Femoropopliteal Atheromatous Lesions
Conditions
Keywords
Femoropopliteal atheromatous lesions, endovascular revascularization, paclitaxel drug-eluting devices
Brief summary
This study aims to assess the all-cause mortality at 2 years of patients treated by a paclitaxel drug-eluting devices or non-drug-eluting devices after an endovascular femoropopliteal artery revascularization based on the French National Healthcare Data System (SNDS).
Detailed description
Endovascular intervention is considered as a first-line treatment for femoropopliteal atheromatous lesions. During the 2000s, the superiority of auto-expandable stent compared to percutaneous transluminal angioplasty had been demonstrated, in terms of effectiveness. Over the past decade, paclitaxel drug-eluting balloons or stents were successfully assessed in order to prevent intimal hyperplasia and to treat restenosis. Nevertheless, in 2018, Katsanos and al. reported in a meta-analysis a higher risk of death at 2 and 5 years for patients treated by a paclitaxel drug-eluting balloons or stents versus non-drug-eluting devices. This study presents many limitations despite being performed as a systematic review of randomized clinical trials. Since then, several studies have been conducted without any statistical trends in favor of a higher mortality in patients treated by drug-eluting stents or drug-coated balloons. Analysis based on US or Germany databases in tens of thousands of patients has been published but individual data were unavailable. In France, there is no national report about the safety of paclitaxel drug-eluting devices prescribed in the case of endovascular femoropopliteal artery treatment. Therefore, this study aims to compare the risk of all-cause death of patients treated by paclitaxel-eluting devices versus non-drug-eluting devices in this indication at a national-scale using real-life data from SNDS. This analysis of the SNDS database will allow (i) to identify all patients across France treated by endovascular intervention for a femoropopliteal revascularization and to know precisely the medical device used; (ii) to reduce confusion bias based on the characterization of patients thanks to their data of medical follow-up, treatment, hospitalization and LTD (long-term condition); (iii) to document their care pathway, especially drugs delivery and diagnosis associated to possible hospitalization, or to all-cause death, in order to compare the 1-, 2- and 5-years prognosis according to the medical device used.
Interventions
DEVICELower limb artery revascularization with paclitaxel-eluting device
Lower limb artery revascularization with paclitaxel-eluting stent and/or paclitaxel-coated balloon
Sponsors
French-Speaking Vascular and Endovascular Surgery Society Support
Boston Scientific Corporation
Cook Research Incorporated
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* age ≥ 18 years old on day of hospital admission for the hereafter related surgical procedure * Affiliated member to the French Social Security system * Admitted in a French hospital, public or private, between October 2011 and December 2019 * Benefitting from an endovascular femoropopliteal surgical procedure coded with ≥ 1 of the 9 codes of the Common Classification of Medical Procedures (EEAF001, EEAF002, EEAF003, EEAF004, EEAF005, EEAF006, EEPF001, EEPF002, EELF002) * Associated to the reimbursement by the health insurance scheme for one device of interest cited in the SAP (statistical analyses plan)
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Midterm mortality after the procedure of interest | 2 years | All-cause death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term mortality after the procedure of interest | 1 year | All-cause death |
| Long-term mortality after the procedure of interest | 5 years | All-cause death |
| Adverse events after the procedure of interest | 1 year, 2 years, 5 years | Hospitalization for coronary artery disease (myocardial infarction or coronary revascularization), cerebrovascular accident, transient ischemic attack, lower limb amputation (minor and major), a major adverse cardiovascular event (define as the composite of death, myocardial infarction, cerebrovascular accident, transient ischemic attack, major amputation), a major adverse limb event (define as the composite of a lower limb revascularization or a major amputation) or all-cause mortality. |
Countries
France
Contacts
Primary ContactCHU Nantes Nantes University Hospital
Outcome results
None listed