Boston Scientific CRT-Ds Approved by FDA for use in NYHA Class I & II Heart Failure Patients
The FDA has approved an indication exclusive to Boston Scientific CRT-Ds, including COGNIS®, for high-risk*, NYHA Class I and II heart failure patients with left bundle branch block (LBBB) based on the landmark MADIT-CRT results.
MADIT-CRT provides clinical evidence that in NYHA Class I and II patients with LBBB, early CRT intervention reduces the relative risk of all-cause mortality or first heart failure event by 57% when compared to ICD therapy, (p < 0.001). **
*High-risk is defined as QRS width ≥ 130 ms, LVEF ≤ 30%, and LBBB
**Left bundle branch block (LBBB) was not an inclusion parameter for the MADIT-CRT trial. However, a significant interaction between treatment and bundle branch block morphology was detected. Further analyses revealed that LBBB is an objective discriminator of patient benefit from CRT-D regardless of other baseline characteristics. The subgroup of MADIT-CRT patients without LBBB did not show statistically significant benefit in the primary and secondary endpoints.