Safety and Efficacy of Treatment With the Luminor DCB and iVolution Stent in TASC C and D Femoropopliteal Atherosclerotic Disease: 12 and 24-Month Outcome of the T.I.N.T.I.N. Physician-Initiated Trial.

Background: There is evidence that the treatment of symptomatic femoropopliteal disease with a drug-coated balloon (DCB) effectively inhibits restenosis. However for longer and more complex lesions, "bailout" remains stenting almost inevitable. Although the combination therapy of DCBs and modern bare metal stent (BMS) has not been widely studied, there are indications that this combination therapy is doing better than BMS alone and could be a potential alternative for drug-eluting stent treatment.

Objective: The aim of this study is to evaluate the long-term outcome of the combination therapy with the Luminor DCB and the iVolution stent of iVascular for the treatment of long femoropopliteal lesions Transatlantic InterSociety Consensus (TASC) C and D.

Methods: The T.I.N.T.I.N. trial is a physician-initiated, prospective, non-randomized, multicenter trial conducted in Belgium, investigating the safety and efficacy of the treatment with the Luminor DCB and the iVolution self-expanding stent in 100 patients. The primary efficacy endpoint was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. The key secondary endpoints were primary patency at 12 months, CD-TLR at 24 months, and survival at 12 and 24 months.

Results: Participants had a mean age of 73.5 ± 9.4 years, with 67.0% being male participants. Sixty-two percent of the patients suffered from severe claudication (Rutherford 3) and 26.0% had limb-threatening ischemia (Rutherford 5). Freedom from CD-TLR at 12 and 24 months was 94.6% (95% CE: 90.0-99.2) and 89.6% (95% CE: 83.2-96.0), respectively. The primary patency rate at 12 months was 90.5% (95% CE: 84.2-96.8). Survival rate at 1 and 2 years was 92.8% (95% CE: 87.8-97.8) and 82.0% (95% CE: 74.2-89.8), respectively. None of the causes of death were procedure or device related.

Conclusion: The combination of a Luminor DCB followed by an iVolution stent implantation resulted in safe and effective outcomes in the treatment of femoropopliteal lesions for up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Luminor DCB appears to improve efficacy at 1 and 2 years compared to the use of BMSs only, as observed in the precursor Evolution study.Clinical ImpactThis study proofs that especially in long and complex femoropopliteal lesions (full cohort of 100 patients instead of a subanalysis in a small subgroup with risk of biases), a combination therapy of a Paclitaxel coated balloon and a modern bare metal stent offers high levels of safety and efficacy up to 2 years. For clinicians it means that beside bypass surgery, covered self-expandable stents and drug eluting stents, they have an extra treatment option in the armamentarium for complex vascular disease in this anatomic area. Depending on personal preferences, reimbursement systems and device availabilities they can opt for one of these methods.