Risk Factor Control Before Orthopedic Surgery

OPTIMIZE - OS (Optimization of Pre-surgical Testing with an Intensive Multifactorial
Intervention to MinimiZe Cardiovascular Events - Orthopedic Surgery) trial is to determine
the best management strategy for patients undergoing orthopedic surgery. OPTIMIZE will be a
prospective randomized trial that will enroll patients during pre-surgical testing before
orthopedic surgery. This trial will investigate different strategies aimed at lowering
cardiovascular events following orthopedic surgery. The study will compare an intensive
multifactorial intervention comprising behavioral modification and polypharmacologic therapy
aimed at several modifiable risk factors versus usual care. The trial hypothesis is that a
personalized optimization approach is superior to usual care in reducing a composite of
death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous
thromboembolism or thrombosis requiring reoperation at 30-days. Secondary endpoints include
length of stay, major bleeding, each individual endpoint from the primary endpoint, and
quality of life.

Inclusion Criteria:

- • ≥ 21 years of age

- Subjects undergoing open orthopedic surgery of the hip, knee or spine

- Surgery is scheduled at least 3 days after PAT visit and no more than 14 days.

- High risk subject cohort

- Coronary artery disease, or

- Cerebrovascular disease (prior stroke, TIA or carotid artery disease (>70%
stenosis), or

- Peripheral artery disease, or

- Prior Venous thromboembolism or arterial thromboembolism, or

- Age ≥ 60 years and 2 of the following

- Renal insufficiency (creatinine clearance < 60ml/min)

- Diabetes

- COPD

- Hypertension

- Active smoker or stopped less than 30 days prior to consent

- Cancer (excluding BCC)

- Heart Failure

Exclusion Criteria:

- • Known intolerance to statins

- Subject is already on maximum dose statin (atorvastatin/Lipitor 80mg daily or
rosuvastatin/crestor 40mg daily)

- Bilateral renal artery stenosis

- End stage renal disease (receiving dialysis or CrCl <30ml/min)

- Known allergy or intolerance to ACE-inhibitor (other than cough) or Angiotensin
receptor blocker (e.g. angioedema, hyperkalemia)

- Known allergy or intolerance to beta blockers

- Known sick sinus syndrome not treated with permanent pacemaker

- Known greater than first degree AV block not treated with a pacemaker

- Excessive alcohol intake

- Acute Coronary Syndrome requiring hospitalization within 1 month

- Stroke within 1 month

- Known pregnancy

- Severe co-morbid condition with life expectancy < 6 months

- Inability to give informed consent or adhere to follow-up as per protocol

- Current participation in another investigational drug or device trial