Journal: Eur Heart J Cardiovasc Pharmacother

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<div><h4>Prasugrel dose de-escalation in diabetic patients with acute coronary syndrome receiving percutaneous coronary intervention: Results from HOST-REDUCE-POLYTECH-ACS trial.</h4><i>Lee KS, Park KH, Park KW, Rha SW, ... Park K, Kim HS</i><br /><b>Aims</b><br />The aim of this study was to evaluate the efficacy and safety of prasugrel-dose de-escalation therapy in patients with diabetes mellitus (DM)-acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI).<br /><b>Methods and results</b><br />This was a post-hoc analysis of the HOST-REDUCE-POLYTECH-ACS randomized trial. The efficacy and safety of prasugrel dose de-escalation therapy (prasugrel 5 mg daily) were compared with conventional therapy (prasugrel 10 mg daily) in patients with DM. The primary endpoint was net adverse clinical events (NACE), defined as a composite of all-cause death, nonfatal myocardial infarction (MI), stent thrombosis (ST), clinically driven revascularization, stroke, and BARC class ≥ 2 bleeding events. The secondary ischemic outcome was major adverse cardiovascular and cerebrovascular events (MACE), defined as the composite of cardiac death, nonfatal MI, ST, or ischemic stroke. Of 2 338 patients randomized, 990 had DM. The primary endpoint of NACE occurred in 38 patients (7.6%) receiving prasugrel dose de-escalation and in 53 patients (11.3%) receiving conventional therapy among patients with DM (HR 0.66; 95% CI 0.43-0.99; P = 0.049). Prasugrel dose de-escalation as compared with conventional therapy did not increase the risk of ischemic events (HR 1.03; 95% CI 0.56-1.88; P = 0.927) but decreased BARC class ≥ 2 bleeding in patients with DM (HR 0.44; 95% CI 0.23-0.84; P = 0.012).<br /><b>Conclusion</b><br />Prasugrel dose de-escalation compared with conventional therapy may reduce the risk of net clinical outcomes, mostly driven by a reduction in bleeding without an increase in ischemic events in patients with DM.<br /><br />© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 28 Jan 2023; epub ahead of print</small></div>
Lee KS, Park KH, Park KW, Rha SW, ... Park K, Kim HS
Eur Heart J Cardiovasc Pharmacother: 28 Jan 2023; epub ahead of print | PMID: 36715152
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<div><h4>Ticagrelor With or Without Aspirin in High-Risk Patients With Anemia Undergoing Percutaneous Coronary Intervention: a subgroup analysis of the TWILIGHT trial.</h4><i>Spirito A, Kastrati A, Cao D, Baber U, ... Pocock S, Mehran R</i><br /><b>Aim</b><br />The aim of this study was to assess the effect of ticagrelor monotherapy among high-risk patients with anemia undergoing percutaneous coronary intervention (PCI).<br /><b>Methods and results</b><br />In the TWILIGHT trial (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention), after 3 months of ticagrelor plus aspirin, high-risk patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. Anemia was defined as hemoglobin <13 g/dL for men and <12 g/dL for women. The primary endpoint was Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding. The key secondary endpoint was a composite of all-cause death, myocardial infarction, or stroke.Out of 6 828 patients, 1 329 (19.5%) had anemia and were more likely to have comorbidities, multivessel disease, and to experience bleeding or ischemic complications than non-anemic patients. Among anemic patients, BARC 2, 3, or 5 bleeding occurred less frequently with ticagrelor monotherapy than with ticagrelor plus aspirin (6.4% vs. 10.7%; HR 0.60; 95% CI 0.41 to 0.88; p = 0.009); the rate of the key secondary endpoint was similar in the two arms (5.2% vs. 4.8%; HR 1.07; 95% CI 0.66 to 1.74; p = 0.779). These effects were consistent in patients without anemia (interaction p-value 0.671 and 0.835, respectively).<br /><b>Conclusions</b><br />In high-risk patients undergoing PCI, ticagrelor monotherapy after 3 months of ticagrelor-based DAPT was associated with a reduced risk of clinically relevant bleeding without any increase in ischemic events irrespective of anemia status. (TWILIGHT: NCT02270242).<br /><br />© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 17 Jan 2023; epub ahead of print</small></div>
Spirito A, Kastrati A, Cao D, Baber U, ... Pocock S, Mehran R
Eur Heart J Cardiovasc Pharmacother: 17 Jan 2023; epub ahead of print | PMID: 36649694
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<div><h4>Antithrombotic Therapy and Cardiovascular Outcomes After Transcatheter Aortic Valve Implantation in Patients Without Indications for Chronic Oral Anticoagulation: A systematic review and network meta-analysis of randomized controlled trials.</h4><i>Guedeney P, Roule V, Mesnier J, Chapelle C, ... Montalescot G, Collet JP</i><br /><b>Aims</b><br />As the antithrombotic regimen which may best prevent ischemic complications along with the lowest bleeding risk offset following transcatheter aortic valve implantation (TAVI) remains unclear, we aimed to compare the safety and efficacy of antithrombotic regimens in patients without having an indication for chronic oral anticoagulation.<br /><b>Methods and results</b><br />We conducted a Prospero-registered (CRD42021247924) systematic review and network meta-analysis of randomized controlled trials evaluating post-TAVI antithrombotic regimens up to April 2022. We estimated the relative risk (RR) and 95% confidence intervals (95%CI) using a random-effects model in a frequentist pairwise and network metanalytic approach. We included 7 studies comprising of 4 006 patients with a mean weighted follow-up of 12.9 months. Risk of all-cause death was significantly reduced with dual antiplatelet therapy (DAPT) compared to low-dose rivaroxaban + 3-month single antiplatelet therapy (SAPT) (RR 0.60, 95%CI 0.41-0.88) while no significant reduction was observed with SAPT versus DAPT (RR 1.02 95%CI 0.67-1.58) and SAPT and DAPT compared to apixaban or edoxaban (RR:0.60 95%CI:0.32-1.14 and RR:0.59 95%CI 0.34-1.02, respectively). SAPT was associated with a significant reduction of life-threatening, disabling, or major bleeding compared to DAPT (RR 0.45 95%CI 0.29-0.70), apixaban or edoxaban alone (RR 0.45, 95%CI 0.25-0.79) and low-dose rivaroxaban + 3-month SAPT (RR 0.30, 95%CI 0.16-0.57). There were no differences between the various regimens with respect to myocardial infarction, stroke, or systemic embolism.<br /><b>Conclusion</b><br />Following TAVI in patients without an indication for chronic oral anticoagulant, SAPT more than halved the risk of bleeding compared to DAPT and direct oral anticoagulant-based regimens without significant ischemic offset.<br /><br />© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 14 Jan 2023; epub ahead of print</small></div>
Guedeney P, Roule V, Mesnier J, Chapelle C, ... Montalescot G, Collet JP
Eur Heart J Cardiovasc Pharmacother: 14 Jan 2023; epub ahead of print | PMID: 36640149
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<div><h4>The potential of colchicine for lowering the risk of cardiovascular events in type 1 diabetes.</h4><i>Johansen NJ, Knop FK</i><br /><AbstractText>In type 1 diabetes, average life expectancy is reduced by more than 10 years as compared with outside of diabetes. Residual cardiovascular risk defines high cardiovascular event rate despite modern, guideline-recommended standard of care of established risk factors like hypertension, dyslipidaemia, and glycaemic control, and it adds importantly to these lost years of life in type 1 diabetes due to atherosclerotic cardiovascular disease like myocardial infarction and ischaemic stroke. With growing understanding of inflammation as an important driver of atherosclerotic cardiovascular disease, residual inflammatory risk is a novel and common risk factor and a promising target for lowering residual cardiovascular risk in type 1 diabetes. Interestingly, the inexpensive anti-inflammatory agent colchicine reduced risk of major adverse cardiovascular events by 25% in cardiovascular outcome trials in the secondary prevention of atherosclerotic cardiovascular disease. Here, we summarise the role of inflammation as a driver of atherosclerosis and review current evidence linking inflammation and atherosclerotic cardiovascular disease in type 1 diabetes. Also, we provide an overview of the evidence base for targeting residual inflammatory risk with colchicine for lowering residual cardiovascular risk in type 1 diabetes.</AbstractText><br /><br />© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 13 Jan 2023; epub ahead of print</small></div>
Johansen NJ, Knop FK
Eur Heart J Cardiovasc Pharmacother: 13 Jan 2023; epub ahead of print | PMID: 36639124
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<div><h4>Cardiovascular, renal, and lower limb outcomes in patients with type 2 diabetes after percutaneous coronary intervention and treated with sodium-glucose cotransporter 2 inhibitors versus dipeptidyl peptidase-4 inhibitors.</h4><i>Lee HF, Chan YH, Chuang C, Li PR, ... Peng JR, See LC</i><br /><b>Aims</b><br />Patients with type 2 diabetes (T2D) who undergo percutaneous coronary intervention (PCI) are at higher risk of adverse cardiovascular and renal events than nondiabetic patients. However, limited evidence is available regarding the cardiovascular, renal, and limb outcomes of patients with T2D after PCI and who were treated with sodium-glucose cotransporter-2 inhibitors (SGLT2i). We compare the specified outcomes in patients with T2D after PCI who were treated with SGLT2i versus dipeptidyl peptidase-4 inhibitors (DPP4i).<br /><b>Methods and results</b><br />In this nationwide retrospective cohort study, we identified 4,248 and 37,037 consecutive patients with T2D who underwent PCI with SGLT2i and DPP4i, respectively, for May 1, 2016, to December 31, 2019. We used propensity score matching (PSM) to balance the covariates between study groups. After PSM, SGLT2i and DPP4i were associated with comparable risks of ischemic stroke, acute myocardial infarction, and lower limb amputation. However, SGLT2i was associated with significantly lower risks of heart failure hospitalization (HFH; 1.35% per year vs. 2.28% per year; hazard ratio [HR]: 0.60; P = 0.0001), coronary revascularization (2.33% per year vs. 3.36% per year; HR: 0.69; P = 0.0003), composite renal outcomes (0.10% per year vs. 1.05% per year; HR: 0.17; P < 0.0001), and all-cause mortality (2.27% per year vs. 3.80% per year, HR: 0.60; P < 0.0001) than were DPP4i.<br /><b>Conclusions</b><br />Our data indicated that SGLT2i, compared with DPP4i, were associated with lower risks of HFH, coronary revascularization, composite renal outcomes, and all-cause mortality for patients with T2D after PCI. Further randomized or prospective studies can investigate the effects of SGLT2i in patients with T2D after PCI.<br /><br />© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 13 Jan 2023; epub ahead of print</small></div>
Lee HF, Chan YH, Chuang C, Li PR, ... Peng JR, See LC
Eur Heart J Cardiovasc Pharmacother: 13 Jan 2023; epub ahead of print | PMID: 36639127
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<div><h4>Finerenone and effects on mortality in chronic kidney disease and type 2 diabetes: a FIDELITY analysis.</h4><i>Filippatos G, Anker SD, August P, Coats AJS, ... Agarwal R, FIDELIO-DKD and FIGARO-DKD investigators</i><br /><b>Aims</b><br />Finerenone reduces the risk of cardiovascular events in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). We investigated the causes of mortality in the FIDELITY population.<br /><b>Methods and results</b><br />The FIDELITY prespecified pooled data analysis from FIDELIO-DKD and FIGARO-DKD excluded patients with heart failure and reduced ejection fraction. Outcomes included intention-to-treat and prespecified on-treatment analyses of the risk of all-cause and cardiovascular mortality. Of 13 026 patients (mean age, 64.8 years; mean estimated glomerular filtration rate [eGFR], 57.6 mL/min/1.73 m2), 99.8% were on renin-angiotensin system inhibitors. Finerenone reduced the incidence of all-cause and cardiovascular mortality vs. placebo (8.5% vs. 9.4% and 4.9% vs. 5.6%, respectively) and demonstrated significant on-treatment reductions (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.70-0.96; P = 0.014 and HR, 0.82; 95% CI, 0.67-0.99; P = 0.040, respectively). Cardiovascular-related mortality was most common, and finerenone lowered the incidence of sudden cardiac death vs. placebo (1.3% [incidence rate 0.44/100 patient-years] vs. 1.8% [0.58/100 patient-years], respectively; HR, 0.75; 95% CI, 0.57-0.996; P = 0.046). The effects of finerenone on mortality were similar across all Kidney Disease: Improving Global Outcomes risk groups. Event probability with finerenone at 4 years was consistent irrespective of baseline urine albumin-to-creatinine ratio, but seemingly more pronounced in patients with higher baseline eGFR.<br /><b>Conclusion</b><br />In FIDELITY, finerenone significantly reduced the risk of all-cause and cardiovascular mortality vs. placebo in patients with T2D across a broad spectrum of CKD stages while on treatment, as well as sudden cardiac death in the intention-to-treat population.<br /><br />© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 13 Jan 2023; epub ahead of print</small></div>
Filippatos G, Anker SD, August P, Coats AJS, ... Agarwal R, FIDELIO-DKD and FIGARO-DKD investigators
Eur Heart J Cardiovasc Pharmacother: 13 Jan 2023; epub ahead of print | PMID: 36639130
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<div><h4>Efficacy and Safety of P2Y12 Inhibitor Monotherapy After Complex PCI: A Collaborative Systematic Review and Meta-Analysis.</h4><i>Nicolas J, Dangas G, Chiarito M, Pivato CA, ... Baber U, Mehran R</i><br /><b>Aims</b><br />Complex percutaneous coronary intervention (C-PCI) is associated with an increased risk of ischemic and bleeding complications. We aimed to assess the safety and efficacy of a 1-3-month dual antiplatelet therapy (DAPT) regimen followed by P2Y12 inhibitor monotherapy after C-PCI.<br /><b>Methods and results</b><br />We conducted a meta-analysis of randomized trials comparing a 1-3-month DAPT regimen followed by P2Y12 inhibitor monotherapy with standard (≥12 months) DAPT in patients undergoing C-PCI. C-PCI criteria and the co-primary bleeding and ischemic outcomes were determined according to each trial. Secondary outcomes included major bleeding, all-cause death, myocardial infarction, and stent thrombosis. All outcomes were evaluated at 12 months after randomization. We used hazard ratios (HRs) and 95% confidence interval (CI) as a metric of choice for treatment effects with random-effects models. Among 8299 screened studies, five randomized trials fulfilled the eligibility criteria. In the pooled population of 34 615 patients, 8818 (25.5%) underwent C-PCI. As compared with standard DAPT, a 1-3-month DAPT regimen followed by P2Y12 inhibitor monotherapy reduced the bleeding risk in C-PCI (HR:0.66, 95% CI:0.44-0.98) and non-C-PCI (HR:0.60, 95% CI:0.45-0.79) patients (p-interaction = 0.735). Furthermore, the risk for the primary ischemic endpoint was similar in patients randomized to either arm, with significant effect modification by PCI complexity showing an enhanced benefit of 1-3-month DAPT in patients undergoing C-PCI (C-PCI, HR:0.69, 95% CI:0.48-1.00; non-C-PCI, HR:1.04, 95% CI:0.84-1.30; p-interaction = 0.028).<br /><b>Conclusion</b><br />As compared with a standard DAPT, a 1-3-month DAPT regimen followed by P2Y12 inhibitor monotherapy reduced bleeding complications after C-PCI without increasing the risk of ischemic events.<br /><br />© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 23 Dec 2022; epub ahead of print</small></div>
Nicolas J, Dangas G, Chiarito M, Pivato CA, ... Baber U, Mehran R
Eur Heart J Cardiovasc Pharmacother: 23 Dec 2022; epub ahead of print | PMID: 36564015
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<div><h4>Design and rationale of randomized evaluation of decreased usage of beta-blockers after acute myocardial infarction (REDUCE-AMI).</h4><i>Yndigegn T, Lindahl B, Alfredsson J, Benatar J, ... Hofmann R, Jernberg T</i><br /><b>Background</b><br />Most trials showing benefit of beta-blocker treatment after myocardial infarction (MI) included patients with large MIs and are from an era before modern biomarker-based MI diagnosis and reperfusion treatment. The aim of the Randomized Evaluation of Decreased Usage of betabloCkErs after Acute Myocardial Infarction (REDUCE-AMI) trial is to determine whether long-term oral beta-blockade in patients with an acute MI and preserved left ventricular ejection fraction (EF) reduces the composite endpoint of death of any cause or recurrent MI.<br /><b>Methods</b><br />It is a registry-based, randomized, parallel, open-label, multicenter trial performed at 38 centers in Sweden, one center in Estonia and six centers in New Zealand. About 5000 patients with an acute MI who have undergone coronary angiography and with EF ≥ 50% will be randomized to long-term treatment with beta-blockade or not. The primary endpoint is the composite endpoint of death of any cause or new non-fatal MI. There are several secondary endpoints, including all-cause death, cardiovascular death, new MI, readmission because of heart failure and atrial fibrillation, symptoms, functional status, health related quality of life after 6-10 weeks and after 1 year of treatment. Safety endpoints are bradycardia, AV-block II-III, hypotension, syncope or need for pacemaker, asthma or chronic obstructive pulmonary disease and stroke.<br /><b>Conclusion</b><br />The results from REDUCE-AMI will add important evidence regarding the effect of beta-blockers in patients with MI and preserved EF and may change guidelines and clinical practice.<br /><br />© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 13 Dec 2022; epub ahead of print</small></div>
Yndigegn T, Lindahl B, Alfredsson J, Benatar J, ... Hofmann R, Jernberg T
Eur Heart J Cardiovasc Pharmacother: 13 Dec 2022; epub ahead of print | PMID: 36513329
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<div><h4>Adenosine as adjunctive therapy in acute coronary syndrome: a meta-analysis of randomized controlled trials.</h4><i>Laborante R, Bianchini E, Restivo A, Ciliberti G, ... Crea F, D\'Amario D</i><br /><b>Aim</b><br />Adenosine has been tested in several randomized controlled trials (RCTs) to minimize the incidence of coronary microvascular obstruction (CMVO). The aim of the present study was to pool all the RCTs comparing intracoronary or intravenous adenosine versus placebo in patients with acute coronary syndrome (ACS) undergoing myocardial revascularization.<br /><b>Methods and results</b><br />PubMed and Scopus electronic databases were scanned for eligible studies up to June 5th 2022. A total of 26 RCTs with 5843 patients were included. Efficacy endpoints were major adverse cardiac events (MACE), all-cause-death, non-fatal myocardial infarction and heart failure. Atrioventricular blocks and ventricular fibrillation/sustained ventricular tachycardia (VF/SVT) were the safety endpoints. Myocardial blush grade, Thrombolysis In Myocardial Infarction (TIMI) flow grade, left ventricular ejection fraction (LVEF), infarct size, and ST-segment resolution were also assessed. Adenosine administration was not associated with any clinical benefit in terms of MACE, all-cause death, non-fatal myocardial infarction, and heart failure. However, adenosine was associated with an increased rate of advanced atrioventricular blocks and of VF/SVT in studies with total mean ischemic time > 3 hours, compared to placebo. Remarkably, among patients undergoing percutaneous coronary intervention, adenosine was associated with reduced myocardial blush grade 0-1 and TIMI flow grade 0-2, compared to placebo. Furthermore, adenosine did not show favourable effects on LVEF and infarct size.<br /><b>Conclusion</b><br />Adenosine infusion, as adjunctive therapy in ACS, was associated with an increased risk of advanced atrioventricular blocks and increased rates of adenosine-triggered ventricular arrhythmias in patients with long ischemic time, without providing any clinical benefit compared to placebo.<br /><br />© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 10 Dec 2022; epub ahead of print</small></div>
Laborante R, Bianchini E, Restivo A, Ciliberti G, ... Crea F, D'Amario D
Eur Heart J Cardiovasc Pharmacother: 10 Dec 2022; epub ahead of print | PMID: 36496163
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<div><h4>Digoxin use in contemporary heart failure with reduced ejection fraction: an analysis from the Swedish Heart Failure Registry.</h4><i>Kapelios CJ, Lund LH, Benson L, Dahlström U, ... Hauptman PJ, Savarese G</i><br /><b>Aims</b><br />Digoxin is included in some heart failure (HF) guidelines but controversy persists about the true role for and impact of treatment with this drug, particularly in the absence of atrial fibrillation (AF). The aim of this study was to assess the association between clinical characteristics and digoxin use and between digoxin use and mortality/morbidity in a large, contemporary cohort of patients with HF with reduced ejection fraction (HFrEF) stratified by history of AF.<br /><b>Methods and results</b><br />Patients with HFrEF (EF < 40%) enrolled in the Swedish HF registry between 2005 and 2018 were analysed. The independent association between digoxin use and patient characteristics was assessed by logistic regression, and between digoxin use and outcomes [composite of all-cause mortality or HF hospitalization (HFH), all-cause mortality, and HFH] by Cox regressions in a 1:1 propensity score matched population. Digoxin use was analysed at baseline and as a time-dependent variable. Of 42 456 patients with HFrEF, 16% received digoxin, 29% in the AF group and 2.8% in the non-AF group. The main independent predictors of use were advanced HF, higher heart rate, history of AF, preserved renal function, and concomitant use of beta blockers. Digoxin use was associated with lower risk of all-cause death/HFH [hazard ratio (HR): 0.95; 95% confidence interval (CI): 0.91-0.99] in AF, but with higher risk in non-AF (HR: 1.24; 95% CI: 1.09-1.43). Consistent results were observed when digoxin use was analysed as a time-dependent variable.<br /><b>Conclusion</b><br />The great majority of digoxin users had a history of AF. Digoxin use was associated with lower mortality/morbidity in patients with AF, but with higher mortality/morbidity in patients without AF.<br /><br />© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 02 Dec 2022; 8:756-767</small></div>
Kapelios CJ, Lund LH, Benson L, Dahlström U, ... Hauptman PJ, Savarese G
Eur Heart J Cardiovasc Pharmacother: 02 Dec 2022; 8:756-767 | PMID: 34921603
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<div><h4>The Effect of a Prasugrel- versus a Ticagrelor-based Strategy on Total Ischemic and Bleeding Events in Patients with Acute Coronary Syndromes.</h4><i>Aytekin A, Coughlan JJ, Ndrepepa G, Cassese S, ... Schunkert H, Kastrati A</i><br /><b>Aims</b><br />The effect of a prasugrel versus a ticagrelor based strategy on total (including both first and recurrent) ischemic and bleeding events in patients with acute coronary syndromes (ACS) has not been evaluated. The aim of this analysis was to investigate the treatment effect of a prasugrel versus a ticagrelor based strategy in patients with ACS undergoing an invasive management strategy when both first and recurrent non-fatal ischemic and bleeding events are taken into account.<br /><b>Methods and results</b><br />This is a post-hoc analysis of the ISAR-REACT-5 randomized control trial, including all 4 018 patients in the trial. The main clinical endpoints of interest included ischemic events (myocardial infarction (MI) and stroke) and bleeding events (Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding). An additional endpoint of interest was definite/probable stent thrombosis. The effect of the prasugrel versus ticagrelor based strategies on these endpoints was evaluated on both time-to-first event and total events analyses. Patients in the prasugrel group had a lower risk of MI in comparison to the ticagrelor group on both time-to-first event (hazard ratio [HR] = 0.61; 95% confidence interval 0.44-0.85) and total events (HR = 0.62 [0.45-0.86]) analysis. The risk of BARC type 3 to 5 bleeding was comparable between the prasugrel and ticagrelor groups on both time-to-first event (HR = 0.96 [0.75-1.25]) and total events (HR = 0.99 [0.76-1.31]) analysis.<br /><b>Conclusion</b><br />A prasugrel based strategy was associated with a reduction in total MI events in comparison to a ticagrelor based strategy in patients with ACS undergoing invasive assessment. Total BARC type 3 to 5 bleeding events were comparable between the two groups. Given the importance of this topic, future studies to confirm these findings would be welcome.<br /><br />© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 26 Nov 2022; epub ahead of print</small></div>
Aytekin A, Coughlan JJ, Ndrepepa G, Cassese S, ... Schunkert H, Kastrati A
Eur Heart J Cardiovasc Pharmacother: 26 Nov 2022; epub ahead of print | PMID: 36434779
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<div><h4>Dual antiplatelet therapy duration after percutaneous coronary intervention in patients with indication to oral anticoagulant therapy. A systematic review and meta-analysis of randomized controlled trials.</h4><i>Montalto C, Costa F, Leonardi S, Micari A, ... Lopes RD, Valgimigli M</i><br /><b>Aims</b><br />Optimal duration of dual antiplatelet therapy (DAPT) in patients with concomitant indication to oral anticoagulation (OAC) is still debated.<br /><b>Methods and results</b><br />A systematic review was performed on electronic databases to search for randomized controlled trials comparing an abbreviated or prolonged (≥3 months) DAPT regimen in patients with OAC and they were analyzed in the framework of standard and network meta-analyses. Co-primary endpoints were major or clinically relevant non-major bleedings (MCRB) and major bleeding, while the composite of major adverse cardiovascular events (MACE) was the key safety endpoint. Five studies and 7 665 patients (abbreviated DAPT n = 3 843; prolonged DAPT n = 3 822) were included. Both MCRB and major bleeding were lower with abbreviated DAPT (risk ratio [RR] 0.69 [0.52-0.91]; P = 0.01 and 0.70 [0.52-0.95]; P = 0.01, respectively) while MACE (RR: 0.96 [0.70-1.33]; P = 0.6), all-cause death, cardiovascular death, stent thrombosis, or myocardial infarction did not differ. Network meta-analysis showed that peri-procedural DAPT had the highest probability to prevent MCRB and major bleeding (97.1% and 92.0% respectively) when compared to both short (4-6 weeks) and longer (≥3 months) DAPT regimens. Sensitivity analyses and meta-regressions showed consistency in different clinical scenarios and suggested a larger bleeding reduction with P2Y12 inhibitors vs. aspirin after DAPT discontinuation.<br /><b>Conclusion</b><br />In patients undergoing PCI with concomitant OAC indication, an abbreviated DAPT regimen reduced MCRB and major bleeding without increasing MACE or other ischemic events. Peri-procedural DAPT and P2Y12 inhibitor monotherapy after DAPT withdrawal appear to be the best strategies to optimize the bleeding and ischemic risk tradeoff.<br /><br />© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 25 Nov 2022; epub ahead of print</small></div>
Montalto C, Costa F, Leonardi S, Micari A, ... Lopes RD, Valgimigli M
Eur Heart J Cardiovasc Pharmacother: 25 Nov 2022; epub ahead of print | PMID: 36427063
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<div><h4>Initial statin dose after myocardial infarction and long-term cardiovascular outcomes.</h4><i>Kytö V, Rautava P, Tornio A</i><br /><b>Aims</b><br />Effective statin therapy is a cornerstone of secondary prevention after myocardial infarction (MI). Real-life statin dosing is nevertheless suboptimal and largely determined early after MI. We studied long-term outcome impact of initial statin dose after MI.<br /><b>Methods and results</b><br />Consecutive MI patients treated in Finland who used statins early after index event were retrospectively studied (N = 72,401; 67% men; mean age 68 years) using national registries. High-dose statin therapy was used by 26.3%, moderate dose by 69.2%, and low dose by 4.5%. Differences in baseline features, comorbidities, revascularization, and usage of other evidence-based medications were adjusted for with multivariable regression. The primary outcome was major adverse cardiovascular or cerebrovascular event (MACCE) within 10-years. Median follow-up was 4.9 years. MACCE was less frequent in high-dose group compared to moderate dose (adjusted HR 0.92; p<0.0001; number needed to treat [NNT] 34.1) and to low dose (adj.HR 0.81; p<0.001; NNT 13.4) as well as in moderate-dose group compared to low dose (adj.HR 0.88; p<0.0001; NNT 23.4). Death (adj.HR 0.87; p<0.0001; NNT 23.6), recurrent MI (adj.sHR 0.91; p = 0.0001), and stroke (adj.sHR 0.86; p<0.0001) were less frequent with a high- versus moderate-dose statin. Higher initial statin dose after MI was associated with better long-term outcomes in subgroups by age, sex, atrial fibrillation, dementia, diabetes, heart failure, revascularization, prior statin usage, or usage of other evidence-based medications.<br /><b>Conclusion</b><br />Higher initial statin dose after MI is dose-dependently associated with better long-term cardiovascular outcomes. These results underline the importance of using a high statin dose early after MI.<br /><br />© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 16 Nov 2022; epub ahead of print</small></div>
Kytö V, Rautava P, Tornio A
Eur Heart J Cardiovasc Pharmacother: 16 Nov 2022; epub ahead of print | PMID: 36385668
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<div><h4>Head-to-head Efficacy and Safety of Rivaroxaban, Apixaban and Dabigatran in an Observational Nationwide Targeted Trial.</h4><i>Talmor-Barkan Y, Yacovzada NS, Rossman H, Witberg G, ... Kornowski R, Segal E</i><br /><b>Aims</b><br />The advantages of direct oral anticoagulants (DOACs) over warfarin are well established in atrial fibrillation (AF) patients, however, studies that can guide in the selection between different DOACs are limited. The aim was to compare the clinical outcomes of treatment with apixaban, rivaroxaban and dabigatran in patients with AF.<br /><b>Methods and results</b><br />We conducted a retrospective, nationwide, propensity score-matched-based observational study from Clalit Health Services. Data from 141,992 individuals with AF was used to emulate a target trial for head-to-head comparison of DOACs therapy. Three-matched cohorts of patients assigned to DOACs, from January-2014 through January-2020, were created. One-to-one propensity score matching was performed. Efficacy/safety outcomes were compared using Kaplan-Meier survival estimates and Cox proportional hazards models. The trial included 56,553 patients (apixaban, n = 35,101; rivaroxaban, n = 15,682; dabigatran, n = 5,770). Mortality and ischemic stroke rates in patients treated with rivaroxaban were lower compared to apixaban (HR,0.88; 95% CI,0.78-0.99;P,0.037 and HR,0.92; 95% CI,0.86-0.99;P,0.024, respectively). No significant differences in the rates of myocardial infarction, systemic embolism and overall bleeding were noticed between the different DOACs groups. Patients treated with rivaroxaban demonstrated lower rate of intracranial hemorrhage compared to apixaban (HR,0.86; 95% CI,0.74-1.0;P,0.044). The rate of gastrointestinal bleeding in patients treated with rivaroxaban was higher compared to apixaban (HR, 1.22; 95% CI,1.01-1.44;P, 0.016).<br /><b>Conclusion</b><br />We demonstrated significant differences in outcomes between the three studied DOACs. The results emphasis the need for randomized controlled trials that will compare between rivaroxaban, apixaban and dabigatran in order to better guide the selection between them.<br /><br />© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 07 Nov 2022; epub ahead of print</small></div>
Talmor-Barkan Y, Yacovzada NS, Rossman H, Witberg G, ... Kornowski R, Segal E
Eur Heart J Cardiovasc Pharmacother: 07 Nov 2022; epub ahead of print | PMID: 36341531
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<div><h4>Predicting performance of the HAS-BLED and ORBIT bleeding risk scores in patients with atrial fibrillation treated with Rivaroxaban: Observations from the prospective EMIR Registry.</h4><i>Esteve-Pastor MA, Rivera-Caravaca JM, Roldán V, Fernández MS, ... Lip GYH, Marin F</i><br /><b>Background</b><br />Assessing bleeding risk during the decision-making process of starting oral anticoagulation (OAC) therapy in atrial fibrillation (AF) patients is essential. Several bleeding risk scores have been proposed for vitamin K antagonist users but, few studies have focused on validation of these bleeding risk scores in patients taking direct oral anticoagulants (DOACs). The aim was to compare the predictive ability of HAS-BLED and ORBIT bleeding risk scores in AF patients taking rivaroxaban in the EMIR (\'Estudio observacional para la identificación de los factores de riesgo asociados a eventos cardiovasculares mayores en pacientes con fibrilación auricular no valvular tratados con un anticoagulante oral directo [Rivaroxaban]) Study.<br /><b>Methods</b><br />EMIR Study was an observational, multicenter, post-authorization and prospective study that involved AF patients under OAC with rivaroxaban at least 6 months before enrolment. We analyzed baseline clinical characteristics and adverse events after 2.5 years of follow up and validated the predictive ability of HAS-BLED and ORBIT scores for major bleeding (MB) events.<br /><b>Results</b><br />We analyzed 1 433 patients with mean age of 74.2 ± 9.7 (44.5% female). Mean HAS-BLED score was 1.6 ± 1.0 and ORBIT score was 1.1 ± 1.2. The ORBIT score categorised a higher proportion of patients as \'low risk\' (87.1%) compared to 53.5% using the HAS-BLED score. There were 33 MB events (1.04%/year) and 87 patients died (2.73%/year). Both HAS-BLED and ORBIT had good predictive ability for MB [AUC 0.770, (95%CI 0.693-0.847; P < 0.001) and AUC 0.765 (95%CI 0.672-0.858; P < 0.001), respectively]. There was a non-significant difference for discriminative ability of the 2 tested scores (P = 0.930) and risk reclassification in terms of NRI -5.7 (CI95% -42.4-31.1; P = 0.762). HAS-BLED score showed the best calibration and ORBIT score showed the largest mismatch in calibration, particularly in higher predicted risk patients.<br /><b>Conclusions</b><br />In a prospective real-world AF population under rivaroxaban from EMIR registry, the HAS-BLED score had good predictive performance and calibration compared to ORBIT score for major bleeding events. ORBIT score presented worse calibration than HAS-BLED in this DOAC treated population.<br /><br />© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.<br /><br /><small>Eur Heart J Cardiovasc Pharmacother: 01 Nov 2022; epub ahead of print</small></div>
Esteve-Pastor MA, Rivera-Caravaca JM, Roldán V, Fernández MS, ... Lip GYH, Marin F
Eur Heart J Cardiovasc Pharmacother: 01 Nov 2022; epub ahead of print | PMID: 36318457
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This program is still in alpha version.