Modifications of coronary risk factors

Abstract

In addition to the revascularization and glycemic management interventions assigned at random, the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) design includes the uniform control of major coronary artery disease risk factors, including dyslipidemia, hypertension, smoking, central obesity, and sedentary lifestyle. Target levels for risk factors were adjusted throughout the trial to comply with changes in recommended clinical practice guidelines. At present, the goals are low-density lipoprotein cholesterol <2.59 mmol/L (<100 mg/dL) with an optional goal of <1.81 mmol/L (<70 mg/dL); plasma triglyceride level <1.70 mmol/L (<150 mg/dL); blood pressure level <130 mm Hg systolic and <80 mm Hg diastolic; and smoking cessation treatment for all active smokers. Algorithms were developed for the pharmacologic management of dyslipidemia and hypertension. Dietary prescriptions for the management of glycemia, plasma lipid profiles, and blood pressure levels were adapted from existing clinical practice guidelines. Patients with a body mass index >25 were prescribed moderate caloric restriction; after the trial was under way, a lifestyle weight-management program was instituted. All patients were formally prescribed both endurance and resistance/flexibility exercises, individually adapted to their level of disability and fitness. Pedometers were distributed as a biofeedback strategy. Strategies to achieve the goals for risk factors were designed by BARI 2D working groups (lipid, cardiovascular and hypertension, and nonpharmacologic intervention) and the ongoing implementation of the strategies is monitored by lipid, hypertension, and lifestyle intervention management centers.

Figure 1

Overview of the lipid management protocol in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) study. LDL-C = low-density lipoprotein cholesterol. To convert conventional units to SI units, multiply by 0.0259 for LDL-C and by 0.0113 for triglycerides. *Optional LDL goal of <1.81 mmol/L (<70 mg/dL) as of October 2004; ^†triglyceride goal reduced to <1.70 mg/dL (<150 mg/dL) in April 2004. If triglycerides are substantially elevated (eg, >600 mg/dL), statin therapy is unlikely to be successful and fibrate therapy may be a more appropriate initial choice.

Figure 2

Background medical therapy in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) study. ACE = angiotensin-converting enzyme; BP = blood pressure; CHF = congestive heart failure; NYHA = New York Heart Association; XL = extended release. *Because all patients in BARI 2D have coronary artery disease, β-blockers will be used (per American Diabetes Association recommendations) unless contraindications exist. β-Blockers vary in their indications, thus selection of agent depends on the particular clinical profile of the patient, eg, presence or absence of hypertension, angina, or CHF. ^†Exceptions: heart rate is ≤60 beats per minute, systolic BP is ≤100 mm Hg, or the maximum tolerated dose is less than the target dose. ^‡Unless ramipril is provided through BARI 2D. ^§Use of 1 anticoagulant only. There have been case reports of INR elevation in patients on warfarin who receive omega-3 fish oils.

Figure 3

Overview of the hypertension management algorithm in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) study. ACE = angiotensin-converting enzyme; BP = blood pressure. *Ensure titration guidelines are met for ACE inhibitors and β-blockers. Target doses of β-blockers can be exceeded to “maximum” doses providing heart rate remains ≥60 beats per minute. ^†If an additional agent is necessary, choose from a central or peripheral α-blocker or a direct vasodilator (eg, hydralazine, minoxidil). ^‡In ACE-inhibitor monotherapy, diltiazem and verapamil may also be considered.