Randomized Controlled Trial Meta Analysis Comparative Study
- Martin Dunkelgrun, Eric Boersma, Olaf Schouten, Ankie W M M Koopman-van Gemert, Frans van Poorten, Jeroen J Bax, Ian R Thomson, Don Poldermans, and Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group.
- Departments of Vascular Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands.
- Ann. Surg.. 2009 Jun 1;249(6):921-6.
ObjectiveThis study evaluated the effectiveness and safety of beta-blockers and statins for the prevention of perioperative cardiovascular events in intermediate-risk patients undergoing noncardiovascular surgery.Summary Background DataBeta-blockers and statins reduce perioperative cardiac events in high-risk patients undergoing vascular surgery by restoring the myocardial oxygen supply/demand balance and/or stabilizing coronary plaques. However, their effects in intermediate-risk patients remained ill-defined.MethodsIn this randomized open-label 2 x 2 factorial design trial 1066 intermediate cardiac risk patients were assigned to bisoprolol, fluvastatin, combination treatment, or control therapy before surgery (median: 34 days). Intermediate risk was defined by an estimated risk of perioperative cardiac death and myocardial infarction (MI) of 1% to 6%, using clinical data and type of surgery. Starting dose of bisoprolol was 2.5 mg daily, titrated to a perioperative heart rate of 50 to 70 beats per minute. Fluvastatin was prescribed in a fixed dose of 80 mg. The primary end point was the composite of 30-day cardiac death and MI. This study is registered in the ISRCTN registry and has the ID number ISRCTN47637497.ResultsPatients randomized to bisoprolol (N = 533) had a lower incidence of perioperative cardiac death and nonfatal MI than those randomized to bisoprolol-control (2.1% vs. 6.0% events; hazard ratios: 0.34; 95% confidence intervals: 0.17-0.67; P = 0.002). Patients randomized to fluvastatin experienced a lower incidence of the end point than those randomized to fluvastatin-control therapy (3.2% vs. 4.9% events; hazard ratios: 0.65; 95% confidence intervals: 0.35-1.10), but statistical significance was not reached (P = 0.17).ConclusionBisoprolol was associated with a significant reduction of 30-day cardiac death and nonfatal MI, while fluvastatin showed a trend for improved outcome.
This article appears in the collection: Peri-operative beta blockade.
The legitimacy of Poldermans' DECREASE trials, in particular DECREASE IV, has been called into question due to scientific misconduct.
Results from other trials, such as POISE greatly undermine the argument for both benefit and safety of starting perioperative beta-blockade, even in high-risk patients. Read more about Poldermans and scientific misconduct.
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