研究经皮闭合左心耳和华法林对房颤预防脑卒中影响的课件.ppt

PROTECT AF研究：经皮闭合左心耳和华法林对房颤预防脑卒中影响的前瞻性随机研究 PROTECT AF trials：Randomized Prospective Trial of Percutaneous LAA Closure vs Warfarin for Stroke Prevention in AF David Holmes, MD;Vivek Reddy, MD; Zoltan Turi, MD，et al Relevant Financial Relationship(s) Mayo receives research support from Atritech and may receive royalties PROTECT AF Trial Sponsor: Atritech (Plymouth, MN) Principal Investigator: David Holmes Clinical Trials Indentifier: NCProspective, Multicenter Randomized Trial of Percutaneous Left Atrial Appendage Occlusion vs Long-term Warfarin Therapy in Patients with Non-Valvular Atrial Fibrillation Facts about Atrial Fibrillation (AF) AF is the most common cardiac arrhythmia Affects more than 3 million individuals in the US Projected to increase to 16 million by 2050 Patients with AF have a 5-fold higher risk of stroke Over 87% of strokes are thromboembolic Greater than 90% of thrombus accumulation originates in the Left Atrial Appendage (LAA) Stroke is the number one cause of long-term disability and the third leading cause of death in patients with AF Non-Valvular Atrial Fibrillation Stroke PreventionMedical Rx 3000838-10 Cooper: Arch Int Med 166, 2006Lip: Thromb Res 118, 2006 Warfarin cornerstone of therapy Assuming 51 ischemic strokes/1000 pt-yr Adjusted standard dose warfarin prevented 28 strokes at expense of 11 fatal bleeds Aspirin prevented 16 strokes at expense of 6 fatal bleeds Warfarin 60-70% risk reduction vs no treatment 30-40% risk reduction vs aspirin Challenges in Treating AF However warfarin is not always well-tolerated Narrow therapeutic range (INR between 2.0 – 3.0) Effectiveness is impacted by interactions with some foods and medications Requires frequent monitoring and dose adjustments Published reports indicate that less than 50% of patients eligible are being treated with warfarin due to tolerance or non-compliance issues SPORTIF trials suggest only 60% of patients treated are within a therapeutic INR range, w