MAESTRO
Macitentan in Eisenmenger Syndrome to Restore Exercise Capacity
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 226 patients with Eisenmenger syndrome in WHO functional class II–III, macitentan did not improve 6-minute walk distance compared with placebo.
N
226
Design
Phase-3, double-blind, placebo-controlled RCT over 16 weeks
Endpunkt
Change from baseline in 6-minute walk distance at week 16
Relevanz
3
Ergebnis+18.3 m vs +19.7 m; least-squares mean difference −4.7 m (95 % CI −22.8 to 13.5; p=0.612). NT-proBNP fell with macitentan; haemoglobin fell by ≥2 g/dL in 36.0 % vs 8.9 %.
Gatzoulis MA, Landzberg M, Beghetti M, et al. Circulation. 2019;139(1):51-63. 10.1161/CIRCULATIONAHA.118.033575
Diskussion & Kritik
Clearly negative, but a quarter of patients were already on a PDE5 inhibitor and most were only class II, so the placebo arm walked further than expected and left little room to show benefit — a design problem as much as a drug problem. It stops the BREATHE-5 result from being generalised to the whole endothelin-antagonist class.