Inova Alexandria Hospital, VA (K.M.S.).
Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.Z.G., G.P.).
Circ Cardiovasc Interv. 2024 Mar;17(3):e013448. doi: 10.1161/CIRCINTERVENTIONS.123.013448. Epub 2024 Jan 24.
Prior clinical trials have demonstrated the efficacy of ultrasound-facilitated catheter-directed thrombolysis (USCDT) for the treatment of acute intermediate-risk pulmonary embolism (PE) using reduced thrombolytic doses and shorter infusion durations. However, utilization and safety of such strategies in broader PE populations remain unclear. The KNOCOUT PE (The EKoSoNic Registry of the Treatment and Clinical Outcomes of Patients With Pulmonary Embolism) registry is a multicenter international registry designed to study the treatment of acute PE with USCDT, with focus on safety outcomes.
The KNOCOUT PE prospective cohort included 489 patients (64 sites internationally) with acute intermediate-high or high-risk PE treated with USCDT between March 2018 and June 2020. Principal safety outcomes were independently adjudicated International Society on Thrombosis and Haemostasis major bleeding at 72 hours post-treatment and mortality within 12 months of treatment. Additional outcomes included change in right ventricular/left ventricular ratio and quality of life measures over 12 months.
Mean alteplase (r-tPA [recombinant tissue-type plasminogen activator]) infusion duration was 10.5 hours. Mean total r-tPA dose was 18.1 mg, with 31.0% of patients receiving ≤12 mg. Major bleeding events within 72 hours occurred in 1.6% (8/489) of patients. One patient experienced worsening of a preexisting subdural hematoma after USCDT and therapeutic anticoagulation, which ultimately required surgery. All-cause mortality at 30 days was 1.0% (5/489). Improvement in PE quality of life score was observed with a 41.1% (243/489, 49.7%) and 44.2% (153/489, 31.3%) mean relative reduction by 3 and 12 months, respectively.
In a prospective observational cohort study of patients with intermediate-high and high-risk PE undergoing USCDT, mean r-tPA dose was 18 mg, and the rates of major bleeding and mortality were low.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03426124.
先前的临床试验已经证明了超声引导下导管溶栓（USCDT）在使用减少的溶栓剂量和更短的输注时间的情况下治疗急性中危肺栓塞（PE）的疗效。然而，在更广泛的 PE 人群中使用这些策略的情况和安全性仍不清楚。KNOCOUT PE（超声引导下治疗肺栓塞患者的 EKoSoNic 注册研究）登记处是一个多中心国际登记处，旨在研究 USCDT 治疗急性 PE，重点关注安全性结果。
KNOCOUT PE 前瞻性队列纳入了 2018 年 3 月至 2020 年 6 月期间接受 USCDT 治疗的 489 例（国际 64 个地点）急性中高危或高危 PE 患者。主要安全性结局为独立评估的国际血栓与止血协会大出血事件在治疗后 72 小时和治疗后 12 个月内的死亡率。其他结局包括 12 个月内右心室/左心室比值和生活质量的变化。
阿替普酶（r-tPA [重组组织型纤溶酶原激活剂]）输注平均持续时间为 10.5 小时。r-tPA 的平均总剂量为 18.1mg，其中 31.0%的患者接受的剂量≤12mg。治疗后 72 小时内发生大出血事件的患者占 1.6%（8/489）。1 例患者在 USCDT 和抗凝治疗后出现先前存在的硬膜下血肿加重，最终需要手术。30 天的全因死亡率为 1.0%（5/489）。通过 3 个月和 12 个月，PE 生活质量评分分别有 41.1%（243/489，49.7%）和 44.2%（153/489，31.3%）的平均相对降低，表明有所改善。
在接受 USCDT 的中高危和高危 PE 患者的前瞻性观察队列研究中，r-tPA 的平均剂量为 18mg，大出血和死亡率均较低。
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