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
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".