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Aims As the antithrombotic regimen that may best prevent ischaemic 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. Methods and results 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% CIs) using a random-effects model in a frequentist pairwise and network metanalytic approach. We included seven studies comprising 4006 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 with 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 vs. DAPT (RR 1.02, 95% CI 0.67–1.58) and SAPT and DAPT compared with 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 with 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. Conclusion Following TAVI in patients without an indication for chronic oral anticoagulant, SAPT more than halved the risk of bleeding compared with DAPT and direct oral anticoagulant-based regimens without significant ischaemic offset.

Aims The European Society of Cardiology (ESC) has released three consecutive guidelines within 5 years addressing cardiovascular prevention, risk scores, and cholesterol treatment. This study aims to evaluate whether the 2021 ESC guidelines improved the eligibility of individuals for primary prevention statin therapy before their first ST-segment elevation myocardial infarction (STEMI), and for intensive lipid-lowering treatments in secondary prevention. Methods and results The cardiovascular risk category of 2757 consecutive individuals admitted for a first STEMI was evaluated to assess whether they would have been eligible for primary prevention statins according to 2021 vs. 2019 and 2016 ESC guidelines. Eligibility for intensive lipid-lowering therapy in secondary prevention was assessed according to the real-life follow-up low-density lipoprotein cholesterol (LDL-C) and the expected follow-up LDL-C. More individuals would have been eligible for primary prevention statins according to 2021 and 2019 vs. 2016 guidelines (61.8% vs. 38.7% vs. 23.6%, P Conclusion The 2021 ESC guidelines improved the detection and treatment of individuals at risk for a first myocardial infarction. In secondary prevention, 70% of patients kept LDL-C levels above 55 mg/dL: increasing the statin dose and adding ezetimibe were the most frequently recommended therapeutic actions.

OBJECTIVES The aim of this study was to evaluate the impact of transit-time flow measurement (TTFM) on early postoperative outcomes in total arterial coronary revascularization. METHODS A single-centre retrospective analysis was conducted on 910 patients undergoing isolated total arterial coronary artery bypass grafting with internal thoracic arteries (ITAs) at our institution, between January 2017 and February 2020. Complete arterial revascularization with bilateral ITAs with a Y-configuration, or single ITA, was planned for all patients. According to the surgeon preference, TTFM was assessed in 430 patients (TTFM group). They were compared with 480 patients without TTFM assessment (no TTFM group). Primary end point was the occurrence of in-hospital major cardiac adverse events (MACE). A propensity score analysis with an inverse probability weighting approach was performed to control for selection bias. RESULTS TTFM was associated with longer cardiopulmonary bypass times (76.0 [62.0; 91.2] vs 79.0 [65.0; 94.0] min, P = 0.042). Six (1.4%) patients in the TTFM group versus no patient in the no TTFM group underwent intraoperative graft revision because of unsatisfying flow values (P = 0.011). MACE were significantly lower in the TTFM group (14, 3.3%) than in the no TTFM group (33, 6.9%, P = 0.014). At crude regression, TTFM was protective against MACE occurrence (odds ratios 0.46, 95% confidence interval 0.23–0.85, P = 0.016). Inverse probability weighting adjustment did not significantly displace P-values and odds ratios for MACE occurrence in the TTFM group 0.44, 95% confidence interval 0.28–0.69, P < 0.001. CONCLUSIONS Even if associated with longer cardiopulmonary bypass times, intraoperative graft flow measurement with TTFM reduces MACE occurrence and it should be recommended for graft evaluation in arterial coronary artery bypass grafting surgery.

Background There are only limited options for long-term cardiac monitoring devices readily available in clinical practice for outpatients. Holter monitoring devices are limited by the uncomfort of wires and patches, the small number of leads for analysis, the quality of recordings or the monitoring duration while insertable cardiac monitors are costly and exposed to potential local complication. Purpose To describe a single center experience with a novel wearable device for cardiac rhythm monitoring. Methods The Cardioskin™ system is a patch-free, wire-free, wearable device with rechargeable batteries that provides a high quality 15-lead electrocardiogram monitoring over 1 month (Figure 1). Data are sent using a mobile application downloaded in the patient smartphone to a central Corelab where they can be interpreted by an expert and/or the prescribing physician. An alarm signal is readily available within the Cardioskin™ device, to allow patients to indicate the presence of symptoms. In this single center retrospective registry, we provide a first report of the use of this novel device in real world practice, with indication and duration of cardiac monitoring left at the physicans “discretion”. Results From January 2019 to December 2019, the Cardioskin™ system was prescribed in 60 patients for an overall median duration of 26.5 (14–32) days. The mean age of the patients was 45±12.2 years and 24 (40%) were male. Indications for cardiac monitoring were post-Stroke, palpitation, syncope and cardiomyopathy assessment in 56%, 30%, 7% and 7% of the cases, respectively. A sustained (>30 seconds) supraventricular tachycardia was detected in 4 cases, including one case of atrial fibrillation, two case of atrial tachycardia and on case of junctional tachycardia. Unsustained ventricular tachycardia and atrial fibrillation burst were detected in another 2 cases (Figure 1). There was no reported case of skin irritation by the Cardioskin™ system or abrupt interruption of the monitoring by the patients. Conclusion The Cardioskin™ system is a novel, discreet and comfortable cardiac rhythm wearable long-term monitoring device which can be used in clinical practice for broad diagnostic indications. Figure 1. Cardioskin system Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): ACTION coeur

Background In the large randomized trials evaluating patent foramen ovale (PFO) closure vs. medical treatment in secondary prevention of stroke, the incidence of atrial fibrillation has been reported more frequently with PFO closure (2.9–6.6%) than with medical treatment (0.4–1.9%). These episodes were clinically reported and may not reflect the real incidence detected by prolonged ECG recording. Purpose To evaluate the incidence and timing of supraventricular tachycardia (SVT) after percutaneous PFO closure. Methods Prolonged cardiac monitoring was proposed to patients undergoing PFO closure at the tertiary center of Pitié Salpétrière Hospital, Paris. According to the estimated risk of SVT, two different approaches were used to monitor cardiac rhythm. A 3-year permanent recording using REVEAL™ XT or LINQ was proposed to high risk patients (age >45 years, multiple CV risk factors, prior palpitations or supraventricular ectopic activity during Holter monitoring prior to the intervention). A 4-week, 15-lead ECG continuous recording using the patch-free, wire-free, wearable Cardioskin™ system was proposed to lower risk patients. Endpoints of interest were the occurrence of SVT episodes (>30 seconds) and unplanned medical consultation or hospitalization for this reason Results From October 2018 to January 2020, a total of 64 patients underwent prolonged ECG monitoring including 32 (50.0%) and 32 (50.0%) patients with Cardioskin™ and REVEAL™ systems, respectively. A SVT was recorded in 11 (17.4%) patients, including atrial fibrillation (AF) in 6 (9.5%) patients. The median delay of SVT occurrence was 33.0 (14.0–39) days after the procedure (Figure 1) and 18 (10.8–34.8) days for the 6 patients with AF. Unplanned hospitalization or emergency medical visit for symptomatic SVT occurred in 5 (45.5%) patients. Antiarrhythmic medication and oral anticoagulation were initiated in 10 (90.1%) and 7 (63.6%) of the 11 patients, respectively, and SVT recurrences were recorded in 5 (45.5%) patients. No stroke was reported in any of the 11 patients during follow-up. There were no significant differences with respect to baseline and procedural characteristics among patients with or without SVT during follow-up. Conclusion Atrial tachycardia is frequent (17.4%) after PFO closure and long-term continuous ECG recording suggests that the incidence is higher than the clinical episodes reported in the randomized trials. This arrhythmic complication of PFO closure seems limited to the first 4 months following the procedure. Larger studies need now to confirm our findings. Figure 1 Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): ACTION coeur

Background Percutaneous left atrial (LA) appendage closure is increasingly used to prevent strokes in patients with atrial fibrillation (AF). While LA appendage plays a key role in LA physiology, data regarding the impact of LA appendage occlusion on LA hemodynamics are lacking. The alteration of LA compliance by LA appendage occlusion may represent a clinical issue in AF patients which are at high risk of heart failure. Purpose To describe the impact of LA appendage occlusion on LA hemodynamics. Material and methods From july 2015 to january 2020, all patients undergoing LA occlusion procedure at Pitié-Salpêtrière Hospital (Paris, France) in whom LA pressure curves were recorded, before and immediately after device implantation, were included. The LA mean pressure was measured at baseline and after LA appendage occlusion during the same procedure. Abnormal LA mean pressure was defined as >15mmHg. We also recorded cardiovascular death and hospitalization for congestive heart failure at longest follow-up. Results We enrolled 85 patients (78±8 years, 46 men), the CHA2DS2-VASc score was 5±1 and the HAS-BLED score was 4±1. The mean LA volume index was 51±15mL/m2, the left ventricular ejection fraction was 60±7%. The LA mean pressure increased significatively after LA appendage closure from 12.6±3.9mmHg to 15.5±5.2mmHg (p During a median follow-up of 364 [124–726] days, 3 (3.5%) patients died from a cardiovascular cause. Hospitalization for heart failure occurred in 6 (16%) of the 38 patients with abnormal postprocedural LA pressure, whereas no congestive episode was observed in the rest of the study population (p=0.006). Conclusion Catheter-based LA appendage occlusion induces an acute alteration of LA hemodynamics. Post procedural abnormal LA pressure may be linked to heart failure episodes in some patients. Further studies are warranted to investigate heart failure as a potential late complication of LA appendage closure. Variations of mean LA pressure Funding Acknowledgement Type of funding source: None

Background Complete revascularization (CR) – assessed by the residual SYNTAX score (rSS) – following PCI is associated with a better prognosis – in stable coronary disease, acute coronary syndrome and myocardial infarction (MI). Whether, the completeness of revascularization impacts the prognosis of patients in cardiogenic shock (CS) remains unclear. Aim Assess the prognosis value of rSS following primary PCI in multivessel patients undergoing MI-related CS. Methods The CULPRIT SHOCK trial – the largest randomized trial (n=706) to date in CS – compared an immediate multivessel PCI (MVPCI) strategy to a culprit lesion only PCI (with possible staged revascularization) strategy in multivessel patients with MI-related CS. The rSS were retrospectively assessed following last PCI (either index or staged) by a central core laboratory and patients were allocated in 4 different groups according to rSS: CR (rSS=0), 0< rSS ≤5, 5< rSS ≤14, rSS >14. The prognostic impact of rSS on the 30-day composite endpoint (mortality and/or severe renal failure) and 30-day and 1-year mortality were assessed using multivariate logistic regression. Results Among the 604 patients with last rSS available, aged 68.2±11.4, the median rSS was 9.0 [4.0–17.0]. CR was achieved in 75 (25%) patients in the MVPCI strategy and in 31 (10.2%) in the culprit lesion only PCI strategy. One hundred and six (17.5%), 102 (16.9%), 198 (32.8%) and 198 (32.8%) patients had a rSS=0, 0< rss ≤5, 5< rSS ≤14 and rSS >14, respectively. Patients with a higher rSS were older, less active smoker, had more triple vessel disease, chronic total occlusion, post-PCI culprit coronary TIMI flow 14 had higher rates of 30-day primary endpoint (OR [95% CI]: 2.02 [1.24; 329] and 2.75 [1.69; 4.49]), 30-day mortality (OR [95% CI]: 2.13 [1.29; 3.51] and 3.14 [1.90; 5.18]) and 1-year mortality (OR [95% CI]: 2.39 [1.46; 3.90] and 3.47 [2.11; 5.71]) compared to patients with CR. After multiple adjustment, rSS – tested as continuous variable – was independently associated with 30-day primary endpoint, 30-day and one-year mortality (Figure) Conclusion Among multivessel patients with MI-related cardiogenic shock, 1) complete revascularization is achieved only in one fourth of the patients using a MVPCI strategy and, 2) the residual SYNTAX score is independently associated with early and late mortality. Acknowledgement/Funding Funded by the European Union 7th Framework Program and others

Background Available data on the long-term impact of coronary artery calcification (CAC) after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) are limited. Purpose We evaluated the long-term impact of CAC on outcomes after PCI and the respective performance of first- and second-generation DES. Methods We pooled patient-level data from 18 randomized trials evaluating DES categorized according to the presence of angiographic core lab-confirmed moderate or severe CAC in any target lesion. Outcome measures of interest were the patient-oriented composite endpoint (POCE; death, myocardial infarction [MI], or any revascularization), the device-oriented composite endpoint of target lesion failure (TLF; cardiac death, target vessel MI or ischemia-driven target lesion revascularization), and definite or probable stent thrombosis (ST). Multivariable Cox proportional regression with study as a random effect was used to assess 5-year outcomes. Results A total of 19,833 patients were included. Moderate or severe CAC was present in 6211 (31.3%) patients and associated with increased 5-year risk of the POCE (adjHR 1.12, 95% CI 1.05–1.20, p Conclusion In this large-scale study, target lesion moderate or severe CAC was associated with adverse patient- and device-related outcomes at 5 years, risks that were reduced but not eliminated with second-generation DES. Acknowledgement/Funding This investigator-sponsored study was funded by Abbott Vascular.

Background Comparative long-term outcomes among women and men treated with percutaneous intervention (PCI) are unknown. Objective To describe and compare mortality and predictors of poor outcomes among men and women who underwent PCI. Methods Consecutive men and women admitted for PCI between 2008 and 2011 were prospectively included and followed-up in this cohort study. Major adverse cardiovascular and cerebrovascular events (MACCE) and causes of death were collected through consultations, calls and death certificate. The primary endpoint was all-cause mortality according to gender. Secondary endpoints were cardiovascular death, non-cardiovascular death and MACCEs. Last detailed cardiovascular and vital status were collected in January 2019. Results A total of 3524 patients including 2720 men (77.1%) and 804 women (22.8%) were followed-up for a median time of 7.0 years (IQ1: 5.4; IQ 3: 7.2). The follow-up rate was 97.6%. Women were older at baseline (70±13.1 vs. 64.6±12), smoked less often (18.9% vs. 30.4%) but suffered more frequently of hypertension (67.9% vs. 58.1%) and chronic kidney disease (42.6% vs. 22.7%). All-cause death occurred for 30.3% (n=1070) and MACCE for 40.9% (n=1443) of patients in the cohort. In unadjusted analyses, women had a higher risk of all-cause mortality (35% vs 29%, HR = 1.25, 95% CI [1.09–1.43], p=0.0015) and cardiovascular mortality (61% vs. 57%, HR = 1.31, 95% CI [1.10–1.56]) but there was no difference on occurrence of MACCE (HR = 1.079, 95% CI = [0.9271–1.221]). After adjustments for baseline cardiovascular risk factors, presentation and severity of coronary disease, women and men shared a similar risk of mortality along time (adHR = 0.90, 95% CI [0.77–1.05]). Survival curves in women vs. men Conclusions In this long-term follow-up, women had a higher risk of all-cause and cardiovascular mortality after PCI in unadjusted analyses. However, gender was not independently associated with mortality after adjustment for cardiovascular risk factors.

Background Incidence and correlates of readmission for heart failure in all-comers, after successful transcatheter aortic valve replacement (TAVR) remain unclear. Objective We sought to evaluate the incidence, risk factors and clinical impact of readmission for HF after successful TAVR in an unselected patient population. Methods All patients who underwent successful TAVR in two high-volume French tertiary centers from February 2010 to December 2016 were prospectively included and followed-up for one year. Cox multivariate model was used to assess risk factors of readmission for heart failure, evaluated a time-updated covariate and mortality. Results A total of 1139 patients (mean age 82.4±7.7 years, 52.2% male) were included. Readmission for heart failure occurred in 99 (8.7%) patients. Risk factors of readmission for HF were chronic pulmonary disease (adjHR 1.8; 95% CI [1.2–2.8], p=0.008), chronic kidney disease (adjHR 1.7; 95% CI [1.1–2.6], p=0.01), diabetes mellitus (adjHR 1.7; 95% CI [1.1–2.5], p=0.01), prior atrial fibrillation (adjHR 1.6; 95% CI [1.1–2.4], p=0.02) and post-TAVR left ventricular ejection fraction (LVEF) ≤35% (adjHR 2.1 95% CI 1.2–3.7, p=0.009). Readmission for HF was strongly associated with mortality (Figure) along with increased STS score (adjHR 1.07 95% CI 1.03–1.12, p=0.002), prior atrial fibrillation (adjHR 2.13 95% CI 1.53–2.96, p Figure 1 Conclusion Readmission for heart failure occurs in one out of ten patients after successful TAVR and is strong risk factor of mortality. Comorbidities and post-TAVR LVEF≤35% are the main correlates of readmission for heart failure. Acknowledgement/Funding ACTION study group

Background Causes of death after percutaneous coronary intervention (PCI) along multiple time-periods are poorly described. Objective To describe causes and predictors of short-term, intermediate-term, and long-term mortality after PCI. Methods Consecutive men and women admitted for PCI from 2008 to 2011 were prospectively included and followed-up in this cohort study. A dedicated follow-up by independent reviewers was performed to collect the outcomes and adjudicate the causes of death. A log-rank analysis was used to compare the occurrence of cardiovascular and non-cardiovascular death at 30 days, one year and up to 8 years. Last detailed cardiovascular and vital status were collected in January 2019. Results A total of 3524 patients including 2720 men (77.2%) and 804 women (22.8%) were followed-up for a median time of 7.0 years (IQ1: 5.4; IQ 3: 7.2). The rate of complete follow-up was 97.6%. All-cause death occurred for 30.3% (n=1070) of patients in the cohort, in a median time of 2.5 years after PCI, with a rate of 5.3 deaths per 100 patient-years. Overall, mortality was mostly related to cardiovascular causes than non-cardiovascular causes (17.7% versus 12.6%, log-rank Survival after PCI Conclusions In this long-term cohort study, cardiovascular death was more frequent than non-cardiovascular death in patients treated with PCI in the short and intermediate-term but not beyond one year. Cancer accounted for one fifth of the overall mortality.

Background Thrombolysis In Myocardial Infarction (TIMI) flow is a prognostic factor which assessment is complex in life-threatening situations. Because TIMI flow evaluation by site investigator (SI) is subject to bias, independent Core-Laboratory (CL) adjudication is the reference standard in clinical trials. Purpose To evaluate the concordance between CL and SI in the evaluation of the culprit artery TIMI flow, and the associated prognosis in the CULPRIT-SHOCK trial. Methods All patients of the CULPRIT-SHOCK trial with CL adjudications were included in this analysis. CL adjudicators were blinded to patient's characteristics and outcomes: pre and post-PCI TIMI flows were solely evaluated on the basis of coronary angiograms. SI determined the TIMI flow before and immediately after PCI of the culprit lesion. The concordance was determined by Cohen's κ coefficient. A multivariate analysis was used to evaluate 1) factors of discordance 2) the association between each method of evaluation and the mortality at 30 days and 1 year. Results Among CULPRIT-SHOCK patients, 663 patients were eligible for this analysis. Of the 214 patients adjudicated TIMI flow 3 by CL before PCI, SI over-estimated the obstruction to TIMI flow 0–1-2 in 121 (56.5%). Of the 139 patients scored TIMI flow 0–1-2 by CL after PCI, SI over-graded their results to TIMI flow 3 in 79 (56.8%). Overall, the K coefficient of agreement was 0.44, 95% CI [0.36; 0.51] before PCI and 0.44, 95% CI [0.35; 0.53] after PCI. Mechanical circulatory support and culprit left main were the main factors of discordance of TIMI flow after PCI. The association between TIMI flow 0–1-2 after PCI and 30-days mortality was significant, whether adjudicated by SI or CL (figure). Post-PCI TIMI-flow 0–1-2 was associated to 1-year mortality only when evaluated by SI (figure). Association between TIMI and mortality Conclusions In comparison to the independant CL evaluation, SI overestimated the severity of coronary slow flow before PCI, and the success of PCI in improving coronary flow. The level of agreement between CL and SI was moderate. While both evaluations predicted 30-days mortality, only SI scoring was associated to 1-year mortality. Acknowledgement/Funding European Union Seventh Framework Program, the German Heart Research Foundation, German Cardiac Society.

Transcatheter left atrial appendage (LAA) closure is an alternative strategy for stroke prevention in atrial fibrillation (AF) patients with an inacceptable risk of bleeding with oral anticoagulation (OAC). A better characterization of major adverse clinical events after LAA closure in daily practice is still needed. Methods We analysed data from all AF patients treated with Watchman or Amplatzer LAA closure according to European guidelines in 8 French cardiology departments. Antithrombotic management was decided for each patient on an individual basis. A Cox regression model was used for multivariable analysis of major adverse events. Yearly rate of ischemic stroke during follow-up was calculated and compared to that expected for a same risk score population. Yearly rate of bleeding was extrapolated from that reported with the HASBLED score. Results A total of 469 consecutive AF patients (299 males, 74.9±8.9 years old, mean CHA2DS2-VASc score 4.5±1.4, HASBLED score 3.7±1.0) received LAA closure from March 2012 to January 2017. There were 272 Watchman devices (58%) and 197 ACP devices (42%) implanted. At discharge, 36% received a single anti platelet therapy (APT), 23% received dual APT, 29% received OAC and no APT, 5% received OAC plus APT and 8% received no antithrombotic therapy. Mean follow up was 11.4 months (median 7, interquartile 3–22 months) during which 70 major adverse events (19 ischemic strokes, 18 major haemorrhages and 33 deaths) were recorded in 69 patients. The annual rate of ischemic stroke was 3.96%, which translates into a 13% relative risk reduction (95% CI −59 to 52%) as compared with the calculated stroke rate for similar CHA2DS2-VASc score after adjustment for exposure to APT and OAC. The annual rate of major bleeding in the study was 3.75%, which corresponds to a 48% relative risk reduction (95% CI 9 to 70%) as compared with the rate that would have been expected based on a comparable HAS-BLED score. Yearly rate of mortality was 7.4% (2.5 to 3 fold higher than in previous randomized trials) and the rate of non-cardiovascular death was 82%. None of the baseline characteristics was predictive of major adverse events, neither in univariate nor in multivariable analysis, which highlights the difficulty in identifying a risk of unfavourable outcome with simple tools. Conclusions AF patients treated with LAA closure may have a lower risk of stroke and bleeding events compared to their theoretical risk. However, our findings indicate that a high rate of major adverse events is observed in these patients during follow-up. This questions the suggested cost-effectiveness of the procedure (with models based on previous trials) for a real-life perspective. A better identification of patients with a relevant benefit of LAA closure is needed among those with long-term anticoagulation contraindication, both for an optimal management of each patient on an individual basis and for a global perspective with limited healthcare resources.

Background Left Ventricular Thrombus (LVT) is associated with a high risk of thromboembolic complications such as stroke. Contemporary data are lacking on the management, prognosis and treatment of LVT, particularly with the emergence of the non-vitamin K antagonist anticoagulants (NOACs). Purpose To study the time and predictive factors associated with thrombus regression on treatment and its association with survival, embolic and bleeding complications. Methods From January 2011 to January 2018, a computerized case sensitive search of LVT was performed on 90 065 consecutive echocardiogram reports. All patients with a confirmed LVT were included in this analysis after imaging review by two independent experts. Repeated echocardiographic data, treatment management and clinical outcomes were collected during follow-up. Major adverse cardiac events (MACE), defined as the composite of death, ischemic stroke or transient ischemic attack (TIA), myocardial infarction (MI) or embolic peripheral artery occlusion were analyzed as well as major bleeding events (BARC ≥3) and the predictive factors and impact of LVT regression. Results We identified 174 patients with a suspected LVT of whom 159 had confirmed LVT on two different cardiac imaging exams. Ischemic cardiomyopathy was the main cause of LVT (n=125, 78.6%) including 56 (35.2%) patients with an acute ST segment elevation MI. The mean left ventricular ejection fraction was 31.9±12.5% with predominant (98.1%) apical location of the LVT. Anticoagulation therapy was achieved with vitamin K antagonists, NOACs and parenteral heparins in 48.7%, 22.8% and 27.8% of patients, respectively. Concomitant antiplatelet therapy was prescribed in 67.9% of patients. Total LVT regression was reached in two third of patients (62.3%, n=99) within a median time of 103 [32–392] days. Independent predictors of total LVT regression were an ischemic cardiomyopathy (HR: 0.36 [0.19–0.70], p=0.002), a larger baseline thrombus area (HR=0.66 [0.45–0.96], p During a median follow-up of 632 [187–1126] days, MACE occurred in 59 (37.1%) patients with a 18.9% rate of mortality and 13.2% of major bleeding. Patients with a total LVT regression had a non-significant lower rate of MACE as compared with patients without total LVT regression (35.4% vs. 40.0%; HR=0.71 [0.42–1.21]; p=0.20), and a significant lower rate of mortality (15.2% vs. 25.0%; HR=0.48 [0.23–0.98]; p=0.039). Occurence of mortality (A) and MACE (B) Conclusions The prognosis of LVT remains severe with a high risk of major cardiovascular event and mortality. Total LVT regression, mostly reached in 3 months, can be obtained with both vitamin K antagonists and NOACs and is associated with a better prognosis.

Background Alirocumab and evolocumab, two proprotein convertase subtilisin–kexin type 9 inhibitors, have both been associated with improved outcomes in patients with atherosclerotic cardiovascular disease in addition to standard lipid-lowering therapies. However, their comparative safety and efficacy profiles are unknown. Purpose To compare the safety and efficacy of alirocumab versus evolocumab. Methods We conducted a systematic review and network meta-analysis of placebo-controlled randomized trials available up to November 2018 evaluating the safety and efficacy of alirocumab and evolocumab. We estimated risk ratio and 95% confidence intervals using fixed effect model in a frequentist pairwise and network metanalytic approach. The primary safety endpoints were any adverse events leading to treatment-discontinuation, injection site reaction, systemic allergic reaction, neurocognitive events, ophthalmologic events and new-onset of diabetes mellitus (DM) or worsening of pre-existing DM. The primary efficacy endpoints were all-cause and cardiovascular (CV) death, myocardial infarction (MI) and stroke. This study was registered in PROSPERO (CRD42018090768). Results A total of 30 trials, enrolling 59,026 patients were included in this analysis, of whom 13,607 received alirocumab and 17,931 received evolocumab. Mean weighted follow-up time was 2.5 years, with an exposure time of 144,907 patients-years. Eligibility criteria varied significantly across trials evaluating alirocumab and evolocumab. There were no significant differences between alirocumab and evolocumab in terms of safety endpoints, except for injection site reaction with a 27% increased risk of injection site reaction with alirocumab compared to evolocumab (Figure). Compared with evolocumab, alirocumab was associated with a reduction of all-cause death but not CV death. There were no significant differences in MI or stroke between alirocumab and evolocumab. Conclusion Alirocumab and evolocumab share a similar safety profile. No significant differences were observed across the efficacy endpoints, except for all-cause death, which may be related to heterogeneity of the studied populations between the two drugs.