Reintervention Patterns Among Patients With In-Stent Restenosis, Long Lesions, and Chronic Total Occlusions

On Tuesday, Gunnar Tepe, MD, from RoMed Hospital in Rosenheim, Germany, provided attendees with an update on reintervention patterns in patients with in-stent restenosis, long lesions, and chronic total occlusions. He reviewed results from the IN.PACT study, which is a real-world, prospective, multicenter, single-arm study of complex femoropopliteal lesions. A total of 1535 patients consented to the study—1416 in the full clinical cohort and the remainder in the 150 mm drug-coated balloon cohort. In the full clinical cohort, patients were divided into a non-imaging cohort and 3 pre-specified imaging cohorts—de novo in-stent restenosis (ISR) (n = 132), long lesion (LL) (≥15 cm) (n = 158), and chronic total occlusion (CTO) (≥5 cm) (n = 127).

The mean age in the prespecified cohorts at baseline were 67.8 in ISR, 69.6 in LL, and 67.4 in CTO. In ISR, LL, and CTO, the population was 68.9%, 66.5%, and 68.5% male, respectively. Subjects across each cohort had diabetes and hypertension; an ankle-brachial index of 0.7 in IS, 0.7 in LL, 0.6 in CTO; CLI Rutherford class 4-5 for 9.2%, 16.6%, and 11% of the ISR, LL, and CTO populations, respectively. Lesion lengths averaged 17.1 cm in ISR, 26.4 cm in LL, and 22.8 cm in CTO.

Initial results showed that freedom from clinically driven target lesion revascularization (CD-TLR) was 58% in the ISR group, 67.3% in the LL group, and 69.8% in the CTO group. It took 45 months, 48 months, and 49 months before the first CD-TLR in the ISR, LL, and CTO groups, respectively.

In a post-hoc analysis of patients undergoing DCB treatment for complex femoropopliteal artery disease, those with ISR had higher TLR rates compared to the LL and CTO groups. They also had a greater incidence of repeat TLRs. The time to the first CD-TLR event was shorter for the ISR cohort. Repeat TLRs were directly correlated with higher Rutherford classification across all 3 cohorts. In the ISR cohort, patients with a first TLR had a 2.1x greater risk of having a second TLR. There was no statistically significant effect in the LL or CTO cohorts.