Zhou Yuhang, Wang Jiarong, Zhao Jichun, Yuan Ding, Weng Chengxin, Wang Tiehao, Huang Bin
Department of Vascular Surgery, West China Hospital, Sichuan University, Chengdu, China.
West China School of Medicine, West China Hospital, Sichuan University, Chengdu, China.
Front Cardiovasc Med. 2022 Aug 19;9:966251. doi: 10.3389/fcvm.2022.966251. eCollection 2022.
Endovascular abdominal aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR) have become the first-line treatment for aortic diseases, but current evidence is uncertain regarding whether a percutaneous approach has better outcomes than cutdown access, especially for patient-centered outcomes (PCOs). This study is designed to compare these outcomes of percutaneous access vs. cutdown access after endovascular aortic repair.
The SWEET study is a randomized, controlled, single-blind, single-center non-inferiority trial with two parallel groups in two cohorts respectively. After eligibility screening, subjects who meet the inclusion criteria will be divided into Cohort EVAR or Cohort TEVAR according to clinic interviews. And then participants in two cohorts will be randomly allocated to either intervention groups receiving percutaneous access endovascular repair or controlled groups receiving cutdown access endovascular repair separately. Primary clinician-reported outcome (ClinRO) is access-related complication, and primary patient-centered outcome (PCO) is time back to normal life. Follow-up will be conducted at 2 weeks, 1 month, 3 months postoperatively.
The choice of either percutaneous or cutdown access may not greatly affect the success of EVAR or TEVAR procedures, but can influence the quality of life and patient-centered experience. Given the very low evidence for ClinROs and few data for PCOs, comparison of the percutaneous vs. cutdown access EVAR and TEVAR is essential for both patient-centered care and clinical decision making in endovascular aortic repair.
Chinese Clinical Trial Registry ChiCTR2100053161 (registered on 13th November, 2021).
血管腔内腹主动脉修复术（EVAR）和胸主动脉腔内修复术（TEVAR）已成为主动脉疾病的一线治疗方法，但目前尚无证据表明经皮入路是否比切开入路具有更好的疗效，尤其是对于以患者为中心的结局（PCO）。本研究旨在比较血管腔内主动脉修复术后经皮入路与切开入路的这些结局。
SWEET研究是一项随机、对照、单盲、单中心非劣效性试验，分别在两个队列中设置两个平行组。经过资格筛选后，符合纳入标准的受试者将根据临床访谈分为EVAR队列或TEVAR队列。然后，两个队列中的参与者将被随机分配到接受经皮入路血管腔内修复的干预组或接受切开入路血管腔内修复的对照组。主要的临床医生报告结局（ClinRO）是与入路相关的并发症，主要的以患者为中心的结局（PCO）是恢复正常生活的时间。术后2周、1个月、3个月进行随访。
经皮入路或切开入路的选择可能不会对EVAR或TEVAR手术的成功率产生太大影响，但会影响生活质量和以患者为中心的体验。鉴于ClinRO的证据非常少，PCO的数据也很少，比较经皮入路与切开入路的EVAR和TEVAR对于以患者为中心的护理和血管腔内主动脉修复的临床决策至关重要。
中国临床试验注册中心ChiCTR2100053161（于2021年11月13日注册）。
