Key Points:

• The RIGHT trial assessed the benefit of post-procedural anticoagulation (PPA) after primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) patients.
• The trial found that overall, PPA did not result in a significant reduction in adverse outcomes compared to placebo in a low-to-intermediate risk population.
• There was a significant interaction between the type of anticoagulant used and the primary endpoint, with enoxaparin showing potential benefit while unfractionated heparin and bivalirudin did not.

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Key Points

• This trial randomizing patients at high bleeding and/or ischemic risk who had successfully completed 9-12 months of dual anti-platelet therapy (DAPT) following initial percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) to an additional 9 months of either continued DAPT or clopidogrel monotherapy plus placebo found that patients in the clopidogrel monotherapy arm had significantly lower rates of clinically relevant bleeding and major adverse cardiovascular and cerebral events (MACCE; defined as all-cause death, MI, stroke, and clinically indicated revascularization).
• These data indicate that among patients at high bleeding and/or ischemic risk who undergo PCI for ACS, after initial 9-12 months of DAPT, de-escalation to clopidogrel alone is superior to continuation of DAPT for 9 additional months in terms of both bleeding and ischemia.
• The exact duration of clopidogrel monotherapy following the initial 9-12 months of DAPT in these patients remains uncertain. When and if they should de-escalate to aspirin monotherapy or if they should remain on lifelong clopidogrel is an area of future research.

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Key Points

• This pragmatic trial randomizing patients to optical coherence tomography (OCT)-guided or intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) found that OCT was non-inferior to IVUS for a composite outcome of cardiovascular death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization.
• These data indicate that OCT has similar outcomes compared with IVUS in PCI across a broad range of coronary lesions, though patients with chronic kidney disease and ST-elevation myocardial infarction (STEMI) were excluded.

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Key Points

• This metanalysis integrating data from ILUMIEN IV and OCTOBER Trials with 18 prior randomized trials found that intravascular imaging (IVI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was associated with a 31% reduction in target lesion failure (TLF) compared to angiography alone.
• In addition, there were statistically significant reductions in all-cause death, all myocardial infarction (MI), and target vessel revascularization (TVR), a novel finding.
• OCT and IVUS performed similarly compared against angiography and one another.
• These data indicate that IVI with either OCT or IVUS is associated with better long-term clinical outcomes compared to angiography alone. The authors plan to update the analysis with data from the OCTIVUS trial, also presented the same day at ESC.

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Key Points:

• Tertiary screening for chronic cardiovascular disease as a means to reduce morbidity, mortality, and economic burden on the healthcare system has been proposed.
• RED-CVD trial was the first cluster randomized trial, that investigated the diagnostic yield of a systematic multi-step early screening strategy for an aggregate of coronary artery disease, heart failure, and atrial fibrillation, compared with usual care among high-risk patients.
• Active screening of patients with type 2 diabetes or COPD more than doubles new diagnoses of cardiovascular disease compared with usual care.

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Key Points

• This trial randomizing patients with stable angina, unstable angina (UA), or non–ST-segment elevation myocardial infarction (NSTEMI) and a true bifurcation lesion to optical coherence tomography (OCT)-guided or angiography-guided percutaneous coronary intervention (PCI) found a significantly lower rate of major adverse cardiovascular events in the OCT arm at two years.
• Results were consistent for both left main (LM) and non-LM bifurcation PCI. Secondary outcomes numerically favored OCT but did not reach statistical significance. Contrast use and procedural time was higher in the OCT arm.
• These data support the routine use of OCT guidance for stable angina, UA, and NSTEMI involving bifurcation lesions, though patients with advanced kidney disease were excluded from this study.

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Key Points:

• The optimal duration of therapy for distal deep vein thrombosis (DVT) among patients with an active malignancy is unknown.
• ONCO-DVT was the first randomized controlled trial comparing 12-months to 3-months of Edoxaban in patients with an active malignancy and recently diagnosed distal DVT
• Treatment with Edoxaban for 12 months compared to 3 months reduced symptomatic recurrent venous thromboembolism (VTE) or VTE-related death events without significantly increasing major bleeding risk.

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Key Points

• This trial randomizing patients with diabetes and/or complex lesions to optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) or angiography-guided PCI found that post-PCI minimum stent area (MSA) was larger in the OCT arm, but there was no significant difference in the two-year rate of target vessel failure (TVF).
• Patients in the OCT arm experienced significantly fewer angiographic complications and stent thrombosis at two years with a trend towards lower mortality.
• These results indicate that among a high-risk cohort, OCT significantly increases the MSA while reducing peri-procedural complications and stent thrombosis at two years, but did not lead to reductions in TVF. COVID-19 might have contributed to lower observed TVF rates due to apprehension to seek care.

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Key Points:

• It is well known that patients with STEMI often have multivessel disease (MVD) and those with MVD have worse outcomes compared to patients without it.
• Current US and European guidelines support complete revascularization in a staged fashion but trials examining immediate versus staged percutaneous coronary intervention (PCI) are lacking.
• The MULTISTARS AMI trial demonstrated that immediate revascularization with PCI was associated with a reduction in non-fatal myocardial infarction and unplanned revascularization compared to staged revascularization at 1 year.

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Key Points:

• The FRAIL-AF trial is an open-label, randomized controlled trial that randomized frail adults (75 years or older) who were on VKA for atrial fibrillation to either continuing VKA or switching to a NOAC.
• The study found a relative 69% increased risk in bleeding events among patients who were switched from VKA to NOACs (p=0.001). This was driven primarily by a 77% increase in clinically relevant non-major bleeding, as there was no significant difference in major bleeding events.

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Key Points:

• Sudden cardiac death causes a fifth of all deaths in industrialized countries, but survival to hospital discharge remains low.
• Transfer to a specialized, cath-lab capable cardiac arrest center may expedite care of patients with an ischemic cause of arrest.
• This multicenter randomized trial compared transfer to a specialized cardiac arrest center with the nearest ED in patients with a resuscitated out-of-hospital cardiac arrest (OHCA). The primary endpoint was 30-day all-cause mortality.
• There were no differences in the primary endpoint of all-cause mortality between the two transportation strategies, nor any difference in the secondary endpoints of 3-month mortality and neurological outcome.

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Key Points:

• Transthyretin amyloid cardiomyopathy develops because of mis-folded proteins infiltrating the myocardium, leading to clinical heart failure. Currently, tafamidis is the only commercially approved medication and is the most expensive cardiovascular drug on the market.
• Acoramidis is a once-daily medication that stabilizes the transthyretin tetrameric protein, preventing its degradation and subsequent deposition into the myocardium.
• Acoramidis in ATTR-CM resulted in a statistically significant reduction in hospitalization for heart failure and mortality based on a hierarchical analysis of a composite outcome with an overall win ratio of 1.8 (p<0.0001) compared to placebo.

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Key Points:

• ADVENT was the first randomized controlled trial comparing pulsed field ablation (PFA) to conventional strategies for ablation (including either radiofrequency or cryothermal ablation).
• The success rate was 73.3% and 71.3% in the PFA and thermal groups, respectively. PFA met the prespecified criteria for noninferiority.
• PFA is as effective and safe as conventional thermal ablation for the treatment of paroxysmal atrial fibrillation.

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Key Points:

• This trial randomized 6,000 patients with high bleeding risk or acute coronary syndrome undergoing planned PCI to a strategy of 3.75mg of prasugrel or DAPT with aspirin 81-100 mg and prasugrel 3.75mg, following a prasugrel load in both arms.
• At 1 month, prasugrel alone failed to demonstrate superiority for the co-primary endpoint of major bleeding. However, the aspirin-free strategy was non-inferior to DAPT for the co-primary endpoint of cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke).
• DAPT remains the standard strategy post-PCI even in the current era with the newest generation of drug-eluting stents.

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Key Points

• The FIRE trial aimed to address the lack of evidence regarding complete revascularization in older MI patients and examined the superiority of complete revascularization based on coronary physiology.
• The trial enrolled 1,445 patients with a median age of 80, and the primary outcome (death, MI, stroke, or ischemia-driven coronary revascularization) occurred in fewer patients in the physiology-guided complete revascularization group compared to the culprit-only group.
• Physiology-guided complete revascularization reduces ischemic events compared with culprit-only revascularization in myocardial infarction patients aged 75 years or older with multivessel disease.

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Key Points:

• Iron-deficiency is common in heart failure (HF) and associated with increased mortality and hospitalization.
• Previous trials of intravenous (IV) iron in the form of ferric carboxymaltose (FCM) in iron-deficient HF patients have shown improvements in symptoms and quality of life, but effects on clinical events have been unclear.
• This meta-analysis pooled data from three randomized controlled trials (RCTs) – CONFIRM-HF, AFFIRM-HF, and HEART-FID – to assess both a composite endpoint of total CV hospitalizations and death, as well as a composite endpoint of total HF hospitalizations and CV death through 52 weeks.
• In iron-deficient patients with HF with reduced ejection fraction (HFrEF) or HF with mildly reduced ejection fraction (HFmrEF), IV FCM is associated with reduced risk of composite outcome of total cardiovascular (CV) hospitalization and death through 52 weeks compared with placebo.

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Key Points:

• The use of ECLS has increased substantially over the past decade despite stagnant, high mortality in cardiogenic shock.
• This multicenter randomized trial compared ECLS with control in patients with acute MI-related cardiogenic shock. The primary endpoint was 30-day all-cause mortality.
• There were no differences in the primary endpoint of all-cause mortality between ECLS and placebo; however, ECLS resulted in higher rates of moderate-to-severe bleeding and peripheral ischemia requiring intervention.

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Key Points:

• Qiliqiangxin is a traditional Chinese herbal medicine extract which has been approved since 2004 for the treatment of HF in China.
• This multicenter, double-blind, placebo-controlled trial compared qiliqiangxin with placebo amongst patients with HFrEF (EF<40%). The primary endpoint was a composite of CV death and HF hospitalizations.
• Over a median follow-up of 18 months, qiliqiangxin use resulted in a reduction in the composite primary endpoint.

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Key Points:

• Prior data suggest that heart failure with reduced ejection fraction (HFrEF) patients with iron deficiency receiving IV iron supplementation had improvement in exercise capacity and HF hospitalizations, but the long-term safety and efficacy of the treatment is unknown.
• The HEART-FID trial was a double-blind, placebo-controlled event-driven randomized trial assessing whether there would be improvement in the incidence of death and hospitalization for heart failure or 6-minute walk distance with ferric carboxymaltose therapy compared with placebo in patients with heart failure with a reduced ejection fraction and iron deficiency.
• Patients receiving IV ferric carboxymaltose (FCM) had slightly fewer all-cause mortality events, HF hospitalizations and modestly longer 6-minute walk duration. However,there was no apparent difference in the hierarchical composite of death, hospitalizations for heart failure, or 6-minute walk distance.
• Overall FCM supplementation is safe and shows potential clinical benefits; further context can be obtained via pooled analysis with other IV FCM trials.

Iron deficiency has a prevalence of nearly 50% among patients with heart failure with reduced ejection fraction (HFrEF) and leads to impaired health-related quality of life, worsening heart failure (HF) symptoms, and adverse outcomes. The mechanism for iron deficiency in HF is not fully understood though thought to be related to reduction in iron intake as well as absorption and mobilization with increased loss as well. Treatment with intravenous (IV) ferric carboxymaltose (FCM) has previously been shown to improve HF patients’ symptoms and functional capacity. Notably, evidence regarding the utility of IV FCM for improving clinical outcomes such as morbidity and mortality is more limited. Information regarding the long-term efficacy and safety of IV iron infusions is also limited. Furthermore, the majority of available data on the subject was obtained in Europe and excluded other geographic HF populations.

The HEART-FID trial (Randomized Placebo-Controlled Trial of Ferric Carboxymaltose as Treatment for Heart Failure With Iron Deficiency) (NCT03037931) was a multicenter, randomized, double-blind, placebo-controlled trial that sought to assess the efficacy and safety of IV FCM in the treatment of symptomatic patients in HFrEF with iron deficiency over a period of at least 12 months. Over three thousand patients were randomized at 281 study locations in various geographic regions that included North America, Australia, New Zealand, and Europe. Heart failure patients had ejection fraction (EF) ≤40% within 24 months or ≤30% within 36 months of screening and NYHA Class II-IV symptoms on maximally tolerated background therapy for ≥2 weeks before randomization. They had to have documented HF hospitalization within 12 months of enrollment or elevated N-terminal-pro-brain natriuretic peptide within 90 days of randomization. Criteria for iron deficiency were ferritin <100 ng/mL or 100 to 300 ng/mL with a transferrin saturation <20% with hemoglobin >9.0 g/dL and <13.5 g/dL (females) or <15.0 g/dL (males). Importantly, the trial included those patients with and without anemia. Active bleeding or recent blood transfusion was prohibitive for enrollment.

Eligible patients were given an initial 28-day screening period and then randomized in a 1:1 ratio to receive FCM or placebo. They were then given the study drug on day 0 and 7 and followed up with additional study visits at 3 month intervals. Patients were eligible for additional dosing of the drug every 6 months as needed. HEART-FID trial clinical endpoints included a hierarchical composite of death and HF hospitalizations in the first 12 months, and change in 6 minute walk test (6-MWT) distance at 6 months. Notably a significance level of 0.01 was pre-specified for regulatory purposes by the US Food and Drug Administration (FDA).

Death by month 12 occurred in 131 patients (8.6%) in the ferric carboxymaltose group and 158 (10.3%) in the placebo group, and a total of 297 and 332 hospitalizations for heart failure, respectively, occurred by month 12. The mean (±SD) change from baseline to 6 months in the 6-minute walk distance was 8±60 and 4±59 m, respectively (Wilcoxon–Mann–Whitney P=0.02; unmatched win ratio, 1.10; 99% confidence interval, 0.99 to 1.23). Repeated dosing of ferric carboxymaltose appeared to be safe with an acceptable adverse-event profile in the majority of patients.

Presented at the 2023 European Society of Cardiology Congress on August 26^th by Dr. Robert Mentz (Duke Clinical Research Institute, Durham, NC) the HEART-FID trial data showed that administration of FCM resulted in modest improvement for the primary hierarchical endpoint which narrowly missed statistical significance (P=0.019).. When reporting the win ratio in order to translate the endpoint into clinical significance, there were 20% more wins with FCM than placebo for all-cause mortality. When assessing heart failure hospitalizations in those without a death event, there were similar wins in both groups. Change in 6MWT slightly benefited the FCM group. There was a similar percentage of treatment emergent adverse events in each group.

Overall Dr. Mentz states that there was “modest improvement” in the FCM group compared to placebo but importantly IV iron supplementation showed “numerical improvements in mortality.” He goes on to say, “FCM is safe and we build on the prior data showing benefit in quality of life and exercise capacity [with FCM]. Each component of the primary endpoint favors FCM.” He believes that the importance of this study is in providing “another tool in our toolkit in addition to quadruple therapy specifically for HFrEF patients with iron deficiency.” He stated that one significant advantage of FCM is that it does not involve another daily medication and can be administered in clinic in a straightforward way to produce net benefit. Overall, FCM can be used clinically for patients with HFrEF and iron deficiency to help them feel and function better with evidence of a clinical outcome benefit as well. The trial results were simultaneously published in The New England Journal of Medicine.

Key Points:

• A high burden of right ventricular pacing among patients with heart failure patients with reduced ejection fraction is known to cause left ventricular dyssynchrony and progressive dysfunction, yet definitive evidence has been lacking to inform the timing of upgrade to CRT devices.
• The BUDAPEST-CRT Upgrade Study randomized 360 patients with LVEF ≤ 35%, NYHA functional classes II–IVa, paced QRS ≥ 150 ms, and RV pacing burden ≥ 20% to either CRT-D (n=215) or traditional ICD (n=145). The primary endpoint was a composite of all-cause mortality, a first HHF event, or <15% reduction in LVESV at 12 months.
• This trial showed a significant reduction in the primary composite endpoint (32.4% in the CRT-D arm versus 78.9% in the ICD arm, aOR = 0.11, 95% CI 0.06-0.19, p-value <0.001), as well as in several individual secondary endpoints. Taken together, these findings support the clinical practice to promptly pursue CRT upgrade among HFrEF patients with intermittent or permanent RV pacing.

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