Aernoud Fiolet

370 Chapter 15 Based on these data, commencing treatment early after myocardial infarction or during outpatient clinic follow-up both appear to be valid strategies. Current data suggest a consistent effect throughout prolonged treatment, irrespective of timing of a prior acute coronary syndrome. Net clinical benefit Thirdly, when evaluating the net clinical benefit and mortality data of low-dose colchicine, it shouldbenoted that although the combinedcolchicine trials so farhave recruited over10,000patients, all-causemortality in the trialswas low.Themajority of deaths were noncardiovascular, and the decreased number of cardiovascular deaths observed was counterbalanced by an increase in noncardiovascular deaths. The low incidence of deaths and varying study durations restrict interpretation of these findings. If an intervention delays cardiovascular death substantially, other causes of death may gain the upper hand. 14 These findings justify additional studies, and long-term follow-up studies will give way to methodological approaches, such as competing risks analyses to evaluate long-term effects and the overall benefit of the drug. Currently there is a plethora of initiatives that are investigating the efficacy of colchicine in various cardiovascular conditions, all of which incorporate cardiovascular mortality in their outcome assessment. (Figure 2 and Table 2) Other vascular beds Fourthly, when considering other vascular beds, particular interest should be given to peripheral artery disease and cerebrovascular disease. No trials have yet reported on the incidence or progression of peripheral arterial disease. Patients with symptomatic peripheral artery disease are at a high risk of adverse cardiovascular events and have an impressive 10% annual risk of death after revascularisation. 15 Based on the common pathophysiological grounds of coronary disease and peripheral artery disease, a similar protective effect is expected in this population. Cerebrovascular disease is part of the same atherogenic continuum, and although patients with cerebrovascular disease have lower absolute risks of recurrent ischemic events, neurological events can result in high levels of morbidity and great loss of quality of life. When considering the effect in cerebrovascular disease, the pooled relative risk reduction of 46% for the risk of strokes was a notable finding in the colchicine trials. 1 The Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke (ClinicalTrials.gov identifier: CONVINCE;