RIVARAD: Post-Procedural Rivaroxaban Use After Radial Access for Coronary Procedures Reduces Radial Artery Occlusion at 30 Days

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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EPIC-STEMI: Early Routine PCSK-9 Use Added to High Intensity Statin Reduces LDL after Primary PCI for STEMI

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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Extended outcomes of BEST: No difference in MACE between PCI and CABG in MVD at 12 years, but higher repeat revascularization and spontaneous MI in PCI arm

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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FLASH: The FlowTriever system has an excellent safety profile in the treatment of pulmonary embolism

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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UNIVERSAL: Routine ultrasound guidance of femoral vascular access did not reduce bleeding or vascular complications but did facilitate access

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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PADN-CFDA: Pulmonary artery denervation in addition to PDE-5i therapy improves exercise capacity in patients with pulmonary arterial hypertension

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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RADIANCE II: Endovascular ultrasound denervation met primary/secondary efficacy BP lowering endpoints at 2 months

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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Amulet IDE: Continued safety and effectiveness of the Amulet LAA occluder device at three years in patients with nonvalvular atrial fibrillation

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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CLASP IID: The PASCAL system is a safe and beneficial therapy for severe degenerative mitral regurgitation

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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PROTECTED TAVR: No Overall Stroke Reduction With Embolic Protection Devices in TAVR, But Fewer Disabling Strokes

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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Novel IL-6 Antibody Crushes CRP in High-risk ASCVD in Phase2

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

Colder Is Not Necessarily Better: CAPITAL CHILL Results

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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Role for Omecamtiv Mecarbil in Pts with EF <35%

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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Revascularization Shows Benefit at 4 years in ISCHEMIA

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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Acute alcohol consumption elevates risk of AF event

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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Radiation-Induced Cardiac Disease

During the third and last day of the 2021 American College of Cardiology Scientific Sessions, Dr. Marjan Boerma, PhD, Associate Professor, University of Arkansas for Medical Sciences, delivered a presentation on radiation-induced heart disease as a panelist during session 748, “Cardio-Oncology: Today’s Standard of Practice.” Aptly entitled “Unchain My Heart,” the presentation began with a focus on studies demonstrating the now well-known increased risk of heart disease as a late effect of cancer treatment in long-term survivors of Hodgkin’s lymphoma as well as in breast cancer patients who received radiotherapy for left-sided compared with right-sided breast cancers.

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Hyperinvasive Approach Improves Survival in Refractory Out-of-Hospital Cardiac Arrest

It goes without saying that refractory out of hospital cardiac arrest (OHCA) is associated with very poor outcomes. In recent decades, E-CPR, or the combination of veno-arterial ECMO and mechanical CPR, has emerged as a potential mitigator of refractory OHCA to improve survival. Given the difficulties in design and enrollment of randomized trials in the OHCA space, however, definitive data favoring the use of E-CPR had yet to be established.

In a Late Breaking Clinical Trials Session at the 2021 American College of Cardiology Scientific Sessions, Dr. J. Belohlavek of the Charles University in Prague presented the results of Prague OHCA, a 7-year trial comparing E-CPR to standard ACLS in refractory OHCA. Patients with a presumed cardiac cause of their OHCA were electronically randomized to a hyperinvasive or standard approach to ACLS during bystander chest compressions. The hyperinvasive approach consisted of a rapid transfer to a hospital center with mechanical CPR and/or the implantation of veno-arterial ECMO could be implemented. Standard of care remained at the discretion of the responders but would include manual chest compressions and progression of ACLS.
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No Advantage to Catheter Ablation for Rhythm Control in Atrial Fibrillation

Atrial fibrillation and heart failure are two common, costly medical conditions that are increasing in prevalence and incidence in the United States. These two comorbidities often accompany one another in the advanced heart failure population. While goal directed medical therapy for those with heart failure with reduced ejection fraction exists, there is limited evidence of therapy for those with concurrent heart failure and atrial fibrillation.
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Hospital-level Intervention Did Not Improve Outcomes or Quality in HFrEF

Key Points:

  • CONNECT-HF, one of the largest heart failure (HF) implementation science trials performed to date, was performed to evaluate how the principles of audit and feedback with personalized feedback by HF and quality improvement experts might impact HF outcomes
  • Results showed that this hospital-level intervention did not meaningfully improve clinical outcomes or quality of care delivery at 12 months compared to usual care
  • According to the investigators, new approaches are needed to improve care above current quality improvement efforts for patients with HFrEF and next steps include finding alternative QI systems that do improve HF outcomes and rigorously studying those practices

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Pirfenidone Shown to Decrease Fibrosis in Patients with HFpEF

Key Points:

Myocardial fibrosis has previously been associated with death and repeat hospitalization in patients with heart failure with preserved ejection fraction.

In a phase II clinical trial, Pirfenidone, an oral antifibrotic agent used in the treatment of idiopathic pulmonary fibrosis, was found to significantly decrease myocardial fibrosis when compared to placebo. Dr. Christopher Miller of the University of Manchester presented the results of the PIROUETTE trial (NCT02932566) at a Late Breaking Clinical Trial session at the 2021 American College of Cardiology Scientific Sessions meeting. Given its effect in reducing pulmonary fibrosis, investigators hypothesized that the TGF-B1 antagonist would work similarly in the myocardium and hoped for a clinical benefit in volume status and quality of life as well.
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