Differences Between Patients With Intermittent Claudication and Critical Limb Ischemia Undergoing Endovascular Intervention: Insights From the Excellence in Peripheral Artery Disease Registry

Abstract

Background: There are limited data on differences in angiographic distribution of peripheral artery disease and endovascular revascularization strategies in patients presenting with intermittent claudication (IC) and critical limb ischemia (CLI). We aimed to compare anatomic features, treatment strategies, and clinical outcomes between patients with IC and CLI undergoing endovascular revascularization. Methods: We examined 3326 patients enrolled in the Excellence in Peripheral Artery Disease registry from 2006 to 2019 who were referred for endovascular intervention for IC (n=1983) or CLI (n=1343). The primary outcome was 1-year major adverse limb events, which included death, repeat target limb revascularization, or target limb amputation. Results: Patients with CLI were older and more likely to have diabetes and chronic kidney disease and less likely to receive optimal medical therapy compared with IC. Patients with IC had higher femoropopliteal artery interventions (IC 87% versus CLI 65%; P <0.001), while below the knee interventions were more frequent in CLI (CLI 47% versus IC 12%; P <0.001). Patients with CLI were more likely to have multilevel peripheral artery disease (CLI 32% versus IC 15%, P <0.001). Patients with IC were predominantly revascularized with stents (IC 48% versus CLI 37%; P <0.001) while balloon angioplasty was more frequent in CLI (CLI 37% versus IC 25%; P <0.001). All-cause mortality was higher in patients with CLI (CLI 4% versus IC 2%; P =0.014). Major adverse limb event rates for patients with IC and CLI were 16% and 26%, respectively ( P <0.001) and remained higher in CLI after multivariable adjustment of baseline risk factors. Conclusions: Patients with IC and CLI have significant anatomic, lesion, and treatment differences with significantly higher mortality and adverse limb outcomes in CLI. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01904851. Graphic Abstract: A graphic abstract is available for this article.

Patient Characteristics in the Recording Courses of Vascular Diseases (Reccord) Registry: Comparison with the Voyager Pad Endovascular Cohort

“…Recently published health claims-based data underscored a substantial risk of MALE after EVR, with a rate of hospitalization for MALE of 12.9% in 400.000 patients who underwent EVR of PAD in the US (median follow-up: 2.7 years) [ 3 ]. CLTI and advanced age, both somewhat more common in the registry compared to the RCT, have been shown to be negatively associated with extremity outcomes (e.g., amputation free survival) in PAD cohorts [ 12 , 13 , 14 , 15 ]. The same is true for advanced chronic kidney disease, which was three times more common in the registry, although absolute numbers were low [ 14 , 16 ].…”

Randomized clinical Trial Comparing drug Eluting Stent Zilver PTX® Versus Bare Metal Stent Zilver Flex® for Treatment of Lesions in Femoral and Popliteal Arteries in Chronic Limb Threatening Ischemia

“…It is expected that subjects with CLTI have higher incidence of vascular complications and mortality compared to a normal population or a population with mostly intermittent claudication. 1,35,36,40,65 All amputations during the 24 months follow up period were performed in the DES group. This finding was not significant (P = .060) but may be an interesting tendency in context of the ongoing discussion regarding risk of amputation in patients treated with drug eluting technology.…”

Endovascular Treatment of Symptomatic Peripheral Artery Disease: Where We Are and Where We Need to Go

“…For these reasons, the results presented by Patel et al 4 Populated with data from 23 hospitals over 13 years, the Excellence in Peripheral Artery Disease registry provides a prospective, multicenter account of symptomatic PAD as captured by elements of medical care and endovascular treatment. In the present report, 1983 patients with intermittent claudication (IC) and 1343 with critical limb ischemia (CLI) were analyzed for clinical history and medical treatment, with core lab adjudication of angiographic and procedure details.…”

“…For these reasons, the results presented by Patel et al 4 from the Excellence in Peripheral Artery Disease registry are timely and impactful. This report details the nature of symptomatic PAD, highlighting areas where additional focus is needed, and what we can tell our patients what they should expect during and after endovascular treatment.…”