LEFT-BUNDLE-CRT: linkerbundeltak-pacing niet aantoonbaar non-inferieur aan biventriculaire CRT

BACKGROUND AND AIMS: Conduction system pacing has emerged as an alternative to biventricular pacing (BiVP) for cardiac resynchronization therapy (CRT). The left-bundle CRT trial evaluated whether left-bundle branch area pacing (LBBAP) is non-inferior to BiVP in patients eligible for CRT. METHODS: The left-bundle CRT trial was a multi-centre, randomized, investigator-initiated, and non-inferiority study. Patients with guideline-based CRT indications and left-bundle branch block per Strauss criteria were randomized to BiVP-CRT or LBBAP-CRT. The primary endpoint was the proportion of patients with a positive CRT response at 6-months, defined as either an improved clinical composite score (CCS) or a ≥15% reduction in left ventricular end-systolic volume. The non-inferiority margin was the lower bound of the 95% confidence interval (CI) and was set at 10%. Patients were followed for 12-months; secondary endpoints included echocardiographic, clinical, and quality-of-life outcomes. RESULTS: The baseline characteristics of the 176 patients randomized to BiVP-CRT (n=84) or LBBAP-CRT (n=92) were similar, except for a wider intrinsic QRS in the LBBAP group: median 172 ms [IQR 158-184] vs. 165 ms [152-180]; P=0.04. Crossovers occurred in 26 patients (14.9%). In the intention-to-treat analysis, the primary endpoint was achieved in 94.6% of BiVP-CRT and 89.7% of LBBAP-CRT patients (RR 0.95; 95% CI 0.88-1.02), not meeting non-inferiority. CCS improved in 77% and 68% of patients randomized to BiVP-CRT and LBBAP-CRT, respectively and 85% and 79% had a ≥15% reduction in left ventricular end-systolic volume. Rates of adverse events and heart failure hospitalization were similar between groups. CONCLUSIONS: In CRT candidates with typical LBBB, LBBAP-CRT was not shown to be non-inferior to BiVP-CRT. Both strategies yielded high response rates and similar clinical outcomes.