Economic Burden Associated with the Treatment with a Cardiovascular Polypill in Secondary Prevention in Spain: Cost-Effectiveness Results of the NEPTUNO Study

Alberto Cordero,1,2 Regina Dalmau González-Gallarza,3 Lluis Masana,4– 6 Valentín Fuster,7,8 Jose Mª Castellano,7,9,10 José Emilio Ruiz Olivar,11 Ilonka Zsolt,11 Antoni Sicras-Mainar,12 Jose Ramón González Juanatey2,13,14 1Cardiology Service, San Juan University Hospital, Alicante, Spain; 2Cardiovascular Diseases Network Research Center (CIBERCV), Madrid, Spain; 3Cardiology Service, La Paz University Hospital, Madrid, Spain; 4Sant Joan University Hospital, Vascular Medicine and Metabolism Unit, Reus, Spain; 5Pere Virgili Institute of Health Research (IISPV), Reus, Spain; 6Center for Biomedical Research Network on Diabetes and Associated Metabolic Diseases (CIBERDEM), Reus, Spain; 7National Center for Cardiovascular Research (CNIC), Carlos III Health Institute, Madrid, Spain; 8Mount Sinai Medical Center, New York, NY, USA; 9Integral Center for Cardiovascular Diseases (CIEC), Montepríncipe University Hospital, HM Hospitales Group, Madrid, Spain; 10School of Medicine, CEU San Pablo University, Madrid, Spain; 11Corporate Medical Affairs, Ferrer, Barcelona, Spain; 12Health Economics and Outcomes Research Department, Atrys Health, Madrid, Spain; 13Cardiology Service, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain; 14Santiago de Compostela Health Research Institute (IDIS), Santiago de Compostela, SpainCorrespondence: Antoni Sicras-Mainar, Atrys Health SA, Calle Príncipe de Vergara, 132, planta 1, Madrid, 28002, Spain, Tel +34 917 819 465, Fax +34 915 776 744, Email [email protected]: The aim of this study was to estimate health-care resources utilization, costs and cost-effectiveness associated with the treatment with CNIC-Polypill as secondary prevention of atherosclerotic cardiovascular disease (ASCVD) compared to other treatments, in clinical practice in Spain.Patients and Methods: An observational, retrospective study was performed using medical records (economic results [healthcare perspective], NEPTUNO-study; BIG-PAC-database) of patients who initiated secondary prevention between 2015 and 2018. Patients were followed up to 2 years (maximum). Four cohorts were balanced with a propensity-score-matching (PSM): 1) CNIC-Polypill (aspirin+atorvastatin+ramipril), 2) Monocomponents (same separate drugs), 3) Equipotent (equipotent drugs) and 4) Other therapies ([OT], other cardiovascular drugs). Incidence of cardiovascular events, health-care resources utilization and healthcare and non-healthcare costs (2020 Euros) were compared. Incremental cost-effectiveness ratios per cardiovascular event avoided were estimated.Results: After PSM, 1614 patients were recruited in each study cohort. The accumulated incidence of cardiovascular events during the 24-month follow-up was lower in the CNIC-Polypill cohort vs the other cohorts (19.8% vs Monocomponents: 23.3%, Equipotent: 25.5% and OT: 26.8%; p< 0.01). During the follow-up period, the CNIC-Polypill cohort also reduced the health-care resources utilization per patient compared to the other cohorts, particularly primary care visits (16.6 vs Monocomponents: 18.7, Equipotent: 18.9 and OT: 21.0; p< 0.001) and hospitalization days (2.3 vs Monocomponents: 3.4, Equipotent: 3.7 and OT: 4.0; p< 0.001). The treatment cost in the CNIC-Polypill cohort was lower than that in the other cohorts (€ 4668 vs Monocomponents: € 5587; Equipotent: € 5682 and OT: € 6016; p< 0.001) (Difference: -€ 919, -€ 1014 and -€ 1348, respectively). Due to the reduction of cardiovascular events and costs, the CNIC-Polypill is a dominant alternative compared to the other treatments.Conclusion: CNIC-Polypill reduces recurrent major cardiovascular events and costs, being a cost-saving strategy as secondary prevention of ASCVD.Keywords: secondary prevention, cardiovascular events, use of healthcare resources, healthcare costs, Spain, CNIC-polypil

Factibilidad y resultados de un programa de rehabilitación cardiaca intensiva. Perspectiva del estudio aleatorizado MxM (Más por Menos)

Introducción y objetivos Los programas de rehabilitación cardiaca (PRC) engloban intervenciones encaminadas a mejorar el pronóstico de la enfermedad cardiovascular influyendo en la condición física, mental y social de los pacientes, pero no se conoce su duración óptima. Nuestro objetivo es comparar los resultados de un PRC estándar frente a otro intensivo más breve tras un síndrome coronario agudo, mediante el estudio Más por Menos. Métodos Diseño prospectivo, aleatorizado, abierto, enmascarado a los evaluadores de eventos y multicéntrico (PROBE). Se aleatorizó a los pacientes al PRC estándar de 8 semanas u otro intensivo de 2 semanas con sesiones de refuerzo. Se realizó una visita final 12 meses después, tras la finalización del programa. Se evaluó: adherencia a la dieta, esfera psicológica, hábito tabáquico, tratamiento farmacológico, capacidad funcional, calidad de vida, parámetros cardiometabólicos y antropométricos, eventos cardiovasculares y mortalidad por cualquier causa durante el seguimiento. Resultados Se analizó a 497 pacientes (media de edad, 57, 8 ± 10, 0 años; el 87, 3% varones; programa intensivo, n = 262; estándar, n = 235). Las características basales de ambos grupos eran similares. Al año, más del 93% había mejorado en al menos 1 MET el resultado de la ergometría. Además, la adherencia a la dieta mediterránea y la calidad de vida mejoraron significativamente con el PRC, sin diferencias significativas entre grupos. Los eventos cardiovasculares ocurrieron de manera similar en ambos grupos. Conclusiones La PRC intensiva podría ser tan efectiva como la PRC estándar en lograr la adherencia a las medidas de prevención secundaria y ser una alternativa para algunos pacientes y centros. Introduction and objectives: Cardiac rehabilitation programs (CRP) are a set of interventions to improve the prognosis of cardiovascular disease by influencing patients’ physical, mental, and social conditions. However, there are no studies evaluating the optimal duration of these programs. We aimed to compare the results of a standard vs a brief intensive CRP in patients after ST-segment elevation and non–ST-segment elevation acute coronary syndrome through the Más por Menos study (More Intensive Cardiac Rehabilitation Programs in Less Time). Methods: In this prospective, randomized, open, evaluator-blind for end-point, and multicenter trial (PROBE design), patients were randomly allocated to either standard 8-week CRP or intensive 2-week CRP with booster sessions. A final visit was performed 12 months later, after completion of the program. We assessed adherence to the Mediterranean diet, psychological status, smoking, drug therapy, functional capacity, quality of life, cardiometabolic and anthropometric parameters, cardiovascular events, and all-cause mortality during follow-up. Results: A total of 497 patients (mean age, 57.8 ± 10.0 years; 87.3% men) were finally assessed (intensive: n = 262; standard: n = 235). Baseline characteristics were similar between the 2 groups. At 12 months, the results of treadmill ergometry improved by = 1 MET in = 93% of the patients. In addition, adherence to the Mediterranean diet and quality of life were significantly improved by CRP, with no significant differences between the groups. The occurrence of cardiovascular events was similar in the 2 groups. Conclusions: Intensive CRP could be as effective as standard CRP in achieving adherence to recommended secondary prevention measures after acute coronary syndrome and could be an alternative for some patients and centers. Registered at ClinicalTrials.gov (Identifier: NCT02619422)