Systemic review of treatment of intermi1ent claudica5on in the lower extremi5es RFS Journal Primer

BOTTOM LINE Given the limited research, supervised exercise therapy, endovascular therapy, and open surgery are superior to medical management in terms of walking distance, pain, and claudication. Blood Alow parameters (ABI) improved faster and better with both forms of revascularization, which may not necessarily correlated with clinical improvement. MAJOR POINTS High quality evidence from 2 Cochrane systematic trials favoring supervised exercise therapy (SET) for improved walking performance High quality evidence favoring revascularization as compared to optimal medical therapy (OMT) for improved walking performance and blood Alow parameters Low quality evidence showing better/faster improvement in ABI with revascularization (open or PTA) as compared to SET Moderate evidence showing increase in 30-day morbidity and mortality, longer length of stay, higher complication rate, but increase in durability and patency in open surgery compared to PTA Limited studies demonstrating higher mean cost of PTA compared to SET CRITICISM

Limited number of trials and systematic reviews from which to draw conclusions

Quick Summary

Meta-analysis of multiple RCTs and systematic reviews A total of 1548 patients in a total of 12 trials. A total of 8 systematic reviews were evaluated (3 Cochrane reviews on exercise therapy, 2 on SET with endovascular therapy, and 3 of nonrandomized surgical case series) The median length of follow-up was 15 months INCLUSION CRITERIA Randomized trials or systematic reviews Enrolled patients with claudication (ie, symptomatic patients with peripheral vascular disease who had exertional pain with walking) Evaluated open bypass, endovascular revascularization, or exercise therapy Measured the outcomes of interest EXCLUSION CRITERIA Duplicates, no original data, or ab irrelevant population (ie: patients with CLI)

Study design

To evaluate the available modalities currently in practice to treat patients with claudication with respect to their efAicacy. Purpose

RCTs and systematic reviews comparing medical management, supervised exercise therapy (SET), endovascular treatment, and open bypass Metrics evaluated were

Mortality/morbidity Amputation QOL Walking distance ABI Patency Cost

Interven7on

Outcome

Exercise therapy 2 systematic reviews, a total of 2818 patients from 44 RCTs Outcomes

Exercise signiAicantly improved maximal walking distance and time compared with usual care or placebo (including pentoxifylline, iloprost, antiplatelet agents and vitamin E, or pneumatic calf compression). Improvements persisted over 2 years. Supervised therapy translated to an increase in walking distance of 180 meters as compared to non-supervised therapy

Comparing endovascular therapy with medical management MIMIC trial: PTA vs no PTA in patients already in SET programs, follow up for 24 months

PTA group had higher adjusted walking distance and ABI, but not QOL Creasy et al, 1990: PTA vs SET, follow-up 9-10 months

SET lead to better mean claudicating distance. PTA had initial improvement for 3 months without subsequent improvement. SET continued to improved over 15 months. Nylaende et al, 2007: PTA + medical therapy vs medical therapy. 2 year follow up

Early management with PTA and medical therapy better than medical therapy alone with regards to pain free walking distance , pain, and QOL. Greatest difference at 3 months. No difference at 2 years.

Outcome

Comparing endovascular therapy with medical management (cont) Hobbs et al, 2006: PTA superior to SET and best medical treatment on basis of ABI, initial claudication distance, and absolute claudication distance at 6 months Perkins et al, 1996. Early improvement with SET, but no difference at long term follow up. PTA increased ABI. Spronk, et al, 2009. No difference between endovascular therapy and SET with respect to pain-free walking distance at 6 and 12 months, and 7 year follow-up. Somewhat faster improvement with PTA. Whyman, et al, 1997. Adding PTA to medical therapy (aspirin, smoking cessation, and exercise) did not result in signiAicant difference in walking, onset of claudication, walking distance, or ABI. CLEVER trial. Longer peak walking time at 6 months in the SET arm compared with optimal medical therapy (OMT) and stenting. ABI improved in the stenting group.

After 6 months, stent revascularization had better patient reported QOL as compared with SET and OMT ABI improved in the stenting group

ERASE trial. Endovascular therapy + SET resulted in signiAicant greater improvement in pain-free and maximum walking disease and health-related QOL compared to SET alone 2 separate systematic reviews (Frans et al and Ahimastos et al) concluded that endovascular therapy and SET are likely equal

Combination of both is likely better than 1 approach alone

Outcome

Comparing endovascular therapy with surgery Van der Zaag et al, 2004: Bypass had higher clinical improvement in Rutherford classiAication than PTA

Bypass had higher 1 year patency and less incidence of reocclusion Wolf et al, 1993. Both had improvement in functional status A systematic review (which also included CLI patients) with a total of 5358 patients showed that bypass was associated with longer hospital stay, higher complication rate, and 30-day mortality. Bypass had higher patency and durability. 2nd review showed increased 30-day morbidity, but no difference in mortality.

Comparing any revascularization with medical management or exercise Gelin et al, 2001. Invasive vascularization increases walking capacity and was more effective than supervised training in alleviating illness speciAic symptoms compared to medical management or exercise Nordanstig et al, 2014. Invasive vascularization is associated with improved QOL and higher initial claudication distance, but not maximum walking distance

Outcome

Cost utilization data. Very limited data due to most RCTs that included cost analysis also included CLI Spronk et al, 2008. Higher cumulative cost per patient for endovascular therapy compared to a hospital-based exercise program, despite similar outcomes at 12-months Bermingham et al, 2013. SET more cost effective than unsupervised therapy Mazari et al, 2013. SET with PTA is more cost effective than PTA alone

Outcome

Credits

SUMMARY BY: Alexander Lam M.D., R1 PGY2 Department of Radiological Sciences University of California, Irvine Medical Center Malgor RD, Alalahdab F, Elraiyah TA, et al. A systematic review of treatment of intermittent claudication in the lower extremities. Journal of vascular surgery. 2015;61(3 Suppl):54S-73S.

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