Multivitamins and Probucol Study - MVP

Description:

The MVP trial was designed to assess the effect of antioxidant vitamins and the antioxidant/lipid-lowering drug probucol on restenosis following percutaneous transluminal coronary angioplasty (PTCA).

Hypothesis:

Probucol, antioxidant vitamins (MVI), or both combined will reduce the rate and extent of restenosis following PTCA more than placebo.

Study Design

Study Design:

Patients Screened: 1,179
Patients Enrolled: 317
Mean Follow Up: Six months
Mean Patient Age: Mean age 58-60 years in each of four groups
Female: 23

Patient Populations:

Patients scheduled to undergo elective PTCA of at least one native coronary artery with ≥50% stenosis

Exclusions:

1. Subjects unable to participate in pretreatment evaluation or follow-up.
2. MI within seven days.
3. Patients scheduled for atherectomy or stenting.
4. Prior PTCA within six months or restenotic lesion.
5. Saphenous vein graft intervention.
6. Unsuccessful PTCA or abrupt closure.

Primary Endpoints:

1. Reduction in mimimal luminal diameter from 15 minutes post-PTCA angiogram to six-month follow-up angiogram.
2. Binary restenosis, defined as >50% stenosis at a PTCA target site at six months, with >15% absolute increase in stenosis compared with the post-PTCA angiogram.

Secondary Endpoints:

Death, MI, CABG, and repeat PTCA

Drug/Procedures Used:

One month before scheduled, elective angioplasty, patients were randomized to one of four groups: probucol 500 mg twice daily, a multivitamin (containing 30,000 IU of beta carotene, 500 mg of vitamin C, and 700 IU of vitamin E) twice daily, both, or double-placebo. The assigned treatment was continued for six months.

Concomitant Medications:

All patients received aspirin for the entire study period.

Principal Findings:

The mean reductions in minimal luminal diameter from 0-6 months for probucol, probucol + MVI, MVI, or placebo groups, respectively, were (in mm): 0.12 ± 0.41, 0.22 ± 0.46, 0.33 ± 0.51, and 0.38 ± 0.50 (p=0.006 for probucol vs. no probucol; p=0.70 for MVI vs. no MVI). Binary restenosis occurred in 20.7%, 28.9%, 40.3%, and 38.9% of the same respective groups (p=0.004 for probucol vs. no probucol; p=0.49 for MVI vs. no MVI).

Repeat PTCA was performed in 11.2% of the probucol group, 16.2% of the combined group, 24.4% of the MVI group, and 26.6% of the placebo group (p=0.009 for probucol vs. no probucol; p=0.75 for MVI vs. no MVI). Death, myocardial infarction (MI), and coronary artery bypass graft surgery (CABG) occurred rarely in all groups.

Interpretation:

Among patients undergoing elective PTCA, probucol, but not an MVI, was associated with lower frequency and magnitude of restenosis than placebo. At the time this study was performed, stents and other adjunctive pharmacologic therapies that prevent restenosis had not penetrated clinical practice.

References:

Tardif JC, Cote G, Lesperance J, et al. Probucol and multivitamins in the prevention of restenosis after coronary angioplasty. Multivitamins and Probucol Study Group. N Engl J Med 1997;337:365-72.

Clinical Topics: Cardiac Surgery, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Lipid Metabolism, Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Myocardial Infarction, beta Carotene, alpha-Tocopherol, Lipids, Constriction, Pathologic, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Probucol, Stents


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