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TCT2019|COAPT:经导管二尖瓣置换术在心力衰竭合并继发重度二尖瓣返流患者中的成本效益
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 编辑:国际循环网 时间:2019/10/17 11:38:26 关键字:心力衰竭 
  COAPT试验最新的经济数据分析结果发现,经导管二尖瓣置换术(TMVr)结合指南导向的药物治疗(GDMT)是治疗心力衰竭继发重度二尖瓣返流(MR)患者的一种经济有效的治疗策略。
 
Press Release
TCT 2019|COAPT
 
  研究结果于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。研究结果也同时发表在《循环杂志》上。
 
  来自COAPT随机试验的两年数据发现,心力衰竭继发功能性二尖瓣返流患者尽管最大程度地接受药物治疗,但仍伴有症状,表现出住院率和死亡率的降低,以及经导管MitraClip装置治疗后,生活质量和功能能力得到改善。这些结果首次在2018年TCT上发表,并发表在《新英格兰医学杂志》上。
 
  使用COAPT试验数据,研究人员从美国医疗系统的角度出发,对心力衰竭继发中重度或重度MR患者TMVr联合GDMT与单独应用GDMT进行正式的、患者层面的经济分析。在试验中观察到的数据被用于预测患者的长期生存率、健康效用(生活质量的一种测量方法)和成本。
 
  分析发现,尽管与单用GDMT相比($26 654 vs. $38 345; P=0.018),GDMT联合TMVr组每位患者的随访费用大约低11000美元,但由于手术的前期费用($73 416 vs. $38 345; P< 0.001),TMVr组的两年累计费用仍然高出许多($73 416 vs. $38 345; P< 0.001)。当在试验生存期、卫生设施和成本在寿命期内进行建模时,TMVr预计将质量调整寿命年(QALYs)增加0.82年,成本为45648美元,产生的寿命增量成本效益比(ICER)为55600美元/QALY。在美国,获得的ICER低于50 000美元/ QALY属于高价值,而获得的ICER低于150 000美元/ QALY属于中等价值。结果在各种敏感性和亚组分析中保持一致。
 
  “对于COAPT患者来说,TMVr的成本效益与其他常用的治疗心力衰竭的技术相当,包括植入式心脏除颤器,而且比使用持续流动左心室辅助设备进行目的地治疗更具成本效益,”马萨诸塞州伯灵顿Lahey医院和医疗中心介入心脏病研究主任Suzanne J.Baron医学博士说。“结合COAPT试验的临床结果有所改善,这些发现表明,基于临床和经济考虑,TMVr是该患者群体的合理治疗策略。”
 
Abstract
TCT 2019|COAPT
 
  Background
  The COAPT trial demonstrated that edge-to-edge transcatheter mitral valve repair (TMVr) using the MitraClip resulted in reduced mortality and heart-failure hospitalizations and improved quality of life when compared with maximally-tolerated guideline-directed medical therapy (GDMT) in heart-failure patients with 3-4+ secondary mitral regurgitation (SMR). Whether TMVr is cost-effective compared with GDMT in this population is unknown.
 
  COAPT研究表明,与GDMT相比,使用二尖瓣钳夹术(MitraClip)进行二尖瓣经导管修复(TMVr)可降低有症状性心力衰竭和3 - 4 二尖瓣返流(SMR)患者的死亡率和心力衰竭住院率,并改善生活质量。在这种人群中,TMVr与GDMT相比是否具有成本效益尚不清楚。
 
  Methods
  We used data from the COAPT trial to perform a formal, patient-level economic analysis of TMVr + GDMT vs. GDMT alone for patients with heart failure and 3-4+ SMR from the perspective of the US health care system. Costs for the index TMVr hospitalization were assessed using a combination of resource-based accounting and hospital billing data (when available). Follow-up medical care costs were estimated based on medical resource use collected during the COAPT trial. Health utilities were estimated for all patients at baseline, 1, 6, 12 and 24 months using the SF-6D.
 
  我们使用COAPT试验数据,从美国医疗体系的角度,对心力衰竭合并3-4 SMR患者分别进行TMVr GDMT和单独GDMT的正式、患者层面的经济分析。结合使用基于资源的会计和医院账单数据(如有),评估TMVr住院指数的成本。根据COAPT试验期间收集的医疗资源使用情况估算后续医疗费用。使用SF-6D对所有患者在基线、1、6、12和24个月的健康效用进行评估。
 
  Results
  Initial costs for the TMVr procedure and index hospitalization were $35,755 and $48,198, respectively. Although follow-up costs were significantly lower with TMVr compared with GDMT ($26,654 vs. $38,345; P=0.018), cumulative 2-year costs remained higher with TMVr due to the up-front cost of the index procedure ($73,416 vs. $38,345; P<0.001). When intrial survival, health utilities, and costs were modeled over a lifetime horizon, TMVr was projected to increase life-expectancy by 1.13 years and quality-adjusted life-years (QALYs) by 0.82 years at a cost of $45,648, yielding a lifetime incremental cost-effectiveness ratio of $40,361/life-year gained and $55,600/QALY gained.
 
  TMVr手术和手术住院的初始费用分别为35 755美元和48 198美元。尽管TMVr的随访费用明显低于单纯GDMR(26654美元 vs. 38345美元;P=0.018),但由于手术的前期费用(73 416美元vs. 38345美元;P<0.001),TMVr的2年累计费用仍较高。当在寿命期内模拟试验生存期、卫生设施和成本时,预计TMVr将使预期寿命延长1.13年,质量调整寿命(QALY)延长0.82年,成本为45 648美元,寿命增量成本效益比为40美元,361/生命年收益,55 600美元/Qaly收益。
 
  Conclusions
  For symptomatic heart-failure patients with 3-4+ SMR, TMVr increases lifeexpectancy and quality-adjusted life-expectancy compared with GDMT at an incremental cost per QALY gained that represents acceptable economic value based on current U.S. thresholds.
 
  对于心力衰竭合并3-4 SMR患者,与GDMT相比,TMVr增加预期寿命和质量调整预期寿命,每QALY增加的成本代表了基于当前美国标准的可接受经济价值。
 
Slides
TCT 2019|COAPT
 
 
 
 
 
  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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