摘要
目的 探讨经导管去肾交感神经术(RDN)对不同心血管风险高血压患者的长期治疗效果、安全性,以及对不良事件、心血管死亡和全因死亡等终点事件的影响.方法 本研究为单中心、单臂的真实世界回顾性研究.纳入2011年7月6日到2015年12月23日在天津市第一中心医院行RDN治疗的难治性高血压患者,并根据基线心血管风险将患者分为高危组和中低危组.通过比较两组RDN后1、5、11年的诊室血压、家庭自测血压和24 h动态血压监测结果,评估不同心血管危险程度的高血压患者对RDN的治疗响应性;通过随访RDN术后1、11年的肌酐、估算肾小球滤过率(eGFR)评估RDN的长期安全性.通过诊室和电话随访RDN术后11年降压药物总每日限定剂量(DDD)及RDN术后长期不良事件、心血管死亡和全因死亡的发生情况.结果 共纳入62例难治性高血压患者,年龄(50.2±15.0)岁,其中男性35例(56.5％).高危组35例,中低危组27例.高危组患者RDN术后5年的诊室收缩压[(-38.0±15.1)mmHg 比(-25.0±16.6)mmHg(1 mmHg=0.133 kPa),P=0.002]、家庭自测收缩压[(-28.4±12.7)mmHg 比(-19.7±13.1)mmHg,P=0.011]以及RDN术后 11 年诊室收缩压[(-43.0±18.4)mmHg 比(-27.8±17.9)mmHg,P=0.003]较基线的下降幅度均明显高于低中危组.心率以及降压药总DDD数下降值两组比较差异均无统计学意义(P均＞0.05).RDN术后1、11年两组的肌酐、eGFR水平与基线值比较,差异均无统计学意义(P均＞0.05).全部患者中RDN术后5、11年的累积心血管死亡率分别为1.6％(1/62)和8.1％(5/62),累积全因死亡率分别为3.2％(2/62)和11.3％(7/62),两组的不良事件发生率、心血管死亡率以及全因死亡率差异均无统计学意义(P均＞0.05).结论 RDN具有长期降压作用且安全性良好.心血管风险高危的高血压患者可能对RDN治疗的响应性更好.
Abstract
Objective To investigate the long-term therapeutic effects and safety of renal denervation(RDN)on hypertensive patients with different cardiovascular risks,as well as its impact on adverse events,cardiovascular death and all-cause mortality.Methods This was a single-center,single-arm,real-world retrospective study.Patients with refractory hypertension who underwent RDN at Tianjin First Central Hospital from July 6,2011 to December 23,2015 were enrolled and divided into either a high or intermediate-low risk group based on baseline cardiovascular risk.The treatment responsiveness of hypertensive patients with different cardiovascular stratification to RDN was assessed by comparing the results of office blood pressure,home blood pressure,and 24-h ambulatory blood pressure monitoring at 1,5,and 11 years after RDN.Long-term safety of RDN was assessed by creatinine,and estimated glomerular filtration rate(eGFR)at 1 and 11 years after RDN.In addition,the total defined daily dose(DDD)of antihypertensive medications and the incidence of long-term adverse events,cardiovascular deaths,and all-cause deaths after RDN were followed up 11 years after RDN in person or by telephone.Results A total of 62 patients with refractory hypertension,aged(50.2±15.0)years,of whom 35(56.5％)were male,were included.There were 35 cases in high-risk group and 27 cases in low and medium risk group.The decrease in clinic systolic blood pressure(high risk vs.low-medium risk:(-38.0±15.1)mmHg vs.(-25.0±16.6)mmHg(1 mmHg=0.133kPa),P=0.002),home self-measured systolic blood pressure((-28.4±12.7)mmHg vs.(-19.7±13.1)mmHg,P=0.011)and clinic systolic blood pressure 11 years after RDN((-43.0±18.4)mmHg vs.(-27.8±17.9)mmHg,P=0.003)in the high-risk group was significantly higher than that in the low-medium risk group.The differences in heart rate and the decrease in total DDD number of antihypertensive drugs between the two groups were not statistically significant(all P＞0.05).Creatinine and eGFR levels in the two groups at 1 and 11 years after RDN were not statistically significant when compared with the baseline values(all P＞0.05).The cumulative cardiovascular mortality rate was 1.6％(1/62)and 8.1％(5/62),and the cumulative all-cause mortality rate was 3.2％(2/62)and 11.3％(7/62)at 5 and 11 years after RDN,respectively.The differences in the incidence rate of adverse events,cardiovascular mortality,and all-cause mortality rate between the two groups were not statistically significant(all P＞0.05).Conclusions RDN has long-term antihypertensive effect and good safety.Hypertensive patients who belong to the high-risk stratification of cardiovascular risk may respond better to RDN treatment.
基金项目
国家自然科学基金(81970303)
天津市医学重点学科(专科)建设项目(TJYXZDXK-054B)
天津市自然科学基金(21JCYBJC00250)
NETL
NSTL
万方数据