Following the actions undertaken by ANSM relating to the use of paclitaxel balloons and stents in the treatment of obliterative arterial disease of the lower limbs (AOMI), EPI-PHARE publishes the monitoring of the use of these devices in France. The study was conducted using comprehensive data from the French National Health Data System (SNDS) between 2017 and 2019.
The results show that over this period, 113,766 patients underwent revascularization by angioplasty of the lower limb arteries: 16% of them (18,235 patients) received stents or paclitaxel balloons almost equally; for the majority the device used was a bare stent or balloon (56% and 28% of patients respectively).
Patients receiving paclitaxel devices were elderly and predominantly male. They had severe co-morbidities/medical history (8 out of 10 patients with a history of known cerebral, coronary and peripheral ischemic disease, hypertension in about 87%, diabetes in about 40% and lipid-lowering therapy in 70%). The private sector was managing 7 out of 10 patients receiving paclitaxel devices. Nine out of 10 patients were implanted in institutions performing more than 10 dilatations per month. This study also shows that the profile of patients receiving paclitaxel stents and balloons appears to be different from patients treated with naked devices with a less severe profile in terms of life expectancy. Finally, temporal changes over the period show that ANSM measures had an impact in 2019 by limiting the increase in the use of paclitaxel devices previously observed between 2017 and 2018.
In conclusion, these clinical practice data provide a comprehensive overview of lower limb angioplasty in France. This type of study could be repeated in the coming years to measure the evolution of the use of stents and balloons used in the AOMI.
The recommendations of ANSM of May 2020 are still applicable.
Find the study report on the use of Stents and balloons used in obliterative arterial disease of the lower limbs in France between 2017 and 2019