Di Micco Pierpaolo, Salazar Vladimir Rosa, Capitan Carmen Fernandez, Dentali Francesco, Cuervo Covadonga Gomez, Torres Jose Luis Fernandez, Porras Jose Antonio, Fidalgo Angeles, Grandone Elvira, Meseguer Manuel Lopez, Monreal Manuel
UOC Medicina y Urgencia-ASL NAPOLI 2 Nord Ospedale Anna Rizzoli di Lacco Ameno, 34110 Naples, Italy.
Department of Internal Medicine, Hospital Universitario Virgen de Arrixaca, 30627 Murcia, Spain.
Life (Basel). 2022 Jul 27;12(8):1128. doi: 10.3390/life12081128.
Background: The use of rivaroxaban in clinical practice often deviates from manufacturer prescribing information. No studies have demonstrated an association between this practice and improved outcomes. Methods: We used the RIETE registry to assess the clinical characteristics of patients with pulmonary embolism (PE) who received off-label rivaroxaban, and to compare their 3-month outcomes with those receiving the labeled therapy. The patients were classified into four subgroups: (1) labeled therapy; (2) delayed start; (3) low doses and (4) both conditions. Results: From May 2013 to May 2022, 2490 patients with PE received rivaroxaban: labeled therapy—1485 (58.6%); delayed start—808 (32.5%); low doses—143 (5.7%); both conditions—54 (2.2%). Patients with a delayed start were more likely to present with syncope, hypotension, raised troponin levels and more severe abnormalities on the echocardiogram than those on labeled therapy. Patients receiving low doses were most likely to have cancer, recent bleeding, anemia, thrombocytopenia or renal insufficiency. During the first 3 months, 3 patients developed PE recurrence, 4 had deep-vein thrombosis, 11 had major bleeding and 16 died. The rates of major bleeding (11 vs. 0; p < 0.001) or death (15 vs. 1; OR: 22.5; 95% CI: 2.97−170.5) were higher in patients receiving off-label rivaroxaban than in those on labeled therapy, with no differences in VTE recurrence (OR: 1.11; 95% CI: 0.25−6.57). Conclusions: In patients with severe PE, the start of rivaroxaban administration was often delayed. In those at increased risk for bleeding, it was often prescribed at low doses. Both subgroups had a worse outcome than those on labeled rivaroxaban.
利伐沙班在临床实践中的使用常常偏离制造商的处方信息。尚无研究表明这种做法与改善预后之间存在关联。方法：我们使用RIETE注册研究来评估接受超说明书剂量利伐沙班治疗的肺栓塞（PE）患者的临床特征，并将他们3个月的预后与接受标准治疗的患者进行比较。患者被分为四个亚组：（1）标准治疗；（2）延迟起始；（3）低剂量；（4）两种情况兼具。结果：2013年5月至2022年5月，2490例PE患者接受了利伐沙班治疗：标准治疗组1485例（58.6%）；延迟起始组808例（32.5%）；低剂量组143例（5.7%）；两种情况兼具组54例（2.2%）。与接受标准治疗的患者相比，延迟起始组患者更易出现晕厥、低血压、肌钙蛋白水平升高以及超声心动图显示更严重的异常。接受低剂量治疗的患者最有可能患有癌症、近期出血、贫血、血小板减少症或肾功能不全。在最初3个月内，3例患者发生PE复发，4例发生深静脉血栓形成，11例发生大出血，16例死亡。接受超说明书剂量利伐沙班治疗的患者大出血发生率（11例 vs. 0例；p<0.001）或死亡率（15例 vs. 1例；OR：22.5；95%CI：2.97−170.5）高于接受标准治疗的患者，静脉血栓栓塞复发率无差异（OR：1.11；95%CI：0.25−6.57）。结论：在重度PE患者中，利伐沙班的给药起始常常延迟。在出血风险增加的患者中，利伐沙班常以低剂量给药。这两个亚组的预后均比接受标准剂量利伐沙班治疗的患者更差。
