Treating Pulmonary Embolism: How Safe and Effective Are New Devices?

A new scientific statement from the American Heart Association identifies the risks and benefits of using novel interventional devices compared to anticoagulation alone to treat patients with pulmonary embolism.

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New TAVR System Safe and Effective for High-Risk Surgical Patients with Severe Aortic Stenosis

The Portico IDE study found that 30-day safety and one-year effectiveness outcomes of a novel self-expanding transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis (AS) at high or extreme-risk for surgery was noninferior to contemporary FDA-approved TAVR systems available in the United States.

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Three-Year COAPT Data Demonstrates Continued Safety and Effectiveness in Patients with Heart Failure and Secondary Mitral Regurgitation

The three-year results from the COAPT trial demonstrated that reducing severe secondary mitral regurgitation (SMR) with the MitraClip device safely improves prognosis in selected heart failure (HF) patients. In addition, those patients that crossed over and received the MitraClip after 24 months showed the same benefits as those who received the device at the beginning of the study. Two-year data were presented at TCT 2018 and published in the New England Journal of Medicine.

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New Five-Year Data Shows Similar Outcomes for TAVR and SAVR in Patients with Severe Aortic Stenosis and Intermediate Surgical Risk

Five-year results from the PARTNER 2A trial found that patients with severe aortic stenosis (AS) and intermediate surgical risk who underwent transcatheter aortic valve replacement (TAVR) had similar rates of death and disabling stroke compared to those who had surgical aortic valve replacement (SAVR). However, TAVR using a transthoracic approach had poorer outcomes compared to SAVR.

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New Data Show that Patients with Left Main Disease Treated with PCI or CABG Have Similar Composite Outcomes at Five Years

Patients with left main coronary artery disease (LMCAD) typically have a poor prognosis due to the large amount of myocardium at risk. Revascularization with either percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) has been shown to prolong survival in patients with left main disease compared with medical therapy alone. Three-year data from the large-scale randomized ECXEL trial found no significant difference in the composite rate of death, stroke or myocardial infarction (MI) between the two treatments, with a reduction in 30-day major adverse events with PCI. These results were first reported at TCT 2016 and published in NEJM.

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Shortened Three-month DAPT Duration After PCI Demonstrates Low Rate of Adverse Events in High-Bleeding Risk Patients

Data from the EVOLVE Short DAPT study found that shortened three-month dual antiplatelet therapy (DAPT) did not increase myocardial infarction (MI) or stent thrombosis (ST) in high bleeding risk (HBR) patients treated with a contemporary drug-eluting stent.

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Ticagrelor Without Aspirin Three Months After Successful PCI and DAPT Reduces Major Bleeding Without Increasing the Risk of Adverse Events

New data from the randomized, placebo-controlled TWILIGHT trial found that compared to ticagrelor plus aspirin, ticagrelor monotherapy reduces bleeding events without increasing the risk of death, myocardial infarction, or stroke in high-risk patients who have undergone successful percutaneous coronary intervention (PCI) and completed three months of dual antiplatelet therapy (DAPT).

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Biodegradable Polymer Everolimus-eluting Stent with Shortened DAPT is Safe and Effective for PCI in Patients with Unprotected Left Main Coronary Artery Disease

New data from the IDEAL-LM trial found that a biodegradable polymer everolimus-eluting stent (BP-EES) followed by four months of dual antiplatelet therapy (DAPT) was safe and effective compared to a conventional durable polymer everolimus-eluting stent (DP-EES) followed by 12 months of DAPT in patients undergoing PCI for unprotected left main coronary artery (uLMCA) disease.

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Durable Polymer Drug-Eluting Stent Noninferior to a Polymer-Free Drug-Coated Stent in Patients at High Risk of Bleeding Treated with One-Month DAPT

The first randomized trial to compare a durable polymer drug-eluting stent to a polymer-free drug-coated stent in patients at high risk of bleeding and treated with one-month dual antiplatelet therapy (DAPT) found that both are clinically safe and effective.

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