Table 4.

Categorical Outcomes

	TMVr	Standard Care	Risk Difference (95% CI)	P-Value
Moderately improved
1 month	163/279 (58.4%)	71/272 (26.1%)	32.3% (24.5, 40.1)	<0.001
6 months	154/252 (61.1%)	88/236 (37.3%)	23.8% (15.2, 32.4)	<0.001
12 months	125/219 (57.1%)	86/188 (45.7%)	11.3% (1.6, 21.0)	0.022
24 months	75/128 (58.6%)	34/88 (38.6%)	19.9% (6.7, 33.2)	0.004
Substantially improved
1 month	106/279 (38.0%)	34/272 (12.5%)	25.5% (18.6, 32.4)	<0.001
6 months	112/252 (44.4%)	54/236 (22.9%)	21.6% (13.4, 29.7)	<0.001
12 months	91/219 (41.6%)	41/188 (21.8%)	19.7% (10.9, 28.5)	<0.001
24 months	60/128 (46.9%)	24/88 (27.3%)	19.6% (6.9, 32.3)	0.004
Alive and moderately improved
1 month	163/286 (57.0%)	71/275 (25.8%)	31.2% (23.4, 38.9)	<0.001
6 months	154/281 (54.8%)	88/269 (32.7%)	22.1% (14.1, 30.2)	<0.001
12 months	125/275 (45.5%)	86/257 (33.5%)	12.0% (3.7, 20.2)	0.005
24 months	75/206 (36.4%)	34/205 (16.6%)	19.8% (11.5, 28.1)	<0.001
Alive and substantially improved
1 month	106/286 (37.1%)	34/275 (12.4%)	24.7% (17.9, 31.5)	<0.001
6 months	112/281 (39.9%)	54/269 (20.1%)	19.8% (12.3, 27.2)	<0.001
12 months	91/275 (33.1%)	41/257 (16.0%)	17.1% (9.8, 25.0)	<0.001
24 months	60/206 (29.1%)	24/205 (11.7%)	17.4% (9.8, 24.8)	<0.001
Alive and well (KCCQ-OS ≥60 points and change of ≥−10 points from baseline)
1 month	199/286 (69.6%)	104/275 (37.8%)	31.8% (23.9, 39.6)	<0.001
6 months	176/281 (62.6%)	108/269 (40.2%)	22.5% (14.3, 30.6)	<0.001
12 months	154/275 (56.0%)	83/257 (32.3%)	23.7% (15.5, 31.9)	<0.001
24 months	87/206 (42.2%)	44/205 (21.5%)	20.8% (12.0, 29.5)	<0.001

TMVr, transcatheter mitral valve repair; KCCQ-OS, Kansas City Cardiomyopathy Questionnaire Overall Summary Score.

Patients who had not yet reached the time point of interest, withdrew from COAPT, or were alive but did not complete the KCCQ-OS were excluded

Moderately improved: ≥10-point improvement in KCCQ-OS; substantially improved: ≥20-point improvement in KCCQ-OS