What is the clinical evidence from this study?

Study design: RCT. Population: Cardiac resynchronization therapy non-responders (n=467). Intervention: MultiPoint Pacing (MPP) vs. Continued biventricular pacing. Primary outcome: Rate of conversion to echocardiographic response (p=0.72).

February 18, 2019Open Access

Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I

Key Result

Investigator-discretionary MultiPoint Pacing did not significantly increase the non-responder to responder conversion rate compared to continued biventricular pacing (31.8% vs 33.8%, P=0.72).

Study Design

Type

RCT (n=467)

Randomization

1:1

Multicenter

Yes

Structured PICO

Does MultiPoint Pacing improve the echocardiographic response rate in patients who are non-responders to standard biventricular pacing?

Population

467 patients classified as volumetric non-responders (<15% reduction in left ventricular end-systolic volume) to standard biventricular pacing after 6 months, from an initial cohort of 1921 patients receiving a quadripolar cardiac resynchronization therapy (CRT) system.

Intervention

MultiPoint Pacing (MPP) programmed according to the physician's discretion for an additional 6 months.

Comparator

Continued standard biventricular pacing for an additional 6 months.

Outcome

Rate of conversion to echocardiographic response (defined as ≥15% reduction in left ventricular end-systolic volume) after an additional 6 months.surrogate

Investigator-discretionary MultiPoint Pacing does not significantly increase echocardiographic response rates compared to continued biventricular pacing in CRT non-responders.

Main Result

Absolute Event Rate: 31.8% vs 33.8%

p-value: p=0.72

Abstract

AIMS: To assess the impact of MultiPoint™ Pacing (MPP)-programmed according to the physician's discretion-in non-responders to standard biventricular pacing after 6 months. METHODS AND RESULTS: The study enrolled 1921 patients receiving a quadripolar cardiac resynchronization therapy (CRT) system capable of MPP™ therapy. A core laboratory assessed echocardiography at baseline and 6 months and defined volumetric non-response to biventricular pacing as <15% reduction in left ventricular end-systolic volume (LVESV). Clinical sites randomized patients classified as non-responders in a 1:1 ratio to receive MPP (236 patients) or continued biventricular pacing (231 patients) for an additional 6 months and evaluated rate of conversion to echocardiographic response. Baseline characteristics of both groups were comparable. No difference was observed in non-responder to responder conversion rate between MPP and biventricular pacing (31.8% and 33.8%, P = 0.72). In the MPP arm, 68 (29%) patients received MPP programmed with a wide LV electrode anatomical separation (≥30 mm) and shortest LV1-LV2 and LV2-RV timing delays (MPP-AS); 168 (71%) patients received MPP programmed with other settings (MPP-Other). MPP-AS elicited a significantly higher non-responder conversion rate compared to MPP-Other (45.6% vs. 26.2%, P = 0.006) and a trend in a higher conversion rate compared to biventricular pacing (45.6% vs. 33.8%, P = 0.10). CONCLUSIONS: After 6 months, investigator-discretionary MPP programming did not significantly increase echocardiographic response compared to biventricular pacing in CRT non-responders.