CAMBRIDGE, Mass.--(BUSINESS WIRE)--Anthos Therapeutics, Inc., a clinical stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences, announced today during a Late-Breaking session of the American Heart Association (AHA) meeting that abelacimab demonstrated a highly significant reduction in bleeding events across all primary and secondary endpoints versus a standard of care direct-oral anticoagulant (DOAC).

马萨诸塞州剑桥-（商业线）-Anthos Therapeutics，Inc.，一家由Blackstone Life Sciences创立的开发心血管疾病创新疗法的临床阶段公司，今天在美国心脏协会（AHA）会议的最后一次会议上宣布，与标准护理直接口服抗凝剂（DOAC）相比，abelacimab显示所有主要和次要终点的出血事件显着减少。

With a median of 21 months of follow-up spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study evaluated the safety and tolerability of abelacimab as compared with rivaroxaban in 1,287 patients with a moderate to high risk of ischemic stroke. Anthos Therapeutics has initiated an extension study to enable patients to transition from rivaroxaban to abelacimab to benefit from the improved bleeding profile..

AZALEA-TIMI 71研究的中位随访时间为21个月，跨越2000多患者年，评估了1287例中度至高度缺血性卒中患者中abelacimab与利伐沙班相比的安全性和耐受性。Anthos Therapeutics已经启动了一项扩展研究，使患者能够从利伐沙班过渡到abelacimab，从而从改善的出血情况中受益。。

Atrial fibrillation, also known as AF, or AFib, is an irregular heartbeat, or arrhythmia which can lead to blood clots, stroke, heart failure and other heart-related complications.1 Approximately 37 million people worldwide are currently diagnosed with atrial fibrillation,2 while in the United States, the Centers for Disease Control and Prevention (CDC) estimates that more than 12 million Americans will develop AF by 2030.3 The goal of anticoagulation therapy is to prevent and or treat thrombosis with minimal disruption of hemostasis.

心房颤动，也称为房颤或AFib，是一种不规则的心跳或心律失常，可导致血栓，中风，心力衰竭和其他心脏相关并发症.1全球约有3700万人被诊断患有心房颤动，2在美国，疾病控制和预防中心（CDC）估计，到2030年将有超过1200万美国人患房颤.3抗凝治疗的目标是预防和/或治疗血栓形成，同时尽量减少止血中断。

Although currently available anticoagulants are effective in preventing strokes in patients with atrial fibrillation, the risk of bleeding remains an issue..

尽管目前可用的抗凝剂可有效预防房颤患者的中风，但出血风险仍然是一个问题。。

“With a substantial 67% lower risk of bleeding for the combined primary endpoint of major or clinically relevant non-major bleeding, these ground-breaking results not only support the superior safety of abelacimab as compared with a commonly used DOAC, but also strongly supports the promise of Factor XI inhibition as a paradigm-shifting treatment approach,” said Christian T.

“主要或临床相关非大出血的主要终点事件出血风险降低67%，这些突破性的结果不仅支持abelacimab与常用DOAC相比的优越安全性，而且强烈支持因子XI抑制作为范式转换治疗方法的承诺，“克里斯蒂安T说。

Ruff, MD, MPH, Principal Investigator, AZALEA-TIMI 71, Director, General Cardiology, Brigham and Women’s Hospital, Associate Member, Broad Institute of MIT and Harvard, Associate Professor of Medicine, Harvard Medical School. “The unfortunate reality today is that too many people who could benefit from DOACs are unable to do so because of a host of clinical challenges, with bleeding or the fear of it, at the top of the list.

Ruff，医学博士，公共卫生硕士，首席研究员，AZALEA-TIMI 71，布莱根妇女医院综合心脏病学主任，麻省理工学院和哈佛大学布罗德研究所副成员，哈佛医学院医学副教授。“今天不幸的现实是，太多可以从DOAC中受益的人由于许多临床挑战，出血或担心而无法做到这一点。

We are hopeful that abelacimab’s remarkably improved bleeding profile and its unique attributes as a once monthly fully human monoclonal antibody with no renal clearance or drug-drug interactions, will help address many of the issues that patients face today.”.

我们希望，abelacimab显着改善出血情况及其作为每月一次完全人类单克隆抗体的独特属性，没有肾脏清除或药物-药物相互作用，将有助于解决患者今天面临的许多问题“。

Summary of Presented Results

呈现结果摘要

Across all bleeding endpoints, abelacimab demonstrated a highly significant reduction versus rivaroxaban

在所有出血终点中，abelacimab与利伐沙班相比显示出非常显着的降低

Factor XI inhibition of ~99% with abelacimab 150 mg dosed once monthly

abelacimab 150mg每月给药一次，因子XI抑制率为99%

Abelacimab 150 mg dosed once monthly via subcutaneous injection has been selected for the Phase 3 clinical study program

已经选择每月一次通过皮下注射给药的Abelacimab 150mg用于3期临床研究计划

Primary endpoint met with a 67% reduction in major or clinically relevant non-major bleeding (CRNM) with abelacimab 150 mg compared with rivaroxaban 20 mg in patients with atrial fibrillation who are at moderate-to-high risk of stroke (P<0.0001, HR 0.33, 95% Cl 0.19–0.55).

主要终点事件发生率为150 mg的abelacimab与20 mg的利伐沙班相比，中度至高度卒中风险的房颤患者主要或临床相关非主要出血事件（CRNM）减少67%（P<0.0001，HR 0.33,95%Cl 0.19-0.55）。

Other Bleeding Endpoints:

其他出血终点：

74% reduction in major bleeding alone with abelacimab 150 mg vs rivaroxaban 20 mg

单用abelacimab 150毫克与利伐沙班20毫克减少74%

(P=0.002, HR 0.26, 95% CI 0.11-0.61)

（p0.002，HR 0.26,95%CI 0.11-0.61）

93% reduction in gastrointestinal (GI) bleeding with abelacimab 150 mg vs rivaroxaban 20 mg

abelacimab 150 mg与利伐沙班20 mg相比，胃肠道（GI）出血减少93%

(P=0.008, HR 0.07, 95% CI 0.01-0.50)

（p0.008，HR 0.07,95%CI 0.01-0.50）

“With dual inhibitory activity against both Factor XI and XIa, abelacimab 150 mg has been proven to maintain approximately 99% inhibition over the monthly dosing interval. By providing patients with the possibility of continuous protection against blood clots, the potential for enhanced adherence and a placebo-like bleeding profile, abelacimab could represent the ‘holy grail’ of hemostasis-sparing anticoagulation,” said Dan Bloomfield, MD, Chief Medical Officer of Anthos Therapeutics.

“对因子XI和XIa具有双重抑制活性，abelacimab 150 mg已被证明在每月给药间隔内保持约99%的抑制率。通过为患者提供持续保护血液凝块的可能性，增强依从性的可能性和安慰剂样出血情况，abelacimab可能代表止血的“圣杯”-Anthos Therapeutics首席医疗官Dan Bloomfield博士说。

“Based on the evidence to date, we are highly confident that abelacimab will offer a potential game-changing treatment approach for patients with atrial fibrillation.'.

“根据迄今为止的证据，我们非常有信心abelacimab将为房颤患者提供一种潜在的改变游戏规则的治疗方法。”。

In patients with atrial fibrillation, suboptimal DOAC adherence is associated with poor clinical outcomes and a 39% higher hazard of stroke and increased risk of thromboembolic events and all-cause mortality. Due to their short elimination half-lives and short duration of anticoagulant effect, even brief periods of DOAC nonadherence may rapidly result in subtherapeutic anticoagulant levels.4.

在房颤患者中，不理想的DOAC依从性与不良的临床结果和中风风险增加39%，血栓栓塞事件和全因死亡风险增加有关。由于其消除半衰期短，抗凝作用持续时间短，即使短暂的DOAC不依从也可能迅速导致亚治疗抗凝剂水平。

In September 2022, the Food and Drug Administration (FDA) granted abelacimab Fast Track Status for the prevention of stroke and systemic embolism in patients with atrial fibrillation recognizing the important unmet medical need and the potential benefits of abelacimab. The Fast Track Designation process is intended to facilitate the development and expedite the review of treatments for serious medical conditions, with the hope of getting important new drugs to the patient earlier.5.

2022年9月，美国食品和药物管理局（FDA）批准abelacimab快速通道预防房颤患者中风和全身栓塞，认识到重要的未满足的医疗需求和abelacimab的潜在益处。快速通道指定过程旨在促进发展并加快对严重医疗条件治疗的审查，希望尽早向患者获得重要的新药。

“We are very optimistic about the potential future for AFib patients after seeing the very impressive reduction that abelacimab demonstrated versus a standard of care anticoagulant in the AZALEA-TIMI 71 study,” said Mellanie True Hills, Founder and Chief Executive Officer of the nonprofit patient advocacy organization StopAfib.org.

非营利组织的创始人兼首席执行官Mellanie True Hills说：“在AZALEA-TIMI 71研究中发现abelacimab与标准护理抗凝剂相比显示出非常显着的降低后，我们对AFib患者的潜在未来非常乐观。患者倡导组织StopAfib.org。

“In a recent large patient survey, a considerable number of AFib patients reported bleeding and/or bruising problems since starting an anticoagulant that had a significant impact on their quality of life.6 If approved, the innovative therapeutic approach of dual Factor XI / XIa inhibition could offer patients the anticoagulation protection they seek with minimal to no risk of bleeding.”.

“在最近的一项大型患者调查中，相当多的AFib患者报告自开始使用对其生活质量有重大影响的抗凝剂以来出现出血和/或瘀伤问题.6如果获得批准，双因素XI/XIa抑制的创新治疗方法可以为患者提供他们寻求的抗凝保护，同时出血风险最小或没有出血风险“。

The FDA has also granted abelacimab Fast Track Status for the treatment of thrombosis associated cancer. With clinical trial programs underway for both atrial fibrillation and Cancer Associated Thrombosis (CAT), abelacimab is the only Factor XI inhibitor being studied for the treatment of arterial and venous thromboembolic events.

FDA还授予abelacimab快速通道状态，用于治疗血栓形成相关癌症。随着心房颤动和癌症相关血栓形成（CAT）的临床试验计划的进行，abelacimab是唯一正在研究用于治疗动脉和静脉血栓栓塞事件的XI因子抑制剂。

Abelacimab is an investigational agent and is not approved for any indication in any country..

Abelacimab是一种研究药物，未被批准用于任何国家的任何适应症。。

About Abelacimab

关于Abelacimab

Abelacimab is a novel, highly selective, fully human monoclonal antibody that locks Factor XI in the inactive state, resulting in dual inhibitory activity against both Factor XI and its activated form, Factor XIa.

Abelacimab是一种新型，高选择性，完全人源化的单克隆抗体，可将因子XI锁定在非活性状态，从而对因子XI及其活化形式因子XIa产生双重抑制活性。

In patients with atrial fibrillation, abelacimab is planned to be dosed subcutaneously (SC) monthly to maintain nearly complete inhibition in a chronic setting. It is also planned to be administered via an initial intravenous (IV) infusion for acute indications requiring immediate onset of action and then followed by subsequent monthly SC administration.

在房颤患者中，abelacimab计划每月皮下（SC）给药，以在慢性环境中维持几乎完全的抑制。还计划通过初始静脉内（IV）输注给予需要立即起效的急性适应症，然后随后每月SC给药。

Abelacimab is the only Factor XI inhibitor being studied for the prevention and treatment of both arterial and venous thromboembolic events..

Abelacimab是唯一正在研究用于预防和治疗动脉和静脉血栓栓塞事件的XI因子抑制剂。。

In a PK / PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.7 In a Phase 2 study published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.8 Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.9.

在PK/PD研究中，静脉注射abelacimab可在治疗开始后1小时内显着抑制因子XI，并在30天内保持接近最大抑制.7在新英格兰医学杂志上发表的2期研究中2021年，膝关节手术后单次静脉注射abelacimab可使静脉血栓栓塞发生率降低80%，与依诺肝素相比，术后10天测量.8因子XI抑制为预防和治疗动脉和静脉血栓栓塞事件提供了止血保留抗凝的前景。

Abelacimab received a Fast Track Designation from the FDA in July 2022 for the treatment of thrombosis associated with cancer. In September 2022, abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

Abelacimab于2022年7月获得FDA的快速通道指定，用于治疗与癌症相关的血栓形成。2022年9月，abelacimab也被授予预防心房颤动患者中风和全身栓塞的快速通道名称。

Abelacimab is an investigational agent and is not approved for any indication in any country.

Abelacimab是一种研究药物，未被批准用于任何国家的任何适应症。

About Atrial Fibrillation

关于心房颤动

Atrial fibrillation, or AF, is the most common type of irregular heartbeat. The most severe complication of AF is stroke. The Centers for Disease Control and Prevention (CDC) estimates that 12.1 million people in the United States will have atrial fibrillation by 2030.3 Unfortunately, 40% to 60% of patients with atrial fibrillation are not prescribed anticoagulants today.

心房颤动或房颤是最常见的不规则心跳类型。房颤最严重的并发症是中风。美国疾病控制和预防中心（CDC）估计，到2030年，美国将有1210万人患有心房颤动.3不幸的是，40%至60%的房颤患者今天没有使用抗凝剂。

This underuse of anticoagulants for stroke prevention has been cited as one of the greatest public health issues facing cardiovascular patients.10 In a physician survey, the foremost barrier to patients taking oral anticoagulants was bleed related.11.

这种用于预防卒中的抗凝剂使用不足被认为是心血管患者面临的最大公共卫生问题之一.10在医生调查中，服用口服抗凝剂的患者最重要的障碍是出血相关的。

About the AZALEA-TIMI 71 Phase 2 Study

关于AZALEA-TIMI 71第二阶段研究

The AZALEA-TIMI 71 study was an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study with a primary endpoint that evaluates the effect of two blinded doses of abelacimab relative to open-label rivaroxaban in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke.

AZALEA-TIMI 71研究是一项事件驱动，随机，主动控制，盲法终点，平行组研究，主要终点评估两种盲法剂量的abelacimab相对于开放标签利伐沙班对房颤患者的影响（AF）中风风险中至高风险。

The primary endpoint of the AZALEA-TIMI 71 study is the composite of the rate of major or clinically relevant non-major bleeding events. A secondary endpoint is major bleeding on its own. Patients were randomized 1:1:1 and administered subcutaneous (SC) abelacimab 150 mg once-monthly, abelacimab 90 mg once-monthly, or rivaroxaban 20 mg daily.

AZALEA-TIMI 71研究的主要终点是主要或临床相关的非主要出血事件发生率的综合。次要终点是自身的大出血。患者以1:1:1随机分组，每月一次皮下（SC）abelacimab 150 mg，每月一次abelacimab 90 mg或利伐沙班20 mg。

With a median follow-up of 21 months, spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to a standard-of-care anticoagulant. The study enrolled 1,287 patients across 95 global study sites including the U.S.

AZALEA-TIMI 71研究的中位随访时间为21个月，跨越2000多个患者年，是对XI因子抑制剂进行的最大和最长的头对头研究，提供了非常显着的证据。与标准护理抗凝剂相比，出血减少。该研究纳入了包括美国在内的95个全球研究地点的1287名患者。

and Canada, Europe and Asia..

和加拿大，欧洲和亚洲。。

About the LILAC-TIMI 76 Phase 3 Study

关于LILAC-TIMI 76第三阶段研究

The LILAC-TIMI 76 study is an event-driven, randomized, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism in patients with atrial fibrillation (AF) who have been deemed to be unsuitable for currently available anticoagulation therapy.

LILAC-TIMI 76研究是一项事件驱动，随机，安慰剂对照，双盲，平行组研究，旨在评估abelacimab相对于安慰剂对心房颤动患者缺血性卒中或全身栓塞发生率的有效性和安全性（AF）被认为不适合目前可用的抗凝治疗。

Patients in the study will be randomized to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly. The study is targeting to enroll approximately 1,900 patients from more than 400 sites in North America, Europe, Latin America, the Middle East and Asia..

研究中的患者将随机接受abelacimab 150 mg皮下（SC）或匹配的安慰剂每月一次。该研究旨在招募来自北美，欧洲，拉丁美洲，中东和亚洲400多个地点的约1900名患者。。

About the Abelacimab Phase 3 Program in Cancer Associated Thrombosis (CAT)

关于癌症相关血栓形成（CAT）的Abelacimab 3期计划

The abelacimab Phase 3 CAT program comprises two complementary studies targeting to enroll approximately 2,700 patients across 220 sites in more than 23 countries -- the largest program of any anticoagulant performed in cancer-associated thrombosis.

abelacimab 3期CAT计划包括两项补充研究，旨在招募超过23个国家220个地点的约2700名患者-这是癌症相关血栓形成中最大的抗凝剂计划。

MAGNOLIA is an international multicenter, randomized, open-label, blinded endpoint evaluation, Phase 3 study in patients with gastrointestinal (GI) / genitourinary (GU) cancer in whom DOAC treatment is not recommended. The study will compare the effect of abelacimab relative to dalteparin on VTE recurrence and bleeding in patients with cancer associated VTE who are at a high bleeding risk with non-resectable, locally or regionally invasive GI / GU tumors.

MAGNOLIA是一项国际多中心，随机，开放标签，盲法终点评估，针对不推荐DOAC治疗的胃肠道（GI）/泌尿生殖系统（GU）癌症患者的3期研究。该研究将比较abelacimab与达肝素对癌症相关VTE患者VTE复发和出血的影响，这些患者出血风险高，不可切除，局部或区域侵袭性GI/GU肿瘤。

Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; dalteparin administered subcutaneously will be given daily, 200 IU/kg/day for the first month, and then 150 IU/kg/day up to 6 months..

Abelacimab 150 mg将在第1天静脉内（IV）给药，此后每月皮下（SC）给药长达6个月；皮下注射达肝素将每天给予，第一个月为200 IU/kg/天，然后为150 IU/kg/天，直至6个月。。

ASTER is an international multicenter, randomized, open-label, blinded endpoint evaluation, Phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE in whom DOAC treatment is recommended. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; Apixaban 10 mg will be administered orally, twice daily (bid) for the first 7 days, followed by 5 mg bid up to 6 months..

ASTER是一项国际多中心，随机，开放标签，盲法终点评估的3期研究，比较abelacimab与阿哌沙班对推荐DOAC治疗的癌症相关VTE患者静脉血栓栓塞（VTE）复发和出血的影响。Abelacimab 150 mg将在第1天静脉内（IV）给药，此后每月皮下（SC）给药长达6个月；阿哌沙班10 mg将口服，前7天每天两次（bid），然后5 mg bid至6个月。。

About Anthos Therapeutics

关于Anthos疗法

Anthos Therapeutics was founded by Blackstone Life Sciences in 2019 and obtained from Novartis Pharma AG the exclusive global rights to develop, manufacture, and commercialize abelacimab. Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for high-risk cardiovascular patients.

Anthos Therapeutics于2019年由Blackstone Life Sciences创立，并从诺华制药公司获得开发，制造和商业化abelacimab的独家全球权利。Anthos Therapeutics是一家临床阶段的生物制药公司，专注于基因和药理学验证的创新疗法的开发和商业化，以推进对高风险心血管患者的护理。

For more information, visit the Company’s website and follow on Twitter and LinkedIn..

欲了解更多信息，请访问公司的网站，并关注Twitter和LinkedIn。。

Forward-Looking Statements

前瞻性声明

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the initiation, and timing, of future clinical trials and its research and development.

本新闻稿包含1995年“私人证券诉讼改革法”含义内的“前瞻性声明”，涉及未来临床试验及其研究与开发的启动，时间安排等重大风险和不确定性。

All statements, other than statements of historical facts, contained in this press release, including statements regarding the company’s strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “become,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

本新闻稿中包含的除历史事实陈述外的所有陈述，包括有关公司战略，未来运营，未来财务状况，前景，管理计划和目标的陈述，均为前瞻性陈述。“预期”，“成为”，“相信”，“继续”，“可以”，“估计”，“期望”，“打算”，“可以”，“计划”，“潜力”，“预测”，“项目”，“应该”，“目标”，“将会”等词语旨在确定前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof.

任何前瞻性陈述均基于管理层对未来事件的当前预期，并受到许多风险和不确定性的影响，这些风险和不确定性可能导致实际结果与此类前瞻性陈述中提出或暗示的实际结果产生重大不利影响。此外，本新闻稿中包含的前瞻性声明代表本公司自本协议签署之日起的观点，不应视为本公司自本协议签署之日起任何日期的观点。

The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so..

公司预计随后的事件和发展将导致公司的观点发生变化。但是，虽然公司可能会选择在未来某个时候更新这些前瞻性声明，但公司明确拒绝任何义务这样做。。

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