Table 2.
Overview of exploratory endpoints
| CHAMPION | GUIDE-HF | MONITOR-HF | ||||
|---|---|---|---|---|---|---|
| Treatment | Control | Treatment | Control | Treatment | Control | |
| Endpoint | ||||||
| Change in mean PAP (AUC) | −156 mmHg·days (6 months) | 33 mmHg·days (6 months) | −792.7 mmHg·days (12 months) | −582.9 mmHg·days (12 months) | −1623.8 mmHg·days (12 months) | N.A. |
| Change in average daily mean PAP | −0.6 mmHg | 0.1 mmHg | −2.4 mmHg | −1.8 mmHg | −4.7 mmHg | N.A. |
| Average mean PAP at 12 months | N.A. | N.A. | N.A. | N.A. | 24.9 mmHg | N.A. |
| Mean change in KCCQ at 12 months (SD) | N.A. | N.A. | 5 (21) | 4 (23) | 7 (25) | 0 (23) |
| Mean change in MLHFQ at 6 months (SD)a | −11 (25) | −7 (25) | N.A. | N.A. | N.A. | N.A. |
| Freedom from device or system related complications (%) | 98.6% | 99% | 97.7% | |||
| Freedom from sensor failure (%) | 100% | N.A. | 98.8% | |||
| Medication changes rate/month | 1.52 | 0.63 | 1.03 | 0.61 | 0.93b | 0.55b |
In combined analysis of the three trials, the freedom from device or system related complications was 98.9% and the freedom from sensor failure was 99.7% in implanted patients.
KCCQ, Kansas City Cardiomyopathy Questionnaire; MLHFQ, Minnesota Living with Heart Failure Questionnaire; PAP, pulmonary artery pressure; AUC, area under the curve; SD, standard deviation; N.A., not available.
Retrieved from the Food and Drug Administration Executive Summary (change not reported in main article).
Changes in guideline-recommended medical therapy and diuretics only (until 12 months of follow-up).