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TCT2019|ECXEL:左主干病变PCI或CABG 5年后的综合疗效相似

作者:国际循环网   日期:2019/10/17 11:31:38

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左主干病变(LMCAD)患者通常由于有严重的心肌损害而预后差。

  左主干病变(LMCAD)患者通常由于有严重的心肌损害而预后差。与单纯药物治疗相比,经皮冠状动脉介入术(PCI)或冠状动脉旁路移植术(CABG)的血运重建已被证明可延长左主干疾病患者的生存期。大规模随机ECXEL试验的三年数据显示,两种治疗方法的死亡、卒中或心肌梗死(MI)的综合发生率无显著差异。PCI减少了30天的主要不良事件。这些结果首次在2016年TCT上报告并发表在NEJM上。
 
Press Release
TCT 2019|EXCEL
 
  研究结果在第三十一届经导管心血管治疗(TCT)学术会议上公布。TCT是由心血管研究基金会(CRF)赞助的世界上最重要的心血管介入医学教育会议。研究同时发表在《新英格兰医学杂志》上。
 
  2010年9月~2014年3月,在17个国家的126个试点招募2905名LMCAD患者。符合条件的LMCAD患者(n=1905),且经现场评估的低或中度冠状动脉疾病的复杂性(SYNTAX评分小于或等于32)被随机分配到含氟聚合物涂层钴铬支架Everolimus洗脱支架再血管化(EES;n=948)或CABG(n=957)。
 
  在5年结果分析中,主要结果是死亡、卒中或心肌梗死的综合结果。长期的次要结果包括5年时治疗失败(明确的支架血栓形成或有症状的狭窄或闭塞),所有血运重建和所有脑血管事件(卒中或短暂的缺血性发作)。
 
  PCI组和CABG组分别有93.2%和90.1%的患者进行5年随访,5年主要复合终点(死亡、卒中或心肌梗死)发生于22.0%的PCI组患者和19.2%的CABG组患者(相差2.8%; 95%CI:-0.9%~6.5%;P=0.13)。PCI与CABG主要结局的相对风险在0~30天的变化(HR=0.61, 95%CI:0.42~0.88)、30天-1年(HR=1.07,95%CI:0.68~1.70)和1~5年(HR=1.61,95%CI :1.23~2.12)。分析表明,随着时间的推移,PCI的早期获益逐渐减少,而随机分配至PCI的患者术后风险增加。5年次要复合终点(死亡、卒中、心肌梗死或缺血驱动的血运重建)发生于31.3%的PCI组患者和24.9%的CABG组患者(相差6.5%;95%CI:2.4%~10.6%)。
 
  全因死亡发生在PCI组13.0%和CABG组9.9%(相差3.1%;95%CI:0.2%~6.1%)。PCI组30例额外死亡中有18例被判定为非心血管死亡,5例为明确的心血管死亡,另外,PCI和CABG术后5年卒中和心肌梗死的发生率无显著差异。与CABG相比,PCI术后5年内缺血性血运重建的发生频率更高,而PCI的5年内所有脑血管事件和明确的支架血栓或有症状的狭窄或闭塞的发生率均低于CABG。
 
  主要研究者Gregg W.Stone医学博士说:“在左主干冠状动脉疾病和低或中等复杂度冠状动脉疾病的患者中,我们发现PCI和CABG在5年死亡、卒中或心肌梗死的复合率方面没有显著差异。需10年或更长时间的随访来描述PCI和CABG的晚期安全性,因为支架和旁路移植都随着时间的推移逐渐失效。”
 
Abstract
TCT 2019|EXCEL
 
  BACKGROUND
 
  Long-term outcomes after percutaneous coronary intervention(PCI)with contemporary drug-eluting stents,as compared with coronary-artery bypass grafting(CABG),in patients with left main coronary artery disease are not clearly established.
 
  与CABG相比,现代药物洗脱支架PCI后左主干病变患者的长期预后尚不清楚。
 
  METHODS
  We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity(according to assessment at the participating centers)to undergo either PCI with fluoropolymer-based cobalt–chromium everolimuseluting stents(PCI group,948 patients)or CABG(CABG group,957 patients).The primary outcome was a composite of death,stroke,or myocardial infarction.
 
  我们随机分配1905名左主干冠状动脉疾病患者(根据参与中心的评估)接受含氟聚合物涂层钴铬支架PCI(PCI组,948例)或CABG(CABG组,957例),主要结果为死亡、卒中或心肌梗死。
 
  RESULTS
  At 5 years,a primary outcome event had occurred in 22.0%of the patients in the PCI group and in 19.2%of the patients in the CABG group(difference,2.8 percentage points;95%confidence interval[CI],?0.9 to 6.5;P=0.13).Death from any cause occurred more frequently in the PCI group than in the CABG group(in 13.0%vs.9.9%;difference,3.1 percentage points;95%CI,0.2 to 6.1).In the PCI and CABG groups,the incidences of definite cardiovascular death(5.0%and 4.5%,respectively;difference,0.5 percentage points;95%CI,?1.4 to 2.5)and myocardial infarction(10.6%and 9.1%;difference,1.4 percentage points;95%CI,?1.3 to 4.2)were not significantly different.All cerebrovascular events were less frequent after PCI than after CABG(3.3%vs.5.2%;difference,?1.9 percentage points;95%CI,?3.8 to 0),although the incidence of stroke was not significantly different between the two groups(2.9%and 3.7%;difference,?0.8 percentage points;95%CI,?2.4 to 0.9).Ischemia-driven revascularization was more frequent after PCI than after CABG(16.9%vs.10.0%;difference,6.9 percentage points;95%CI,3.7 to 10.0).
 
  在5年时,PCI组22.0%的患者和CABG组19.2%的患者发生主要结果事件(相差2.8%;95%CI:?0.9~6.5;P=0.13);PCI组全因死亡率高于CABG组(13.0% vs. 9.9%;相差3.1%; 95%CI:0.2~6.1);PCI组和CABG组明确心血管死亡的发生率(5.0% vs. 4.5%; 相差0.5%;95%CI:?1.4~2.5)和心肌梗死(10.6% vs. 9.1%;相差1.4%;95%CI:?1.3~4.2)无显著差异。PCI术后所有脑血管事件的发生率均低于CABG术后(3.3% vs. 5.2%;相差?1.9%;95%CI:?3.8~0)。两组之间卒中的发生率没有显著差异(2.9% vs. 3.7%;相差?0.8%;95%CI:?2.4 ~ 0.9)。PCI后缺血驱动的血管重建比CABG后更频繁(16.9% vs. 10.0%;相差6.9%;95%CI: 3.7~10.0)。
 
  CONCLUSIONS
  In patients with left main coronary artery disease of low or intermediate anatomical complexity,there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death,stroke,or myocardial infarction at 5 years.(Funded by Abbott Vascular;EXCEL ClinicalTrials.gov number,NCT01205776.)
 
  在解剖结构复杂度较低或中等的左主干冠状动脉疾病患者中,PCI和CABG在5年死亡、卒中或心肌梗死的综合预后率方面没有显著差异(由Abbott Vascular资助的EXCEL 研究在ClinicalTrials.gov编号为NCT01205776)
 
Slides
TCT 2019|EXCEL
 
 
 
 
 
 
  About CRF and TCT
 
  The Cardiovascular Research Foundation (CRF) is one of the world’s leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For nearly 30 years, CRF has helped pioneer medical advances and educated doctors on the latest treatments for heart disease. CRF is comprised of the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.
 
  Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Now in its 31st year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. TCT also includes interactive training pavilions where clinicians can gain vital skills to apply immediately to their practices.
 
  For more information,
  visit www.crf.org and www.tctconference.com.
 

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