Met bisoprolol minder perioperatieve cardiale complicaties bij hoogrisicopatiënten die een grote vaatchirurgische ingreep ondergaan

To compare the frequency of cardiac complications in patients undergoing a major vascular operation with high cardiac risk, with use of bisoprolol or of the standard medication.

Design

Randomized, open.

Method

In 7 centres in the Netherlands, Belgium and Italy in the period 1 May 1996-31 March 1999, patients referred in order to undergo a major vascular operation were examined for the presence of cardiac risk factors. In the presence of at least one risk factor, dobutamine stress echocardiography was performed. If this revealed ischaemia, the patients were randomized for additional bisoprolol therapy. Endpoints were perioperative cardiac death or myocardial infarction until 30 days postoperatively. The Kaplan-Meier method was used for the analysis.

Results

A total of 1351 patients were screened, 1056 males and 295 females, with a mean age of 67 years. Of these, 846 patients had at least one risk factor and 173 of them had an abnormal stress echocardiogram; 112 were randomized for the trial. During the follow-up there were 18 cardiac complications: 9 patients died and 9 suffered a myocardial infarction. Of the 59 patients treated with bisoprolol 2 died, of the 53 patients in the control group 7 died and 9 suffered a non-fatal myocardial infarction. The proportions of cardiac complications were 3.4 in the bisoprolol group and 34 in the control group (p < 0.001).

Conclusion

In high-risk patients undergoing a major vascular operation, the perioperative cardiac morbidity and mortality were lower with use of bisoprolol.