HJAR Jul/Aug 2020

HEALTHCARE JOURNAL OF ARKANSAS I  JUL / AUG 2020 61 For weekly eNews updates and to read the journal online, visit HealthcareJournalAR.com “This pandemic is showing us that we are truly all in this together.” Planning for the room upgrades began in March, and the work was completed on April 4. CHI St. Vincent Announces First Patient in PROACT Xa Clinical Trial CryoLife, Inc. (NYSE: CRY) announced that it has initiated enrollment in the PROACT Xa clini- cal trial, a prospective, randomized, trial to deter- mine if patients with an On-X mechanical aortic valve can be maintained safely and effectively on apixaban (Eliquis®) rather than on warfarin Pat Mackin, chairman, president, and chief exec- utive officer of CryoLife, said, “We are pleased to announce that the first patient in our PROACT Xa clinical trial has been enrolled at CHI St. Vincent Heart Institute in Little Rock, Arkansas. Under the PROACT Xa trial, we will study the use of apixaban in patients with the On-X Aortic Valve, the first and only mechanical aortic heart valve to receive both FDA approval, and the CE Mark for labeling to permit use with a reduced warfarin dosage, based on results of the original PROACT trial that dem- onstrated a greater than a 60 percent reduction in bleeding events, without increased risk of stroke.” Mackin added, “Despite the ongoing COVID-19 pandemic, many institutions are continuing to enroll patients in important clinical trials. As a result, if the trial meets its endpoints, we believe we can still achieve FDA approval for the use of apixaban with the On-X Aortic Valve in 2024.” Dr. John Alexander, chair of the PROACT Xa trial and professor of cardiology at Duke, said, “We are excited to have started enrollment in the PROACT Xa study. This pragmatic trial, designed using the principles of Quality-by-Design, will generate high quality evidence on whether apixaban can safely be used as an alternative to warfarin in patients with a mechanical aortic heart valve. If apixaban is proven non-inferior to warfarin, it would offer improved quality of life for these patients who cur- rently require frequent INR testing and would be a paradigm shift for clinicians managing patients with valvular heart disease.” Patients with mechanical heart valves are anti- coagulated with warfarin, which requires rou- tine blood testing to manage their INR (Interna- tional Normalized Ratio) within a certain range to minimize the likelihood of bleeding and stroke. INR management within prescribed ranges can be challenging due to dietary restrictions and drug interactions. Despite multiple studies showing that tissue valves are associated with worse out- comes, including higher reoperation rates com- pared to mechanical valves, younger patients sometimes opt for a tissue valve to avoid the need to take warfarin due to its side effects. Providing an alternative to warfarin, such as apixaban, gives younger patients a strong incentive to choose an On-X Aortic Valve with greater durability, gener- ally better long-term survival, and better clinical outcomes. Dr. Thomas Rayburn III, MD, CHI St. Vincent Heart Institute, said, “The CHI St. Vincent Heart Institute is pleased to be the first site in the United States to take the next step in this important research. We look forward to answering this vital clinical question and are especially excited that we can continue to collaborate remotely using telehealth technologies to maintain momentum at this time. Our role in this important research is indicative of CHI St. Vincent’s healing ministry and commitment to delivering the most advanced, compassionate care to our communities across Arkansas which suffer from a high prevalence of cardiac disease, stroke, obesity and diabetes.” Dr. Tracy Wang, principal investigator of the PROACT Xa coordinating center at the Duke Clinical Research Institute said, “Being able to enroll our first patient under the disruptive cloud of COVID-19 underscores just how much patients and clinicians alike have been looking forward to this study. The pragmatic nature of the study design is appealing to potential participants, enabling enrollment to move forward even during a time when research activities are often curtailed, and enhancing the likelihood of high-quality fol- low-up by participants even if social distancing remains necessary.” The PROACT Xa trial is a prospective, mul- ticenter, randomized clinical trial consisting of approximately 1,000 participants (500 participants in each arm) at up to 60 sites in North America, who are 18 years of age or older and have been implanted with the On-X Aortic Valve. Partici- pants will be randomized to either continue war- farin or switch to apixaban. Each participant will be followed for at least two years. The co-primary efficacy endpoints are to (1) determine if apixa- ban is non-inferior to warfarin (INR target range 2.0 - 3.0) for patients with an On-X Aortic Valve for the primary composite outcome of valve throm- bosis and valve-related thromboembolism, and (2) determine if apixaban provides acceptable anticoagulation for patients with an On-X Aortic Valve for the primary composite outcome of valve thrombosis and valve-related thromboembolism as compared with objective performance crite- ria. The primary safety endpoint is to determine if apixaban is superior to warfarin (INR target range 2.0 - 3.0) in the safety outcome of major bleeding in participants with an On-X Aortic Valve. ELIQUIS is a registered trademark of Bristol- Myers Squibb Company. Neither CryoLife nor the PROACT Xa Trial are affiliated with, sponsored, or endorsed by the Bristol-Myers Squibb Company. Conway Regional Health Foundation Receives Blue & You COVID-19 Relief Grant The Blue & You Foundation for a Healthier Arkansas has awarded Conway Regional Health Foundation with a $150,000 grant as part of its Rapid-Response COVID-19 Relief program. In addition to Conway Regional, six additional grants were awarded to recipients throughout the state. The program has now funded $1.7 million in grants to organizations in Arkansas working to prevent the spread of COVID-19 or helping com- munities deal with its effects. “We are immensely grateful for this grant from the Blue & You Foundation,” said Matt Troup, president and CEO of Conway Regional Health System. “At Conway Regional, we are committed to serving as our community’s resource during this unprecedented time. The receival of this grant will help further our efforts to protect the health and safety of our community and our team, as well as expanding services such as screening and testing to care for those in need. As we stand on the front lines of the COVID-19 pandemic, support from organizations such as the Blue & You Foundation is pivotal in furthering our mission to provide the highest-quality care.” The $150,000 grant will aid Conway Regional in providing lifesaving treatment, protecting the sys- tem’s healthcare workers, and minimizing commu- nity risk by creating a 26-bed critical care unit with