Babushkina G V, Shaikhlislamova G I
Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation, Ufa.
State Budgetary Institution of Health Care of the Republic of Bashkortostan City Clinical Hospital №13, Ufa.
Kardiologiia. 2020 Oct 10;60(10):33-37. doi: 10.18087/cardio.2020.10.n1324.
Aim To evaluate the effect of combination ivabradine-containing therapy for chronic heart failure (CHF) with preserved ejection fraction on quality of life (QoL) and the primary composite endpoint during a one-year follow-up.Material and methods This study included 160 patients aged 45 to 65 years with NYHA functional class (FC) II-III CHF with preserved left ventricular ejection fraction (CHF-PEF) and grade I and II diastolic dysfunction associated with FC III stable angina with sinus rhythm and a heart rate (HR) higher than 70 bpm. Presence of CHF-PEF was confirmed by results of echocardiography and myocardial tissue Doppler imaging. During one year of prospective observation, effects of bisoprolol and ivabradine as a part of the combination therapy on the primary composite endpoint, including death from cardiovascular complications (CVC) and hospitalizations for myocardial infarction (MI) or CHF, were evaluated in patients with CHF-PEF. Patients were randomized to three groups: A, bisoprolol with dose titration from 2.5 to 10 mg; В, combination of bisoprolol 2.5-10 mg and ivabradine 10-15 mg/day; and С, ivabradine 10-15 mg/day. All patients were on a chronic background therapy, including angiotensin-converting enzyme inhibitors (lisinopril) or, if not tolerated, angiotensin II receptor blockers (valsartan), antiaggregants, statins (atorvastatin, rosuvastatin), and short-acting nitrates as required. If edema developed diuretics were added. The follow-up duration was one year.Results After 12 weeks of follow-up, the achievement of goal HR in group A was associated with a tendency to increased distance in the 6-min walk test from 279±19 to 341±21 m (р>0,05); in group B the distance increased from 243±25 to 319±29 m (р<0.05); and in group C the distance increased from 268±21 to 323±22 m (р<0.05). In the combination ivabradine and bisoprolol treatment group, results of the 24-h electrocardiogram monitoring showed a more pronounced anti-ischemic effect associated with a decrease in the number of myocardial ischemic episodes (p<0.05). QoL was evaluated with the Minnesota questionnaire against the background of treatment. At 12 weeks of observation, the total score decreased from 44.5±2.6 to 38.4±2.1 in group A; from 45±2.9 to 38±2.2 in group B; and from 50.9±3.2 to 42.7±2.8 in group C (р<0.05). The risk of acute MI and repeated hospitalization for CHF during the year of observation, as evaluated according to the Kaplan-Meier method, decreased in both bisoprolol and ivabradine combination treatment groups.Conclusion The inclusion of bisoprolol and ivabradine into the background therapy of CHF-PEF patients with stable IHD provided an improvement of QoL and a decrease in the risk of hospitalization for acute MI and CHF during the year of observation.
目的 评估含伊伐布雷定的联合治疗对射血分数保留的慢性心力衰竭(CHF)患者生活质量(QoL)及一年随访期间主要复合终点的影响。
材料与方法 本研究纳入160例年龄在45至65岁之间、纽约心脏协会(NYHA)心功能分级(FC)为II - III级、左心室射血分数保留(CHF-PEF)、I级和II级舒张功能障碍、伴有FC III级稳定型心绞痛、窦性心律且心率(HR)高于70次/分的患者。通过超声心动图和心肌组织多普勒成像结果确认CHF-PEF的存在。在一年的前瞻性观察期间,评估比索洛尔和伊伐布雷定作为联合治疗一部分对CHF-PEF患者主要复合终点的影响,主要复合终点包括心血管并发症(CVC)导致的死亡、心肌梗死(MI)或CHF住院。患者被随机分为三组:A组,比索洛尔剂量从2.5毫克滴定至10毫克;B组,比索洛尔2.5 - 10毫克与伊伐布雷定10 - 15毫克/天联合;C组,伊伐布雷定10 - 15毫克/天。所有患者均接受慢性基础治疗,包括血管紧张素转换酶抑制剂(赖诺普利),若不耐受则使用血管紧张素II受体阻滞剂(缬沙坦)、抗血小板药物、他汀类药物(阿托伐他汀、瑞舒伐他汀)以及根据需要使用短效硝酸盐类药物。若出现水肿则加用利尿剂。随访期为一年。
结果 随访12周后,A组达到目标心率与6分钟步行试验距离有增加趋势相关,从279±19米增至341±21米(p>0.05);B组距离从243±25米增至319±29米(p<0.05);C组距离从268±21米增至323±22米(p<0.05)。在伊伐布雷定与比索洛尔联合治疗组,24小时心电图监测结果显示抗缺血作用更显著,心肌缺血发作次数减少(p<0.05)。在治疗背景下用明尼苏达问卷评估生活质量。观察12周时,A组总分从44.5±2.6降至38.4±2.1;B组从45±2.9降至38±2.2;C组从50.9±3.2降至42.7±2.8(p<0.05)。根据Kaplan-Meier法评估,在观察的一年中,比索洛尔和伊伐布雷定联合治疗组急性心肌梗死风险及CHF再次住院风险均降低。
结论 将比索洛尔和伊伐布雷定纳入稳定性缺血性心脏病的CHF-PEF患者的基础治疗中,在观察的一年中可改善生活质量,并降低急性心肌梗死和CHF住院风险。