Interventional Takeaways From AHA 2020 Trials
Editor's Note: The virtual American Heart Association Scientific Sessions 2020 (AHA 2020) provided a number of important trials of interest for interventional cardiologists. The ACC.org Editorial Board prepared teaching points for trials they deem of particular benefit for various subspecialities of cardiology. Three of these related to interventional cardiology are presented below. Four more teaching points from AHA 2020 trials of interest to interventionalists are included; these were written by practitioners in the field who graciously provided their perspectives. As always, I am grateful for our authors and believe their input is most beneficial, providing practitioners easy, timely updates from the meetings.
ALPHEUS (Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting)1,2
By Anthony A. Bavry, MD, MPH, FACC
This study examined if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective percutaneous coronary intervention (PCI). The study reported that ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding but did increase the rate of minor bleeding at 30 days. Overall, these findings suggest that clopidogrel should remain the recommended standard of care in stable coronary patients undergoing PCI. Furthermore, these data suggest that improvement in surrogate outcomes do not necessarily result in improved hard outcomes.
A total of 1,910 patients was randomly assigned at 49 sites (956 to the ticagrelor group and 954 to the clopidogrel group); 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 hours, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio 0.97; 95% confidence interval [CI], 0.80-1.17; p = 0.75). The primary safety outcome did not differ between the 2 groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 [11%] of 941 patients in the ticagrelor group vs. 71 [8%] of 942 patients in the clopidogrel group; odds ratio 1.54; 95% CI, 1.12-2.11; p = 0.0070).
ARREST (Advanced Reperfusion Strategies for Refractory Cardiac Arrest)3,4
By Anthony A. Bavry, MD, MPH, FACC
In this phase 2, single-center trial, patients with out-of-hospital cardiac arrest and ventricular fibrillation unresponsive to initial standard advanced cardiac life support treatment were randomly assigned to early resuscitation facilitated by extracorporeal membrane oxygenation (ECMO) or standard advanced cardiac life support treatment on hospital arrival. Survival to hospital discharge was observed in 6 (43%) of 14 patients in the early ECMO-facilitated resuscitation group versus 1 (7%) of 15 patients in the standard advanced cardiac life support treatment group (risk difference 36.2%; 3.7-59.2; posterior probability of ECMO superiority 0.9861).
STRENGTH (Long-Term Outcomes Study to Assess Statin Residual Risk With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia)5,6
By Anthony A. Bavry, MD, MPH, FACC
Among statin-treated patients at high cardiovascular risk, the addition of eicosapentaenoic acid and docosahexaenoic acid in combination compared with a corn oil placebo resulted in no significant difference in the risk of major adverse cardiovascular events.
Among 13,078 patients randomized to the combined omega-3 fatty acid combination, the risk of major adverse cardiovascular events (death, non-fatal myocardial infarction [MI], non-fatal stroke, coronary revascularization, and unstable angina) occurred in percentages similar to patients randomized to corn oil (12.0% vs. 12.2%; hazard ratio 0.99; 95% CI, 0.90-1.09). Results were similar in both groups when restricted to a core set of major adverse cardiovascular event outcomes (cardiovascular death, non-fatal MI, and non-fatal stroke).
HARP-MINOCA (Heart Attack Research Program-Imaging Study)7,8
By Kathleen E. Kearney, MD
The majority of women presenting with MI with nonobstructive coronary arteries (MINOCA) on angiography had diagnostic findings using a combination of optical coherence tomography (OCT) and cardiac magnetic resonance imaging (MRI). In this multi-center cohort, 301 women meeting the universal definition of MI undergoing angiography were included, with 170 meeting MINOCA criteria. Of these, 145 underwent OCT and 116 cardiac MRI. OCT identified a culprit lesion in 46%, with intra-plaque cavity (21%), layered plaque (13%), and plaque rupture (6%) being the most common findings. Additionally, 33% of patients undergoing MRI demonstrated infarction, with 21% with regional injury and 21% with nonischemic findings, and 26% of patients had a normal cardiac MRI. In concert, a culprit lesion on OCT correlated with ischemic injury on MRI in 69%, and no cause was determined in 15% of patients.
Care of this patient population is challenging due to variable and poorly understood pathophysiology. This study demonstrated that women without a culprit lesion on initial angiography may benefit from further intracoronary evaluation with OCT and myocardial evaluation with cardiac MRI, though any influence on clinical outcomes by downstream intervention warrants further evaluation.
RAPID-CTCA (Early Coronary CT Angiography in Patients With Suspected or Provisionally Diagnosed Acute Coronary Syndrome)9,10
By Thom G. A. Dahle, MD, FACC
Among intermediate- and high-risk patients with chest pain and patients with suspected acute coronary syndrome, the use of cardiac computed tomography (CT) angiography did not reduce 1-year mortality or MI compared to usual care but did result in longer hospital stay and higher cost.
A total of 1,748 patients was randomized to cardiac CT angiography (n = 877) versus usual care (n = 871). Although there was a decrease in invasive coronary angiography in the cardiac CT angiography group (hazard ratio 0.81; 95% CI, 0.72-0.92), there was no difference in coronary revascularization, 1-year mortality, or MI. Despite the decrease in invasive coronary angiography, this strategy resulted in longer length of hospitalization (2.2 days vs. 2.0 day for usual care) and higher total cost ($9,494 for cardiac CT angiography vs. $8,776 for usual care).
RHAPSODY (Rilonacept Inhibition of Interleukin-1 Alpha and Beta for Recurrent Pericarditis: a Pivotal Symptomatology and Outcomes Study)11
By George W. Vetrovec, MD, MACC
In a small, randomized study of 61 patients with recurrent pericarditis, an interleukin 1-alpha and 1-beta inhibiter (rilonacept) significantly reduced the primary endpoint of recurrent pericarditis. Only 6.7% of the rilonacept treatment group had a recurrent event versus 74.2% of the placebo group (p < 0.0001).
Recurrent pericarditis is often a difficult clinical problem. In the RHAPSODY trial, patients with at least 2 episodes of pericarditis (multiple etiologies) on baseline non-steroidal anti-inflammatory drugs (67%), colchicine (80%), and corticosteroids (49%) with a C-reactive protein of >1 were randomized to subcutaneous rilonacept versus placebo after a 12-week run-in phase with all patients on drug. At 16 weeks, 81% of patients on rilonacept were asymptomatic/minimal symptoms compared to 25% of the placebo group (p = 0.0006). No serious adverse events occurred, but 23.3 % of the rilonacept treatment group experienced upper respiratory infections compared to 0% in the control group. In addition, 16.7% of the rilonacept group experienced an infection-site reaction compared to 0% for the control group. Overall, these results are encouraging for this challenging problem.
One-Month DAPT (One-Month Dual Antiplatelet Therapy Followed by Aspirin Monotherapy After Drug-Eluting Stent Implantation)12
By Gautam Kumar, MD, FACC
In a mixture of patients (stable angina and acute coronary syndrome) with varied bleeding risk, the One-Month DAPT trial showed that 1-month dual antiplatelet therapy (DAPT) was non-inferior to 6- to 12-month DAPT duration. However, applicability in the United States is limited by unavailability of the stent platforms used in this trial.
The One-Month DAPT trial is a randomized, controlled trial that examined the hypothesis that 1-month DAPT followed by aspirin monotherapy would be non-inferior to the currently recommended 6- to 12-month DAPT for preventing the composite primary endpoint of major adverse cardiovascular/cerebrovascular events or major bleeding. In the 1-month DAPT arm, 1,507 subjects received the polymer-free drug-coated BioFreedom (Biosensors Interventional Technologies Pte Ltd, Singapore) stent; in the 6- to 12-month DAPT arm, 1,513 patients received either the BioMatrix (Biosensors Interventional Technologies Pte Ltd, Singapore) stent or Ultimaster (Terumo Corporation; Tokyo, Japan) stent. Analysis was performed on intention-to-treat basis. Around 60% of patients enrolled had stable angina. In the 1-month DAPT arm, 17% of patients received longer duration of DAPT. There was no statistically significant difference in the primary endpoint (5.9% for 1-month vs. 6.5% for 6- to 12-month; p < 0.001 for non-inferiority).
- Silvain J, Lattuca B, Beygui F, et al. Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS): a randomised, open-label, phase 3b trial. Lancet 2020;396:1737-44.
- Bavry AA. Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting ALPHEUS (ACC.org website). November 14, 2020. Available at https://www.acc.org/latest-in-cardiology/clinical-trials/2020/11/11/21/23/alpheus. Accessed December 23, 2020.
- Yannopoulos D, Bartos J, Raveendran G, et al. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial. Lancet 2020;396:1807-16.
- Bavry AA. Advanced REperfusion STrategies for refractory cardiac arrest ARREST (ACC.org website). November 14, 2020. Available at https://www.acc.org/latest-in-cardiology/clinical-trials/2020/11/11/21/09/arrest. Accessed December 23, 2020.
- Nicholls SJ, Lincoff AM, Garcia M, et al. Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial. JAMA 2020;324:2268-80.
- Bavry AA. Long-Term Outcomes Study to Assess Statin Residual Risk With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia STRENGTH (ACC.org website). November 15, 2020. Available at https://www.acc.org/latest-in-cardiology/clinical-trials/2020/11/11/21/29/strength. Accessed December 23, 2020.
- Reynolds HR, Maehara A, Kwong RY, et al. Coronary Optical Coherence Tomography and Cardiac Magnetic Resonance Imaging to Determine Underlying Causes of MINOCA in Women. Circulation 2020;Nov 14:[Epub ahead of print].
- HARP-MINOCA: Multi-Modality Imaging in Determining Underlying Causes of MINOCA in Women (ACC.org website). November 14, 2020. Available at https://www.acc.org/latest-in-cardiology/articles/2020/11/12/20/28/sat-120pm-harp-minoca-aha-2020. Accessed December 23, 2020.
- Bavry AA. Early Coronary CT Angiography in Patients With Suspected or Provisionally Diagnosed Acute Coronary Syndrome - RAPID CTCA (ACC.org website). November 16, 2020. Available at https://www.acc.org/latest-in-cardiology/clinical-trials/2020/11/11/21/58/rapid-ctca. Accessed December 23, 2020.
- Klein AL, Imazio M, Cremer P, et al. Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis. N Engl J Med 2021;384:31-41.
- Bavry AA. Rilonacept inHibition of interleukin-1 Alpha and beta for recurrent Pericarditis: a pivotal Symptomatology and Outcomes stuDY - RHAPSODY (ACC.org website). November 16, 2020. Available at https://www.acc.org/latest-in-cardiology/clinical-trials/2020/11/11/21/56/rhapsody. Accessed December 23, 2020.
- Bavry AA. One-Month Dual Antiplatelet Therapy Followed by Aspirin Monotherapy After Drug-Eluting Stent Implantation - One-Month DAPT (ACC.org website). November 15, 2020. Available at https://www.acc.org/latest-in-cardiology/clinical-trials/2020/11/11/21/39/one-month-dapt. Accessed December 23, 2020.
Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Diabetes and Cardiometabolic Disease, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Pericardial Disease, Stable Ischemic Heart Disease, ACS and Cardiac Biomarkers, SCD/Ventricular Arrhythmias, Hypertriglyceridemia, Lipid Metabolism, Nonstatins, Novel Agents, Statins, Interventions and ACS, Interventions and Imaging, Angiography, Magnetic Resonance Imaging, Nuclear Imaging, Chronic Angina
Keywords: Angiography, Coronary Angiography, AHA20, AHA Annual Scientific Sessions, Platelet Aggregation Inhibitors, Drug-Eluting Stents, Eicosapentaenoic Acid, Docosahexaenoic Acids, Hydroxymethylglutaryl-CoA Reductase Inhibitors, C-Reactive Protein, Extracorporeal Membrane Oxygenation, Percutaneous Coronary Intervention, Acute Coronary Syndrome, Aspirin, Angina, Stable, Coronary Vessels, Ventricular Fibrillation, Advanced Cardiac Life Support, Out-of-Hospital Cardiac Arrest, Fatty Acids, Omega-3, Tomography, Optical Coherence, Odds Ratio, Patient Discharge, Colchicine, Control Groups, Polymers, Interleukin-1alpha, Cardiovascular Diseases, Confidence Intervals, Intention to Treat Analysis, Length of Stay, Standard of Care, Risk Factors, Myocardial Infarction, Magnetic Resonance Imaging, Angina, Unstable, Stroke, Infarction, Reperfusion, Pericarditis, Hypertriglyceridemia, Pharmaceutical Preparations, Hospitals, Hospitals, Respiratory Tract Infections, Adrenal Cortex Hormones, Biosensing Techniques, Anti-Inflammatory Agents, Reference Standards, Necrosis
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