Boston Scientific (BSX) trials show EKOS and WATCHMAN FLX hit key safety and efficacy goals
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Boston Scientific filed an 8-K to share landmark clinical data for two cardiovascular therapies. The HI-PEITHO randomized trial in 544 patients with intermediate-risk pulmonary embolism showed the EKOS endovascular system plus anticoagulation was superior to anticoagulation alone on a composite endpoint (4.0% vs. 10.3%; 61% relative reduction), without intracranial bleeding through 30 days and with shorter hospital stays.
The CHAMPION-AF trial in 3,000 patients with non-valvular atrial fibrillation found the WATCHMAN FLX left atrial appendage closure device met all primary and secondary safety and efficacy endpoints versus leading blood thinners over 36 months, delivering markedly lower non-procedural bleeding (10.9% vs. 19.0%) and similar protection from stroke and cardiovascular death, with a 99% procedural success rate.
Positive
- HI-PEITHO superiority in pulmonary embolism: EKOS plus anticoagulation achieved a 4.0% primary endpoint rate versus 10.3% for anticoagulation alone, a 61% relative reduction, with no intracranial bleeding through 30 days and shorter hospital stays.
- CHAMPION-AF net clinical benefit vs. NOACs: WATCHMAN FLX reduced non-procedural bleeding to 10.9% vs. 19.0% and showed non-inferior stroke and cardiovascular outcomes over 36 months in 3,000 NVAF patients, with a 99% procedural success rate and favorable combined safety–efficacy endpoint.
Negative
- None.
Insights
Two large pivotal trials show strong safety and efficacy signals for core Boston Scientific cardiovascular franchises.
The 8-K highlights highly favorable results from the HI-PEITHO and CHAMPION-AF trials. HI-PEITHO demonstrated the EKOS system plus anticoagulation significantly reduced serious pulmonary embolism events versus anticoagulation alone, with a composite primary endpoint of 4.0% vs. 10.3% and no intracranial bleeding through 30 days.
CHAMPION-AF, enrolling 3,000 non-valvular atrial fibrillation patients, showed the WATCHMAN FLX device cut non-procedural major and clinically relevant non-major bleeding to 10.9% vs. 19.0% for NOACs over 36 months, with non-inferior protection from stroke, systemic embolism and cardiovascular or unexplained death. A 99% implant success rate across 141 sites underscores procedural reliability for a therapy already widely used.
A secondary combined safety and efficacy endpoint showed a net clinical benefit, with key events (cardiovascular death, stroke, systemic embolism and non-procedural bleeding) at 15.1% for WATCHMAN FLX vs. 21.8% for NOACs. These data materially strengthen the clinical foundations of the EKOS and WATCHMAN platforms and may support future indication expansions and guideline updates as regulatory and reimbursement processes evolve.
Randomized data in PE and AF support device-based first-line strategies against established drug standards.
HI-PEITHO is a randomized, controlled trial of 544 intermediate-risk pulmonary embolism patients across 59 sites in the U.S. and Europe. It used a hard composite endpoint—PE-related mortality, hemodynamic cardiorespiratory decompensation or collapse, and symptomatic PE recurrence within seven days—and showed statistically significant superiority of EKOS plus anticoagulation versus anticoagulation alone.
CHAMPION-AF, the largest left atrial appendage closure study to date, randomized 3,000 NVAF patients suitable for oral anticoagulation to WATCHMAN FLX versus NOACs. It met its primary safety endpoint with a 45% relative reduction in non-procedural bleeding and demonstrated non-inferior efficacy for stroke, cardiovascular or unexplained death and systemic embolism at 36 months. A secondary analysis, including procedural bleeding, still favored the device with a 34% relative bleeding reduction, and overall net clinical benefit on combined safety and efficacy measures.
Both trials were presented as late-breaking sessions at a major cardiology meeting and simultaneously published in The New England Journal of Medicine, reinforcing the rigor and visibility of the evidence base. Longer-term follow-up to one year in HI-PEITHO and five years in CHAMPION-AF is planned, which may further clarify durability and late safety outcomes.
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________________________________________________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
_____________________________________________________________________
Date of Report (Date of earliest event reported): March 28, 2026
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||||||||
(Address of principal executive offices) (Zip Code)
(508 ) 683-4000
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On March 28, 2026, Boston Scientific Corporation (the “Company”) issued a press release announcing results from the Company's HI-PEITHO clinical trial. Also on March 28, 2026, the Company issued a second press release announcing results from the Company's CHAMPION-AF clinical trial.
Copies of each press release are included as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K and incorporated herein by reference; provided, however, that information on or connected to the Company's website or the website of any third-party hyperlinked from or referenced in the press releases included as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K is expressly not incorporated by reference into or intended to be filed as a part of this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Press Release, dated March 28, 2026.
99.2 Press Release, dated March 28, 2026.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: | March 30, 2026 | BOSTON SCIENTIFIC CORPORATION | |||||||||
| By: | /s/ Susan Thompson | ||||||||||
| Susan Thompson | |||||||||||
| Vice President, Chief Corporate Counsel and Assistant Secretary | |||||||||||
Exhibit 99.1
HI-PEITHO trial demonstrates Boston Scientific EKOS™ Endovascular System is superior to standard of care for treatment of acute pulmonary embolism
Global randomized trial demonstrated statistically significant reduction in clinical event rates in patients with intermediate-risk PE when treated with the EKOS device plus anticoagulation vs. anticoagulation alone
Late breaking findings presented at ACC.26 and simultaneously published in The New England Journal of Medicine
MARLBOROUGH, Mass. and NEW ORLEANS, March 28, 2026 -- Boston Scientific Corporation (NYSE: BSX) today announced positive data from the HI-PEITHO global randomized clinical trial evaluating the use of the EKOS™ Endovascular System in patients with intermediate-risk pulmonary embolism (PE). The study met the composite primary endpoint, with data demonstrating that the EKOS system plus anticoagulation was superior to the current standard of care – anticoagulation alone – for the treatment of acute PE. Findings from the trial were presented in a late-breaking science session at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in The New England Journal of Medicine.
PE is a blood clot that causes a blockage in one or more pulmonary arteries that bring blood to the lungs, and is the third leading cause of cardiovascular mortality.1 Current medical guidelines for treating PE recommend medical management with anticoagulation as the standard of care for patients at all risk levels. A minimally invasive intervention, the EKOS system delivers a low dose of clot-dissolving medication directly to the blood clot and uses ultrasound energy to facilitate the dispersion of the medication deep into the clot to dissolve it.
"The data presented today offer clinicians a greater understanding of the impact of intervention via ultrasound-facilitated catheter-directed thrombolysis with the EKOS system," said Dr. Stavros Konstantinides, MD, PhD, FESC, principal investigator of the HI-PEITHO trial and medical director, Center for Thrombosis and Hemostasis, University Medical Center Mainz, Germany.* "These highly anticipated findings underscore the clinical efficacy for patients treated with this therapy, while also demonstrating that treatment was not accompanied by an increased risk of major bleeding and offered the added benefit of a shorter hospital stay compared to patients treated with anticoagulation alone."
The trial met the combined primary endpoint of PE-related mortality, non-fatal hemodynamic cardiorespiratory decompensation or collapse and non-fatal symptomatic recurrence of PE within seven days. The EKOS system plus anticoagulation demonstrated superiority to anticoagulation alone (4.0% vs. 10.3%; P=0.005), representing a 61% reduction in primary
endpoint events. Data from patients treated with the EKOS system also demonstrated a lower rate of cardiorespiratory decompensation or collapse (3.7% vs. 10.3%), in which inability of the heart to maintain adequate blood flow can lead to serious complications, often requiring emergency intervention. These results were achieved with no episodes of bleeding within the brain through 30 days.
"The HI-PEITHO trial evaluated clear, clinically meaningful endpoints using rigorous patient enrollment criteria and demonstrated a definitive impact with the EKOS system over the standard of care for treating acute PE," said Dr. Michael R. Jaff, vice president and chief medical officer, Vascular Therapies, Boston Scientific. "For the first time, we have robust randomized clinical trial data available to inform treatment decisions by interventionalists and referring physicians and support consideration of EKOS plus anticoagulation as a first-line therapy."
The randomized, controlled HI-PEITHO trial enrolled 544 patients with intermediate-risk PE across 59 sites in the United States and Europe. The trial is a joint research study led by Boston Scientific in partnership with The PERT Consortium® and the University Medical Center of Mainz and in collaboration with the PEITHO International Study Network. Patients will be followed to one year post procedure.
For more information on the HI-PEITHO trial, visit https://www.bostonscientific.com/hi-peitho.
About Boston Scientific
Boston 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 healthcare. 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 follow us on LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
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, product performance and impact, and clinical trials. 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.
Factors that may cause such differences include, among other things: economic conditions, including the impact of foreign currency fluctuations; future U.S. and global political, competitive, reimbursement and regulatory conditions, including changing trade and tariff policies; geopolitical events, conflicts and tensions; 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; the execution and effect of our business strategy, including our cost-savings and growth initiatives; 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.
CONTACTS:
Blake Rouhani
Media Relations
+1 (763) 494-2268
Blake.rouhani@bsci.com
Lauren Tengler
Investor Relations
+1 (508) 683-4479
BSXInvestorRelations@bsci.com
* Dr. Stavros Konstantinides is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.
1 Wendelboe, A.M, et al. Global Burden of Thrombosis: Epidemiologic Aspects. Circulation Research.2016 Apr 29; 118(9): 1340-1347. doi: 10.1161/CIRCRESAHA.115.306841.
SOURCE Boston Scientific Corporation
Exhibit 99.2
CHAMPION-AF study of the WATCHMAN FLX™ Left Atrial Appendage Closure Device as a first-line therapy for stroke risk reduction meets all primary and secondary safety and efficacy endpoints
Data highlights the WATCHMAN FLX device provided statistically superior protection from bleeding, demonstrated similar efficacy compared to blood thinners in patients with non-valvular atrial fibrillation
Late-breaking findings presented at ACC.26 and simultaneously published in The New England Journal of Medicine
MARLBOROUGH, Mass. and NEW ORLEANS, March 28, 2026 -- Boston Scientific Corporation (NYSE: BSX) today announced that the CHAMPION-AF global clinical trial met all primary and secondary safety and efficacy endpoints. The study evaluated the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device compared to non-vitamin K antagonist oral anticoagulants (NOACs) as a first-line option for stroke risk reduction in a broad population of patients with non-valvular atrial fibrillation (NVAF). Key results were presented as a late-breaking clinical trial at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in The New England Journal of Medicine.
Atrial fibrillation (AF) is an increasingly common heart rhythm disorder that affects approximately 59 million people worldwide1 and increases stroke risk by five times compared to people with a normal heart rhythm.2 In patients with NVAF, more than 90% of heart-related blood clots form in the left atrial appendage (LAA).3 An alternative to long-term NOACs – considered the leading contemporary blood thinners for stroke risk reduction in patients with NVAF – the WATCHMAN technology is designed to permanently close off the LAA and is implanted in a single procedure.
"The success of the landmark CHAMPION-AF trial represents a meaningful milestone that will undoubtedly transform the treatment approach to stroke risk reduction in a broader population of patients who historically have needed to rely on medication," said Martin Leon, M.D., study co-chair and Mallah Family professor of cardiology, chief innovation officer and director, Cardiovascular Data Science Center, Columbia University Medical Center.* "These results should give clinicians confidence in the potential of the WATCHMAN FLX device to become a first-line treatment option for reducing the risk of stroke for a rapidly growing number of patients with AF."
The randomized, controlled trial enrolled 3,000 patients with NVAF who were suitable for oral anticoagulation therapy across a broad spectrum of stroke and bleeding risk. At 36 months:
•The primary safety endpoint was met with data demonstrating the WATCHMAN FLX device was statistically superior to NOACs (10.9% vs. 19.0%; P<0.001) for non-procedural major and clinically relevant non-major bleeding, achieving a 45% relative reduction in non-procedural bleeding risk.
◦When including procedural bleeding in a secondary analysis, the WATCHMAN FLX device performance was consistent with the primary safety endpoint, demonstrating a significant reduction in bleeding compared to NOACs (12.8% vs. 19.0%; P<0.001) for major and clinically relevant non-major bleeding, representing a 34% relative reduction in procedural and non-procedural bleeding risk.
•The primary efficacy endpoint, defined as occurrence of stroke, cardiovascular or unexplained death or systemic embolism, was met with the WATCHMAN FLX device achieving statistical non-inferiority compared to NOACs (5.7% vs. 4.8%; P<0.001).
The study's secondary safety endpoint underscored the WATCHMAN FLX device is statistically non-inferior to NOACs at 36 months for procedural and non-procedural major bleeding (5.9% vs. 6.4%; P<0.001). Additionally, a secondary combined safety and efficacy endpoint highlighted a net clinical benefit with the device demonstrating statistical superiority to NOACs for the occurrence of cardiovascular death, stroke, systemic embolism and non-procedural major bleeding and clinically relevant non-major bleeding (15.1% vs. 21.8%; P<0.001).
CHAMPION-AF is the largest clinical trial comparing an LAAC device to NOACs for patients with NVAF to date and included 141 sites in the U.S., Canada, Europe, Japan and Australia, which implanted the devices with a 99% procedural success rate. Patient follow-up in the CHAMPION-AF trial will continue through five years and will include additional primary and secondary endpoints.
"These positive data, which have the potential to support updated clinical guidelines globally, will be used in our submission to expand the indication and coverage for the well-established WATCHMAN platform as a first-line stroke risk reduction option, providing physicians with more choices in care for a wider range of patients who have atrial fibrillation," said Brad Sutton, M.D., chief medical officer, Atrial Fibrillation Solutions, Boston Scientific. "Today, 40% of patients with AF who are prescribed blood thinners for stroke risk reduction are not taking their medications consistently, significantly increasing their risk of stroke.4 The CHAMPION-AF data add to Boston Scientific's robust body of clinical evidence supporting the WATCHMAN device as a one-time implant that helps provide stroke risk protection over a patient's lifetime."
More than 600,000 people have been treated with the WATCHMAN implant, which is the most implanted and studied LAAC device on the market. The WATCHMAN LAAC device was first introduced to the European market in 2009 and was approved by the U.S. Food and Drug Administration (FDA) in 2015. The latest-generation WATCHMAN FLX™ Pro LAAC Device was approved in the U.S. in 2023 and is currently being studied in several clinical trials, including the SIMPLAAFY randomized controlled trial, which is evaluating single-drug alternatives to dual anti-platelet therapy as a post-procedural regimen.
For more information about the CHAMPION-AF trial, visit watchman.com/CHAMPION
About Boston Scientific
Boston 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 healthcare. 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 follow us on LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
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, product performance and impact, clinical trials, and new and anticipated product approvals and/or indications or coverage expansions. 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.
Factors that may cause such differences include, among other things: economic conditions, including the impact of foreign currency fluctuations; future U.S. and global political, competitive, reimbursement and regulatory conditions, including changing trade and tariff policies; geopolitical events, conflicts and tensions; 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; the execution and effect of our business strategy, including our cost-savings and growth initiatives; 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.
CONTACTS:
Kirsten Lesak-Greenberg
Media Relations
+1 (763) 300-9254
Kirsten.Lesak-Greenberg@bsci.com
Lauren Tengler
Investor Relations
+1 (508) 683-4479
BSXInvestorRelations@bsci.com
* Dr. Martin Leon is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.
1 Linz, Dominik, et al. Atrial fibrillation: epidemiology, screening and digital health. Lancet Reg Health Eur. 2024 Feb 1:37:100786. https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(23)00205-3/fulltext. Accessed Feb. 3, 2026.
2 FAQ About AFib. American Heart Association, Inc., 2023. https://www.heart.org/-/media/Files/Health-Topics/Atrial-Fibrillation/FAQ-About-AFib.pdf. Accessed Feb. 3, 2026.
3 Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61:755-759.
4 Tarn, D, Shih, K, Tseng, C. et al. Reasons for Nonadherence to the Direct Oral Anticoagulant Apixaban: A Cross-Sectional Survey of Atrial Fibrillation Patients. JACC Adv. 2023 Jan, 2 (1). https://doi.org/10.1016/j.jacadv.2022.100175.
SOURCE Boston Scientific Corporation
FAQ
What did Boston Scientific (BSX) announce about the HI-PEITHO trial?
Boston Scientific reported that the HI-PEITHO trial in 544 intermediate-risk pulmonary embolism patients showed the EKOS system plus anticoagulation was superior to anticoagulation alone, reducing the composite primary endpoint to 4.0% versus 10.3%, without intracranial bleeding through 30 days and with shorter hospital stays.
How effective was the EKOS system in treating pulmonary embolism in HI-PEITHO?
The EKOS system plus anticoagulation significantly lowered the composite endpoint of PE-related death, cardiorespiratory decompensation or collapse, and symptomatic recurrence to 4.0% compared with 10.3% for anticoagulation alone, a 61% relative reduction, and showed fewer decompensation events (3.7% vs. 10.3%) without brain bleeding through 30 days.
What are the key CHAMPION-AF trial results for WATCHMAN FLX reported by BSX?
CHAMPION-AF showed the WATCHMAN FLX device met all primary and secondary safety and efficacy endpoints versus NOACs in 3,000 NVAF patients, cutting non-procedural bleeding to 10.9% from 19.0% and achieving non-inferior rates of stroke, cardiovascular or unexplained death and systemic embolism over 36 months.
How did WATCHMAN FLX compare to NOACs on bleeding outcomes in CHAMPION-AF?
WATCHMAN FLX reduced non-procedural major and clinically relevant non-major bleeding to 10.9% versus 19.0% for NOACs, a 45% relative reduction. Including procedural bleeding, rates were 12.8% versus 19.0%, representing a 34% relative reduction in overall bleeding risk over 36 months.
What combined safety and efficacy benefits did WATCHMAN FLX show in CHAMPION-AF?
A secondary combined endpoint demonstrated net clinical benefit for WATCHMAN FLX, with cardiovascular death, stroke, systemic embolism and non-procedural major or clinically relevant non-major bleeding occurring in 15.1% of patients versus 21.8% on NOACs, showing statistical superiority at 36 months of follow-up.
How large and global were the HI-PEITHO and CHAMPION-AF trials disclosed by Boston Scientific?
HI-PEITHO enrolled 544 pulmonary embolism patients across 59 sites in the U.S. and Europe, while CHAMPION-AF included 3,000 non-valvular atrial fibrillation patients at 141 sites in the U.S., Canada, Europe, Japan and Australia, with a 99% WATCHMAN FLX implant success rate.
Where and how were the HI-PEITHO and CHAMPION-AF findings for BSX presented?
Both HI-PEITHO and CHAMPION-AF results were presented as late-breaking sessions at the American College of Cardiology’s Annual Scientific Session & Expo and were simultaneously published in The New England Journal of Medicine, highlighting their clinical importance and peer-reviewed validation.