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Published on: September 22, 2020
Percutaneous Transluminal Angioplasty for Infrapopliteal Chronic Limb-Threatening Ischemia: A Systematic Review and
Daniel J Snyder1, Robert S Zilinyi2, Sonal Pruthi2
1Department of Medicine, Columbia University Irving Medical Center, New York-Presbyterian, New York, NY, USA.
Insights
This meta-analysis reveals higher primary patency and restenosis rates for percutaneous transluminal angioplasty (PTA) in chronic limb-threatening ischemia (CLTI). These findings offer improved benchmarks for future clinical trial power calculations.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Devices
Background:
- Percutaneous transluminal angioplasty (PTA) is a primary endovascular treatment for infrapopliteal chronic limb-threatening ischemia (CLTI).
- High-quality data characterizing PTA outcomes, specifically primary patency and binary restenosis, are limited.
- Existing benchmarks used for power calculations in randomized controlled trials (RCTs) may not accurately reflect current outcomes.
Purpose of the Study:
- To establish an updated benchmark for primary patency and binary restenosis rates following PTA in patients with infrapopliteal CLTI.
- To utilize prospectively collected, core-lab adjudicated data from RCTs for a robust analysis.
- To provide more accurate estimates for future research and clinical trial design.
Main Methods:
- A systematic meta-analysis of RCTs published up to November 2022 was conducted.
- Studies involving PTA as a control arm for infrapopliteal CLTI were included, excluding those with significant intermittent claudication or other vessel interventions.
- Random effects models were used to pool primary patency and binary restenosis rates, with heterogeneity and publication bias assessed.
Main Results:
- Seventeen RCTs comprising 1048 patients and 1279 lesions were analyzed.
- Pooled 12-month primary patency rates were 66% (95% CI: 51%-79%), and pooled 9-12 month binary restenosis rates were 60% (95% CI: 39%-78%).
- Significant heterogeneity was observed across all outcomes, but no publication bias was detected.
Conclusions:
- This meta-analysis provides updated, high-quality estimates for primary patency and binary restenosis after PTA for infrapopliteal CLTI.
- The 1-year primary patency rate of approximately 66% is higher than previously assumed in power calculations.
- These findings will enable more accurate power analyses for future RCTs in this critical area of vascular intervention.
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 (I2>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 ImpactRates 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.
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