Maintain your POISE and don’t block….

Devereaux PJ, Yang H, Yusuf S et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet 2008; 371: 1839-1847.

RHH Journal Club. June 28th, 2012. Dr Carol Holgate

No free full-text available

To evaluate the effect of metoprolol vs. placebo on the 30-day risk of postoperative cardiovascular events.

Background

Trials of beta blockers in patients undergoing non-cardiac surgery have reported conflicting results. This randomised controlled trial, done in 190 hospitals in 23 countries, was designed to investigate the effects of perioperative beta blockers.

Study design

Randomised controlled trial comparing the effects of metoprolol Vs placebo on 30 day risk of major cardiovascular events

Multicentre

Methods

Population

  • Patients recruited between Oct 2002 and July 2007.
  • 8351 patients.  Metoprolol 4174, placebo 4177.
  • > 45yrs, undergoing non-cardiac surgery, expected to stay in hospital > 24hrs and filled one criteria of hx coronary artery disease, PVD, stroke, hospitalisation for CCF within 3yrs prior, having major vascular surgery or have 3 of the stated 7 risk factors for atherosclerotic disease.
  • Excluded if HR < 50, 3rd degree HB, asthma, receiving a BB, adverse reaction, CABG within 5 yrs prior without ischaemia post-op, low risk surgical procedure, on verapamil, previously in POISE.

Intervention

  • Treatment was started 2-4 hours before surgery and continued for 30 days.
  • Metoprolol MR  100mg or placebo 2-4 hours prior to surgery.
  • Metoprolol MR 100mg or placebo when HR>80 bpm & SBP > 100mmHg post op or at 6hrs if not already given.
  • Metoprolol MR 200mg OD started 12hrs after first post-op dose for 30 days.

Control

Matching placebo.

Outcomes

Primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal cardiac arrest.

Validity

  • Randomly assigned to treatment group via a 24hr computerised randomisation phone service
  • Block randomisation stratified by centre
  • Participants, health-care providers, data collectors and outcome adjudicators were blinded.  Data analysts were not.

Results

  • 8331 (99.8%) patients completed the 30-day follow-up.
  • Fewer patients in the metoprolol group reached the primary endpoint (5.8%  vs 6.9%; p=0.0399) or had a myocardial infarction (4.2% vs 5.7%;  p=0.0017).
  • More deaths in the metoprolol group (3.1% vs 2.3%;  p=0.0317). More patients in the metoprolol group had a stroke (1.0% vs 0.5%; p=0.0053).

Conclusions/In practice

  • Highlighted the risk in assuming a perioperative beta-blocker regimen has benefit without harm.
  • Patients are unlikely to accept these risks.

 

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