Major Practice Changing Cardiology Trials in 2023
M3 India Newsdesk Dec 28, 2023
The area of cardiology is seeing tremendous growth due to several recent developments. A summary of a few notable clinical cardiology trials that were published in 2023 is provided in this article, which should be of use to researchers and clinicians in practice.
Updated expert recommendations for conduction system pacing
Conduction system pacing is a technique for pacing that aims to restore left ventricular function by resynchronising right and left ventricular contraction by directly stimulating the cardiac conduction system at the His bundle or left bundle branch.
Guidelines on the use of conduction system pacing to establish cardiac resynchronization treatment (CRT) were published for the first time by the Heart Rhythm Society, Asia Pacific Heart Rhythm Society, and Latin American Heart Rhythm Society.
According to recommendations, conduction system pacing is a feasible option for patients with heart failure (HF) who are unable to perform standard CRT using a coronary sinus lead, although it is not usually the first choice for establishing CRT.
CRT pacing with a coronary sinus lead is the recommended form of CRT pacing for patients with HF who are eligible for it; however, an alternate way for individuals who are unable to undergo this pacing procedure is CRT with conduction system pacing.
Leadless two-chamber pacing
Atrial pacing and stable atrioventricular synchronisation are not supported by the single-chamber leadless pacing devices currently on the market.
About 300 patients with atrioventricular block or sinus node dysfunction participated in prospective multicenter research to assess an experimental dual-chamber leadless pacing device.
Nearly all patients had successful implants and the main safety goal of not having any problems from the device or surgery after 90 days was achieved.
Atrioventricular synchronisation and atrial pacing performance targets were also fulfilled by the device.
These results imply that leadless pacing may be made available for a wider variety of indications, such as atrioventricular block and sinus node dysfunction.
Liberal transfusion strategy for acute myocardial infarction
Randomised studies have shown that restrictive transfusion—transfusing at a lower haemoglobin level, usually <7 or 8 g/dL—is suitable for the majority of patients.
However, trial results for patients with acute myocardial infarction (MI) have been slower to come in. There was a tendency towards improved outcomes with the liberal approach (transfusing for haemoglobin <10 g/dL) in the MINT study, which randomly allocated 3504 patients with acute MI with anaemia to a restricted or liberal method.
The liberal strategy did this without increasing the risk of adverse events. A liberal approach is now suggested for acute MI. For stable, asymptomatic individuals, a little lower haemoglobin may be appropriate, whereas a higher haemoglobin may be needed for patients with hemodynamic instability.
Patients with AMI-related cardiogenic shock do not benefit from conventional V-A ECMO.
Patients suffering from refractory cardiogenic shock due to a range of diseases may have a higher chance of survival if they get venoarterial extracorporeal membrane oxygenation (V-A ECMO).
The advantage of routinely using V-A ECMO for acute myocardial infarction (AMI)-related cardiogenic shock, however, has not been shown.
Routine V-A ECMO usage increased rates of both severe bleeding and peripheral vascular ischemia compared with medical therapy alone, and there was no mortality benefit, according to a meta-analysis of four randomised studies (including roughly 570 patients with AMI-related cardiogenic shock).
A low incidence of active left ventricular uploading during ECMO treatment and crossover across groups are limitations of this meta-analysis that may have skewed the results in favour of the control group.
These results point to no appreciable advantage for patients with AMI-related cardiogenic shock when using V-A ECMO routinely, but they do not rule out benefits for certain patients who qualify for salvage treatments such as heart transplants.
Complete revascularisation in elderly acute myocardial infarction patients
Percutaneous coronary intervention (PCI) is mostly used to revascularise the culprit artery in patients suffering from acute myocardial infarction (MI), however, it is uncertain how best to treat non-culprit lesions that remain in older individuals.
In a recent trial, patients randomly assigned to PCI of non-culprit lesions (i.e., complete revascularisation) during the index admission had a lower rate of all-cause death and recurrent MI compared with those assigned to no additional planned PCI.
The patients were nearly 1500 older patients (mean age 80 years) with acute MI and multivessel coronary artery disease who were not candidates for coronary artery bypass grafting (CABG).
The two groups' rates of safety endpoints, such as haemorrhage, were similar. Complete revascularisation of all stenotic lesions before discharge is recommended whenever possible for patients with acute MI who undergo PCI and do not qualify for CABG.
Semaglutide in obese individuals with heart failure with a preserved ejection fraction
Losing weight is expected to enhance functional status and quality of life in patients with heart failure with preserved ejection fraction (HFpEF), however, it might be challenging to lose weight in this patient population.
Patients randomly assigned to semaglutide treatment had better improvements in exercise capacity (six-minute walk distance), quality of life, and weight loss (-13 per cent mean change in body weight versus -2.6 per cent) at 52 weeks compared to patients assigned to placebo in a recent trial involving over 500 patients with HFpEF.
Semaglutide-treated patients may have a decreased risk of emergency hospitalisation for heart failure. Patients with HFpEF who are also obese, like other obese patients, should get the proper care to lose weight.
Intravenous iron administration in patients with heart failure and a decreased ejection fraction
Heart failure (HF) patients often have an iron deficit, although it is yet unknown whether iron treatment lowers hospitalisation or death rates in this group. The following findings were made in recently released studies on the effects of intravenous (IV) iron supplementation:
- IV iron supplementation increased iron reserves in a study including over 3100 individuals with HF and decreased ejection fraction (HFrEF), but it did not significantly lower the risk of cardiovascular death or HF hospitalisation.
- IV iron decreased the incidence of HF hospitalisation in a meta-analysis of randomised trials in individuals with HFrEF, but its impact on cardiovascular mortality was not evident.
These findings back up the use of IV iron to lower hospitalisation rates for HFrEF patients who are iron deficient.
Deficiency in iron and anaemia caused by using low-dose aspirin daily
Although aspirin may raise the risk of bleeding, there is not enough information available on anaemia and iron shortage in those who do not exhibit overt bleeding.
A small but statistically significant increase in the rates of anaemia (51 per 1000 person-years in the aspirin group versus 43 per 1000 person-years with placebo) and iron deficiency (13 per cent with aspirin versus 10 per cent with placebo) has been found in a new analysis of a randomised trial in older adults assigned to daily low-dose aspirin or placebo.
Although the choice to monitor for anaemia or iron shortage in aspirin users is personal, our findings support the use of monitoring in those who so choose.
Mavacamten's experience treating obstructive hypertrophic cardiomyopathy
Recent clinical studies involving individuals with symptomatic obstructive hypertrophic cardiomyopathy (HCM) indicate that a novel class of medications known as myosin inhibitors may be able to lessen blockage symptoms.
More information on the impacts of these compounds is provided by two recent investigations:
- In a randomised study, mavacamten treated individuals with symptomatic obstructive pulmonary disease had a decrease in symptoms relative to placebo-treated patients.
- In a different randomised study, patients who got mavacamten at week 56 showed less need for heart surgery (septal myectomy) than patients who started with a placebo for 16 weeks and then switched to mavacamten.
Mavacamten may lessen symptoms and postpone the need for heart surgery in people with symptomatic obstructive chorio cardial hypertrophy.
Better results from OCT-guided PCI compared To angiography-guided PCI
When compared to PCI of non-bifurcation lesions, percutaneous coronary intervention (PCI) of complicated bifurcation lesions is more difficult, carries a higher procedural risk, and produces inferior clinical results.
The accurate placement of stents is restricted due to the insufficiency of angiographic visualisation for bifurcation lesions. In patients having complicated bifurcation PCI, the OCTOBER Trial showed that imaging-guided PCI utilising OCT was linked with decreased MACE compared with angiography-guided PCI.
The two groups did not vary in terms of procedure-related problems. In certain patient demographics, such as those with chronic renal illness, the OCT-guided PCI group's higher contrast use and longer operation times may be taken into account.
Bempedoic acid and cardiovascular outcomes in patients intolerant to statins: The CLEAR outcomes trial - a visible hope
"Statins," or hydroxy-methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitors, are a cornerstone treatment for reducing the risk of atherosclerotic cardiovascular (CV) disease in both primary and secondary cases.
Nonetheless, up to 20% of patients experience statin intolerance, which typically manifests as muscle-related symptoms. This persists as a challenging issue for clinicians as it is a primary cause of patients stopping therapy and raises the risk of cardiovascular events, including in those who stop taking statins due to the "nocebo" effect.
Bempedoic acid (BA) has been shown in the CLEAR Outcomes (Cholesterol Lowering by Bempedoic Acid, an ACL-Inhibiting Regimen - CLEAR Outcomes) study to lower CV events in statin-intolerant patients and to provide a CLEAR glimmer of hope for this difficult clinical circumstance.
Inclisiran's long-term safety in the treatment of hypercholesterolemia
When administered subcutaneously twice a year (after the first and three-month dosages), inclisiran, a small interfering ribonucleic acid (siRNA), reduces PCSK9 synthesis and significantly lowers plasma low-density lipoprotein cholesterol.
Using patients treated with 300 mg inclisiran sodium or placebo in the completed (ORION-1, ORION-3, ORION-5, ORION-9, ORION-10, and ORION-11) and continuing (ORION-8) trials, the investigators conducted a post hoc analysis to assess the safety of inclisiran. Important details on the long-term safety profile of this cholesterol-controlling drug are provided by this post hoc analysis.
The administration of long-term inclisiran to a broad group of patients with dyslipidemia for up to six years seems safe and well tolerated overall.
Among individuals using inclisiran, treatment-induced antidrug antibodies were rare.
Disclaimer- The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of M3 India.
About the author of this article: Dr Monish Raut is a practising super specialist from New Delhi.
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