- Hello, my name is Aernoud Fiolet. I'm one of the investigators of the LoDoCo2 Trial which I will take along the next few minutes. The LoDoCo2 trial is an acronym for the Low Dose Colchicine in Coronary Disease, and I'm giving this presentation on behalf the other LoDoCo2 investigators. The LoDoCo2 Trial aim to investigate the efficacy of low dose colchicine in patients with chronic coronary disease, and used an open-label run-in phase in which patients were exposed during a month to colchicine 0.5 milligrams open-label, prior to randomization. Six and a half thousand patients were included in this open-label run-in phase, and approximately 10% did not undergo randomization due to perceived side effects. Then some others had other reasons not to pursue to randomization, and finally we randomised five and a half thousand patients. To go into the trial, in which we had a follow up of approximately 29 months, 25% was followed up for more than four years, with a very good follow up, with only one patient lost to follow up during the complete trial. And the premature discontinuation rate of trial medication did not differ between trial arms and no major issues seen on that front. Approximately 10 and a half percent quit drugs. Patients were regular patients from an outpatient cardiology clinic. Majority was male, only 15% female patients, and were all treated according to contemporary standards of secondary prevention with the majority using high intensity statins almost all lipid lowering agents and almost all using antiplatelet agents or anticoagulants. And the primary outcome of the LoDoCo2 trial was cardiovascular death myocardial infarction, ischemic stroke or coronary revascularization. And these are the results of the analysis on the primary outcome in patients treated with colchicine we noticed 31% relative risk reduction on that primary outcome which was also seen in the individual components of the composite with the effect estimates all pointing out in the same direction and a small change in death from any cause as well as broad confidence intervals for cardiovascular death, which occurred very infrequently. There was a numerical increase in non cardiovascular death which did not reach statistical significance and could not be explained by the major safety outcomes that were collected due to trial which were among others, cancer, pneumonia, and infection. And we saw a small increase in the occurrence of myalgia which was more common in the treatment group than in the placebo group, though it was common in both groups with almost 20% reporting that. When the outcomes of the LoDoCo trial are pooled with the outcomes of the COLCOT trial investigating the same dose of colchicine in patients with acute myocardial infarction rather than chronic coronary disease and two other large colchicine trials, we have a pooled efficacy outcome or a pooled rather risk reduction of 25% for major adverse cardiovascular events So that will be myocardial infarction stroke or cardiovascular death and looking in the individual components of that composite outcome. In particular the extraordinary effect on stroke should be noticed with an almost 50% relative risk reduction in the occurrence of any stroke. Well, this is one answer on a trial of colchicine and coronary disease but we do have some more questions left. One of those is what the guidelines would recommend us and 2021 ESC guidelines have provided us with some answer for that giving a 2B recommendation as a step two in cardiovascular risk management, as depicted over here. And there are some remaining questions among which are what time treatments should be commenced what compliance of the drug is. And if there are any important drug interactions which patients would benefit most and in particular what long term effects would be focusing on the mortality.