Dataset Information

Longitudinal Assessment of Safety of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices Among Medicare Beneficiaries: The SAFE-PAD Study.

ABSTRACT:

Importance

Paclitaxel-coated peripheral devices have been associated with increased mortality, yet this harm signal has not been replicated outside of meta-analyses of small trials.

Objective

To provide a longitudinal assessment of the safety of femoropopliteal endovascular treatment with peripheral drug-coated devices (DCDs) among Medicare beneficiaries.

Design, setting, and participants

SAFE-PAD (Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices) was a retrospective cohort study designed with the US Food and Drug Administration to evaluate the noninferiority of mortality between DCDs and non-drug-coated devices (NDCDs) for femoropopliteal revascularization performed in 2978 inpatient and outpatient facilities in the US from April 1, 2015, through December 31, 2018. Evaluation of the primary outcome was assessed through May 31, 2020. Participants were Medicare fee-for-service beneficiaries 66 years and older with 1 or more years of enrollment prior to femoropopliteal revascularization. Prespecified subgroups included low-risk cohorts, procedure location, disease severity, and device type. Inverse probability weighting was used to account for imbalances of observed characteristics. Sensitivity analyses were used to evaluate the potential influence of unmeasured confounding.

Exposures

Treatment with DCDs vs NDCDs as determined by claims codes during the index procedure.

Main outcomes and measures

The primary outcome was all-cause mortality. Secondary outcomes included repeated hospitalization, repeated lower extremity revascularization, and lower extremity amputation. Falsification end points were acute myocardial infarction, congestive heart failure, and pneumonia.

Results

Of 168 553 patients, 70 584 (41.9%) were treated with a DCD. The mean (SD) age was 77.0 (7.6) years, 75 744 (44.9%) were female, 136 916 of 167 197 (81.9%) were White individuals, 85 880 of 168 553 (51.0%) had diabetes, 82 554 of 168 553 (49.0%) used tobacco, 78 665 of 168 553 (45.7%) had critical limb ischemia (CLI), and 13 296 of 168 553 (7.9%) had a prior amputation. Median follow-up was 2.72 years (interquartile range, 0.87-3.77; longest, 5.16 years). After weighting, the cumulative incidence of all-cause mortality was 53.8% with DCDs and 55.1% with NDCDs (hazard ratio [HR], 0.95; 95% CI, 0.94-0.97; noninferiority P < .001). Cox regression and instrumental variable analyses were consistent with the primary findings. No harm associated with DCDs was observed among subgroups, including those treated with stents (HR, 0.97; 95% CI, 0.95-1.00) or balloons (HR, 0.94; 95% CI, 0.92-0.96), with or without CLI (CLI: HR, 0.95; 95% CI, 0.93-0.97; non-CLI: HR, 0.97; 95% CI, 0.95-0.99), and those within the lowest quartile of total comorbidities (HR, 0.95; 95% CI, 0.92-0.99).

Conclusions and relevance

In this initial report from the SAFE-PAD cohort study, DCDs were found to be noninferior to NCDCs in respect to mortality through a median follow-up of 2.72 years. This finding remained robust in sensitivity analyses and was consistent across prespecified subgroups.

SUBMITTER: Secemsky EA

PROVIDER: S-EPMC8126993 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundClinical benefit of paclitaxel-coated devices for patients with peripheral arterial disease has been confirmed in randomized controlled trials (RCTs). A meta-analysis published in 2018 identified late mortality risk over a long follow-up period due to use of paclitaxel-coated devices in the femoropopliteal arteries, which caused enormous controversy and debates globally. This study aims to further evaluate the safety of paclitaxel-coated devices by incorporating the most recently published data.MethodsWe searched for candidate studies in PubMed (MEDLINE), Scopus, EMBASE (Ovid) online databases, government web archives and international cardiovascular conferences. Safety endpoints of interest included all-cause mortality rates at one, two and five years and the risk ratio (RR) was used as the summary measure. The primary analysis was performed using random-effects models to account for potential clinical heterogeneity.FindingsThirty-nine RCTs including 9164 patients were identified. At one year, the random-effects model yielded a pooled RR of 1.06 (95% CI [0.87, 1.29]) indicating no difference in short-term all-cause deaths between the paclitaxel and control groups (crude mortality, 4.3%, 214/5025 versus 4.5%, 177/3965). Two-year mortality was reported in 26 RCTs with 382 deaths out of 3788 patients (10.1%) in the paclitaxel arm and 299 out of 2955 patients (10.1%) in the control arm and no association was found between increased risk of death and usage of paclitaxel-coated devices (RR 1.08, 95% CI [0.93, 1.25]). Eight RCTs recorded all-cause deaths up to five years and a pooled RR of 1.18 (95% CI [0.92, 1.51]) demonstrated no late mortality risk due to use of paclitaxel-coated devices (crude mortality, paclitaxel 18.2%, 247/1360 versus control 15.2%, 122/805).ConclusionsWe found no significant difference in either short- or long-term all-cause mortalities between patients receiving paclitaxel-coated and uncoated devices. Further research on the longer-term safety of paclitaxel usage (e.g., 8- or 10-year) is warranted.RegistrationPROSPERO, CRD42021246291.

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