Observational studyCirculation. Cardiovascular quality and outcomes2021
Rationale and Design of the SAFE-PAD Study.
Observational study in Circulation. Cardiovascular quality and outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 15 citations in OpenAlex.
- Drug-Coated Balloon Versus Plain Old Balloon Angioplasty in Isolated Popliteal and/or Superficial Femoral Artery Disease: A Retrospective Single-Center Comparative Cohort Study.Journal of clinical medicine · 2026Article
- Evaluating Cardiovascular Devices Using Observational Analyses.Circulation · 2026Review
- Contemporary Administrative Codes to Identify Pulmonary Vein Isolation Procedures for Atrial Fibrillation.Journal of the American Heart Association · 2025Observational
- The End of a Controversy: The Rise, Fall, and Redemption of Paclitaxel-Coated Devices.The American journal of cardiology · 2024Article
- Association of Clinical Setting With Sociodemographics and Outcomes Following Endovascular Femoropopliteal Artery Revascularization in the United States.Circulation. Cardiovascular quality and outcomes · 2023Article
- Update From the Longitudinal Assessment of Safety of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices Among Medicare Beneficiaries: The SAFE-PAD Study.Circulation. Cardiovascular interventions · 2022Article
- Outcomes Associated With Peripheral Artery Disease in Myocardial Infarction With Cardiogenic Shock.Journal of the American College of Cardiology · 2022Article
- Sex Disparities in Long-Term Mortality after Paclitaxel Exposure in Patients with Peripheral Artery Disease: A Nationwide Claims-Based Cohort Study.Journal of clinical medicine · 2021Article
- Five-Year Independent Patient-Level Mortality Analysis of the Pooled ILLUMENATE Pivotal and EU Randomized Controlled Trials.Journal of the Society for Cardiovascular Angiography & InterventionsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundRecent evidence from randomized controlled trials has raised concerns about the long-term safety of paclitaxel-coated peripheral devices used for femoropopliteal artery revascularization. In response to a call for more real-world data on the safety of these devices, the SAFE-PAD study (Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was designed with input from the Food and Drug Administration to provide a long-term, comprehensive evaluation of the mortality risk associated with paclitaxel-coated devices among Medicare beneficiaries. METHODS AND
resultsSAFE-PAD is an observational cohort study of fee-for-service Medicare beneficiaries that underwent femoropopliteal artery revascularization with either a drug-coated device or nondrug-coated device from 2015 through 2018. All patients age 66 years or older who underwent revascularization will be identified using a combination of
conclusionsThe SAFE-PAD study will evaluate the long-term safety of drug-coated devices compared with nondrug-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.