:41616808
ER  - 

摘要

Transcatheter edge-to-edge repair (TEER) has emerged as an important therapy for severe mitral regurgitation. Current guidelines lack evidence-based recommendations for optimal postprocedural antithrombotic strategies, leading to heterogeneous clinical practices. And there are no randomized controlled trials (RCTs) available to compare different antithrombotic strategies following TEER. STAR-TEER trial is an investigator-initiated, multicenter, randomized, parallel controlled, open-label trial, aiming to assess the safety and efficacy of de-escalated antithrombotic strategies with monotherapy in post-TEER patients with or without indications for oral anticoagulation (OAC) respectively. This trial plans to enroll 1,912 patients stratified into 2 cohorts: patients in Cohort A (requiring long-term OAC, n = 880) will be randomized 1:1 to rivaroxaban monotherapy or rivaroxaban plus clopidogrel, and patients in Cohort B (no OAC indication, n = 1,032) will be randomized 1:1 to aspirin monotherapy or aspirin plus clopidogrel. The primary outcome is all bleeding complications within 12 months post-TEER. The 2 key secondary outcomes are nonprocedure-related bleeding within 12 months post-TEER (key secondary outcome 1) and a composite of ischemic events including all-cause mortality, stroke, systemic embolism, and myocardial infarction within 12 months post-TEER (key secondary outcome 2). A hierarchical hypothesis testing will be performed, with the primary outcome and key secondary outcome 1 tested for superiority, followed by the key secondary outcome 2 tested for noninferiority. The STAR-TEER trial is the first large randomized controlled trial (RCT) to stratify patients based on OAC indication and compare different antithrombotic strategies following TEER in these 2 distinct cohorts. URL: https://www. gov. Unique identifier: NCT06901466 (Cohort A), NCT07007143 (Cohort B).

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