BRIGHT-4, OPTION, PRECISE, ISCHEMIA EXTENDed Trials Provide Insights on Strategies For Managing ACS and Revascularization

Drugs and strategies in managing acute coronary syndrome and revascularization were the focus of the BRIGHT-4, OPTION, PRECISE and ISCHEMIA-EXTENDed trials presented during a dedicated late-breaking science session Nov. 6 during AHA 2022 in Chicago.

Findings from the BRIGHT-4 study presented by Gregg W. Stone, MD, FACC, on behalf of Yaling Han, MD, FACC, and simultaneously published in The Lancet, found that bivalirudin with a median three-hour post-PCI high-dose infusion significantly reduced the 30-day composite rate of all-cause mortality or BARC types 3-5 major bleeding compared with heparin monotherapy in Chinese patients with STEMI undergoing primary PCI with radial artery access. "Strengths of BRIGHT-4 include its large size, few exclusion criteria, and use of radial artery access in most patients," researchers said. "Excluding patients with pre-random-assignment use of heparin or bivalirudin and restricting tirofiban use for patients with procedural thrombotic complications allowed the specific effects of bivalirudin with a post-PCI high-dose infusion and heparin monotherapy to emerge."

In OPTION, dual antiplatelet therapy (DAPT) with indobufen plus clopidogrel significantly reduced the risk of one-year net clinical outcomes in Chinese patients with negative cardiac troponin undergoing drug-eluting stent (DES) implantation, compared to conventional DAPT of aspirin plus clopidogrel. This difference was mainly driven by a reduction in bleeding events without an increase in ischemic events, according to Junbo Ge, MD, FACC, who presented the findings, which were also published in Circulation. In terms of clinical implications, Ge and colleagues note their findings suggest that aspirin replacement with indobufen on top of a P2Y12 inhibitor is feasible in patients with negative cardiac troponin undergoing coronary DES implantation. "This trial provides an important insight that could aid in decision-making for the optimal DAPT strategy in patients at high bleeding risk," they said.

Results from PRECISE found a personalized "precision" testing approach led to more efficient evaluations for cardiovascular disease risk and improved diagnosis and treatment of coronary artery disease when compared to usual care in more than 2,000 adults with stable chest pain. Researchers compared a strategy of initial risk screening with delayed testing for low-risk participants and computed tomography for all others to a strategy without initial screening and with immediate testing for all participants to determine the need for treatment or further testing for heart disease. "The PRECISE study provides the first randomized evidence for a risk-based testing strategy to reduce extra testing and improve efficiency of care while maintaining excellent patient outcomes, such as using guideline-directed medications, reducing chest pain and minimizing the number of heart attacks or heart disease-related deaths," said Pamela S. Douglas, MD, MACC. She added that the study findings may help with chest pain evaluations by accurately identifying those who can safely delay diagnostic testing and identifying a preferred test for those who need testing.

In ISCHEMIA-EXTENDed, also simultaneously published in Circulation, Judith S. Hochman, MD, FACC, provided a follow-up interim report of the ISCHEMIA trial, which randomized patients to an invasive strategy of routine cardiac catheterization followed by optimal revascularization with PCI or CABG surgery vs. a conservative strategy with cardiac catheterization if there was failure of optimal medical therapy. The interim report findings show an initial invasive strategy compared with an initial conservative strategy resulted in no difference in all-cause mortality with nearly twice the number of deaths; lower risk of cardiovascular mortality; and higher risk of non-cardiovascular mortality, over a media follow-up period of 5.7 years. Follow-up is ongoing.

Clinical Topics: Anticoagulation Management, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Computed Tomography, Nuclear Imaging

Keywords: AHA Annual Scientific Sessions, AHA22, Aspirin, Computed Tomography Angiography, Coronary Angiography, Coronary Artery Disease, Drug-Eluting Stents, Everolimus, Heparin, Hirudins, Ischemia, Peptide Fragments, Sirolimus

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