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亚洲高出血风险经皮冠状动脉介入治疗患者的1个月双联抗血小板治疗——玛瑙ONE清除2年结果

One-Month Dual Antiplatelet Therapy in High Bleeding Risk Asian Patients Undergoing Percutaneous Coronary Intervention - Onyx ONE Clear 2-Year Results.

作者信息

Kang Jeehoon, Abdul Ghapar Abdul Kahar, Selvaraj Kamaraj, Hur Seung-Ho, Tam Chor Cheung, Jang Yangsoo, Chae In-Ho, Kandzari David E, Kirtane Ajay J, Latib Azeem, Kedhi Elvin, Lung Te-Hsin, You So-Jeong, Windecker Stephan, Stone Gregg W, Kim Hyo-Soo

机构信息

Seoul National University Hospital Seoul Republic of Korea.

Hospital Serdang Kajang Malaysia.

出版信息

Circ Rep. 2024 Jul 6;6(8):333-340. doi: 10.1253/circrep.CR-24-0037. eCollection 2024 Aug 9.

DOI:10.1253/circrep.CR-24-0037
PMID:39132335
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11309775/
Abstract

BACKGROUND

One-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with the Resolute Onyx zotarolimus-eluting stents (ZES) is safe and effective. Asian patients have a unique ischemia/bleeding risk profile. Here, we compare the outcomes between Asian and non-Asian patients after PCI and 1-month DAPT.

METHODS AND RESULTS

Onyx ONE Clear was a prospective, multicenter study enrolling HBR patients undergoing PCI with the Resolute Onyx ZES (ClinicalTrials.gov identifier NCT03647475). Event-free patients after 1-month DAPT transitioned to single antiplatelet therapy. Clinical outcomes between 1 month and 2 years were compared between patients from Asian and non-Asian countries after 1 : 1 propensity score matching accounting for baseline differences. Patients from Asian countries represented 18% (n=273) of the study group (n=1,507). Non-Asian patients had greater clinical complexity; however, these differences were minimal after matching. There were no significant differences in ischemic outcomes between matched cohorts from 1 month to 2 years, including the primary composite endpoint of cardiac death or myocardial infarction (12% vs. 12%; P>0.99). However, there were significantly fewer Bleeding Academic Research Consortium types 3-5 bleeding events in the Asian vs. non-Asian cohort (4% vs. 9%; P=0.007), despite similar bleeding risk profiles after matching.

CONCLUSIONS

After propensity score matching, HBR patients from Asian countries undergoing PCI treated with 1-month DAPT had similar ischemic outcomes but fewer bleeding events between 1 month and 2 years compared with patients from non-Asian countries.

摘要

背景

对于接受经皮冠状动脉介入治疗(PCI)并植入雷帕霉素洗脱支架(ZES)的高出血风险(HBR)患者,为期1个月的双重抗血小板治疗(DAPT)是安全有效的。亚洲患者具有独特的缺血/出血风险特征。在此,我们比较PCI术后及1个月DAPT治疗后亚洲和非亚洲患者的结局。

方法与结果

Onyx ONE Clear是一项前瞻性、多中心研究,纳入接受Resolute Onyx ZES进行PCI的HBR患者(ClinicalTrials.gov标识符NCT03647475)。1个月DAPT后无事件的患者转为单一抗血小板治疗。在对基线差异进行1:1倾向评分匹配后,比较亚洲和非亚洲国家患者在1个月至2年期间的临床结局。亚洲国家的患者占研究组(n = 1507)的18%(n = 273)。非亚洲患者的临床复杂性更高;然而,匹配后这些差异很小。从1个月到2年,匹配队列之间的缺血结局无显著差异,包括心源性死亡或心肌梗死的主要复合终点(12%对12%;P>0.99)。然而,尽管匹配后出血风险特征相似,但亚洲队列中出血学术研究联盟3 - 5型出血事件明显少于非亚洲队列(4%对9%;P = 0.007)。

结论

在倾向评分匹配后,接受1个月DAPT治疗的亚洲国家HBR PCI患者与非亚洲国家患者相比,在1个月至2年期间缺血结局相似,但出血事件较少。

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