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Daniel I. Sessler Department of O UTCOMES R ESEARCH Cleveland Clinic

POISE-2. P eri O perative IS chemic E valuation- 2 Trial. Clonidine in patients having noncardiac surgery. Daniel I. Sessler Department of O UTCOMES R ESEARCH Cleveland Clinic on behalf of POISE-2 Investigators. Background. Myocardial injury is the leading cause of death after surgery

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Daniel I. Sessler Department of O UTCOMES R ESEARCH Cleveland Clinic

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  1. POISE-2 PeriOperative ISchemic Evaluation-2 Trial Clonidine in patients having noncardiac surgery Daniel I. Sessler Department of OUTCOMES RESEARCH Cleveland Clinic on behalf of POISE-2 Investigators

  2. Background Myocardial injury is the leading cause of death after surgery 8% of surgical inpatients >45 years 10% 30-day mortality Safe prophylactic strategies unknown beta blockers decrease risk of MI but increase risk of stroke and mortality Clonidine decreases central sympathetic outflow Analgesic and anti-inflammatory Hypothesis: clonidine reduces composite MI or death after noncardiac surgery

  3. Subjects 10,010 patients at 135 centers in 23 countries Noncardiac inpatient surgery, age >45 years History of CAD, stroke, PVD, having vascular surgery or 3 of 9 risk factors

  4. Methods Blinded 2 x 2 factorial randomized trial low-dose clonidine vs. placebo 0.2 mg/day X 72 hours, started just before surgery Primary outcome composite of death and MI at 30 days Definitions MI: abnormal troponin and symptoms, ECG, or echo Hypotension: systolic <90 mmHg requiring treatment Bradycardia: HR <55 beats/min requiring treatment

  5. Eligible patients (33,509) Eligible pts not rand (23,499) Refused consent (10,329) Pt not identified <Sx (4735) Physician refused (3569) Other reason (4866) Randomized (10,010) Allocated to clonidine (5009) Allocated to placebo (5001) Withdrew (1) Lost to follow (4) Withdrew (4) Lost to follow (2) Analyzed by I.T.T. (5009) Complete 30d FUP data (5004) Analyzed by I.T.T. (5001) Complete 30d FUP data (4995)

  6. Preoperative characteristics

  7. 30-day Results No interactions with aspirin

  8. 7% 6% 5% 4% HR (95%CI) = 1.08 (0.93-1.26), P = 0.29 cumulative percentage of patients with event 3% 2% Placebo Clonidine 1% 0% 0 5 10 15 20 25 30 Days No. at Risk Placebo 5001 4728 4697 4681 4675 4669 4658 Clonidine 5009 4709 4677 4664 4651 4647 4638 Death or MI

  9. Tertiary outcomes

  10. Safety outcomes

  11. Independent predictor of MI

  12. Risk and duration of hypotension

  13. Conclusions Clonidine does not reduce postop MI or death increases clinically important hypotension Low-dose clonidine should not be given to patients having noncardiac surgery in an effort to reduce perioperative mortality or MI A safe and effective way of preventing postoperative infarctions remains to be determined

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