Comparison of percutaneous versus cutdown access in patients after endovascular abdominal aortic repair: a randomized controlled trial (SWEET-EVAR trial)

被引:0
作者
Zhou, Yuhang [1 ,2 ]
Wang, Jiarong [1 ]
Zhao, Jichun [1 ]
Yuan, Ding [1 ]
Weng, Chengxin [1 ]
Huang, Bin [1 ]
Wang, Tiehao [1 ]
机构
[1] Sichuan Univ, West China Hosp, Dept Gen Surg, Div Vasc Surg, Chengdu, Sichuan Provinc, Peoples R China
[2] Sichuan Univ, West China Hosp, West China Sch Med, Chengdu, Peoples R China
基金
中国国家自然科学基金;
关键词
cutdown; endovascular abdominal aortic repair; percutaneous; randomized controlled trial; OPEN FEMORAL EXPOSURE; ANEURYSM REPAIR; CLOSURE; PREDICTORS; OUTCOMES; FAILURE;
D O I
10.1097/JS9.0000000000002233
中图分类号
R61 [外科手术学];
学科分类号
摘要
Introduction:The optimal choice of either percutaneous or cutdown access for endovascular abdominal aortic repair (EVAR) remains uncertain due to insufficient evidence, particularly regarding patient-centered outcomes (PCOs). This study aimed at comparing both clinician-reported outcomes (ClinROs) and PCOs of percutaneous versus cutdown access in patients after EVAR.Methods:The study was a single-blind, single-center, non-inferiority, randomized controlled trial. After eligibility screening, patients diagnosed with abdominal aortic diseases were randomly assigned to either the intervention group receiving percutaneous EVAR or the control group receiving cutdown EVAR. Primary ClinRO was access-related complications, and primary PCO was time return to normal life/work.Results:Overall, 120 patients (containing 240 accesses) were allocated to either intervention group (n = 62) or control group (n = 58). Percutaneous EVAR (10/124, 8.1%) was non-inferior and not superior to cutdown EVAR (17/116, 14.7%) regarding access-related complications (P = 0.110; OR: 0.521, 95% CI: 0.225-1.157). As for PCOs, the recovery time back to normal life or work was superior in percutaneous EVAR compared to cutdown EVAR (16 vs. 28 days, P = 0.025; median difference: 7 days, 95% CI: 0-13 days). Moreover, percutaneous access did better in other PCOs, including a reduction in the duration of access-related pain (4 vs. 8 days, P = 0.001), decreased use of analgesics for access-related pain (0/61, 0% vs. 6/55, 10.9%; P = 0.026), and improved quality of life scores at 2 weeks following EVAR (0.876 vs. 0.782; P = 0.022). Prespecified subgroup analyses demonstrated percutaneous access significantly reduced the incidence of access-related complications compared to cutdown access in patients with thick subcutaneous tissue (1/42, 2.4% vs. 7/32, 21.9%; P = 0.026).Conclusion:In patients without massive common femoral artery calcification, percutaneous access may accelerate postoperative recovery and enhance patient experience and quality of life following EVAR, but did not provide obvious advantages regarding access-related complications.
引用
收藏
页码:2535 / 2545
页数:11
相关论文
共 50 条
[41]   A meta-analysis pooling survival curves in randomized controlled trials and propensity-score matched studies of endovascular versus open abdominal aortic aneurysm repair [J].
Takagi, Hisato ;
Umemoto, Takuya .
INTERNATIONAL JOURNAL OF CARDIOLOGY, 2014, 174 (03) :785-788
[42]   Conservative treatment versus elective repair of umbilical hernia in patients with liver cirrhosis and ascites: results of a randomized controlled trial (CRUCIAL trial) [J].
de Goede, B. ;
van Rooijen, M. M. J. ;
van Kempen, B. J. H. ;
Polak, W. G. ;
de Man, R. A. ;
Taimr, P. ;
Lange, J. F. ;
Metselaar, H. J. ;
Kazemier, G. .
LANGENBECKS ARCHIVES OF SURGERY, 2021, 406 (01) :219-225
[43]   Meta-analysis of phase-specific survival after elective endovascular versus surgical repair of abdominal aortic aneurysm from randomized controlled trials and propensity score-matched studies [J].
Yokoyama, Yujiro ;
Kuno, Toshiki ;
Takagi, Hisato .
JOURNAL OF VASCULAR SURGERY, 2020, 72 (04) :1464-+
[44]   Cost-effectiveness and cost-utility of endovascular versus open repair of ruptured abdominal aortic aneurysm in the Amsterdam Acute Aneurysm Trial [J].
Kapma, M. R. ;
Dijksman, L. M. ;
Reimerink, J. J. ;
de Groof, A. J. ;
Zeebregts, C. J. ;
Wisselink, W. ;
Balm, R. ;
Dijkgraaf, M. G. W. ;
Vahl, A. C. .
BRITISH JOURNAL OF SURGERY, 2014, 101 (03) :208-215
[45]   Comparison of a Behavioral Versus an Educational Weight Management Intervention After Renal Transplantation: A Randomized Controlled Trial [J].
Schmid-Mohler, Gabriela ;
Zala, Patrizia ;
Graf, Nicole ;
Witschi, Patrick ;
Mueller, Thomas F. ;
Wuthrich, Rudolf Peter ;
Huber, Laura ;
Fehr, Thomas ;
Spirig, Rebecca .
TRANSPLANTATION DIRECT, 2019, 5 (12)
[46]   Comparison of immediate versus optional delayed surgical repair for treatment of acute anterior cruciate ligament injury through a parallel, multicentric, pragmatic randomized controlled trial - IODA trial [J].
Smeets, Annemie ;
Ahwaz, Feryal Ghafelzadeh ;
Bogaerts, Stijn ;
Berger, Pieter ;
Peers, Koen .
BMC SPORTS SCIENCE MEDICINE AND REHABILITATION, 2024, 16 (01)
[47]   Risk Factors for Development of Incisional Hernia after Aortic Aneurysm Repair: Secondary Analysis of the OVER Randomized Controlled Trial [J].
Yi, Jeniann A. ;
Kawahara, Matt ;
Hurley, Landon ;
Bennett, Kyla M. ;
Freischlag, Julie A. ;
Stroupe, Kevin ;
Matsumura, Jon S. ;
Kundu, Anupam ;
Kyriakides, Tassos C. .
ANNALS OF VASCULAR SURGERY, 2024, 106 :419-425
[48]   Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk Results From the Randomized SURTAVI Trial [J].
Sondergaard, Lars ;
Popma, Jeffrey J. ;
Reardon, Michael J. ;
Van Mieghem, Nicolas M. ;
Deeb, G. Michael ;
Kodali, Susheel ;
George, Isaac ;
Williams, Mathew R. ;
Yakubov, Steven J. ;
Kappetein, Arie P. ;
Serruys, Patrick W. ;
Grube, Eberhard ;
Schiltgen, Molly B. ;
Chang, Yanping ;
Engstrom, Thomas .
CIRCULATION, 2019, 140 (16) :1296-1305
[49]   A Comparison of Suprapubic and Transurethral Catheterization on Postoperative Urinary Retention after Vaginal Prolapse Repair: A Randomized Controlled Trial [J].
Stekkinger, Eva ;
van der Linden, Paul J. Q. .
GYNECOLOGIC AND OBSTETRIC INVESTIGATION, 2011, 72 (02) :109-116
[50]   Long-term Cost-effectiveness in the Veterans Affairs Open vs Endovascular Repair Study of Aortic Abdominal Aneurysm A Randomized Clinical Trial [J].
Lederle, Frank A. ;
Stroupe, Kevin T. ;
Kyriakides, Tassos C. ;
Ge, Ling ;
Freischlag, Julie A. .
JAMA SURGERY, 2016, 151 (12) :1139-1144