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
Notice bibliographique
Résumé
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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».