Rotational and aspiration atherectomy for infrainguinal in-stent restenosis

Area of Science:

• Cardiovascular Interventions
• Vascular Surgery
• Medical Device Technology

Background:

• In-stent restenosis (ISR) following peripheral vascular interventions poses a significant clinical challenge.
• The Pathway PV™ Atherectomy System offers a potential solution for managing ISR.
• Assessing the feasibility and safety of this device is crucial for its clinical adoption.

Purpose of the Study:

• To evaluate the feasibility and safety of the Pathway PV™ Atherectomy System for percutaneous peripheral vascular interventions in patients with in-stent restenosis.
• To determine the rate of serious adverse events (SAEs) within 30 days post-procedure.
• To assess the clinical and angiographic outcomes in a cohort of patients with symptomatic infrainguinal ISR.

Main Methods:

• A prospective study involving 33 patients with symptomatic infrainguinal ISR treated at 5 study sites.
• The primary endpoint was the 30-day SAE rate. A subgroup of 13 patients underwent additional duplex follow-up.
• Forty lesions were treated, with a mean lesion length of 85.7 mm, including total occlusions and infrapopliteal lesions.

Main Results:

• Procedural success was achieved in 40% with atherectomy alone; 57.5% required adjunctive angioplasty.
• Device-related SAEs were absent (100% freedom). Two serious adverse events (retroperitoneal bleeding, access site infection) occurred in 11 total unexpected events.
• Ankle-brachial index and Rutherford category significantly improved at 30 days. Primary patency was 33% at 12 months and 25% at 24 months; secondary patency was 92% at both time points.

Conclusions:

• The Pathway PV™ Atherectomy System demonstrates feasibility and safety for treating peripheral in-stent restenosis.
• The system's long-term patency may not be sustainable as a standalone solution.
• Combination therapy with drug-eluting balloons warrants further investigation in clinical trials.