Jun-Won Lee MD, PhD , Chan Joon Kim MD, PhD , Bong-Ki Lee MD, PhD , Sung Gyun Ahn MD, PhD , Young Jin Youn MD, PhD , Jung-Hee Lee MD, PhD , Ho Sung Jeon MD , Su Yong Kim MD , Jaehyuk Jang MD , Seonghyeon Bu MD , Hyo-Suk Ahn MD, PhD , Sungmin Lim MD, PhD , Hyeon Woo Yim MD, PhD , Seung-Hwan Lee MD, PhD
{"title":"st段抬高型心肌梗死患者桡骨远端通路vs桡骨经桡骨通路:DRAMI试验","authors":"Jun-Won Lee MD, PhD , Chan Joon Kim MD, PhD , Bong-Ki Lee MD, PhD , Sung Gyun Ahn MD, PhD , Young Jin Youn MD, PhD , Jung-Hee Lee MD, PhD , Ho Sung Jeon MD , Su Yong Kim MD , Jaehyuk Jang MD , Seonghyeon Bu MD , Hyo-Suk Ahn MD, PhD , Sungmin Lim MD, PhD , Hyeon Woo Yim MD, PhD , Seung-Hwan Lee MD, PhD","doi":"10.1016/j.jacadv.2025.102200","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Distal radial access (DRA) has emerged as an alternative to transradial access (TRA) in coronary procedures. However, evidence supporting its use in ST-segment elevation myocardial infarction (STEMI) remains limited.</div></div><div><h3>Objectives</h3><div>The purpose of this study was to assess whether DRA is noninferior to TRA in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI.</div></div><div><h3>Methods</h3><div>This multicenter, open-label, randomized controlled trial was conducted at 3 centers in South Korea. Patients undergoing primary PCI for STEMI were randomly assigned to either the DRA or TRA group. The primary endpoint was the puncture success rate. A noninferiority testing with a prespecified margin of 5.65% was performed in the intention-to-treat, per-protocol, and as-treated populations (<span><span>NCT03611725</span><svg><path></path></svg></span>).</div></div><div><h3>Results</h3><div>From August 2018 to February 2023, 354 patients were randomized to DRA (n = 176) or TRA (n = 178). The primary endpoint, puncture success rate was 94.3% in DRA and 96.1% in TRA (difference −1.75%; 95% CI −6.20% to 2.71%) in the intention-to-treat analysis. The per-protocol analysis also failed to demonstrate noninferiority (difference −1.72%; 95% CI -5.99% to 2.54%). DRA demonstrated noninferiority to TRA in the as-treated population (difference −1.17%; 95% CI -5.56% to 3.22%). The rates of successful coronary angiography and PCI, access-site crossover, and bleeding complications were comparable between groups. One radial artery occlusion occurred in TRA group at 1-month follow-up.</div></div><div><h3>Conclusions</h3><div>In STEMI patients, DRA failed to demonstrate noninferiority to TRA in terms of puncture success. However, both access routes showed comparable procedural efficacy and safety. Further validation with a larger, adequately powered study is required to confirm these findings.</div></div>","PeriodicalId":73527,"journal":{"name":"JACC advances","volume":"4 11","pages":"Article 102200"},"PeriodicalIF":0.0000,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Distal Radial Access vs Transradial Access in Patients With ST-Segment Elevation Myocardial Infarction\",\"authors\":\"Jun-Won Lee MD, PhD , Chan Joon Kim MD, PhD , Bong-Ki Lee MD, PhD , Sung Gyun Ahn MD, PhD , Young Jin Youn MD, PhD , Jung-Hee Lee MD, PhD , Ho Sung Jeon MD , Su Yong Kim MD , Jaehyuk Jang MD , Seonghyeon Bu MD , Hyo-Suk Ahn MD, PhD , Sungmin Lim MD, PhD , Hyeon Woo Yim MD, PhD , Seung-Hwan Lee MD, PhD\",\"doi\":\"10.1016/j.jacadv.2025.102200\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Distal radial access (DRA) has emerged as an alternative to transradial access (TRA) in coronary procedures. However, evidence supporting its use in ST-segment elevation myocardial infarction (STEMI) remains limited.</div></div><div><h3>Objectives</h3><div>The purpose of this study was to assess whether DRA is noninferior to TRA in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI.</div></div><div><h3>Methods</h3><div>This multicenter, open-label, randomized controlled trial was conducted at 3 centers in South Korea. Patients undergoing primary PCI for STEMI were randomly assigned to either the DRA or TRA group. The primary endpoint was the puncture success rate. A noninferiority testing with a prespecified margin of 5.65% was performed in the intention-to-treat, per-protocol, and as-treated populations (<span><span>NCT03611725</span><svg><path></path></svg></span>).</div></div><div><h3>Results</h3><div>From August 2018 to February 2023, 354 patients were randomized to DRA (n = 176) or TRA (n = 178). The primary endpoint, puncture success rate was 94.3% in DRA and 96.1% in TRA (difference −1.75%; 95% CI −6.20% to 2.71%) in the intention-to-treat analysis. The per-protocol analysis also failed to demonstrate noninferiority (difference −1.72%; 95% CI -5.99% to 2.54%). DRA demonstrated noninferiority to TRA in the as-treated population (difference −1.17%; 95% CI -5.56% to 3.22%). The rates of successful coronary angiography and PCI, access-site crossover, and bleeding complications were comparable between groups. One radial artery occlusion occurred in TRA group at 1-month follow-up.</div></div><div><h3>Conclusions</h3><div>In STEMI patients, DRA failed to demonstrate noninferiority to TRA in terms of puncture success. However, both access routes showed comparable procedural efficacy and safety. 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引用次数: 0
摘要
背景:桡动脉远端通路(DRA)已成为冠状动脉手术中经桡动脉通路(TRA)的替代方案。然而,支持其用于st段抬高型心肌梗死(STEMI)的证据仍然有限。目的:本研究的目的是评估在STEMI患者接受初级经皮冠状动脉介入治疗(PCI)时,DRA是否优于TRA。方法:这项多中心、开放标签、随机对照试验在韩国的3个中心进行。STEMI患者接受首次PCI治疗随机分为DRA组或TRA组。主要终点是穿刺成功率。在意向治疗人群、按方案治疗人群和已治疗人群(NCT03611725)中进行非劣效性检验,预定裕度为5.65%。结果:2018年8月至2023年2月,354例患者随机分为DRA组(n = 176)和TRA组(n = 178)。意向治疗分析的主要终点,DRA穿刺成功率为94.3%,TRA为96.1%(差异为-1.75%;95% CI为-6.20%至2.71%)。每个方案分析也未能证明非劣效性(差异-1.72%;95% CI -5.99%至2.54%)。在治疗人群中,DRA与TRA表现出非劣效性(差异-1.17%;95% CI -5.56%至3.22%)。两组间冠状动脉造影和PCI成功率、入路交叉率和出血并发症发生率具有可比性。随访1个月,TRA组发生1例桡动脉闭塞。结论:在STEMI患者中,DRA在穿刺成功率方面未能表现出与TRA的非劣效性。然而,这两种途径显示出相当的程序有效性和安全性。需要更大规模、更有力的研究来进一步证实这些发现。
Distal Radial Access vs Transradial Access in Patients With ST-Segment Elevation Myocardial Infarction
Background
Distal radial access (DRA) has emerged as an alternative to transradial access (TRA) in coronary procedures. However, evidence supporting its use in ST-segment elevation myocardial infarction (STEMI) remains limited.
Objectives
The purpose of this study was to assess whether DRA is noninferior to TRA in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI.
Methods
This multicenter, open-label, randomized controlled trial was conducted at 3 centers in South Korea. Patients undergoing primary PCI for STEMI were randomly assigned to either the DRA or TRA group. The primary endpoint was the puncture success rate. A noninferiority testing with a prespecified margin of 5.65% was performed in the intention-to-treat, per-protocol, and as-treated populations (NCT03611725).
Results
From August 2018 to February 2023, 354 patients were randomized to DRA (n = 176) or TRA (n = 178). The primary endpoint, puncture success rate was 94.3% in DRA and 96.1% in TRA (difference −1.75%; 95% CI −6.20% to 2.71%) in the intention-to-treat analysis. The per-protocol analysis also failed to demonstrate noninferiority (difference −1.72%; 95% CI -5.99% to 2.54%). DRA demonstrated noninferiority to TRA in the as-treated population (difference −1.17%; 95% CI -5.56% to 3.22%). The rates of successful coronary angiography and PCI, access-site crossover, and bleeding complications were comparable between groups. One radial artery occlusion occurred in TRA group at 1-month follow-up.
Conclusions
In STEMI patients, DRA failed to demonstrate noninferiority to TRA in terms of puncture success. However, both access routes showed comparable procedural efficacy and safety. Further validation with a larger, adequately powered study is required to confirm these findings.