2020 in a nutshell: The hottest developments in the field of cardiology this year. Section 1. General and preventive cardiology
3. LoDoCo2 (Low-Dose Colchicine vs. Placebo in Patients With Chronic Coronary Disease)trial :Colchicine protective in chronic coronary disease.
Enrolling from Australia and the Netherlands, LoDoCo2 investigators studied 5,522 participants who had chronic CAD (any evidence on invasive or CT angiography or a coronary artery calcium score of ≥ 400 Agatston units) and had been clinically stable for at least 6 months, randomizing them to colchicine 0.5 mg or placebo.
Over a median follow-up duration of 28.6 months, primary endpoint events (CV death, nonprocedural MI, ischemic stroke, or ischemia-driven coronary revascularization) were decreased with colchicine (6.8%) compared with placebo (9.6%). These rates amounted to an incidence of 2.5 events per 100-person years for colchicine and 3.6 events per 100 person-years for placebo (HR 0.69; 95% CI 0.57-0.83). Results were consistent across subgroups.While these findings support the growing body of evidence of the role of inflammation in cardiovascular disease, the study failed to monitor levels of inflammatory markers. Only 15% of the participants were women, a shortcoming that needs to be addressed in future trials. There is some concern regarding GI intolerance of colchicine, and drug interactions need to be carefully explored."Over a decade, more than one in three heart patients will have another heart attack or stroke, or die from heart disease, despite taking preventive medication," said study author Dr. Mark Nidorf of GenesisCare, Australia. "Our study shows that this could be reduced to one in four with the addition of low-dose colchicine.LoDoCo2 provides strong evidence to support repurposing colchicine for routine secondary prevention in patients with chronic coronary disease," added Mark Nidorf in a press briefing. Source: American heart journal: Nidorf SM, Fiolet ATL,et al The LoDoCo2 trial rationale, design, and baseline characteristics. Am Heart J. 2019 Dec; 218:46-56. doi: 10.1016/j.ahj.2019.09.011.
From addressing the concerns of ACE inhibitors in the COVID19 era to defining a new target population for antihypertensive treatment, the following trials from 2020 will serve as landmarks for future research. Here are some of the important trials of 2020 in the field of General and preventive cardiology
1. BRACE CORONA trial
Continuing Versus Suspending Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers
Heart patients hospitalized with COVID-19 can safely continue taking common cardiac drugs.
Membrane-bound angiotensin-converting enzyme 2 (ACE2) is the functional receptor for SARS-CoV-2. Initial concerns and conflicting observational evidence about the potential clinical impact of ACE-inhibitors and ARBs on COVID-19 patients, compelled an urgent need for randomized clinical trial evidence.
The BRACE CORONA trial was an academic-led, phase 4, randomised study testing two strategies: temporarily stopping the ACE inhibitor/ARB for 30 days versus continuing ACE inhibitors/ARBs in patients who were taking these medications chronically and were hospitalised with a confirmed diagnosis of COVID-19. The primary outcome was the number of days alive and out of hospital at 30 days.
The trial enrolled 659 patients from 29 sites in Brazil. All participants were chronically using an ACE inhibitor or ARB and were hospitalised with COVID-19. Patients were randomly allocated to stopping the ACE inhibitor/ARB for 30 days or continuing the ACE inhibitor/ARB.
The BRACE CORONA Trial concluded that with patients hospitalized with COVID-19, suspending ACE inhibitors and ARBs for 30 days did not impact the number of days alive and out of hospital, so they should generally be continued for those with an indication.
"This is the first randomised data assessing the role of continuing versus stopping ACE inhibitors and ARBs in patients with COVID-19," said principal investigator Professor Renato Lopes of Duke Clinical Research Institute, Durham, US. "In patients hospitalised with COVID-19, suspending ACE inhibitors and ARBs for 30 days did not impact the number of days alive and out of hospital."
He concluded: "Because these data indicate that there is no clinical benefit from routinely interrupting these medications in hospitalised patients with mild to moderate COVID-19, they should generally be continued for those with an indication."
Source: European heart journal: Cardiovascular Research, Volume 116, Issue 14, 1 December 2020, Pages e198–e199, https://doi.org/10.1093/cvr/cvaa325
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