Journal: Eur Heart J Cardiovasc Pharmacother

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Abstract

Different left ventricular remodeling patterns and clinical outcomes between non-ischemic and ischemic etiologies in heart failure patients receiving sacubitril/valsartan treatment.

Lee YH, Chiou WR, Hsu CY, Lin PL, ... Lin WY, Chang HY
Aims
Although the beneficial effect of sacubitril/valsartan (SAC/VAL) compared to enalapril was consistent across ischaemic (ICM) and non-ischaemic cardiomyopathy (NICM) groups, the PARADIGM-HF study did not analyze the effect of ventricular remodelling on patients with different etiologies, which may affect clinical treatment outcomes. This study aimed to compare left ventricular ejection fraction (LVEF) following SAC/VAL treatment and its association with clinical outcomes.
Methods and results
A total of 1,576 patients were analyzed. Patients were grouped by LVEF changes following SAC/VAL treatment for 8-month period. LVEF improvement ≥15% was defined as \"significant improvement\", and <5% or worse was classified as \"lack of improvement\". The primary outcome was a composite of cardiovascular death and unplanned hospitalization for heart failure.Patients with NICM had lower baseline LVEF but improvement was significantly greater comparing to those with ICM (baseline 28.0 ± 7.7% vs. 30.1 ± 7.1%, p < 0.001, LVEF increase of 11.1 ± 12.6% vs. 6.7 ± 10.2%, p < 0.001). The effect of functional improvement of SAC/VAL on NICM patients showed bimodal distribution. Primary endpoints were inversely associated with LVEF changes in NICM patients: adjusted hazard ratio was 0.42 (95% confidence interval [CI] 0.31-0.58, p < 0.001) for NICM patients with significant improvement, and was 1.73 (95% CI 1.38-2.16, p < 0.001) for NICM patients but lack of improvement. Primary endpoints of ICM patients did not demonstrate an association with LVEF changes.
Conclusion
Patients with NICM had higher degree of LVEF improvement than those with ICM following SAC/VAL treatment, and significant improvement of LVEF in NICM patients indicates favorable outcome.

© Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 28 Oct 2020; epub ahead of print
Lee YH, Chiou WR, Hsu CY, Lin PL, ... Lin WY, Chang HY
Eur Heart J Cardiovasc Pharmacother: 28 Oct 2020; epub ahead of print | PMID: 33119090
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Abstract

Intensive blood pressure lowering in different age categories: insights from the Systolic Blood Pressure Intervention Trial.

Byrne C, Pareek M, Vaduganathan M, Biering-Sørensen T, ... Olsen MH, Bhatt DL
Aims
The 2018 ESC/ESH guidelines for hypertension recommend differential management of patients who are <65, 65-79, and ≥80 years of age. However, it is unclear whether intensive blood pressure lowering is well-tolerated and modifies risk uniformly across the age spectrum.
Methods and results
SPRINT randomized 9361 high-risk adults without diabetes and age ≥50 years with systolic blood pressure 130-180 mmHg to either intensive or standard antihypertensive treatment. The primary efficacy endpoint was the composite of acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. The primary safety endpoint was composite serious adverse events. We assessed whether age modified the efficacy and safety of intensive vs. standard blood pressure lowering using Cox proportional-hazards regression and restricted cubic splines. In all, 3805 (41%), 4390 (47%), and 1166 (12%) were <65, 65-79, and ≥80 years. Mean age was similar between the two study groups (intensive group 67.9 ± 9.4 years vs. standard group 67.9 ± 9.5 years; P = 0.94). Median follow-up was 3.3 years. In multivariable models, age was linearly associated with the risk of stroke (P < 0.001) and non-linearly associated with the risk of primary efficacy events, death from cardiovascular causes, death from any cause, heart failure, and serious adverse events (P < 0.001). The safety and efficacy of intensive blood pressure lowering were not modified by age, whether tested continuously or categorically (P > 0.05).
Conclusion
In SPRINT, the benefits and risks of intensive blood pressure lowering did not differ according to the age categories proposed by the ESC/ESH guidelines for hypertension.
Trial registration
SPRINT (Systolic Blood Pressure Intervention Trial); ClinicalTrials.gov Identifier: NCT01206062, https://clinicaltrials.gov/ct2/show/NCT01206062.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:356-363
Byrne C, Pareek M, Vaduganathan M, Biering-Sørensen T, ... Olsen MH, Bhatt DL
Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:356-363 | PMID: 31529024
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Abstract

Differential effects on out-of-hospital cardiac arrest of dihydropyridines: real-world data from population-based cohorts across two European countries.

Eroglu TE, Mohr GH, Blom MT, Verkerk AO, ... Gislason GH, Tan HL
Aims
Various drugs increase the risk of out-of-hospital cardiac arrest (OHCA) in the general population by impacting cardiac ion channels, thereby causing ventricular tachycardia/fibrillation (VT/VF). Dihydropyridines block L-type calcium channels, but their association with OHCA risk is unknown. We aimed to study whether nifedipine and/or amlodipine, often-used dihydropyridines, are associated with increased OHCA risk, and how these drugs impact on cardiac electrophysiology.
Methods and results
We conducted a case-control study with VT/VF-documented OHCA cases with presumed cardiac cause from ongoing population-based OHCA registries in the Netherlands and Denmark, and age/sex/index date-matched non-OHCA controls (Netherlands: PHARMO Database Network, Denmark: Danish Civil Registration System). We included 2503 OHCA cases, 10 543 non-OHCA controls in Netherlands, and 8101 OHCA cases, 40 505 non-OHCA controls in Denmark. To examine drug effects on cardiac electrophysiology, we performed single-cell patch-clamp studies in human-induced pluripotent stem cell-derived cardiomyocytes. Use of high-dose nifedipine (≥60 mg/day), but not low-dose nifedipine (<60 mg/day) or amlodipine (any-dose), was associated with higher OHCA risk than non-use of dihydropyridines [Netherlands: adjusted odds ratios (ORadj) 1.45 (95% confidence interval 1.02-2.07), Denmark: 1.96 (1.18-3.25)] or use of amlodipine [Netherlands: 2.31 (1.54-3.47), Denmark: 2.20 (1.32-3.67)]. Out-of-hospital cardiac arrest risk of (high-dose) nifedipine use was not further increased in patients using nitrates, or with a history of ischaemic heart disease. Nifedipine and amlodipine blocked L-type calcium channels at similar concentrations, but, at clinically used concentrations, nifedipine caused more L-type calcium current block, resulting in more action potential shortening.
Conclusion
High-dose nifedipine, but not low-dose nifedipine or any-dose amlodipine, is associated with increased OHCA risk in the general population. Careful titration of nifedipine dose should be considered.

© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.

Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:347-355
Eroglu TE, Mohr GH, Blom MT, Verkerk AO, ... Gislason GH, Tan HL
Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:347-355 | PMID: 31504369
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Abstract

Combination of empagliflozin and linagliptin improves blood pressure and vascular function in type 2 diabetes.

Jung S, Bosch A, Kannenkeril D, Karg MV, ... Ott C, Schmieder RE
Aims
Preserved vascular function represents a key prognostic factor in type 2 diabetes mellitus (T2DM), but data on vascular parameters in this patient cohort are scarce. Patients with T2DM often need more than one drug to achieve optimal glucose control. The aim of this study was to analyse the efficacy of two combination therapies on vascular function in subjects with T2DM.
Methods and results
This prospective, randomized study included 97 subjects with T2DM. Subjects were randomized to either the combination therapy empagliflozin (E) 10 mg with linagliptin (L) 5 mg once daily or metformin (M) 850 or 1000 mg twice daily with insulin glargine (I) once daily. At baseline and after 12 weeks, subjects had peripheral office and 24-h ambulatory blood pressure (BP) measurement and underwent vascular assessment by pulse wave analysis under office and ambulatory conditions. Office, 24-h ambulatory and central BP as well as pulse pressure (PP) decreased after 12 weeks of treatment with E + L, whereas no change was observed in M + I. There were greater decreases in 24-h ambulatory peripheral systolic (between-group difference: -5.2 ± 1.5 mmHg, P = 0.004), diastolic BP (-1.9 ± 1.0 mmHg, P = 0.036), and PP (-3.3 ± 1.0 mmHg, P = 0.007) in E + L than M + I. Central office systolic BP (-5.56 ± 1.9 mmHg, P = 0.009), forward pressure height of the pulse wave (-2.0 ± 0.9 mmHg, P = 0.028), 24-h ambulatory central systolic (-3.6 ± 1.4 mmHg, P = 0.045), diastolic BP (-1.95 ± 1.1 mmHg, P = 0.041), and 24-h pulse wave velocity (-0.14 ± 0.05m/s, P = 0.043) were reduced to a greater extent with E + L.
Conclusion
Beyond the effects on glycaemic control, the combination therapy of E + L significantly improved central BP and vascular function compared with the classic combination of M + I.
Clinicaltrials.gov
NCT02752113.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:364-371
Jung S, Bosch A, Kannenkeril D, Karg MV, ... Ott C, Schmieder RE
Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:364-371 | PMID: 31816038
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Abstract

Peripartum management of hypertension: a position paper of the ESC Council on Hypertension and the European Society of Hypertension.

Cífková R, Johnson MR, Kahan T, Brguljan J, ... Regitz-Zagrosek V, de Simone G

Hypertensive disorders are the most common medical complications in the peripartum period associated with a substantial increase in morbidity and mortality. Hypertension in the peripartum period may be due to the continuation of pre-existing or gestational hypertension, de novo development of pre-eclampsia or it may be also induced by some drugs used for analgesia or suppression of postpartum haemorrhage. Women with severe hypertension and hypertensive emergencies are at high risk of life-threatening complications, therefore, despite the lack of evidence-based data, based on expert opinion, antihypertensive treatment is recommended. Labetalol intravenously and methyldopa orally are then the two most frequently used drugs. Short-acting oral nifedipine is suggested to be used only if other drugs or iv access are not available. Induction of labour is associated with improved maternal outcome and should be advised for women with gestational hypertension or mild pre-eclampsia at 37 weeks\' gestation. This position paper provides the first interdisciplinary approach to the management of hypertension in the peripartum period based on the best available evidence and expert consensus.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:384-393
Cífková R, Johnson MR, Kahan T, Brguljan J, ... Regitz-Zagrosek V, de Simone G
Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:384-393 | PMID: 31841131
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Abstract

Smoking and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients: a substudy from the randomized TROPICAL-ACS trial.

Orban M, Trenk D, Geisler T, Rieber J, ... Hein R,
Aims
Prior analyses disclosed variations in antiplatelet drug response and clinical outcomes between smokers and non-smokers, thus the safety and efficacy of any dual antiplatelet therapy (DAPT) de-escalation strategy may differ in relation to smoking status. Hence, we assessed the impact of smoking on clinical outcomes and adenosine diphosphate-induced platelet aggregation following guided de-escalation of DAPT in invasively managed acute coronary syndrome (ACS) patients.
Methods and results
The multicentre TROPICAL-ACS trial randomized 2610 biomarker-positive ACS patients 1:1 to standard treatment with prasugrel for 12 months (control group) or a platelet function testing guided de-escalation of DAPT. Current smokers (n = 1182) showed comparable event rates between study groups [6.6% vs. 6.6%; hazard ratio (HR) 1.0, 95% confidence interval (CI) 0.64-1.56, P > 0.99]. In non-smokers (n = 1428), a guided DAPT de-escalation was associated with a lower 1-year incidence of the primary endpoint [cardiovascular death, myocardial infarction, stroke, or bleeding ≥ Grade 2 according to Bleeding Academic Research Consortium (BARC) criteria] compared with control group patients (7.9% vs. 11.0%; HR 0.71, 95% CI 0.50-0.99, P = 0.048). This reduction was mainly driven by a lower rate of BARC ≥ Grade 2 bleedings (5.2% vs. 7.7%; HR 0.68, 95% CI 0.45-1.03, P = 0.066). There was no significant interaction of smoking status with treatment effects of guided DAPT de-escalation (Pint = 0.23). Adenosine diphosphate-induced platelet aggregation values were higher in current smokers [median 28 U, interquartile range (IQR: 20-40)] vs. non-smoker [median 24 U (16-25), P < 0.0001] in the control group and in current smokers [median 42 U, IQR (27-68)] vs. non-smoker [median 37 U, IQR (25-55), P < 0.001] in the monitoring group.
Conclusion
Guided DAPT de-escalation appears to be equally safe and effective in smokers and non-smokers. Regardless of smoking status and especially for those patients deemed unsuitable for 1 year of potent platelet inhibition this DAPT strategy might be used as an alternative antiplatelet treatment regimen.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:372-381
Orban M, Trenk D, Geisler T, Rieber J, ... Hein R,
Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:372-381 | PMID: 31855244
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Abstract

The interplay between cardiology and diabetology: a renewed collaboration to optimize cardiovascular prevention and heart failure management.

Sabouret P, Galati G, Angoulvant D, Germanova O, ... Metra M, Margonato A

Type 2 diabetes mellitus (T2DM) portends high risk of atherosclerotic cardiovascular (CV) events and of CV mortality; moreover, this group of patients has a very high probability of developing heart failure (HF). In this review, we discuss new advances in pharmacological treatment both in CV prevention and in HF management with a special focus on T2DM patients. A large number of randomized clinical trials and meta-analyses provided strong evidence about therapeutic strategies acting on glucose metabolism, such as GLP-1 RA and SGLT2i and about lipid-lowering treatment, such as PCSK9i and icosapent ethyl. Moreover, SGLT2i demonstrated strong evidence of benefit particularly in HF management both in diabetic and non-diabetic patients. The pathophysiological bases of multiple mechanisms of benefit of this class of drug explain the unexpected and remarkable results demonstrated both by prevention trials and by trials dedicated only to HF (like DAPA-HF). These, new drugs in the CV therapeutic armamentarium are establishing a new comprehensive approach from prevention to therapy of HF, giving more emphasis on HF classification in four stages (A→D). New therapies, which are on the horizon, promise to further reduce CV mortality and morbidity in HF patients irrespective of diabetic status.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:394-404
Sabouret P, Galati G, Angoulvant D, Germanova O, ... Metra M, Margonato A
Eur Heart J Cardiovasc Pharmacother: 31 Oct 2020; 6:394-404 | PMID: 32402065
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Abstract

PRECISE-DAPT score for bleeding risk prediction in patients on dual or single antiplatelet regimens: insights from the GLOBAL LEADERS and GLASSY.

Gragnano F, Heg D, Franzone A, McFadden EP, ... Valgimigli M,
Aims
The 5-item PRECISE-DAPT, integrating age, haemoglobin, white-blood-cell count, creatinine clearance, and prior bleeding, predicts bleeding risk in patients on dual antiplatelet therapy (DAPT) after stent implantation. We sought to assess whether the bleeding risk prediction offered by the PRECISE-DAPT remains valid among patients receiving ticagrelor monotherapy from 1 month onwards after coronary stenting instead of standard DAPT and having or not having centrally-adjudicated bleeding endpoints.
Methods and results
The PRECISE-DAPT was calculated in 14,928 and 7,134 patients from GLOBAL LEADERS and GLASSY trials, respectively. The ability of the score to predict BARC 3 or 5 bleeding was assessed and compared among patients on ticagrelor monotherapy (experimental strategy) or standard DAPT (reference strategy) from 1 month after drug-eluting stent implantation. Bleeding endpoints were investigator-reported or centrally-adjudicated in GLOBAL LEADERS and GLASSY, respectively.At 2 years, the c-indexes for the score among patients treated with the experimental or reference strategy were 0.67 (95% confidence interval [CI]:0.63-0.71) vs. 0.63 (95% CI:0.59-0.67) in GLOBAL LEADERS (p = 0.27), and 0.67 (95% CI:0.61-0.73) vs. 0.66 (95% CI:0.61-0.72) in GLASSY (p = 0.88). Decision curve analysis showed net benefit using the PRECISE-DAPT to guide bleeding risk assessment under both treatment strategies. Results were consistent between investigator-reported and adjudicated endpoints and using the simplified 4-item PRECISE-DAPT.
Conclusions
The PRECISE-DAPT offers a prediction model that proved similarly effective to predict clinically-relevant bleeding among patients on ticagrelor monotherapy from 1 month after coronary stenting compared with standard DAPT and appears to be unaffected by the presence or absence of adjudicated bleeding endpoints.

© Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 16 Sep 2020; epub ahead of print
Gragnano F, Heg D, Franzone A, McFadden EP, ... Valgimigli M,
Eur Heart J Cardiovasc Pharmacother: 16 Sep 2020; epub ahead of print | PMID: 32941620
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Abstract

Potentially Inappropriate Prescriptions in Heart Failure with Reduced Ejection Fraction (PIP-HFrEF).

El Hadidi S, Rosano G, Tamargo J, Agewall S, ... Lewis BS, Coats AJS

Heart failure (HF) is a chronic debilitating and potentially life-threatening condition. Heart Failure patients are usually at high risk of polypharmacy and consequently, potentially inappropriate prescribing leading to poor clinical outcomes. Based on the published literature, a comprehensive HF-specific prescribing review tool is compiled to avoid medications that may cause HF or harm HF patients and to optimize the prescribing practice of HF guideline-directed medical therapies. Recommendations are made in line with the last versions of ESC guidelines, ESC position papers, scientific evidence, and experts\' opinions.

© Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 16 Sep 2020; epub ahead of print
El Hadidi S, Rosano G, Tamargo J, Agewall S, ... Lewis BS, Coats AJS
Eur Heart J Cardiovasc Pharmacother: 16 Sep 2020; epub ahead of print | PMID: 32941594
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Abstract

Impact of White Blood Cell Count on Clinical Outcomes in Patients Treated with Aspirin-Free Ticagrelor Monotherapy after Percutaneous Coronary Intervention: Insights from the GLOBAL LEADERS Trial.

Ono M, Tomaniak M, Koenig W, Khamis R, ... Serruys PW,
Aims
To investigate the efficacy and safety of ticagrelor monotherapy in patients undergoing percutaneous coronary intervention (PCI) stratified according to the baseline white blood cell (WBC) count.
Methods and results
This is a post-hoc analysis of the GLOBAL LEADERS trial, a multicentre, open-label, randomized all-comer trial in patients undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual anti-platelet therapy [DAPT]) with the reference strategy (12-month aspirin monotherapy following 12-month DAPT). Patients were stratified into two WBC groups, either < or ≥median WBC count of 7.8 x 109 cells/L (lower or higher WBC group, respectively). The primary endpoint was a composite of all-cause mortality or new Q-wave myocardial infarction (MI) at 2 years.Out of 14,576 patients included in the present study, 7,212 patients (49.5%) were classified as the lower WBC group, who had a significantly lower risk of both ischemic and bleeding outcomes at 2 years. At 2 years, the experimental strategy was associated with a significant lower incidence of the primary endpoint compared with the reference strategy in the lower WBC group (2.8% vs. 4.2%; hazard ratio [HR]: 0.67; 95% CI: 0.52-0.86) but not in the higher WBC group (4.8% vs. 4.7%; HR: 1.01; 95% CI: 0.82-1.25; pinteraction=0.013). There were no significant differences in the risks of BARC type 3 or 5 bleeding between two antiplatelet strategies regardless of the WBC groups.
Conclusions
Increased WBC counts, which may reflect degree of inflammation, at the time of index procedure may attenuate the anti-ischemic benefits of ticagrelor monotherapy observed in patients with lower WBC counts.

© Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 20 Sep 2020; epub ahead of print
Ono M, Tomaniak M, Koenig W, Khamis R, ... Serruys PW,
Eur Heart J Cardiovasc Pharmacother: 20 Sep 2020; epub ahead of print | PMID: 32956446
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Abstract

Medication in adults after atrial switch for transposition of the great arteries: clinical practice and recommendations.

Woudstra OI, Kuijpers JM, Jongbloed MRM, van Dijk APJ, ... Mulder BJM, Bouma BJ
Aims
Heart failure is the main threat to long-term health in adults with transposition of the great arteries(TGA) corrected by an atrial switch operation(AtrSO). Current guidelines refrain from recommending heart failure medication in TGA-AtrSO, as there is insufficient data to support the hypothesis that it is beneficial. Medication is therefore prescribed based on personal judgements. We aimed to evaluate medication use in TGA-AtrSO patients and examine the association of use of Renin-Angiotension-Aldosteron System(RAAS) inhibitors and β-blockers with long-term survival.
Methods and results
We identified 150 TGA-AtrSO patients(median age 30 years[IQR 25-35], 63% male) included in the CONCOR registry from five tertiary medical centers with subsequent linkage to the Dutch Dispensed Drug Register for the years 2006-2014. Use of RAAS inhibitors, β-blockers, and diuretics increased with age, from respectively 21%[95%CI 14-40], 12%[95%CI 7-21], and 3%[95%CI 2-7] at age 25, to 49%[95%CI 38-60], 51%[95%CI 38-63], and 41%[95%CI 29-54] at age 45. Time-varying Cox marginal structural models that adjusted for confounding medication showed a lower mortality risk with use of RAAS inhibitors and β-blockers in symptomatic patients(HR = 0.13[95%CI 0.03-0.73]; p=0.020 and HR = 0.12[95%CI 0.02-0.17]; p=0.019, respectively). However, in the overall cohort, no benefit of RAAS inhibitors and β-blockers was seen(HR = 0.93[95%CI 0.24-3.63]; p=0.92 and HR = 0.98[0.23-4.17]; p=0.98, respectively).
Conclusion
The use of heart failure medication is high in TGA-AtrSO patients, although evidence of its benefit is limited. This study showed lower risk of mortality with use of RAAS inhibitors and β-blockers in symptomatic patients only. These findings can direct future guidelines, supporting use of RAAS inhibitors and β-blockers in symptomatic, but not asymptomatic patients.

© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.

Eur Heart J Cardiovasc Pharmacother: 24 Sep 2020; epub ahead of print
Woudstra OI, Kuijpers JM, Jongbloed MRM, van Dijk APJ, ... Mulder BJM, Bouma BJ
Eur Heart J Cardiovasc Pharmacother: 24 Sep 2020; epub ahead of print | PMID: 32976560
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Abstract

Effectiveness and Safety of Oral Anticoagulants Among Non-Valvular Atrial FibrillationPatients with Polypharmacy.

Lip GYH, Keshishian A, Kang A, Dhamane AD, ... Yuce H, Deitelzweig S
Aims
Polypharmacy is prevalent among non-valvular atrial fibrillation (NVAF) patients and presents a potential issue for the effective management of NVAF. This study compared the risk of stroke/systemic embolism (SE) and major bleeding (MB) among NVAF patients with polypharmacy newly prescribed oral anticoagulants (OACs).
Methods and results
A retrospective study of NVAF patients with polypharmacy who initiated OACs from 01JAN2013-30SEP2015 was conducted using US CMS Medicare and four commercial databases. Polypharmacy was defined as ≥ 6 concomitant medications on the index date. Propensity score matching was conducted to compare non-Vitamin K antagonists OACs (NOACs) to warfarin as well as between NOACs. Cox proportional hazard models were used to evaluate the risk of stroke/SE and MB. A total of 188,893 patients with polypharmacy were included, with an average of 8 concomitant medications (IQR 6-9). Compared to warfarin, apixaban (HR: 0.59, 95% CI: 0.52-0.68) and rivaroxaban (HR: 0.75, 95% CI: 0.69-0.83) were associated with a lower risk of stroke/SE. Apixaban (HR: 0.57, 95% CI: 0.54-0.61) and dabigatran (HR: 0.76, 95% CI: 0.66-0.88) were associated with a decreased risk of MB compared with warfarin. Compared with dabigatran and rivaroxaban, apixaban was associated with a lower risk of stroke/SE and MB. Dabigatran was associated with lower risk of MB compared with rivaroxaban.
Conclusions
In this observational study of anticoagulated NVAF patients with polypharmacy, effectiveness and safety profiles are more favorable for NOACs vs warfarin. Our observations are hypothesis generating and may help inform future clinical trials regarding appropriate OAC treatment selection in polypharmacy patients.

© Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 02 Oct 2020; epub ahead of print
Lip GYH, Keshishian A, Kang A, Dhamane AD, ... Yuce H, Deitelzweig S
Eur Heart J Cardiovasc Pharmacother: 02 Oct 2020; epub ahead of print | PMID: 33010157
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Abstract

Effect of Ticagrelor Monotherapy on Mortality After PCI: A Systematic Review and Meta-Analysis of Randomized Trials Including 26143 patients.

Hong SJ, Ahn CM, Kim JS, Kim BK, ... Jang Y, Hong MK
Background
Optimal timing and strategy of antiplatelet monotherapy after dual-antiplatelet therapy (DAPT) consisting of aspirin and P2Y12 inhibitor for patients who underwent percutaneous coronary intervention (PCI) is still being debated. The aim of this study to evaluate the effect of ticagrelor monotherapy after short-term DAPT after PCI on mortality.
Methods and results
A systematic review and meta-analysis was performed using PubMed to search for ticagrelor monotherapy after short-term DAPT comparing conventional DAPT in patients who underwent PCI. Three randomized trials encompassing 26143 patients (ticagrelor monotherapy after 1 to 3 months of DAPT [n = 13062] vs. conventional therapy [n = 13081]) were included. The efficacy endpoint of all-cause mortality was significantly lower with the ticagrelor monotherapy group vs. the conventional therapy group (risk ratio [RR]=0.80, 95% confidence interval [CI]=0.65 - 0.98; P = 0.03; I2=0%; number needed to treat for benefit [NNTB]=320). The safety endpoint of Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding was also significantly lower with the ticagrelor monotherapy group vs. the conventional therapy group (RR = 0.67, 95% CI = 0.49 - 0.92; P = 0.01; I2=65%; NNTB = 156). There were no significant differences in ischaemic stroke, acute myocardial infarction, and stent thrombosis. The favorable effects of the ticagrelor monotherapy vs. the conventional therapy on all-cause mortality and BARC type 3 or 5 bleeding were consistent in the subset of patients presenting acute coronary syndromes (n = 15157).
Conclusion
Ticagrelor monotherapy after short-term DAPT of 1 to 3 months was associated with decreased all-cause mortality and BARC type 3 or 5 bleeding not offset by increase of cardiac death, ischaemic stroke, acute myocardial infarction, and stent thrombosis.

© Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 08 Oct 2020; epub ahead of print
Hong SJ, Ahn CM, Kim JS, Kim BK, ... Jang Y, Hong MK
Eur Heart J Cardiovasc Pharmacother: 08 Oct 2020; epub ahead of print | PMID: 33035298
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Impact:
Abstract

Patients with diabetes mellitus and atrial fibrillation treated with NOACs: Meta-analysis of 8 outcomes in 58, 634 patients across 4 randomized controlled trials.

Plitt A, Zelniker TA, Park JG, McGuire DK, ... Braunwald E, Giugliano RP
Aims
Concomitant atrial fibrillation (AF) and diabetes mellitus (DM) increases risk of stroke and systemic embolic events. This meta-analysis assessed the benefit/risk balance of non-vitamin K antagonist oral anticoagulants (NOACs) vs warfarin, and explored whether there was effect modification by DM or heterogeneity in outcomes between NOACs in patients with and without DM.
Methods
We performed a meta-analysis of 58,634 patients from four phase 3 trials of NOAC vs warfarin in patients with AF, comparing the primary outcomes of efficacy and safety and 6 other secondary outcomes in patients stratified by the presence of DM. Interaction testing was used to assess for heterogeneity of treatment effects. A meta-regression was performed to evaluate the influence of baseline characteristics.
Results
NOACs reduced the risk of stroke/SEE in 18,134 patients with DM [hazard ratio (HR) 0.80; 95% confidence interval (CI) (0.69-0.93), I2 3.90] to a similar degree as in 40,500 patients without DM [HR 0.82; 95% CI (0.74-0.91)], I2 16.33 p-int 0.81). There was no effect modification of DM on the relative reduction with NOACs vs warfarin in major bleeding (DM : 0.95, 95% CI 0.75-1.20, I2 43.83; no DM: 0.83, 95% CI 0.55-1.24; I2 87.90; p-int 0.37). Intracranial Haemorrhage (HRs 0.51 and 0.47, p-int 0.70) and cardiovascular death (HRs 0.87 and 0.90, p-int 0.70) were significantly reduced by NOACs in the presence or absence of DM.
Conclusion
NOACs are more effective and safer than warfarin in AF patients with or without DM and absent contraindications, NOACs should be the anticoagulation treatment choice in diabetics.

© Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 15 Oct 2020; epub ahead of print
Plitt A, Zelniker TA, Park JG, McGuire DK, ... Braunwald E, Giugliano RP
Eur Heart J Cardiovasc Pharmacother: 15 Oct 2020; epub ahead of print | PMID: 33063112
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Abstract

The burden of cholesterol accumulation through the lifespan: why pharmacological intervention should start earlier to go further?

Zambon A, Mello E Silva A, Farnier M

Among the cardiovascular risk factors, cholesterol-rich atherogenic lipoproteins play a central role in the pathogenesis of atherosclerosis. In middle-aged adults, the size of the total atherosclerotic plaque burden is influenced by both the concentration of circulating atherogenic lipoproteins and by the total duration of exposure to these lipoproteins. This review describes the evidence supporting a causal link between life-long elevations in atherogenic lipoproteins and future risk of atherosclerosis; evidence strengthened by recent epidemiological, genetic and clinical data. By consequence, adolescence and early adulthood are a crucial time for determining later cardiovascular disease risk. Arguments showing that early optimal lipid control leads to improved outcomes will be presented, and suggestions put forward for how those most at risk should be identified and managed.

© Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 28 Oct 2020; epub ahead of print
Zambon A, Mello E Silva A, Farnier M
Eur Heart J Cardiovasc Pharmacother: 28 Oct 2020; epub ahead of print | PMID: 33119073
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Abstract

Safety and efficacy of double versus triple antithrombotic therapy in patients with atrial fibrillation with or without acute coronary syndrome undergoing percutaneous coronary intervention: a collaborative meta-analysis of NOAC-based randomized clinical trials.

Gargiulo G, Cannon CP, Gibson CM, Goette A, ... Vranckx P, Valgimigli M
Aims
Safety and efficacy of antithrombotic regimens in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) may differ based on clinical presentation. We sought to comparing double vs. triple antithrombotic therapy (DAT vs TAT) in AF patients with or without acute coronary syndrome (ACS) undergoing PCI.
Methods and results
A systematic review and meta-analysis was performed using PubMed to search for non-vitamin K antagonist oral anticoagulant (NOAC)-based randomized clinical trials. Data on subgroups of ACS or elective PCI were obtained by published reports or trial investigators. A total of 10,193 patients from 4 NOAC trials were analyzed, of whom 5,675 presenting with ACS (DAT = 3,063 vs. TAT = 2,612) and 4,518 with SCAD (DAT = 2,421 vs. TAT = 2,097). The primary safety endpoint of ISTH major bleeding or CRNMB was reduced with DAT compared with TAT in both ACS (12.2% vs 19.4%; RR 0.63, 95% CI 0.56-0.71; p < 0.0001; I2=0%) and SCAD (14.6% vs 22.0%; RR 0.68, 95% CI 0.55-0.85; p = 0.0008; I2=66%), without interaction (p-int = 0.54). Findings were consistent for secondary bleeding endpoints, including intracranial Haemorrhage. In both subgroups, there was no difference between DAT and TAT for all-cause death, major adverse cardiovascular events, or stroke. Myocardial infarction and stent thrombosis were numerically higher with DAT vs. TAT consistently in ACS and SCAD (p-int = 0.60 and 0.86 respectively). Findings were confirmed by multiple sensitivity analyses, including a separate analysis on dabigatran regimens and a restriction to PCI population.
Conclusions
DAT, compared with TAT, is associated with lower bleeding risks, including intracranial Haemorrhage, and a small non-significant excess of cardiac ischaemic events in both patients with or without ACS.

© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.

Eur Heart J Cardiovasc Pharmacother: 28 Oct 2020; epub ahead of print
Gargiulo G, Cannon CP, Gibson CM, Goette A, ... Vranckx P, Valgimigli M
Eur Heart J Cardiovasc Pharmacother: 28 Oct 2020; epub ahead of print | PMID: 33119069
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Abstract

Duration of dual antiplatelet therapy and subsequent monotherapy type in patients undergoing drug eluting stent implantation: a network Meta-analysis.

Benenati S, Crimi G, Canale C, Pescetelli F, ... Crea F, Porto I
Aims
To compare safety and efficacy of very short (≤3 months), short (6 months), standard (12 months) and extended (>12 months) DAPT, and subsequent monotherapies, after DES.
Methods and results
Twenty-two RCT (n = 110059 patients/year) were selected and included in a Bayesian network meta-analysis. The primary efficacy endpoint (PEP) was a composite of cardiac death, myocardial infarction (MI) and stent thrombosis (ST), the primary safety endpoint was major bleeding. Compared to standard, we found lower rate of MI (OR 0.56, 95% CI 0.44-0.77) in extended DAPT; lower rate of major bleeding (OR 0.61, 95% CI 0.39-0.87) in very short and lower rate of any bleeding (OR 0.61, 95% CI 0.38-0.90) in short DAPT. All DAPT durations were comparable regarding the secondary efficacy endpoints. Very short followed by P2Y12 inhibition was the treatment of choice to reduce both major bleeding and myocardial infarction. In the ACS subgroup, extended (as compared to standard DAPT) reduced PEP and ST (but not MI).
Conclusion
The efficacy of short and very short is comparable with that of standard DAPT after DES implantation, whereas extended DAPT reduces MI rate. Very short DAPT reduces haemorrhagic events and, followed by a P2Y12 inhibitor monotherapy, may be preferred in order to pursue a trade-off between major bleeding and ischemia.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 01 Nov 2020; epub ahead of print
Benenati S, Crimi G, Canale C, Pescetelli F, ... Crea F, Porto I
Eur Heart J Cardiovasc Pharmacother: 01 Nov 2020; epub ahead of print | PMID: 33135064
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Abstract

EFFECT oF STATIN THERAPY oN SARS-CoV-2 INFECTION-RELATED.

Masana L, Correig E, Rodríguez-Borjabad C, Anoro E, ... Pedro-Botet J, Group OBOTSR
Aim
Assessing the effect of statin therapy at hospital admission for COVID-19 on in-hospital mortality.
Methods and results
Retrospective observational study. Patients taking statins were 11 years older and had significantly more comorbidities than patients who were not taking statins. A genetic matching (GM) procedure was performed prior to analysis of the mortality risk. A Cox proportional hazards model was used for the cause-specific hazard (CSH) function, and a competing-risks Fine and Gray (FG) model was also used to study the direct effects of statins on risk.Data from reverse transcription-polymerase chain reaction-confirmed 2157 SARS-CoV-2-infected patients (1234 men, 923 women; age: 67 y/o (IQR 54-78)) admitted to the hospital were retrieved from the clinical records in anonymized manner. 353 deaths occurred. 581 patients were taking statins. Univariate test after GM showed a significantly lower mortality rate in patients on statin therapy than the matched non-statin group (19.8% vs. 25.4%, χ2 with Yates continuity correction: p = 0.027). The mortality rate was even lower in patients (n = 336) who maintained their statin treatments during hospitalization compared to the GM non-statin group (17.4%; p = 0.045). The Cox model applied to the CSH function (HR = 0.58(CI: 0.39-0.89); p = 0.01) and the competing risks FG model (HR = 0.60(CI: 0.39-0.92); p = 0.02) suggest that statins are associated with reduced COVID-19-related mortality.
Conclusions
A lower SARS-CoV-2 infection-related mortality was observed in patients treated with statin therapy prior to hospitalization. Statin therapy should not be discontinued due to the global concern of the pandemic or in patients hospitalized for COVID-19.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 01 Nov 2020; epub ahead of print
Masana L, Correig E, Rodríguez-Borjabad C, Anoro E, ... Pedro-Botet J, Group OBOTSR
Eur Heart J Cardiovasc Pharmacother: 01 Nov 2020; epub ahead of print | PMID: 33135047
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Abstract

Management of pregnancy-related hypertensive disorders in patients infected with SARS CoV-2: pharmacological and clinical issues.

Fogacci S, Fogacci F, Favari E, Toth PP, Borghi C, Cicero AFG

Coronavirus-19 disease (COVID-19) continues to spread throughout the world. It is known that among patients with hypertension, diabetes, chronic respiratory disease, or cardiovascular diseases, COVID-19 is associated with greater morbidity and mortality compared with patients without these conditions. This correlation is of great importance in pregnant women affected by COVID-19, since it usually leads to the development of a serious clinical complication. In particular, managing hypertensive disorders in pregnancy can be problematic because antihypertensive medications may interact pharmacologically with drugs used to treat COVID-19. This review focuses on the safety of drug treatment for COVID-19 in pregnant women treated with antihypertensive medication. Several databases were searched to identify relevant literature. A few antihypertensive drugs and antithrombotic treatments are known for having a beneficial effect in the management of hypertension and hypertensive disorders in pregnancy. In this review, we focus on the expected drug-drug interactions with the experimental agents most often used to treat COVID-19. The current indications for the management of hypertension-related disorders in pregnancy maintain their validity, while the risk of pharmacological interaction with the currently tested anti-SARS-CoV-2 medications is relatively low.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 09 Sep 2020; epub ahead of print
Fogacci S, Fogacci F, Favari E, Toth PP, Borghi C, Cicero AFG
Eur Heart J Cardiovasc Pharmacother: 09 Sep 2020; epub ahead of print | PMID: 33155016
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Abstract

Unravelling the puzzle of antithrombotic therapies for complex percutaneous coronary intervention.

De Luca L, Valgimigli M

Percutaneous coronary intervention (PCI) has remarkably evolved in the last decades. This has resulted in a larger number of patients treated with PCI, including those with more complex anatomic lesions. Several studies demonstrated that PCI involving complex lesions is associated with increased rate of procedural complications and adverse clinical outcomes. In this setting, optimal adjunctive antithrombotic regimens still need to be defined. In this review, we sought to summarize and discuss the recent evidence deriving from analyses appraising antithrombotic therapies in patients undergoing complex PCI.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 15 Sep 2020; epub ahead of print
De Luca L, Valgimigli M
Eur Heart J Cardiovasc Pharmacother: 15 Sep 2020; epub ahead of print | PMID: 33175148
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Abstract

Efficacy and safety of early initiation of eplerenone treatment in patients with acute heart failure (EARLIER trial): a multicenter, randomized, double-blind, placebo-controlled trial.

Asakura M, Ito S, Yamada T, Saito Y, ... Kitakaze M,
Aims
A mineralocorticoid receptor antagonist (MRA) is effective in patients with chronic heart failure; however, the effects of the early initiation of an MRA in patients with acute heart failure (AHF) have not been elucidated.
Methods and results
In this multicenter, randomized, double-blind, placebo-controlled, parallel-group study, we focused on the safety and effectiveness of the treatment with eplerenone, a selective MRA in 300 patients with AHF, that is, 149 in the eplerenone group and 151 in the placebo group in 27 Japanese institutions. The key inclusion criteria were (1) patients aged 20 years or older and (2) those with left ventricular ejection fraction of ≤ 40%. The primary outcome was a composite of cardiac death or first re-hospitalization due to cardiovascular disease within 6 months. The mean age of the participants was 66.8 years, 27.3% were women, and the median levels of brain natriuretic peptide were 376.0 pg/mL. The incidences of the primary outcome were 19.5% in the eplerenone group and 17.2% in the placebo group (hazard ratio (HR): 1.09, 95% confidence interval (CI): 0.642-1.855). In prespecified secondary outcomes, HR for the composite endpoint, cardiovascular death, or first re-hospitalization due to heart failure (HF) within 6 months was 0.55 (95% CI: 0.213 to 1.434). The safety profile for eplerenone was as expected.
Conclusion
The early initiation of eplerenone in patients with AHF could safely be utilized. The reduction of the incidence of a composite of cardiovascular death or first re-hospitalization for cardiovascular diseases by eplerenone is inconclusive because of inadequate power.

© Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 10 Nov 2020; epub ahead of print
Asakura M, Ito S, Yamada T, Saito Y, ... Kitakaze M,
Eur Heart J Cardiovasc Pharmacother: 10 Nov 2020; epub ahead of print | PMID: 33175088
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Abstract

Depressive symptoms and non-adherence to treatable cardiovascular risk factors\' medications in the CONSTANCES cohort.

Hamieh N, Kab S, Zins M, Blacher J, ... Melchior M, Lemogne C
Aims
Depression is associated with increased risk of cardiovascular disease (CVD) and the role of poor medical adherence is mostly unknown. We studied the association between depressive symptoms and non-adherence to medications targeting treatable cardiovascular risk factors in the CONSTANCES population-based French cohort.
Methods and results
We used CONSTANCES data linked to the French national healthcare database to study the prospective association between depressive symptoms (assessed at inclusion with the Center for Epidemiological Studies Depression scale) and non-adherence to medications (less than 80% of trimesters with at least one drug dispensed) treating type 2 diabetes, hypertension, and dyslipidaemia over 36 months of follow-up. Binary logistic regression models were adjusted for socio-demographics, body mass index, and personal history of CVD at inclusion. Among 4998 individuals with hypertension, 793 with diabetes, and 3692 with dyslipidaemia at baseline, respectively 13.1% vs. 11.5%, 10.5% vs. 5.8%, and 29.0% vs. 27.1% of those depressed vs. those non-depressed were non-adherent over the first 18 months of follow-up (15.9% vs. 13.6%, 11.1% vs. 7.4%, and 34.8% vs. 36.6% between 19 and 36 months). Adjusting for all covariates, depressive symptoms were neither associated with non-adherence to medications for hypertension, diabetes, and dyslipidaemia over the first 18 months of follow-up, nor afterwards. Depressive symptoms were only associated with non-adherence to anti-diabetic medications between the first 3-6 months of follow-up.
Conclusion
Non-adherence to medications targeting treatable cardiovascular risk factors is unlikely to explain much of the association between depressive symptoms and CVD at a population level. Clinicians are urged to search for and treat depression in individuals with diabetes to foster medications adherence.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: [email protected]

Eur Heart J Cardiovasc Pharmacother: 27 Oct 2020; epub ahead of print
Hamieh N, Kab S, Zins M, Blacher J, ... Melchior M, Lemogne C
Eur Heart J Cardiovasc Pharmacother: 27 Oct 2020; epub ahead of print | PMID: 33200205
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Abstract

Antithrombotic therapy according to baseline bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention: applying the PRECISE-DAPT score in RE-DUAL PCI.

Costa F, Valgimigli M, Steg PG, Bhatt DL, ... Oldgren J, Cannon CP
Aims
Patients with atrial fibrillation undergoing coronary intervention are at higher bleeding risk due to the concomitant need for oral anticoagulation and antiplatelet therapy. The RE-DUAL PCI trial demonstrated better safety with dual antithrombotic therapy (DAT: dabigatran 110 or 150 mg bid, clopidogrel or ticagrelor) compared to triple antithrombotic therapy (TAT: warfarin, clopidogrel or ticagrelor, and aspirin). We explored the impact of baseline bleeding risk based on the PRECISE-DAPT score for decision-making regarding DAT vs. TAT.
Methods and results
A score ≥25 points qualified high bleeding-risk (HBR). Comparisons were made for the primary safety endpoint ISTH major or clinically relevant non-major bleeding, and the composite efficacy endpoint of death, thromboembolic events, or unplanned revascularization, analyzed by time-to-event analysis. PRECISE-DAPT was available in 2,336/2,725 patients, and 37.9% were HBR. Compared to TAT, DAT with dabigatran 110 mg reduced bleeding risk both in non-HBR (HR 0.42, 95%CI, 0.31-0.57) and HBR (HR 0.70, 95%CI, 0.52-0.94), with a greater magnitude of benefit among non-HBR (Pint=0.02). DAT with dabigatran 150 mg vs. TAT reduced bleeding in non-HBR (HR 0.60, 95%CI, 0.45-0.80), with a trend toward less benefit in HBR patients (HR 0.92, 95%CI, 0.63-1.34, Pint=0.08). Risk of ischaemic events was similar on DAT with dabigatran (both 110 and 150 mg) vs. TAT in non-HBR and HBR patients (Pint=0.45 and Pint=0.56, respectively).
Conclusions
PRECISE-DAPT score appeared useful to identify AF patients undergoing PCI at further increased risk of bleeding complications, and may help clinicians identifying the antithrombotic regimen intensity with the best benefit-risk ratio in an individual patient.

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Eur Heart J Cardiovasc Pharmacother: 30 Nov 2020; epub ahead of print
Costa F, Valgimigli M, Steg PG, Bhatt DL, ... Oldgren J, Cannon CP
Eur Heart J Cardiovasc Pharmacother: 30 Nov 2020; epub ahead of print | PMID: 33258897
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Impact:

This program is still in alpha version.