Key Points:

• In the original EMPEROR-PRESERVED study, patients with chronic heart failure with preserved ejection fraction (EF>40%) with or without diabetes were treated with empagliflozin and experienced significant reductions in combined CV death/HF hospitalizations, as well as first or recurrent HHF.
• In this sub-study, the outcomes above were compared between patients with “true” HFpEF (EF>50%) and patients with mid-range EF (HFmrEF, EF 41-49%).
• Patients with both true HFpEF and HFmrEF had a reduction in the primary endpoint (combined CV death and HF hospitalizations) as well as time to first HF hospitalizations at a median follow-up of 26 months; patients with HFmrEF additionally had a reduction in total HF hospitalizations. There were no differences in CV death alone or all-cause mortality.

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Key Points:

• Icosapent ethyl (IPE) had previously shown a signal for improvement in COVID-19 symptoms and decreased inflammatory marker levels in COVID-19 patients
• PREPARE-IT 2 sought to determine if icosapent ethyl would reduce planned COVID-19-related hospitalizations or mortality in patients with a positive diagnosis of COVID-19 assessed up to 28 days
• PREPARE-IT 2 was a pragmatic trial which randomized >2,000 patients to very high dose EPA (8 grams/day) or placebo
• There was a neutral result regarding prevention of COVID-19-related hospitalization or mortality at 28 days, though trend towards improved outcomes amongst all clinical endpoints in the IPE group
• The safety and tolerability of high-dose IPE was again established
• Further studies determining potential effects of IPE in COVID-19 outpatients are warranted

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Key Points:

• To date, P2Y-12 inhibitors do not have a commercially approved reversal agent.
• The use of ticagrelor, which unlike clopidogrel and prasugrel, reversibly inhibits platelets has increased over the past years, as clinical trial data emerge in favor of its use.
• Bentracimab is a recombinant IgG1 monoclonal antibody that reverses the effect of ticagrelor.
• In this phase 3 clinical trial, 150 patients on ticagrelor who had upcoming surgery or experienced bleeding were infused with bentracimab. Platelet inhibition was achieved within four hours of infusion and was sustained for twenty-fours, verified by two different platelet reactivity assays (p<0.001).

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Key Points:

•  Milvexian is a first-in-class rapidly absorbed oral Factor XIa inhibitor being tested for safety and efficacy for prevention and treatment of venous thromboembolism (VTE)
• Across a 16-fold range of milvexian doses, there was a significant reduction in VTE events with milvexian 100mg total a day or more compared with enoxaparin; a dose-response relationship was established
• There were similar bleeding events in the milvexian arm at all doses compared with enoxaparin, establishing the safety of the drug
•  In combination with the trial evaluating milvexian for secondary stroke prevention (AXIOMATIC-SSP), milvexian may prove to be a safer, more effective option for oral anticoagulation

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Key Points:

• The ASCEND trial sought to determine whether low-dose aspirin could prevent dementia in >15,000 older individuals in the United Kingdom
• The randomized comparison showed that for both the narrow and broad (including delirium, cognitive impairment) dementia definitions there was no significant difference between the aspirin and placebo groups over median 7.4 years of follow-up
• Results excluded proportional harms of >2% and benefits of >19%
• Future studies evaluating whether aspirin might have more modest proportional impacts of 15-18% may be warranted in the future

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Key Points

• Wearable technologies have optical photoplethysmography (PPG) sensors to measure heart rate coupled with software algorithms that can infer the presence of atrial fibrillation (AF)
• The Fitbit Heart Study sought to evaluate a novel Fitbit device compatible algorithm for detecting AF
• Investigators found that their novel PPG software algorithm for Fitbit wearers had a positive predictive value of 98% for detecting AF amongst patients found to have irregular heart rhythm detection (IHRD) notifications and confirmed AF on subsequent ECG patch monitoring. This was stable for the key subgroup of patients age 65 years and older who are at higher risk of stroke
• The false-positive rate for IHRD alerts was 70%
• Further evaluation of clinical and cost-effectiveness of AF monitoring in the United States population via wearable devices is needed

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CHIEF-HF

Key Points:

• In the CHIEF-HF study, patients with HF of any ejection fraction with or without diabetes were treated with either canagliflozin or placebo for 12 weeks. The primary outcome was 12-week change in Kansas City Cardiomyopathy Questionnaire (KCCQ) total summary score. Secondary analyses included subgroup analysis for the primary outcome by ejection fraction and presence of diabetes, as well as 6- and 9- month repeated KCCQ screening.
• Treatment with canagliflozin reduced the 12-week KCCQ score relative to placebo, with similar results seen across EF and diabetes subgroups.

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Key Points:

• Interest in this study was generated by patients with atrial fibrillation, who wanted to know if avoiding triggers really did create an impact.
• The design of the trial was a randomized n-of-1 study, in which patients were asked to avoid, then re-introduce, self-reported triggers for atrial fibrillation in their lives three times for a total of six weeks.
• Participants were given an instant remote ECG device (KardiaMobile) and asked to periodically test their rhythm. ECGs concerning for AF were automatically reviewed by a Cardiologist.
• At the end of ten weeks, there was no difference in overall quality of life in participants who chose to avoid AF triggers, despite fewer incidences of AF when resisting the trigger.

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Key Points:

• Previously, the impact of risk prediction on clinical decision-making and outcomes in heart failure had not been tested in a randomized control trial
• The REVeAL-HF trial showed that mortality estimates of admitted heart failure patients during standard EHR-based workflow did not lead to significant reductions in rehospitalization or mortality
• Mortality estimates did not significantly influence use of medical therapies, ICD implantation, HT/VAD or referrals to palliative care
• Bedside clinicians may require more prescriptive decision support though alert-based systems should be studied in a randomized fashion prior to implementation

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Key Points:

• Conventional medical wisdom warns against excessive coffee and/or caffeine consumption due to the perceived risk of arrhythmia.
• Most evidence against coffee consumption is derived from observational data.
• CRAVE is the first randomized trial to assess the effects of coffee consumption on cardiac arrhythmias in real time, using data from wearable technology. Participants who owned a smartphone and did not have a history of cardiac arrhythmias were enrolled into the trial, in which they continuously wore a FitBit Flex to track steps and sleep, a Ziopatch to monitor their cardiac rhythm, and a continuous glucose monitor to track coffee metabolism.
• Caffeine consumption was not associated with an increase in atrial arrhythmias but was associated with more PVCs, especially in faster metabolizers.

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Key Points

• Rural areas represent particularly vulnerable areas for the control of cardiovascular disease, due to the lack of data to identify at-risk populations and the logistical challenges associated with delivering sustainable health interventions.
• Rural doctors can implement feasible and scalable interventions to empower patients in rural communities so that they can achieve blood pressure control.
• A randomized trial of almost 35,000 patients living in rural communities in China showed a statistically significant and clinically meaningful reduction in blood pressure, as a result of lifestyle coaching and protocol-based antihypertensive treatment delivered by rural physicians.

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Key Points

• The rates of control of key cardiovascular conditions like hypertension and hyperlipidemia remain low (~50%) across the US, even if these conditions could be easily addressed through generic, guideline-directed, and cost-effective medications.
• A remote program les by patient navigators can deliver algorithmic care pathways to reach a diverse patient population and achieve control of key cardiovascular conditions through rapid initiation and intensification of guideline-directed medications.
• On a cohort of 10,000 patients, the Brigham and Women’s Cardiovascular Innovation Team was able to demonstrate a statistically significant and clinically meaningful reduction of both systolic and diastolic blood pressure as well as LDL cholesterol, through effective intensification of medical therapy.

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Key Points

• Severe aortic stenosis is associated with high mortality once patients become symptomatic. There is equipoise, however, as to whether patients with severe aortic stenosis need to be treated in the absence of symptoms.
• Current ACC/AHA guidelines recommend further provocative/exercise stress testing to determine whether patients with severe aortic stenosis are indeed symptomatic prior to valve replacement.
• AVATAR randomized asymptomatic patients with severe aortic stenosis and normal left ventricular function to watchful waiting or surgical AVR. Patients who underwent early surgery had a significantly lower endpoint of all cause mortality, acute myocardial infarction, stroke or heart failure hospitalization compared to the conservative management group. The trial was stopped early as the pre-specified event target was met

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Key Points

• Current US Guidelines recommend a 5- day waiting period for non-urgent CABG after cessation of ticagrelor to prevent high bleeding rates; European guidelines recommend 3 days.
• In the PLATO trial, a higher proportion of patients who died from CABG had received Ticagrelor within 1 day of surgery.
• RAPID CABG randomized participants undergoing non-urgent CABG to an early surgery (2-3 days after ticagrelor administration) versus a delayed surgery (5 days or more after ticagrelor administration).
• Patients who underwent early surgery were found to have no difference in Class 3 or 4 bleeding when compared to those undergoing delayed surgery. Participants in the early CABG arm also had lower lengths of stay.

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Key Points

• Many patients with severe mitral valve regurgitation are not candidates for surgical valve replacement or transcatheter edge to edge repair due to anatomical limitations.
• Transcatheter mitral valve replacement is currently under investigation with mostly transapical devices, which could be of added risk to patients.
• In an early feasibility study of 15 patients, the APOLLO transcatheter mitral valve, a trans-septal based transcatheter valve replacement, was shown to significantly decrease mitral regurgitation in all patients.
• At 30 day follow up there were no patient deaths. Major vascular access complications were seen in 40% of patients, which is an area that investigators hope to improve upon in the near future.

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Key Points

• Transcatheter Tricuspid Valve Replacement with the EVOQUE valve is being studied in the TRISCEND study
• Patients with symptomatic, moderate to severe tricuspid regurgitation were evaluated for the TRISCEND study, a single-arm prospective multicenter study.
• At six months, there was sustained significant reduction in tricuspid regurgitation.
• Procedural complications were low, and mostly driven by severe bleeding.

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Key Points:

• Patients undergoing PCI for in-stent restenosis (ISR) were treated with either SeQuent paclitaxel-coated balloons (the current standard of care) or SeQuent sirolimus-coated balloons. Only patients with stable angina, unstable angina, or a positive functional study were included (ie, not acute STEMI patients). Two parallel multicenter trials were performed and pooled for this analysis.
• The primary outcome was late luminal loss at 6 months. Important secondary outcomes included target lesion revascularization, stent thrombosis, all-cause death, and MI.
• Treatment with sirolimus-coated balloons was noninferior to paclitaxel-coated balloons in the primary endpoint, and there were no significant differences in the secondary outcomes. Further evidence with long-term outcomes and larger studies for clinical endpoints will be required.

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Key Points:

• In this follow-up study to GUIDE-HF, HF patients with hemodynamic-guided therapy using a CardioMEMS device were compared to those with standard care. The primary outcome was a composite of all-cause mortality and HF events (including HF hospitalizations and urgent HF visits) at one year. In this sub-study, only patients in the pre-COVID era were examined. All results were stratified by ejection fraction (HFrEF vs HFpEF) and NYHA class (II/III vs II-IV).
• Treatment with hemodynamic-guided therapy resulted in a reduction in the primary outcome, but only in the HFpEF group in NYHA II-III populations; this was not seen in HFrEF or in NYHA II-IV populations. HF events were reduced in both HFrEF and HFpEF populations in the treatment arm, but once again only in the NYHA II-III (and not II-IV) population. The mean PA pressure was reduced in the treatment arm only in the HFrEF population.

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Key Points:

• In the OPT-PEACE trial, patients undergoing complete revascularization with current generation stents received 6 months of DAPT with aspirin and clopidogrel and were subsequently randomized to either a) ongoing DAPT, b) aspirin alone, or c) clopidogrel alone for the remaining 6 months.
• The primary outcome was gastrointestinal mucosal injury (erosion, ulceration or bleeding) at 6 or 12 months. Important secondary outcomes included clinically relevant bleeding and ischemic events. GI mucosal injury was evaluated via a novel non-invasive capsule monitoring system (AMCE).
• Treatment with SAPT resulted in lower GI mucosal injury as well as clinically relevant bleeding at 6 or 12 months. No ischemic events were observed by 12 months.

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Key Points

• • To determine success of percutaneous left atrial appendage occlusion (LAAO), residual patency of the appendage is assessed at 45 days, either via transesophageal echocardiogram or cardiac CT-A.
  • AMULET IDE showed that the Amulet device was noninferior to the Watchman device in preventing residual leak. This trial, however, did not assess the newer generation Watchman FLX device, one of the main counterarguments to the results.
  • Participants in this study were randomized to receive either the Amulet device or Watchman FLX for left atrial appendage occlusion. Device leak and appendage patency was assessed at 45 days by Cardiac CT-A.
  • At 45 days, the Amulet device was no different to Watchman when comparing patent appendages, but did have fewer rates of intra-device leak and mixed leak when assessed by TEE. Procedure-related complications, including death, CVA, major bleeding, and pericardial effusion were all higher in the Amulet arm when compared to the Watchman arm.

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