PMID- 38008929 OWN - NLM STAT- Publisher LR - 20240328 IS - 1545-1550 (Electronic) IS - 1526-6028 (Linking) DP - 2023 Nov 26 TI - Percutaneous Transluminal Angioplasty for Infrapopliteal Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-analysis of Primary Patency and Binary Restenosis Rates. PG - 15266028231212133 LID - 10.1177/15266028231212133 [doi] AB - PURPOSE: Percutaneous transluminal angioplasty (PTA) remains the mainstay of endovascular therapy for infrapopliteal chronic limb-threatening ischemia (CLTI), but outcomes have not been well characterized using high-quality data. The aim of this meta-analysis was to provide an updated benchmark for rates of primary patency and binary restenosis after PTA using prospectively collected, predominantly core-lab adjudicated randomized controlled trial (RCT) data. MATERIALS AND METHODS: MEDLINE, EMBASE, Cochrane Central, and ClinicalTrials.gov were queried for RCTs published through November 2022 using PTA as a control arm and including patients with infrapopliteal CLTI. Studies were excluded if >25% of patients had intermittent claudication, other vessels were included, or primary patency or binary restenosis were not outcomes. Outcomes were analyzed using random effects models. This analysis was publicly registered (PROSPERO ID#394543). No funding was utilized. RESULTS: Seventeen RCTs were included (1048 patients, 1279 lesions). Pooled primary patency rates using data from 6 RCTs were 68% at 6 months (95% confidence interval [CI]=45%-84%) and 66% at 12 months (95% CI=51%-79%). Pooled binary restenosis rates using data from 11 RCTs were 54% at 6 months (95% CI=33%-73%) and 60% at 9 to 12 months (95% CI=39%-78%). Significant heterogeneity was present in all outcomes (I(2)>50%, p<0.0001). Publication bias was not observed (Egger's p>0.1). CONCLUSIONS: This meta-analysis provides estimates for binary restenosis and primary patency following PTA utilizing prospectively collected, predominantly core-lab adjudicated data. Results demonstrate 1-year primary patency rates that are 10% to 20% higher than what has been historically used in power calculations. These new estimates will help facilitate more accurate power analysis for future RCTs. CLINICAL IMPACT: Rates of primary patency and binary restenosis after percutaneous transluminal angioplasty (PTA) have not been well-described using high-quality data, and investigators have been utilizing estimates of 40% to 50% and 45% to 65%, respectively, when performing power calculations for trials. This meta-analysis demonstrates using high-quality, prospectively collected, and predominantly core-lab adjudicated randomized controlled trial data that actual rates of primary patency are closer to 60% up to 1 year following PTA and provides the first meta-analysis estimate of binary restenosis rates up to 1 year after PTA. These estimates will help facilitate more accurate power calculations for future RCTs in this space. FAU - Snyder, Daniel J AU - Snyder DJ AUID- ORCID: 0000-0002-6018-1443 AD - Department of Medicine, Columbia University Irving Medical Center, New York-Presbyterian, New York, NY, USA. FAU - Zilinyi, Robert S AU - Zilinyi RS AD - Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA. FAU - Pruthi, Sonal AU - Pruthi S AD - Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA. FAU - George, Sareena AU - George S AD - Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA. FAU - Tirziu, Daniela AU - Tirziu D AD - Yale Cardiovascular Research Group, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA. FAU - Lansky, Alexandra AU - Lansky A AUID- ORCID: 0000-0001-8002-7497 AD - Yale Cardiovascular Research Group, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA. FAU - Mintz, Ari J AU - Mintz AJ AD - Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA. FAU - Sethi, Sanjum S AU - Sethi SS AD - Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA. FAU - Parikh, Sahil A AU - Parikh SA AD - Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA. LA - eng GR - T32 HL007343/HL/NHLBI NIH HHS/United States PT - Journal Article DEP - 20231126 PL - United States TA - J Endovasc Ther JT - Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists JID - 100896915 SB - IM OTO - NOTNLM OT - angioplasty OT - below-the-knee OT - chronic limb-threatening ischemia OT - infrapopliteal COIS- Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: S.A.P. receives institutional grants/research support from Abbott Vascular, Shockwave Medical, TriReme Medical, Surmodics, Silk Road Medical, and the National Institutes of Health. He has received consulting fees from Terumo and Abiomed and served on the advisory boards of Abbott, Medtronic, Boston Scientific, CSI, Janssen, and Philips. S.S.S. reports honoraria from Janssen and Chiesi inc. A.L. received institutional grants/research support from Abbott Vascular, TriReme Medical, Surmodics, Abiomed, and Shockwave and receives consulting fees from MedAlliance, Boston Scientific, and Abiomed. All other authors have no conflicts of interest to report. This trial did not receive any funding from the public, commercial, or not-for-profit sectors. EDAT- 2023/11/27 06:47 MHDA- 2023/11/27 06:47 CRDT- 2023/11/27 01:22 PHST- 2023/11/27 06:47 [medline] PHST- 2023/11/27 06:47 [pubmed] PHST- 2023/11/27 01:22 [entrez] AID - 10.1177/15266028231212133 [doi] PST - aheadofprint SO - J Endovasc Ther. 2023 Nov 26:15266028231212133. doi: 10.1177/15266028231212133.