Key Points:

• HF patients frequently present to the ED for acute exacerbations, and the decision whether to discharge, observe, or admit these patients can be complex.
• The COACH trial randomized acute HF patients presenting to the ED to either a standardized clinical risk stratification algorithm (based on the EHMRG30-ST score) with associated rapid outpatient HF clinic or to standard of care.
• Patients receiving the intervention had reduced 30-day and 20-month composite death and non-elective cardiovascular hospitalizations.

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Key Points:

• Transthyretin Amyloidosis (ATTR) is a highly morbid and often fatal cause of cardiomyopathy. Existing therapies targeting TTR protein reduction have been effective, but have not managed to achieved complete or sustained knockdown of TTR levels.
• This was a Phase I study of a novel in vivo Crisp/Cas9 editing system (NTLA-2001) to reduce TTR. The primary objective was to assess safety, tolerability and PK and PD, and the secondary objective was to evaluate efficacy on clinical measures of cardiac disease.
• NTLA-2001 was generally well tolerated, with largely mild-moderate adverse events reported. Patients receiving NTLA-2001 achieved sustained, >90% reduction in TTR up to 4-6 months after infusion.

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Key Points:

• Thiazide type diuretics are first-line medications for hypertension (HTN); while chlorthalidone (CTD) has been shown to lower blood pressure to a greater extent than hydrochlorothiazide (HCTZ), whether this translates into improved cardiovascular outcomes is unknown.
• The DCP trial enrolled Veterans Affairs (VA) patients aged 65 or older currently on HCTZ 25-50mg daily and randomized them to either continue taking HCTZ or to switch to an equivalent dose of CTD.
• There was no difference between the two groups for the primary composite outcome of time to non-cancer death, stroke, myocardial infarction (MI), urgent revascularization, or heart failure hospitalization.
• The DCP used a novel pragmatic “point of care” design in which the primary care providers (PCPs) managed the medications, no study staff were present at study sites, and the outcome data was collected passively through the electronic medical record (EMR) or national databases, thereby mitigating the cost of study execution.

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Key Points

• High triglyceride levels are associated with increased cardiovascular risk, but whether reductions in these levels would reduce the incidence of cardiovascular events is not clear.
• In the PROMINENT study, patients with dyslipidemia and type 2 diabetes mellitus were randomized to a new cholesterol medication, pemafibrate, or placebo, the primary outcome being a clinical composite endpoint of MI, ischemic stroke, coronary revascularization, or CV death.
• In patients receiving pemafibrate , the incidence of CV events was not lower than those who received placebo, although pemafibrate lowered triglyceride levels, VLDL, and apolipoprotein C-III. There were worrisome adverse events such as an increased risk of venous thromboembolism and renal events in the pemafibrate arm.

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Key points:

• Loop diuretics are routinely used to manage congestion in heart failure (HF) but have never been directly compared in a large-scale randomized trial.
• The TRANSFORM-HF trial compared torsemide vs. furosemide for long-term clinical outcomes among patients hospitalized with HF.
• At median follow up of 17.4 months, there was no significant difference in clinical outcomes (all-cause mortality) between torsemide and furosemide in HF patients.
• The pragmatic nature of the TRANSFORM-HF study allowed for diverse patient recruitment, high site engagement and clinically generalizable results.

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Key Points:

• Radial artery occlusion (RAO) is the most common complication after radial access for coronary procedures; while routine intra-procedural heparin administration is a protective factor, the role of post-procedural anticoagulation has not been established.
• In the RIVARAD study, patients undergoing trans-radial access for coronary procedures were randomized to a week of post-procedural rivaroxaban vs no additional treatment. The primary outcome of interest was 30-day incidence of RAO by ultrasound.
• Patients receiving rivaroxaban experienced a 50% reduction in RAO by ultrasound and a 52% reduction in RAO by palpation compared to the control group. Rivaroxaban use was safe with no increase in overall hemorrhagic complications relative to the control arm.

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Key Points:

• Early high-intensity statin therapy is standard of practice in acute STEMI patients, but this is often insufficient to achieve LDL targets. PCSK-9 therapy has never been tested as routine therapy in STEMI.
• In the EPIC STEMI trial, routine PCSK-9 initiation in addition to high-intensity statin prior to primary PCI resulted in a 22% LDL reduction at 6 weeks relative to sham, with a higher proportion of patients achieving therapeutic LDL targets.

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Key Points:

• Previous studies have demonstrated the superiority of CABG over PCI in the treatment of multivessel disease; however, most studies were performed without the use of newer second-generation stents.
• The two-year outcomes of the BEST trial demonstrated superiority of CABG compared to PCI with second-generation everolimus-eluting DES; however, the authors then pursued an extended outcome analysis up to a median follow-up of 11.8 years.
• There was no difference between PCI and CABG at extended follow-up in the primary outcome composite of all-cause death, MI, and total revascularization. However, the rate of spontaneous MI and repeat revascularization was higher in the PCI arm.
• IVUS use reduced the incidence of the primary composite amongst patients undergoing PCI.

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Key Points:

• Mortality for acute PE remains high. While percutaneous mechanical thrombectomy has been used in patients with hemodynamic instability, safety and effectiveness data from large clinical trials are needed.
• In the single-arm FLASH study, patients with acute lobar or main PA pulmonary embolism received the FlowTriever System (percutaneous mechanical thrombectomy), and both short-term and 6 month safety and effectiveness outcomes were assessed. This was perfomed as part of the FLASH multicenter, prospective registry enrolling up to 1,000 US and European PE patients.
• The FlowTriever had an excellent safety profile with only 1.8% risk of MAE and all-cause mortality of 0.8% at 30 days. Additionally, FlowTriever use was associated with substantial immediate improvements in hemodynamics, sustained improvement in echocardiographic measures of RV function, and improvement in quality of life and dyspnea at 6 months relative to presentation.

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Key Points:

• Femoral access is used for 30% of all coronary procedures, and femoral access site complication can be catastrophic. Since the development of ultrasound-guided vascular access, many institutions have adopted ultrasound-guidance as the standard of care for femoral access. However, there is a paucity of randomized data to understand the role of ultrasound in improving the safety of coronary procedures via femoral access.
• In the UNIVERSAL study, patients randomized to ultrasound-guided femoral access did not experience a reduction in major bleeding or vascular complications at 30 days; however, ultrasound guidance did improve first attempt success and reduce the number of attempts and accidental venipuncture.

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Key Points:

• Pulmonary artery denervation (PADN) has never been studied with a randomized trial in the treatment of pulmonary arterial hypertension (PAH). The PADN-CFDA study was a sham-control randomized trial conducted in China evaluating PADN in addition to phosphodiesterase inhibitor (PDE-5i) therapy in patients with PAH compared to PDEi therapy with a sham procedure.
• In the primary analysis, PADN with PDE-5i therapy resulted in substantial increase in 6-minute walk distance (a measure of exercise capacity) at 6 months. PADN also reduced PVR, NT-pro BNP, and mPAP, as well as improved echocardiographic measures of RV function compared to sham treatment.

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Key Points:

• Endovascular ultrasound denervation (uRDN) is a potentially useful technique in the management of hypertension; however, its effect in patients with mild to moderate HTN has not been well studied. The RADIANCE II study was a sham-controlled RCT aimed at determining the efficacy and safety of uRDN on patients with mild-moderate HTN.
• uRDN resulted in substantial reductions in daytime ambulatory sBP compared to sham and led to a higher percentage of time spent in therapeutic BP range.
• uRDN was a safe procedure, with no major adverse events at 30 days.

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Key Points:

• In 2021, the Amulet IDE study demonstrated that the novel Amulet left atrial appendage occluder device was noninferior to the standard Watchman device for stroke prevention in patients with nonvalvular atrial fibrillation. The study investigators have now pursued an analysis of the three year outcomes.
• The Amulet device continued to demonstrate safety and effectiveness through 3 years of follow up.

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Key Points:

• The MitraClip system has been established as a robust platform for transcatheter repair of both degenerative and functional mitral regurgitation. However, it has not been compared against more novel therapies (such as the PASCAL system). The CLASP IID trial is the first RCT to directly compare two transcatheter valve repair therapies for degenerative MR.
• The PASCAL system met the primary safety and effectiveness endpoints of this pivotal noninferiority trial. There was a low composite MAE rate (3.4%) at 30 days, and 97.7% of patients achieved sustained reduction of MR (≤ 2+) at 6 months.
• This trial establishes the PASCAL system as a safe, beneficial therapy for patients with significant symptomatic DMR and prohibitive surgical risk.

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Key Points:

• Stroke is a feared complication of TAVR. However, the potential impact of cerebral embolic protection (CEP) devices is unclear. The PROTECTED TAVR study was a post-market RCT to examine the utility of CEP devices in TAVR patients across all risk categories.
• CEP device use did not result in a significant difference in all strokes at 72 hours or discharge, but it did reduce the rate of disabling strokes in secondary analysis.
• CEP device use was safe, with no difference in the safety composite of all-cause mortality and stroke and only a 0.1% risk of vascular complication related to CEP.

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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 →

Key Points:

• Survivors of out of hospital cardiac arrest (OHCA) suffer very poor outcomes including high rates of mortality and neurologic dysfunction, with optimal protocol for therapeutic hypothermia (TH) unknown
• CAPITAL CHILL is the first double-blinded, randomized trial to evaluate outcomes of moderate hypothermia (31 degrees Celsius) as opposed to mild hypothermia (34 degrees Celsius) after suffering OHCA
• Trial results showed that patients who were cooled below 31 degrees Celsius for 24 hours (moderate TH) showed no difference in terms of death or poor neurological outcomes at six months compared with patients receiving guideline-recommended cooling of 34 degrees Celsius (mild TH)

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KEY POINTS:

• An experimental new therapeutic for heart failure, omecamtiv mecarbil is a novel, selective cardiac myosin activator that was previously shown in the GALACTIC-HF trial to improve heart failure (HF) outcomes amongst patients with heart failure with reduced ejection fraction (HFrEF)
• This extended analysis of the GALACTIC-HF trial showed that omecamtiv mecarbil exerts a greater relative and absolute therapeutic benefit in patients with worsening ejection fraction (EF), in keeping with the drug’s mechanism of selectively improving cardiac function
• The relative and absolute benefits from omecamtiv mecarbil significantly improved with progressively lower EF
• No clear benefit of omecamtiv mecarbil among patients with EF >30% was shown, with more research into this subgroup forthcoming
• The potential role for omecamtiv mecarbil is to be additive to other guideline-directed medical therapies (GDMT) for all patients with LVEF <35% and 1+ heart failure hospitalization in the prior year

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Key Points:

• ISCHEMIA trial patients in the invasive management arm were assessed for completeness in revascularization.
• Patients who achieved complete revascularization were found to have better outcomes at 4 years than those who did not.
• If all patients in the invasive arm were to have achieved complete revascularization, the primary endpoint of ISCHEMIA would have favored invasive management even more strongly at 4 years.

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Presented as a Late Breaking Clinical Trial at the American College of Cardiology 2021 Scientific Sessions by Gregory M. Marcus MD, Professor of Medicine, UCSF, demonstrated that acute alcohol consumption was associated with an elevated risk of discrete atrial fibrillation (AF) event. This event may appear within several hours of the drink and even one drink may increase the risk of such events.
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