Acute Coronary Syndrome

— Data confirm the use of FFRCT and Plaque Analysis helps assess long-term risks, informing more personalized and effective treatment plans for patients with coronary artery disease -– FFRCT further validated in new study demonstrating diagnostic accuracy and greater ability than CCTA alone to rule out hemodynamically significant stenoses in patients with high-risk NSTE-ACS WASHINGTON, Oct. 27, 2024 (GLOBE NEWSWIRE) -- HeartFlow, Inc., the global leader in non-invasive artificial intelligence (AI) heart care solutions, today announced seven-year data confirming the use of HeartFlow’s AI-enabled fractional flow reserve computed tomography (FFRCT) and Plaque Analysis in the assessment of long-term risk of coronary artery disease (CAD) in clinically stable, symptomatic patients. The data show the HeartFlow platform provides clinicians with the insights needed to anticipate and mitigate adverse events, including myocardial infarctions, in symptomatic patients with stable chest pain. The data were presented at the 36th annual Transcatheter Cardiovascular Therapeutics® (TCT) conference in Washington, D.C. ADVANCE-DK is data from a subset of the larger ADVANCE Registry, which prospectively evaluated the use of a coronary computed tomography angiography (CCTA) and FFRCT diagnostic pathway in real-world settings to determine the impact on decision-making, downstream invasive coronary angiography (ICA), revascularization, and major adverse cardiovascular events (MACE). ADVANCE-DK assessed three patient sets: those with normal FFRCT, those with subsequent complete revascularization (CR), and those with subsequent incomplete revascularization (IR). Seven-year follow-up data from ADVANCE-DK demonstrates the completeness of revascularization predicts clinical outcomes and can be assessed non-invasively using coronary CCTA and FFRCT. Patients with IR, as assessed by FFRCT, had a higher long-term risk of adverse events than patients whose FFRCT assessment showed CR or patients who had normal FFRCT (16.2% IR versus 7.8% CR and 5.7% normal FFRCT, respectively)The combination of plaque quantification and characterization and lesion-specific physiology from FFRCT is a superior predictor of adverse cardiovascular events, through seven-year follow-up (AUC 0.73 vs 0.63 inclusive of baseline risk variables + CCTA) “We theorized that by leveraging non-invasive FFRCT we could identify critical issues that had previously gone unnoticed, such as significant coronary lesions that would likely have been mistakenly categorized as visually insignificant,” said Kristian Tækker Madsen, M.D., cardiologist at University Hospital of Southern Denmark. “The prospective data with long-term follow-up in ADVANCE-DK alongside Plaque Analysis data gave us far more than that. FFRCT remains valuable for patients across all categories, and the combination of FFRCT and quantitative plaque data, especially after four years of follow up, can offer providers invaluable insight into a patient’s long-term risks informing more personalized and effective treatment plans.” In a separate study, “Usefulness of FFRCT to Exclude Hemodynamically Significant Lesions in High-Risk NSTE-ACS,” lesion-specific FFRCT was further validated in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS). The authors found that the use of CCTA with or without FFRCT “would have avoided 54% to 64% of unnecessary invasive assessments” in the high-risk population studied. At the lesion level, FFRCT far outperformed CCTA alone in identifying significant lesions likely to benefit from revascularization (AUC 0.84 versus 0.65, p<0.01), suggesting an enhanced capability to avoid unnecessary invasive coronary angiography (ICA). The data were published concurrently in the EuroIntervention journal in a peer-reviewed article titled “Usefulness of FFR-CT in Patients with High-risk NSTE-ACS.”1 “The ADVANCE-DK data show that our technologies go beyond identifying the immediate risks of CAD to include long-term residual risks across the spectrum of the disease. Data from patients with high-risk NSTE-ACS further suggest lesion-specific FFRCT provides an enhanced capability to avoid unnecessary invasive tests. With HeartFlow, clinicians receive actionable insights and data that are currently missing from traditional non-invasive and invasive diagnostic tools,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer of HeartFlow. “We’re grateful to all the participants and investigators who supported the collection of these valuable data as we build upon our clinical evidence demonstrating the value of HeartFlow ONE including FFRCT Analysis and AI-enabled Plaque Analysis in managing CAD.” Cardiovascular diseases are the most common cause of death globally for both men and women, yet four out of five heart attacks and strokes are preventable with lifestyle and nutrition changes if patients at high risk are identified early.1 Understanding plaque burden – where plaque is in the coronary arteries, the amount of plaque, and the type of plaque – is one of the best ways for physicians to identify patients at high risk of death from a heart attack.2 HeartFlow is dedicated to defeating heart disease through partnering with physicians to generate robust, high-quality clinical evidence. HeartFlow has been adopted by more than 1,300 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population worldwide. About HeartFlow, Inc.HeartFlow is transforming precision coronary care with the only AI-powered, non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap™ Analysis, and Plaque Analysis. More than 500 peer-reviewed publications have validated our approach and more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com. Media Contact:Elliot Levymedia@heartflow.com Investor Contact:Nick Laudiconlaudico@heartflow.com References1. Meier, D. et al, Usefulness of FFR-CT in Patients with High-risk NSTE-ACS. EuroIntervention. 2024; In press.2. World Heart Federation. Prevention. Accessed Oct. 25, 2024.3. Thomsen, C., Characteristics of high-risk coronary plaques identified by computed tomographic angiography and associated prognosis: a systematic review and meta-analysis. EHJ. 2016; 17, 120-129. A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fa3731a5-d3f1-4e09-bfc8-6af4b78d11ab

Greater than 2-fold predictive value (p=0.001) for heart attack, stroke, and death Significant unmet need in balancing the risks and benefits of antithrombotic treatment in patients with acute coronary syndrome (ACS) Supports trend in individualized antiplatelet therapy PHILADELPHIA, PA / ACCESSWIRE / October 21, 2024 / Prolocor, Inc., a healthcare startup developing the innovative diagnostic Prolocor pFCG® test that identifies patients at higher and lower risk of thrombotic events (heart attack, stroke, and death), announced today the publication of results from the confirmatory 800 patient ACS trial titled: FcγRIIa: A Marker of Cardiovascular Risk after Myocardial Infarction in the prestigious Journal of the American College of Cardiology (JACC).The trial was conducted in 25 sites across the United States. Prolocor Logo Dr. David Schneider, Prolocor Co-Founder and Chief Scientific Officer said, “I would like to thank the investigators and patients for their participation in this important study. The Prolocor pFCG ® test is poised to become a critical tool for clinical decision making in ACS patients.” The trial was a prospective, multicenter non-interventional cohort study. The primary objective of the study was to determine whether the Prolocor pFCG ® test, which quantifies the expression of FcγRIIa on the platelet surface, predicts risk of heart attack, stroke and death. Patients with a high pFCG had a significantly higher risk of an event than those in the low-risk group a hazard ratio of 2.09 (1.34-3.26;) p = 0.001. Dr Deepak L. Bhatt, the Director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai, stated, “We need tools to enable better risk stratification and treatment of ACS patients. A simple blood test that assists in decisions regarding intensity and duration of antiplatelet therapy would be extremely useful if it subsequently leads to better patient outcomes.” “We have now studied Prolocor pFCG ® in nearly 1,000 ACS patients, with consistent results,” said CEO and Co-founder Dr. Pete DiBattiste. “We at Prolocor understand the challenges clinicians face in treating this patient population and are working closely with our cardiology colleagues to provide them with this additional tool to support their clinical decision.” Additional information regarding the Prolocor pFCG ® test and our clinical development program are available at Prolocor.com . ABOUT PROLOCOR, INC. Founded by a team that deeply understands thrombosis and cardiovascular disease, Prolocor is building its strategy around platelet FcγRIIa and embarking on a journey to commercialize an innovative precision diagnostic test that quantifies FcγRIIa on the surface of platelets. For more information on Prolocor, please visit the company’s website at and follow us on LinkedIn. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although Prolocor’s management believes that the expectations reflected in such forward-looking statements are reasonable, forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Prolocor, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, Prolocor’s planned level of revenues and capital expenditures, Prolocor’s available cash and its ability to obtain additional funding, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities regarding whether and when to approve any device or application that may be filed for any such product candidates and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Prolocor’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, and risks associated with intellectual property. Other than as required by applicable law, Prolocor does not undertake any obligation to update or revise any forward-looking information or statements. CONTACT ray.russo@prolocor.com SOURCE: Prolocor Inc. View the original press release on newswire.com.

WASHINGTON, Oct. 15, 2024 /PRNewswire/ -- A new Scientific Statement published by the Heart Failure Society of America (HFSA) has revealed a critical connection between heart failure (HF) and cancer, with shared mechanisms contributing to the incidence and progression of both diseases. Cardio-Oncology and Heart Failure: A Scientific Statement from the Heart Failure Society of America, published today in the Journal of Cardiac Failure (JCF), shows that patients with cancer are at increased risk of developing HF, while HF patients face a higher risk of cancer, emphasizing the need for coordinated care between cardiology and oncology. Continue Reading "Integrating heart failure clinicians into the care of cancer patients is crucial..." Ana Barac, MD, PhD, co-lead author Post this Journal of Cardiac Failure "We are only scratching the surface in the expanding field of cancer therapeutics. As we advance, it becomes clear that understanding the full spectrum of cardiac toxicities, including heart failure, is essential for maximizing treatment benefits and safeguarding patient heart health," said co-lead author Michelle Bloom, MD (Leon H. Charney Division of Cardiology, NYU Langone Heart, NYU Grossman School of Medicine, New York, NY). Ana Barac, MD, PhD, co-lead author (Inova Schar Heart and Vascular, Inova Schar Cancer, Falls Church, Virginia) went on to add, " Integrating heart failure clinicians into the care of cancer patients is crucial; their expertise ensures early detection and management of cardiac toxicity, ultimately enhancing patient outcomes and preserving quality of life. This statement underscores the critical need for a multidisciplinary approach in managing heart failure among cancer patients, emphasizing that understanding the intersection of these two complex conditions is essential for improving patient outcomes and addressing disparities in care." The Cardio-Oncology and Heart Failure: A Scientific Statement from the Heart Failure Society of America points out that more uniform guidelines are needed regarding standardized cardiac imaging protocols during cancer therapies to prevent heart-related complications. More protocols are also needed regarding the notion of "permissive cardiotoxicity," which acknowledges the need to balance some increased HF risk to ensure optimal cancer treatment. Careful assessment by heart failure specialists is crucial in cancer treatments including during risk assessments for heart transplantation and durable left ventricular assist device (LVAD) placements. As noted in the HF STATS 2024: Heart Failure Epidemiology and Outcomes Statistics An Updated 2024 Report from the Heart Failure Society of America paper, also published in JCF, the area of cardio-oncology, with systemic challenges such as delayed screenings and limited access to quality treatment, contributing to worse outcomes. This must be addressed to improve heart failure and cancer care. The Cardio-Oncology and Heart Failure: A Scientific Statement from the Heart Failure Society of America is available online in the JCF at . DOI: 10.1016/j.cardfail.2024.08.045 In addition to the statement, two supplemental articles have also been published: Cardio-Oncology and Heart Failure: AL Amyloidosis for the Heart Failure Clinician A Supplement to the Scientific Statement from the Heart Failure Society of America DOI: 10.1016/j.cardfail.2024.08.046 Heart Failure in Patients with Cancer – A Patient's Perspective DOI: 10.1016/j.cardfail.2024.08.047Authored by Cynthia Chauhan, recent winner of the HFSA Heartfelt Hero Award, this article provides a thought-provoking glimpse into the experience of clinical heart failure in a patient with cancer, providing a unique context with which HF clinicians can frame patient discussions and overall care. View all HFSA published scientific statements, guidelines and other clinical documents. Top 10 Key Takeaways HF and cancer share common pathophysiological mechanisms for disease incidence and progression with evidence for reciprocal relationship. Patients with cancer are at increased risk for development of HF and patients with HF are at higher risk of developing cancer. Beyond anthracyclines and HER2-targeted monoclonal antibodies, very few cancer therapeutics have standardized cardiac imaging surveillance recommendations, resulting in significant variations in clinical practices. The concept of "permissive cardiotoxicity" highlights an emerging approach of maintaining lifesaving cancer therapies while accepting some degree of cardiac toxicity and mitigating risk through cardioprotective strategies. Heart failure with preserved ejection fraction (HFpEF) is an important yet under-recognized aspect of cancer therapy-related cardiac toxicity, described in a wide array of cancer therapeutics including BTK inhibitors, CAR-T therapies, and hematopoietic stem cell transplantation (HSCT). Cardiogenic shock in cancer patients can arise from various causes, including LV dysfunction due to cancer therapies, acute coronary syndrome, stress-induced cardiomyopathy, and immune checkpoint inhibitor-associated myocarditis. Durable left ventricular assist devices (LVADs) are feasible for patients with Stage D HF due to chemotherapy-induced cardiomyopathy, with similar survival rates compared to other causes of cardiomyopathy. For candidates with a history of cancer, careful and individualized risk assessment in collaboration with oncology specialists is crucial to determine eligibility for heart transplantation. This includes evaluating the impact of pre-existing neoplasms and the risk of cancer recurrence, with a personalized approach essential to prevent unnecessary delays in transplant listing. ICI-associated myocarditis should be recognized and treated urgently due to its severe nature and high mortality risk. Multidisciplinary care is crucial for accurate diagnosis and effective management, especially in hemodynamically unstable patients. Palliative care involvement is essential for enhancing the quality of life in patients with both cancer and HF, and should be integrated early to manage symptoms, psychological stress, and care coordination. There is a growing push to integrate palliative care practices from oncology and cardiology to better support these patients, supported by clinical research and professional recommendations. Racial and ethnic minorities and LGBTQI+ populations experience significant health disparities in cancer and cardiovascular care due to systemic issues like delayed screenings and limited access to quality care. Strategies to address these inequities include community outreach, inclusive research, and improved access to care and clinical trials. About the Heart Failure Society of America The Heart Failure Society of America, Inc. (HFSA) represents the first organized effort by heart failure experts from the Americas to provide a forum for all those interested in heart function, heart failure, and congestive heart failure (CHF) research and patient care. The mission of HFSA is to provide a platform to improve and expand heart failure care through collaboration, education, innovation, research, and advocacy. HFSA members include physicians, scientists, nurses, nurse practitioners, pharmacists, trainees, other healthcare workers and patients. For more information, visit hfsa.org. About the Journal of Cardiac Failure The Journal of Cardiac Failure (JCF) publishes the highest quality science in the field of heart failure with a focus on diversity, equity, and inclusion, mentorship, multidisciplinary partnerships, and patient-centeredness. Published papers span original investigator-initiated work to state-of-the-art reviews, guidelines and scientific statements, expert perspectives, early career and trainee spotlight pieces, patient and patient-partner narratives. JCF also emphasizes the power of language and prioritizes innovative approaches to dissemination of published work to reach and impact the broader heart failure community. Media Contact: Laura Poko, 301-798-4493, ext. 226, [email protected] SOURCE Heart Failure Society of America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED