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Mortality After Paclitaxel-Coated Device Use in Patients With Chronic Limb-Threatening Ischemia: A Systematic Review
Krystal Dinh1, Miguel Lemos Gomes2, Shannon D Thomas2,3,4
1Department of Vascular Surgery, Westmead Hospital, Sydney, NSW, Australia.
Insights
Paclitaxel-coated devices showed no significant difference in all-cause mortality compared to uncoated devices for patients with chronic limb-threatening ischemia (CLTI). This meta-analysis of randomized controlled trials suggests similar short- to midterm survival outcomes.
Area of Science:
- Vascular Medicine and Interventional Cardiology
- Biomaterials and Medical Devices
Background:
- Chronic limb-threatening ischemia (CLTI) is a severe condition associated with high mortality and morbidity.
- Paclitaxel-coated devices are utilized in peripheral artery disease (PAD) to improve outcomes, but their impact on mortality in CLTI patients requires evaluation.
Purpose of the Study:
- To determine the risk of all-cause mortality in patients with CLTI treated with paclitaxel-coated devices versus uncoated controls.
Main Methods:
- A systematic literature search of multiple databases (PubMed, Embase, Cochrane, etc.) was conducted up to November 5, 2019.
- Included were randomized controlled trials (RCTs) comparing paclitaxel-coated devices to uncoated devices in PAD patients with at least 6-month follow-up, focusing on CLTI or CLTI subgroups.
- All-cause mortality was the primary endpoint, analyzed using a random effects model, with results expressed as relative risk ratios (RR) and 95% confidence intervals (CI).
Main Results:
- Eleven RCTs comprising 1450 patients (866 paclitaxel-coated, 584 uncoated) were analyzed; 94.3% of patients had CLTI.
- The mean follow-up duration was 25.6 months.
- There was no statistically significant difference in all-cause mortality between the paclitaxel-coated device group (18.6% deaths) and the uncoated control group (19.9% deaths), with an RR of 0.93 (95% CI 0.78 to 1.12, p=0.45).
Conclusions:
- The study found no significant difference in short- to midterm all-cause mortality for CLTI patients treated with paclitaxel-coated devices compared to uncoated controls.
- These findings suggest comparable survival rates between the two treatment strategies in this high-risk patient population.
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.
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