Funded by the BHF PG/2000084

POBBLE1 is a trial to evaluate the effectiveness of beta blockade given before vascular surgery to patients without previous myocardial infarction.

Recent evidence has pointed to the benefits of ß-blockade for a subset of patients undergoing vascular surgery, who have very severe coronary artery disease. Since most patients with peripheral arterial disease have significant, if silent, coronary disease, it is possible that all patients undergoing vascular surgery would benefit from peri-operative ß-blockade. Therefore we shall investigate, in a randomised trial, the potential benefits of a pragmatic regime of perioperative ß-blockade for all patients undergoing distal arterial surgery.

We shall investigate whether the use of a ß-blocker during and for one week after vascular surgery:

• reduces the incidence of cardiovascular events within 30 days of surgery
• reduces myocardial ischaemia in the first post-operative week (a prognostic indicator for 2-year survival)
• decreases the length of post-operative hospital stay
• improves long term patient survival

Patients undergoing major vascular surgery (n=400) will be randomised to receive either metoprolol or an identical placebo, with trial medication continuing for one week after surgery. During this period there will be close monitoring for evidence of myocardial ischaemia.

Participating trial centres are:

• University Hospitals of Coventry & Warwickshire NHS Trust
  (trial co-ordinator: Alison Dry)
• Gloucester hospital
• Charing Cross Hospital, London

Inclusion Criteria

• Patients undergoing major elective peripheral vascular surgery
• Must have given signed, informed consent

The scheduled operative procedures of eligible patients include:

• Abdominal aortic aneurysm repair, open or endovascular
• Aorto-iliac surgery, open
• Iliac aneurysm repair, open or endovascular
• Axillobifemoral grafting
• Femoropopliteal bypass, using vein or prosthetic
• Femorodistal bypass, using vein or prosthetic
• Above or below knee amputation

Patient Exclusions

1. Carotid Surgery
2. Patients already taking ß-blockers
3. Patients in whom it would be dangerous to give ß-blockers, for various reasons including:
   • known intolerance to ß-blockers
   • current treatment for asthma
   • aortic stenosis (awaiting valve surgery or peak gradient > 40 mmHg)
   • bradycardia (pulse =45)
   • hypotension (systolic pressure < 100mmHg)
4. Patients in whom it could be dangerous to give ß-blockers. For patients taking Verapamil, a cardiological opinion is sought. The cardiologist must sign any agreement for ß-blockade.
5. Patients in whom peri-operative ß-blockade has been shown to be beneficial including those with:
   • previous documented MI
   • unstable angina
   • angina with positive dobutamine stress test