Rationale and Design of the SAFE-PAD Study.
Circ Cardiovasc Qual Outcomes
; 14(1): e007040, 2021 01.
Article
em En
| MEDLINE
| ID: mdl-33435732
ABSTRACT
BACKGROUND:
Recent 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 ANDRESULTS:
SAFE-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 International Classification of Diseases, Tenth Revision procedural codes, Current Procedural Terminology codes, and Healthcare Common Procedure Coding System C-codes. The safety end point of all-cause death will be updated semiannually and continued until the median duration of follow-up surpasses 5 years. Sub-group analyses will be conducted by device type, patient characteristics, and procedural setting. Registration The SAFE-PAD study has been registered on URL https//www.clinicaltrials.gov; Unique identifier NCT04496544.CONCLUSIONS:
The 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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Angioplastia com Balão
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Aged
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Female
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Humans
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Male
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Circ Cardiovasc Qual Outcomes
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Marrocos