TCT-365 Contemporary Outcomes in No-Option Chronic Critical Limb Ischemia: A Systematic Review and Meta-Analysis

Ghare, Mohammed Imran; Pietras, Cody; Tı̂rziu, Daniela; Tsay, Cynthia; Parise, Helen; White, Roseann; Lansky, Alexandra J.

doi:10.1016/j.jacc.2018.08.1517

Cited by 2 publications

(2 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The pooled 1-year limb salvage rate in our analysis was slightly lower (76.7% vs. 78.6%) than that reported by Ucci et al (2023) [39]. A meta-analysis by Ghare et al (2021) reported AFS rate of 58.6% and 50.3% at 6 months and 1 year, respectively, in patients with no-option CLTI undergoing standard care conservative therapy [41]. A comparison of this finding with those of the present study indicates that pDVA leads to higher AFS rates (68.7% and 65.6%, respectively) at 6 months and 1 year in no-option CLTI patients.…”

Section: Discussioncontrasting

confidence: 69%

Short-Term Outcomes and Efficacy of Percutaneous Deep Vein Arterialization for No-Option Critical Limb Ischemia: A Systematic Review and Meta-Analysis

Roustazadeh,

Gombert,

Krabbe

et al. 2024

Biomedicines

View full text Add to dashboard Cite

Background: Percutaneous deep vein arterialization (pDVA) is considered a treatment modality in patients with no-option critical limb ischemia. However, there is still a paucity of evidence regarding its safety and efficacy. Data sources: MEDLINE (via PubMed), Embase and Web of Science databases as well as the CENTRAL registry up to the end of June 2023. Methods: This review adhered to the PRISMA guidelines (PROSPERO registration no. CRD42023445171). The risk of bias was assessed using the methodological index for non-randomized studies (MINORS). Primary endpoints included technical success, overall survival and limb salvage during the follow-up. Amputation-free survival at 30 days, 6 months and 1 year as well as complete wound healing, major adverse limb events and reintervention were investigated as secondary outcomes. Results: Five observational studies, comprising 208 patients (142 Rutherford class 5/77 Rutherford class 6), were included. MINORS revealed a low risk of bias. The meta-analysis reached a pooled technical success rate of 96.2% (95% CI: 91.5–98.4), an overall survival of 82.8% (95% CI: 70.5–95.2) and a limb salvage rate of 77.2% (95% CI: 65.2–89.1) during the follow-up. The amputation-free survival at 30 days, 6 months and 1 year was 87.8%, 68.7% and 65.6%, respectively. Furthermore, pDVA resulted in a complete wound healing rate of 53.4% (95% CI: 30.3–76.5). The pooled reintervention rate was as high as 46.7% (37.1–56.3%). Conclusions: PDVA seems a feasible bail-out strategy for patients with no option for routine treatment of CLTI. However, due to the small number of studies, the strength of the evidence is low.

show abstract

Section: Discussioncontrasting

confidence: 69%

Short-Term Outcomes and Efficacy of Percutaneous Deep Vein Arterialization for No-Option Critical Limb Ischemia: A Systematic Review and Meta-Analysis

Roustazadeh,

Gombert,

Krabbe

et al. 2024

Biomedicines

View full text Add to dashboard Cite

show abstract

“…However, 20–40% of these patients are considered unsuitable for revascularization owing to anatomical limitations and co-morbidities, and are referred to as ‘no-option’ patients. Previous studies 2 , 5 have demonstrated poor outcomes in such patients, with a mortality rate of 20% and a 40% risk of amputation in the first 6 months after diagnosis, although a recent study 6 reported better than expected 5-year amputation-free survival (AFS) among no-option patients.…”

Section: Introductionmentioning

confidence: 98%

PACE: randomized, controlled, multicentre, multinational, phase III study of PLX-PAD for critical limb ischaemia in patients unsuitable for revascularization: randomized clinical trial

Norgren,

Weiss,

Nikol

et al. 2024

British Journal of Surgery

View full text Add to dashboard Cite

Background Revascularization is the primary treatment modality for chronic limb-threatening ischaemia (CLTI), but is not feasible in all patients. PLX-PAD is an off-the-shelf, placental-derived, mesenchymal stromal cell-like cell therapy. This study aimed to evaluate whether PLX-PAD would increase amputation-free survival in people with CLTI who were not candidates for revascularization. Methods People with CLTI and minor tissue loss (Rutherford 5) who were unsuitable for revascularization were entered into a randomized, parallel-group, placebo-controlled, multinational, blinded, trial, in which PLX-PAD was compared with placebo (2 : 1 randomization), with 30 intramuscular injections (0.5 ml each) into the index leg on days 0 and 60. Planned follow-up was 12–36 months, and included vital status, amputations, lesion size, pain and quality-of-life assessments, haemodynamic parameters, and adverse events. Results Of 213 patients enrolled, 143 were randomized to PLX-PAD and 70 to placebo. Demographics and baseline characteristics were balanced. Most patients were Caucasian (96.2%), male (76.1%), and ambulatory (85.9%). Most patients (76.6%) reported at least one adverse event, which were mostly expected events in CLTI, such as skin ulcer or gangrene. The probability of major amputation or death was similar for placebo and PLX-PAD (33 and 28.6% respectively; HR 0.93, 95% c.i. 0.53 to 1.63; P = 0.788). Revascularization and complete wound healing rates were similar in the two groups. A post hoc analysis of a subpopulation of 121 patients with a baseline haemoglobin A1c level below 6.5% showed improved 12-month amputation-free survival (HR 0.46, 0.21 to 0.99; P = 0.048). Conclusion Although there was no evidence that PLX-PAD reduced amputation-free survival in the entire study population, benefit was observed in patients without diabetes mellitus or whose diabetes was well controlled; this requires confirmation in further studies. Trial registration: NCT03006770 (http://www.clinicaltrials.gov); 2015-005532-18 (EudraCT Clinical Trials register - Search for 2015-005532-18).

show abstract

TCT-365 Contemporary Outcomes in No-Option Chronic Critical Limb Ischemia: A Systematic Review and Meta-Analysis

Cited by 2 publications

References 0 publications

Short-Term Outcomes and Efficacy of Percutaneous Deep Vein Arterialization for No-Option Critical Limb Ischemia: A Systematic Review and Meta-Analysis

Short-Term Outcomes and Efficacy of Percutaneous Deep Vein Arterialization for No-Option Critical Limb Ischemia: A Systematic Review and Meta-Analysis

PACE: randomized, controlled, multicentre, multinational, phase III study of PLX-PAD for critical limb ischaemia in patients unsuitable for revascularization: randomized clinical trial

Contact Info

Product

Resources

About