Safety and Effectiveness of Four-Factor Prothrombin Complex Concentrate in Special Populations with INR Below 2: A Post-Marketing Surveillance Study

• DOI: 10.1007/s40119-024-00380-7
• Publication Date: 2024-08-03T06:02:00Z
• Authors: Masahiro Yasaka; Fumihiko Shimizu; Yuki Niwa; Ayako Kiyonaga; Naoki Terasaka
• Keywords: Postmarketing surveillance; Prothrombin complex concentrate

We previously conducted a prospective, observational post-marketing surveillance study to assess the safety and effectiveness of four-factor prothrombin complex concentrate (4F-PCC) for rapid vitamin K antagonist (VKA) reversal in Japanese patients. This subgroup analysis compared safety, especially thromboembolic events (TEEs), 4F-PCC by stratifying patients into two subgroups according baseline international normalized ratio (INR) levels with < 2.0 ≥ 2.0. Of 1271 eligible patients, 215 (17.9%) had INR 987 (82.1%) Overall characteristics were similar between groups; age (74.0 years vs 74.0 years), body mass index (22.1 kg/m2 21.9 kg/m2), inpatients (90.2% 88.7%), manifested atrial fibrillation (46.0% 48.8%). Median INRs at 1.72 (minimum 0.92, maximum 1.99) group 2.95 (2.00, 27.11) group. The most common reason administration was intracranial hemorrhage (67.0% 59.5%), lesser gastrointestinal bleeding (0.9% 7.5%). After (average doses 24.5 IU/kg [INR group] 29.2 group]), significantly reduced 1.21 (− 28%) 1.31 68%), respectively, resulted hemostasis similarly manner. incidences adverse drug reactions 3.7% each TEEs occurred 4 (1.9%) 11 (1.1%) predominantly composed stroke, while rates 62.9%) post-anticoagulant resumption observed groups. supports favorable tolerability efficacy regardless (< or 2.0), prompt reduction substantial hemostatic real-world setting requiring urgent VKA reversal, although no indicated dose exists date.