Table 13Post-revascularization trials

Study
Drug, patients
Clinical endpointClinical events
FLARE163
Fluvastatin 40 mg twice daily vs. placebo to reduce restenosis after successful single-lesion PTCA
Prespecified composite clinical endpoint of death, myocardial infarction, coronary artery bypass graft surgery, or re-intervention.No effect on restenosis or on the preplanned composite clinical end-point at 40 weeks (22.4% vs. 23.3%; log rank P=0.74); incidence of total death and myocardial infarction was lower in the fluvastatin group (1.4% vs. 4.0%; log rank P=0.025)
Weintraub 1994164
Lovastatin 40 mg twice daily vs. placebo to reduce restenosis after PTCA
Spontaneous reportNo effect on restenosis; NS trend to more MIs in the lovastatin group; no difference in fatal or nonfatal events at 6 months
PCABG159
Lovastatin 40 mg (aggressive) vs. lovastatin 2.5 mg titrated to target; before and after CABG
Pre-specified composite clinical endpoint of death from cardiovascular disease or unknown causes, nonfatal MI, stroke, CABG, or angioplastyNo difference in composite outcome (12.6% vs. 15.3%, P=0.12); no differences in individual components except a lower rate of repeat PTCA or CABG (6.5% vs. 9.2%; P=0.03; NS by study criteria for multiple comparisons)
CLAPT162
Lovastatin plus diet vs. lovastatin, before and after PTCA.
Pre-specified endpoint of MI, revascularization, or deathNo effect on restenosis; significant reduction in 2nd or 3rd re-PTCA (P=0.02)
PREDICT160
Pravastatin 40 mg vs. placebo after PTCA
Secondary endpoint of death, myocardial infarction, target vessel revascularizationNo effect on restenosis or on clinical endpoints.
CARE (subgroup)161
Pravastatin vs. placebo in patients with CABG and/or PTCA
Primary endpoint coronary heart disease death or nonfatal MIReduction in primary endpoint (relative risk, 36; 95% CI, 17 to 51; P=0.001)
LIPS167, 188
Fluvastatin vs. placebo in patients who had PCI and average cholesterol values
Primary endpoint cardiac death, nonfatal MI, CABG, or repeat PCIFor primary endpoint (relative risk, 0.78; 95% CI, 0.64 to 0.95; P=0.01)
Kayikcioglu 2002165
Pravastatin 40 mg and thrombolytics vs. thrombolytics in patients who under went coronary balloon angioplasty during 1st month of acute MI (6 month study)
Major adverse cardiovascular events: fatal or nonfatal MI, cardiac death, anginaNo difference in reducing cardiac deaths, rate of reinfarctions, or repeat revascularizations. Rate of angina was reduced with pravastatin (30%) compared with control (59.5%), P=0.018

Abbreviations: CABG, coronary artery bypass graft; MI, myocardial infarction; NS, non-significant; PCI, percutaneous coronary intervention; PTCA, percutaneous transluminal coronary angioplasty.

From: Adults

Cover of Drug Class Review: HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin
Drug Class Review: HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin: Final Report Update 5 [Internet].
Smith MEB, Lee NJ, Haney E, et al.
Portland (OR): Oregon Health & Science University; 2009 Nov.
Copyright © 2009, Oregon Health & Science University, Portland, Oregon.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.