Resultado del tratamiento percutáneo de la reestenosis de stents farmacoactivos: ¿depende de si el stent tenía o no recubrimiento polimérico? / Do outcomes following intervention for drug-eluting stent restenosis depend on whether the restenosed stent was polymer-free or polymer-coated?

INTRODUCCIÓN Y OBJETIVOS: Los resultados de los pacientes con reestenosis de stents farmacoactivos (SFA) son peores que los de pacientes con reestenosis de stents metálicos. No se sabe si está relacionado o no con la presencia de recubrimiento de polímero. Se compararon los resultados tras la intervención sobre la reestenosis del stent (RS) de SFA sin polímero y SFA recubiertos de polímero duradero. MÉTODOS: Se incluyó a los pacientes del estudio aleatorizado ISAR-TEST 5 sometidos a un nuevo intervencionismo percutáneo por RS durante el seguimiento. Se analizaron los resultados angiográficos a los 6 y a los 8 meses y los eventos clínicos a los 2 años, y se compararon los 2 grupos en función del tipo de stent. Las diferencias entre uno y otro grupo se ajustaron mediante análisis multivariable. RESULTADOS: Se incluyó a 326 pacientes con RS: 220 de SFA sin polímero y 106 de SFA con polímero. Se dispuso de angiografía de control del 83,4% de los pacientes. No se observaron diferencias entre los grupos en cuanto a reestenosis binaria recurrente (el 31,7 y el 27,0%; p = 0,38; pajustada=0,29). A los 2 años, el objetivo compuesto de muerte, infarto de miocardio o nueva revascularización de la lesión diana fue similar en los 2 grupos (el 35,7 frente al 34,0%; HR=1,04; IC95%, 0,70-1,55; p = 0,83; pajustada=0,79). Las tasas de nueva revascularización de la lesión diana de ambos grupos también fueron comparables (el 29,8 y el 31,5%; HR=0,91; IC95%, 0,60-1,39; p = 0,68; pajustada=0,62). CONCLUSIONES: No se encontraron diferencias entre los pacientes sometidos a reintervención por RS de SFA en cuanto a eventos clínicos o angiográficos en función del tipo de stent, con o sin polímero

INTRODUCTION AND OBJECTIVES: Outcomes of patients undergoing percutaneous intervention for drug-eluting stent (DES) restenosis are poorer than those in patients with bare-metal stent restenosis. It is unknown if this is related to the presence of polymer coating. We sought to compare outcomes after interventions for in-stent restenosis (ISR) of polymer-free DES vs durable polymer DES. METHODS: Patients enrolled in the ISAR-TEST 5 randomized trial who underwent repeat percutaneous intervention for ISR during follow-up were included. Angiographic outcomes at 6 to 8 months and clinical outcomes at 2 years were analyzed and compared between 2 groups according to whether the restenosed stent was a polymer-free or a durable polymer DES. Multivariate analysis was used to adjust for differences between groups. RESULTS: A total of 326 patients with ISR were included: 220 with ISR in polymer-free DES and 106 with ISR in durable polymer DES. Angiographic follow-up was available for 83.4% of patients. No difference was observed in recurrent binary restenosis between the 2 groups (31.7% vs 27.0%; P=.38; Padjusted=.29). At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR=1.04, 95%CI, 0.70-1.55; P=.83; Padjusted=.79). The rate of repeat target lesion revascularization was also similar in the 2 groups (29.8% vs 31.5%; HR=0.91, 95%CI, 0.60-1.39; P=.68; Padjusted=.62). CONCLUSIONS: In patients undergoing reintervention for DES-ISR, we found no evidence of differences in outcomes according to whether the restenosed stent was a polymer-free or durable polymer DES

Do outcomes following intervention for drug-eluting stent restenosis depend on whether the restenosed stent was polymer-free or polymer-coated?

INTRODUCTION AND OBJECTIVES: Outcomes of patients undergoing percutaneous intervention for drug-eluting stent (DES) restenosis are poorer than those in patients with bare-metal stent restenosis. It is unknown if this is related to the presence of polymer coating. We sought to compare outcomes after interventions for in-stent restenosis (ISR) of polymer-free DES vs durable polymer DES. METHODS: Patients enrolled in the ISAR-TEST 5 randomized trial who underwent repeat percutaneous intervention for ISR during follow-up were included. Angiographic outcomes at 6 to 8 months and clinical outcomes at 2 years were analyzed and compared between 2 groups according to whether the restenosed stent was a polymer-free or a durable polymer DES. Multivariate analysis was used to adjust for differences between groups. RESULTS: A total of 326 patients with ISR were included: 220 with ISR in polymer-free DES and 106 with ISR in durable polymer DES. Angiographic follow-up was available for 83.4% of patients. No difference was observed in recurrent binary restenosis between the 2 groups (31.7% vs 27.0%; P=.38; Padjusted=.29). At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR=1.04, 95%CI, 0.70-1.55; P=.83; Padjusted=.79). The rate of repeat target lesion revascularization was also similar in the 2 groups (29.8% vs 31.5%; HR=0.91, 95%CI, 0.60-1.39; P=.68; Padjusted=.62). CONCLUSIONS: In patients undergoing reintervention for DES-ISR, we found no evidence of differences in outcomes according to whether the restenosed stent was a polymer-free or durable polymer DES.

Comparative efficacy of two paclitaxel-coated balloons with different excipient coatings in patients with coronary in-stent restenosis: A pooled analysis of the Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 3 and 4 (ISAR-DESIRE 3 and ISAR-DESIRE 4) trials.

BACKGROUND: Angioplasty with paclitaxel-coated balloons (PCB) is recommended for treatment of patients with coronary in-stent restenosis (ISR) according to European clinical practice guidelines. Most clinical trials have investigated iopromide-based PCB and there is a paucity of data comparing efficacy against butyryl-tri-hexyl citrate (BTHC)-based PCB. Our aim was to compare the performance of two widely-used PCB in the treatment of coronary ISR. METHODS: We analysed patients treated with BTHC- or iopromide-PCB for treatment of drug-eluting stent ISR in the setting of 2 consecutive trials with identical inclusion and exclusion criteria. The primary endpoint was diameter stenosis at 6-8month angiographic surveillance. The secondary endpoint of interest was the composite of death, myocardial infarction (MI) or target-lesion revascularisation (TLR) at 1year. Multivariate analysis was performed to adjust for differences in baseline characteristics between groups. RESULTS: In total, 264 patients were treated with BTHC-PCB (n=127) or iopromide-PCB (n=137). Baseline patient characteristics were similar for both groups. Post-procedure stenosis was slightly larger with BTHC-PCB (22.3 [SD 8.2]% vs. 18.4 [SD 9.9]%, P=0.001). At 6-8month angiography, diameter stenosis was 40.4 [SD 21.9]% vs. 37.4 [SD 21.4]% in the BTHC-PCB and iopromide-PCB groups, respectively (P=0.16, Padjusted=0.32). At 1year, death, MI or TLR occurred in 29 (23.2%) vs. 32 (23.4%) patients in the BTHC-PCB and iopromide-PCB groups, respectively (HR 1.03 [95% CI 0.62-1.70], P=0.91, Padjusted=0.96). CONCLUSIONS: In patients undergoing intervention for ISR, angioplasty with BTHC-PCB showed similar angiographic and clinical results at 1year compared with iopromide-PCB.