Contemporary Therapy of Femoropopliteal In-Stent Restenosis / Occlusion, 36-month Follow up Study

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Medical Device Technology

Background:

• Drug-eluting devices have enhanced endovascular therapy (EVT) for femoropopliteal lesions, primarily de novo cases.
• Endovascular therapy for in-stent restenosis/occlusion (ISR/O) presents significant challenges with limited large-scale, long-term data.
• Investigating novel device efficacy in ISR/O is crucial for improving patient outcomes.

Purpose of the Study:

• To evaluate the effectiveness of new devices (drug-coated balloon, drug-eluting stent, covered stent) versus conventional methods for treating femoropopliteal ISR/O.
• To compare primary patency rates between new devices and control groups at 12 and 36 months.
• To identify potential baseline characteristic interactions influencing treatment outcomes.

Main Methods:

• Retrospective, multicenter study involving 346 cases of first femoropopliteal ISR/O from 7 Japanese institutes.
• Propensity score matching created 112 pairs for comparative analysis.
• New devices (drug-coated balloon, drug-eluting stent, covered stent) were compared against a control group (balloon angioplasty, bare nitinol stent).

Main Results:

• At 12 months, the new device group demonstrated a significantly higher primary patency rate (80.3%) compared to the control group (52.7%) (P = .004).
• By 36 months, primary patency rates converged, with no significant difference between groups (43.3% vs 39.2%, P = .090).
• No significant interaction effects were observed between baseline characteristics and treatment groups (all P > .05).

Conclusions:

• New devices offer superior short-term efficacy for femoropopliteal ISR/O compared to conventional treatments.
• The initial patency advantage of new devices diminishes over time, with comparable outcomes by 3 years.
• Further research may be needed to understand long-term performance differences and patient selection for novel devices in ISR/O treatment.