Randomized trial of the effects of cholesterol-lowering with simvastatin on peripheral vascular and other major vascular outcomes in 20,536 people with peripheral arterial disease and other high-risk conditions

Effects of simvastatin allocation on first major coronary event, stroke, or revascularization in participants presenting with or without peripheral artery disease. Rate ratios (RRs) are plotted (black squares with area proportional to the amount of statistical information in each subdivision) comparing outcome among participants allocated simvastatin to that among those allocated placebo, along with their 95% CIs (horizontal lines). For particular subtotals and totals, the result and its 95% CI are represented by a diamond, with the RR (95% CI) and its statistical significance given alongside. Squares or diamonds to the left of the solid vertical line indicate benefit with simvastatin, but this is conventionally significant (P < .05) only if the horizontal line or diamond does not overlap the solid vertical line. A broken vertical line indicates the overall RR for a particular subtotal or total. P-values without adjustment for multiplicity are given for heterogeneity between rate ratios. Analyses are of the number of participants with a first event of each type during follow-up, so there is some non-additivity between different types of events.

Absolute effects of simvastatin allocation on 5-year rates of first major vascular events among participants subdivided by prior PAD. S, Simvastatin allocated; P, placebo-allocated. Shaded portion of each bar represents percentage having a revascularization during follow-up.

Effects of simvastatin allocation on major vascular events in prior disease subgroups. Symbols and conventions as in figure 1. There is no overlap between participants in “PAD” and “No PAD” baseline disease categories, but within each of these categories there is some overlap (and hence, some non-additivity).

Effects of simvastatin allocation on first major vascular event in participants with or without PAD subdivided by other presenting features. Symbols and conventions as in Fig 1. Lipid categories relate to measured values at the initial screening visit prior to starting any statin therapy.

Effects of simvastatin allocation on first peripheral vascular event subdivided by presenting features. Symbols and conventions as in Fig 1. “Peripheral vascular event” was defined retrospectively as the first occurrence of a non-coronary revascularization, aneurysm repair, major amputation or PAD death.