Revascularization and Patency in Lower Limb Peripheral Arterial Disease: A Systematic Review and Meta-Analysis Comparing Paclitaxel-Eluting with Bare Metal Stents
Author(s)
Antonia Bosworth Smith, BSc, MSc1, Fabian Distler, BSc, MSc, PhD1, Sabine Steiner, Prof2, Yann Gouëffic, MD, PhD3, Juliane O. Hafermann, BSc, MSc, PhD1, Rhodri Saunders, BSc, MSc, PhD1.
1Coreva Scientific GmbH & Co KG, Koenigswinter, Germany, 2Department of Internal Medicine II, Division of Angiology, Medical University Vienna, Viena, Austria, 3Vascular and endovascular surgical center, Hôpital Paris St Joseph, Paris, France.
1Coreva Scientific GmbH & Co KG, Koenigswinter, Germany, 2Department of Internal Medicine II, Division of Angiology, Medical University Vienna, Viena, Austria, 3Vascular and endovascular surgical center, Hôpital Paris St Joseph, Paris, France.
Presentation Documents
OBJECTIVES: Stent implantation is indicated for revascularization of symptomatic patients with lower limb peripheral arterial disease. Common stent options are self-expanding bare metal stents (BMS) or paclitaxel-eluting stents (PES). Given limited direct comparative data from randomized controlled trials, this analysis uses meta-analysis of proportions to examine primary patency (PP) and target-lesion revascularization (TLR) across single arm and comparative studies.
METHODS: The systematic review (PROSPERO CRD42024528559) identified studies reporting on BMS or PES, as either polymer-based PES (PB-PES) or polymer-free PES (PF-PES), used for management of femoropopliteal lesions. Studies were published between January 1, 2009 and July 1, 2024 and included ≥50 patients. Data extracted included stent used, lesion length, PP, and TLR. Study quality was assessed using Downs and Black. As considerable between-study heterogeneity was expected, a random intercept logistic regression (generalized linear mixed model) was used to pool the data. The 95% confidence interval (CI) around the pooled effect was calculated using Knapp-Hartung adjustments.
RESULTS: Of 870 studies screened, 142 were included for data extraction. For primary patency at 12 months, 50 PES studies (16 PB-PES and 34 PF-PES) and 93 BMS studies were included. The pooled estimates were PB-PES 86.9% (95% CI 85.2-88.5), PF-PES 76.9% (73.4-80.1), and BMS 75.3% (72.9-77.6). Fewer studies (86) report 24-month data, but trends were similar with PB-PES performing best. The 12-month TLR pooled estimates were PB-PES 7.3% (95% CI 5.9-9.0), PF-PES 13.0% (10.0-16.7), and BMS 14.3% (12.5-16.3). When considering lesion length <150mm versus ≥150mm the trend in results remained the same.
CONCLUSIONS: PB-PES showed higher primary patency and lower TLR rates than PF-PES and BMS, both at 12 and 24 months of follow-up and for shorter and longer lesions.
METHODS: The systematic review (PROSPERO CRD42024528559) identified studies reporting on BMS or PES, as either polymer-based PES (PB-PES) or polymer-free PES (PF-PES), used for management of femoropopliteal lesions. Studies were published between January 1, 2009 and July 1, 2024 and included ≥50 patients. Data extracted included stent used, lesion length, PP, and TLR. Study quality was assessed using Downs and Black. As considerable between-study heterogeneity was expected, a random intercept logistic regression (generalized linear mixed model) was used to pool the data. The 95% confidence interval (CI) around the pooled effect was calculated using Knapp-Hartung adjustments.
RESULTS: Of 870 studies screened, 142 were included for data extraction. For primary patency at 12 months, 50 PES studies (16 PB-PES and 34 PF-PES) and 93 BMS studies were included. The pooled estimates were PB-PES 86.9% (95% CI 85.2-88.5), PF-PES 76.9% (73.4-80.1), and BMS 75.3% (72.9-77.6). Fewer studies (86) report 24-month data, but trends were similar with PB-PES performing best. The 12-month TLR pooled estimates were PB-PES 7.3% (95% CI 5.9-9.0), PF-PES 13.0% (10.0-16.7), and BMS 14.3% (12.5-16.3). When considering lesion length <150mm versus ≥150mm the trend in results remained the same.
CONCLUSIONS: PB-PES showed higher primary patency and lower TLR rates than PF-PES and BMS, both at 12 and 24 months of follow-up and for shorter and longer lesions.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO195
Topic
Clinical Outcomes
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory), SDC: Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)