Århus Universitetshospital

MONDAY, Nov. 18, 2024 -- Patients with venous thromboembolism (VTE) initiating oral anticoagulants have an increased risk for bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDs), according to a study published online Nov. 17 in the European Heart Journal . Søren Riis Petersen, from Aarhus University Hospital in Denmark, and colleagues conducted a nationwide cohort study of 51,794 VTE patients initiating oral anticoagulants between Jan. 1, 2012, and Dec. 31, 2022. Adjusted hazard ratios between NSAID use and hospital-diagnosed bleeding episodes were computed. The researchers found that the event rates for any bleeding per 100 person-years were 3.5 and 6.3 during periods without and with NSAID use, respectively (number needed to harm, 36 patients treated for one year). The adjusted hazard ratios for any bleeding associated with NSAID use versus nonuse were 2.09, 1.79, 3.30, and 4.10 overall, for ibuprofen, for diclofenac, and for naproxen, respectively. The adjusted hazard ratios associated with NSAID use versus nonuse were 2.24, 3.22, 1.36, 1.57, and 2.99 for gastrointestinal bleeding, intracranial bleeding, thoracic and respiratory tract bleeding, urinary tract bleeding, and anemia caused by bleeding, respectively. For anticoagulant and VTE subtypes, the results were consistent. "The common use of NSAIDs in patients with cardiovascular disease emphasizes the importance of being aware of the bleeding risks associated with their use," the authors write. Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text Editorial Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

MONDAY, Nov. 18, 2024 -- People on blood thinners have a doubled risk of dangerous internal bleeding if they also take a non-steroidal anti-inflammatory drug (NSAID) like ibuprofen or naproxen, a new study warns. People typically are prescribed blood thinners to treat or prevent strokes , heart attacks, or blood clots in the legs or lungs, researchers said. NSAIDs also are known to thin the blood, and the new study shows that they can increase risk of uncontrolled bleeding in the gut, brain, lungs and bladder if taken alongside a blood thinner. “We found that for patients taking blood thinners for blood clots in the legs or lungs, using NSAIDs doubled the risk of bleeding compared with not using NSAIDs,” said researcher Soren Riis Peterson , a medical student with Aarhus University Hospital in Denmark. “The increased bleeding risk associated with NSAID use was not limited to the digestive tract but also seemed to affect other organ systems.” For the study, researchers analyzed data on nearly 52,000 Danish patients prescribed a blood thinner to treat a blood clot between 2012 and 2022. In Denmark, the NSAIDs diclofenac and naproxen can only be obtained through a prescription. This allowed researchers to track the health of patients who had been prescribed both a blood thinner and an NSAID. Overall, the risk of a bleed was two times higher when people took a blood thinner and an NSAID, compared to just taking a blood thinner, researchers found. The specific risk was four times higher for naproxen, three times higher for diclofenac and nearly twice as high for ibuprofen. Specific bleed risks included: Using NSAIDs with a blood thinner also tripled a person’s risk of anemia, researchers found. The pattern of risk remained similar across a wide variety of blood thinners, including rivaroxaban , apixaban , dabigatran , edoxaban and warfarin , results show. The new study was published Nov. 17 in the European Heart Journal . “For people taking blood thinners for blood clots in their legs or lungs, our research highlights the importance of being cautious when considering NSAIDs for pain or inflammation,” Petersen concluded in a journal news release. “We recommend that patients consult their doctor before taking NSAIDs along with a blood thinner.” In an accompanying editorial, Dr. Robert Storey , a professor of clinical cardiology with the University of Sheffield in the U.K., noted that NSAIDs are widely used, making up about 8% of prescriptions worldwide and often available over-the-counter. “It seems clear that avoiding NSAIDs in combination with [blood thinners] is the safest strategy to avoid excess bleeding risk,” Storey wrote. “However, if this is not possible, what mitigation can be put in place? NSAID prescription should obviously be at the lowest dose and for the shortest time possible, but choice of agent and route may also be important.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Study will assess the Company's Next-Generation device under Intracardiac Echocardiography (ICE) imaging for Left Atrial Appendage Occlusion (LAAO) procedures. NASHUA, N.H., Oct. 1, 2024 /PRNewswire/ -- Conformal Medical, Inc. today announced the initiation of the GLACE Study. This European study* aims to assess the use of intracardiac echocardiography (ICE) imaging of the left atrial appendage (LAA) during appendage closure procedures with the next-generation CLAAS® AcuFORM™ device in patients with non-valvular atrial fibrillation. The prospective, multicenter, non-randomized, single-arm investigation will enroll approximately 80 patients in Denmark, Italy, and the Czech Republic. Continue Reading "Simplified sizing and ease of use enabled by this device will drive improved workflow in the lab." Post this Conformal CLAAS AcuFORM LAAO Initial patients were treated by the study's co-principal investigators Professor Jens Erik Nielsen-Kudsk, M.D. of Aarhus University Hospital and Professor Ole De Backer, M.D. of Rigshospitalet, Copenhagen University Hospital at their respective institutions in Denmark. Additionally, Shephal Doshi, M.D., from Providence Saint John's Health Center and the Pacific Heart Institute in Santa Monica, California and Principal Investigator of the CONFORM Pivotal Trial was present for the initial cases. "I am excited about the new CLAAS AcuFORM implant and the ability to confirm seal with angiography providing procedural confidence, ensuring the patient has been properly treated," stated Nielsen-Kudsk. "ICE has become our primary imaging platform for LAAO, the GLACE Study allows us to validate the use of ICE with this innovative technology." ICE imaging facilitates real-time visualization of cardiac structures during LAAO closure, enhancing precision while reducing radiation exposure and procedure time. This approach often eliminates the need for general anesthesia, improving patient comfort and operational efficiency."The CLAAS AcuFORM device enhances and simplifies the procedure, with only two sizes, one of which effectively treats over 90% of patients," stated Dr. Doshi. "Simplified sizing and ease of use enabled by this device will drive improved workflow in the lab."Designed to optimize anchor penetration and featuring an improved ePTFE material, and a simplified delivery system, the CLAAS AcuFORM LAAO System builds upon the novel CLAAS device and is engineered to conform to and seal the LAA with its proprietary foam-based architecture. The implant addresses the clinical spectrum of LAA anatomies with only two sizes. The system aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram (TEE) so that physicians may perform the procedure without general anesthesia, a significant advancement with the potential to shift clinical practice to a same-day, single-operator procedure. Over 350 patients have been successfully implanted with the Conformal CLAAS System as part of early feasibility studies and the ongoing CONFORM Pivotal Trial."The use of ICE imaging in LAAO is growing significantly and will continue," said James Reinstein, President and CEO of Conformal Medical. "Our next-generation LAAO technology conforms to individual anatomies, enabling clinicians to simplify the procedure with 2 sizes, the ability to confirm seal, and eliminate general anesthesia & intubation." About Conformal MedicalConformal Medical, Inc., is a medical device company developing devices to prevent stroke in patients with non-valvular atrial fibrillation. The company's proprietary technology is intended to make left atrial appendage closure a same-day, single-operator procedure. For more information, visit . About Left Atrial Appendage ClosureMore than six million people in the United States suffer from Afib, placing them at an increased risk of stroke.1 Current standard of care for stroke prevention is chronic oral anticoagulants, which are not well accepted by patients due to concern about associated risk of bleeding. Left Atrial Appendage Occlusion (LAAO) is emerging as an important alternative to blood thinners for preventing strokes in patients with non-valvular Afib. First-generation LAAO devices are an estimated $1.4B global market in 2023 and are expected to grow to over $6B by 2030.2,3 CAUTION: Investigational Device. The CLAAS System is limited by Federal (or United States) law to investigational use*Study is designed to comply with EU MDR Chapter VI, Article 62 4(i). Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20. Piper Sandler Market Analyst Report, September 2023. Boston Scientific Investor Update, September 2023. SOURCE Conformal Medical, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED