Cardiovascular and interventional radiology · 2025
Off-Label Stent as a Rescue Option for Angulated Proximal Internal Carotid Artery Stenosis in Technically Unfeasible or Inoperable Patients.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Ozdemir Gokhan, Eren Fettah, Ersoy Ayse Nur, Dogruer Begum Asena, Gultekin Muhammet Mustafa, Ozturk Leyla, Ongun Gozde, Gundogdu Omer Lutfi, Kocaturk Idris, Kızıldag Nazım, Eren Alper, Demirdogen Filiz, Akcay Halil Ibrahim, Donmez Recep, Gorgulu Umit, Unal Nursen, Peynir Sehrivan, Utku Uygar, Keskin Emrah, Ildiz Omer Faruk, Guzel Abdullah, Demirbas Hayri
Аннотация
PURPOSE: To evaluate the feasibility, safety, and short-term outcomes of off-label stent use for extracranial internal carotid artery (ICA) revascularization in anatomically challenging patients.
METHODS: We conducted a retrospective multicenter cohort study including all consecutive patients treated for extracranial internal carotid artery stenosis between 2017 and 2025 across several high-volume stroke centers. Patients underwent one of three revascularization strategies: carotid endarterectomy (CEA), conventional carotid artery stenting (CAS), or off-label intracranial stent deployment in patients where severe tortuosity, high-cervical anatomy, sharply angulated bulbs, or unfavorable access rendered CEA and standard CAS technically unfeasible. Clinical presentation, angiographic severity, technical success, 30 day mortality, restenosis ≥ 50% at 3 months, and functional outcome (modified Rankin Scale (mRS) ≤ 2) were recorded. Three-group comparisons were performed using ANOVA/Kruskal-Wallis and chi-square/Fisher's exact tests. Given the small, anatomically preselected off-label cohort and low event numbers, neither propensity score matching nor multivariable regression was feasible. Statistical significance was set at p < 0.05.
RESULTS: A total of 1,522 patients underwent carotid revascularization (48 ACCLINO® stent, 1,274 CAS, 200 CEA). At baseline, pre-procedural near-occlusion or complete occlusion was significantly more common in the off-label group (68.8% [33/48]) compared with CAS (25.5% [325/1274]) and CEA (23.0% [46/200]) (p < 0.001). Symptomatic presentation was also highest in the off-label cohort (100% [48/48]) versus CAS (75.6% [963/1274]) and CEA (81.5% [163/200]) (p < 0.001). Acute ischemic stroke occurred in 25.0% (12/48), 7.8% (99/1274), and 6.0% (12/200) respectively (p < 0.001). Technical success was achieved in all off-label and CEA procedures and in 99.4% of CAS (p = 0.41). Thirty-day mortality did not differ significantly (6.3% vs. 2.7% vs. 3.0%; p = 0.17). At 3 months, restenosis ≥ 50% was comparable across groups (4.2% vs. 5.3% vs. 5.5%; p = 0.78). Functional independence (mRS ≤ 2) improved from 31.3 to 100% in the off-label cohort (p < 0.001), compared with 87.2% → 96.5% in CAS and 82.0% → 94.0% in CEA (all p < 0.001).
CONCLUSIONS: Off-label stenting may offer high technical feasibility, acceptable vessel patency, and meaningful functional recovery in patients with complex, surgically challenging proksimal ICA stenosis, suggesting that it could serve as a potential rescue option in carefully selected anatomically difficult patients.
METHODS: We conducted a retrospective multicenter cohort study including all consecutive patients treated for extracranial internal carotid artery stenosis between 2017 and 2025 across several high-volume stroke centers. Patients underwent one of three revascularization strategies: carotid endarterectomy (CEA), conventional carotid artery stenting (CAS), or off-label intracranial stent deployment in patients where severe tortuosity, high-cervical anatomy, sharply angulated bulbs, or unfavorable access rendered CEA and standard CAS technically unfeasible. Clinical presentation, angiographic severity, technical success, 30 day mortality, restenosis ≥ 50% at 3 months, and functional outcome (modified Rankin Scale (mRS) ≤ 2) were recorded. Three-group comparisons were performed using ANOVA/Kruskal-Wallis and chi-square/Fisher's exact tests. Given the small, anatomically preselected off-label cohort and low event numbers, neither propensity score matching nor multivariable regression was feasible. Statistical significance was set at p < 0.05.
RESULTS: A total of 1,522 patients underwent carotid revascularization (48 ACCLINO® stent, 1,274 CAS, 200 CEA). At baseline, pre-procedural near-occlusion or complete occlusion was significantly more common in the off-label group (68.8% [33/48]) compared with CAS (25.5% [325/1274]) and CEA (23.0% [46/200]) (p < 0.001). Symptomatic presentation was also highest in the off-label cohort (100% [48/48]) versus CAS (75.6% [963/1274]) and CEA (81.5% [163/200]) (p < 0.001). Acute ischemic stroke occurred in 25.0% (12/48), 7.8% (99/1274), and 6.0% (12/200) respectively (p < 0.001). Technical success was achieved in all off-label and CEA procedures and in 99.4% of CAS (p = 0.41). Thirty-day mortality did not differ significantly (6.3% vs. 2.7% vs. 3.0%; p = 0.17). At 3 months, restenosis ≥ 50% was comparable across groups (4.2% vs. 5.3% vs. 5.5%; p = 0.78). Functional independence (mRS ≤ 2) improved from 31.3 to 100% in the off-label cohort (p < 0.001), compared with 87.2% → 96.5% in CAS and 82.0% → 94.0% in CEA (all p < 0.001).
CONCLUSIONS: Off-label stenting may offer high technical feasibility, acceptable vessel patency, and meaningful functional recovery in patients with complex, surgically challenging proksimal ICA stenosis, suggesting that it could serve as a potential rescue option in carefully selected anatomically difficult patients.