June 25, 2020
Boston Scientific's Eluvia DES Evaluated in IMPERIAL Long Lesion Substudy
June 25, 2020—Frank Vermassen, MD, presented 2-year outcomes from the IMPERIAL Long Lesion substudy during the 2020 Vascular Interventional Advances (VIVA) late-breaking clinical trial live-stream.
The Long Lesion substudy is a single-arm branch of the prospective, global IMPERIAL study to evaluate the long-term safety and effectiveness of the Eluvia drug-eluting vascular stent system (Boston Scientific Corporation) for treating superficial femoral artery and/or proximal popliteal artery lesions > 140 and ≤ 190 mm in length. Primary patency, patient outcomes, and major adverse events have been assessed through 24 months.
As summarized in the VIVA abstract, the substudy was composed of 50 patients, 40% with diabetes, 28% with severe calcification, and 32% with occlusion. The mean lesion length was 162.8 ± 34.7 mm.
Clinical follow-up at 24 months was completed for 43 of 50 patients (two died, one withdrew, four missed the visit).
Dr. Vermassen reported these findings:
- Freedom from clinically driven target lesion revascularization rate was 86.7% (38/44)
- Kaplan-Meier estimate of primary patency was 77.2%
- 88.1% (37/42) of patients presented as Rutherford category 0 or 1
- Improvement of at least one Rutherford category without the need for target lesion revascularization was demonstrated in 88.1% (37/42) of patients
Excellent vessel patency and a good safety profile were observed after 2 years in patients treated with Eluvia in the IMPERIAL Long Lesion substudy, despite the lesion complexity; and clinical outcome improvements were sustained through 2 years, concluded the investigators at VIVA.