Defining high bleeding risk in patients undergoing transcatheter aortic valve implantation: a VARC-HBR consensus document.

The identification and management of patients at high bleeding risk (HBR) undergoing transcatheter aortic valve implantation (TAVI) are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. VARC-HBR is an initiative of the CERC (Cardiovascular European Research Center), aiming to develop a consensus definition of TAVI patients at HBR, based on a systematic review of the available evidence, to provide consistency for future clinical trials, clinical decision-making, and regulatory review. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI..

A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study.

BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.

Clinical effects of permanent pacemaker implantation after transcatheter aortic valve implantation: Insights from the nationwide FRANCE-TAVI registry.

BACKGROUND: The influence of permanent pacemaker implantation upon outcomes after transcatheter aortic valve implantation (TAVI) remains controversial. AIMS: To evaluate the impact of permanent pacemaker implantation after TAVI on short- and long-term mortality, and on the risk of hospitalization for heart failure. METHODS: Data from the large FRANCE-TAVI registry, linked to the French national health single-payer claims database, were analysed to compare 30-day and long-term mortality rates and hospitalization for heart failure rates among patients with versus without permanent pacemaker implantation after TAVI. Multivariable regressions were performed to adjust for confounders. RESULTS: A total of 36,549 patients (mean age 82.6years; 51.6% female) who underwent TAVI from 2013 to 2019 were included in the present analysis. Among them, 6999 (19.1%) received permanent pacemaker implantation during the index hospitalization, whereas 232 (0.6%) underwent permanent pacemaker implantation between hospital discharge and 30days after TAVI, at a median of 11 (interquartile range: 7-18) days. In-hospital permanent pacemaker implantation was not associated with an increased risk of death between discharge and 30days (adjusted odds ratio: 0.91, 95% confidence interval: 0.64-1.29). At 5years, the incidence of all-cause death was higher among patients with versus without permanent pacemaker implantation within 30days of the procedure (adjusted hazard ratio: 1.13, 95% confidence interval: 1.07-1.19). Permanent pacemaker implantation within 30days of TAVI was also associated with a higher 5-year rate of hospitalization for heart failure (adjusted subhazard ratio: 1.17, 95% confidence interval: 1.11-1.23). CONCLUSIONS: Permanent pacemaker implantation after TAVI is associated with an increased risk of long-term hospitalization for heart failure and all-cause mortality. Further research to mitigate the risk of postprocedural permanent pacemaker implantation is needed as TAVI indications expand to lower-risk patients.

Takotsubo syndrome : A cause of reversible microvascular coronary dysfunction.

Since the first description of takotsubo syndrome 30 years ago, only a little is known on the underlying physiopathology leading to peculiar left ventricular function alteration and myocardial damage related to acute emotional or physical stress. In the present case, we used continuous invasive thermodilution to evaluate coronary microvascular function at the acute phase of takotsubo and after recovery. The acute phase of takotsubo was characterized by a reduced coronary output and altered reserved flow with persistently high resistance during hyperaemia. At 6 weeks, we described a complete recovery of microvascular function, concomitant to LVEF recovery.

Ticagrelor vs Clopidogrel for Complex Percutaneous Coronary Intervention in Chronic Coronary Syndrome.

BACKGROUND: Whether ticagrelor in chronic coronary syndrome patients undergoing complex percutaneous coronary intervention (PCI) can prevent cardiovascular events is unknown. OBJECTIVES: The authors sought to evaluate outcomes of complex PCI and the efficacy of ticagrelor vs clopidogrel in stable patients randomized in the ALPHEUS (Assessment of Loading with the P2Y12 inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting) trial. METHODS: All PCI procedures were blindly reviewed and classified as complex if they had at least 1 of the following criteria: stent length >60 mm, 2-stent bifurcation, left main, bypass graft, chronic total occlusion, use of atherectomy or guiding catheter extensions, multiwire technique, multiple stents. The primary endpoint was a composite of type 4a or b myocardial infarction (MI) and major myocardial injury during the 48 hours after PCI. We compared the event rates according to the presence or not of complex PCI criteria and evaluated the interaction with ticagrelor or clopidogrel. RESULTS: Among the 1,866 patients randomized, 910 PCI (48.3%) were classified as complex PCI. The primary endpoint was more frequent in complex PCI (45.6% vs 26.6%; P < 0.001) driven by higher rates of type 4 MI and angiographic complications (12.2% vs 4.8 %; P < 0.001 and 19.3% vs 8.6%; P < 0.05, respectively). The composite of death, MI, and stroke at 48 hours (12.7% vs 5.1 %; P < 0.05) and at 30 days (13.4% vs 5.3%; P < 0.05) was more frequent in complex PCI. No interaction was found between PCI complexity and the randomized treatment for the primary endpoint (Pinteraction = 0.47) nor the secondary endpoints. CONCLUSIONS: In chronic coronary syndrome, patients undergoing a complex PCI have higher rates of periprocedural and cardiovascular events that are not reduced by ticagrelor as compared with clopidogrel.

GRACE scores or high-sensitivity troponin for timing of coronary angiography in non-ST-elevation acute coronary syndromes.

BACKGROUND: The GRACE risk score is generically recommended by guidelines for timing of invasive coronary angiography without stating which score should be used. The aim was to determine the diagnostic performance of different GRACE risk scores in comparison to the ESC 0/1 h-algorithm using high-sensitivity cardiac troponin (hs-cTn). METHODS: Prospectively enrolled patients presenting with symptoms suggestive of myocardial infarction (MI) in two large studies testing biomarker diagnostic strategies were included. Five GRACE risk scores were calculated. The amount of risk reclassification and the theoretical impact on guideline-recommended timing of invasive coronary angiography was studied. RESULTS: Overall, 8,618 patients were eligible for analyses. Comparing different GRACE risk scores, up to 63.8% of participants were reclassified into a different risk category. The proportion of MIs identified (i.e., sensitivity) dramatically differed between GRACE risk scores (range 23.8-66.5%) and was lower for any score than for the ESC 0/1 h-algorithm (78.1%). Supplementing the ESC 0/1 h-algorithm with a GRACE risk score slightly increased sensitivity (P < 0.001 for all scores). However, this increased the number of false positive results. CONCLUSION: The substantial amount of risk reclassification causes clinically meaningful differences in the proportion of patients meeting the recommended threshold for pursuing early invasive strategy according to the different GRACE scores. The single best test to detect MIs is the ESC 0/1 h-algorithm. Combining GRACE risk scoring with hs-cTn testing slightly increases the detection of MIs but also increases the number of patients with false positive results who would undergo potential unnecessarily early invasive coronary angiography.

Phenotyping coronary plaque by computed tomography in premature coronary artery disease.

AIMS: Premature coronary artery disease (CAD) is an aggressive disease with multiple recurrences mostly related to new coronary lesions. This study aimed to compare coronary plaque characteristics of individuals with premature CAD with those of incidental plaques found in matched individuals free of overt cardiovascular disease, using coronary computed tomography angiography (CCTA). METHODS AND RESULTS: Of 1552 consecutive individuals who underwent CCTA, 106 individuals with history of acute or stable obstructive CAD ≤45 years were matched by age, sex, smoking status, cardiovascular heredity, and dyslipidaemia with 106 controls. CCTA were analysed for Coronary Artery Disease Reporting and Data System score, plaque composition, and high-risk plaque (HRP) features, including spotty calcification, positive remodelling, low attenuation, and napkin-ring sign. The characteristics of 348 premature CAD plaques were compared with those of 167 incidental coronary plaques of matched controls. The prevalence of non-calcified plaques was higher among individuals with premature CAD (65.1 vs. 30.2%, P < 0.001), as well as spotty calcification (42.5 vs. 17.9%, P < 0.001), positive remodelling (41.5 vs. 9.4%, P < 0.001), low attenuation (24.5 vs. 3.8%, P < 0.001), and napkin-ring sign (1.9 vs. 0.0%). They exhibited an average of 2.2 (2.7) HRP, while the control group displayed 0.4 (0.8) HRP (P < 0.001). Within a median follow-up of 24 (16, 34) months, individuals with premature CAD and ischaemic recurrence (n = 24) had more HRP [4.3 (3.9)] than those without ischaemic recurrence [1.5 (1.9)], mostly non-calcified with low attenuation and positive remodelling. CONCLUSION: Coronary atherosclerosis in individuals with premature CAD is characterized by a high and predominant burden of non-calcified plaque and unusual high prevalence of HRP, contributing to disease progression with multiple recurrences. A comprehensive qualitative CCTA assessment of plaque characteristics may further risk stratify our patients, beyond cardiovascular risk factors.

Transcatheter Mitral Valve Replacement Using Transcatheter Aortic Valve or Dedicated Devices: Current Evidence and Future Prospects.

Transcatheter mitral valve replacement (TMVR) is a novel and evolving field dedicated to addressing the therapeutic challenges posed by patients at high surgical risk with mitral valve disease. TMVR can be categorized into two distinct fields based on the type of device and its specific indications: TMVR with transcatheter aortic valves (TAV) and TMVR with dedicated devices. Similar to aortic stenosis, TMVR with TAV requires a rigid support structure to secure the valve in place. As a result, it is indicated for patients with failing bioprothesis or surgical rings or mitral valve disease associated with severe mitral annular calcification (MAC), which furnishes the necessary foundation for valve anchoring. While TMVR with TAV has shown promising outcomes in valve-in-valve procedures, its effectiveness remains more contentious in valve-in-ring or valve-in-MAC procedures. Conversely, TMVR with dedicated devices seeks to address native mitral regurgitation, whether accompanied by MAC or not, providing an alternative to Transcatheter Edge-to-Edge Repair (TEER) when TEER is not feasible or expected to yield unsatisfactory results. This emerging field is gradually surmounting technical challenges, including anchoring a valve in a non-calcified annulus and transitioning from the transapical route to the transeptal approach. Numerous devices are presently undergoing clinical trials. This review aims to furnish an overview of the supporting evidence for TMVR using TAV in each specific indication (valve-in-valve, valve-in-ring, valve-in-MAC). Subsequently, we will discuss the anticipated benefits of TMVR with dedicated devices over TEER, summarize the characteristics and clinical results of TMVR systems currently under investigation, and outline future prospects in this field.

Heart disease in hemodialysis: physiopathology and therapeutic breakthroughs / Atteintes cardiaques en hémodialyse : physiopathologie et avancées thérapeutiques

Especially exposed to frequent cardiovascular events and its related mortality, some cardiovascular therapies of the hemodialyzed population as well as coronary investigations remain controversial. We have collected data and discussed recent trials and guidelines dedicated to this patient subset.

Tout particulièrement exposé aux complications cardiovasculaires, le sujet dialysé fait l'objet de multiples controverses sur les traitements antihypertenseurs, les anticoagulants, les statines, les explorations et le traitement de la coronaropathie. Nous revenons sur les données récentes sur la physiopathologie et les recommandations pour l'exploration et les traitements à visée cardiovasculaire.

Bioprosthetic leaflet thrombosis and reduced leaflet motion after transcatheter aortic valve replacement: A systematic review and meta-analysis.

BACKGROUND: Leaflet thrombosis and reduced leaflet motion have become a concern with the expanding use of transcatheter aortic valve replacement in lower-risk patients. AIMS: To assess the proportions, predictors and clinical impact of leaflet thrombosis and reduced leaflet motion after transcatheter aortic valve replacement. METHODS: We performed a meta-analysis of studies assessing the proportions of and/or clinical outcomes according to the presence of leaflet thrombosis after transcatheter aortic valve replacement identified with computed tomography and/or echocardiography. RESULTS: Fifty-three studies, representing 25,258 patients undergoing transcatheter aortic valve replacement, were considered. The proportion of leaflet thrombosis was 5.2% overall, and was higher in computed tomography versus echocardiography (16.4% vs. 1.1%, respectively); reduced leaflet motion was identified in 11% of patients with four-dimensional computed tomography. Intra-annular bioprostheses were associated with a higher proportion of leaflet thrombosis, whereas chronic oral anticoagulation was protective for leaflet thrombosis in both computed tomography and echocardiographic studies (9.7% vs. 17.5%; relative risk [RR]: 0.51, 95% confidence interval [95% CI]: 0.37-0.71 and 0.9% vs. 2.7%; RR: 0.22, 95% CI: 0.06-0.79, respectively) and for reduced leaflet motion (2.5% vs. 12.4%; RR: 0.32, 95% CI: 0.13-0.76). Leaflet thrombosis was not associated with an increased risk of death, but with a higher risk of stroke in computed tomography studies (2.8% vs. 2.4%; RR: 1.63, 95% CI: 1.05-2.55), a difference more pronounced when considering reduced leaflet motion (3.5% vs. 1.7%; RR: 2.39, 95% CI: 0.63-8.34). CONCLUSIONS: The proportion of leaflet thrombosis is highly variable according to the screening approach, the type of valve and the use of oral anticoagulation. The occurrence of cerebral events is increased when leaflet thrombosis and/or reduced leaflet motion are diagnosed, but leaflet thrombosis has no impact on survival.

The France PCI registry: Design, methodology and key findings.

BACKGROUND: Obstructive coronary artery disease is the main cause of death worldwide. By tracking events and gaining feedback on patient management, the most relevant information is provided to public health services to further improve prognosis. AIMS: To create an inclusive and accurate registry of all percutaneous coronary intervention (PCI) procedures performed in France, to assess and improve the quality of care and create research incentives. Also, to describe the methodology of this French national registry of interventional cardiology, and present early key findings. METHODS: The France PCI registry is a multicentre observational registry that includes consecutive patients undergoing coronary angiography and/or PCI. The registry was set up to provide online data analysis and structured reports of PCI activity, including process of care measures and assessment of risk-adjusted outcomes in all French PCI centres that are willing to participate. More than 150 baseline data items, describing demographic status, PCI indications and techniques, and in-hospital and 1-year outcomes, are captured into local reporting software by medical doctors and local research technicians, with subsequent encryption and internet transfer to central data servers. Annual activity reports and scoring tools available on the France PCI website enable users to benchmark and improve clinical practices. External validation and consistency assessments are performed, with feedback of data completeness to centres. RESULTS: Between 01 January 2014 and 31 December 2022, participating centres increased from six to 47, and collected 364,770 invasive coronary angiograms and 176,030 PCIs, including 54,049 non-ST-segment elevation myocardial infarction cases and 31,631 ST-segment elevation myocardial infarction cases. Fifteen studies stemming from the France PCI registry have already been published. CONCLUSIONS: This fully electronic, daily updated, high-quality, low-cost, national registry is sustainable, and is now expanding. Merging with medicoeconomic databases and nested randomized scientific studies are ongoing steps to expand its scientific potential.

Comparison of three echo-guidance techniques in percutaneous patent foramen ovale closure for stroke prevention: Conventional transoesophageal, microprobe transoesophageal and intracardiac echocardiography.

BACKGROUND: Recent randomized trials have demonstrated a consistent reduction in recurrent stroke after percutaneous transcatheter patent foramen ovale closure versus medical therapy in patients with recent cryptogenic stroke. AIM: To compare the safety and efficacy of intracardiac echocardiography-guided and microprobe transoesophageal echocardiography-guided patent foramen ovale closure under local anaesthesia with transoesophageal echocardiography-guided patent foramen ovale closure under general anaesthesia. METHODS: This prospective observational single-centre study included 194 consecutive patients scheduled for patent foramen ovale closure for secondary prevention of stroke from February 2018 to December 2019. Patients were asked to choose between an intracardiac echocardiography-guided, microprobe transoesophageal echocardiography-guided or transoesophageal echocardiography-guided procedure. The primary endpoint was the rate of successful closure at 6 months, defined as correct positioning of the device without severe shunt on 6-month contrast echocardiography. RESULTS: Successful closure was high and did not differ between groups: 97.8% (95% confidence interval 88.5-99.9%) in the intracardiac echocardiography-guided group versus 96.9% (95% confidence interval 83.8-99.9%) in the microprobe transoesophageal echocardiography-guided group and 99.1% (95% confidence interval 95.3-99.9%) in the transoesophageal echocardiography-guided group (P=0.63). Adverse events related to patent foramen ovale closure were low and did not differ between groups. CONCLUSION: Our preliminary real-world experience suggests good efficacy and safety with intracardiac echocardiography and microprobe transoesophageal echocardiography guidance compared with conventional transoesophageal echocardiography guidance for percutaneous transcatheter patent foramen ovale closure in recurrent stroke prevention.

Pharmacological coronary spasm provocative testing in clinical practice: A French Coronary Atheroma and Interventional Cardiology Group (GACI) position paper.

Vasospastic angina, also described as Prinzmetal angina, was first described as a variant form of angina at rest with transient ST-segment elevation; it is common and present in many clinical scenarios, including chronic and acute coronary syndromes, sudden cardiac death, arrhythmia and syncope. However, vasospastic angina remains underdiagnosed, and provocative tests are rarely performed. The gold-standard diagnostic approach uses invasive coronary angiography to induce coronary spasm using ergonovine, methylergonovine or acetylcholine as provocative stimuli. The lack of uniform protocol decreases the use and performance of these tests, accounting for vasospastic angina underestimation. This position paper from the French Coronary Atheroma and Interventional Cardiology Group (GACI) aims to review the indications for provocative tests, the testing conditions, drug protocols and positivity criteria.

Defining Strategies of Modulation of Antiplatelet Therapy in Patients With Coronary Artery Disease: A Consensus Document from the Academic Research Consortium.

Antiplatelet therapy is the mainstay of pharmacologic treatment to prevent thrombotic or ischemic events in patients with coronary artery disease treated with percutaneous coronary intervention and those treated medically for an acute coronary syndrome. The use of antiplatelet therapy comes at the expense of an increased risk of bleeding complications. Defining the optimal intensity of platelet inhibition according to the clinical presentation of atherosclerotic cardiovascular disease and individual patient factors is a clinical challenge. Modulation of antiplatelet therapy is a medical action that is frequently performed to balance the risk of thrombotic or ischemic events and the risk of bleeding. This aim may be achieved by reducing (ie, de-escalation) or increasing (ie, escalation) the intensity of platelet inhibition by changing the type, dose, or number of antiplatelet drugs. Because de-escalation or escalation can be achieved in different ways, with a number of emerging approaches, confusion arises with terminologies that are often used interchangeably. To address this issue, this Academic Research Consortium collaboration provides an overview and definitions of different strategies of antiplatelet therapy modulation for patients with coronary artery disease, including but not limited to those undergoing percutaneous coronary intervention, and consensus statements on standardized definitions.

European practice patterns for antiplatelet management in NSTE-ACS patients: Results from the REal-world ADoption survey focus on Acute antiPlatelet Treatment (READAPT) survey.

BACKGROUND: The 2020 European Society of Cardiology (ESC) guidelines for the diagnosis and management of patients with non-ST elevation-acute coronary syndrome (NSTE-ACS) recommend early invasive coronary angiography in high-risk patients and no routine pre-treatment with oral P2Y12 receptor inhibitor in NSTE-ACS patients prior to defining coronary anatomy. OBJECTIVE: To assess the implementation of this recommendation in the real-life setting. METHODS: A web-survey in 17 European countries collected physician profiles and their perceptions of the diagnosis, medical and invasive management of NSTE-ACS patients at their hospital. A sample size of at least 1100 responders permitted the estimation of proportions with a precision of at least ±3.0%. RESULTS: Among the 3024 targeted participants, 1154 provided valid feedback defined as a 50% response rate of answers to the survey questions. Overall, >60% of the participants declared full implementation of the guidelines at their institution. The time delay from admission to coronary angiography and PCI was reported to be <24 h in over 75% of the hospitals while pre-treatment was intended in >50% of NSTE-ACS patients. Ad-hoc percutaneous coronary intervention (PCI) was performed in >70% of the cases while intravenous platelet inhibition was rarely used (<10%). Between countries differences in practice patterns for antiplatelet management for NSTE-ACS were observed, suggesting heterogeneous implementation of the guidelines. CONCLUSIONS: This survey indicates that the implementation of 2020 NSTE-ACS guidelines on early invasive management and pre-treatment is heterogeneous, potentially due by local logistical constraints.

Implication of the new definition of pulmonary hypertension in patients evaluated for heart transplantation.

BACKGROUND: The 2018 World Symposium on Pulmonary Hypertension (WSPH) changed the definition of pulmonary hypertension (PH) with a new threshold of mean pulmonary artery pressure (mPAP) above 20 mmHg. OBJECTIVE: To evaluate the profile and prognosis of patients with chronic heart failure (HF) considered for heart transplantation with the new definition of PH. METHODS: Patients with chronic HF considered for heart transplantation were classified as mPAP≤20mmHg, mPAP 20-25 mmHg, and mPAP≥25mmHg. Using a multivariate Cox model, we compared the mortality of patients with mPAP20-25mmHg, and mPAP≥25mmHg versus those with mPAP≤20mmHg. RESULTS: Of 693 patients with chronic HF considered for heart transplantation, 12.7%, 77.5% and 9.8% were classified as mPAP20-25mmHg, mPAP≥ 25mmHg and mPAP≤20mmHg. Patients of mPAP ≥ 25mmHg and mPAP 20-25 mmHg categories were older than mPAP ≤ 20 mmHg (56 versus 55 and 52 year-old, p = 0.02) with more frequent co-morbidities. Within 2.8 years, the mPAP20-25mmHg category displayed a higher risk of mortality compared with those of the mPAP≤20mmHg category (aHR 2.75, 95% CI 1.27-5.97, p = 0.01). Overall, the new PH definition using a threshold of mPAP >20 mmHg was associated with a higher risk of death (adj HR 2.71, 95% CI 1.26-5.80) than the previous definition (mPAP >25 mmHg, aHR: 1.35 95% CI 1.00-1.83, p = 0.05). CONCLUSIONS: One out of 8 patients with severe HF are reclassified as having PH following the 2018 WSPH. Patients with mPAP20-25 evaluated for heart transplantation displayed significant co-morbidities and high mortality rates.

Impact of the antiplatelet strategy following patent foramen ovale percutaneous closure.

AIMS: Temporary dual antiplatelet therapy (DAPT) is recommended following patent foramen ovale (PFO) percutaneous closure although its benefit, compared to single antiplatelet therapy (SAPT), has not been demonstrated in this setting. We aimed at assessing outcomes following PFO closure according to the antiplatelet strategy at discharge. METHODS AND RESULTS: The ambispective AIR-FORCE cohort included consecutive patients from seven centres in France and Canada undergoing PFO closure and discharged without anticoagulation. Patients treated in French and Canadian centres were mostly discharged with DAPT and SAPT, respectively. The primary endpoint was the composite of death, stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, or BARC type ≥2 bleeding with up to 5 years of follow-up. The impact of the antiplatelet strategy on outcomes was evaluated with a marginal Cox model (cluster analyses per country) with inverse probability weighting according to propensity score. A total of 1532 patients (42.2% female, median age: 49 [40-57] years) were included from 2001 to 2022, of whom 599 (39.1%) were discharged with SAPT and 933 (60.9%) with DAPT, for ≤3 months in 894/923 (96.9%) cases. After a median follow-up of 2.4 [1.1-4.4] years, a total of 58 events were observed. In the weighted analysis, the rate of the primary endpoint up to 5 years was 7.8% in the SAPT strategy and 7.3% in the DAPT strategy (weighted hazard ratio 1.04, 95% confidence interval 0.59-1.83). CONCLUSION: The antiplatelet strategy following PFO closure did not seem to impact clinical outcomes, thus challenging the current recommendations of temporary DAPT.