A well-functioning hemodialysis vascular access is a decisive factor in the survival of hemodialysis patients, who have a high mortality rate. 85% of these hemodialysis patients, are treated via an arteriovenous fistula (AVF). However, the primary patency of AVFs at 1 year is 60%, mainly due to neointimal hyperplasia developing in the drainage vein, which leads to stenosis and, if left untreated, thrombosis of the AVF. Indeed, forty percent of hemodialysis patients require re-intervention on their vascular access within the year, due to stenosis on their AVF.
Transluminal angioplasty (TLA) is currently used as first-line treatment for these stenoses but TLA itself causes vascular damage, with early recurrence of the stenosis in 50% of cases at 6 months, and necessitating repeated interventions.
In recent years several endovascular techniques have been developed to limit the risk of re-stenosis, none of which have produced significantly better results than simple TLA. Eliminating intimal hyperplasia using a minimally invasive endovascular technique, rather than crushing it with simple angioplasty, would improve restenosis-free survival in these patients.
Today, endovascular rotational atherectomy techniques are available to improve the patency of angioplasty in the treatment of complex arterial lesions of the coronary arteries and lower limbs. The atherotome is a guide-mounted catheter with a small burr at its distal end, which resects the atheromatous plaque whereas angioplasty simply crushes it. Atherectomy is followed by drug-eluting balloon (DEB) angioplasty with paclitaxel release to limit restenosis through its anti-inflammatory and anti-proliferative activity. A few cases of rotational atherectomy for the treatment of calcified stenoses in saphenous vein coronary bypasses have been reported in the literature, with encouraging results. If AVF re-stenosis should occur, the intimal hyperplasia can be removed endovascularly, thereby limiting the risk of short-term iterative stenosis.
The aim of this study was to compare the 6-month re-stenosis rate with this technique (atherectomy + drug-eluting balloon) versus standard angioplasty + drug-eluting balloon for the treatment of restenosis of hemodialysis vascular accesses.
Hemodialysis patient on arteriovenous fistula (AVF) with re-stenosis defined on echodoppler by a combination of >50% venous lumen reduction with a systolic peak ratio >2 associated with either : i) an internal residual diameter of < 2 mm, or ii) a flow reduction > 25% or a flow rate < 500 ml/min.
Patient with at least one history of angioplasty on his/her AVF at the same site.
Patient available for 6-month follow-up.
Patient with free and informed consent and signed consent form.
Patient with an intraoperative technical impossibility.
Patient with a septic complication.
Patient participating in another interventional trial.
Patient in an exclusion period determined by another study.
Parallel
Standard angioplasty + drug-eluting balloon technique
Procedure/SurgeryTreatment of restenosis of hemodialysis vascular access via the standard angioplasty + drug-eluting balloon technique
Atherectomy + drug-eluting balloon
Procedure/SurgeryTreatment of restenosis of hemodialysis vascular access via the atherectomy + drug-eluting balloon technique
Re-stenosis rate at 6 months in the control group
YES/NO Significant restenosis is defined on echodoppler by a combination of \> 50% venous lumen reduction with a systolic peak ratio \> 2 associated with: i) either an internal residual diameter \< 2 mm, ii) or a flow reduction \> 25% or flow \< 500 ml/min.
Re-stenosis rate at 6 months in the experimental group
YES/NO Significant restenosis is defined on echodoppler by a combination of \> 50% venous lumen reduction with a systolic peak ratio \> 2 associated with: i) either an internal residual diameter \< 2 mm, ii) or a flow reduction \> 25% or flow \< 500 ml/min.
Time to re-stenosis in the control group
Time (days) from surgery to onset of restenosis as defined above.
Time to re-stenosis in the experimental group
Time (days) from surgery to onset of restenosis as defined above.
Rate of complications in the control group
Collection of complications related to surgical technique: perforation (assessed by the operator intraoperatively: extravasation of contrast medium at fistulographic control), false aneurysm (assessed at follow-up echodoppler).
Rate of complications in the experimental group
Collection of complications related to surgical technique: perforation (assessed by the operator intraoperatively: extravasation of contrast medium at fistulographic control), false aneurysm (assessed at follow-up echodoppler).
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