![]() ![]() Cumulative incidence curves were used to plot survival (outcome-free) rates during follow-up according to the peripheral pulse status at baseline. χ 2, ANOVA, or Wilcoxon tests were used to compare baseline characteristics of participants with the absence of at least one peripheral pulse (left or right side) with those with the presence of all peripheral pulses. Categorical variables were presented as the number of patients with the corresponding percentage. Quantitative variables were expressed as mean (SD) or median (interquartile range) for variables with skewed distribution. The data and safety monitoring committee regularly reviewed all such events for each center. When study outcomes or serious adverse events occurred, the responsible investigator of the center ensured that the event was reported immediately by completing a serious adverse events form. Information about the occurrence of study outcomes and of all serious adverse events was reported at the time of occurrence between visits. The other secondary outcomes were reported systematically during the scheduled study visits, every 2 years, from case report forms and reports of serious adverse events, without adjudication. ![]() The primary outcomes, their separate components, and all-cause mortality were adjudicated by an independent end point adjudication committee. The secondary outcomes comprised all-cause mortality, heart failure (death, hospitalization, or worsening New York Heart Association class), ESRD (requirement for renal replacement therapy) or death induced by renal disease, new or worsening peripheral neuropathy (disturbance of 10-g monofilament sensation or absence of ankle or knee reflex), decline in cognitive function (reduction in the Mini-Mental State Examination score by at least 3 points compared with the baseline score), dementia (satisfying the criteria in the DSM-IV), and all-cause hospitalization for ≥24 h. Two primary end points were prespecified as a composite of major macrovascular events (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) and a composite of major microvascular events (new or worsening nephropathy or retinopathy). Every additional absent pulse increases the risk of all outcomes. Risks increased proportionally with the number of absent peripheral pulses, with the highest risks observed in patients with three or four absent pulses. Participants with absent dorsalis pedis or posterior tibial pulses had comparable hazard ratios. Absent compared with present peripheral pulses ( n = 2,218) were associated with increased 5-year risks for major macrovascular events (hazard ratio 1.47, P < 0.0001), myocardial infarction (1.45, P = 0.003), stroke (1.57, P = 0.0003), cardiovascular death (1.61, P < 0.0001), heart failure (1.49, P = 0.0002), all-cause mortality (1.48, P < 0.0001), major microvascular events (1.17, P = 0.04), nephropathy (1.24, P = 0.04), end-stage renal disease or renal death (2.04, P = 0.02), and peripheral neuropathy (1.13, P = 0.0008) after multiple adjustment.
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