SISANews

Rosuvastatina e scompenso cardiaco. Una rivisitazione dello studio CORONA

Lo studio CORONA era stato lanciato per valutare l'effetto di rosuvastatina su morte cardiovascolare, infarto e ictus in pazienti con scompenso cardiaco cronico su base ischemica e ridotta frazione di eiezione. I risultati non sono stati quelli sperati, ma nemmeno del tutto negativi secondo la Rogers e coll. che, analizzando retrospettivamente quanto raccolto durante lo studio, dimostrano che il trattamento con rosuvastatina di pazienti con scompenso cardiaco di origine ischemica ha avuto comunque un effetto positivo in quanto ha ridotto del 15-20% l'ospedalizzazione per scompenso che, in termini assoluti equivaleva a 76 ricoveri in meno ogni 1.000 pazienti trattati per un periodo mediano di 33 mesi. Dato che lo scompenso cardiaco è una delle più frequenti o, secondo alcune statistiche, la più frequente causa di ricovero ospedaliero nella popolazione adulta, l'analisi dello studio CORONA apre interessanti prospettive cliniche. Quanto al perché la rosuvastatina ridurrebbe gli episodi di scompenso acuto o rallenterebbe l'evoluzione dello scompenso verso il peggioramento, al momento ci sono solo ipotesi basate sugli effetti pleiotropici delle statine, in particolare, quelli antiinfiammatori.

Effect of rosuvastatin on repeat heart failure hospitalizations: the CORONA Trial (Controlled Rosuvastatin Multinational Trial in Heart Failure)

Rogers JK, Jhund PS, Perez AC, Böhm M, Cleland JG, Gullestad L, Kjekshus J, van Veldhuisen DJ, Wikstrand J, Wedel H, McMurray JJ, Pocock SJ

JACC Heart Fail 2014;2:289-97

OBJECTIVES: This study sought to examine the effect of statin therapy hospitalizations for heart failure (HFH) in patients in the CORONA (Controlled Rosuvastatin Multinational Trial in Heart Failure) trial.
BACKGROUND: HFH is an important, frequently recurrent event. Conventional time-to-first event analyses do not take account repeat events. We used a number of statistical approaches to examine the effect of treatment on first and repeat HFH in the CORONA trial.
METHODS: In the CORONA trial, 5,011 patients =60 years of age with chronic New York Heart Association functional classes II to IV systolic heart failure resulting from ischemia were randomized to receive rosuvastatin or placebo. Poisson, Andersen-Gill, and negative binomial methods (NB) were used to analyze the effect of rosuvastatin on HFH, and the NB and a parametric joint frailty model (JF) were used to examine this effect while accounting for the competing risk of cardiovascular (CV) death. Rosuvastatin/placebo rate ratios were calculated, both unadjusted and adjusted.
RESULTS: A total of 1,291 patients had 1 or more HFH (750 of these had a single HFH only), and there were a total of 2,408 HFHs. The hazard ratio for the conventional time-to-first event analysis for HFH was 0.91 (95% confidence interval [CI]: 0.82 to 1.02, p = 0.105). In contrast, the NB on repeat hospitalizations gave an unadjusted RR (RR) for HFH of 0.86 (95% CI: 0.75 to 0.99, p = 0.030), adjusted 0.82 (95% CI: 0.72 to 0.92, p = 0.001), and after including CV death as the last event, adjusted RR of 0.85 (95% CI: 0.77 to 0.94, p = 0.001). The JF gave an adjusted RR of 0.82 (95% CI: 0.73 to 0.92, p = 0.001). Similar results were found in analyses of all CV hospitalizations and all-cause hospitalizations.
CONCLUSIONS: When repeat events were included, rosuvastatin was shown to reduce the risk of HFH by approximately 15% to 20%, equating to approximately 76 fewer admissions per 1,000 patients treated over a median 33 months of follow-up. Including repeat events could increase the ability to detect treatment effects in heart failure trials.

JACC Heart Fail 2014;2:289-97