Key result
Peri-infarct pacing fails to reduce change in LVEDV vs control at 18 months.
Why the study?
It was uncertain whether peri-infarct pacing prevents left ventricular remodelling and improves outcomes in patients with large first myocardial infarction.
Does peri-infarct pacing prevent adverse left ventricular remodelling in patients with large first myocardial infarction?
RCT (n=126)
1:1:1
Yes
Does peri-infarct pacing prevent adverse left ventricular remodelling in patients with large first myocardial infarction?
Mean Difference: 0.6 (95% CI -12.3–13.5)
Absolute Event Rate: 16.7% vs 15.3%
p-value: p=0.92
Peri-infarct pacing did not prevent adverse left ventricular remodeling or improve functional or clinical outcomes at 18 months in patients with a large first myocardial infarction.
Does not support peri-infarct pacing to prevent post-MI remodeling; challenges the therapeutic hypothesis.
AIMS: We sought to determine whether peri-infarct pacing prevents left ventricular (LV) remodelling and improves functional and clinical outcomes in patients with large first myocardial infarction (MI). METHODS AND RESULTS: A total of 126 patients at 27 international sites within 10 days of onset of anterior or non-anterior MI with creatine phosphokinase >3000 U/L and QRS duration ≤120 ms were randomized 1:1:1 to dual-site biventricular pacing vs. single-site LV only pacing vs. non-implanted control. The primary endpoint was the echocardiographic core laboratory-assessed change in LV end-diastolic volume (ΔLVEDV) from baseline to 18 months between the pooled pacing therapy groups and the control group. ΔLVEDV increased by 15.3 ± 28.6 mL in the control group and by 16.7 ± 30.5 mL in the pooled pacing groups during follow-up (adjusted mean difference (95% CI) = 0.6 (-12.3, 13.5) mL, P = 0.92). There were also no significant between-group differences in the change in LV end-systolic volume or ejection fraction over time. Quality of life, as assessed by the Minnesota Living with Heart Failure (HF) and European Quality of Life-5 Dimension questionnaires and New York Heart Association class, was also similar between groups during 18-month follow-up. Six-minute walk distance improved during follow-up to an equal degree between groups, and there were no significant differences in the 18-month rates of death or HF hospitalization between the pooled pacing therapy vs. control groups (17.4 vs. 21.7% respectively, P = 0.59). CONCLUSIONS: In the present multicentre, randomized trial, peri-infarct pacing did not prevent LV remodelling or improve functional or clinical outcomes during 18-month follow-up in patients with large first MI. CLINICALTRIALSGOV IDENTIFIER: NCT01213251.
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Stone et al. (2015) conducted an RCT in large first myocardial infarction (n=126). Peri-infarct pacing vs. Non-implanted control was evaluated on Change in LV end-diastolic volume (ΔLVEDV) from baseline to 18 months (adjusted mean difference 0.6, 95% CI -12.3, 13.5, p=0.92). Peri-infarct pacing did not significantly reduce the change in left ventricular end-diastolic volume compared to control at 18 months (adjusted mean difference 0.6 mL; 95% CI -12.3 to 13.5; P=0.92).
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