Center for Thrombosis and Hemostasis, University Medical Center, Mainz, Germany; Department of Cardiology, Democritus University of Thrace, Alexandroupoli, Greece.
Clinical Research Unit, Fernand-Widal Hospital, Assistance Publique Hôpitaux de Paris, University Paris Diderot, Paris, France.
J Am Coll Cardiol. 2017 Mar 28;69(12):1536-1544. doi: 10.1016/j.jacc.2016.12.039.
The long-term effect of thrombolytic treatment of pulmonary embolism (PE) is unknown.
This study investigated the long-term prognosis of patients with intermediate-risk PE and the effect of thrombolytic treatment on the persistence of symptoms or the development of late complications.
The PEITHO (Pulmonary Embolism Thrombolysis) trial was a randomized (1:1) comparison of thrombolysis with tenecteplase versus placebo in normotensive patients with acute PE, right ventricular (RV) dysfunction on imaging, and a positive cardiac troponin test result. Both treatment arms received standard anticoagulation. Long-term follow-up was included in the third protocol amendment; 28 sites randomizing 709 of the 1,006 patients participated.
Long-term (median 37.8 months) survival was assessed in 353 of 359 (98.3%) patients in the thrombolysis arm and in 343 of 350 (98.0%) in the placebo arm. Overall mortality rates were 20.3% and 18.0%, respectively (p = 0.43). Between day 30 and long-term follow-up, 65 deaths occurred in the thrombolysis arm and 53 occurred in the placebo arm. At follow-up examination of survivors, persistent dyspnea (mostly mild) or functional limitation was reported by 36.0% versus 30.1% of the patients (p = 0.23). Echocardiography (performed in 144 and 146 patients randomized to thrombolysis and placebo, respectively) did not reveal significant differences in residual pulmonary hypertension or RV dysfunction. Chronic thromboembolic pulmonary hypertension (CTEPH) was confirmed in 4 (2.1%) versus 6 (3.2%) cases (p = 0.79).
Approximately 33% of patients report some degree of persistent functional limitation after intermediate-risk PE, but CTEPH is infrequent. Thrombolytic treatment did not affect long-term mortality rates, and it did not appear to reduce residual dyspnea or RV dysfunction in these patients. (Pulmonary Embolism Thrombolysis study [PEITHO]; NCT00639743).
溶栓治疗肺栓塞（PE）的长期效果尚不清楚。
本研究旨在探讨中危 PE 患者的长期预后，以及溶栓治疗对症状持续存在或晚期并发症发展的影响。
PEITHO（肺栓塞溶栓）试验是一项随机（1:1）比较溶栓治疗与替奈普酶与安慰剂在急性 PE、影像学右心室（RV）功能障碍和心脏肌钙蛋白检测阳性的正常血压患者中的疗效。两组均接受标准抗凝治疗。长期随访纳入第三次方案修订中；28 个试验点纳入了 1006 例患者中的 709 例。
溶栓组 353 例（98.3%）和安慰剂组 343 例（98.0%）患者长期（中位 37.8 个月）生存情况得到评估。两组死亡率分别为 20.3%和 18.0%（p=0.43）。溶栓组 30 天至长期随访期间有 65 例死亡，安慰剂组有 53 例死亡。随访时存活患者报告持续性呼吸困难（主要为轻度）或功能受限的分别占 36.0%和 30.1%（p=0.23）。接受超声心动图检查的 144 例和 146 例随机分配至溶栓组和安慰剂组的患者均未发现残余肺动脉高压或 RV 功能障碍的显著差异。慢性血栓栓塞性肺动脉高压（CTEPH）在 4 例（2.1%）和 6 例（3.2%）患者中得到确认（p=0.79）。
约 33%的中危 PE 患者报告存在一定程度的持续性功能受限，但 CTEPH 并不常见。溶栓治疗并未影响长期死亡率，也未显示出可降低此类患者的残余呼吸困难或 RV 功能障碍。（肺栓塞溶栓研究[PEITHO]；NCT00639743）。
