Mortality After Paclitaxel-Coated Device Use in Patients With Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract

Purpose: To report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A search of the PubMed, Embase, Cochrane, CINAHL, DARE, and PROSPERO databases was made on 5 November 2019 to identify randomized controlled trials (RCT) using intention-to-treat analysis to compare a paclitaxel-coated device to an uncoated device in PAD patients having clinical follow-up of at least 6 months. Half of the study population had to have CLTI or extractable data on the CLTI subgroup if <50%. The search identified 11 trials having 1450 patients randomized to a paclitaxel-coated device (n=866) or an uncoated control (n=584). There were 1367 (94.3%) patients with CLTI (range 10–429). The single endpoint was all-cause mortality, which was analyzed by pooling the mortality data in a DerSimonian and Laird random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). Results: The mean follow-up was 25.6 months (range 6–60); 10 of 11 studies reported a minimum 12-month follow-up. There were 161 (18.6%) deaths among 866 subjects in the paclitaxel device group and 116 deaths among 584 (19.9%) subjects in the non-coated control group (RR 0.93, 95% CI 0.78 to 1.12, p=0.45). Conclusion: There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.

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

“…48 While the presence or causality of the late mortality signal is unclear, the benefit-risk analysis clearly demonstrated a consistent clinical benefit of paclitaxel-coated devices compared to uncoated devices across all studies. 38 , 41 , 49 – 51 Along this line, a recent update from the FDA recommends that for individual patients judged to be at particularly high risk for restenosis and repeat femoropopliteal interventions, clinicians may determine that the benefits of using a paclitaxel-coated device outweigh the risk of late mortality. 52 There is no doubt, however, that further investigations with large datasets are required and more research should be encouraged.…”

Long‐term results of a prospective, single‐arm evaluation of everolimus‐eluting bioresorbable vascular scaffolds in infrapopliteal arteries

“…During a mean follow‐up period of 35.2 ± 20.4 months 22 (45.8%) patients had died, consistent with the natural history of a predominantly critical limb ischemia population 20 . All patients who were alive were available for the clinical and ultrasound follow‐up.…”

“…First, they have severely limited life expectancy; however, their very presentation is defined by a limb which is under threat. 13,20 Major amputation typically results in deterioration of general health, independence and life expectancy giving them a comparable prognosis to aggressive malignancy. 21 properties of DES were important in arteries below-the-knee.…”

Randomized controlled trials and real-world evidence for market access and surveillance of high-risk products—The example of paclitaxel

“…A total of 11 RCTs with 1450 patients were identified, with a mean follow-up period of 25.6 months. The authors found no differences in the short-term and medium-term outcomes [12].…”