TABLE 2.
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.