National Heart and Lung Institute, Imperial College London, London, UK.
Royal Brompton and Harefield Hospitals, London, UK.
Eur Respir J. 2023 Apr 27;61(4). doi: 10.1183/13993003.02063-2022. Print 2023 Apr.
Lung volume reduction surgery (LVRS) and bronchoscopic lung volume reduction (BLVR) with endobronchial valves can improve outcomes in appropriately selected patients with emphysema. However, no direct comparison data exist to inform clinical decision making in people who appear suitable for both procedures. Our aim was to investigate whether LVRS produces superior health outcomes when compared with BLVR at 12 months.
This multicentre, single-blind, parallel-group trial randomised patients from five UK hospitals, who were suitable for a targeted lung volume reduction procedure, to either LVRS or BLVR and compared outcomes at 1 year using the i-BODE score. This composite disease severity measure includes body mass index, airflow obstruction, dyspnoea and exercise capacity (incremental shuttle walk test). The researchers responsible for collecting outcomes were masked to treatment allocation. All outcomes were assessed in the intention-to-treat population.
88 participants (48% female, mean±sd age 64.6±7.7 years, forced expiratory volume in 1 s percent predicted 31.0±7.9%) were recruited at five specialist centres across the UK and randomised to either LVRS (n=41) or BLVR (n=47). At 12 months follow-up, the complete i-BODE was available in 49 participants (21 LVRS/28 BLVR). Neither improvement in the i-BODE score (LVRS -1.10±1.44 BLVR -0.82±1.61; p=0.54) nor in its individual components differed between groups. Both treatments produced similar improvements in gas trapping (residual volume percent predicted: LVRS -36.1% (95% CI -54.6- -10%) BLVR -30.1% (95% CI -53.7- -9%); p=0.81). There was one death in each treatment arm.
Our findings do not support the hypothesis that LVRS is a substantially superior treatment to BLVR in individuals who are suitable for both treatments.
肺减容手术（LVRS）和支气管镜下肺减容术（BLVR）联合支气管内活瓣治疗肺气肿，可改善合适患者的预后。然而，尚无直接比较数据可用于指导适合两种治疗方法的患者的临床决策。我们旨在研究与 BLVR 相比，LVRS 在 12 个月时是否能产生更优的健康结果。
这是一项多中心、单盲、平行组试验，纳入了来自英国五家医院的合适靶向性肺减容术的患者，将他们随机分为 LVRS 或 BLVR 组，并在 1 年时使用 i-BODE 评分比较结果。该综合疾病严重程度指标包括体重指数、气流阻塞、呼吸困难和运动能力（递增穿梭步行试验）。负责收集结果的研究人员对治疗分配进行了盲法。所有结局均在意向治疗人群中进行评估。
在英国五家专科中心共招募了 88 名患者（48%为女性，平均年龄 64.6±7.7 岁，第 1 秒用力呼气量占预计值百分比 31.0±7.9%），并随机分为 LVRS 组（n=41）或 BLVR 组（n=47）。12 个月随访时，49 名参与者（LVRS 组 21 名，BLVR 组 28 名）完成了完整的 i-BODE 评分。两组间 i-BODE 评分的改善（LVRS -1.10±1.44 ，BLVR -0.82±1.61；p=0.54）或其各组成部分的改善均无差异。两种治疗方法均能显著改善气体潴留（残气量占预计值百分比：LVRS -36.1%（95%CI -54.6- -10%），BLVR -30.1%（95%CI -53.7- -9%）；p=0.81）。每组各有 1 例死亡。
我们的研究结果不支持 LVRS 在适合两种治疗方法的患者中明显优于 BLVR 的假设。
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