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METOPROLOL AFTER VASCULAR SURGERY (MaVS)

Dept of Anesthesia McMaster University, University of Western Ontario, & Queen’s University H Yang, University of Ottawa, B309, 1053 Carling Ave, Ottawa. K1Y 4E9

INTRODUCTION: In vascular surgery, ß-blockers are increasingly used to prevent peri-operative cardiac complications. This is a report of a RCT on the peri-operative use of metoprolol.

METHODS: After REB approval, patients undergoing abdominal aortic surgery, infra-inguinal or extra-anatomical revascularization were recruited to a double-blind RCT of peri-operative metoprolol versus placebo. Consenting eligible patients were randomized to either IV/oral metoprolol or placebo 2 hours pre-op. Study medication was continued IV q6h or po bid until hospital discharge or maximum 5 days post-op. The primary outcome on an intent-to-treat basis was the 30-day post-op composite incidence of non-fatal MI; unstable angina; new CHF; new atrial or ventricular dysrhythmia requiring treatment; or cardiac death.

RESULTS: 497 patients consented and were randomized: 247 metoprolol and 250 placebo. The groups were balanced in demographics and pre-op co-morbidities. Early study drug discontinuation was 12% in placebo and 13% in metoprolol patients. One or more events in the primary outcome cluster occurred in 30 (12.0%) placebo and 25 (10.1%) metoprolol patients. The risk difference, –1.9% (CI –7.6% to 4.0%), was not significant (p=0.40). The observed effects in the primary cluster are shown (Table). Intra-operatively, more metoprolol patients had bradycardia requiring treatment (53/247 vs 19/250, p=0.00001) and hypotension requiring treatment (26/250 vs 84/247, p=0.0046).

Primary Outcome Cardiac Death Non-fatal MI New CHF Unstable Angina Dysrhythmia Non-cardiac Death Metoprolol 25(10.1%) 0(0.0%) 19(7.7%) 5(2.0%) 0(0.0%) 7(2.8%) 1(0.4%) Placebo 30(12.0%) 1(0.4%) 21(8.4%) 3(1.2%) 1(0.4%) 10(4.1%) 6(2.4%) p-value 0.4 1 0.87 0.5 1 0.62 0.12

DISCUSSION: This is the largest peri-operative ß-blocker RCT completed to-date. An unblinded study ¹ on 112 patients found a 10-fold reduction in MI and cardiac mortality. Our study was double-blinded and our patients were considered moderate/high risk. Another study reported 17–32% cardiovascular event rate². It was under-powered to detect 30-day treatment effects although an effect beyond 6 months was noted. Our event rate was lower than previous reports, decreasing the study’s calculated power to detect 50% RRR from 80% to about 40%. In summary, our preliminary 30-day results did not support a clinically useful metoprolol effect in reducing the cardiac event rate in these vascular patients. The 6-month and longer-term follow-ups have yet to be completed.

Reference List

1 Poldermans D, Boersma E, Bax JJ, Thomson IR, van de Ven LL, Blankensteijn JD et al. The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group. N Engl J Med 1999;341[24]: 1789–94.[Abstract/Free Full Text]

2 Mangano DT, Layug EL, Wallace A, Tateo I. Effect of atenolol on mortality and cardiovascular morbidity after noncardiac surgery. Multicenter Study of Perioperative Ischemia Research Group. N Engl J Med 1996; 335(23):1713–20.[Abstract/Free Full Text]

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