Key Points

-The RAPID study achieved its primary efficacy endpoint of terminating PSVT with self-administered Etripamil using a symptom-based optimal repeat dosing.

-Pooled analysis with the NODE-301 study showed that self-administered etripamil showed a significant reduction in emergency department utilization and medical intervention.

-This Phase III trial showed a favorable safety and tolerability profile of etripamil consistent with prior etripamil trials.

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Key Points:

-In a Phase II, dose-ranging trial of epicardial fat pad injection of botulinum toxin type A (AGN-151607) there was no significant differences in the rates of post-operative atrial fibrillation (POAF).

-Subgroup analyses suggest a lower rate of POAF and rehospitalization in patients >65 years of age who received the 125 U dose of AGN-151607, and those undergoing isolated CABG.

-The mechanism of POAF within the first 30 days may be related to both direct autonomic influences and decreased inflammation.

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Key Points:

• Indobufen, a platelet aggregation inhibitor, has been shown to be a shorter acting antiplatelet in comparison to aspirin. However, it has not been studied as a component of DAPT in patients requiring stent implantation.
• In the OPTION study, patients with CAD undergoing stent placement were randomized to either indobufen or aspirin. The primary outcome of interest was a 1-year composite of CV death, nonfatal MI, ischemic stroke, definite or probable stent thrombosis, or BARC type-2, 3, or 5 bleeding
• Indobufen was found to be non-inferior to aspirin in the primary endpoint.

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Key Points:

• There is substantial heterogeneity in the use of different non-invasive and invasive modalities for CAD risk stratification; however, there limited is RCT evidence dictating the optimal strategy.
• In the PRECISE study, patients with typical or atypical symptoms suggestive of potential CAD were randomized to either a risk-score based, “precision” strategy or usual care. The primary outcome of interest was a 1-year composite of death, nonfatal MI, or a coronary catheterization yielding no obstructive CAD.
• The precision strategy resulted in a significant 70% reduction in the primary outcome at 1 year compared to usual care.

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Key Points

• Clinicians estimate heart failure (HF) health status using New York Heart Association (NYHA) class; however, this is often discordant with patient-reported symptom burden.
• The Patient-Reported Outcomes in Heart Failure Clinic (PRO-HF) is a pragmatic, randomized, unblinded trial comparing routine Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) collection prior to outpatient HF clinic visits, which is then shared with the treating clinician, to usual care.
• The primary objectives in this pre-specified sub study were to determine the effect of this intervention on the accuracy of clinician assessment of patient health status and patient experience.
• Provider assessment of NYHA class in the KCCQ-12 arm was more accurate, and patients in the KCCQ-12 arm felt their providers better understood their symptoms.
• Future investigations will determine the effect of routine KCCQ-12 administration on longer term clinical outcomes.

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Key Points:

• Recent guidelines have supported the use of arterial grafts over venous grafts in coronary artery bypass grafting (CABG), but there has yet to be a single randomized trial examining long-term cardiovascular outcomes with these different grafting methods.
• In the RAPCO study, patients undergoing CABG were randomized to either a) radial artery (RA) grafting versus right internal thoracic artery (RITA) grafting or b) radial artery (RA) grafting versus saphenous vein grafting (SVG). The primary outcome of interest was MACE, a composite of cardiovascular mortality, acute MI, and revascularization.
• RA grafting was superior to both RITA and SVG grafting over 15 years of follow-up.

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Key Points:

• ECMO has been used as a salvage strategy in severe cardiogenic shock. However, it is unclear whether immediate ECMO initiation is superior to an initial trial of medical therapy with subsequent MCS utilization as needed if no improvement occurs.
• In the ECMO-CS study, patients presenting with severe cardiogenic shock (SCAI stage D-E) were randomized to either immediate ECMO or medical therapy (with downstream MCS as needed) The primary outcome of interest was a 30-day composite of death from any cause, resuscitated circulatory arrest, and implementation of any other MCS device.
• Immediate ECMO initiation was not associated with a significant reduction in the primary outcome relative to medical therapy with downstream as-needed MCS. There was a 40% crossover in the conservative arm to eventual downstream ECMO.

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Key Points:

• Tongxinluo (TXL) is a traditional Chinese medicine with endothelial-protective effects which has been used for angina and stroke prevention in China. It has yet to be tested as a means of improving clinical outcomes in acute STEMI.
• In the CTS-MI study, patients presenting with STEMI were randomized to either TXL (at randomization, and then continued for a year) or placebo. The primary outcome of interest was 30-day MACCE, a composite of cardiovascular mortality, recurrent MI, stroke, and emergent coronary revascularization. Secondary outcomes included 1-year MACCE as well as the individual components of MACCE, severe MI complications, and adverse events.
• TXL use resulted in a 36% reduction of MACCE at 30-days and 1-year, as well as reduced severe STEMI complications. TXL use was safe, with no increase in adverse events.

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Key Points:

• Iron deficiency is common and a poor prognostic feature in patients with heart failure. However, while iron infusion has improved symptoms in patients with HFrEF, there has been no association with improved “hard” outcomes such as hospitalization or CV death.
• In the IRONMAN study, patients with HFrEF and iron deficiency were randomized to Intravenous Ferric Derisomaltose (IV FDI) or placebo. The primary outcome of interest was a composite of recurrent HF hospitalizations and CV death.
• The observed reduction in primary endpoint with Intravenous Ferric Derisomaltose did not reach statistical significance compared to usual care.

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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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