Anand Inder S, Win Sithu, Rector Thomas S, Cohn Jay N, Taylor Anne L
From the Medicine Service Line (I.S.A., S.W., J.N.C., A.L.T.) and Research Service Line (T.S.R.), VA Medical Center, Minneapolis, MN (I.S.A., T.S.R.); Department of Medicine, University of Minnesota, Minneapolis (I.S.A., S.W., T.S.R., J.N.C.); and Department of Medicine, Columbia University Medical Center, College of Physicians and Surgeons, New York, NY (A.L.T.).
Circ Heart Fail. 2014 Sep;7(5):759-65. doi: 10.1161/CIRCHEARTFAILURE.114.001360. Epub 2014 Jun 26.
Fixed-dose combination of isosorbide dinitrate and hydralazine (FDC-I/H) reduced mortality by 43% and death or first hospitalization for heart failure (HF) by 37% in the African-American Heart Failure Trial (A-HeFT). Reduction in mortality makes it difficult to determine the effect on hospitalizations unless the analysis adjusts for death as a competing risk.
In A-HeFT, 1050 self-identified black patients with moderate to severe HF were randomized to FDC-I/H or placebo. The effects of FDC-I/H on first and all hospitalizations and 30-day readmission rates were analyzed. Deaths as competing risks were adjusted using Fine-Gray regression and joint models of hospitalizations and mortality. There were 558 all-cause and 251 HF hospitalizations in placebo compared with 435 and 173 hospitalizations in the FDC-I/H group. Adjusting for deaths as a competing risk, the effect of FDC-I/H on the first hospitalization for HF, expressed in hazard ratio (95% confidence interval), was 0.61 (0.47-0.80; P<0.001) and 0.88 (0.72-1.06; P=0.18) on the first all-cause hospitalization. The effect of FDC-I/H on all recurrent hospitalizations for HF was 0.66 (0.52-0.83; P=0.0005), similar to the effect on the first hospitalizations for HF, whereas the effect on all hospitalizations for any cause was 0.75 (0.63-0.91; P=0.003). The 30-day all-cause readmission rate after the first hospitalization for HF was 23.6% (29 of 123) in placebo versus 14.8% (12 of 81) in the FDC-I/H group, but the effect (0.59; 0.30-1.16; P=0.12) in this small subgroup was not significant.
Treatment with FDC-I/H was associated with a substantial reduction in the first and recurrent HF hospitalizations, and in total all-cause hospitalizations, reducing the total burden of costly and distressing hospitalizations.
http://www.clinicaltrials.gov. Unique identifier: NCT00047775.
在非裔美国人心力衰竭试验（A-HeFT）中，固定剂量复方硝酸异山梨酯和肼屈嗪（FDC-I/H）使死亡率降低了43%，因心力衰竭（HF）导致的死亡或首次住院率降低了37%。死亡率的降低使得难以确定其对住院率的影响，除非分析将死亡作为竞争风险进行调整。
在A-HeFT中，1050名自我认定为患有中度至重度HF的黑人患者被随机分为FDC-I/H组或安慰剂组。分析了FDC-I/H对首次和所有住院治疗以及30天再入院率的影响。使用Fine-Gray回归以及住院治疗和死亡率的联合模型对作为竞争风险的死亡进行了调整。安慰剂组有558例全因住院和251例HF住院，而FDC-I/H组分别有435例和173例住院。将死亡作为竞争风险进行调整后，FDC-I/H对首次HF住院的影响，以风险比（95%置信区间）表示为0.61（0.47 - 0.80；P<0.001），对首次全因住院的影响为0.88（0.72 - 1.06；P = 0.18）。FDC-I/H对所有复发性HF住院的影响为0.66（0.52 - 0.83；P = 0.0005），与对首次HF住院的影响相似，而对任何原因的所有住院的影响为0.75（0.63 - 0.91；P = 0.003）。首次HF住院后30天的全因再入院率在安慰剂组为23.6%（123例中的29例），在FDC-I/H组为14.8%（81例中的12例），但在这个小亚组中的影响（0.59；0.30 - 1.16；P = 0.12）不显著。
FDC-I/H治疗与首次和复发性HF住院以及全因住院总数的大幅减少相关，减轻了代价高昂且令人痛苦的住院治疗的总体负担。
