Abstract :
[en] At present, vascular brachytherapy is the only efficient therapy for in-stent restenosis. Nevertheless, edge restenosis often related to geographical miss has been identified as a major limitation of the technique. The non-slippery cutting balloon has the potential to limit vascular barotraumas, which, together with low-dose irradiation at both ends of the radioactive source, are the prerequisite for geographical miss. This prospective study aimed to examine the efficacy of combining cutting balloon angioplasty and brachytherapy for in-stent restenosis. The Radiation in Europe NOvoste (RENO) registry prospectively tracked all patients who had been treated by coronary β-radiation with the Beta-Cath System (Novoste Corporation, Brussels, Belgium) but were not included in a randomized radiation trial. A subgroup of patients with in-stent restenosis treated by cutting balloon angioplasty and coronary β-radiation (group 1, n = 166) was prospectively defined, and clinical outcomes of patients at 6 months were compared with those of patients treated by conventional angioplasty and coronary β-radiation (group 2, n = 712). At 6-month follow-up, there was a significant difference between groups 1 and 2 in target vessel revascularization (10.2% versus 16.6% respectively; p = 0.04) and in the incidence of major adverse clinical events (MACE) including death, myocardial infarction, and revascularization (10.8% versus 19.2%; p = 0.01). This observation was confirmed by a multivariate analysis indicating a lower risk for MACE at 6 months (odds ratio: 0.49; confidence intervals: 0.27-0.88; p = 0.02). Compared to conventional angioplasty, cutting balloon angioplasty prior to coronary beta-radiation with the Beta-Cath System seems to improve the 6-month clinical outcome in patients with in-stent restenosis.
[fr] À l'heure actuelle, la curiethérapie vasculaire est le seul traitement efficace pour la resténose intra-stent. Nevertheless, edge restenosis often related to geographical miss has been identified as a major limitation of the technique. Néanmoins, la resténose bord souvent liés à manquez géographique a été identifié comme une limitation majeure de cette technique. The non-slippery cutting balloon has the potential to limit vascular barotraumas, which, together with low-dose irradiation at both ends of the radioactive source, are the prerequisite for geographical miss. Le ballon non glissante de coupe a le potentiel pour limiter barotraumatismes vasculaire, qui, avec l'irradiation à faible dose aux deux extrémités de la source radioactive, sont la condition sine qua non pour des raisons géographiques manquer. This prospective study aimed to examine the efficacy of combining cutting balloon angioplasty and brachytherapy for in-stent restenosis. Cette étude prospective visant à examiner l'efficacité de la combinaison de coupe angioplastie par ballonnet et la curiethérapie de la resténose intra-stent. The Radiation in Europe NOvoste (RENO) registry prospectively tracked all patients who had been treated by coronary beta-radiation with the Beta-Cath System (Novoste Corporation, Brussels, Belgium) but were not included in a randomized radiation trial. Le rayonnement en Europe Novoste (Reno) Registre suivis de façon prospective tous les patients qui avaient été traités par des bêta-coronarien rayonnement avec la version Beta-Cath System (Novoste Corporation, Bruxelles, Belgique) mais n'ont pas été inclus dans un essai randomisé de rayonnement. A subgroup of patients with in-stent restenosis treated by cutting balloon angioplasty and coronary beta-radiation (group 1, n = 166) was prospectively defined, and clinical outcomes of patients at 6 months were compared with those of patients treated by conventional angioplasty and coronary beta-radiation (group 2, n = 712). Un sous-groupe de patients avec une resténose intra-stent traités en coupant l'angioplastie par ballonnet et le rayonnement bêta coronaires (groupe 1, n = 166) a été défini prospectivement, et les résultats cliniques des patients à 6 mois ont été comparés à ceux des patients traités par angioplastie classique et coronaire bêta-irradiation (groupe 2, n = 712). At 6-month follow-up, there was a significant difference between groups 1 and 2 in target vessel revascularization (10.2% versus 16.6% respectively; p = 0.04) and in the incidence of major adverse clinical events (MACE) including death, myocardial infarction, and revascularization (10.8% versus 19.2%; p = 0.01). A 6 mois de suivi, il y avait une différence significative entre les groupes 1 et 2 de la revascularisation du vaisseau cible (10,2% contre 16,6% respectivement, p = 0,04) et de l'incidence des événements indésirables cliniques majeurs (MACE), y compris la mort, l'infarctus infarctus et revascularisation (10,8% versus 19,2%, p = 0,01). This observation was confirmed by a multivariate analysis indicating a lower risk for MACE at 6 months (odds ratio: 0.49; confidence intervals: 0.27 0.88; p = 0.02). Cette observation a été confirmée par une analyse multivariée indiquant un risque plus faible pour MACE à 6 mois (odds ratio: 0,49; intervalle de confiance: 0,27 0,88; p = 0,02). Compared to conventional angioplasty, cutting balloon angioplasty prior to coronary beta-radiation with the Beta-Cath System seems to improve the 6-month clinical outcome in patients with in-stent restenosis. Par rapport à l'angioplastie conventionnelle, la coupe avant l'angioplastie par ballonnet coronaire beta-radiation avec le Beta-Cath système semble améliorer les 6 mois, les résultats cliniques chez les patients présentant une resténose intra-stent.
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