|Year : 2019 | Volume
| Issue : 1 | Page : 14-17
Cardiology update - The first quarter
Satyavir Yadav, Faraz Ahmed Farooqui, Swati Singh
Department of Cardiology, AIIMS, New Delhi, India
|Date of Web Publication||2-May-2019|
Dr. Satyavir Yadav
Department of Cardiology, AIIMS, New Delhi
Source of Support: None, Conflict of Interest: None
The first round of this year covers a lot about dual-antiplatelet therapy duration after stent placement, coronary angiography after a cardiac arrest, transcatheter aortic valve replacement indications in low-risk patients, sodium–glucose cotransporter 2 inhibitor results, angiotensin receptor neprilysin inhibitor in acute heart failure, and many other trials.
Keywords: Cardiology update, partner, review, sglt2
|How to cite this article:|
Yadav S, Farooqui FA, Singh S. Cardiology update - The first quarter. J Pract Cardiovasc Sci 2019;5:14-7
| P2Y12 Inhibitor Monotherapy Versus Dual-Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention – smart-Choice|| |
In patients undergoing percutaneous coronary intervention (PCI), the goal of the trial was to compare the safety and efficacy of short-duration dual-antiplatelet therapy (DAPT) (3 months) compared with long-duration DAPT (12 months). The results of this trial indicate that short-duration DAPT (3 months) is noninferior to long-duration DAPT (12 months) among unselected patients undergoing PCI with a drug-eluting stent.
| Coronary Angiography After Cardiac Arrest|| |
The goal was to compare emergent coronary angiography with PCI compared with delayed angiography among patients presenting with out-of-hospital cardiac arrest who did have ST-segment elevation on electrocardiogram (ECG) post–return of spontaneous circulation (ROSC). The results of this trial indicate that immediate angiography with intent to revascularize is not superior to delayed angiography among patients presenting with out-of-hospital cardiac arrest secondary to a shockable rhythm and with no ECG evidence of ST-segment elevations post-ROSC. Only 5% of patients had evidence of a true thrombotic lesion on angiography.
| The International Registry of Acute Aortic Dissection|| |
It was done at 55 centers in 13 countries from 1996 to 2019. Investigators compared diagnosis, treatment, inhospital mortality, and 5-year mortality. Hypertension, smoking, and atherosclerosis were the most common risk factors. Computed tomography scan was the most common diagnostic imaging test. Surgical management for Type A dissection was done for 88.6%, overall inhospital mortality was 16.3%, and 5-year survival rate was 88.5%. For Type B management, endovascular therapy was used for 31.2%, surgery for 6.1%, overall inhospital mortality for Type B dissection was 7.4%, and 5-year survival was 83.7%.
SAFARI-ST-segment elevation myocardial infarction trial
Acute myocardial infarction (MI) patients who undergo PCI have the same 30-day mortality regardless of whether radial or femoral access is used for PCI.
Declare TIMI 58 study
The sodium–glucose cotransporter 2 inhibitor dapagliflozin reduced heart failure (HF) hospitalization and cardiovascular mortality in patients with type 2 diabetes and HF across a wide spectrum of left ventricular (LV) ejection fraction. The greatest benefit was found in those with HF with reduced ejection fraction (HFrEF). In patients with reduced LV function, there was a significant 38% reduction in death or hospitalization with dapagliflozin versus placebo. In patients without LV dysfunction, the reduction in the primary endpoint was 12% with dapagliflozin versus placebo.
| Ticagrelor in Patients With St-Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis – treat|| |
In patients who were treated with fibrinolysis for ST-segment elevation MI, delayed administration of ticagrelor was noninferior to clopidogrel. There was no apparent ischemic benefit with ticagrelor nor was there any excess of major bleeding, fatal bleeding, or intracranial bleeding.
| One-Month Dual-Antiplatelet Therapy Followed by Clopidogrel Monotherapy Versus Standard 12-Month Dual-Antiplatelet Therapy With Clopidogrel After Drug-Eluting Stent Implantation – stopdapt-2|| |
In patients undergoing PCI, 1-month DAPT followed by clopidogrel monotherapy was superior to 12-month DAPT followed by aspirin monotherapy in preventing adverse clinical events.
Patients with both atrial fibrillation (AF) and acute coronary syndrome had a significantly reduced risk of bleeding when treated with apixaban versus a Vitamin K antagonist and when taking placebo versus aspirin.
| Evolut Surgical Replacement and Transcatheter Aortic Valve Implantation in Low-Risk Patients – evolut Low Risk|| |
The results of this trial indicate that transcatheter aortic valve replacement (TAVR) with the self-expanding CoreValve Evolut valve is noninferior to surgical aortic valve replacement (SAVR) for the primary endpoint of mortality/disabling stroke at 24 months for the treatment of severe symptomatic aortic stenosis in low-risk patients (median STS PROM 1.9%) (death, disabling stroke, life-threatening bleeding, major vascular complications, and Stage 2/3 kidney injury: 5.3% vs. 10.7%).
| Placement of Aortic Transcatheter Valves 3 – partner 3|| |
The primary outcome, all-cause mortality, stroke, or rehospitalization at 1 year occurred in 8.5% of the TAVR group compared with 15.1% of the SAVR group.
The Apple Heart Study
It was a prospective, single-arm pragmatic study with an enrollment of 419,093 participants. The primary objective was to measure the proportion of participants with an irregular pulse detected by the Apple Watch (Apple Inc., Cupertino, CA, USA) with AF on subsequent ambulatory ECG patch monitoring. The results of this trial will provide initial evidence for the ability of a Smartwatch Algorithm to identify pulse irregularity and variability which may reflect previously unknown AF. The apple heart study will help provide a foundation for how wearable technology can inform the clinical approach to AF identification and screening.
Patients undergoing placement of a cardiac implantable electronic device were randomized to an absorbable antibiotic eluting envelope (n = 3495) versus control patients (n = 3488). Among patients undergoing placement of a cardiac implantable electronic device, an absorbable antibiotic eluting envelope was superior to control in preventing system extraction or revision, long-term antibiotic therapy with infection recurrence, or death within 12 months. Procedure-related or system-related complications were similar between treatment groups. Cardiac implantable electronic device infections are uncommon but result in significant morbidity and mortality. This strategy reduced infectious complications in addition to standard preprocedure intravenous antibiotics and sterile technique.
PIONEER heart failure study
It enrolled patients with HFrEF who were hospitalized for acute decompensated HF at 129 sites in the United States. After hemodynamic stabilization, patients were randomly assigned to receive sacubitril–valsartan (target dose, 97 mg of sacubitril with 103 mg of valsartan twice daily) or enalapril (target dose, 10 mg twice daily). Among patients with HFrEF who were hospitalized for acute decompensated heart failure, the initiation of sacubitril–valsartan therapy led to a greater reduction in the NT-proBNP concentration than that of enalapril therapy. Rates of worsening renal function, hyperkalemia, symptomatic hypotension, and angioedema did not differ significantly between the two groups.
Patients with recent acute coronary syndrome were randomized to depression screening/notification of results/treatment (n = 499) versus depression screening/notification of results (n = 501) versus no screening (n = 500). Among patients with recent acute coronary syndrome, screening for depression was not beneficial. This intervention failed to improve quality-adjusted life-years or depression-free days compared with no screening. Approximately 6%–7% of individuals were screened for depression. Depression screening guidelines may need to be reconsidered.
Home treatment of pulmonary embolism study
It was a prospective, investigator-initiated and academically sponsored, international, multicenter, single-arm phase 4 management trial with 3-month follow-up (plus 1-year follow-up for survival). To determine whether early discharge and out-of-hospital treatment of patients with acute low-risk pulmonary embolism (PE) with the FXa inhibitor rivaroxaban is feasible, effective, and safe. In patients with acute low-risk PE (including absence of right ventricular dysfunction and intracardiac thrombi), early discharge and home treatment with rivaroxaban was feasible, effective, and safe. The results of home treatment of PE support the selection of appropriate PE patients for ambulatory treatment with a direct oral anticoagulant, possibly helping to reduce hospital-related complications and rationalize the use of healthcare resources.
Patients with infective endocarditis on the left side of the heart and stabilized with intravenous antibiotics were randomized to oral antibiotic therapy (n = 201) versus continuation of intravenous antibiotic therapy (n = 199). Among patients with infective endocarditis of the left side of the heart being treated with intravenous antibiotics, changing to oral antibiotic therapy was noninferior to remaining on intravenous antibiotics. The safety of this strategy was demonstrated in long-term follow-up. Individual components of the composite outcome were similar between treatment groups.
Phase 2b, parallel-group, dose-finding, randomized controlled trial (RCT). Randomized 3:1:2:2:2:2 (placebo, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg neladenoson). It is a first RCT of a partial adenosine A1-receptor agonist in HF with preserved ejection fraction (HFpEF). Rapid enrollment (300 + patients in 6 months) with evidence of true HFpEF multidomain endpoint evaluation. No neladenoson dose–response effect for any of the studied endpoints was found. There was a good safety profile at 20 weeks, though there were slight decreases in renal function and heart rate.
Cardio MEMS study
The prospective, open-label trial of 1200 patients at 104 sites in the US was initiated as a postapproval study to evaluate the efficacy and safety of the CardioMEMS sensor in clinical practice as per the U. S. Food and Drug Administration (FDA) mandates. The device was approved by the FDA in May 2014 for use in patients who have New York Heart Association Class III HF and who have been hospitalized for HF in the previous year. Among the study participants, 38% were women, 17% were nonwhite, 30% had HFpEF, and 52% had HFrEF. Results showed a significant difference in the rate of HF-related hospitalizations within the year after the device was placed compared with the year before (0.52 vs. 1.24, respectively). Patients with more than two hospitalizations in the year before receiving the sensor experienced a similar decrease. Hospitalizations decreased regardless of the patient's level of ejection fraction.
This study was designed to prospectively implement an independent central adjudication process of both reported events and potential unreported event triggers to further assess the impact of this novel experimental treatment in a large stratified sample of patients included in the GLOBAL LEADERS trial and to assess the comparative effectiveness of the experimental treatment strategy as compared to conventional 12-month DAPT followed by aspirin on the primary efficacy EP of CEC-adjudicated all-cause death, nonfatal MI, nonfatal stroke, or urgent target-vessel revascularization (TVR). Ticagrelor monotherapy after 1-month DAPT was noninferior to conventional DAPT in the prevention of all-cause death, nonfatal MI, nonfatal stroke, or urgent TVR at 2 years. It shows that discontinuation of aspirin after 30 days while continuing ticagrelor alone does not expose patients to a higher ischemic risk as compared to a standard DAPT for 1 year and may reduce the rates of MI and stent thrombosis as compared to aspirin alone.
Advancing the horizon of angiotensin receptor neprilysin inhibitor (ARNI), this double-blind trial randomized HF patients with chronic secondary mitral regurgitation (MR) to either saucabitril-valsartan or valsartan alone in addition to standard medical therapy. At 1-year follow–up, patients on ARNI have significant decrease in MR in the form of decreased effective regurgitant orifice area (primary endpoint) as well as regurgitant volume (secondary endpoint). No significant differences between groups are found there regarding the changes in incomplete mitral leaflet closure area and LV volumes, with the exception of LV end-diastolic volume index. No significant differences in adverse effects between the groups have been seen.
REDUCE IT study
Omega-3 fatty acids are in news again. Icosapent ethyl, a highly purified eicosapentaenoic acid ethyl ester, in a 5-year follow-up double-blind study with 8179 study participants showed that in patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly lower among those who received icosapent ethyl compared to placebo.
CLEAR harmony study
It shows the safety of bempedoic acid which inhibits cholesterol synthesis upstream of HMG-CoA reductase by inhibition of ATP citrate lyase in patients already on maximally tolerated high-intensity statin therapy with atherosclerotic cardiovascular disease (ASCVD), heterozygous familial hypercholesterolemia, or both with low-density lipoprotein (LDL) >70 mg/dl. This 52-week follow-up double-blind study after a hint of benefit after a mendelian randomization study showed that bempedoic acid decreased the mean LDL level by 19.2 mg/dl at 52 weeks. This is more than additional lowering of LDL when doubling statin dose despite both drugs acting on the same pathway at different levels. There were more adverse effects although they were mostly nonsignificant with wide confidence intervals except more occurrence of gout; however, skeletal muscle symptoms were less in bempedoic acid arm.
| New Guidelines|| |
Important changes include the dropping of female sex alone as a risk factor in CHA2 DS2-VASc scores, narrowing down of definition of valvular heart diseases, the preference of NOACs to warfarin, clarifications regarding triple therapy in patients undergoing PCI, and recommendations for left atrial appendage occlusion devices and catheter ablation in patients with HFrEF.
Primary prevention guidelines ACC/AHA 2019
The cardiovascular nutrition literature is limited by the paucity of large-scale prospective randomized trials with ASCVD outcomes. Although RCTs focused on hard endpoints are limited, multiple observational studies have focused on the association of CVD mortality with dietary patterns, specifically sugar, low-calorie sweeteners, high-carbohydrate diets, low-carbohydrate diets, refined grains, trans fat, saturated fat, sodium, red meat, and processed red meat (e.g., bacon, salami, ham, hot dogs, and sausage). Processed meats are any meat preserved by smoking, curing, or salting, or additional chemical preservatives (S3.1-28a). The guidelines emphasised on personal and social barriers to CVD prevention, it recommends healthy lifestyle and provide objective advice regarding lifestyle goals. They reinforce cardiovascular risk assessment as a cornerstone of CVD primary prevention. They state that aspirin for primary prevention is rarely recommended in view of high bleeding risk.
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Conflicts of interest
There are no conflicts of interest.
| References|| |
Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LS, Dubois EA, Meuwissen M, et al.
Coronary angiography after cardiac arrest without ST-segment elevation. N Engl J Med 2019;380:1397-407.
Eagle KA. IRAD Shows Improvements in Survival for Acute Aortic Dissection. Annual Scientific Session News Story; 18 March, 2019.
May ML. SAFARI-STEMI: Similar 30-Day Mortality For Radial vs. Femoral Access PCI. Annual Scientific Session News Story; 18 March, 2019.
Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, et al.
Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-57.
Berwanger O, Lopes RD, Moia DD, Fonseca FA, Jiang L, Goodman SG, et al.
Ticagrelor versus clopidogrel in patients with STEMI treated with fibrinolytic therapy: TREAT trial. J Am Coll Cardiol 2019. doi: 10.1016/j.jacc.2019.03.011.
Watanabe H. One-Month Dual Antiplatelet Therapy followed By Clopidogrel Monotherapy Versus Standard 12-Month Dual Antiplatelet Therapy with Clopidogrel after Drug-Eluting Stent Implantation: STOPDAPT-2 Trial. Presented at: ACC 2019. New Orleans, LA; 2019.
Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, et al.
Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation. N Engl J Med 2019;380:1509-24.
Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, et al
. On behalf of the evolut low risk trial investigators. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 2019. doi: 10.1056/NEJMoa1816885. [Epub ahead of print].
Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, et al
. On behalf of the PARTNER 3 investigators. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019. doi: 10.1056/NEJMoa1814052. [Epub ahead of print].
Turakhia MP, Desai M, Hedlin H, Rajmane A, Talati N, Ferris T, et al
. Rationale and design of a large-scale, app based study to identify cardiac arrhythmias using a smart watch: The apple heart study. Am Heart J 2019;207:66-75.
Tarakji KG, Mittal S, Kennergren C, Corey R, Poole JE, Schloss E, et al
. On behalf of the WRAP-IT investigators. Antibacterial envelope to prevent cardiac implantable device infection. N Engl J Med 2019. doi: 10.1056/NEJMoa1901111. [Epub ahead of print].
Morrow DA, Velazquez EJ, DeVore AD, Desai AS, Duffy CI, Ambrosy AP, et al
. Clinical Outcomes in Patients With Acute Decompensated Heart Failure Randomly Assigned to Sacubitril/Valsartan or Enalapril in the PIONEER-HF Trial. Circulation 2019. doi: 10.1161/CIRCULATIONAHA.118.039331. [Epub ahead of print].
Kronish IM. Depression Screening Does not Improve Quality of Life After ACS CODIACS-QoL: Annual Scientific Session News Story; 16 March, 2019.
Iversen K, Ihlemann N, Gill SU, Madsen T, Elming H, Jensen KT, et al
. Partial oral versus intravenous antibiotic treatment of endocarditis. N Engl J Med 2019;380:415-24.
Voors AA, Shah SJ, Bax JJ, Butler J, Gheorghiade M, Hernandez AF, et al.
Rationale and design of the phase 2b clinical trials to study the effects of the partial adenosine A1-receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced (PANTHEON) and preserved (PANACHE) ejection fraction. Eur J Heart Fail 2018;20:1601-10.
Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, et al
. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: A randomised controlled trial. The Lancet 2011;377:658–66.
Vranckx P, Valgimigli M, Jüni P, Hamm C, Steg PG, Heg D, et al
. GLOBAL-LEADERS study. Lancet 2018;392:940-49.
Kang DH, Park SJ, Shin SH, Hong GR, Lee S, Kim MS, et al
. Angiotensin receptor neprilysin inhibitor for functional mitral regurgitation PRIME study. Circulation 2019;139:1354-65.
Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, et al.
Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med 2019;380:11-22.
Ray KK, Bays HE, Catapano AL, Lalwani ND, Bloedon LT, Sterling LR, et al.
Safety and efficacy of bempedoic acid to reduce LDL cholesterol. N Engl J Med 2019;380:1022-32.
January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, et al.
2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. J Am Coll Cardiol 2019. CIR0000000000000665. doi: 10.1161/CIR.0000000000000665. [Epub ahead of print].
Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, et al.
2019 ACC/AHA guideline on the primary prevention of cardiovascular disease. J Am Coll Cardiol 2019;1097:33876-8.