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老年高血压患者的强化降压试验
Trial of Intensive Blood-Pressure Control in Older Patients with Hypertension


Weili Zhang ... 心脑血管疾病 • 2021.09.30
NEJM 动画解读

老年患者的强化降压
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• 抗高血压药对各年龄和各血压水平的人群发挥的预防作用 • 强化降压与标准降压比较试验的最终报告 • 强化降压与标准降压比较的随机试验

强化降压降低老年高血压患者心血管事件

 

刘蓉,魏盟*

上海嘉会国际医院心脏中心*通讯作者

 

高血压是心血管事件发生的危险因素之一。随着人口老龄化的趋势逐渐显现,确定老年高血压患者收缩压(systolic blood pressure,SBP)控制的有效及安全范围具有非常重要的意义。目前,老年高血压患者SBP的控制标准在全球范围内仍有争议。美国医师学会和美国家庭医生学会指南的标准为SBP<150 mmHg,欧洲高血压指南为130~139 mmHg,美国心脏学会-美国心脏病学会(AHA-ACC)指南为<130 mmHg,2019年中国老年高血压防治指南中的标准为<140 mmHg。

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摘要


背景

可降低老年高血压患者心血管风险的合适收缩压目标尚未明确。

 

方法

在此项多中心、随机、对照试验中,我们将中国60~80岁的高血压患者随机分组,两组的收缩压目标分别设定为110~<130 mmHg(强化降压)或130~<150 mmHg(标准降压)。主要结局是由卒中、急性冠脉综合征(急性心肌梗死和不稳定型心绞痛住院)、急性失代偿性心力衰竭、冠状动脉血运重建、心房颤动或心血管原因死亡构成的复合结局。

 

结果

在接受筛选的9,624例患者中,8,511例被纳入试验;4,243例被随机分配到强化降压组,4,268例被分配到标准降压组。1年随访时,强化降压组的平均收缩压为127.5 mmHg,标准降压组为135.3 mmHg。在中位3.34年随访期间,强化降压组147例患者(3.5%)发生了主要结局事件,而标准降压组为196例患者(4.6%)(风险比,0.74;95%置信区间[CI],0.60~0.92;P=0.007)。主要结局中各构成部分的结果大多为强化降压优于标准降压:卒中的风险比为0.67(95% CI,0.47~0.97),急性冠脉综合征的风险比为0.67(95% CI,0.47~0.94),急性失代偿性心力衰竭的风险比为0.27(95% CI,0.08~0.98),冠状动脉血运重建的风险比为0.69(95% CI,0.40~1.18),心房颤动的风险比为0.96(95% CI,0.55~1.68),心血管原因死亡的风险比为0.72(95% CI,0.39~1.32)。除低血压发生率在强化降压组较高之外,两组的其他安全性和肾脏结局结果均无显著差异。

 

结论

在老年高血压患者中,与将收缩压目标设定为130~<150 mmHg的标准降压相比,将目标设定为110~<130 mmHg的强化降压降低了心血管事件的发生率(由中国医学科学院等资助,STEP在ClinicalTrials.gov注册号为NCT03015311)。





作者信息

Weili Zhang, M.D., Ph.D., Shuyuan Zhang, Ph.D., Yue Deng, Ph.D., Shouling Wu, M.D., Jie Ren, M.D., Gang Sun, M.D., Jinfeng Yang, M.D., Yinong Jiang, M.D., Xinjuan Xu, M.D., Tzung-Dau Wang, M.D., Ph.D., Youren Chen, M.D., Yufeng Li, M.D., Lianchen Yao, M.D., Dianfang Li, M.D., Lixin Wang, M.D., Xiaomei Shen, M.D., Xinhua Yin, M.D., Wei Liu, M.D., Xiaoyang Zhou, M.D., Bingpo Zhu, M.D., Zihong Guo, M.D., Hualing Liu, M.D., Xiaoping Chen, M.D., Yingqing Feng, M.D., Gang Tian, M.D., Xiuyin Gao, B.Sc., Kazuomi Kario, M.D., Ph.D., and Jun Cai, M.D., Ph.D. for the STEP Study Group*
From the Hypertension Center, FuWai Hospital, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Peking Union Medical College, Chinese Academy of Medical Sciences (W.Z., S.Z., Y.D., J.C.), Peking Union Medical College Hospital (S.Z.), Beijing Pinggu Hospital (Y.L.), and Beijing Hospital (W.L.), Beijing, Kailuan General Hospital, Tangshan (S.W.), Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences (J.R.), and the First Affiliated Hospital of Shanxi Medical University (X.S.), Taiyuan, the Second Affiliated Hospital of Baotou Medical College, Baotou (G.S.), the People’s Hospital of Ji Xian District, Tianjin (J.Y.), the First Affiliated Hospital of Dalian Medical University (Y.J.) and Omron Dalian (X.G.), Dalian, the First Affiliated Hospital of Xinjiang Medical University, Urumqi (X.X.), the Second Affiliated Hospital of Medical College Shantou University, Shantou (Y.C.), Benxi Railway Hospital, Benxi (L.Y.), Hongxinglong Center Hospital, Shuangyashan (D.L.), the First Affiliated Hospital of Hebei North University, Zhangjiakou (L.W.), the First Affiliated Hospital of Harbin Medical University, Harbin (X.Y.), Renmin Hospital of Wuhan University, Wuhan (X.Z.), Kang Ya Hospital, Yiyang (B.Z.), FuWai Yunnan Cardiovascular Hospital, Kunming (Z.G.), Zhoukou City Central Hospital, Zhoukou (H.L.), West China Hospital, Sichuan University, Chengdu (X.C.), Guangdong Cardiovascular Institute, Guangzhou (Y.F.), and the First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (G.T.) — all in China; the Cardiovascular Center and Divisions of Cardiology and Hospital Medicine, Department of Internal Medicine, National Taiwan University Hospital, Taipei (T.-D.W.); and Jichi Medical University School of Medicine, Shimotsuke, Japan (K.K.). Address reprint requests to Dr. Cai (caijun@fuwaihospital.org) or Dr. Zhang (zhangweili1747@yahoo.com) at the Hypertension Center, FuWai Hospital, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Peking Union Medical College, Chinese Academy of Medical Sciences, Beilishi Rd. 167, Xicheng District, Beijing, 100037, China. *A complete list of members of the STEP Study Group is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

1. NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19·1 million participants. Lancet 2017;389:37-55.

2. Lewington S, Lacey B, Clarke R, et al. The burden of hypertension and associated risk for cardiovascular mortality in China. JAMA Intern Med 2016;176:524-532.

3. Messerli FH, Bangalore S, Messerli AW. Age, blood pressure targets, and guidelines: rift between those who preach, those who teach, and those who treat? Circulation 2018;138:128-130.

4. Qaseem A, Wilt TJ, Rich R, et al. Pharmacologic treatment of hypertension in adults aged 60 years or older to higher versus lower blood pressure targets: a clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med 2017;166:430-437.

5. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J 2018;39:3021-3104.

6. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2018;71(19):e127-e248.

7. The SPRINT Research Group. Final report of a trial of intensive versus standard blood-pressure control. N Engl J Med 2021;384:1921-1930.

8. Williamson JD, Supiano MA, Applegate WB, et al. Intensive vs standard blood pressure control and cardiovascular disease outcomes in adults aged ≥75 years: a randomized clinical trial. JAMA 2016;315:2673-2682.

9. Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet 2016;387:957-967.

10. Qi Y, Han X, Zhao D, et al. Long-term cardiovascular risk associated with stage 1 hypertension defined by the 2017 ACC/AHA hypertension guideline. J Am Coll Cardiol 2018;72:1201-1210.

11. Douros A, Tölle M, Ebert N, et al. Control of blood pressure and risk of mortality in a cohort of older adults: the Berlin Initiative Study. Eur Heart J 2019;40:2021-2028.

12. Krousel-Wood M, Joyce C, Holt E, et al. Predictors of decline in medication adherence: results from the cohort study of medication adherence among older adults. Hypertension 2011;58:804-810.

13. Asayama K, Ohkubo T, Kikuya M, et al. Prediction of stroke by self-measurement of blood pressure at home versus casual screening blood pressure measurement in relation to the Joint National Committee 7 classification: the Ohasama study. Stroke 2004;35:2356-2361.

14. Hoshide S, Yano Y, Mizuno H, Kanegae H, Kario K. Day-by-day variability of home blood pressure and incident cardiovascular disease in clinical practice: the J-HOP Study (Japan Morning Surge–Home Blood Pressure). Hypertension 2018;71:177-184.

15. Umemura S, Arima H, Arima S, et al. The Japanese Society of Hypertension guidelines for the management of hypertension (JSH 2019). Hypertens Res 2019;42:1235-1481.

16. Unger T, Borghi C, Charchar F, et al. 2020 International Society of Hypertension global hypertension practice guidelines. Hypertension 2020;75:1334-1357.

17. Zhang S, Wu S, Ren J, et al. Strategy of blood pressure intervention in the elderly hypertensive patients (STEP): rational, design, and baseline characteristics for the main trial. Contemp Clin Trials 2020;89:105913-105913.

18. D’Agostino RB Sr, Vasan RS, Pencina MJ, et al. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation 2008;117:743-753.

19. Chen W-W, Gao R-L, Liu L-S, et al. China cardiovascular diseases report 2015: a summary. J Geriatr Cardiol 2017;14:1-10.

20. Fine JP, Gray RJ. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc 1999;94:496-509.

21. DeMets DL, Lan KK. Interim analysis: the alpha spending function approach. Stat Med 1994;13:1341-1352.

22. Reboussin DM, DeMets DL, Kim KM, Lan KKG. Computations for group sequential boundaries using the Lan-DeMets spending function method. Control Clin Trials 2000;21:190-207.

23. SHEP Cooperative Research Group. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension: final results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA 1991;265:3255-3264.

24. Staessen JA, Fagard R, Thijs L, et al. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. Lancet 1997;350:757-764.

25. Beckett NS, Peters R, Fletcher AE, et al. Treatment of hypertension in patients 80 years of age or older. N Engl J Med 2008;358:1887-1898.

26. Feigin VL, Lawes CMM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol 2009;8:355-369.

27. Wang W, Jiang B, Sun H, et al. Prevalence, incidence, and mortality of stroke in China: results from a nationwide population-based survey of 480687 adults. Circulation 2017;135:759-771.

28. McEvoy JW, Chen Y, Rawlings A, et al. Diastolic blood pressure, subclinical myocardial damage, and cardiac events: implications for blood pressure control. J Am Coll Cardiol 2016;68:1713-1722.

29. Park J-H, Ovbiagele B. Post-stroke diastolic blood pressure and risk of recurrent vascular events. Eur J Neurol 2017;24:1416-1423.

30. Spence JD, Azarpazhooh MR, Larsson SC, Bogiatzi C, Hankey GJ. Stroke prevention in older adults: recent advances. Stroke 2020;51:3770-3777.

31. The ACCORD Study Group. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010;362:1575-1585.

32. Yusuf S, Bosch J, Dagenais G, et al. Cholesterol lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med 2016;374:2021-2031.

33. Hanazawa T, Asayama K, Watabe D, et al. Association between amplitude of seasonal variation in self-measured home blood pressure and cardiovascular outcomes: HOMED-BP (Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure) study. J Am Heart Assoc 2018;7(10):e008509-e008509.

34. Narita K, Hoshide S, Fujiwara T, Kanegae H, Kario K. Seasonal variation of home blood pressure and its association with target organ damage: the J-HOP Study (Japan Morning Surge–Home Blood Pressure). Am J Hypertens 2020;33:620-628.

35. Cai L, Dong J, Cui WL, You DY, Golden AR. Socioeconomic differences in prevalence, awareness, control and self-management of hypertension among four minority ethnic groups, Na Xi, Li Shu, Dai and Jing Po, in rural southwest China. J Hum Hypertens 2017;31:388-394.

36. Gao S, Bell EC, Zhang Y, Liang D. Racial disparity in drug disposition in the digestive tract. Int J Mol Sci 2021;22:1038-1038.

37. Wu Y, Liu X, Li X, et al. Estimation of 10-year risk of fatal and nonfatal ischemic cardiovascular diseases in Chinese adults. Circulation 2006;114:2217-2225.

38. Yang X, Li J, Hu D, et al. Predicting the 10-year risks of atherosclerotic cardiovascular disease in Chinese population: the China-PAR Project (Prediction for ASCVD Risk in China). Circulation 2016;134:1430-1440.

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