摘要
经皮支架重建血运治疗粥样硬化性肾动脉狭窄的中远期临床结果及疗效相关因素分析
目的评估经皮支架置入重建血运治疗粥样硬化性肾动脉狭窄的安全性、中远期临床结果,并分析疗效相关因素。
方法2003年1月开始我们进行了一项前瞻性非随机研究,至2008年10月共连续入选238例粥样硬化性肾动脉严重狭窄的患者,其中男性178例(74.8%),女性60例(25.2%),肾动脉直径狭窄≥60%,因严重高血压或伴有肾功能不全而进行经皮肾动脉支架术(PTRAS),并随诊6～72个月,观察该手术对患者肾功能、血压、心血管事件的影响,并分析影响临床疗效的相关因素。
结果238例患者PTRAS血运重建技术成功率99%(303/306),手术操作相关的并发症总计5.5%(13/238)。与术前基线值比较,在6～72个月随访中血压显著下降(P＜0.05),并且服药种数显著减少(P＜0.05);血肌酐在6～48个月时显著下降(P＜0.05),54～72个月时差异无统计学意义(P＞0.05);血尿素氮在6～24个月时显著下降(P＜0.05),30～72个月时差异无统计学意义(P＞0.05)。随访期间共失访23例(9.7%),发生心血管事件24例(10.1%),包括肾脏事件5例(2.1%)、心肌梗死4例(1.7%)、脑卒中4例(1.7%)和心脑血管死亡11例(4.6%)。术后第1、2、3、4、5、6年的无事件生存率分别为92.7%(203/219)、92.4%(146/158)、82.9%(92/111)、81.1%(60/74)、66.7%(30/45)、42.3%(11/26)。术后第1、2、3、4、5、6年的生存率分别为95.0%(208/219)、92.4%(146/158)、88.3%(98/111)、81.1%(60/74)、66.7%(30/45)、42.3%(11/26)。术前基线收缩压值高和术前服用降压药种类数多是术后12个月时高血压治愈或改善的显著独立预测因素,术前基线血肌酐值高是术后12个月时肾功能改善的显著独立预测因素,术后12个月高血压治愈或改善和术后12个月肾功能改善或稳定是术后远期心脑血管死亡率、总死亡率和所有心血管事件发生率降低的显著独立预测因素。
结论经皮支架置入重建血运治疗粥样硬化性肾动脉严重狭窄有较好的安全性,中远期降压和稳定肾功能的获益肯定。本研究也提示肾动脉支架术有可能显著减少心血管事件的发生率并降低死亡率,但还需要进一步研究予以证实。
Objectives:
To evaluate the safety and clinical efficacy of stent revascularization as treatment for atherosclerotic renal artery stenosis,and to analysed the predictors for clinical efficacy..
Methods:
In the prospective non-randomized cohort study in our hospital from January 2003 to October 2008,238 consecutive patients with severe atherosclerotic renal artery stenosis(ARAS)(diameter reduction≥60%) underwent percutaneous transluminal renal angioplasty and stenting(PTRAS) for severe hypertension and reserving renal function. They were followed up for 6-72 months and the effects of the procedure on renal function,blood pressure and cardiovascular events were observed.The predictors for improvement in blood pressure,renal function and cardiovascular events were analysed.
Results:
The success rate of stent revascularization was 99%.During 6～72 months of follow-up, both systolic and diastolic blood pressure significantly decreased(P＜0.05),and less antihypertensive medication was taken(P＜0.05).Serum creatinine was decreased significantly at 6～48 months(P＜0.05) and did not change significantly at 54～72 months (P＞0.05).Blood urea nitrogen was decreased significantly at 6～24 months(P＜0.05) and did not change significantly at 30～72 months(P＞0.05).Complications related with the procedure occurred in 13 cases(5.5%).23 patients failed to follow up(9.7%). Cardiovascular events occurred(10.1%) in 24 patients,including 5 cases of renal events (2.1%),4 cases of myocardial infarction(1.7%),4 cases of stroke(1.7%) and 11 cases of cardiovascular deaths(4.6%) during follow-up.The survival rates of free-of-events at year 1,2,3,4,5 and 6 were 92.7%(203/219),92.4%(146/158),82.9%(92/111),81.1% (60/74),66.7%(30/45) and 42.3%(11/26),respectively.The survival rates at year 1,2,3, 4,5 and 6 were 95.0%(208/219),92.4%(146/158),88.3%(98/111),81.1%(60/74),66.7% (30/45) and 42.3%(11/26),respectively.Higher baseline systolic blood pressure and more number of antihypertensive drugs taken before the procedure were independent predictors of improved blood pressure.Higher baseline serum creatinine was the independent predictor of improved renal function.Both improved blood pressure and improved renal function at 12 months were independent predictors of decreased mortality and decreased all cardiovascular events.
Conclusions:
Renal artery stenting as treatment for ARAS has a beneficial effect on blood pressure control and on renal function during mid-term and long-term follow-up.The treatment may be helpful in reduction of cardiovascular events and mortality,which should be investigated further.
引文
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