Intermediate Versus Standard-Dose Prophylactic Anticoagulation in Critically Ill Patients With COVID-19 - INSPIRATION-S

May 16, 2021
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Rajaie Cardiovascular Medical and Research Center
Date Presented:
05/16/2021
Date Updated:
05/16/2021
Original Posted Date:
05/16/2021
References

Contribution To Literature:

The INSPIRATION-S trial failed to show that atorvastatin was beneficial in critically ill COVID-19 patients.

Description:

The goal of the trial was to evaluate atorvastatin compared with placebo among patients admitted to the intensive care unit (ICU) with coronavirus disease 2019 (COVID-19) infection.

Study Design

  • Randomized
  • Parallel
  • Stratification
  • Double-blind

Patients admitted to the ICU with COVID-19 infection were randomized to atorvastatin 20 mg daily (n = 303) versus placebo (n = 302).

  • Total number of enrollees: 605
  • Duration of follow-up: 30 days
  • Mean patient age: 57 years
  • Percentage female: 43%
  • Percentage with diabetes: 17%

Inclusion criteria:

  • Critically ill patients with COVID-19 infection

Exclusion criteria:

  • Liver function tests >6 times the upper limit of normal (>3 times the upper limit of normal plus findings of cirrhosis)
  • Creatine kinase >500 U/L
  • Routine statin use prior to hospitalization
  • Statin intolerance

Principal Findings:

The primary outcome of all-cause death, venous or arterial thrombosis, or treatment with extracorporeal membrane oxygenation, occurred in 32.7% of the atorvastatin group compared with 36.3% of the placebo group (p = 0.35).

Secondary outcomes:

  • Major bleeding (Bleeding Academic Research Consortium [BARC] 3 or 5): in 3.7% of the atorvastatin group compared with 1.6% of the placebo group (p = 0.12)

Interpretation:

Among critically ill patients with COVID-19 infection, atorvastatin was not beneficial. Atorvastatin compared with placebo was not associated with a reduction in composite adverse events. Atorvastatin did not increase bleeding events.

References:

Presented by Dr. Behnood Bikdeli at the American College of Cardiology Virtual Annual Scientific Session (ACC 2021), May 16, 2021.

Clinical Topics: Anticoagulation Management, COVID-19 Hub, Dyslipidemia, Prevention, Vascular Medicine, Nonstatins, Novel Agents, Statins

Keywords: ACC21, ACC Annual Scientific Session, Anticoagulants, Coronavirus, Coronavirus Infections, COVID-19, Critical Illness, Extracorporeal Membrane Oxygenation, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Intensive Care Units, Liver Function Tests, Primary Prevention, Thrombosis, Venous Thrombosis


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