journal club lei zhang pgy 3 7/16/09. case 55 y.o. f, pmh htn, dm, tia, and diverticulosis had...
TRANSCRIPT
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Journal ClubJournal ClubJournal ClubJournal ClubLei Zhang PGY 3Lei Zhang PGY 3
7/16/097/16/09
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Case• 55 y.o. F, PMH HTN, DM, TIA, and
diverticulosis• Had multitple diverticulitis, lower GIB in
the past • Scheduled to have elective colon
resection in 2 wks• Presented to the office for pre-op
clearance• Denied CP, SOB, swelling
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Case• HTN well controlled with Lisinopril and
HCTZ• DM well controlled with Glipizide and
Metformin• Also taking ASA and Zocor• Good functional status, able to climb 2
flight of stairs carrying grocery• Recent EKG/CXR within normal limits • Recent CBC, Chem 7 within normal limits
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Anything Else Needed Anything Else Needed Pre-operatively? Pre-operatively?
Anything Else Needed Anything Else Needed Pre-operatively? Pre-operatively?
Add Beta-blocker? Add Beta-blocker?
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Perioperative Beta Blocker use
• Circulation, 2006• Feringa and colleagues performed an
observational cohort study of 272 vascular surgery patients
• Higher doses of -blockers and tight heart rate (< 70 bpm) control associated with reduced perioperative myocardial ischemia and troponin release and improved long-term outcome
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Perioperative Beta Blocker use
• J AM Coll Cardio, 2006• Poldermans and colleagues randomly
assigned 770 intermediate-risk patients to cardiac stress testing (n386) or no testing (n384) preoperatively
• Concluded that cardiac testing can safely be omitted in intermediate-risk patients if beta blockers aimed at tight heart rate control are prescribed
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Perioperative Beta Blocker use
• BMJ, 2005• Donald Redelmeier & colleague
performed retrospective cohort study in Canada in 37,151 asymptomatic patients older than 65 admitted for elective surgery (mainly abd & ortho procedure)
• Patients receiving long-acting beta-blockers have lower perioperative cardiac risk than short-acting agent
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ACC/AHA Guideline for Pre-op Beta-blocker
Use
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Perioperative Beta Blocker use
• Am Heart J. 2006• Yang & colleague performed a double-blind
randomized controlled trial of perioperative metoprolol versus placebo in 496 patients undergoing vascular surgery
• Metoprolol was not effective in reducing the 30-day & 6-month postop cardiac event rates.
• Concluded that prophylactic use of perioperative beta-blockers in all vascular patients is not indicated
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Perioperative Beta Blocker use
• BMJ, 2006• Anne Benedicte Juul & colleague designed a
randomized, controlled and blinded multicentre trial in 921 diabetic patients, age > 39, scheduled for major non-cardiac surgery
• 100 mg metoprolol extended release or placebo given from the day before surgery to a max of 8 perioperative days
• Conclusions: Perioperative metoprolol did not significantly affect mortality and cardiac morbidity
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Perioperative Beta Blocker use
• BMJ, 2006• Devereaux & colleague published a
meta-analysis of randomized controlled trials in non-cardiac surgery pts
• β blockers might prevent major cardiovascular events but increase the risk of hypotension & bradycardia
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Peri-operative Use of Peri-operative Use of Beta-blockerBeta-blocker
Peri-operative Use of Peri-operative Use of Beta-blockerBeta-blocker
Yes or NOYes or NO
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POISE TRIAL• PeriOperative ISchemic
Evaluation• Purpose of the trial:
– Comparing the effect of extended-release metoprolol with that of placebo on 30-day risk of major cardiovascular events in patients with, or at risk of, atherosclerotic disease who were undergoing non-cardiac surgery.
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POISE TRIAL• Research question
– Does peri-operative β-blocker regimen benefit noncardiac surgery pts without substantial harm?
• Double-blinded, randomized, controlled, multi-center trial
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POISE TRIAL• Involved 8,351 pts and 190
hospitals in 23 countries• Study period 10/2002 – 7/2007
• Ethical approval for all participating sites obtained
• Written informed consent obtained from all pts
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POISE TRIAL• Inclusion criteria
– undergoing non-cardiac surgery– aged 45 years or older– expected length of hospital stay > 24 h– any one of the following criteria
• hx of CAD • hx of PVD• Stroke
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POISE TRIAL• hospitalization for CHF within past 3 years • undergoing major vascular surgery
– Or, any three of seven risk criteria• undergoing intrathoracic or intraperitoneal
surgery• hx of CHF• hx of TIA• hx of diabetes• creatinine >175 μmol/L ( >2.0 mg/dL)• age >70 years• undergoing emergent or urgent surgery
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POISE TRIAL• Exclusion criteria
– HR < 50 bpm– 2nd or 3rd AVB– Asthma– Receiving β blocker or planned to start one
perioperatively– Prior adverse reaction to β blocker– CABG in the preceding 5 years with no
ischemia– Low-risk surgical procedure– On verapamil
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POISE TRIAL• Patients were randomly assigned to
two groups via a 24-h computerized randomization phone service
• Participants, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation
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Trial Profile…
Figure 1
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Table 2
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Method• 1st dose of the study drug (ie, oral
extended-release metoprolol 100 mg or matching placebo) given 2–4 h before surgery
• VS checked each time before medication to ensure HR > 50 bpm & SBP > 100 mm Hg
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Method• Within 6 h postop, pt received 1st post-
op dose• 12 h after 1st post-op dose, start
Metoprolol extended-release 200mg or placebo p.o. daily for 30 days
• If HR <45bpm or SBP < 100, study drug withheld until recovered
• Study drug was then restarted at 100mg daily
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Method• If HR consistently 45–49 bpm, SBP
>100 mm Hg, delayed taking the study drug for 12 h
• If unable to take p.o., study drug given by slow or rapid IV infusion q6h
• Investigators were allowed to select either the slow or rapid IV infusion
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Method• Slow infusion
– 15 mg of study drug in 25 mL NS over 60 min
– HR & BP checked at 10, 30, and 60 min into the infusion
• If HR/BP drop, study drug reduce to 10mg
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Method• Rapid infusion
– 5 mg of the study drug IV over 2 min and repeated every 5 min for a total of 15 mg
• ECG recorded 6–12 h postoperatively and on the 1st, 2nd , and 30th days
• Troponin or CK-MB at 6–12 h postoperatively & on the 1st , 2nd , and 3rd days
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POISE TRIAL• Primary outcome
– cardiovascular death– non-fatal MI – non-fatal cardiac arrest at 30 days
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Statistical Analysis• Study has 85% power to detect a
relative risk reduction of 25%• All analyses used Cox proportional
hazards models
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Table 3
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Results• Fewer in the metoprolol group reached
the primary endpoint (hazard ratio 0·84, 95% CI 0·70–0·99, p=0·039)
• Fewer patients in the metoprolol group had a non-fatal MI (hazard ratio 0·70, 95% CI 0·57–0·86; p=0·0008)
• Fewer in the metoprolol group had cardiac revascularisation or developed new A fib
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Result• More in the Metoprolol group had a
stroke (hazard ratio 2·17, 95% CI 1·26–3·74, p=0·0053)
• More people receiving metoprolol died (1·33, 1·03–1·74, p=0·0317)
• More pts receiving Metoprolol had significant hypotension and bradycardia
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Primary MIs
Strokes Death
Figure 2
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Results• Median length of hospital stay was
8 (IQR 4–14) days in the Metoprolol group and 8 (4–15) days in the placebo group (p=0·4046)
• The number of nights spent in ICU/CCU was much the same in the two groups
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Results• At discharge, Metoprolol group
had – a lower mean HR(71·6 [SD 12·0]vs
78·6 [11·8]; p<0·0001)– lower mean SBP & DBP (129
[18·9]/72 [11·1] vs 131 [18·2]/74 [11·1]mm Hg; p<0·0001)
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Discussion• Why extended-release Metoprolol
have increased risk of death and stroke?
• Clinically significant hypotension, bradycardia and stroke contribute to the increasing risk of death
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Table 5
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Discussion• Sepsis or infection was the only
cause of death that was significantly more common in Metoprolol group
• Hypotension caused by β blockers could have predisposed pts to developing nosocomial infection
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Discussion• β blockers suppress tachycardia
could delay the recognition of sepsis and infection, therefore delaying treatment, which might increase the risk of death
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Discussion• Pts receiving β-blocker who
develop sepsis or infection might not have the capacity to mount enough response to sustain life or allow adequate delivery of antibiotics to tissue
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Discussion• POISE researchers also performed
several meta-analysis of trials of periop Beta-blocker use– Decrease risk of non-fatal MI– Increase risk of death– Increase risk of non-fatal stroke
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Figure 4
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Conclusion
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Summary• Are the results valid?
– Yes• Are the results important?
– Yes• Can you apply the results to your
patient?– Yes
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Validity• This is a large, multi-center,
randomized, double-blind, controlled clinical trial
• Both groups were comparable in terms of back ground information, type of surgery, anesthesia, and medications
• Both groups were treated equally
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Validity• Confounding criteria were well-
accounted between the two groups• Clear inclusion and exclusion criteria• Study has detailed medication
administration and side-effect monitoring protocol
• Follow-up was complete for majority of pts
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Validity
• Although involving large of amount of pts and study personnel from 190 hospitals in 23 countries, the study was well regulated by central and on-site monitoring system
• Problems found in Iran and Colombia were caught immediately and data excluded from the study
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Applicability• This is a large multi-country study,
involving different racial, ethnic & economic population; it is safe to generalized the study results to our practice patients
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Significance• The study have enormous
influence on current medicine practice
• It challenged the currently popular concept of perioperative Beta-blocker use
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Significance• For every 15 patients in POISE
trial, one had a cardiovascular death, non-fatal myocardial infarction, non-fatal cardiac arrest, or non-fatal stroke at 30-day follow-up
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Significance• Suggest that the addition of
perioperative Beta-blocker potentially has serious risks
• Lead to the further question of who will benefit from Beta-blocker and who will not?
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Thank YouThank YouThank YouThank You
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ACC/AHA Guideline for Preop Eval for
Noncardiac Surgery• Pts with active cardiac conditions,
indicate major clinical risk– unstable coronary syndromes,
• acute MI < 7 days• recent MI > 7 days but </= 1 month with
evidence of ischemia• unstable or severe angina
– decompensated heart failure,– significant arrhythmias– severe valvular disease
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ACC/AHA Guideline for Preop Eval for
Noncardiac Surgery• Pts with clinical risk factors
– history of heart disease,• hx MI or Q waves by ECG
– history of compensated or prior CHF– history of cerebrovascular disease, TIA,
stroke– diabetes mellitus, preop use of insulin– renal insufficiency, preop Cr >2.0
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