Angina e isquemia a los 2 años con armazón vascular bioabsorbible y stents farmacoactivos metálicos. Estudio ESTROFA Isquemia AVB-SFAm / Angina and ischemia at 2 years with bioresorbable vascular scaffolds and metallic drug-eluting stents. ESTROFA Ischemia BVS-mDES study

Introducción y objetivos: Los armazones vasculares bioabsorbibles (AVB) tienen el potencial de restaurar la vasomotilidad, pero se desconocen las implicaciones clínicas. En este estudio se evalúan la angina y la isquemia a largo plazo tras el implante de AVB y stents farmacoactivos metálicos (SFAm). Métodos: Estudio multicéntrico, que incluyó a pacientes tras 24 ± 6 meses de evolución sin eventos a los que se realizó ecografía de estrés y se aplicó el Seattle Angina Questionnaire (SAQ). El objetivo primario fue el resultado positivo en la ecografía de estrés. Resultados: Se incluyó a 102 pacientes tratados con AVB y 106 con SFAm, sin diferencias basales significativas. Se produjo recurrencia de la angina en 18 pacientes (17,6%) con AVB frente a 25 (23,5%) con SFAm (p = 0,37), pero los resultados del SAQ fueron significativamente mejores en el grupo AVB (frecuencia de angina, 96.0 ± 8.0 frente a 89,2 ± 29,7; p = 0,02). La ecografía de estrés fue positiva en 11/92 (11,9%) con AVB frente a 9/96 (9,4%) con SFAm (p = 0,71) y se indujo angina en 2/102 (1,9%) frente a 7/106 (6,6%) (p = 0,18), pero el desempeño en el ejercicio fue mejor con AVB incluso en aquellos con tests positivos (duración del ejercicio, 9,0 ± 2,0 frente a 7,7 ± 1,8 min; p = 0,02). Un análisis por puntuación de propensión de tratamiento ofreció resultados similares. Conclusiones: El objetivo primario fue comparable en ambos grupos. La recurrencia de la angina fue similar entre los tratados con AVB y con SFAm. El mejor estado funcional, medido por SAQ y nivel de ejercicio, detectado en pacientes con AVB tendría que confirmarse en futuros estudios

Introduction and objectives: Bioresorbable vascular scaffolds (BVS) have the potential to restore vasomotion but the clinical implications are unknown. We sought to evaluate angina and ischemia in the long-term in patients treated with BVS and metallic drug-eluting stents (mDES). Methods: Multicenter study including patients with 24 ± 6 months of uneventful follow-up, in which stress echocardiography was performed and functional status was assessed by the Seattle Angina Questionnaire (SAQ). The primary endpoint was a positive result in stress echocardiography. Results: The study included 102 patients treated with BVS and 106 with mDES. There were no differences in the patients' baseline characteristics. Recurrent angina was found in 18 patients (17.6%) in the BVS group vs 25 (23.5%) in the mDES group (P = .37), but SAQ results were significantly better in the BVS group (angina frequency 96.0 ± 8.0 vs 89.2 ± 29.7; P = .02). Stress echocardiography was positive in 11/92 (11.9%) of BVS patients vs 9/96 (9.4%) of mDES patients in the (P = .71) and angina was induced in 2/102 (1.9%) vs 7/106 (6.6%) (P = .18), respectively, but exercise performance was better in the BVS group even in those with positive tests (exercise duration 9.0 ± 2.0 minutes vs 7.7 ± 1.8 minutes; P = .02). A propensity score matching analysis yielded similar results. Conclusions: The primary endpoint was similar in both groups. In addition, recurrent angina was similar in patients with BVS and mDES. The better functional status, assessed by means of SAQ and exercise performance, detected in patients receiving BVS should be confirmed in further studies

Angina and Ischemia at 2 Years With Bioresorbable Vascular Scaffolds and Metallic Drug-eluting Stents. ESTROFA Ischemia BVS-mDES Study.

INTRODUCTION AND OBJECTIVES: Bioresorbable vascular scaffolds (BVS) have the potential to restore vasomotion but the clinical implications are unknown. We sought to evaluate angina and ischemia in the long-term in patients treated with BVS and metallic drug-eluting stents (mDES). METHODS: Multicenter study including patients with 24 ± 6 months of uneventful follow-up, in which stress echocardiography was performed and functional status was assessed by the Seattle Angina Questionnaire (SAQ). The primary endpoint was a positive result in stress echocardiography. RESULTS: The study included 102 patients treated with BVS and 106 with mDES. There were no differences in the patients' baseline characteristics. Recurrent angina was found in 18 patients (17.6%) in the BVS group vs 25 (23.5%) in the mDES group (P = .37), but SAQ results were significantly better in the BVS group (angina frequency 96.0 ± 8.0 vs 89.2 ± 29.7; P = .02). Stress echocardiography was positive in 11/92 (11.9%) of BVS patients vs 9/96 (9.4%) of mDES patients in the (P = .71) and angina was induced in 2/102 (1.9%) vs 7/106 (6.6%) (P = .18), respectively, but exercise performance was better in the BVS group even in those with positive tests (exercise duration 9.0 ± 2.0minutes vs 7.7 ± 1.8minutes; P = .02). A propensity score matching analysis yielded similar results. CONCLUSIONS: The primary endpoint was similar in both groups. In addition, recurrent angina was similar in patients with BVS and mDES. The better functional status, assessed by means of SAQ and exercise performance, detected in patients receiving BVS should be confirmed in further studies.

Percutaneous intervention in chronic total coronary occlusions caused by in-stent restenosis: procedural results and long-term clinical outcomes in the TORO (Spanish registry of chronic TOtal occlusion secondary to an occlusive in-stent RestenOsis) multicentre registry.

AIMS: Limited data exist on the treatment and outcomes of patients with chronic total occlusions due to in-stent restenosis (CTO-ISR). We sought to evaluate results and clinical outcomes in percutaneous interventions over CTO-ISR. METHODS AND RESULTS: We conducted a registry in 16 centres involving consecutive patients undergoing attempted percutaneous intervention over CTO-ISR. A total of 233 patients were included, 192 (82.4%) with a successful acute result. The success rate was significantly lower in patients with: lesion in the circumflex artery, ostial lesions, J score >3 and no femoral access. The presence of tandem lesions (OR 0.19, 95% CI: 0.06-0.68; p=0.01) was identified as an independent predictor for outcome. After a median follow-up of 20 months, cardiac death in the successful vs. failed groups was 3% and 8.3%, respectively (p=0.09). Independent predictors for mortality were previous CABG (HR 8, 95% CI: 1.3-50; p=0.02) and multivessel disease (HR 2.3, 95% CI: 1.2-4.3; p=0.01). In the successful group, TLR was 15%, re-occlusion 6% and definite/probable stent thrombosis 1.8%. CONCLUSIONS: Percutaneous treatment of CTO due to ISR in contemporary practice shows a high success rate, resulting in good long-term results. The angiographic and procedural predictors identified may contribute to improving procedural outcome through better patient selection.

Terapia antiplaquetaria doble de 6 o de 12 meses tras implante de stents farmacoactivos de nueva generación: análisis emparejado de los registros ESTROFA-DAPT y ESTROFA-2 / Dual antiplatelet therapy for 6 months vs 12 months after new-generation drug-eluting stent implantation: matched analysis of ESTROFA-DAPT and ESTROFA-2

Introducción y objetivos: El periodo de uso recomendado del tratamiento antiagregante plaquetario combinado doble tras implante de stents farmacoactivos va de los 6 a los 12 meses o más. Ensayos recientes indican que es seguro utilizar un tratamiento antiagregante plaquetario combinado doble durante 6 meses, si bien ciertas limitaciones de estos estudios hacen que sea escasa la aplicabilidad de esta estrategia de tratamiento antiagregante plaquetario combinado doble de menor duración en la práctica clínica real. Métodos: Se puso en marcha un registro con la inscripción de pacientes consecutivos a los que se había implantado stent farmacoactivo de nueva generación seguido de una prescripción de 6 meses de tratamiento antiagregante plaquetario combinado doble. Se realizó una igualación por puntuación de propensión con una cohorte histórica de pacientes tratados con stentsfarmacoactivos de segunda generación que recibieron luego 12 meses de tratamiento antiagregante plaquetario combinado doble del registro ESTROFA-2. El tamaño muestral se calculó para el criterio de no inferioridad y el objetivo principal fue la combinación de muerte cardiaca, infarto de miocardio, revascularización o hemorragia mayor a los 12 meses. Resultados: Se incluyó en el análisis a 1.286 pacientes de cada grupo, que no presentaban diferencias significativas en sus características basales. Se produjeron episodios del objetivo principal en el 5,0 y el 6,6% de los pacientes en los grupos de 6 y de 12 meses respectivamente (p = 0,001 para no inferioridad). La incidencia de trombosis del stent definitiva o probable fue del 0,5 y el 0,7% en los grupos de tratamiento de 6 y 12 meses respectivamente (p = 0,4). Los episodios de hemorragia mayor fueron menos en el grupo de 6 meses que en el de 12 (el 0,8 y el 1,4%; p = 0,2). Conclusiones: En pacientes seleccionados de este amplio estudio multicéntrico, la seguridad y la eficacia de 6 meses de tratamiento antiagregante plaquetario combinado doble después del implante de stents farmacoactivos de nueva generación fueron no inferiores a las observadas con 12 meses de tratamiento antiagregante plaquetario combinado doble (AU)

Introduction and objectives: The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings. Methods: A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months. Results: The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively (P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively (P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) Conclusions: In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen (AU)

Dual Antiplatelet Therapy for 6 Months vs 12 Months After New-generation Drug-eluting Stent Implantation: Matched Analysis of ESTROFA-DAPT and ESTROFA-2.

INTRODUCTION AND OBJECTIVES: The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings. METHODS: A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months. RESULTS: The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively (P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively (P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) CONCLUSIONS: In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen.