Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): two randomised trials
Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): two randomised trials
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DOI：
10.1016/s0140-6736(07)61634-1
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发表时间：
2007-10-01
期刊：
影响因子：
168.9
通讯作者：
Kitamura, Soichiro
中科院分区：
文献类型：
--
作者：
Kitakaze, Masafumi;Asakura, Masanori;Kitamura, Soichiro
背景急性心肌梗死患者仍是心血管事件的主要危险因素。我们的目的是评估无论是人心钠素或尼可地尔对梗死面积和心血管outcome.Methods的影响，我们招募了1216例急性心肌梗死，并正在接受再灌注治疗的两个前瞻性，单盲试验在日本65家医院。我们将277例患者随机分配接受静脉注射心房利钠肽（0 - 025 μ g/kg/min，持续3天），292例患者接受相同剂量的安慰剂。276例患者被分配接受尼可地尔静脉给药（0-067 mg/kg推注，随后以1.67 μ g/kg/min持续输注24小时），269例患者接受相同剂量的安慰剂。心房利钠肽试验中患者的中位随访时间为2.7（IQR 1 - 5-3 - 6）年，尼可地尔试验中患者的中位随访时间为2.5（1.5-3.7）年。主要终点是梗死面积（估计从肌酸激酶）和左心室射血分数（测量左心室血管造影）。结果43例患者随机后撤回同意，59例没有急性心肌梗死。我们没有评估50例血液样本少于6份的患者的梗死面积。383例患者未行左心室造影。给予心房利钠肽的患者总肌酸激酶为66459.9 IU/mL/h，对照组为77878.9 IU/mL/h，两组之间的比值为0.85（95% CI 0.75-0.97，p=0.016），表明梗死面积减少14.7%（95% CI 3.0-24.9%）。心钠素组6-12个月时左心室射血分数增加（比值1.05，95% CI 1.01-1.10 p=0.024）。尼可地尔组患者（70 520.5 IU/mL/h）和Q对照组患者（70 852.7 IU/mL/h）的肌酸激酶总活性无差异（比值0 - 995，95% CI 0 - 878-1.138，p=0.94）。静脉注射尼可地尔不影响左心室射血分数的大小，尽管在随访期间口服尼可地尔增加了慢性期和急性期之间的左心室射血分数。心房利钠肽组中有29名患者出现严重低血压，而相应的安慰剂组中只有1名患者出现严重低血压。我们认为，心钠素是一种安全有效的急性心肌梗死患者经皮冠状动脉介入治疗的后续治疗。
Background Patients who have acute myocardial infarction remain at major risk of cardiovascular events. We aimed to assess the effects of either human atrial natriuretic peptide or nicorandil on infarct size and cardiovascular outcome.Methods We enrolled 1216 patients who had acute myocardial infarction and were undergoing reperfusion treatment in two prospective, single-blind trials at 65 hospitals in Japan. We randomly assigned 277 patients to receive intravenous atrial natriuretic: peptide (0 - 025 mu g/kg per min for 3 days) and 292 the same dose of placebo. 276 patients were assigned to receive intravenous nicorandil (0-067 mg/kg as a bolus, followed by 1.67 mu g/kg per min as a 24-h continuous infusion), and 269 the same dose of placebo. Median follow-up was 2.7 (IQR 1 - 5-3 - 6) years for patients in the atrial natriuretic peptide trial and 2.5 (1.5-3.7) years for those in the nicorandil trial. Primary endpoints were infarct size (estimated from creatine kinase) and left ventricular ejection fraction (gauged by angiography of the left ventricle).Findings 43 patients withdrew consent after randomisation, and 59 did not have acute myocardial infarction. We did not assess infarct size in 50 patients for whom we had fewer than six samples of blood. We did not have angiographs of left ventricles in 383 patients. Total creatine kinase was 66459.9 IU/mL per h in patients given atrial natriuretic peptide, compared with 77878.9 IU/mL per h in controls, with a ratio of 0.85 between these groups (95% CI 0.75-0.97, p=0.016), which indicated a reduction of 14.7% in infarct size (95% CI 3.0-24.9%). The left ventricular ejection fraction at 6-12 months increased in the atrial natriuretic peptide group (ratio 1.05, 95% Cl 1.01-1.10 p=0.024). Total activity of creatine kinase did not differ between patients given nicorandil (70 520.5 IU/mL per h) Q controls (70 852.7 IU/mL per h) (ratio 0 - 995, 95% CI 0 - 878-1.138, p=0.94). Intravenous nicorandil did not affect the size of the left ventricular ejection fraction, although oral administration of nicorandil during follow-up increased the left ventricular ejection fraction between the chronic and acute phases. 29 patients in the atrial natriuretic: peptide group had severe hypotension, compared with one in the corresponding placebo group.Interpretation Patients with acute myocardial infarction who were given atrial natriuretic peptide had lower infarct size, fewer reperfusion injuries, and better outcomes than controls. We believe that atrial natriuretic: peptide could be a safe and effective adjunctive treatment in patients with acute myocardial infarction who receive percutaneous coronary intervention.