Boston Scientific Corporation (NYSE:BSX) shares are down on Monday as the company faces pressure following a significant clinical trial data announcement.
WATCHMAN FLX Shows Bleeding Advantage, Matches Efficacy
The CHAMPION-AF study results shared on Saturday highlighted the WATCHMAN FLX device’s efficacy compared to traditional blood thinners as a first-line option for stroke risk reduction in a broad population of patients with non-valvular atrial fibrillation (NVAF), a common heart rhythm disorder.
The CHAMPION-AF trial demonstrated that the WATCHMAN FLX device provided statistically superior protection from bleeding while showing similar efficacy to non-vitamin K antagonist oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation.
The study, which enrolled 3,000 patients, reported a 99% procedural success rate and will continue to follow patients for five years to gather additional data.
The study met the primary safety endpoint, with data demonstrating the WATCHMAN FLX device was statistically superior to NOACs (10.9% vs. 19.0%) for non-procedural major and clinically relevant non-major bleeding, achieving a 45% relative reduction in non-procedural bleeding risk.
The primary efficacy endpoint, defined as the 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%).
The study’s secondary safety endpoint underscored that 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%). 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%).
Boston Scientific EKOS System Data Signals Benefit
On Saturday, Boston Scientific also shared data from the HI-PEITHO trial 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.
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 the heart is not able to maintain adequate blood flow. These results were achieved with no episodes of bleeding within the brain through 30 days.
Boston Scientific Analyst Reactions Turn Mixed Despite Positive Data
Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $103.45. Recent analyst moves include:
- Raymond James: Downgraded to Outperform (Lowers Target to $88.00) (March 30)
- Needham: Buy (Maintains Target to $97.00) (March 30)
- Goldman Sachs: Buy (Lowers Target to $93.00) (March 27)
BSX Price Action: Boston Scientific shares were down 9.02% at $62.93 at the time of publication on Monday. The stock is trading at a new 52-week low, according to Benzinga Pro data.
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