Yesterday, the American Heart Association (AHA) and American College of Cardiology (ACC) joint committee updated its guidelines for pulmonary embolism (PE). This marks the first update since the AHA last published PE guidelines in 2011.
BTIG analysts Marie Thibault, Sam Eiber and Alexandra Pang say the update had been expected this quarter and proves most relevant to Stryker after its acquisition of Inari Medical, as well as Boston Scientific ahead of its planned acquisition of Penumbra. Both companies develop leading mechanical thrombectomy (MT) systems. Other thrombectomy technology players include the likes of Imperative Care, Inquis Medical and Jupiter Endovascular.
The analysts say the new guidelines are a welcome change to the existing classifications for PE.
“A higher recommendation for mechanical thrombectomy (MT) has been hoped for since there have been a couple of RCT readouts in the space over the past couple of years,” the analysts wrote.
In their published guidelines, the AHA and ACC say the de novo guideline provides comprehensive recommendations for the evaluation, management and follow-up of adult patients (18 and older) with acute PE.
“A key feature of this guideline is the introduction of the AHA/ACC Acute Pulmonary Embolism Clinical Categories, which enhance the precision of severity classification, prognosis assessment, and evidence-based therapeutic decision-making,” the abstract reads.
More on the new guidelines that could benefit Boston Scientific, Stryker and more
The new guidelines set out a new clinical classification scheme for PE severity. It assigns a higher level of evidence supporting the use of MT. However, it keeps the use of MT and catheter-directed thrombolysis at the same recommendation for both massive PE and submassive PE.
Categories A-E (A being lowest risk, E being highest risk) now encompass PE grading. The guidelines now recommend that advanced therapies like systemic lysis, CDT, MT and surgical embolectomy are reasonable (Class 2a) for Category E1 and can be considered (Class 2b) for Category D1-2. MT and CDT may also be considered for Category D1-E1 over systemic lytics to reduce major bleeding risks (Class 2b).
The categories and subcategories range from low to high risk for adverse outcomes. It aims to enhance the precision of severity classification, prognosis assessment, and evidence-based therapeutic decision-making for patients presenting with acute PE.
According to the analysts, the societies maintain the labels of “limited data” or “non-randomized” in spite of recent trials. Additional large trials in progress could influence new iterations of the guidelines, too, the analysts said.
The analysts maintain a “Buy” rating for both Boston Scientific and Stryker in the wake of the guideline updates.
