Endovascular Therapy Versus Bypass Surgery as First-Line Treatment Strategies for Critical Limb Ischemia: Results of the Interim Analysis of the CRITISCH Registry (original) (raw)
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Journal of Endovascular Therapy, 2018
Purpose: To examine the outcomes of all first-line strategies for the treatment of critical limb ischemia (CLI), identify factors that influenced the treatment choice, and determine the risk of amputation or death after each treatment. Methods: CRITISCH ( ClinicalTrials.gov identifier NCT01877252) is a multicenter, national, prospective registry evaluating all available treatment strategies applied in 1200 consecutive CLI patients in 27 vascular centers in Germany. The recruitment started in January 2013 and was completed in September 2014. Treatment options were endovascular revascularization (642, 53.5%), bypass surgery (284, 23.7%), femoral artery patchplasty (126, 10.5%) with or without concomitant peripheral intervention, conservative treatment (118, 9.8%), and primary major amputation (30, 2.5%). The primary endpoint of this study was amputation-free survival (AFS). The Society of Vascular Surgery’s suggested objective performance goal (OPG) for AFS (71%) was used as the effec...
Open versus Endovascular Intervention for Critical Limb Ischemia: A Population-Based Study
Journal of the American College of Surgeons, 2010
BACKGROUND: Endovascular techniques are considered by many as the first-line treatment for critical limb ischemia (CLI). The purpose of this study is to assess the impact of endovascular therapy on CLI and amputation in South Carolina during the past decade. STUDY DESIGN: This is a retrospective, comparative analysis of treatment outcomes for CLI in the preendovascular era and the endovascular era. The South Carolina Office of Research and Statistics database was reviewed using ICD-9 diagnosis and procedure codes to identify patients who underwent limb revascularization in 1996 (pre-endovascular era) and 2005 (endovascular era) for CLI and to determine those who required subsequent limb amputation and additional revascularization.
Journal of the American Heart Association, 2016
Critical limb ischemia (CLI) is increasing in prevalence, and remains a significant source of mortality and limb loss. The decision to recommend surgical or endovascular revascularization for patients who are candidates for both varies significantly among providers and is driven more by individual preference than scientific evidence. The Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial is a prospective, randomized, multidisciplinary, controlled, superiority trial designed to compare treatment efficacy, functional outcomes, quality of life, and cost in patients undergoing best endovascular or best open surgical revascularization. Approximately 140 clinical sites in the United States and Canada will enroll 2100 patients with CLI who are candidates for both treatment options. A pragmatic trial design requires consensus on patient eligibility by at least 2 investigators, but leaves the choice of specific procedural strategy within ...
Endovascular management of patients with critical limb ischemia: Long-term results
Journal of Vascular …, 2011
Background: Although percutaneous intervention (PTA) is considered first-line therapy for peripheral vascular disease in many scenarios, its role in critical limb ischemia (CLI), wherein anatomic disease is more extensive, remains unclear. In the present study, late (5-year) clinical and patency data for PTA in CLI are defined. Methods: From January 2002 to December 2007, 409 patients underwent infrainguinal PTA ؎ stent for CLI (Rutherford IV-VI) of 447 limbs. Primary patency, assisted patency, limb salvage, and survival were assessed using Kaplan-Meier. Predictors of patency, limb salvage, and death were determined using multivariate models. Results: Demographics included age (70 ؎ 12 years old), diabetes (65.8%), and dialysis dependence (13%). The superficial femoral artery was treated in 58% of the patients, 16% were limited to the crural vessels, 38% had multilevel treatment, and stents were placed in 26%. Eighty percent of patients received postprocedure clopidogrel. Mean follow-up was 28 months (0-83). Five-year primary and assisted patency were 31% ؎ 0.04 and 75% ؎ 0.04, respectively. Limb salvage at 5 years was 74% ؎ 0.038. Sixty-three patients had major amputations. Survival at 5 years was 39% ؎ 0.03. Multivariate analysis identified dialysis dependence (P ؍ .0005; 2.7 [1.6-4.8]), <1 vessel runoff (P ؍ .02; 1.5 [1.1-2.0]), and warfarin use (P ؍ .001; 1.7 [1.25-2.3]) as negative predictors of primary patency, but none of these were negative predictors of assisted patency. Dialysis dependence (P ؍ .006; 2.5 [1.3-4.8]), female gender (P ؍ .02; 2.0 [1.1-3.7]), and <1 vessel runoff (P ؍ .04; 1.8 [1.0-3.2]) predicted limb loss. Dialysis dependence (P ؍ .0003; 2.3 [1.5-3.5]), diabetes (P ؍ .04; 1.5 [0.5-2.1]), and poor runoff (P ؍ .04; 1.6 [1.2-2.1]) were predictors of mortality. Conclusion: Although primary patency is low, excellent limb salvage rates can be achieved in patients with CLI through close follow-up and secondary interventions. These data, and the 12% annual death rate, validate PTA as first-line therapy in patients with CLI.
Current practice of first-line treatment strategies in patients with critical limb ischemia
Journal of vascular surgery, 2015
Critical limb ischemia (CLI) is growing in global prevalence and is associated with high rates of limb loss and mortality. However, a relevant gap of evidence about the most optimal treatment strategy still exists. The aim of this study of the prospective, multicenter First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry was to assess the current practice of all first-line treatments strategies in CLI patients in German vascular centers. Between January 2013 and September 2014, five first-line treatment strategies-endovascular revascularization (ER), bypass surgery (BS), femoral/profundal artery patchplasty (FAP), conservative treatment, and primary amputation-were determined among CLI patients in 27 vascular tertiary centers. The main composite end point was major amputation or death, or both, during the hospital stay. Secondary outcomes were hemodynamic failure, major adverse cardiovascular and cerebral events, and reintervention. Univariate logistic mo...
Endovascular management of patients with critical limb ischemia
Journal of Vascular Surgery, 2011
Background: Although percutaneous intervention (PTA) is considered first-line therapy for peripheral vascular disease in many scenarios, its role in critical limb ischemia (CLI), wherein anatomic disease is more extensive, remains unclear. In the present study, late (5-year) clinical and patency data for PTA in CLI are defined. Methods: From January 2002 to December 2007, 409 patients underwent infrainguinal PTA ؎ stent for CLI (Rutherford IV-VI) of 447 limbs. Primary patency, assisted patency, limb salvage, and survival were assessed using Kaplan-Meier. Predictors of patency, limb salvage, and death were determined using multivariate models. Results: Demographics included age (70 ؎ 12 years old), diabetes (65.8%), and dialysis dependence (13%). The superficial femoral artery was treated in 58% of the patients, 16% were limited to the crural vessels, 38% had multilevel treatment, and stents were placed in 26%. Eighty percent of patients received postprocedure clopidogrel. Mean follow-up was 28 months (0-83). Five-year primary and assisted patency were 31% ؎ 0.04 and 75% ؎ 0.04, respectively. Limb salvage at 5 years was 74% ؎ 0.038. Sixty-three patients had major amputations. Survival at 5 years was 39% ؎ 0.03. Multivariate analysis identified dialysis dependence (P ؍ .0005; 2.7 [1.6-4.8]), <1 vessel runoff (P ؍ .02; 1.5 [1.1-2.0]), and warfarin use (P ؍ .001; 1.7 [1.25-2.3]) as negative predictors of primary patency, but none of these were negative predictors of assisted patency. Dialysis dependence (P ؍ .006; 2.5 [1.3-4.8]), female gender (P ؍ .02; 2.0 [1.1-3.7]), and <1 vessel runoff (P ؍ .04; 1.8 [1.0-3.2]) predicted limb loss. Dialysis dependence (P ؍ .0003; 2.3 [1.5-3.5]), diabetes (P ؍ .04; 1.5 [0.5-2.1]), and poor runoff (P ؍ .04; 1.6 [1.2-2.1]) were predictors of mortality. Conclusion: Although primary patency is low, excellent limb salvage rates can be achieved in patients with CLI through close follow-up and secondary interventions. These data, and the 12% annual death rate, validate PTA as first-line therapy in patients with CLI.
Surgical Practice, 2014
The aim of the present study was to evaluate current results of endovascular and open-bypass treatment of critical limb ischaemia subsequent to advancement in endovascular instruments and the development of endovascular technique in the past decade. Patients and Methods: A total of 160 patients with 167 limbs treated at a single centre between 2008 and 2012 were followed up for at least 2 years and reviewed retrospectively. Patients were stratified into an endovascular group and an open-bypass group based on first intervention received. The two groups demonstrated comparable demographics, clinical profile classified by Rutherford Classifications and lesion characteristics evaluated according to TransAtlantic Intersociety Consensus staging standards. One-year primary patency, 2-year primary patency, secondary patency, overall survival rate and amputation-free-survival rate were compared between the endovascular group and open-bypass group. Results: The endovascular group showed superior results to the bypass group in terms of 1-year amputation-free-survival (endovascular: 78.2 per cent, open bypass: 61.3 per cent, P = 0.023) and 2-yearamputation-free-survival (endovascular: 73.1 per cent, open bypass: 56 per cent, P = 0.027). No significant difference was found between the two groups in 1-year primary patency (endovascular: 80.3 per cent, open bypass: 67.8 per cent, P = 0.103), 2-year primary patency (endovascular: 80.3 per cent, open bypass: 64.8 per cent, P = 0.056), 1-year secondary patency (endovascular: 77.8 per cent, open bypass: 66.7 per cent, P = 0.577) and two-year secondary patency (endovascular: 77.8 per cent, open bypass: 58.3 per cent, P = 0.350). Comparable results were noted in the 1-year survival rate (endovascular: 91 per cent, open bypass: 81.3 per cent, P = 0.082) and 2-year survival rate (endovascular: 84.6 per cent, open bypass: 72 per cent, P = 0.058). Lower median blood loss (endovascular: 15 mL, open bypass: 100 mL) and shorter mean operative time (endovascular: 27.2 min, open bypass: 143.1 min) were demonstrated in the endovascular group. Conclusion: Endovascular intervention has demonstrated superior results to bypass surgery in critical limb ischaemia in terms of 1-year and 2-year amputation-free-survival, with potential benefits of lower intraoperative blood loss and a shorter operative time. Primary patency, secondary patency and overall survival in 2 years are currently comparable between the two intervention modalities.
Journal of Vascular Surgery, 2012
The adoption of endovascular interventions has been reported to lower amputation rates, but patients who undergo endovascular and open revascularization are not directly comparable. We have adopted an endovascular-first approach but individualize the revascularization technique according to patient characteristics. This study compared characteristics of patients who had endovascular and open procedures and assessed the long-term outcomes. Methods: From December 2002 to September 2010, 433 patients underwent infrainguinal revascularization for critical limb ischemia (CLI; Rutherford IV-VI) of 514 limbs (endovascular: 295 patients, 363 limbs; open: 138 patients, 151 limbs). Patency rates, limb salvage (LS), and survival, as also their predictors, were calculated using Kaplan-Meier and multivariate analysis. Results: The endovascular group was older, with more diabetes, renal insufficiency, and tissue loss. More reconstructions were multilevel (72% vs 39%; P < .001) and the most distal level of intervention was infrapopliteal in the open group (64% vs 49%; P ؍ .001). The 30-day mortality was 2.8% in the endovascular and 6.0% in the open group (P ؍ .079). Mean follow-up was 28.4 ؎23.1 months (0-100). In the endovascular vs open groups, 7% needed open, and 24% needed inflow/runoff endovascular reinterventions with or without thrombolysis vs 6% and 17%. In the endovascular vs open group, 5-year LS was 78% ؎ 3% vs 78% ؎ 4% (P ؍ .992), amputation-free survival was 30% ؎ 3% vs 39% ؎ 5% (P ؍ .227), and survival was 36% ؎ 4% vs 46% ؎ 5% (P ؍ .146). Five-year primary patency (PP), assisted-primary patency (APP), and secondary patency (SP) rates were 50 ؎ 5%, 70 ؎ 5% and 73 ؎ 6% in endovascular, and 48 ؎ 6%, 59 ؎ 6% and 64 ؎ 6% in the open group, respectively (P ؍ .800 for PP, 0.037 for APP, 0.022 for SP). Multivariate analysis identified poor functional capacity (hazard ratio, 3.5 [95% confidence interval, 1.9-6.5]; P < .001), dialysis dependence (2.2 [1.3-3.8]; P ؍ .003), gangrene (2.2 [1.4-3.4]; P < .001), need for infrapopliteal intervention (2.0 [1.2-3.1]; P ؍ .004), and diabetes (1.8 [1.1-3.1]; P ؍ .031) as predictors of limb loss. Poor functional capacity (3.3 [2.4-4.6]; P < .001), coronary artery disease (1.5 [1.1-2.1]; P ؍ .006), and gangrene (1.4 [1.1-1.9]; P ؍ .007) predicted poorer survival. Statin use predicted improved survival (0.6 [0.5-0.8]; P ؍ .001). Need for infrapopliteal interventions predicted poorer PP (0.6 [0.5-0.9-2.2]; P ؍ .007), whereas use of autologous vein predicted better PP (1.8 [1.1-2.9]; P ؍ .017). Conclusions: Patients who undergo endovascular revascularization for CLI are medically higher-risk patients. Those who have bypass have more complex disease and are more likely to require multilevel reconstruction and infrapopliteal intervention. Individualizing revascularization results in optimization of early and late outcomes with acceptable LS, although survival remains low in those with poor health status.