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.
Koen Deloose, Laura Drudi, Jürgen Verbist et al.
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In 30 seconds
The T.I.N.T.I.N. trial was a prospective, non-randomized, multicenter study in Belgium evaluating a paclitaxel-coated Luminor balloon followed by an iVolution self-expanding bare-metal stent for long, complex TASC C and D femoropopliteal lesions. Among 100 patients, freedom from clinically driven target lesion revascularization was 94.6% (95% CE: 90.0-99.2) at 12 months and 89.6% (95% CE: 83.2-96.0) at 24 months. Primary patency at 12 months was 90.5% (95% CE: 84.2-96.8). The authors reported safe and effective outcomes through 24 months.
Key findings
- Freedom from clinically driven target lesion revascularization was 94.6% (95% CE: 90.0-99.2) at 12 months and 89.6% (95% CE: 83.2-96.0) at 24 months.
- Primary patency at 12 months was 90.5% (95% CE: 84.2-96.8).
- Survival was 92.8% (95% CE: 87.8-97.8) at 1 year and 82.0% (95% CE: 74.2-89.8) at 2 years; no deaths were procedure- or device-related.
Why it matters
Long femoropopliteal lesions can require stenting despite balloon-based treatment. These results provide prospective multicenter evidence on a drug-coated balloon plus bare-metal stent strategy in complex lesions, including patients with severe claudication or limb-threatening ischemia. The findings may inform consideration of this approach among available options, while the non-randomized design limits comparative conclusions.
What to keep in mind
The trial was non-randomized, so it cannot establish comparative efficacy against other treatments. Follow-up reported here extends to 24 months.