Table 4.

Adverse Events^a

Events	LIBERATE trial (%)			EMPROVE trial (%)
	Control	EBV	diff T-C	Control	EBV	diff T-C
Safety composite adverse eventsb
45 days	4.8	35.2	30.4	NR	NR	NR
6 months	NR	NR	NR	11.9	31.0	19.1
12 months	30.6	33.6	3c	10.6	21.4	10.7c
Pneumothorax
<45 days	NA	30.5	—	NA	24.8	—
12 months	NA	34	—	NA	31	—
COPD exacerbation
Short-termd	4.8	7.8	3c	10.2	16.8	6.6c
Long-terme	30.6	23	7.6c	8.5	13.6	5.1c
Pneumonia
Short-termd	0	0.8	0.8c	1.7	7.1	5.4c
Long-terme	8.1	5.7	2.4c	2.1	7.8	5.6c
Valve removal owing to pneumothorax	NA	12% of subjects	—	NA	9.7% of total number of valves	—
Valve removal owing to any cause n(% of subjects)/total number reimplanted	NA	18 (14.1%)/10 (7.8%)	—	NA	9.7%, 4.4%	—
Re-bronchoscopy for valve adjustment, n (% of subjects)	NA	8.6 (n = 11)	—	NA	0	—
Device migration rate	NA	0.6	—	NA	0	—
Device expectoration rate	NA	0.4		NA	0
Deaths
<6 mo
All cause	0	3.1 (n = 4)	—	1.7 (n = 1)	5.3 (n =6)	—c
Procedure related	—	3.1 (n = 4)	—	0	0.88 (n = 1)	—c
6-12 mo
All cause	1.6 (n = 1)	0.8 (n = 1)	—	6.4 (n = 3)	3.9 (n = 4)	—c
Procedure related	0	0	—	0	0.88 (n = 1)	—c

^aCOPD = chronic obstructive pulmonary disease; EBV = endobronchial valve; EMPROVE = Evaluation of the Spiration Valve System for Emphysema to Improve Lung Function; LIBERATE = Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema; NA = not applicable; NR = not reported.

^bFor the EMPROVE trial, this includes death, pneumothorax requiring intervention or >7-d air leak, COPD exacerbation, pneumonia, and respiratory failure. For the LIBERATE trial, this includes death, pneumothorax, COPD exacerbation, pneumonia, respiratory failure and arrhythmia.

^cNot statistically significant.

^dShort-term: 0-45 days (LIBERATE) and 0-6 months (EMPROVE) from valve implantation.

^eLong-term: 45 days to 12 months (LIBERATE) and 6 to 12 months (EMPROVE) from valve implantation.