Clinical trial NCT05254106: The DETECT Project
Official title: The Drug Eluting Devices French Safety Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoropopliteal Atheromatous Lesions
Keywords: Femoropopliteal atheromatous lesions
endovascular revascularization
paclitaxel drug-eluting devices
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: French-Speaking Vascular and Endovascular Surgery Society Support
name: Boston Scientific Corporation
name: Cook Research Incorporated
First posted: 2022-02-24
Enrollment: 250000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in this study were all patients identified in SNDS with an endovascular femoropopliteal artery intervention by non-drug-eluting balloon/stent or paclitaxel drug-eluting balloon/stent between October 2011 and December 2019 in France.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Midterm mortality after the procedure of interest
timeFrame: 2 years
Secondary outcomes:
measure: Short-term mortality after the procedure of interest
timeFrame: 1 year
measure: Long-term mortality after the procedure of interest
timeFrame: 5 years
measure: Adverse events after the procedure of interest
timeFrame: 1 year, 2 years, 5 years
Other outcomes:
Locations:
city: Whole Country
country: France
facility: France
Study officials:
References: