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DES improves patency, event-free survival in CLI vs. BMS

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SAN DIEGO — Patients with critical limb ischemia and infrapopliteal lesions who were treated with drug-eluting stents had improved clinical and morphological long-term results compared with those treated with bare-metal stents, according to data presented at TCT 2018.

Thijs Wakkie, radiology resident at the HagaZiekenhuis at The Hague in the Netherlands, and colleagues analyzed information on 74 limbs from 137 patients with CLI and infrapopliteal lesions. Lesions included in this study were greater than 50% stenotic, 90 mm or less in length and with a diameter between 2 mm and 6 mm. A maximum of three lesions per leg were analyzed.

Patients were assigned percutaneous transluminal angioplasty plus a bailout BMS (66 limbs from 64 patients; mean age, 73 years; 73% men) or a DES with paclitaxel (Taxus Liberté, Boston Scientific; 74 limbs from 73 patients; mean age, 74 years; 67% men).

Follow-up was conducted at 3, 6 and 12 months, and annually up to 5 years after treatment. The primary endpoint was patency of treated lesions. Secondary endpoints were defined as major amputation, death and either infrapopliteal surgical or endovascular reintervention. An additional morphological endpoint was preserved primary patency of treated lesions, defined as less than 50% restenosis.

During 5 years of follow-up, patients assigned DES had a lower major amputation rate compared with those assigned a bailout BMS (19.3% vs. 34%; P = .091). The DES group also had higher rates of amputation-free survival (31.8% vs. 20.4%; P = .043) and event-free survival (26.2% vs. 15.3%; P = .041) at 5 years vs. the bailout BMS group.

The groups had comparable rates of overall survival.

Preserved patency rates were numerically higher in patients assigned DES vs. the bailout BMS in the intention-to-treat analysis (48% vs. 35.1%; P = .096), a difference that was significant in the per-protocol analysis (51.9% vs. 35.1%; P = .037).

Cumulative costs were higher in patients assigned BMS vs. DES. – by Darlene Dobkowski

References:

Wakkie T, et al. Abstract 115. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.

Spreen M, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.08.1217.

Disclosure: Wakkie reports no relevant financial disclosures.