After Eighty study

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Tegn N, et al. "Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial". The Lancet. 2016. 387(10023):1057-1065.
PubMedFull text

Clinical Question

In patients older than 80 who have NSTEMI or Unstable Angina, does an invasive strategy compared with optimal medical management reduce the risk of cardiovascular events?

Bottom Line

Invasive strategy reduces risk of a composite outcome of cardiovascular events, namely MI and need for early revascularization.

Major Points

Several large randomized trials in NSTEMI and Unstable Angina had previously demonstrated a benefit of an invasive strategy for cardiac catherization in reducing cardiovascular risk. The FRISCII and the RITA-3 trials showed a reduce cardiovascular risk, but the age was younger.

Guidelines

AHA/ACC 2014 guidelines recommend routine invasive strategy for intermediate to high risk patients with NSTEMI/ACS (TIMI score of 2 or greater or a GRACE score of 109 or greater).

Design

  • Multicenter, open-label, parallel-group, randomized, controlled trial
  • N= 457
    • Invasive (n=229)
    • Standard (n=228)
  • Setting: 16 centers in Norway
  • Enrollment: December 2010 to February 2014
  • Mean follow-up: 1.53 years
  • Analysis: Intention-to-treat
  • Primary outcome: Composite cardiovascular outcome of myocardial infarction, stroke, urgent revascularization, and death

Population

Inclusion Criteria

  • Age 80 and older
  • NSTEMI or unstable angina
  • clinically stable

Exclusion Criteria

  • clinically unstable (cardiac or bleeding)
  • less than 1 year prognosis
  • significant mental disorders

Baseline Characteristics

  • Mean age:84.8 years
  • Mean Creatinine: 1.17 mg/dL
  • Diabetes Mellitus Type 2: 17%
  • Hypertension: 59%
  • Smoking status (Previous or Present): 48%
  • Prior MI: 43%
  • Prior PCI: 22%
  • Prior CABG: 17%
  • Mean GRACE score 138 (corresponds with estimated 2.9% in hospital mortality risk

Interventions

  • Randomized to invasive or conservative approaches

    • Assessed within 2 days of hospitalization
    • 48% of Invasive group had 3 vessel disease or Left main disease, 17% had calcification without significant stenosis, 1% was normal
  • Invasive strategy cohort was transferred from non-PCI hospitals to a PCI hospital(Oslo University Hospital) within one day of randomizaiton
  • Conservative therapy group remained at the initial community hospital and treated according to guidelines

Outcomes

Comparisons are invasive therapy vs. conservative therapy.

Primary Outcomes

Composite cardiovascular endpoint (MI, Need for urgent revascularization, stroke, death)
41% vs. 61% (HR 0.48; 95% CI 0.37-0.63; P=0.0001)

Secondary Outcomes

Death from any cause
25% vs. 27% (HR 0.87; 95% CI 0.59-1.27; P=0.53)

Subgroup Analysis

Age 90 years or less

HR 0.47; 95% CI 0.35-0.62; P=0.0001

Age more than 90 years

HR 1.21; 95% CI 0.53-2.7; P=0.6420

But the was a low number of patients over 90 (34)

Adverse Events

Bleeding complications
2% vs. 2% (NA)
10% vs. 7% (NA)

Criticisms

Funding

Norwegian Health Association and Inger and John Fredriksen Heart Foundation

Further Reading

  1. Boden WE, O’Rourke RA, Crawford MH, et al. Outcomes in patients with acute non-Q-wave myocardial infarction randomly assigned to an invasive as compared with a conservative management strategy. Veterans Aff airs Non-Q-Wave Infarction Strategies in Hospital (VANQWISH) Trial Investigators. N Engl J Med 1998; 338: 1785–92.
  2. Wallentin L, Lagerqvist B, Husted S, Kontny F, Stahle E, Swahn E. Outcome at 1 year after an invasive compared with a non-invasive strategy in unstable coronary-artery disease: the FRISC II invasive randomised trial. FRISC II Investigators. Fast revascularization during Instability in coronary artery disease. Lancet 2000; 356: 9–16.
  3. Fox KA, Poole-Wilson P, Clayton TC, et al. 5-year outcome of an interventional strategy in non-ST-elevation acute coronary syndrome: the British Heart Foundation RITA 3 randomised trial. Lancet 2005; 366: 914–20.
  4. TIMI
  5. ACC/AHA 2014 J Am Coll Cardiol. 2014;64(24):2645-2687.