Department of Vascular Surgery, Sahlgrenska University Hospital, Sweden.
Eur J Vasc Endovasc Surg. 2011 Aug;42(2):220-7. doi: 10.1016/j.ejvs.2011.02.019. Epub 2011 Mar 11.
Despite limited scientific evidence for the effectiveness of invasive treatment for intermittent claudication (IC), revascularisation procedures for IC are increasingly often performed in Sweden. This randomised controlled trial compares the outcome after 2 years of primary invasive (INV) versus primary non-invasive (NON) treatment strategies in unselected IC patients.
MATERIALS/METHODS: Based on arterial duplex and clinical examination, IC patients were randomised to INV (endovascular and/or surgical, n = 100) or NON (n = 101). NON patients could request invasive treatment if they deteriorated during follow-up. Primary outcome was maximal walking performance (MWP) on graded treadmill test at 2 years and secondary outcomes included health-related quality of life (HRQL), assessed with Short Form (36) Health Survey (SF-36).
MWP was not significantly (p = 0.104) improved in the INV versus the NON group. Two SF-36 physical subscales, Bodily Pain (p < 0.01) and Role Physical (p < 0.05) improved significantly more in the INV versus the NON group. There were 7% crossovers against the study protocol in the INV group.
Although invasive treatment did not show any significant advantage regarding MWP, the HRQL improvements associated with invasive treatment tentatively suggest secondary benefits of this regimen. On the other hand, a primary non-invasive treatment strategy seems to be accepted by most IC patients.
尽管间歇性跛行（IC）的有创治疗效果的科学证据有限，但在瑞典，IC 的血运重建手术越来越频繁地进行。本随机对照试验比较了未经选择的 IC 患者在 2 年的主要有创（INV）与非侵入性（NON）治疗策略后的结果。
材料/方法：根据动脉双功能超声和临床检查，将 IC 患者随机分为 INV（血管内和/或手术，n = 100）或 NON（n = 101）组。如果 NON 组患者在随访期间病情恶化，他们可以要求进行有创治疗。主要终点是 2 年时分级跑步机测试的最大步行能力（MWP），次要终点包括健康相关生活质量（HRQL），采用简明健康调查量表（SF-36）评估。
INV 组与 NON 组相比，MWP 无显著改善（p = 0.104）。INV 组的两个 SF-36 身体子量表，身体疼痛（p < 0.01）和身体角色（p < 0.05）的改善明显优于 NON 组。INV 组有 7%的患者违反了研究方案。
尽管 INV 治疗在 MWP 方面没有显示出任何显著优势，但与 INV 治疗相关的 HRQL 改善提示该方案具有次要益处。另一方面，主要的非侵入性治疗策略似乎被大多数 IC 患者所接受。
