PDF(Pubmed)
Abstract：
UNASSIGNED: Mechanical thrombectomy is a promising treatment option for deep vein thrombosis; however, long-term data are lacking. Here, we report for the first time the 1-year clinical outcomes from the completely enrolled ClotTriever Outcomes (CLOUT) registry evaluating mechanical thrombectomy with the ClotTriever System (Inari Medical).
UNASSIGNED: The CLOUT registry (NCT03575364) is a prospective, multicenter, single-arm study that enrolled 500 patients with proximal lower extremity deep vein thrombosis. Prespecified 1-year outcomes include Villalta score and corresponding postthrombotic syndrome (PTS) severity, duplex ultrasound findings of patency (defined as the presence of flow with normal or partial compressibility), Revised Venous Clinical Severity Score, and quality of life (QoL).
UNASSIGNED: In CLOUT, the median age was 61.9 years and 50.5% of patients were women. A total of 310 patients completed the 1-year visit. The 1-year PTS rate (Villalta score ≥ 5) was 19.3% and the moderate-to-severe PTS rate (Villalta score ≥ 10) was 8.8%. Median Villalta score decreased from 9.0 (IQR, 5.0-14.0) at baseline to 1.0 (IQR, 0.0-4.0) at 1 year (P < .0001). Similar rates of PTS and moderate-to-severe PTS were observed among limbs assessed at all study time points. Patency was observed in 94.2% of limbs. Median Revised Venous Clinical Severity Score was 6.0 (IQR, 3.0-9.0) at baseline and 3.0 (IQR, 1.0-4.0) at 1 year (P < .0001). Additionally, 90.4% of patients experienced improvements in QoL.
UNASSIGNED: One-year outcomes from the CLOUT registry demonstrate low PTS rates and preserved patency accompanied by improved symptom relief and QoL. Study follow-up through 2 years is ongoing.
UNASSIGNED: The CLOUT registry (NCT03575364) is a prospective, multicenter, single-arm study that enrolled 500 patients with proximal lower extremity deep vein thrombosis. Prespecified 1-year outcomes include Villalta score and corresponding postthrombotic syndrome (PTS) severity, duplex ultrasound findings of patency (defined as the presence of flow with normal or partial compressibility), Revised Venous Clinical Severity Score, and quality of life (QoL).
UNASSIGNED: In CLOUT, the median age was 61.9 years and 50.5% of patients were women. A total of 310 patients completed the 1-year visit. The 1-year PTS rate (Villalta score ≥ 5) was 19.3% and the moderate-to-severe PTS rate (Villalta score ≥ 10) was 8.8%. Median Villalta score decreased from 9.0 (IQR, 5.0-14.0) at baseline to 1.0 (IQR, 0.0-4.0) at 1 year (P < .0001). Similar rates of PTS and moderate-to-severe PTS were observed among limbs assessed at all study time points. Patency was observed in 94.2% of limbs. Median Revised Venous Clinical Severity Score was 6.0 (IQR, 3.0-9.0) at baseline and 3.0 (IQR, 1.0-4.0) at 1 year (P < .0001). Additionally, 90.4% of patients experienced improvements in QoL.
UNASSIGNED: One-year outcomes from the CLOUT registry demonstrate low PTS rates and preserved patency accompanied by improved symptom relief and QoL. Study follow-up through 2 years is ongoing.
摘要：
■机械血栓切除术是深静脉血栓形成的一种有前途的治疗选择；然而，缺乏长期数据。这里,我们首次报告了完全纳入的ClotTriever结局(CLOUT)注册中心评估ClotTriever系统(InariMedical)机械血栓切除术的1年临床结局.
■《法规的判例法》登记处(NCT03575364)是一个潜在的，多中心，单臂研究纳入500例下肢近端深静脉血栓形成患者。预先确定的1年结局包括Villalta评分和相应的血栓后综合征（PTS）严重程度，双超声发现通畅（定义为存在正常或部分可压缩性的血流），修订静脉临床严重程度评分,和生活质量(QoL)。
■在法规判例中，中位年龄为61.9岁,50.5%的患者为女性.共有310名患者完成了为期1年的访问。1年PTS率（Villalta评分≥5）为19.3％，中重度PTS率（Villalta评分≥10）为8.8％。Villalta得分中位数从9.0下降（IQR，5.0-14.0)在基线至1.0(IQR，0.0-4.0），1年（P<0.0001）。在所有研究时间点评估的肢体中观察到相似的PTS和中度至重度PTS比率。在94.2%的肢体中观察到通畅。修订后的静脉临床严重程度评分中位数为6.0(IQR，3.0-9.0)在基线和3.0(IQR，1.0-4.0），1年（P<0.0001）。此外,90.4%的患者经历了QoL的改善。
■《法规的判例法》注册的一年结果表明，PTS率低，通畅性保持，症状缓解和生活质量改善。研究随访持续2年。
■《法规的判例法》登记处(NCT03575364)是一个潜在的，多中心，单臂研究纳入500例下肢近端深静脉血栓形成患者。预先确定的1年结局包括Villalta评分和相应的血栓后综合征（PTS）严重程度，双超声发现通畅（定义为存在正常或部分可压缩性的血流），修订静脉临床严重程度评分,和生活质量(QoL)。
■在法规判例中，中位年龄为61.9岁,50.5%的患者为女性.共有310名患者完成了为期1年的访问。1年PTS率（Villalta评分≥5）为19.3％，中重度PTS率（Villalta评分≥10）为8.8％。Villalta得分中位数从9.0下降（IQR，5.0-14.0)在基线至1.0(IQR，0.0-4.0），1年（P<0.0001）。在所有研究时间点评估的肢体中观察到相似的PTS和中度至重度PTS比率。在94.2%的肢体中观察到通畅。修订后的静脉临床严重程度评分中位数为6.0(IQR，3.0-9.0)在基线和3.0(IQR，1.0-4.0），1年（P<0.0001）。此外,90.4%的患者经历了QoL的改善。
■《法规的判例法》注册的一年结果表明，PTS率低，通畅性保持，症状缓解和生活质量改善。研究随访持续2年。
