BACKGROUND There are a lack of randomized controlled trial data comparing outcomes of different catheter-based interventions for intermediate-risk pulmonary embolism. METHODS PEERLESS is a prospective, multicenter, randomized controlled trial that enrolled 550 patients with intermediate-risk pulmonary embolism 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 end point was a hierarchal win ratio composite of the following (assessed at the sooner of hospital discharge or 7 days after the procedure): (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) postprocedural intensive care unit admission and length of stay. Assessments at the 24-hour visit included respiratory rate, modified Medical Research Council dyspnea score, New York Heart Association classification, right ventricle/left ventricle ratio reduction, and right ventricular function. End points through 30 days included total hospital stay, all-cause readmission, and all-cause mortality. RESULTS The primary end point occurred significantly less frequently with LBMT compared with CDT (win ratio, 5.01 [95% CI, 3.68-6.97]; P<0.001). There were significantly fewer episodes of clinical deterioration and/or bailout (1.8% versus 5.4%; P=0.04) with LBMT compared with CDT and less postprocedural intensive care unit use (P<0.001), including admissions (41.6% versus 98.6%) and stays >24 hours (19.3% versus 64.5%). There were no significant differences in mortality, intracranial hemorrhage, or major bleeding between strategies or in a secondary win ratio end point including the first 4 components (win ratio, 1.34 [95% CI, 0.78-2.35]; P=0.30). At the 24-hour visit, respiratory rate was lower for patients treated with LBMT (18.3±3.3 versus 20.1±5.1; P<0.001), and fewer had moderate to severe modified Medical Research Council dyspnea scores (13.5% versus 26.4%; P<0.001), New York Heart Association classifications (16.3% versus 27.4%; P=0.002), and right ventricular dysfunction (42.1% versus 57.9%; P=0.004). Right ventricle/left ventricle ratio reduction was similar (0.32±0.24 versus 0.30±0.26; P=0.55). Patients treated with LBMT had shorter total hospital stays (4.5±2.8 overnights versus 5.3±3.9 overnights; P=0.002) and fewer all-cause readmissions (3.2% versus 7.9%; P=0.03), whereas 30-day mortality was similar (0.4% versus 0.8%; P=0.62). CONCLUSIONS PEERLESS met its primary end point in favor of LBMT compared with CDT in treatment of intermediate-risk pulmonary embolism. LBMT had lower rates of clinical deterioration and/or bailout and postprocedural intensive care unit use compared with CDT, with no difference in mortality or bleeding. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT05111613.

中文翻译：

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


背景 缺乏比较不同基于导管的干预措施对中等风险肺栓塞的结局的随机对照试验数据。方法 PEERLESS 是一项前瞻性、多中心、随机对照试验，招募了 550 名伴有右心室扩张和其他临床危险因素的中危肺栓塞患者，以 1：1 的比例随机分配接受大口径机械血栓切除术 （LBMT） 或导管定向溶栓 （CDT） 治疗。主要终点是以下的分层胜率复合（在出院前或手术后 7 天评估）：（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） 术后重症监护病房收治和住院时间。24 小时就诊时的评估包括呼吸频率、改良医学研究委员会呼吸困难评分、纽约心脏协会分类、右心室/左心室比值降低和右心室功能。到 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 与 CDT 相比，LBMT 的主要终点发生率显著降低 （胜率，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 CDT 相比，术后重症监护病房使用较少 （P<0.001），包括入院 （41.6% 对 98.6%） 和住院时间 >24 小时 （19.3% 对 64.5%）。 策略之间或次要胜率终点（包括前 4 个组成部分）在死亡率、颅内出血或大出血方面无显著差异（胜率，1.34 [95% CI，0.78-2.35];P=0.30）。在 24 小时就诊时，接受 LBMT 治疗的患者的呼吸频率较低 （18.3±3.3 vs 20.1±5.1;P<0.001），中度至重度改良医学研究委员会呼吸困难评分较少 （13.5% 对 26.4%;P<0.001）、纽约心脏协会分类 （16.3% 对 27.4%;P = 0.002）和右心室功能障碍 （42.1% 对 57.9%;P=0.004）。右心室/左心室比值降低相似 （0.32±0.24 vs 0.30±0.26;P=0.55）。接受 LBMT 治疗的患者总住院时间较短（4.5±2.8 夜对 5.3±3.9 夜;P=0.002）和更少的全因再入院率 （3.2% 对 7.9%;P = 0.03），而 30 天死亡率相似 （0.4% 对 0.8%;P=0.62）。结论 PEERLESS 达到了其主要终点，与 CDT 相比，LBMT 治疗中危肺栓塞。与 CDT 相比，LBMT 的临床恶化率和/或救助率以及术后重症监护病房使用率较低，死亡率或出血率没有差异。注册网址：https://www.clinicaltrials.gov;唯一标识符：NCT05111613。