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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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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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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No benefit to FFR-guided PCI over angiographic-guided PCI of Nonculprit Lesions after STEMI: Results from FLOWER-MI Show

Key Points:

  • While FFR-guided PCI is superior in chronic coronary syndrome, its role in primary PCI of acute coronary syndrome remained unknown.
  • Patients with STEMI and multivessel disease, were randomized to undergo FFR-guided PCI versus angiography-guided PCI of non-culprit lesions after treatment of the culprit.
  • There was no difference in MACE at one year between the two intervention arms at one year.

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Aspirin Vs. Clopidogrel During Chronic Maintenance Monotherapy After Percutaneous Coronary Intervention: The Host Exam Randomized Controlled Trial


  • Clopidogrel is superior to aspirin as chronic maintenance therapy after drug eluting stent (DES) placement with contemporary percutaneous coronary intervention (PCI) following 12 ± 6 months of dual antiplatelet therapy (DAPT)
  • Specifically, those on Clopidogrel had a reduction in the composite endpoint of myocardial infarction, stroke, readmission for ACS as well was the secondary endpoints of thrombotic and bleeding events

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Rivaroxaban shown to lower future vascular events after peripheral revascularization: results from VOYAGER-PAD

Rivaroxaban should be considered as adjunctive therapy to aspirin alone in patients undergoing peripheral limb revascularization, authors of the VOYAGER-PAD trial concluded today. In the Late Breaking Clinical Trials session earlier today at the 2021 American College of Cardiology Scientific Sessions, Dr. Rupert Bauersachs of Darmstadt, Germany, presented the anticipated results of the trial, which attempted to answer whether post-intervention rivaroxaban could prevent future limb ischemia and need for repeat revascularization.

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Tricuspid Valve Replacement with the Transcatheter Evoque Valve is Safe and Effective at 30 days

Transcatheter tricuspid valve replacement has become a feasible alternative to surgery in patients deemed to be at high risk of adverse events, and in the past decade, various devices have been designed to meet this clinical need. In his Focused Clinical Research session on the opening day of the American College of Cardiology 2021 Scientific Sessions, Dr. Susheel Kodali, director of the Structural Heart & Valve Center at New York-Presbyterian/ Columbia University Medical Center presented the 30-day results from the implantation of the EVOQUE valve, as part of the TRISCEND study. Continue reading

Real-World Data Supports Continued use of Transcatheter Left Atrial Appendage Occlusion

The WATCHMAN left atrial appendage occluder device has been widely accepted as an alternative to oral anticoagulation for stroke prevention in patients with underlying atrial fibrillation. However, the indications for WATCHMAN implantation laid forth by the Centers for Medicare & Medicaid Services in the United States differ from the original trials supporting its use. Real-world practice, therefore, highlights significant differences in the characteristics of patients receiving the therapy from those originally studied.  In a Focused Clinical Research Session at the 2021 American College of Cardiology meeting, Dr. Matthew Price, Director of the Cardiac Cath Lab at Scripps Green Hospital and Assistant Professor at the Scripps Translational Science Institute, La Jolla, California, presented the results of his study from the NCDR LAAO Registry (NCT02699957), assessing one- year real-world outcomes for patients undergoing WATCHMAN implantation.

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Apixaban Associated with Fewer Subclinical Valve Thrombosis Events: Results from the ATLANTIS 4D-CT Substudy

Subclinical valve thrombosis after transcatheter aortic valve intervention (TAVI) has emerged as a challenge to the standardization of antithrombotic therapy after valve implantation. Results of the randomized ATLANTIS trial, presented also today, May 15, as a Late Breaking Clinical Trial at ACC 2021, showed no superiority of apixaban over standard of care after transcatheter aortic valve intervention, irrespective of the baseline need for anticoagulants. In his Focused Clinical Research Session, Gilles Montalescot, MD, PhD, Professor of Cardiology at the Pitié-Salpêtrière Hospital, Paris, presented the 4D-CT substudy results to assess the incidence and implications of CT-proven valve thrombosis. Continue reading

STOP AF First Trial: Cryoballoon Ablation Is Superior to Antiarrhythmic Drug Therapy for the Prevention of Atrial Arrhythmia Recurrence in Patients With Paroxysmal Atrial Fibrillation

A recent trial by Dr. Oussama M. Wazni, published in the New England Journal of Medicine, indicated that in patients with paroxysmal atrial fibrillation, cryoballoon ablation therapy is superior as compared with antiarrhythmic drug therapy, in the prevention of atrial fibrillation recurrence. The study also showed the non-inferiority of this procedure over the drug therapy approach in terms of safety.

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Early Atrial Fibrillation Clinical Trial: Superiority of Catheter Cryoablation Over Antiarrhythmic Therapy as First Line Therapy for Paroxysmal Atrial Fibrillation

A recent study by Dr. Jason G. Andrade, published in New England Journal of Medicine, found that the use of catheter cryoablation as first-line therapy for patients with newly diagnosed, symptomatic, paroxysmal atrial fibrillation is associated with lower recurrence of arrhythmia and a better quality of life when compared to an antiarrhythmic treatment approach. Continue reading

Post-Hoc Analysis of ISCHEMIA Trial: The Choice of Myocardial Infarction Definition Influences Clinical Interpretation of Results

A recent study by Dr. Bernard R. Chaitman, published in Circulation investigated the impact on clinical interpretation of using different definitions for myocardial infarctions in the ISCHEMIA trial.

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EMPEROR-Reduced Trial: Empagliflozin Use Was Associated With a Better Clinical Outcomes Among Patients With Heart Failure and a Reduced Ejection Fraction

A recent study by Dr. Milton Packer, published in Circulation, demonstrated that empagliflozin use has been associated with a reduction in the total number of inpatient and outpatient visits in patients with heart failure and a reduced ejection fraction. These benefits were observed within  12-28 days of treatment initiation and were persisted over the duration of the trial. Continue reading

DAPA Trial: Prophylactic Defibrillator Implantation After Primary Percutaneous Coronary Intervention Lowers Long Term Mortality in Patients at High Risk of Death

Results of the DAPA trial, published in Circulation: Arrhythmia and Electrophysiology, demonstrated that the use of early prophylactic implantable cardioverter defibrillator (ICD) in high-risk post-primary percutaneous coronary intervention (PCI) patients was associated with lower all-cause and cardiac mortality rates. However, the results of this trial should be interpreted with caution, since the trial was stopped prematurely.

The optimal timing of ICD implantation in STEMI patients treated with primary angioplasty is not identified yet. Previous clinical trials have failed to show the benefit of early ICD implantation (4-60 days) in post-MI patients with a low left ventricular ejection fraction (≤35-40%). The risk of sudden cardiac death (SCD) is high within the post STEMI period.  However, ICD implantation after 40 days may not be indicated due to left ventricular remodeling and a potential increase in LVEF post-primary PCI. The Defibrillator After Primary Angioplasty (DAPA) trial evaluated all-cause and cardiac mortality of patients undergoing early prophylactic ICD implantation after PCI for STEMI. Following a recommendation from the data safety board, the trial was terminated early after just 38% of the planned sample size was enrolled due to slow enrollment.

This multicenter, randomized, controlled trial included patients with STEMI who had undergone primary PCI and met at least one of the following criteria: LVEF<30% within 4 days after admission, primary ventricular fibrillation (VF) within 24 hours (during PCI excluded), signs of heart failure on admission (Killip class ≥ 2), and/or thrombolysis in myocardial infarction (TIMI) flow post PCI < 3. The participants were randomized in a 1:1 ratio to receive either ICD implantation or conventional therapy within 30 to 60 days of the STEMI event. The primary endpoint was all-cause mortality at 3 and 9-years. The secondary endpoints of the study included the incidence of sudden cardiac death (SCD) and hospital admission for sustained ventricular tachyarrhythmias or appropriate ICD therapy.

A total of 266 patients with primary PCI for STEMI were included in the study with 131 patients allocated to the ICD arm and 135 patients assigned to the conventional therapy arm. After 3-years of follow-up, the primary outcome of interest was significantly lower among patients who received ICD implantation (5%) compared to the conventional therapy group (13%) (Hazard ratio (HR):0.37; [95% CI: 0.15-0.95]; p=0.04). This result remained similar at a median of 9-years follow-up (HR: 0.58; [95% CI: 0.37-0.91]; p=0.02). In terms of cardiac mortality, ICD implantation was associated with fewer deaths (11%) compared to the control group (22%) (HR: 0.52; [95% CI: 0.28-0.99]; p=0.04). Although not statistically significant, the incidence of SCD was also lower in the ICD group (3.1%) compared to the control group (5.9%) (HR 0.45; [95% CI 0.14–1.50]; p=0.19).

The results of this study should be interpreted with consideration of the following limitations. First, the premature termination of the study makes it underpowered for analysis. Second, the study used more than one inclusion criteria, so results should be interpreted with consideration of the patient characteristics. The high treatment crossovers (10.2%) within the first 3 years of the study and the lack of information on treatment crossovers between 3 and 9 years are additional limitations of the trial.  Furthermore, while pharmacotherapy of the participants was similar at baseline, there is a lack of data regarding the follow-up medical therapy which may have impacted the mortality rates.

In conclusion, this prematurely terminated trial suggests that early prophylactic ICD implantation may be associated with a better survival rate in patients at high risk of death after primary PCI for STEMI. The results of this trial should be confirmed in future studies.

Study Shows Emergent Percutaneous Coronary Intervention in Patients with Unstable Coronary Plaque Improves the Survival After Sudden Cardiac Arrest

The emergent percutaneous coronary intervention (PCI) of unstable plaques, compared to stable plaques, was associated with a better survival rate among patients with sudden cardiac arrest in a recent study by Dr. Louis Pechmajou et al. The results of the study were recently published in Circulation: Cardiovascular Interventions. Continue reading

COACT Trial Shows Immediate Coronary Angiography Does Not Change the 1-Year Clinical Outcomes of Patients After Cardiac Arrest Without ST-Segment Elevation

A trial by Dr. Jorrit S. Lemkes, published in JAMA Cardiology, demonstrated that immediate coronary angiography and percutaneous coronary intervention (PCI) does not improve the 1-year clinical outcomes of patients after successful resuscitation from non-ST segment elevation cardiac arrest. Also, the survival rate was comparable between patients whose angiography was performed immediately (61.4%) versus those whose angiography was delayed (64.0%).

Given the high prevalence of coronary artery disease among patients with cardiac arrest, coronary angiography and PCI should be considered in these patients with suggested evidence of coronary artery involvement. However, the current data regarding the appropriate timing of this intervention is lacking. The interim results of the Coronary Angiography after Cardiac Arrest (COACT) trial failed to find a significant difference between the 90-days clinical outcomes of patients with delayed coronary angiography versus patients with immediate coronary angiography after non-ST segment elevation cardiac arrest. The 1-year follow-up study investigated the long-term clinical outcomes of immediate coronary angiography in these patients.

COACT study, an open-label, multicenter, randomized trial, compared the short-term clinical outcomes of immediate versus delayed coronary angiography in patients resuscitated from cardiac arrest without ST-segment elevation on the electrocardiogram tracing. Briefly, a total of 552 patients with out-of-hospital arrest and no signs of ST-segment elevation myocardial infarction (STEMI) who successfully resuscitated from cardiac arrest were randomized in a 1:1 ratio to undergo immediate (within 2 hours of randomization) or delayed (after neurological recovery or discharge from intensive care unit) coronary angiography. The 1-year endpoints of the study included survival rate, myocardial infarction, repeated revascularization, hospitalization for heart failure, and implantable cardiac defibrillator (ICD) shock since the index hospitalization.

At 1-year follow-up, 94.6% of the participants (n=522) were available for analysis. The recent analysis of the data indicated no significant differences between the two groups. The survival rate was 61.4% and 64.0% in the immediate and delayed coronary angiography group, respectively (odds ratio (OR)=0.90; 95%Confidence Interval (CI):0.63-1.28). Additionally, the endpoints of the interest were equivalent in the 2 groups. For example, the rate of myocardial infarction was 0.8%in the immediate group and 0.4%in the delayed group (OR=1.96; 95%CI: 0.18-21.8). The study also showed that the post-cardiac arrest mortality usually occurs within the first 90 days after the arrest, and the survival rate after this period is relatively favorable.

The trial has some limitations that need to be taken into account. First, the study is not powered for a 1-year analysis. Second, the findings of this study are not generalizable to patients with shock, severe renal dysfunction, or persistent ST-segment elevation due to their exclusion from the trial.

The results of this trial suggest that in patients with out-of-hospital cardiac arrest with no signs of STEMI, the coronary angiography, if necessary, can be delayed until after neurological recovery.

PREMIER Trial Shows Incremental Plaque Regression by a Single Lipid Apheresis and Maintained Statin Therapy in ACS Patients Treated With PCI

A recent study by Dr. Banerjee, published in Circulation: Cardiovascular Interventions, demonstrated the efficacy and safety of low-density lipoprotein (LDL) lowering therapy via a single LDL apheresis treatment plus ongoing statin therapy in nonfamilial hyperlipidemia acute coronary syndrome patients treated with the percutaneous coronary intervention (PCI).
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Study Shows Aortic Valve Replacement Was Associated With Better Outcomes in Patients with Low-Gradient Aortic Stenosis and Preserved Left Ventricular Ejection Fraction Compared With High-Gradient Aortic Stenosis Analysis of PARTNER 2A randomized trial and SAPIEN 3 registry

A recent study by Dr. Salaun, published in Circulation: Cardiovascular Interventions, demonstrated that aortic valve replacement in patients with the low gradient (LG, defined as mean gradient <40 mmHg) severe aortic stenosis (AS) and preserved ejection fraction (EF) has resulted in better outcomes versus in those with the high gradient (HG, defined as a mean transvalvular gradient (MG) 40 mmHg) AS. Also, the study revealed that patients with classical low flow, low gradient (CLF-LG, defined as MG <40 mmHg and LVEF <50%) AS were at higher risk of death, rehospitalization, or stroke at 2 years.

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ADRIFT Study: Reduced Rivaroxaban Doses Are Associated With Lower Thrombin Generation Following Percutaneous Left Atrial Appendage Closure Compared to Dual Antiplatelet Therapy

A recent study by Dr. Duthoit, MD, published in Circulation: Cardiovascular Interventions, showed that compared to dual antiplatelet therapy, nonvitamin k antagonist monotherapy using a reduced dose of rivaroxaban (10 and 15 mg) in patients undergone left atrial appendage closure was associated with lower thrombin generation. This data supported that reduced rivaroxaban doses could be a substitute for the antithrombotic medications currently used after this procedure. Continue reading

100,000 Patient Meta-Analysis Shows Carotid Intima-Media Thickness Progression Can Be Used as a Surrogate Marker for Cardiovascular Risk

A recent meta-analysis of clinical trials with more than 100,000 patients has shown that the carotid intima-media thickness (cIMT) progression can be used as a surrogate marker for cardiovascular risk in the clinical trials. The results of this study published in Circulation. According to Dr. Willeit, the assessment of cIMT progression can provide a link for the development and license of new therapies for cardiovascular disease. Continue reading