Key Points

• The YELLOW III study aimed to assess the effect of 26 weeks of evolocumab on plaque morphology using intravascular imaging (OCT and NIRS/IVUS) and peripheral blood mononuclear cell (PBMC) gene expression analysis in patients with stable CAD on maximally tolerated statin therapy.
• In patients with stable CAD on maximally tolerated statins, more intensive lipid lowering with addition of evolocumab for 26 weeks resulted in significant and substantial increase in the minimum FCT by OCT, reduction in NIRS maxLCBI4mm and reduction in atheroma volume by IVUS in angiographically non-obstructive lesions.
• The prevalence of high-risk vulnerable TCFA lesions was reduced from 48% to 13%.
• This is the first multimodality imaging report in stable patients with non-obstructive lesions and lower levels of LDL-C at baseline.

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Key Points:

• Imaging may be underused in patients with ischemic heart failure (HF) to evaluate ischemia/viability and guide management.
• The Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) Project directly compared advanced imaging modalities (CMR or PET vs. SPECT) to determine its impact on a composite endpoint of cardiac death, myocardial infarction, resucitated cardiac arrest and cardiac re-hospitalization.
• For the total study population, the primary endpoint was similar between the CMR/PET vs. SPECT groups, with a trend towards improved outcomes in the CMR/PET groups (HR 0.95, 95% CI 0.71-1.25, p=0.696).
• Investigators concluded that choice of imaging study was not associated with a difference in outcomes, though an advanced imaging strategy with PET/CMR may be associated with a reduction in CV death.

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Key Points:
-It is unclear whether myocardial viability tests should be used to guide decisions about
revascularization in patients with ischemic cardiomyopathy (ICMP).
-The randomized trial REVIVED-BCIS 2 found that for patients with severe ICMP,
multivessel percutaneous coronary intervention (PCI) plus optimal medical therapy
(OMT) was not superior to OMT alone for event-free survival or recovery of left
ventricular ejection fraction (LVEF).
-This analysis of REVIVED-BCIS 2 data asked whether myocardial viability was
predictive of event-free survival (a composite of death or heart failure hospitalization),
LVEF recovery, or positive response to PCI among ICMP patients
-No significant association was found between baseline viability characteristics for event-
free survival, LVEF recovery, or positive response to PCI. However, scar burden was
predictive of both event-free survival and LVEF recovery, and LVEF recovery was
associated with improved clinical outcomes.

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Key Points

-Anthracycline therapy is associated with the development of heart failure, yet anthracyclines are among the most widely used and most effective antineoplastics.

-Limiting the cumulative dose of anthracycline, when possible, and screening for cardiotoxicity with echocardiograms should be standard practice.

-In the STOP-CA study, in patients with lymphoma treated with anthracyclines, the prophylactic use of atorvastatin over 12 months was associated with a lower rate of left ventricular dysfunction compared to placebo.

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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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Key Points:

• In the DREAM-HF study, patients with persistent NYHA II-III HFrEF were treated with transendocardial mesenchymal precursor cells (MPCs) or a sham procedure. The primary outcome was a mean cumulative rate of recurrent non-fatal decompensated HF events. Pre-specified secondary analyses included evaluation of non-fatal MI or non-fatal stroke and cardiac death; post—hoc analyses included time to first event for cardiac death or non-fatal MI/stroke, as well as cardiac death alone, stratified by baseline CRP.
• Treatment with MPCs did not reduce the primary endpoint, but MPC administration did significantly reduce non-fatal MI or non-fatal stroke, cardiac death in NYHA II but not III patients, and a composite of cardiac death, non-fatal-MI, and non-fatal stroke (which appeared to be largely driven by patients with elevated baseline CRP).

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Key Points:

• In the EMPULSE study, patients admitted with acute HF of any ejection fraction with or without diabetes were treated with either empagliflozin or placebo. The primary outcome was 90-day clinical benefit determined by a stratified “win ratio,” which included a comparison of death, HF events, time to first HF event, and change in baseline Kansas City Cardiomyopathy Questionnaire Total Summary Score (KCCQ). Secondary analyses included change in KCCQ from baseline, subgroup analyses of the primary endpoint by clinical characteristics including diabetes, and individual outcome components of the primary endpoint.
• Treatment with empagliflozin resulted in a reduction in the primary outcome, as well as a significant reduction in time to all-cause death or HF events. There was also a significant improvement in KCCQ score. The primary outcome was similar in patients with or without diabetes.

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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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