Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.
Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.
Eur J Vasc Endovasc Surg. 2022 Mar;63(3):421-429. doi: 10.1016/j.ejvs.2021.09.042. Epub 2022 Feb 10.
International guidelines recommend supervised exercise therapy (SET) as primary treatment for all patients with intermittent claudication (IC), yet primary endovascular revascularisation (ER) might be more effective in patients with iliac artery obstruction.
This was a multicentre RCT including patients with IC caused by iliac artery stenosis or occlusion (NCT01385774). Patients were allocated randomly to SET or ER stratified for maximum walking distance (MWD) and concomitant SFA disease. Primary endpoints were MWD on a treadmill (3.2 km/h, 10% incline) and disease specific quality of life (VascuQol) after one year. Additional interventions during a mean follow up of 5.5 years were recorded.
Between November 2010 and May 2015, 114 patients were allocated to SET, and 126 to ER. The trial was terminated prematurely after 240 patients were included. Compliance with SET was 57/114 (50%) after six months. Ten patients allocated to ER (8%) did not receive this intervention. One year follow up was complete for 90/114 (79%) SET patients and for 104/126 (83%) ER patients. The mean MWD improved from 187 to 561 m in SET patients and from 196 to 574 m in ER patients (p = .69). VascuQol sumscore improved from 4.24 to 5.58 in SET patients, and from 4.28 to 5.88 in ER patients (p = .048). Some 33/114 (29%) SET patients had an ER within one year, and 2/114 (2%) surgical revascularisation (SR). Some 10/126 (8%) ER patients had additional ER within one year and 10/126 (8%) SR. After a mean of 5.5 years, 49% of SET patients and 27% of ER patients underwent an additional intervention for IC.
Taking into account the many limitations of the SUPER study, both a strategy of primary SET and primary ER improve MWD on a treadmill and disease specific Qol of patients with IC caused by an iliac artery obstruction. It seems reasonable to start with SET in these patients and accept a 30% failure rate, which, of course, must be discussed with the patient. Patients continue to have interventions beyond one year.
国际指南建议间歇性跛行（IC）患者接受监督下的运动治疗（SET）作为主要治疗方法，但对于髂动脉阻塞的患者，主要的血管内血运重建（ER）可能更有效。
这是一项多中心 RCT，纳入了由髂动脉狭窄或闭塞引起的 IC 患者（NCT01385774）。患者根据最大步行距离（MWD）和同时存在的股浅动脉疾病进行分层，随机分配至 SET 或 ER 治疗。主要终点是在跑步机上的 MWD（3.2km/h，10%坡度）和一年后的疾病特异性生活质量（VascuQol）。在平均 5.5 年的随访期间记录了其他干预措施。
2010 年 11 月至 2015 年 5 月，114 名患者被分配至 SET 组，126 名患者被分配至 ER 组。在纳入 240 名患者后，该试验提前终止。6 个月后，SET 组的依从性为 57/114（50%）。10 名被分配至 ER 组（8%）的患者未接受该干预措施。114 名 SET 患者中有 90 名（79%）和 126 名 ER 患者中有 104 名（83%）完成了一年的随访。SET 组的 MWD 从 187m 增加到 561m，ER 组从 196m 增加到 574m（p=0.69）。SET 组的 VascuQol 总分从 4.24 增加到 5.58，ER 组从 4.28 增加到 5.88（p=0.048）。114 名 SET 患者中有 33 名（29%）在一年内接受了 ER，2 名（2%）接受了手术血运重建（SR）。126 名 ER 患者中有 10 名（8%）在一年内接受了额外的 ER，10 名（8%）接受了 SR。平均随访 5.5 年后，49%的 SET 患者和 27%的 ER 患者因 IC 接受了额外的介入治疗。
考虑到 SUPER 研究的许多局限性，主要的 SET 和 ER 策略都能改善由髂动脉阻塞引起的 IC 患者在跑步机上的 MWD 和疾病特异性生活质量。对于这些患者，首先采用 SET 似乎是合理的，接受 30%的失败率是合理的，当然，这必须与患者讨论。患者在一年后继续进行干预。
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