Asthma/COPD Clinical Research Centre, Gartnavel General Hospital, Glasgow, UK; Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, UK.
Department of Pulmonary Medicine, Santa Casa of Porto Alegre Hospital, Federal University of Health Ciencies of Porto Alegre (UFCSPA), Porto Alegre, Brazil.
Lancet Respir Med. 2021 May;9(5):457-466. doi: 10.1016/S2213-2600(20)30408-2. Epub 2021 Jan 29.
Bronchial thermoplasty is an endoscopic treatment for uncontrolled asthma. Previous randomised clinical trials have shown that bronchial thermoplasty reduces severe exacerbations in people with asthma. However, the long-term efficacy and safety of bronchial thermoplasty beyond 5 years is unknown. The BT10+ study aimed to investigate the efficacy and safety of bronchial thermoplasty after 10 or more years of follow-up.
BT10+ was an international, multicentre, follow-up study of participants who were previously enrolled in the AIR, RISA, and AIR2 trials and who had 10 or more years of follow-up since bronchial thermoplasty treatment. Data on patient demographics, quality of life, lung function, CT scans (AIR2 participants only), severe exacerbations, and health-care use during the previous year were collected at the BT10+ 10-year outcomes study visit. The primary effectiveness endpoint was durability of the thermoplasty treatment effect, determined by comparing the proportion of participants who had severe exacerbations during the first and fifth years after bronchial thermoplasty treatment with the proportion of participants who had severe exacerbations during the 12-month period before the BT10+ visit. The primary safety endpoint was the absence of clinically significant post-treatment respiratory image changes after bronchial thermoplasty, defined as bronchiectasis or bronchial stenosis as confirmed by pulmonary volumetric high-resolution CT scan at the BT10+ visit (AIR2 participants only). All analyses were done on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03243292. The last patient was enrolled on Dec 11, 2018. The last patient completed follow-up on Jan 10, 2019.
The BT10+ study enrolled 192 (45%) of the 429 participants who were enrolled in the AIR, RISA, and AIR2 trials. The BT10+ participants comprised 136 who received bronchial thermoplasty (52% of the 260 participants who received bronchial thermoplasty in the original trials), and 56 sham or control participants (33% of 169 from the original trials). 18 (32%) sham or control participants received bronchial thermoplasty after the previous trials concluded. The participants included in BT10+ were followed for 10·8-15·6 years (median 12·1 years) post-treatment. Baseline characteristics were similar between participants enrolled in BT10+ and those not enrolled. Participants treated with bronchial thermoplasty had similar proportions of severe exacerbations at the BT10+ visit (34 [25%] of 136 participants) compared with 1 year (33 [24%] of 135 participants; difference 0·6%, 95% CI -9·7 to 10·8) and 5 years (28 [22%] of 130 participants; difference 3·5%, -6·7% to 13·6) after treatment. Quality of life measurements and spirometry were similar between year 1, year 5, and the BT10+ visit. At the BT10+ study visit, pulmonary high-resolution CT scans from AIR2 participants treated with bronchial thermoplasty showed that 13 (13%) of 97 participants had bronchiectasis. When compared with baseline high-resolution CT scans, six (7%) of 89 participants treated with bronchial thermoplasty who did not have bronchiectasis at baseline had developed bronchiectasis after treatment (5 classified as mild, 1 classified as moderate). Participants treated with bronchial thermoplasty after the original study and participants in the sham or control group also had reductions in severe exacerbations at the BT10+ visit compared with baseline.
Our findings suggest that efficacy of bronchial thermoplasty is sustained for 10 years or more, with an acceptable safety profile. Therefore, bronchial thermoplasty is a long-acting therapeutic option for patients with asthma that remains uncontrolled despite optimised medical treatment.
Boston Scientific.
支气管热成形术是一种用于治疗不受控制的哮喘的内镜治疗方法。先前的随机临床试验表明，支气管热成形术可减少哮喘患者的严重加重。然而，支气管热成形术在 5 年以上的长期疗效和安全性尚不清楚。BT10+研究旨在调查支气管热成形术 10 年或更长时间随访后的疗效和安全性。
BT10+是一项国际多中心随访研究，参与者为先前参加 AIR、RISA 和 AIR2 试验且支气管热成形术治疗后随访时间超过 10 年的患者。在 BT10+ 10 年结果研究访问时，收集了患者人口统计学、生活质量、肺功能、CT 扫描（仅 AIR2 参与者）、严重加重以及过去一年的医疗保健使用情况等数据。主要有效性终点是热成形术治疗效果的持久性，通过比较支气管热成形术治疗后第 1 年和第 5 年严重加重的参与者比例与 BT10+访问前 12 个月严重加重的参与者比例来确定。主要安全性终点是支气管热成形术后无临床意义的呼吸图像变化，定义为支气管扩张或支气管狭窄，通过 BT10+访问时的肺部容积高分辨率 CT 扫描（仅 AIR2 参与者）确认。所有分析均基于意向治疗进行。该试验在 ClinicalTrials.gov 上注册，NCT03243292。最后一名患者于 2018 年 12 月 11 日入组。最后一名患者于 2019 年 1 月 10 日完成随访。
BT10+研究纳入了在 AIR、RISA 和 AIR2 试验中入组的 429 名参与者中的 192 名（45%）。BT10+ 参与者包括 136 名接受支气管热成形术治疗的患者（原试验中接受支气管热成形术治疗的 260 名患者中的 52%）和 56 名假手术或对照组参与者（原试验中 169 名患者中的 33%）。18 名（32%）假手术或对照组参与者在原试验结束后接受了支气管热成形术治疗。BT10+ 纳入的参与者在治疗后 10.8-15.6 年（中位 12.1 年）进行了随访。入组 BT10+的参与者和未入组的参与者在基线特征方面相似。接受支气管热成形术治疗的患者在 BT10+访问时严重加重的比例与 1 年（33[24%]名 135 名患者；差异 0.6%，95%CI-9.7 至 10.8）和 5 年（28[22%]名 130 名患者；差异 3.5%，-6.7%至 13.6）时相似。1 年、5 年和 BT10+访问时的生活质量测量和肺活量计测量结果相似。在 BT10+研究访问时，接受支气管热成形术治疗的 AIR2 参与者的肺部高分辨率 CT 扫描显示，97 名参与者中有 13 名（13%）患有支气管扩张症。与基线高分辨率 CT 扫描相比，基线时无支气管扩张症的 89 名接受支气管热成形术治疗的患者中有 6 名（7%）在治疗后出现了支气管扩张症（5 名轻度，1 名中度）。在原始研究后接受支气管热成形术治疗的参与者和假手术或对照组的参与者在 BT10+访问时与基线相比，严重加重的情况也有所减少。
我们的研究结果表明，支气管热成形术的疗效可维持 10 年以上，具有可接受的安全性。因此，支气管热成形术是一种长效治疗选择，适用于经过优化药物治疗仍不受控制的哮喘患者。
波士顿科学公司。
