One-Year Results of First-Line Treatment Strategies in Patients With                     Critical Limb Ischemia (CRITISCH Registry)

Stavroulakis, Konstantinos; Borowski, Matthias; Torsello, Giovanni; Bisdas, Theodosios

doi:10.1177/1526602818771383

Cited by 44 publications

(29 citation statements)

References 40 publications

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“…These conservatively treated patients reported a 1-year survival of 81% and AFS of 72%. 21 Santema et al reported 1-year survival (73%) and AFS (73%) in 22 conservatively treated patients in 144 patients with CLI. 20 The slightly better results of CRITISCH group and Santema et al compared to our study could probably be explained by the older patients included in our study (76 vs 83 years old) and heterogeneity of the included conservatively treated patients.…”

Section: Discussionmentioning

confidence: 99%

Quality of Life and Traditional Outcome Results at 1 Year in Elderly Patients Having Critical Limb Ischemia and the Role of Conservative Treatment

Vries

Raats

Verbogt

et al. 2019

Vasc Endovascular Surg

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Introduction: Revascularization is the cornerstone of the treatment of critical limb ischemia (CLI), but the number of elderly frail patients increase. Revascularization is not always possible in these patients and conservative therapy seems to be an option. The goals of this study are to analyze the 1-year quality of life (QoL) results and mortality rates of elderly patients with CLI and to investigate if conservative treatment could be an acceptable treatment option. Methods: Patients with CLI ≥70 years old were included in a prospective observational cohort study in 2 hospitals in the Netherlands between 2012 and 2016 and were divided over 3 treatment modalities: endovascular therapy, surgical revascularization, and conservative treatment. The World Health Organization Quality of Life (WHOQoL-Bref) instrument, a generic QoL assessment tool that includes components of physical, psychological, social relationships and environment, was used to evaluate QoL at baseline, 6 months, and 1 year. Results: In total, 195 patients (56% male, 33% Rutherford 4, mean age of 80) were included. Physical QoL significantly increased after surgical (10.4 vs 14.9, P < .001), endovascular (10.9 vs 13.7, P < .001), and conservative therapy (11.6 vs 13.2, P = .01) at 1 year. One-year mortality was relatively low after surgery (10%) compared to endovascular (40%) and conservative therapy (37%). Conclusion: The results of this study could not be used to designate the superior treatment used in elderly patients with CLI. Conservative treatment could be an acceptable treatment option in selected patients with CLI unfit for revascularization. Treatment of choice in elderly patients with CLI is based on multiple factors and should be individualized in a shared decision-making process.

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Section: Discussionmentioning

confidence: 99%

Quality of Life and Traditional Outcome Results at 1 Year in Elderly Patients Having Critical Limb Ischemia and the Role of Conservative Treatment

Vries

Raats

Verbogt

et al. 2019

Vasc Endovascular Surg

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“…In recent years, endovascular treatments for patients with peripheral artery disease (PAD) of the lower extremities have gained growing acceptance among all vascular specialties and have become the primary mode of revascularization in both claudicants and patients with chronic limb-threatening ischemia (CLTI). 1 , 2 The continuous development of endovascular technologies has offered a variety of different modalities and devices for the treatment of peripheral atherosclerosis. 3 – 11 In the femoropopliteal segment, the introduction of paclitaxel drug-coated balloons (DCBs) has led to a paradigm shift from primary scaffolding with permanent metallic implants to a “leave nothing behind” or “leave less behind” approach.…”

Section: Introductionmentioning

confidence: 99%

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

et al. 2020

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Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study ( ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

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“…13,15 In several cohorts of >300 patients treated by standard endovascular techniques, AFS rates of 74% to 76% and 52% to 55% at 12 and 36 months, respectively, were reported. [19][20][21][22] In the majority of cases, patients were treated using plain balloon angioplasty. In the current study, AFS rates of 83.9%, 71.0%, and 67.2% were achieved at 6, 12, and 24 months, respectively, in CLTI patients with no further possibility of conventional revascularization.…”

Section: Discussionmentioning

confidence: 99%

Midterm Outcomes of Percutaneous Deep Venous Arterialization With a Dedicated System for Patients With No-Option Chronic Limb-Threatening Ischemia: The ALPS Multicenter Study

et al. 2020

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Purpose: To evaluate the midterm results of patients suffering from no-option chronic limb-threatening ischemia (CLTI) treated with a dedicated system for percutaneous deep venous arterialization (pDVA). Materials and Methods: Thirty-two consecutive CLTI patients (mean age 67±14 years; 20 men) treated with pDVA using the Limflow device at 4 centers between 11 July 2014 and 11 June 2018 were retrospectively analyzed. Of all patients, 21 (66%) had diabetes, 8 (25%) were on immunosuppression, 4 (16%) had dialysis-dependent renal failure, 9 (28%) had Rutherford category 6 ischemia, and 25 (78%) were deemed at high risk of amputation. The primary outcome was amputation-free survival (AFS) at 6 months. Secondary outcomes were wound healing, limb salvage, and survival at 6, 12, and 24 months. Results: Technical success was achieved in 31 patients (96.9%). The median follow-up was 34 months (range 16–63). At 6, 12, and 24 months, estimates were 83.9%, 71.0%, and 67.2% for AFS, 86.8%, 79.8% and 79.8% for limb salvage, and 36.6%, 68.2%, and 72.7% for complete wound healing, respectively. Median time to complete wound healing was 4.9 months (range 0.5–15). The DVA circuit occluded during follow-up in 21 patients; the median time to occlusion was 2.6 months. Reintervention for occlusion was performed in 17 patients: 16 because of unhealed wounds and 1 for a newly developed ulcer. Conclusion: This study represents the largest population of patients with no-option CLTI treated with pDVA using the LimFlow device with midterm results. In this complex group of patients, pDVA using the LimFlow device has been shown to be feasible, with a high technical success rate and AFS at 6 up to 24 months coupled with wound healing. In selected patients with no-option CLTI, pDVA could be a recommended treatment to prevent amputation and heal wounds.

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One-Year Results of First-Line Treatment Strategies in Patients With Critical Limb Ischemia (CRITISCH Registry)

Abstract: CRITISCH registry data revealed that all first-line treatment strategies selected and indicated by the treating physicians met the suggested OPGs. CKD was an important determinant of patient prognosis after treatment regardless of the revascularization method.

Cited by 44 publications

References 40 publications

Quality of Life and Traditional Outcome Results at 1 Year in Elderly Patients Having Critical Limb Ischemia and the Role of Conservative Treatment

Quality of Life and Traditional Outcome Results at 1 Year in Elderly Patients Having Critical Limb Ischemia and the Role of Conservative Treatment

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

Midterm Outcomes of Percutaneous Deep Venous Arterialization With a Dedicated System for Patients With No-Option Chronic Limb-Threatening Ischemia: The ALPS Multicenter Study

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