Artivion Announces Presentation of Real World Data from Post Market Study of On-X® Aortic Heart Valve Replacement Patients Treated with Low Dose Warfarin
Artivion宣布了来自真实世界数据的On-X®主动脉心脏瓣膜置换患者低剂量华法林治疗的上市后研究结果
Late-Breaking Science Presented at the 37th European Association for Cardio-Thoracic Surgery Annual Meeting
在37届欧洲心胸外科年会(Late-Breaking Science)上发布
ATLANTA, GA – (October 5, 2023) – Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced data from its On-X Aortic Heart Valve Low INR post-market study presented in a Late-Breaking Science session at the 37th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Vienna, Austria. Real world interim results for all patients confirm that the On-X Aortic Valve remains safe and effective with lowdose warfarin.
亚特兰大，乔治亚州 - (2023年10月5日) - Artivion公司(NYSE: AORT)，一家领先的专注于主动脉疾病的心脏和血管外科公司，今天宣布了其On-X主动脉心脏瓣膜低INR上市后研究的结果。该研究在奥地利维也纳举行的第37届欧洲心胸外科年会(EACTS)的Late-Breaking Science会议上进行了报告。对所有患者的真实世界中期结果证实，在低剂量华法林治疗下，On-X主动脉瓣膜仍然安全有效。
Professor Aung Oo, Clinical Lead for Aortovascular Surgery at Barts Heart Centre, London, England, presented an abstract titled, Real World Experience of 510 On-X Aortic Valve Replacement Patients Treated with Low Dose Warfarin. The abstract included at least 1-year and up to 5 years of clinical data on study participants, with median follow up time of 3.4 years. Results show a significantly lower composite primary endpoint of thromboembolism, valve thrombosis, and major bleeding (linearized occurrence rate (LOR) of 2.31% compared to the pre-defined historic control rate of 5.39%, p<0.0001),driven by an 85% reduction in major bleeding and a 73% reduction in all bleeding. Notably, the data reflected an improvement in outcomes compared to the On-X Aortic Low INR IDE Study (IDE Study) data first published in 2014.
英格兰伦敦Barts心脏中心的Aung Oo教授，在题为《Real World Experience of 510 On-X Aortic Valve Replacement Patients Treated with Low Dose Warfarin》的摘要中进行了报告。摘要中包括了至少1年和最多5年的临床数据，研究参与者的中位随访时间为3.4年。
结果显示，主要复合终点事件(血栓栓塞、瓣膜血栓形成和大出血)的发生率显著降低：与对照组相比，降低INR组的线性化发生率(LOR)显著降低，5.39% vs 2.31%，p<0.0001。主要是由大出血事件降低了85%和所有出血事件降低了73%所致。值得注意的是，这些数据与2014年首次发表的On-X主动脉低INR IDE研究数据相比有所改善。
Prof. Oo said, “Heart valve replacement therapy presents several post-operative challenges for patients, especially the need for blood thinners and the related risk of bleeding and thrombotic events. These longterm data demonstrate the clinical benefits of a lower-dose post-operative warfarin regimen, further validating the use-case for On-X valves with low-dose warfarin.”
Oo教授说：“心脏瓣膜置换术给患者术后提出了几个挑战，特别是对抗凝剂的使用需求以及出血和血栓事件的相关风险。这些长期数据显示了术后低剂量华法林方案的临床益处，进一步验证了在低剂量华法林下使用On-X瓣膜的有效性和安全性。”
“The data presented by Professor Oo validate the safety and benefit of physicians managing On-X aortic valve patients at a lower INR compared to other mechanical valves and reinforce our conviction in OnX as a key component of our product portfolio,” said Pat Mackin, Chairman, President, and Chief Executive Officer of Artivion. “With these data, we are increasingly confident in our ability to gain further market share globally with On-X, the only mechanical aortic heart valve that can be maintained at an INR of 1.5 to 2.0 backed by that recommendation in the American College of Cardiology / American Heart Association Guideline for the Management of Patients With Valvular Heart Disease.2 ”
Artivion公司董事长、总裁兼首席执行官Pat Mackin表示：“Oo教授的数据证实了医生以低于其他机械瓣膜的INR管理On-X主动脉瓣膜患者的安全性及获益，并加强了我们坚信On-X是我们产品组合的关键组成部分。有了这些数据，我们越来越有信心通过On-X在全球获得更多的市场份额，On-X是唯一可以在1.5-2.0的INR范围内使用的机械瓣，并且这一建议得到了美国心脏病学会/美国心脏协会瓣膜性心脏病管理指南的支持。”
About the On-X Aortic Low INR Post-Market Study
The On-X Aortic Low INR post-market study is a prospective, international, multi-center, observational study to assess the occurrence of bleeding, valve-related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Valve when targeted at an International Normalized Ratio (INR), level of 1.8 (1.5-2.0 range) during a 5-year follow-up period. The trial is designed to compare adverse event rates for patients with target INR range of 1.5 to 2.0 per On-X instructions for use, to rates from the previous IDE trial. The trial consisted of 510 participants who have only an On-X aortic prosthetic heart valve implant. The combined primary efficacy and safety endpoints determine the impact of the On-X Aortic Prosthetic Valve on reducing thrombotic events, major bleeding events, and mortality.
关于On-X主动脉低INR上市后研究
On-X主动脉低INR上市后研究是一项前瞻性、国际性、多中心、观察性研究，旨在评估在5年随访期间，当国际标准化比值(INR)目标为1.8(1.5-2.0范围)时，On-X主动脉瓣膜出血、瓣膜相关血栓栓塞和瓣膜血栓形成的发生率。该试验旨在比较按照On-X使用说明的目标INR范围为1.5-2.0的患者的不良事件发生率，与之前IDE试验的发生率。试验包括仅植入On-X主动脉瓣膜的510名参与者。主要疗效和安全性终点共同决定了On-X主动脉瓣膜对减少血栓栓塞事件、主要出血事件和死亡率的整体影响。
About Artivion, Inc.
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, www.artivion.com.
关于Artivion公司
Artivion公司总部位于乔治亚州亚特兰大郊区，是一家医疗设备公司，专注于开发简单、优雅的解决方案，解决心脏和血管外科医生在治疗主动脉疾病患者时面临的最困难挑战。Artivion的四个主要产品组包括：主动脉支架移植物、外科密封剂、On-X机械心脏瓣膜和可植入的心脏和血管人体组织。Artivion在100多个国家销售产品。如需了解更多关于Artivion的信息，请访问我们的网站www.artivion.com。
参考文献
1.Puskas J, Gerdisch M, Nichols D, Quinn R, Anderson C, Rhenman B, Fermin L, McGrath M, Kong B, Hughes C, Sethi G, Wait M, Martin T, Graeve A, Investigators P. Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg. 2014;147:1202– 1210. discussion 1210- 1201.
2.J Am Coll Cardiol. 2021 Feb, 77 (4) e25–e197
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