Avtandil M Babunashvili, Samir Pancholy, Aleksei B Zulkarnaev, Alexander L Kaledin, Igor N Kochanov, Alexander V Korotkih, Dmitriy S Kartashov, Mikhail A Babunashvili
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Published literature describing the RAO rate after DRA versus TRA from various RCT and clinical registries has shown conflicting results.</p><p><strong>Objectives: </strong>This study compared the forearm radial artery occlusion (RAO) rate assessed by Doppler ultrasound between distal and conventional radial access at 1-year follow-up after the initial procedure.</p><p><strong>Methods: </strong>TENDERA was a multicenter, randomized controlled study comparing DRA versus TRA for coronary diagnostic and interventional procedures using 5 or 6F hydrophilic-coated sheaths. The primary endpoint was forearm RAO at 12 months after radial access. The secondary endpoints included puncture time, sheath insertion and total procedure time, radiation dose, and vascular access site-related complications.</p><p><strong>Results: </strong>Eight hundred and fifty patients were randomized to either TRA (n = 418) and DRA (n = 432) groups. In the intention-to-treat analysis, the rate of forearm RAO at 12 months was observed in 39 patients (4.6%) and was significantly reduced in the DRA group compared with the TRA group (2.5% vs. 6.7%, RR 2.59 [95% CI 1.29-5.59], p = 0.010). Analysis in per protocol population has shown consistent results with forearm RAO rate 2.8% in the DRA group versus 6.5% in the TRA group (p = 0.008). The crossover rate was higher (4.6% vs. 1%, p = 0.013) and median hemostasis time was shorter (156.5 min vs. 180 min, p < 0.001) with DRA. Overall bleeding (BARC 1-2) and postprocedure hematoma > 5 cm occurred less frequently in the DRA group compared with the TRA group (3.2% vs. 20.5%, p < 0.001% and 9.0% vs. 27.0%, p < 0.001, respectively). No significant differences were observed in total procedure time and radiation dose between groups.</p><p><strong>Conclusions: </strong>DRA for coronary diagnostic and interventional procedures is associated with reduced forearm RAO rate and shorter hemostasis time, but a longer sheath insertion time and higher crossover rate compared with TRA.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT04211584.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":" ","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Traditional Versus Distal Radial Access for Coronary Diagnostic and Revascularization Procedures: Final Results of the TENDERA Multicenter, Randomized Controlled Study.\",\"authors\":\"Avtandil M Babunashvili, Samir Pancholy, Aleksei B Zulkarnaev, Alexander L Kaledin, Igor N Kochanov, Alexander V Korotkih, Dmitriy S Kartashov, Mikhail A Babunashvili\",\"doi\":\"10.1002/ccd.31271\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Traditional transradial access (TRA) is widely used for coronary and non-coronary interventions with significant improvements in procedural outcomes; however, it is associated with RAO that precludes repeat use of the same artery for possible future TRI and other purposes. Distal radial access (DRA) has been proposed as an effective alternative to decrease RAO rates. Published literature describing the RAO rate after DRA versus TRA from various RCT and clinical registries has shown conflicting results.</p><p><strong>Objectives: </strong>This study compared the forearm radial artery occlusion (RAO) rate assessed by Doppler ultrasound between distal and conventional radial access at 1-year follow-up after the initial procedure.</p><p><strong>Methods: </strong>TENDERA was a multicenter, randomized controlled study comparing DRA versus TRA for coronary diagnostic and interventional procedures using 5 or 6F hydrophilic-coated sheaths. The primary endpoint was forearm RAO at 12 months after radial access. The secondary endpoints included puncture time, sheath insertion and total procedure time, radiation dose, and vascular access site-related complications.</p><p><strong>Results: </strong>Eight hundred and fifty patients were randomized to either TRA (n = 418) and DRA (n = 432) groups. In the intention-to-treat analysis, the rate of forearm RAO at 12 months was observed in 39 patients (4.6%) and was significantly reduced in the DRA group compared with the TRA group (2.5% vs. 6.7%, RR 2.59 [95% CI 1.29-5.59], p = 0.010). Analysis in per protocol population has shown consistent results with forearm RAO rate 2.8% in the DRA group versus 6.5% in the TRA group (p = 0.008). The crossover rate was higher (4.6% vs. 1%, p = 0.013) and median hemostasis time was shorter (156.5 min vs. 180 min, p < 0.001) with DRA. Overall bleeding (BARC 1-2) and postprocedure hematoma > 5 cm occurred less frequently in the DRA group compared with the TRA group (3.2% vs. 20.5%, p < 0.001% and 9.0% vs. 27.0%, p < 0.001, respectively). 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引用次数: 0
摘要
背景：传统的经桡动脉入路（TRA）被广泛用于冠状动脉和非冠状动脉介入治疗，并显著改善了手术效果；然而，它与 RAO 有关，这就排除了将来可能重复使用同一动脉进行 TRI 和其他目的的可能性。桡动脉远端入路 (DRA) 被认为是降低 RAO 发生率的有效替代方法。已发表的文献描述了 DRA 与 TRA 术后的 RAO 率，这些文献来自各种 RCT 和临床登记，结果相互矛盾：本研究比较了远端桡动脉入路和传统桡动脉入路在初次手术后随访 1 年时通过多普勒超声评估的前臂桡动脉闭塞（RAO）率：TENDERA 是一项多中心随机对照研究，比较了使用 5F 或 6F 亲水涂层鞘管进行冠状动脉诊断和介入手术的 DRA 与 TRA。主要终点是桡动脉入路后 12 个月的前臂 RAO。次要终点包括穿刺时间、鞘插入和总手术时间、辐射剂量和血管通路部位相关并发症：8500 名患者被随机分为 TRA 组（418 人）和 DRA 组（432 人）。在意向治疗分析中，39 名患者（4.6%）在 12 个月时出现前臂 RAO，与 TRA 组相比，DRA 组的前臂 RAO 发生率显著降低（2.5% 对 6.7%，RR 2.59 [95% CI 1.29-5.59]，P = 0.010）。按方案人群的分析结果一致，DRA 组前臂 RAO 率为 2.8%，而 TRA 组为 6.5%（P = 0.008）。与 TRA 组相比，DRA 组的交叉率更高（4.6% 对 1%，p = 0.013），中位止血时间更短（156.5 分钟对 180 分钟，p 5 cm 发生率更低（3.2% 对 20.5%，p 结论：DRA 在冠状动脉诊断中的应用与 TRA 组相同：与 TRA 相比，用于冠状动脉诊断和介入手术的 DRA 可降低前臂 RAO 发生率，缩短止血时间，但鞘插入时间更长，交叉率更高：试验注册：ClinicalTrials.gov：试验注册：ClinicalTrials.gov: NCT04211584。
Traditional Versus Distal Radial Access for Coronary Diagnostic and Revascularization Procedures: Final Results of the TENDERA Multicenter, Randomized Controlled Study.
Background: Traditional transradial access (TRA) is widely used for coronary and non-coronary interventions with significant improvements in procedural outcomes; however, it is associated with RAO that precludes repeat use of the same artery for possible future TRI and other purposes. Distal radial access (DRA) has been proposed as an effective alternative to decrease RAO rates. Published literature describing the RAO rate after DRA versus TRA from various RCT and clinical registries has shown conflicting results.
Objectives: This study compared the forearm radial artery occlusion (RAO) rate assessed by Doppler ultrasound between distal and conventional radial access at 1-year follow-up after the initial procedure.
Methods: TENDERA was a multicenter, randomized controlled study comparing DRA versus TRA for coronary diagnostic and interventional procedures using 5 or 6F hydrophilic-coated sheaths. The primary endpoint was forearm RAO at 12 months after radial access. The secondary endpoints included puncture time, sheath insertion and total procedure time, radiation dose, and vascular access site-related complications.
Results: Eight hundred and fifty patients were randomized to either TRA (n = 418) and DRA (n = 432) groups. In the intention-to-treat analysis, the rate of forearm RAO at 12 months was observed in 39 patients (4.6%) and was significantly reduced in the DRA group compared with the TRA group (2.5% vs. 6.7%, RR 2.59 [95% CI 1.29-5.59], p = 0.010). Analysis in per protocol population has shown consistent results with forearm RAO rate 2.8% in the DRA group versus 6.5% in the TRA group (p = 0.008). The crossover rate was higher (4.6% vs. 1%, p = 0.013) and median hemostasis time was shorter (156.5 min vs. 180 min, p < 0.001) with DRA. Overall bleeding (BARC 1-2) and postprocedure hematoma > 5 cm occurred less frequently in the DRA group compared with the TRA group (3.2% vs. 20.5%, p < 0.001% and 9.0% vs. 27.0%, p < 0.001, respectively). No significant differences were observed in total procedure time and radiation dose between groups.
Conclusions: DRA for coronary diagnostic and interventional procedures is associated with reduced forearm RAO rate and shorter hemostasis time, but a longer sheath insertion time and higher crossover rate compared with TRA.
期刊介绍：
Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.
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