Endobronchial Coil System versus Standard-of-Care Medical Management in the Treatment of Subjects with Severe Emphysema.
Klooster K, Valipour A, Marquette CH, Boutros J, Mal H, Marceau A, Shah PL, Conway F, Deslée G, Bourdin A, Pison C, Grah C, Hetzel M, Schumann C, Kessler R, Huebner RH, Skowasch D, Darwiche K, Hammerl P, Stanzel F, Bezzi M, Dutau H, Herth FJF, Slebos DJ.
Respiration. 2021;100(8):804-810. doi: 10.1159/000515744. Epub 2021 May 7. PMID: 33965944; PMCID: PMC8491498.
What is the key question?
- Determining the efficacy and safety of endobronchial coils in select chronic obstructive pulmonary disease patients.
What is the bottom line?
- A partly-completed multicentre randomized control trial was performed comparing coils to standard COPD care (2:1), in patients with evidence of hyperinflation (total lung capacity >100% and residual volume >200%).
- The trial reached 57% (n=120) enrolment before being terminated by the sponsor.
- Coil-treated patients achieved the set co-primary outcomes of improvement in FEV1 of at least 10% and improvement in St George Respiratory Questionnaire of at least 7 points. Residual volume was also reduced by a mean of -460ml, with 50% achieving the minimum clinical RV reduction of -350ml.
- Five patients (6.8%) deaths were recorded in the coil-treated arm with only one possibly being attributed to the device. Common adverse events were pneumonia, COPD exacerbations and pneumothorax.
Why read on?
- The authors provide specifics regarding the procedure, and discuss the adverse events and device’s potential despite being unable to complete the trial.