Very EaRly vs Deferred Invasive evaluation using Computerized Tomography - VERDICT

Aug 28, 2018
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Presenter/Author:
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Presented:
08/28/2018
Date Published:
08/28/2018
Date Updated:
08/28/2018
Original Posted Date:
08/28/2018
References

Contribution To Literature:

The VERDICT trial showed that early invasive therapy was associated with similar outcomes to delayed invasive therapy except for higher-risk patients. 

Description:

The goal of the trial was to evaluate invasive therapy compared with delayed invasive therapy among patients with non–ST-segment elevation acute coronary syndrome (NSTE-ACS).


Study Design

  • Randomized
  • Parallel

Patients with NSTE-ACS were randomized to early invasive therapy within 12 hours (n = 1,075) versus delayed invasive therapy within 48-72 hours (n = 1,072). Prior to randomization all patients received clopidogrel 600 mg or ticagrelor 180 mg, aspirin 300 mg, oral beta-blocker, and fondaparinux 2.5 mg subcutaneously. Unfractionated heparin was used during PCI (target activated clotting time 250-300 seconds).

  • Total number of enrollees: 2,147
  • Duration of follow-up: median 4.3 years
  • Mean patient age: 64 years
  • Percentage female: 33%
  • Percentage with diabetes: 15%

Inclusion criteria:

  • Patients ≥18 years of age with NSTE-ACS

Exclusion criteria:

  • Pregnancy
  • Inability to consent to the trial
  • Indication for very early invasive therapy

Other salient features/characteristics:

  • Time to invasive therapy: median 4.7 hours in the early invasive group vs. median 61.6 hours in the delayed invasive group
  • Femoral access: 84% in the early invasive group vs. 80% in the delayed invasive group

Principal Findings:

The primary outcome of all-cause death, myocardial infarction, hospitalization for recurrent ischemia, or heart failure occurred in 27.5% of the early invasive group compared with 29.5% of the delayed invasive group (p = 0.29).

Among those with a GRACE score >140, early invasive therapy was associated with a reduction in major adverse cardiac events (hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.67-1.01) compared with those with GRACE score ≤140 (HR, 1.21; 95% CI, 0.92-1.60; p for interaction = 0.023).

Secondary outcomes:

  • Myocardial infarction: 8.4% of the early invasive group vs. 11.2% of the delayed invasive group (p = 0.025)
  • Heart failure: 9.2% of the early invasive group vs. 11.8% of the delayed invasive group (p = 0.06)
  • Bleeding: 1.8% of the early invasive group vs. 1.8% of the delayed invasive group (p = 1.0)

Interpretation:

Among patients with NSTE-ACS, early invasive therapy within 12 hours (median 4.7 hours) did not improve major adverse cardiac events compared with delayed invasive therapy within 48-72 hours (median 61.6 hours). However, among high-risk patients (i.e., GRACE >140), there was evidence of benefit for very early invasive therapy. Although femoral access was used in the majority of patients, bleeding events were low and similar between treatment groups. An important message from this trial may be utilization of the GRACE score in risk stratifying NSTE-ACS patients.

References:

Kofoed KF, Kelbæk H, Hansen PR, et al. Early Versus Standard Care Invasive Examination and Treatment of Patients with Non-ST-Segment Elevation Acute Coronary Syndrome: The VERDICT (Very EaRly vs Deferred Invasive evaluation using Computerized Tomography) - Randomized Controlled Trial. Circulation 2018;Aug 28:[Epub ahead of print].

Presented by Dr. Thomas Engstrom at the European Society of Cardiology Congress, Munich, Germany, August 28, 2018.

Clinical Topics: Anticoagulation Management, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Acute Heart Failure, Interventions and Imaging, Computed Tomography, Nuclear Imaging

Keywords: ESC Congress, ESC18, Aspirin, Adrenergic beta-Antagonists, Heart Failure, Hemorrhage, Heparin, Myocardial Infarction, Percutaneous Coronary Intervention, Purinergic P2Y Receptor Antagonists, Risk Assessment, Secondary Prevention, Tomography, Tomography, X-Ray Computed


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