Center for Thrombosis and Hemostasis, Johannes Gutenberg University Medical Center, Langenbeckstrasse 1, Bldg. 403, 55131 Mainz, Germany.
Hamostaseologie. 2013;33(1):43-50. doi: 10.5482/HAMO-12-12-0024. Epub 2013 Jan 22.
Management of acute pulmonary embolism (PE) has advanced considerably in the past year, and progress is expected to continue in 2013. To help determine the optimal management strategy for normotensive patients with intermediate-risk PE, the Pulmonary Embolism Thrombolysis (PEITHO) study completed enrolment of 1006 patients with evidence of right ventricular dysfunction (by echocardiography or computed tomography) plus a positive troponin test. Patients have been randomised to thrombolytic treatment with tenecteplase versus placebo, and the effects on clinical end points (death or haemodynamic collapse) assessed at 7 and 30 days. The results are expected in spring 2013; long-term follow-up is also being performed. The results of a randomised trial on ultrasound-enhanced low-dose catheter-delivered thrombolysis will also become available soon. While optimisation of treatment with vitamin K antagonists incorporating pharmacogenetic testing is still being pursued, new oral anticoagulants are entering the field of PE treatment and secondary prophylaxis. Following the successful use of rivaroxaban as single oral drug therapy in the EINSTEIN-PE trial, the approval of this drug has recently been extended to cover, apart from deep vein thrombosis, PE as well. The apixaban (AMPLIFY) and edoxaban (HOKUSAI) trials have finished recruitment of PE patients, and their results will become available shortly. In the meantime, the AMPLIFY-EXT trial showed that both the therapeutic (5 mg twice daily) and the prophylactic dose (2.5 mg twice daily) of apixaban are effective and safe for long-term secondary prophylaxis after PE. For the extended prophylaxis (after the reommended initial anticoagulation period) of the (few) patients who are unable to tolerate any form of anticoagulation, low-dose asprin may be a safe albeit moderately efficacious option, as indicated by two recent investigator-initiated trials with a total of 1224 patients.
过去一年中，急性肺栓塞（PE）的管理取得了重大进展，预计 2013 年将继续取得进展。为了帮助确定伴有中度风险 PE 的血压正常患者的最佳治疗策略，肺栓塞溶栓（PEITHO）研究完成了 1006 例伴有右心室功能障碍（超声心动图或计算机断层扫描）和阳性肌钙蛋白试验的患者入组。患者被随机分配接受替奈普酶溶栓治疗或安慰剂治疗，并在第 7 天和第 30 天评估临床终点（死亡或血流动力学崩溃）的影响。结果预计在 2013 年春季公布，也正在进行长期随访。一项关于超声增强低剂量导管溶栓的随机试验结果也即将公布。虽然仍在努力优化维生素 K 拮抗剂治疗并结合药物遗传学检测，但新的口服抗凝剂也已进入 PE 治疗和二级预防领域。在 EINSTEIN-PE 试验中成功使用利伐沙班作为单一口服药物治疗后，该药物的批准最近已扩展至涵盖深静脉血栓形成和 PE。阿哌沙班（AMPLIFY）和依度沙班（HOKUSAI）试验已完成 PE 患者的招募，其结果将很快公布。与此同时，AMPLIFY-EXT 试验表明，阿哌沙班的治疗剂量（每日两次 5 毫克）和预防剂量（每日两次 2.5 毫克）对 PE 后的长期二级预防均有效且安全。对于无法耐受任何形式抗凝的少数患者（少数患者），低剂量阿司匹林可能是一种安全但中等疗效的选择，两项最近的研究者发起的试验共纳入了 1224 例患者，表明了这一点。
