The DETECT Project (DETECT)

The Drug Eluting Devices French Safety Survey

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).

Study Overview

• Status: Recruiting
• Conditions: Femoropopliteal Atheromatous Lesions
• Intervention / Treatment: Device: Lower limb artery revascularization with paclitaxel-eluting device

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.

• Study Type: Observational
• Enrollment (Anticipated): 250000

Contacts and Locations

• Study Contact: Name: CHU Nantes Nantes University Hospital; Email: bp-prom-regl@chu-nantes.fr

Study Locations

• France
  • Whole Country, France
    • Recruiting
    • France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Paclitaxel drug-eluting devices; Patients treated by at least one paclitaxel drug-eluting balloon or stent after an endovascular femoropopliteal artery revascularization between October 2011 and December 2019 in France.	Device: Lower limb artery revascularization with paclitaxel-eluting device; Lower limb artery revascularization with paclitaxel-eluting stent and/or paclitaxel-coated balloon
Non-drug-eluting devices; Patients exclusively treated by a non-drug-eluting balloon or stent after an endovascular femoropopliteal artery revascularization between October 2011 and December 2019 in France.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Midterm mortality after the procedure of interest	All-cause death	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term mortality after the procedure of interest	All-cause death	1 year
Long-term mortality after the procedure of interest	All-cause death	5 years
Adverse events after the procedure of interest	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.	1 year, 2 years, 5 years

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Boston Scientific Corporation; Cook Research Incorporated; French-Speaking Vascular and Endovascular Surgery Society Support

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2011
• Primary Completion (Actual): December 31, 2021
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Femoropopliteal atheromatous lesions; endovascular revascularization; paclitaxel drug-eluting devices
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: RC20_0067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes