Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent.
Aged
Aged, 80 and over
Datasets as Topic
Drug-Eluting Stents
Endovascular Procedures
/ methods
Female
Femoral Artery
/ physiopathology
Follow-Up Studies
Humans
Male
Middle Aged
Paclitaxel
/ therapeutic use
Peripheral Arterial Disease
/ surgery
Popliteal Artery
/ physiopathology
Prospective Studies
Recurrence
Time Factors
Treatment Outcome
Tubulin Modulators
/ therapeutic use
Vascular Patency
/ drug effects
Drug-eluting stent
Paclitaxel
Peripheral artery disease
Prediction model
Target lesion revascularization
Journal
Cardiovascular and interventional radiology
ISSN: 1432-086X
Titre abrégé: Cardiovasc Intervent Radiol
Pays: United States
ID NLM: 8003538
Informations de publication
Date de publication:
Feb 2021
Feb 2021
Historique:
received:
04
08
2020
accepted:
08
09
2020
pubmed:
8
10
2020
medline:
29
5
2021
entrez:
7
10
2020
Statut:
ppublish
Résumé
Develop a prediction model to determine the impact of patient and lesion factors on freedom from target lesion revascularization (ffTLR) for patients who are candidates for Zilver PTX drug-eluting stent (DES) treatment for femoropopliteal lesions. Patient factors, lesion characteristics, and TLR results from five global studies were utilized for model development. Factors potentially associated with TLR (sex, age, diabetes, hypertension, hypercholesterolemia, renal disease, smoking status, Rutherford classification, lesion length, reference vessel diameter (RVD), popliteal involvement, total occlusion, calcification severity, prior interventions, and number of runoff vessels) were analyzed in a Cox proportional hazards model. Probability of ffTLR was generated for three example patient profiles via combinations of patient and lesion factors. TLR was defined as reintervention performed for ≥ 50% diameter stenosis after recurrent clinical symptoms. The model used records from 2227 patients. The median follow-up time was 23.9 months (range: 0.03-60.8). The Kaplan-Meier estimates for ffTLR were 90.5% through 1 year and 75.2% through 5 years. In a multivariate analysis, sex, age, Rutherford classification, lesion length, RVD, total occlusion, and prior interventions were significant factors. The example patient profiles have predicted 1-year ffTLRs of 97.4, 92.3, and 86.0% and 5-year predicted ffTLRs of 92.8, 79.5, and 64.8%. The prediction model is available as an interactive web-based tool ( https://cooksfa.z13.web.core.windows.net ). This is the first prediction model that uses an extensive dataset to determine the impact of patient and lesion factors on ffTLR through 5 years and provides an interactive web-based tool for expected patient outcomes with the Zilver PTX DES. Zilver PTX RCT unique identifier: NCT00120406; Zilver PTX single-arm study unique identifier: NCT01094678; Zilver PTX China study unique identifier: NCT02171962; Zilver PTX US post-approval study unique identifier: NCT01901289; Zilver PTX Japan post-market surveillance study unique identifier: NCT02254837. Zilver PTX RCT: Level 2, randomized controlled trial; Single-arm study: Level 4, large case series; China study: Level 4, case series; US post-approval study: Level 4, case series Japan PMS study: Level 4, large case series.
Identifiants
pubmed: 33025243
doi: 10.1007/s00270-020-02648-6
pii: 10.1007/s00270-020-02648-6
pmc: PMC7806559
doi:
Substances chimiques
Tubulin Modulators
0
Paclitaxel
P88XT4IS4D
Banques de données
ClinicalTrials.gov
['NCT00120406', 'NCT01094678', 'NCT02171962', 'NCT01901289', 'NCT02254837']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
196-206Références
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