Absence of Long-term Benefit of Revascularization in Patients With Intermittent Claudication: Five-Year Results From the IRONIC Randomized Controlled Trial

Djerf, Henrik; Millinger, Johan; Falkenberg, Mårten; Jivegård, Lennart; Svensson, Mikael; Nordanstig, Joakim

doi:10.1016/j.jvs.2020.05.003

Cited by 7 publications

(8 citation statements)

References 1 publication

Supporting

Mentioning

Contrasting

Order By: Relevance

“…20 Unfortunately, subsequent 5-year results demonstrated that revascularization lost the early benefit and did not contribute to any long-term QOL improvement. 21 Considering both the results of the IRONIC trial and the mean follow-up period of about 2 years in our study, appropriate and longstanding advice about the unsupervised exercise therapy would result in the long-term maintenance of walking distance and good daily activity, leading to favorable graft patency and AFS.…”

Section: Discussionmentioning

confidence: 67%

Long-Term Results of Distal Bypass for Intermittent Claudication

Kobayashi

Hamamoto

Okazaki

et al. 2020

Vasc Endovascular Surg

View full text Add to dashboard Cite

Background: Distal bypass (DB) is the optimal treatment for patients with critical limb ischemia (CLI). However, effectiveness of DB for patients with intermittent claudication (IC) remains uncertain. This study aimed to analyze long-term results of DB for IC patients (IC-DB) compared with those of DB for CLI patients (CLI-DB). Methods: Patients undergoing DB from January 2009 to July 2018 at a single institution were retrospectively reviewed. Operative details, primary and secondary patency, amputation free survival rate (AFS), and long-term exercise capacity using Barthel index were analyzed. Results: Out of 302 DB (245 patients), 49 IC-DB were performed in 43 patients: 38 males, mean age 70.3 ± 8.0 years, diabetes mellitus 51%, chronic renal failure with hemodialysis 7%. The Great saphenous vein was used in 47 limbs, the small saphenous vein in 1, and the arm vein in 1. These grafts were bypassed in a non-reversed fashion for 35 limbs, in an in-situ fashion in 9, and in a reversed fashion in 5. The mean operative time was 173 min. The mean follow-up was 25 ± 26 months. Primary and secondary patency of IC-DB was 79% and 94% at 1 year, 71% and 90% at 3 years, 65% and 90% at 5 years, which were significantly higher than those of CLI-DB (primary patency: P = .007, secondary patency: P = .025). AFS of IC-DB and CLI-DB was 100% and 77% at 1 year, 93% and 52% at 3 years, and 90% and 43% at 5 years (IC-DB vs. CLI-DB, p < .0001). Barthel index of IC-DB unchanged at discharge (median 100) and at the last visit (median 100), showing daily activity was maintained adequately. Conclusions: DB could offer a promising approach for patients with IC because of durable graft patency, acceptable AFS, and maintenance of daily activity.

show abstract

Section: Discussionmentioning

confidence: 67%

Long-Term Results of Distal Bypass for Intermittent Claudication

Kobayashi

Hamamoto

Okazaki

et al. 2020

Vasc Endovascular Surg

View full text Add to dashboard Cite

show abstract

“…However, the serious nature of the reported adverse cardiac, kidney, and limb events is significant, given that claudication can usually be managed effectively without invasive intervention. 10 The severity of the complications we have reported is reflected by their associated cost burdens. The baseline crude hospital cost for an uncomplicated LEB procedure reported in the PHD was $11,783, similar to previous reported studies.…”

Section: Discussionmentioning

confidence: 98%

“…An increasing number of lower extremity revascularizations have been performed for claudication in the United States, despite multiple society recommendations against revascularization as primary management and a lack of apparent benefit in terms of longterm functional outcomes. 2,4,5,10 In the present study, we sought to quantify the costs associated with postoperative complications after elective LEB for claudication. We found an overall in-hospital complication rate of 8.5%, and most complications were acute kidney injury and wound complications.…”

Section: Discussionmentioning

confidence: 99%

“…[5][6][7] Although LEB has had reasonable shortterm outcomes and long-term patency, 8,9 the long-term benefits and cost-effectiveness of surgery performed for claudication are questionable. 10 In addition, the occurrence of postoperative complications after LEB is not uncommon. 11,12 A recent analysis of data from the National Surgical Quality Improvement Program (NSQIP) reported that postoperative complications occurred in ≤17% of patients undergoing LEB for claudication.…”

mentioning

confidence: 99%

See 1 more Smart Citation

Quantifying the risk-adjusted hospital costs of postoperative complications after lower extremity bypass in patients with claudication

Sorber

Alshaikh

Nejim

et al. 2021

Journal of Vascular Surgery

View full text Add to dashboard Cite

Objective: Increasing evidence has shown that the risks associated with surgical revascularization for intermittent claudication outweigh the benefits. The aim of our study was to quantify the cost of care associated with perioperative complications after elective lower extremity bypass (LEB) in patients presenting with intermittent claudication.Methods: All patients undergoing first-time LEB for claudication in the Healthcare Database (2009)(2010)(2011)(2012)(2013)(2014)(2015) were included. The primary outcome was in-hospital postoperative complications, including major adverse limb events (MALE), major adverse cardiac events (MACE), acute kidney injury, and wound complications. The overall crude hospital costs are reported, and a generalized linear model with log link and inverse Gaussian distribution was used to calculate the predicted hospital costs for specific complications.

show abstract

“…However, for a clear majority of patients, only one re-intervention is commonly required to maintain long term patency, which might not be a very serious issue for the patient. 4 It might still be worthwhile to revascularise IC patients to improve functional endpoints such as walking distance and/or health-related quality of life. The observed difference in mortality rates between treatment groups is also an uncertain finding that is probably largely explained by case mix differences.…”

mentioning

confidence: 99%