RESCUE, a phase II, trial presented by Paul M. Ridker, MD, Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital, at the American College of Cardiology 2021 meeting and simultaneously published in The Lancet , revealed that the use of ziltivekimab, a fully human monoclonal antibody targeting interleukin-6 (IL-6) ligand and developed specifically for atherosclerosis, was associated with a decrease in the serum level of multiple anti-inflammatory biomarkers among patients with an elevated risk of atherosclerotic disease. Of note, this IL-6 inhibitor was not associated with adverse effects observed with other agents in its class. Continue reading
A recent study by Dr. David J. A. Jenkins, published in the New England Journal Of Medicine, demonstrated that the glycemic index of the diet is directly associated with the risk of cardiovascular disease and death. This study was conducted in multiple countries and the results were similar across various economic and geographic regions. Continue reading
A recent study by Dr. David D. Berg, published in JAMA Cardiology, found that the use of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, was associated with reducing the risk of cardiovascular death and heart failure hospitalization, emerging very early after randomization. Of note, patients with a recent history of hospitalization due to heart failure worsening tend to benefit more and experienced greater relative and absolute risk reductions when treated with dapagliflozin. Continue reading
A recent trial by Dr. Oussama M. Wazni, published in the New England Journal of Medicine, indicated that in patients with paroxysmal atrial fibrillation, cryoballoon ablation therapy is superior as compared with antiarrhythmic drug therapy, in the prevention of atrial fibrillation recurrence. The study also showed the non-inferiority of this procedure over the drug therapy approach in terms of safety.
A recent trial by Dr. Salim Yusuf, published in The New England Journal of Medicine, indicated that combination therapy with aspirin plus a polypill (consisting of a statin plus three blood-pressure-lowering drugs) can reduce the incidence of cardiovascular events compared with placebo among participants without established cardiovascular disease, but at moderate cardiovascular risk.
A recent trial by Dr. Jordana B Cohen, published in The LANCET, indicated that consistent with international society recommendations, patients admitted to the hospital with COVID-19 can safely continue treatment with renin-angiotensin system inhibitors (angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB)) unless there is a distinct medical contraindication to ongoing therapy.
A recent study by Dr. Milton Packer, published in Circulation, demonstrated that empagliflozin use has been associated with a reduction in the total number of inpatient and outpatient visits in patients with heart failure and a reduced ejection fraction. These benefits were observed within 12-28 days of treatment initiation and were persisted over the duration of the trial. Continue reading
Results of the DAPA trial, published in Circulation: Arrhythmia and Electrophysiology, demonstrated that the use of early prophylactic implantable cardioverter defibrillator (ICD) in high-risk post-primary percutaneous coronary intervention (PCI) patients was associated with lower all-cause and cardiac mortality rates. However, the results of this trial should be interpreted with caution, since the trial was stopped prematurely.
The optimal timing of ICD implantation in STEMI patients treated with primary angioplasty is not identified yet. Previous clinical trials have failed to show the benefit of early ICD implantation (4-60 days) in post-MI patients with a low left ventricular ejection fraction (≤35-40%). The risk of sudden cardiac death (SCD) is high within the post STEMI period. However, ICD implantation after 40 days may not be indicated due to left ventricular remodeling and a potential increase in LVEF post-primary PCI. The Defibrillator After Primary Angioplasty (DAPA) trial evaluated all-cause and cardiac mortality of patients undergoing early prophylactic ICD implantation after PCI for STEMI. Following a recommendation from the data safety board, the trial was terminated early after just 38% of the planned sample size was enrolled due to slow enrollment.
This multicenter, randomized, controlled trial included patients with STEMI who had undergone primary PCI and met at least one of the following criteria: LVEF<30% within 4 days after admission, primary ventricular fibrillation (VF) within 24 hours (during PCI excluded), signs of heart failure on admission (Killip class ≥ 2), and/or thrombolysis in myocardial infarction (TIMI) flow post PCI < 3. The participants were randomized in a 1:1 ratio to receive either ICD implantation or conventional therapy within 30 to 60 days of the STEMI event. The primary endpoint was all-cause mortality at 3 and 9-years. The secondary endpoints of the study included the incidence of sudden cardiac death (SCD) and hospital admission for sustained ventricular tachyarrhythmias or appropriate ICD therapy.
A total of 266 patients with primary PCI for STEMI were included in the study with 131 patients allocated to the ICD arm and 135 patients assigned to the conventional therapy arm. After 3-years of follow-up, the primary outcome of interest was significantly lower among patients who received ICD implantation (5%) compared to the conventional therapy group (13%) (Hazard ratio (HR):0.37; [95% CI: 0.15-0.95]; p=0.04). This result remained similar at a median of 9-years follow-up (HR: 0.58; [95% CI: 0.37-0.91]; p=0.02). In terms of cardiac mortality, ICD implantation was associated with fewer deaths (11%) compared to the control group (22%) (HR: 0.52; [95% CI: 0.28-0.99]; p=0.04). Although not statistically significant, the incidence of SCD was also lower in the ICD group (3.1%) compared to the control group (5.9%) (HR 0.45; [95% CI 0.14–1.50]; p=0.19).
The results of this study should be interpreted with consideration of the following limitations. First, the premature termination of the study makes it underpowered for analysis. Second, the study used more than one inclusion criteria, so results should be interpreted with consideration of the patient characteristics. The high treatment crossovers (10.2%) within the first 3 years of the study and the lack of information on treatment crossovers between 3 and 9 years are additional limitations of the trial. Furthermore, while pharmacotherapy of the participants was similar at baseline, there is a lack of data regarding the follow-up medical therapy which may have impacted the mortality rates.
In conclusion, this prematurely terminated trial suggests that early prophylactic ICD implantation may be associated with a better survival rate in patients at high risk of death after primary PCI for STEMI. The results of this trial should be confirmed in future studies.
A recent study by Dr. Holger J Schünemann, published in THE LANCET Haematology, demonstrated that, in patients with solid tumors, venous thromboembolic events can be reduced by administering low-molecular-weight heparin without an increase in the risk of bleeding complications or a change in the survival rate.
The emergent percutaneous coronary intervention (PCI) of unstable plaques, compared to stable plaques, was associated with a better survival rate among patients with sudden cardiac arrest in a recent study by Dr. Louis Pechmajou et al. The results of the study were recently published in Circulation: Cardiovascular Interventions. Continue reading
A trial by Dr. Jorrit S. Lemkes, published in JAMA Cardiology, demonstrated that immediate coronary angiography and percutaneous coronary intervention (PCI) does not improve the 1-year clinical outcomes of patients after successful resuscitation from non-ST segment elevation cardiac arrest. Also, the survival rate was comparable between patients whose angiography was performed immediately (61.4%) versus those whose angiography was delayed (64.0%).
Given the high prevalence of coronary artery disease among patients with cardiac arrest, coronary angiography and PCI should be considered in these patients with suggested evidence of coronary artery involvement. However, the current data regarding the appropriate timing of this intervention is lacking. The interim results of the Coronary Angiography after Cardiac Arrest (COACT) trial failed to find a significant difference between the 90-days clinical outcomes of patients with delayed coronary angiography versus patients with immediate coronary angiography after non-ST segment elevation cardiac arrest. The 1-year follow-up study investigated the long-term clinical outcomes of immediate coronary angiography in these patients.
COACT study, an open-label, multicenter, randomized trial, compared the short-term clinical outcomes of immediate versus delayed coronary angiography in patients resuscitated from cardiac arrest without ST-segment elevation on the electrocardiogram tracing. Briefly, a total of 552 patients with out-of-hospital arrest and no signs of ST-segment elevation myocardial infarction (STEMI) who successfully resuscitated from cardiac arrest were randomized in a 1:1 ratio to undergo immediate (within 2 hours of randomization) or delayed (after neurological recovery or discharge from intensive care unit) coronary angiography. The 1-year endpoints of the study included survival rate, myocardial infarction, repeated revascularization, hospitalization for heart failure, and implantable cardiac defibrillator (ICD) shock since the index hospitalization.
At 1-year follow-up, 94.6% of the participants (n=522) were available for analysis. The recent analysis of the data indicated no significant differences between the two groups. The survival rate was 61.4% and 64.0% in the immediate and delayed coronary angiography group, respectively (odds ratio (OR)=0.90; 95%Confidence Interval (CI):0.63-1.28). Additionally, the endpoints of the interest were equivalent in the 2 groups. For example, the rate of myocardial infarction was 0.8%in the immediate group and 0.4%in the delayed group (OR=1.96; 95%CI: 0.18-21.8). The study also showed that the post-cardiac arrest mortality usually occurs within the first 90 days after the arrest, and the survival rate after this period is relatively favorable.
The trial has some limitations that need to be taken into account. First, the study is not powered for a 1-year analysis. Second, the findings of this study are not generalizable to patients with shock, severe renal dysfunction, or persistent ST-segment elevation due to their exclusion from the trial.
The results of this trial suggest that in patients with out-of-hospital cardiac arrest with no signs of STEMI, the coronary angiography, if necessary, can be delayed until after neurological recovery.
A recent study by Dr. Ryusuke Ae, published in the Journal of the American Heart Association, demonstrated the efficacy of combining the initial intravenous immunoglobulin (IVIG) treatment with multiple-dose corticosteroids in the prevention of coronary artery abnormalities in selected patients at high risk for Kawasaki disease. The study showed a reduction in coronary artery abnormalities and treatment failure after applying this treatment strategy.
A recent study by Dr. Banerjee, published in Circulation: Cardiovascular Interventions, demonstrated the efficacy and safety of low-density lipoprotein (LDL) lowering therapy via a single LDL apheresis treatment plus ongoing statin therapy in nonfamilial hyperlipidemia acute coronary syndrome patients treated with the percutaneous coronary intervention (PCI).
The post hoc analyses of GLOBAL LEADERS study by Dr. Hara, published in Circulation: Cardiovascular Quality and Outcomes reported that in multiple statistical analyses considering the total number and severity of bleeding and ischemic events, ticagrelor monotherapy consistently decreased the risk of these events by 5% to 8% compared to 1-year conventional dual antiplatelet therapy. This analysis supported the beneficial effects of ticagrelor monotherapy after percutaneous coronary intervention. Continue reading
A recent study by Dr. Salaun, published in Circulation: Cardiovascular Interventions, demonstrated that aortic valve replacement in patients with the low gradient (LG, defined as mean gradient <40 mmHg) severe aortic stenosis (AS) and preserved ejection fraction (EF) has resulted in better outcomes versus in those with the high gradient (HG, defined as a mean transvalvular gradient (MG) ≥ 40 mmHg) AS. Also, the study revealed that patients with classical low flow, low gradient (CLF-LG, defined as MG <40 mmHg and LVEF <50%) AS were at higher risk of death, rehospitalization, or stroke at 2 years.
A recent study by Dr. Duthoit, MD, published in Circulation: Cardiovascular Interventions, showed that compared to dual antiplatelet therapy, nonvitamin k antagonist monotherapy using a reduced dose of rivaroxaban (10 and 15 mg) in patients undergone left atrial appendage closure was associated with lower thrombin generation. This data supported that reduced rivaroxaban doses could be a substitute for the antithrombotic medications currently used after this procedure. Continue reading
A recent study by Dr. Alice M. Jackson M.D., published in Circulation journal, showed that the use of dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with reduced ejection fraction heart failure (HF) is associated with reduced risk of cardiovascular (CV) death or a worsening HF event, and all-cause death. These effects remained consistent among different subgroups of diuretic therapy.
A recent meta-analysis of clinical trials with more than 100,000 patients has shown that the carotid intima-media thickness (cIMT) progression can be used as a surrogate marker for cardiovascular risk in the clinical trials. The results of this study published in Circulation. According to Dr. Willeit, the assessment of cIMT progression can provide a link for the development and license of new therapies for cardiovascular disease. Continue reading
A recent study by Dr. O’Donoghue, published in Circulation, shows that early aspirin discontinuation with continued P2Y12 inhibitor monotherapy, after the percutaneous coronary intervention (PCI), was associated with a significant reduction in major bleeding compared to dual antiplatelet therapy. This study did not show a significant increase in major adverse cardiovascular events (MACE) after aspirin discontinuation in the participants.