Real-world Registry Research Articles

Clinical characteristics and short-term outcomes of patients with critical acute pulmonary embolism requiring extracorporeal membrane oxygenation: from the COMMAND VTE Registry-2

BackgroundExtracorporeal membrane oxygenation (ECMO) might be required as a treatment option in patients with critical pulmonary embolism (PE). However, the clinical features and outcomes of the use of ECMO for critical acute PE are still limited. The present study aimed to clarify the clinical characteristics, management strategies and outcomes of patients with acute PE requiring ECMO in the current era using data from a large-scale observational database.MethodsWe analyzed the data of the COMMAND VTE Registry-2: a physician-initiated, multicenter, retrospective cohort study enrolling consecutive patients with acute symptomatic venous thromboembolism (VTE). Among 2035 patients with acute symptomatic PE, there were 76 patients (3.7%) requiring ECMO.ResultsOverall, the mean age was 58.4 years, and 34 patients (44.7%) were men. Cardiac arrest or circulatory collapse at diagnosis was reported in 67 patients (88.2%). The 30-day incidence of all-cause death was 30.3%, which were all PE-related deaths. The 30-day incidence of major bleeding was 54.0%, and the vast majority of bleedings were procedure site-related bleeding events and surgery-related bleeding (22.4%). The 30-day incidence of all-cause death was 6.3% in 16 patients with surgical intervention, 43.8% in 16 patients with catheter intervention, 25.0% in 16 patients with thrombolytic therapy, and 39.3% in 28 patients with anticoagulation only.ConclusionsThe current large real-world VTE registry in Japan revealed clinical features and outcomes of critical acute PE requiring ECMO in the current era, which suggested several unmet needs for future clinical trials.

Disease progression, survival, and molecular disparities among Black and White patients with endometrioid endometrial carcinoma in real-world registries and legacy NRG oncology phase III trials

Disease progression, survival, and molecular disparities among Black and White patients with endometrioid endometrial carcinoma in real-world registries and legacy NRG oncology phase III trials

Racial disparities in survival and molecular features among Black versus White patients with uterine serous carcinoma: An integrated study in real-world registries and legacy NRG Oncology/Gynecologic Oncology Group clinical trials

Racial disparities in survival and molecular features among Black versus White patients with uterine serous carcinoma: An integrated study in real-world registries and legacy NRG Oncology/Gynecologic Oncology Group clinical trials

Evolving use and clinical outcomes of coronary intravascular lithotripsy: insights from an international, multicentre registry

BackgroundIntravascular lithotripsy (IVL) is increasingly used for treatment of coronary artery calcification. This study aimed to evaluate contemporary utilisation patterns, safety and efficacy of IVL in an unselected real-world patient cohort.MethodsWe included 454 patients undergoing IVL from May 2019 to February 2024 across seven centres in two European countries. Key endpoints included device success, technical success, procedural success, IVL-related complications and major adverse cardiovascular events (MACE) at 1-year follow-up.ResultsThe cohort (mean age 73±9 years, 75% male) had a mean SYNTAX Score of 22.0±13.6. Device, technical and procedural success were achieved in 98%, 91% and 89% of patients, respectively. IVL-related complications occurred in six patients (1%). At 1-year follow-up, MACE was observed in 37 patients (13%). Over time, IVL use increased in patients with acute coronary syndrome (p=0.004) and in combination with intracoronary imaging (p=0.002), while use of other calcium modification devices decreased (p=0.034).ConclusionIn this real-world registry, IVL demonstrated efficacy across diverse clinical and anatomical settings. High success rates, low complication rates and MACE rates were observed acutely and at 1-year follow-up. Utilisation patterns evolved over time, with increased adoption in acute scenarios and alongside intracoronary imaging.

Sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide 1 receptor agonists and cancer mortality. A real-world registry

Abstract Background Sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1ra) reduce cardiovascular events through different mechanisms, nevertheless, their association with cancer remains unclear. Purpose We aim to compare the combined treatment (SGLT2i and GLP1ra) with monotherapy regarding hospitalization or/and death for cancer in a general population and a subgroup of patients with cardiovascular disease (CVD). Methods Retrospective observational study of patients who were prescribed SGLT2i, GLP1ra, or both drugs. Multinomial propensity score was performed in all the population and in a subgroup of patients with CVD (atrial fibrillation [AF], heart failure [HF], coronary artery disease [CAD], peripheral arterial disease [PAD], or cerebrovascular accident [CVA]). The following variables were included to adjust the three groups: Sex, Age, Obesity, diabetes mellitus (DM), high blood pressure (HBP), dyslipidemia (DLP), CAD, HF, AF, and CVA. The three primary outcomes were (i) hospitalization for any cancer, (ii) death for any cancer, and (iii) the combined event in the included population and the subgroup of patients with CVD. The multivariate Cox regression analysis determined the hazard rate (HR) of age, sex, risk factors, and treatment for each outcome. Results We included 14709 patients (11366 with SGLT2i, 1016 with GLP1ra, and 2327 with both treatments) from the treatment initiation. The subgroup with CVD included 4957 (33.7%) patients (Fig 1). After 33 months of median follow-up, the incidence of cancer events was similar between patients with and without CVD (3.4% or 3.7%, respectively). Sex (male) and age were the main risk factors for the 3 outcomes in both groups. Combined treatment and its duration had a protector role for cancer mortality regarding monotherapy with SGLT2i or GLP1ra in all population (HR [95%CI]) 0.2216 [0.106-0.459]; p<0.001 or 0.1928 [0.071-0.519]; p=0.001, respectively) (Fig 2a) and in the subgroup of patients with CVD (HR [95%CI]) 0.279 [0.078-0.994]; p<0.049 or 0.129 [0.024-0.668]; p=0.014, respectively) (Fig 2b), but these results were not found for the outcome of hospitalization for cancer. The combined therapy concerning SGLT2i and duration of treatment showed a protective role against the combined event (HR [95%CI]) 0.709 [0.521-0.967]; p=0.029) and (HR [95%CI]) 0.991 [0.983-0.999]; p=0.032) in the general population but not in the group of CVD. A higher survival rate for any cancer mortality was observed in those patients with the combined therapy respect to monotherapy (SGLT2i or GLP1ra) in the general population (Fig 2c) and the subgroup of patients with CVD (Fig 2d). Conclusions Initiation of combined therapy vs. monotherapy was associated with a lower rate of cancer mortality in the general population and patients with CVD. Future clinical trials and mechanistic studies will clarify the possible role of these drugs on carcinogenesis.Figure 1Figure 2

Impact of sex, age, comorbidities, and culprit lesion location on symptoms in patients with non-ST-segment elevation myocardial infarction

Abstract Background Among patients with non-ST-segment elevation myocardial infarction (NSTEMI) about 80% present with chest discomfort. Others have less obvious symptoms, but early diagnosis is crucial. Sex differences in symptoms have been reported to delay diagnosis in about half of women. This study aims to analyze the symptoms and its disparities caused by sex, age, comorbidities, and culprit lesion location. Methods Patients presenting with troponin elevation and at least one angiographically confirmed atherosclerotic lesion causing the myocardial ischemia (culprit lesion) between February 2018 and July 2023 were prospectively included in a single-center, all-comers, real-world registry. Results Information regarding symptoms was available for 842 NSTEMI patients with an identifiable culprit lesion. Chest discomfort was reported by 684 patients (81.2%), dyspnea by 361 (42.9%) with it being the primary symptom in 102 (12.1%), and atypical symptoms by 317 (37.6%) with it being the primary symptom in 56 (6.7%). Concretely, dizziness or syncope was reported by 82 patients (9.7%), nausea, vomiting or any other gastrointestinal symptoms by 73 (8.7%), epigastric, shoulder, arm, back, neck or jaw pain by 57 (6.8%), diaphoresis by 66 (7.8%), other vegetative symptoms like palpitations or anxiety by 56 (6.7%), fatigue by 37 (4.4%), and neurologic symptoms like sensory or motor impairments by 28 (3.3%). In women, the primary complaint was less often chest discomfort (76.3 vs. 82.9%, p=0.040), more often atypical symptoms (9.8 vs. 5.6%, p=0.049) and equally often dyspnea (14.0 vs. 11.5%, p=0.403). Gastrointestinal symptoms were more often reported by women (13.5 vs. 7.0%, p=0.006). Elderly, i.e., age ≥80 years, reported chest discomfort less often (75.4 vs. 83.0%, p=0.023), dyspnea more often (19.5 vs. 9.9%, p<0.001) and atypical symptoms equally often (5.1 vs. 7.1%, p=0.418). Likewise, diabetic had chest discomfort less often (74.3 vs. 84.5%, p<0.001), dyspnea more often (18.2 vs. 9.2%, p<0.001), and atypical symptoms equally often (7.4 vs. 6.3%, p=0.633). No differences regarding primary symptoms were observed for dyslipidemia (82.1 vs. 78.9% for chest discomfort, 12.1 vs. 12.1% for dyspnea, 5.8 vs. 9.0% for atypical symptoms, p>0.05 for all) and obesity (84.5 vs. 81.2% for chest discomfort, 9.8 vs. 12.5% for dyspnea, 5.7 vs. 6.3% for atypical symptoms, p>0.05 for all). For LM culprit lesions, dyspnea was more often the primary symptom compared to LAD, LCX, and RCA culprit lesions (17.4% for LM vs. 13.6% for LAD, 5.7% for LCX, and 13.2% for RCA, p=0.023), while no differences were observed for chest pain (73.9% for LM, 80.6% for LAD, 86.1% for LCX, and 80.2% for RCA, p=0.235) and atypical symptoms (8.7% for LM, 5.9% for LAD, 8.1% for LCX, and 6.6% for RCA, p=0.758). Conclusions Chest discomfort is significantly less often the primary symptom of NSTEMI in women, elderly and diabetic making these groups more vulnerable for delayed diagnosis or misdiagnosis.

Comparative clinical outcomes of amphilimus-eluting stents in diabetic versus non-diabetic patients

Abstract Background Patients with diabetes mellitus (DM) are at an increased risk of experiencing adverse events following percutaneous coronary intervention (PCI). The Cre8 EVO stent, which releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, has demonstrated clinical benefits specifically in diabetic populations. We aimed to explore the impact of DM on clinical outcomes in a large, real-world registry of all-comer patients treated with Cre8 and Cre8 EVO stents. Methods We did an investigator-initiated, prospective, single-arm observational trial at 28 sites in South Korea. The primary endpoint was a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically-driven repeat revascularization at 12 months. All-cause mortality was a key secondary endpoint. Results A total of 2,045 patients (66.0 ± 11.5 years of age; 76.2% male) were analyzed. Diabetic patients (n = 774; 37.8%) were more likely to be older, female, and have hypertension, dyslipidemia, or chronic kidney disease. There were 39 cases of primary events, 17 (2.5%) in the DM group and 22 (1.9%) in the non-DM group (hazard ratio, 1.34; 95% confidence interval, 0.74–2.41; log-rank p = 0.33). Overall, the primary endpoint occurred in 2.1% of patients, with a cardiac death rate of 0.4%, a target vessel-related MI rate of 0.3%, and a clinically driven TLR rate of 1.8%. Among the secondary endpoints, the DM group exhibited a significantly higher all-cause mortality rate compared to the non-DM group (2.0% vs. 0.9%; hazard ratio, 2.20; 95% confidence interval, 1.04–4.65). Conclusion In this real-world registry, diabetic patients treated with amphilimus-eluting stents demonstrated excellent safety and effectiveness at 12 months, with a similar occurrence of MACE compared to non-diabetics. These results underscore the potential for amphilimus-eluting stents to become a preferred option for PCI in diabetic patients, prompting further investigation into their long-term benefits and mechanisms of action.

Survival penalty in patients undergoing transcatheter versus surgical aortic valve replacement: is it just a question of frailty? Insights from a large cohort with demographic matching

Abstract Background Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are the reference treatments for aortic stenosis. Conflicting data exist on late survival results of these two techniques. While randomised controlled trials (with highly selected patients) assert the non-inferiority of TAVR, real-world data from large registries (with potential uncorrected confounders) suggest the opposite. Comparing the survival rates of SAVR and TAVR with those of a matched reference population could help circumvent potential biases of direct procedural comparisons and quantify the impact of frailty on post-operative survival. Purpose Our study aims to compare the 5-year overall survival rates of SAVR, non-frail TAVR, and frail TAVR patients with the survival of their demographically matched reference population. Methods This study included all consecutive patients undergoing either SAVR or TAVR at a tertiary hospital between January 2010 and December 2021. Each patient underwent a comprehensive geriatric assessment by an experienced geriatric team, from which a Clinical Frailty Scale (CFS) was derived using a validated classification tree. Frailty was defined as a CFS ≥ 6, in accordance with ESC guidelines. The patients were stratified into 3 subgroups: SAVR, non-frail TAVR, and frail TAVR patients. For each subgroup, a corresponding reference population was generated using national actuarial tables to ensure individual-level matching based on age, gender, and year of observation. Survival of each subgroup was then compared to its corresponding reference population over a 5-year period using standardized mortality ratios (SMR) and one-sample logrank tests. Results Our cohort included 1183 SAVR, 254 non-frail TAVR, and 151 frail TAVR patients, with mean ages of 74.1, 85.4, and 85.7 years, and median EuroSCORE II of 2.0%, 4.2%, and 5.4%, respectively. Survival of SAVR patients was equivalent to the reference population (80.1 vs 80.9% survival; SMR = 1.06 [0.89 – 1.25]; p = 0.454; Figure 1A). Similarly, non-frail TAVR patients also achieved survival rates comparable to those of the reference population (50.9 vs 54.0% survival; SMR = 0.94 [0.76 – 1.18]; p = 0.549; Figure 1B). However, frail TAVR patients faced a significantly reduced survival rate (41.7% vs 54.0% survival; SMR = 1.48 [1.15 – 1.90]; p < 0.001; Figure 1C). The frailty of this subgroup could therefore explain a 48% increase in mortality risk compared with their reference population after 5 years. Conclusions Treating non-frail patients with aortic stenosis through TAVR or SAVR restores life expectancy to levels comparable with their reference population, challenging results from other real-world registries. In contrast, TAVR in frail patients is associated with worse survival, raising the question of treatment futility in this specific subgroup. Refining the selection of frail patients who may benefit from TAVR remains an important clinical challenge.

Clinical outcomes of edoxaban treatment in atrial fibrillation patients with high bleeding risk: insights from the ETNA-AF-China 1-year follow-up

Abstract Background In China and many other countries, anticoagulated atrial fibrillation (AF) patients with high bleeding risk often raises clinical concern; the optimal dose of direct oral anticoagulants (DOACs) preventing stroke/systemic embolic events (SEE) in those population remains unclear. Purpose To assess the effectiveness and safety of edoxaban treatment in Chinese AF patients with high bleeding risk, and to compare 60 mg vs 30 mg dose in this real-world registry. Methods ETNA-AF-China is a prospective, observational study conducted in 89 centres across Chinese Mainland enrolling AF patients receiving edoxaban. This subgroup analysis was based on 1-year follow-up data. Patients were categorized to high bleeding risk group who had a DOAC score ≥6 (age, creatinine clearance, underweight, history of stroke/TIA/SEE, diabetes, hypertension, antiplatelet use, NSAIDs use, history of major/critical bleeding, liver disease) at baseline, or moderate-to-low bleeding risk group meeting criteria of DOAC score <6. The safety, effectiveness, and composite outcomes were reported by comparison between patient subgroups using Cox proportional hazards models. Results Of 4883 patients with 1-year follow-up, 1534 (31.4%, 60 mg: n=518, 30 mg: n=1016) were identified as high bleeding risk and 3349 (68.6%) as moderate-to-low bleeding risk. As expected, patients with high bleeding risk were more often elderly (48.2% ≥80 years), had lower body weight, worse renal function, higher CHA2DS2-VASc score than those with moderate-to-low risk (Figure 1). In both high risk and moderate-to-low risk subgroups, patients receiving 60 mg edoxaban were younger, with better renal function, lower CHA2DS2-VASc score compared with 30 mg. Annualised event rates of major bleeding (HR 2.95, 95%CI 1.62–5.36), all cause death (3.42, 2.29–5.09), CV death (3.27, 1.52–7.04), major adverse cardiac events (MACE, 2.61, 1.69–4.02) and all NCOs were significant higher in patients with high bleeding risk compared with moderate-to-low risk (Figure 2). After multivariable adjustment, edoxaban dose of 60 mg other than 30 mg were associated with significantly lower rates of all cause death (adjusted HR 0.41, 0.18–0.90) and lower trend of NCO3 (0.51, 0.28–0.92) and NCO4 (0.51, 0.30–0.88) by composite of stroke/SEE, major bleeding and death events in high risk subgroup; no significant difference between edoxaban doses and stroke or bleeding outcomes with cumulative low event rates were observed. Conclusion In routine clinical care, AF patients at high bleeding risk faces worse outcomes of death events, MACE, as well as the composite outcomes over moderate-to-low risk patients. Among patients with high bleeding risk, edoxaban use showed effectiveness and safety with overall low incidence, and potential better survival, composite endpoint benefit could be associated with 60mg. Further investigation is ongoing.

Favorable impact of FFRCT on myocardial revascularization outcomes: results from an observational real-world registry

Abstract Background Based on excellent clinical outcomes data, coronary computed tomography angiography (CCTA)-derived fractional flow reserve (FFRCT) is endorsed by guidelines to diagnose obstructive coronary artery disease (OCAD)(1). Dedicated outcome analyses in revascularized patients are essential to assess the additional value of FFRCT in revascularization. Purpose To assess the impact of FFRCT use on the postprocedural myocardial injury (PMI) and long-term outcomes of patients with OCAD undergoing myocardial revascularization. Methods Patients with suspected OCAD on CCTA (at least one stenosis of >50% in any vessel) were included from a 2013-2021 tertiary hospital registry. Propensity score adjusted Cox- regression and logistic regression analysis were used to assess the impact of FFRCT on the outcomes of OCAD patients post-revascularization. PMI was defined as cardiac troponin (cTn)>5 times the 99th percentile URL for percutaneous coronary intervention (PCI) and cTn>10 times the 99th percentile URL for coronary artery bypass graft (CABG) (2). Major adverse cardiovascular events (MACE) comprised all – cause mortality, acute myocardial infarction (AMI), stroke, hospitalization for heart failure (HHF) and new revascularization. Results From a registry of 7541 patients, suspected CCTA - derived OCAD was reported in 1601 cases. 559 OCAD patients were revascularized: 386(69.05%) by PCI, 166(29.7%) by CABG and 7(1.25%) by PCI and CABG. FFRCT was performed in 252(45.1%) patients. During a follow-up of 4.4±2.2 years, MACE occurred in 137(24.5%) patients: 43(7.7%) died, 21(3.8%) patients were hospitalized for AMI, 14(2.5%) patients had a stroke, 12 (2.1%) patients had HHF and 77(13.8%) patients had a new revascularization. Survival analysis indicated significant differences in MACE and all-cause mortality–rates between FFRCT use and no FFRCT use (log- rank p = 0.033 and 0.004, Fig 1). Multivariable propensity–adjusted Cox–regression analysis showed a non–significant trend towards reduced MACE risk by using FFRCT (HR 0.736, 95% CI 0.513-1.055, P=0.095) and a significant reduction in all-cause mortality risk (HR 0.476, 95% CI 0.230–0.985, P=0.046). Sub-analysis in the PCI and CABG groups showed no significant association between FFRCT and MACE. Among the 477 patients with available cTn values, 203 (42.5%) had PMI. In the CABG group, FFRCT use correlated with low PMI incidence (5.3% vs. 15.6%, p=0.044). However, multivariable Cox regression analysis revealed no significant association between FFRCT use and PMI(Fig 2). Conclusion This observational designed study reveals for the first time that FFRCT reduces post-myocardial revascularization MACE, primarily driven by reduced all-cause mortality. No clear reduction of PMI was observed suggesting that FFRCT value extends beyond procedural enhancements. Although derived from a large real-world registry, these promising observations need to be confirmed by randomized studies.Figure 1Figure 2

Influence of a three-dimensional mapping system on acute safety and efficacy of pulsed-field ablation for atrial fibrillation

Abstract Background Visualization of the multi-electrode pulsed-field ablation (PFA) catheter within a 3D-mapping system holds the potential to improve catheter maneuverability and enhance ablation outcomes, thereby improving procedural metrics. Purpose The aim of our analysis, from a real-world nationwide registry, is to evaluate the impact of 3D-mapping system on acute safety and efficacy in the context of PFA of atrial fibrillation (AF). Methods All consecutive patients undergoing de novo AF ablation with the Farapulse system at 13 centers were included. Protocol-directed PVI was delivered using 2kV with 8 applications per vein, that is, 4 applications each in the basket and flower poses. Additional lesions were performed at the operator’s discretion. Procedures were stratified according to the use or not of 3D-mapping system to validate the lesions (MAP vs Standard). Results Among 1002 patients, 28.3% were females, 28.2% had persistent AF, mean age was 62.9±10 years, mean LVEF was 57.4±8%. A more extensive lesion set than PVI only (PVI plus) was performed in 230 (23.0%) of the cases. A 3D-mapping system was used to validate the lesion set in 201 (20.1%) of the cases, mostly when a more extensive lesion set was applied (40% in PVI plus vs 14.1% in PVI only, p<0.001). Four-thousand forty-five (99.1%) PVs were acutely isolated on first pass (26 patients with at least 1 PVs not isolated at first pass, 2.6%), as confirmed by both entrance/exit block and/or on subsequent 3D-mapping. No differences between MAP and Standard procedures were found in terms of first pass PVI (98.8% vs 99.1%, p=0.416) or number of patients with all PV isolated at first pass (95.5% vs 97.9%, p=0.079). At the end of the procedure PVI was achieved in all patients. By looking at procedural metrics, the total number of PFA deliveries (43±12 vs 39±10, p<0.0001) and PFA deliveries outside PVs (19.6±8 vs 15.1±6, p<0.0001) were higher in the MAP group, whereas the number of PFA deliveries to achieve PVI were lower (34±4 vs 36.4±7, p<0.0001). MAP procedures had longer skin-to-skin time (94[80-120]min vs 60[50-70]min, p<0.0001), time to PVI (20[15-27]min vs 18[14-24]min, p=0.0001) or fluoroscopy time (22[18-29]min vs 14[11-18]min, p<0.0001). The MAP group exhibited increased skin-to-skin time and fluoroscopy time, even when analyzing procedures separately for those involving PVI only and those involving PVI plus. Conversely, the total number of PFA deliveries to achieve PVI (53.8±8 vs 53.3±10, p=0.254) and time to PVI (17.5[14.5-22]min vs 18[12-25]min, p=0.516) were comparable between MAP and Standard groups during PVI plus. No major complications occurred in both groups. Conclusion In our real-life experience, the use of Farapulse PFA system for de novo AF ablation was rapid, safe and acutely effective resulting in a very high first-pass isolation rate. 3D-mapping system was used in a minority of patients and was not associated with an increase in acute success-rate.

Clinical outcomes of edoxaban treatment without parenteral anticoagulation therapy for acute venous thromboembolism: Insight from the COMMAND VTE Registry-2

Abstract Background Direct oral anticoagulants (DOACs) including edoxaban are currently widely used all over the world. Each DOAC has a specific usage for the treatment and second prevention of venous thromboembolism (VTE) in the acute phase as well as in the chronic phase. Edoxaban is recommended to be administered after an appropriate initial treatment including parenteral anticoagulation therapy such as heparin. However, because of the rapid anticoagulant effect of edoxaban after oral intake, some physicians could administer edoxaban initially without parenteral anticoagulation therapy in the daily clinical practice, which has not been investigated so far. Purpose The purpose of this study is to explore the effectiveness and safety of edoxaban treatment for VTE without initial parenteral anticoagulation therapy. Methods The COMMAND VTE Registry-2 is a multicenter registry enrolling 5,197 consecutive acute symptomatic VTE patients among 31 centers in Japan between January 2015 and August 2020. Of those, 1842 patients received edoxaban including 848 patients with pulmonary embolism (PE) and 994 patients with deep vein thrombosis (DVT) alone, who were divided into 2 groups based on the presence or absence of initial parenteral anticoagulation therapy with heparin. Propensity score matching (PSM) was performed to adjust for potential baseline differences in the 2 groups. Results PE and DVT patients with initial parenteral anticoagulation therapy with heparin accounted for 623 (73.5%) and 244 (24.5%), respectively. After the PSM, 195 pairs of PE patients and 226 pairs of DVT patients were matched. In PE patients, those matched by the PSM were relatively mild cases compared to the unmatched cases (simplified PESI score=0: 25.9% vs. 12.4%, P<0.001). Whereas, in DVT patients, those matched were relatively severe cases compared to unmatched cases (isolated distal DVT: 24.1% vs. 71.0%, P<0.001). In the matched cohort, there was no significant difference in baseline characteristics between the 2 groups, including simplified PESI score in PE patients and thrombus location profile in DVT patients. In both PE patients and DVT patients, the 30-day cumulative incidences of all-cause death were not significantly different between the 2 groups (PE patients: 3.7% vs. 2.6%, P=0.56; DVT patients: 2.7% vs. 4.5%, P=0.31). Similarly, the 30-day cumulative incidences of recurrent VTE and major bleeding were not significantly different between the 2 groups (recurrent VTE: PE patients: 0% vs. 0.5%, P=0.32; DVT patients: 0.6% vs. 0.9%, P=0.99; major bleeding: PE patients: 1.5% vs. 3.2%, P=0.32; DVT patients: 2.2% vs. 3.2%, P=0.54) Conclusion In this current real-world VTE registry, a certain number of patients received edoxaban without parenteral anticoagulation therapy, who did not show a signal of worse clinical outcomes.

Impact of rhythm control strategy on outcomes in patients with first diagnosed atrial fibrillation in an 11-year real-world registry

Abstract Background Atrial fibrillation (AF) is a highly prevalent arrhythmia with a high burden of disease. This sub-study of the Heidelberg Registry of Atrial Fibrillation (HERA-FIB) sought to evaluate clinical characteristics, treatment strategies and outcomes in patients with first diagnosed AF (FDAF). Methods Patients with AF presenting to the emergency department (ED) of an University Hospital between June 2009 and March 2020 were consecutively enrolled. Follow-up was performed for all-cause mortality, stroke, major bleeding and myocardial infarction (MI). Outcomes were were related to patients with FDAF or pre-existing AF, as well as assigned treatement strategy (rhythm vs. rate control). The trial was registered at ClinicalTrials.gov Identifier: NCT05995561. Results Overall 2,758 (27%) of all patients presented with FDAF. Compared to FDAF, patients with pre-existing AF showed higher all-cause mortality HR 1.41 (95%CI 1.28-1.55, p<0.0001) and major bleeding events 1.29 (95% CI 1.06-1.56, p=0.0098). Non-implementation of rhythm control in FDAF was seen in 2,079 cases (75.4%) and was associated with an excess of all-cause mortality HR 1.66 (95%CI 1.30-1.99, p<0.0001) and incident MI HR 1.79 (95% CI 1.03-3.09, p=0.0385). A non-implementation of rhythm control remained an independent predictor for all-cause mortality and MI even after adjustment for significant univariate variables aHR: 1.34 (95%CI: 1.04-1.72, p=0.0234) and aHR: 1.79 (95%CI: 1.03-3.09, p=0.0385). Conclusion Real-world data from FDAF patients presenting in the setting of an ED showed a potential benefit regarding mortality and MI for rhythm control strategy. Further research is needed to validate this hypothesis.

Comparison of clinical outcomes in diabetic and non-diabetic patients undergoing coronary bifurcation stenting

Abstract Background Diabetes mellitus (DM) is a well-known risk factor for cardiovascular diseases, including coronary artery diseases (CAD). Due to poor post-intervention outcomes, bypass surgery is often recommended in preference to percutaneous coronary intervention (PCI) in DM patients with complex scenarios, such as bifurcation lesions. Methods In this retrospective, multicentre, observational, real-world registry of 2,648 patients with coronary bifurcation lesions undergoing PCI with 2nd-generation drug-eluting stents (DES), the effect of DM on cardiovascular outcomes was analysed. The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of all-cause death, myocardial infarction, and stroke, at 5 years. The adjusted outcomes were compared using 1:1 propensity score (PS) matching. Results Overall, DM patients were more likely to be older, female, and have hypertension or chronic kidney disease. In the PS-matched cohort, the cumulative incidence of the primary outcome was numerically higher in the DM group, but without statistical significance (7.9% vs. 5.5%, log-rank p=0.276). Secondary outcomes including all-cause mortality (5.5% vs. 3.9%, log-rank p=0.090) and cardiac mortality (3.2% vs. 1.8%, log-rank p=0.060) were also comparable between the two groups. Conclusion For patients with coronary bifurcation lesions undergoing contemporary PCI, the outcomes were comparable for DM and non-DM patients. Bifurcation PCI can thus be successfully performed in diabetic patients with 2nd-generation DES.

The long-term clinical benefit of early versus delayed invasive strategies in elderly patients with non-ST-segment elevation myocardial infarction who have undergone percutaneous coronary intervention

Abstract Background The data regarding long-term outcomes of early versus delayed invasive strategies in elderly patients who have undergone percutaneous coronary intervention (PCI) for non-ST-segment elevation myocardial infarction (NSTEMI) is limited. Purpose We aimed to investigate the long-term clinical benefit of early versus delayed invasive strategies in elderly patients who underwent PCI for NSTEMI. Methods From a nationwide, prospective, real-world registry of 13,104 patients with acute myocardial infarction (MI) who underwent PCI, 2818 elderly patients (aged ≥70 years) who underwent PCI for NSTEMI were included. Of these, 2299 patients were treated with an early invasive strategy (early invasive group), and 519 were treated later (delayed invasive group). The incidence of major adverse cardiac events (MACE; all-cause death, recurrent MI, any revascularization, stroke, readmission due to heart failure [HF], or definite/probable stent thrombosis [ST]) and the components of MACE were compared using multivariable Cox regression, propensity score (PS) matched, and PS-adjusted analyses. Results During a median follow-up of 1047 days, MACE, all-cause death, and cardiac death occurred in 1018 (36.1%), 660 (23.4%), and 423 patients (15.0%), respectively. The early invasive group showed significantly lower risks of MACE (entire: 35.0% vs. 41.2%, hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.66-0.90, p=0.001; PS-matched: n=984, 33.3% vs. 40.8%, HR 0.75, 95% CI 0.62-0.91, p=0.005), all-cause death (entire: 22.5% vs. 27.4%, HR 0.76, 95% CI 0.63-0.92, p=0.004; PS-matched: 21.8% vs. 27.2%, HR 0.75, 95% CI 0.58-0.90, p=0.005), cardiac death (entire: 13.8% vs. 20.2%, HR 0.64, 95% CI 0.51-0.79, p<0.001; PS-matched: 13.1% vs. 19.4%, HR 0.67, 95% CI 0.55-0.86, p=0.011), and readmission due to HF (entire: 6.5% vs. 9.2%, HR 0.64, 95% CI 0.46-0.89, p=0.007; PS-matched: 6.7% vs. 9.4%, HR 0.68, 95% CI 0.51-0.96, p=0.017) than the delayed invasive group. There were no significant differences in the risks of recurrent MI, any revascularization, stroke, and definite/probable ST between the groups. Furthermore, in patients aged ≥80 years, the early invasive group had significantly reduced rates of MACE (42.9% vs. 49.5%, HR 0.71, 95% CI 0.55-0.91, p=0.039), all-cause death (31.7% vs. 39.0%, HR 0.71, 95% CI 0.55-0.92, p=0.010), and cardiac death (20.9% vs. 31.0%, HR 0.59, 95% CI 0.44-0.80, p=0.001) compared to the delayed invasive group. Conclusions In elderly patients with NSTEMI, an early invasive intervention strategy was associated with favorable long-term clinical outcomes compared to a delayed invasive intervention strategy.

Sex differences in clinical data and long-term outcomes of elderly patients with acute myocardial infarction presenting with cardiogenic shock undergoing percutaneous coronary intervention

Abstract Background Data on contemporary clinical practice and long-term outcomes for sex differences in elderly patients with acute myocardial infarction (MI) who have undergone percutaneous coronary intervention (PCI) presenting with cardiogenic shock (CS) is limited. Purpose This study aimed to investigate contemporary clinical data and long-term clinical outcomes according to sex differences in elderly patients undergoing PCI for acute MI complicated by CS. Methods We analyzed data from a nationwide, prospective, and real-world registry comprising elderly patients (≥65 years) with acute MI who have undergone PCI and presented with CS. Of the 540 patients included, 228 were women, and 312 were men. We compared major adverse cardiac events (MACE; all-cause death, recurrent MI, any revascularization, stroke, heart failure [HF] readmission, or definite/probable stent thrombosis [ST]) and the components of MACE between the groups using multivariable Cox regression, propensity score (PS) matching, and PS-adjusted analyses. Results Compared to men, women were younger and had higher incidences of hypertension and elevated pro-BNP levels. No significant differences were observed in other cardiovascular risk factors, left ventricular systolic function levels, or adherence to guideline-directed medical therapy between the groups. Over a median follow-up of 1035 days, MACE, all-cause death, and cardiac death occurred in 257 (47.6%), 212 (39.3%), and 170 (31.5%) patients, respectively. Women exhibited significantly increased risks of MACE (overall: 53.5% vs. 43.3%, hazard ratio [HR] 0.76, 95% confidence interval [CI] 0.59-0.97, p=0.023; PS-matched: n=368, 52.3% vs. 41.8%, HR 0.73, 95% CI 0.53-0.94, p=0.033), all-cause death (overall: 44.7% vs. 35.3%, HR 0.77, 95% CI 0.58-0.97, p=0.032; PS-matched: 42.8% vs. 33.4%, HR 0.71, 95% CI 0.54-0.95, p=0.041), cardiac death (overall: 35.1% vs. 28.8%, HR 0.81, 95% CI 0.60-0.97, p=0.048; PS-matched: 34.4% vs. 26.9%, HR 0.78, 95% CI 0.54-0.95, p=0.043) compared to men. There were no significant differences in the risks of recurrent MI, any revascularization, stroke, HF readmission, and definite/probable ST between the groups. Conclusions In this nationwide registry, women compared to men exhibited increased risks of long-term clinical outcomes in elderly patients with acute MI who have undergone PCI presenting with CS.

Derivation and Validation of the PRECISE-HBR Score to Predict Bleeding After Percutaneous Coronary Intervention.

Accurate bleeding risk stratification after percutaneous coronary intervention (PCI) is important for treatment individualization. However, there is still an unmet need for a more precise and standardized identification of high bleeding risk patients. We derived and validated a novel bleeding risk score by augmenting the PRECISE-DAPT score with the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria. The derivation cohort comprised 29,188 patients undergoing PCI, of whom 1136 (3.9%) had a Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding at 1 year, from four contemporary real-world registries and the XIENCE V USA trial. The PRECISE-DAPT score was refitted with a Fine-Gray model in the derivation cohort and extended with the ARC-HBR criteria. The primary outcome was BARC 3 or 5 bleeding within 1 year. Independent predictors of BARC 3 or 5 bleeding were selected at multivariable analysis (p<0.01). The discrimination of the score was internally assessed with apparent validation and cross-validation. The score was externally validated in 4578 patients from the MASTER DAPT trial and 5970 patients from the STOPDAPT-2 total cohort. The PRECISE-HBR score (age, estimated glomerular filtration rate, hemoglobin, white-blood-cell count, previous bleeding, oral anticoagulation, and ARC-HBR criteria) showed an area under the curve (AUC) for 1-year BARC 3 or 5 bleeding of 0.73 (95% CI, 0.71-0.74) at apparent validation, 0.72 (95% CI, 0.70-0.73) at cross-validation, 0.74 (95% CI, 0.68-0.80) in the MASTER DAPT, and 0.73 (95% CI, 0.66-0.79) in the STOPDAPT-2, with superior discrimination than the PRECISE-DAPT (cross-validation: Δ AUC, 0.01; p=0.02; MASTER DAPT: Δ AUC, 0.05; p=0.004; STOPDAPT-2: Δ AUC, 0.02; p=0.20) and other risk scores. In the derivation cohort, a cut-off of 23 points identified 11,414 patients (39.1%) with a 1-year BARC 3 or 5 bleeding risk ≥4%. An alternative version of the score, including acute myocardial infarction on admission instead of white-blood-cell count, showed similar predictive ability. The PRECISE-HBR score is a contemporary, simple 7-item risk score to predict bleeding after PCI, offering a moderate improvement in discrimination over multiple existing scores. Further evaluation is required to assess its impact on clinical practice.

Transcatheter Valve Repair for TricuspidRegurgitation: 1-Year Results from a Large European Real-World Registry.

Tricuspid valve transcatheter edge-to-edge repair has emerged as a valuable treatment option for patients with severe tricuspid regurgitation (TR). This study aims to investigate the safety and effectiveness of the PASCAL transcatheter valve repair system in treating severe TR in a real-world patient population. The PASTE (PASCAL for Tricuspid Regurgitation-a European registry) study is an investigator-initiated, multicenter, retrospective, and prospective observational cohort analysis conducted across 16 European heart valve centers including consecutive patients treated with the PASCAL transcatheter valve repair system from February 2019 to November 2023. Echocardiographic assessments were performed at baseline, discharge, and follow-up, and were subjected to centralized analysis. The study included 1,059 high-risk patients (mean age 79 ± 9 years; 53% female; TRI-SCORE risk 23% ± 18%; 87% NYHA functional class III/IV) with multiple comorbidities. Severe or higher graded TR was observed in 96% of patients. Intraprocedural success according to Tricuspid Valve Academic Research Consortium criteria was achieved in 85%, and TR reduced to ≤moderate in 87%. Independent predictors for a postprocedure residual TR of >moderate were coaptation gaps≥8mm (OR: 1.67; 95%CI: 1.03-2.72; P=0.038), tenting height≥10mm (OR: 2.18; CI: 1.30-3.65; P=0.003), the presence of a transvalvular lead (OR: 1.91; 95% CI: 1.19-3.05; P=0.007), right ventricular dilatation >42mm (OR: 3.35; 95% CI: 1.37-9.1; P=0.009) and massive/torrential TR at baseline (OR: 4.59; 95% CI:2.35-8.96; P< 0.001). At 1 year, 83% of patients showed ≤moderate TR. Significant clinical improvements included enhanced NYHA functional class (66% class I/II vs 17% at baseline; P< 0.001). Patients treated with the first-generation PASCAL system (n = 570) and with the new PASCAL Precision system (n = 489) had similar clinical profiles and TR severity at baseline. However, the Precision cohort showed greater TR reduction to trace/mild (63% vs 49%; P< 0.001), shorter procedure times (median 93minutes [Q1-Q3: 69-130 minutes] vs 120minutes [Q1-Q3: 82-165 minutes]; P< 0.001), and higher clinical success rates according to the Tricuspid Valve Academic Research Consortium at 30days and 1 year (87% vs 81% [P=0.021] and 56% vs 50% [P=0.044], respectively). Higher center experience (≥21 patients/year) resulted in higher intraprocedural and clinical success. The PASCAL system effectively treats severe TR in high-risk patients, offering sustained TR reduction and significant clinical improvements at 1-year follow-up. (PASCAL for Tricuspid Regurgitation-a European registry [PASTE]; NCT05328284).

Impact of Ticagrelor vs. Clopidogrel in Patients With Acute Coronary Syndrome Undergoing Left Main Percutaneous Coronary Intervention

Abstract Objective: There is limited evidence regarding the choice of P2Y12 receptor inhibitors as a component of dual antiplatelet therapy (DAPT) in patients with left main (LM) disease undergoing percutaneous coronary intervention (PCI). This study aimed to evaluate long-term clinical outcomes of ticagrelor- vs. clopidogrel-based DAPT strategy in acute coronary syndrome (ACS) patients undergoing LM PCI. Methods: This is a post-hoc analysis from a prospective, single-center, real-world PCI registry. A total of 1,163 patients discharged post-ACS who underwent LM PCI and received ticagrelor or clopidogrel between March 2016 and March 2019 were included in the study. The primary endpoint was ischemic events at 12 months, including cardiac death, myocardial infarction, or stroke. Secondary outcomes included all-cause death and Bleeding Academic Research Consortium types 2, 3, and 5, and types 3 and 5 bleeding. Propensity score matching was used to adjust for bias due to confounders between the 2 groups. Results: The ticagrelor and clopidogrel groups comprised 529 (45.49%) and 634 (54.51%) patients, respectively. During the follow-up period, ticagrelor significantly reduced the rate of ischemic events compared to clopidogrel before (1.32% (7/529) vs. 3.63% (23/634), P = 0.0136) and after propensity score matching (1.41% (6/425) vs. 4.00% (17/425), P = 0.0201). The rates of all-cause death, Bleeding Academic Research Consortium-defined type 2, 3, and 5 bleeding, and type 3 and 5 bleeding were similar between the ticagrelor group and clopidogrel group before or after propensity score matching adjustment (all P &gt; 0.05). Conclusion: Among patients with ACS undergoing LM PCI, ticagrelor use was associated with ischemic events benefit without excessive risk of bleeding at 12 months compared with clopidogrel.

Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT).

Lung cancer, predominantly non-small cell lung cancer (NSCLC), remains a formidable challenge, necessitating an in-depth understanding of evolving treatment paradigms. The Italian Lung Cancer Observational Study (LUCENT) addresses this need by investigating the outcomes of patients with early and locally advanced lung cancer in Italy. With a focus on real-world data and patient registries, this study aims to provide comprehensive insights into clinical, psychosocial, and economic impacts, contributing to informed decision-making in health care. LUCENT is a prospective observational multicenter cohort study enrolling patients eligible for minimally invasive manual, robot-assisted, or traditional open surgery. The study will develop a web-based registry to collect longitudinal surgical, oncological, and socioeconomic outcome data. The primary objectives include performance assessment through the establishment of national benchmarks based on risk-adjusted outcomes and processes of care indicators. The secondary objectives encompass economic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter design ensures a diverse and representative study population. The evolving landscape of NSCLC treatment necessitates a nuanced approach with consideration of the dynamic shifts in therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analyzing real-world data, emphasizing the importance of patient-reported outcomes in enhancing the understanding of the disease. By developing a web-based registry, the study not only facilitates efficient data collection but also addresses the limitations of traditional methods, such as suboptimal response rates and costs associated with paper-and-pencil questionnaires. Recruitment will be conducted from January 01, 2024, to December 31, 2026. Follow-up will be performed for a minimum of 2 years. The study will be completed in the year 2028. LUCENT's potential implications are substantial. Establishing national benchmarks will enable a thorough evaluation of outcomes and care processes, guiding clinicians and policymakers in optimizing patient management. Furthermore, the study's secondary objectives, focusing on economic and psychosocial impacts, align with the contemporary emphasis on holistic cancer care. Insights gained from this study may influence treatment strategies, resource utilization, and patient well-being, thereby contributing to the ongoing refinement of lung cancer management. ClinicalTrials.gov NCT05851755; https://clinicaltrials.gov/study/NCT05851755. ISRCTN 67197140; https://www.isrctn.com/ISRCTN67197140. PRR1-10.2196/57183.