Effect of Pravastatin on Angiographic Restenosis After Coronary Balloon Angioplasty - PREDICT

May 14, 2004
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Date Published:
01/01/1997
Date Updated:
05/14/2004
Original Posted Date:
05/14/2004
References

Description:

The goal of this study was to assess the safety and efficacy of pravastatin in the prevention of restenosis among patients after successful coronary angioplasty.

Hypothesis:

At the time this study was performed, there were experimental and limited clinical data suggesting that therapy with lipid-lowering agents might lead to a reduction in restenosis after percutaneous transluminal coronary angioplasty (PTCA). It was therefore hypothesized that pravastatin therapy would be associated with a reduction in the rate of restenosis after PTCA.

Study Design

Study Design:

Patients Enrolled: 695
Mean Follow Up: Six months
Mean Patient Age: 31-75 years
Female: 16
Mean Ejection Fraction: >40%

Patient Populations:

Patients aged 25 to 75 years, with a left ventricular ejection fraction >40% who had undergone successful, uncomplicated PTCA were eligible for inclusion. Additionally, all patients had to have total cholesterol levels between 200 and 310 mg/dl and triglyceride levels <500 mg/dl.

Exclusions:

Patients were excluded from this study if they had MI within 15 days of their procedure or had previously undergone PTCA or CABG of the target vessel. Additionally, patients were excluded if they were taking fish oil or other lipid-lowering agents within one month of the procedure, or required corticosteroids or immunosuppressive drugs.

Primary Endpoints:

The primary endpoint was MLD, late loss, and net gain at the site of PTCA on six-month angiography.

Secondary Endpoints:

The secondary endpoints included angiographic restenosis (recurrence of >50% stenosis at the PTCA site) and clinical events (i.e., death, AMI, CABG, or repeat target lesion PTCA).

Drug/Procedures Used:

Within 24 hours of the procedure, eligible patients were randomized to receive either pravastatin 40 mg/day or placebo.

Concomitant Medications:

All patients in the study received aspirin 100 mg/day.

Principal Findings:

At six-month follow-up, there was no significant difference in minimal luminal diameter (MLD) between the pravastatin group and placebo (1.54 ± 0.66 mm vs. 1.47 ± 0.62 mm, p=0.21). Likewise, there was no significant difference between pravastatin and placebo in terms of late loss in MLD (0.46 ± 0.58 mm vs. 0.48 ± 0.56 mm, p=0.54) or net gain in MLD (0.71 ± 0.62 vs. 0.62 ± 0.59 mm, p=0.07).

The rate of restenosis, defined as recurrence of >50% stenosis, was also not significant between the pravastatin and placebo groups (39.2% vs. 43.8%, p=0.26). Last, there was no significant difference in the occurrence of clinical events (i.e., death, acute myocardial infarction [AMI], coronary artery bypass graft surgery [CABG], or repeat target lesion PTCA) between patients treated with pravastatin versus placebo (21.3% vs. 23%, p=NS).

Interpretation:

Among patients undergoing coronary angioplasty, pravastatin was not associated with a significant difference in angiographic or clinical outcomes at six months compared to placebo. These findings suggest that pravastatin does not prevent restenosis in patients after PTCA.

References:

Bertrand ME, McFadden EP, Fruchart JC, et al. Effect of pravastatin on angiographic restenosis after coronary balloon angioplasty. The PREDICT Trial Investigators. Prevention of Restenosis by Elisor after Transluminal Coronary Angioplasty. J Am Coll Cardiol 1997;30:863-9.

Keywords: Cholesterol, Myocardial Infarction, Follow-Up Studies, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Pravastatin, Stroke Volume, Constriction, Pathologic, Coronary Artery Bypass, Triglycerides, Angioplasty, Balloon, Coronary


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