AIM: To study effects of ivabradin on clinicohemodynamic and prognostic parameters in patients after myocardial infarction (MI) with systolic chronic cardiac failure (SCCF). MATERIAL AND METHODS: A population-based randomized prospective trial enrolled 49 patients (40 males--81.6%, mean age 63.1 +/- 8.1 years) with sinus rhythm and a longer than 3 month history of MI. The patients were randomized into 2 groups: 23 patients of group 1 received standard treatment plus ivabradin, 26 patients of group 2 receivedstandard treatment alone. Follow-up was 36.1 +/- 6.2 months. We analysed the trend in heart rate (HR), blood pressure (BP), parameters of echocardiography, ECG, levels of electrolytes, creatinin in blood plasma, frequency of hospitalizations, recurrent non-fatal MI and lethality (combined endpoint). RESULTS: In the end of the trial ivabradin significantly decreased HR from 71 to 64 b/m. Frequency of combined end point of efficacy was 30.4 and 50% in group 1 and 2, respectively. In group 1 primary end point in high baseline HR occurred more frequently than in HR < 70 b/m in 6 (50%) and 1 (9.1%) cases, respectively, but these differences were not significant (p = 0.068). In group 2 the differences were significant--9 (90%) and 4 (25%) cases, respectively (p = 0.004). By none of the parameters of ECG, plasma electrolytes, creatinine level significant intergroup differences were found. CONCLUSION: In the same trend in BP and ECG, group 1 patients showed significant and more pronounced HR lowering than group 2 patients. Addition of ivabradin to standard treatment of SCCF after MI promoted less frequency of hospitalizations, recurrent non-fatal MI, fatal cardiovascular events. This effect was especially strong in high baseline HR.
RCT Entities:
AIM: To study effects of ivabradin on clinicohemodynamic and prognostic parameters in patients after myocardial infarction (MI) with systolic chronic cardiac failure (SCCF). MATERIAL AND METHODS: A population-based randomized prospective trial enrolled 49 patients (40 males--81.6%, mean age 63.1 +/- 8.1 years) with sinus rhythm and a longer than 3 month history of MI. The patients were randomized into 2 groups: 23 patients of group 1 received standard treatment plus ivabradin, 26 patients of group 2 received standard treatment alone. Follow-up was 36.1 +/- 6.2 months. We analysed the trend in heart rate (HR), blood pressure (BP), parameters of echocardiography, ECG, levels of electrolytes, creatinin in blood plasma, frequency of hospitalizations, recurrent non-fatal MI and lethality (combined endpoint). RESULTS: In the end of the trial ivabradin significantly decreased HR from 71 to 64 b/m. Frequency of combined end point of efficacy was 30.4 and 50% in group 1 and 2, respectively. In group 1 primary end point in high baseline HR occurred more frequently than in HR < 70 b/m in 6 (50%) and 1 (9.1%) cases, respectively, but these differences were not significant (p = 0.068). In group 2 the differences were significant--9 (90%) and 4 (25%) cases, respectively (p = 0.004). By none of the parameters of ECG, plasma electrolytes, creatinine level significant intergroup differences were found. CONCLUSION: In the same trend in BP and ECG, group 1 patients showed significant and more pronounced HR lowering than group 2 patients. Addition of ivabradin to standard treatment of SCCF after MI promoted less frequency of hospitalizations, recurrent non-fatal MI, fatal cardiovascular events. This effect was especially strong in high baseline HR.
Authors: Mathias Maagaard; Emil Eik Nielsen; Naqash Javaid Sethi; Ning Liang; Si-Hong Yang; Christian Gluud; Janus Christian Jakobsen Journal: BMJ Evid Based Med Date: 2021-11-17