BACKGROUND There is a lack of randomized controlled trial (RCT) data comparing outcomes of different catheter-based interventions for intermediate-risk pulmonary embolism (PE). METHODS PEERLESS is a prospective, multicenter, RCT that enrolled 550 intermediate-risk PE patients with right ventricular dilatation and additional clinical risk factors randomized 1:1 to treatment with large-bore mechanical thrombectomy (LBMT) or catheter-directed thrombolysis (CDT). The primary endpoint was a hierarchal win ratio (WR) composite of the following: 1) all-cause mortality, 2) intracranial hemorrhage, 3) major bleeding, 4) clinical deterioration and/or escalation to bailout, and 5) postprocedural intensive care unit (ICU) admission and length of stay, assessed at the sooner of hospital discharge or 7 days post-procedure. Assessments at the 24-hour visit included respiratory rate, mMRC dyspnea score, NYHA classification, right ventricle (RV)/left ventricle (LV) ratio reduction, and RV function. Endpoints through 30 days included total hospital stay, all-cause readmission, and all-cause mortality. RESULTS The primary endpoint occurred significantly less frequently with LBMT vs CDT (WR 5.01 [95% CI: 3.68-6.97]; P<0.001). There were significantly fewer episodes of clinical deterioration and/or bailout (1.8% vs 5.4%; P=0.04) with LBMT vs CDT and less postprocedural ICU utilization (P<0.001), including admissions (41.6% vs 98.6%) and stays >24 hours (19.3% vs 64.5%). There was no significant difference in mortality, intracranial hemorrhage, or major bleeding between strategies, nor in a secondary WR endpoint including the first 4 components (WR 1.34 [95% CI: 0.78-2.35]; P=0.30). At the 24-hour visit, respiratory rate was lower for LBMT patients (18.3±3.3 vs 20.1±5.1; P<0.001) and fewer had moderate to severe mMRC dyspnea scores (13.5% vs 26.4%; P<0.001), NYHA classifications (16.3% vs 27.4%; P=0.002), and RV dysfunction (42.1% vs 57.9%; P=0.004). RV/LV ratio reduction was similar (0.32±0.24 vs 0.30±0.26; P=0.55). LBMT patients had shorter total hospital stays (4.5±2.8 vs 5.3±3.9 overnights; P=0.002) and fewer all-cause readmissions (3.2% vs 7.9%; P=0.03), while 30-day mortality was similar (0.4% vs 0.8%; P=0.62). CONCLUSIONS PEERLESS met its primary endpoint in favor of LBMT vs CDT in treatment of intermediate-risk PE. LBMT had lower rates of clinical deterioration and/or bailout and postprocedural ICU utilization compared with CDT, with no difference in mortality or bleeding.

中文翻译：

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大口径机械血栓切除术与导管溶栓治疗中危肺栓塞的比较：PEERLESS 随机对照试验的主要结果。


背景 缺乏随机对照试验 （RCT） 数据来比较不同基于导管的干预措施对中等风险肺栓塞 （PE） 的结局。方法 PEERLESS 是一项前瞻性、多中心、随机对照试验，招募了 550 名患有右心室扩张和其他临床危险因素的中危 PE 患者，以 1：1 的比例随机分配至大口径机械血栓切除术 （LBMT） 或导管定向溶栓 （CDT） 治疗组。主要终点是以下各项的分层胜率 （WR） 复合：1） 全因死亡率，2） 颅内出血，3） 大出血，4） 临床恶化和/或升级为救助，以及 5） 术后重症监护病房 （ICU） 收治和住院时间，在出院前或手术后 7 天（以较早者为准）进行评估。24 小时就诊时的评估包括呼吸频率、 mMRC 呼吸困难评分、NYHA 分类、右心室 （RV）/左心室 （LV） 比值降低和 RV 功能。截至 30 天的终点包括总住院时间、全因再入院和全因死亡率。结果LBMT 与 CDT 相比，主要终点的发生率显著降低 （WR 5.01 [95% CI： 3.68-6.97];P<0.001）。临床恶化和/或救助的发作显著减少 （1.8% 对 5.4%;P=0.04） 与 LBMT 与 CDT 和较少的术后 ICU 利用率 （P<0.001），包括入院 （41.6% 对 98.6%） 和住院率 >24 小时 （19.3% 对 64.5%）。两种策略在死亡率、颅内出血或大出血方面没有显著差异，包括前 4 个组成部分的次要 WR 终点也没有显著差异（WR 1.34 [95% CI： 0.78-2.35];P=0.30）。在 24 小时就诊时，LBMT 患者的呼吸频率较低 （18.3±3.3 vs 20.1±5.1;P<0 的。001），中度至重度 mMRC 呼吸困难评分较少 （13.5% 对 26.4%;P<0.001）、NYHA 分类 （16.3% 对 27.4%;P=0.002） 和 RV 功能障碍 （42.1% 对 57.9%;P=0.004）。RV/LV 比值降低相似 （0.32±0.24 vs 0.30±0.26;P=0.55）。LBMT 患者的总住院时间较短 （4.5±2.8 vs 5.3±3.9;P = 0.002） 和更少的全因再入院 （3.2% 对 7.9%;P=0.03），而 30 天死亡率相似 （0.4% vs 0.8%;P=0.62）。结论 PEERLESS 达到了其主要终点，支持 LBMT 与 CDT 治疗中度风险 PE。与 CDT 相比，LBMT 的临床恶化率和/或救助率和术后 ICU 利用率较低，死亡率或出血率没有差异。