VEST

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The Vest Prevention of Early Sudden Death Trial

 
Purpose

  • This randomized controlled trial was designed to study the use of the WCD and its effect on sudden death and total mortality measured at three months following myocardial infarction among patients who have ventricular dysfunction.
  • VEST Trial investigators performed an initial intent-to-treat analysis and subsequent per-protocol analysis.

 
Methods

  • Intent-to-treat (ITT) analysis:
    • Randomized controlled trial of 2,302 post-MI, EF ≤ 35% patients (mean age of 60.9 ± 12.6 years; mean EF of 28.2% ± 6.1%) randomized 2:1 to receive the WCD plus guideline-directed medical therapy or guideline-directed medical therapy alone.
    • Inclusion criteria included post-MI patients with or without revascularization, EF ≤ 35%, and age ≥ 18 years who were enrolled within 7 days of hospital discharge.
    • Primary outcome: sudden cardiac death and death due to ventricular arrhythmias at 90 days
    • Key secondary outcomes:
      • Total mortality
      • Non-sudden death (i.e. non-arrhythmic)
    • Outcomes were adjudicated through use of hospitalization records, autopsy reports, death certificates and narratives of accounts from witnesses of the events (or circumstances of last being seen). Data from the WCD were not used in the adjudication of outcomes.
  • Pre-protocol analysis:
    • To evaluate the impact of early stopping of WCD use, investigators performed a per-protocol analysis measuring patient outcomes from randomization to last day of WCD use.
    • Patient data were censored at death, ICD implant, last day the WCD was worn (WCD cohort only; defined as all subsequent days with 0 wear time).

 
Key Results

Intent-to-Treat1:

VEST Sudden Death or Death from VT and Death from Any Cause

Per-Protocol2:

Charts for Arrhythmic Death and Death from Any Cause in VEST Per Protocol

 
Conclusions

  • Mortality is high in the 90 days following an MI.
    • 1 in 20 low-EF (EF ≤ 35%) patients died in the 90 days following an MI.
  • In an Intent-to-Treat (ITT) analysis1
    • WCD use in post-MI patients with an EF ≤35% resulted in a reduction in the sudden death endpoint, although this did not reach statistical significance at 90 days.
    • WCD use resulted in a significant reduction of 36% in total mortality (1.8% ARR; uncorrected p=0.04) at 90 days.
    • There was a low rate of inappropriate therapies at <0.6%.
  • A per-protocol analysis confirms that when worn, WCD use resulted in significant reductions in sudden death and total mortality2:
    • WCD use resulted in a significant reduction of 62% in arrhythmic death (p=0.02).
    • WCD use resulted in a significant reduction of 75% in total mortality (p<0.001).
    • Among the patients who choose to wear the WCD, median use was high at >22 hours/day.

 

Click below to read the full publications
1Olgin JE, Pletcher MJ, Vittinghoff E, et al. Wearable Cardioverter-Defibrillator after Myocardial Infarction. N Engl J Med. 2018;379(13):1205–1215.
2Olgin JE, Lee BK, Vittinghoff E, et al. Impact of wearable cardioverter-defibrillator compliance on outcomes in the VEST trial: As-treated and per-protocol analyses. J Cardiovasc Electrophysiol 2020;1–10. https://doi.org/10.1111/jce.14404.

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