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. 2023 Dec 20;32(170):230004. doi: 10.1183/16000617.0004-2023

TABLE 2.

Overview of randomised controlled trials on bronchoscopic lung volume reduction

Trial Design Treated (n) Emphysema and CV Follow-up (months) FEV1 RV 6MWD SGRQ Advantage Risk
% R (%) mL R (%) m R (%) Points R (%)
Drug-eluting transbronchial stent
 EASE, 2011 [61] Multicentre double-blind, sham-controlled, 2:1 208 Homogeneous 6 −1.5# / −61# / −7# / −2# / Possible in CV+ Large short-term effect Low stent patency Severe respiratory adverse events
EBV: Pulmonx
 VENT, 2010 [64] Multicentre, 2:1 220 Heterogeneous No fissure or CV assessment 6 +7 24 / / +19 25 −3.4 / FDA approved Reversible Pneumothorax Granulation tissue
 BeLieVer-HiFi, 2015 [65] Single-centre double-blind, sham-controlled, 1:1 25 Heterogeneous Visual fissure intact 3 +9#,¶ 39 −260# 48 +25#,¶ 52 −4.4# 48
 STELVIO, 2015 [66] Single-centre, 1:1 34 Hetero- and homogeneous Chartis CV− 6 +18 72 −831 71 +74 87 −14.7 79
 IMPACT, 2016 [67] Multicentre, 1:1 43 Homogeneous Chartis CV− 3 +17 42 −480 44 +40 48 −9.64 68
 TRANSFORM, 2017 [10] Multicentre, 2:1 65 Heterogeneous Chartis CV− 6 +29 66 −670 68 +79 65 −6.5 66
 LIBERATE, 2018 [11] Multicentre, 2:1 128 Heterogeneous Chartis CV− 12 +18 56 −522 62 +39 42 −7,05 56
EBV: Spiration Valve System
 REACH, 2018 [68] Multicentre, 2:1 66 Heterogeneous Visual fissure intact 6 +91 mL#,¶ 41 −420# 66 +21#,¶ / −8.4#,¶ / FDA approved Reversible
Severe respiratory adverse events: exacerbations, pneumothorax Granulation tissue
 EMPROVE, 2019 [69] Multicentre, 2:1 113 Heterogeneous Visual fissure intact 6 +101 mL 37 −361 51 +7 32 −13 54
AeriSeal sealant
 ASPIRE, 2015 [70] Multicentre, 3:2 34 Heterogeneous upper lobe-predominant 6 +19#,¶ 52 / / +31#,¶ 52 −12#,¶ 76 Possible in CV+ Low pneumothorax risk
No foreign body
Severe respiratory adverse events: acute inflammatory response, exacerbations, pneumonia
Endobronchial coils
 RESET, 2013 [71] Multicentre, 1:1 23 Heterogeneous and homogeneous 3 +11 57 −310 57 +64 74 −8.4 65 Possible in CV+ and/or homogeneous emphysema
Low pneumothorax risk
Staged treatment Not in clinical airway disease Severe respiratory adverse events: coil-associated opacity, exacerbations, pneumonia Granulation tissue
 REVOLENS, 2016 [72] Multicentre, 1:1 50 Heterogeneous and homogeneous 6 +11 / −370 / +21 36 −13.4 /
 RENEW, 2016 [73] Multicentre, 1:1 158 Heterogeneous and homogeneous 12 +7 / −310 / +15 40 −8.9 61
 ELEVATE, 2021 [74] Multicentre, 2:1 57 Heterogeneous and homogeneous 6 +10 42 −460 50 / / −10.6 57
Thermal vapour ablation
 STEP-UP, 2016 [75] Multicentre, 2:1 46 Heterogeneous upper lobe-predominant 6 +15 50 −303 / +31 42 −9.7 70 Possible in CV+ Low pneumothorax risk
No foreign body
Staged treatment Severe respiratory adverse events: exacerbations, pneumonia, pneumonitis

Outcome results (FEV1, RV, 6MWD and SGRQ) are presented as between-group difference in change from baseline (treated versus standard of care). The reported response rate (R) is shown as % in the per protocol population, unless only the response rate of the intention-to-treat population was reported (in RESET, REVOLENS and RENEW). For the minimal clinically important differences used, we refer to the specific study reports. FEV1: forced expiratory volume in 1 s; RV: residual volume; 6MWD: 6-min walk distance; SGRQ: St George's Respiratory Questionnaire; CV: collateral ventilation; CV−: absence of CV; CV+: presence of CV; EBV: endobronchial valve; FDA: US Food and Drug Administration. #: results presented as change from baseline in the treated group; : significant between-group difference or significant difference between treated and standard of care group, p<0.05.