Data also demonstrates that the stroke risk reduction device is as effective as oral anticoagulants for patients with atrial fibrillation following a cardiac ablation

数据还表明，对于心脏消融后的房颤患者，中风风险降低装置与口服抗凝剂一样有效

MARLBOROUGH, Mass. and CHICAGO, Nov. 16, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced positive three-year primary endpoint results from the OPTION global clinical trial of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. Key findings from the study comparing the device to first-line oral anticoagulation (OAC) – including direct oral anticoagulants (DOAC) (95%) and warfarin (5%) – for stroke risk reduction in patients with non-valvular atrial fibrillation following a cardiac ablation were presented in a late-breaking science session at the American Heart Association's Scientific Sessions 2024, and simultaneously published in The New England Journal of Medicine..

马萨诸塞州马尔伯勒和芝加哥，2024年11月16日/PRNewswire/--波士顿科学公司（纽约证券交易所：BSX）今天宣布WATCHMAN FLX™左心耳闭合（LAAC）装置的OPTION全球临床试验的三年主要终点结果为阳性。该研究将该装置与一线口服抗凝（OAC）进行比较，包括直接口服抗凝剂（DOAC）（95%）和华法林（5%），以降低心脏消融后非瓣膜性心房颤动患者的卒中风险，这项研究的主要发现发表在美国心脏协会2024年科学会议的晚期科学会议上，同时发表在《新英格兰医学杂志》上。。

The trial met the primary safety endpoint of non-procedural major bleeding or clinically relevant non-major bleeding at 36 months, with the WATCHMAN FLX device demonstrating superiority to OAC (8.5% vs.18.1%; P<0.0001). It also met the primary efficacy endpoint of all-cause death, stroke or systemic embolism at 36 months, with the data showing non-inferiority of the device to OAC (5.4% vs.

该试验在36个月时达到了非手术性大出血或临床相关非大出血的主要安全终点，WATCHMAN FLX装置显示出优于OAC（8.5%比18.1%；P<0.0001）。它在36个月时也达到了全因死亡，中风或全身栓塞的主要疗效终点，数据显示该装置对OAC的非劣效性（5.4%vs。

5.8%; P<0.0001). Additional findings included non-inferiority of the WATCHMAN FLX device for the combined secondary endpoint of procedural and non-procedural major bleeding at 36 months (3.9% vs. 5.0%; P<0.0001)..

5.8%；P＜0.0001）。其他发现包括WATCHMAN FLX装置在36个月时程序性和非程序性大出血联合次要终点的非劣效性（3.9%比5.0%；P<0.0001）。。

In recent years, the number of patients with atrial fibrillation who have undergone a cardiac ablation procedure to prevent symptoms has grown significantly. Due to the risk of atrial fibrillation recurrence following an ablation, current treatment guidelines recommend that patients with multiple stroke risk factors remain on OAC long term to reduce the risk of stroke.

近年来，接受心脏消融手术以预防症状的心房颤动患者数量显着增加。由于消融后房颤复发的风险，目前的治疗指南建议患有多种卒中危险因素的患者长期使用OAC以降低卒中风险。

However, symptomatic relief can lead these patients to stop taking their blood thinners, increasing this risk, while long-term use of OAC also presents a risk of serious bleeding..

然而，症状缓解可能导致这些患者停止服用血液稀释剂，增加了这种风险，而长期使用OAC也有严重出血的风险。。

'The OPTION trial data provide clinical evidence indicating that, among patients who have undergone an ablation, LAAC with the WATCHMAN FLX device is not only as safe, but superior to OAC therapy for reducing the risk of long-term bleeding events,' said Dr. Oussama Wazni, vice chairman of Cardiovascular Medicine and section head, Cardiac Electrophysiology, Cleveland Clinic, and principal investigator of the OPTION trial.* 'Notably, we found high rates of procedural success in patients who had a WATCHMAN FLX implant after an ablation, and of patient adherence to their prescribed medication regimen following the procedures, which likely reinforced positive outcomes such as the low rates of ischemic and hemorrhagic stroke within the trial population.'.

The randomized, controlled OPTION trial included 1,600 patients enrolled across 114 sites in the United States, Europe and Australia, and demonstrated high rates of procedural success. In the trial, approximately 60% of device patients had their WATCHMAN FLX implant 90-180 days following their ablation procedure.

这项随机对照OPTION试验纳入了美国，欧洲和澳大利亚114个地点的1600名患者，并显示出较高的手术成功率。在该试验中，大约60%的设备患者在消融手术后90-180天接受了WATCHMAN FLX植入物。

The other nearly 40% of the device patients had the two procedures performed concomitantly, with the WATCHMAN FLX implant taking place after the ablation..

另外近40%的设备患者同时进行了这两个程序，WATCHMAN FLX植入物在消融后进行。。

'The OPTION trial is the first large, randomized trial to rigorously evaluate LAAC as a safe and effective stroke risk reduction treatment following a cardiac ablation in a head-to-head fashion against commonly used oral anticoagulants, including DOAC,' said Brad Sutton, M.D., chief medical officer, Atrial Fibrillation Solutions, Boston Scientific.

波士顿科学（Boston Scientific）房颤解决方案首席医疗官医学博士布拉德·萨顿（BradSutton）说：“OPTION试验是第一个严格评估LAAC作为一种安全有效的中风风险降低治疗方法的大型随机试验，该方法是针对常用的口服抗凝剂（包括DOAC）进行心脏消融后进行的。”。

'These positive primary outcomes mean that patients receiving the WATCHMAN FLX device were able to eliminate long-term medication use while maintaining stroke protection. With this data, we see potential to both expand the indication for the WATCHMAN FLX platform and ultimately elevate it to become a frontline therapy for patients receiving cardiac ablation for atrial fibrillation to reduce their risk of stroke.'.

“这些积极的主要结果意味着接受WATCHMAN FLX设备的患者能够消除长期用药，同时保持中风保护。有了这些数据，我们看到了扩大WATCHMAN FLX平台适应症的潜力，并最终将其提升为接受心房颤动心脏消融治疗的患者的一线治疗，以降低其中风风险。”。

In addition to the OPTION trial, the WATCHMAN technology is being evaluated against DOAC as a first-line therapy in lower-risk patients within the CHAMPION-AF randomized trial. The latest-generation WATCHMAN FLX™ Pro LAAC Device, which was approved in the United States in 2023, is similarly being studied in several clinical trials, including the SIMPLAAFY randomized controlled trial that is evaluating a single-drug alternative to dual anti-platelet therapy as a post-procedural regimen..

除了OPTION试验之外，WATCHMAN技术正在CHAMPION-AF随机试验中针对DOAC作为低风险患者的一线治疗进行评估。。。

For more information on the OPTION trial, visit https://www.watchman.com/en-us-implanter/clinical-evidence/option.html.

有关OPTION试用的更多信息，请访问https://www.watchman.com/en-us-implanter/clinical-evidence/option.html.

About Boston ScientificBoston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care.

关于波士顿科学波士顿科学通过创新的医疗技术改变生活，改善世界各地患者的健康。作为全球医疗技术领导者已有45多年的历史，我们通过提供广泛的高性能解决方案来解决未满足的患者需求并降低医疗保健成本，从而推动生命科学的发展。

Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter..

我们的设备和疗法组合可帮助医生诊断和治疗复杂的心血管、呼吸、消化、肿瘤、神经和泌尿系统疾病和病症。请访问www.bostonscientific.com了解更多信息，并在LinkedIn和X（前身为Twitter）上进行连接。。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警示声明

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like 'anticipate,' 'expect,' 'project,' 'believe,' 'plan,' 'estimate,' 'intend' and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding our business plans and product performance and impact, clinical trials, and new and anticipated product approvals and launches.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. .

本新闻稿包含1933年《证券法》第27A节和1934年《证券交易法》第21E节所指的前瞻性声明。前瞻性声明可以用“预期”、“预期”、“项目”、“相信”、“计划”、“估计”、“打算”等词和类似词来识别。这些前瞻性陈述基于我们当时可用的信息，基于我们的信念、假设和估计，并不旨在保证未来的事件或表现。。如果我们的基本假设不正确，或者出现某些风险或不确定性，实际结果可能与我们的前瞻性陈述所表达或暗示的预期和预测有很大差异。在某些情况下，这些因素已经产生影响，并且在未来（连同其他因素）可能会影响我们实施业务战略的能力，并可能导致实际结果与本新闻稿中所述的预期结果产生重大差异。因此，提醒读者不要过度依赖我们的任何前瞻性陈述。。

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law.  This cautionary statement is applicable to all forward-looking statements contained in this document..

可能导致这种差异的因素包括：未来的经济、竞争、报销和监管条件；地缘政治事件；制造、分销和供应链中断以及成本增加；网络安全事件造成的中断；公共卫生突发事件或极端天气或其他气候变化相关事件造成的中断；劳动力短缺和劳动力成本增加；正在进行和未来的临床试验和市场研究结果的变化；新产品介绍；预期的程序量；收购的结束和整合；；知识产权；诉讼；金融市场状况；以及我们和竞争对手做出的未来业务决策。所有这些因素都很难或不可能准确预测，其中许多因素超出了我们的控制范围。有关这些和其他可能影响我们未来运营的重要风险和不确定性的进一步列表和描述，请参阅我们向证券交易委员会提交的最新10-K表年度报告中的第一部分第1A项-风险因素，我们可能会在第二部分第1A项-我们已经提交或将在以后提交的10-Q表季度报告中的风险因素中进行更新。我们不打算或有义务公开更新或修订任何前瞻性声明，以反映我们的期望或这些期望可能基于的事件、条件或情况的任何变化，或者可能影响实际结果与前瞻性声明中所载结果不同的可能性，除非法律要求。本警告声明适用于本文件中包含的所有前瞻性声明。。

CONTACTS:Angela MineoMedia Relations+1 (763) 955-8325Angela.Mineo@bsci.com

联系人：Angela MineoMedia Relations+1（763）955-8325Angela.Mineo@bsci.com

Jon MonsonInvestor Relations+1 (508) 683-5450BSXInvestorRelations@bsci.com

Jon MonsonInvestor关系+1（508）683-5450BSXInvestorRelations@bsci.com

*Dr. Oussama Wazni is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.

*博士。Oussama Wazni是波士顿科学公司的有偿顾问。他没有得到与本新闻稿有关的赔偿。

SOURCE Boston Scientific Corporation

来源波士顿科学公司