Resultados clínicos do cateter de revascularização endovascular de Santreva-ATK em pacientes com claudicação e isquemia crítica do membro

Resumo original em inglês

O que aconteceu

Patients with femoropopliteal (FP) chronic total occlusions (CTOs) presenting with intermittent claudication (IC) and chronic limb threatening ischemia (CLTI) differ in disease severity and lesion complexity. We performed a subgroup analysis of the prospective, multicenter RESTOR-1 trial to evaluate the safety and effectiveness of the Santrev-ATK Endovascular Revascularization Catheter in these patient populations. Compare procedural and short-term clinical course outcomes of the Santreva-ATK catheter in patients with IC and CLTI enrolled in RESTOR-1 pivotal trial. About 74 patients with Rutherford class (RC) 2 to 5 peripheral artery disease and de novo FP CTOs were stratified into IC (RC 2 to 3, n = 48) and CLTI (RC 4 to 5, n = 26). The primary endpoint was clinical success, defined as successful device-facilitated guidewire placement into the distal true lumen without device-related major adverse events (MAEs). Secondary endpoints included procedural success, intravascular (IVUS)-determined crossing trajectory, and 30-day clinical outcomes. Clinical success was achieved in 89.6% of patients with IC and 84.6% of patients with CLTI, with similarly high technical and procedural success rates between groups. IVUS evaluation was performed in 85.4% (41/48) of patients with IC and 76.9% (20/26) of patients with CLTI. Among patients with documented crossing trajectory, 86.9% (53/61) demonstrated intraplaque crossing and 13.1% (8/61) demonstrated extraplaque crossing. Although patients with CLTI had a numerically higher prevalence of diabetes mellitus and heavily calcified lesions, these differences were not statistically significant, and crossing performance remained comparable between groups. Santreva-ATK catheter demonstrated high clinical success and an excellent safety profile across the spectrum of FP CTO disease, supporting its use in both IC and CLTI patients.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.