Shalini Sharma, Anand Gupta, Peter Soukas, Mallik Thatipelli, Venkatesh G Ramaiah, Sameh Sayfo, Shirling Tsai, Ashish Pershad, Javier Vasquez, John F Eidt, Subhash Banerjee
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.
BACKGROUND: 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 Santreva™-ATK Endovascular Revascularization Catheter in these patient populations.
OBJECTIVES: 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.
METHODS: 74 patients with Rutherford class (RC) 2-5 peripheral artery disease and de novo FP CTOs were stratified into IC (RC 2-3, n=48) and CLTI (RC 4-5, 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.
RESULTS: 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.
CONCLUSION: 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.