Complete versus incomplete revascularization in patients with a non-ST-elevation myocardial infarction: Analysis from the e-ULTIMASTER registry.

BACKGROUND: Incomplete revascularization (ICR) has been associated with a worse prognosis after a percutaneous coronary intervention (PCI). In NSTEMI patients with multivessel disease (MVD) however, the benefit of a complete revascularization (CR) remains unclear. METHODS: Patients presenting with an NSTEMI and MVD were selected from the global e-ULTIMASTER registry and grouped according to completeness of revascularization at index hospitalization discharge. The primary endpoint was the patient oriented composite endpoint (POCE) defined as all death, any myocardial infarction, and any revascularization at 1 year. Target lesion failure (TLF) was defined as the composite of cardiac death, target vessel related myocardial infarction and clinically driven target lesion revascularization. Inverse propensity score weighting (IPSW) was performed to harmonize the patient's baseline characteristics between the groups. RESULTS: CR was achieved in 1800 patients (47.0 %) and ICR in 2032 patients (53.0 %). The incidence of POCE at 1 year was lower in the CR group compared to the ICR group: 7.0 % vs. 12.9 %, p < 0.0001. Similarly for TLF at 1 year: 3.6 % vs. 5.5 %, p < 0.01. After IPSW, the incidence of POCE was 7.7 % vs. 12.0 %, p < 0.0001, due to a lower all-cause mortality: 2.7 % vs. 4.2 %, p = 0.02 and less revascularizations: 4.9 % vs. 7.9 %, p < 0.001. The incidence of TLF was no longer statistically significant: CR 3.9 % vs. IR 5.0 %, p = 0.10. CONCLUSIONS: Patients with a NSTEMI and multi vessel disease undergoing a percutaneous coronary revascularization with a complete revascularization during index hospitalization have better 1-year clinical outcomes. Randomized studies are warranted to confirm these results.

Impact of coronary calcium morphology on intravascular lithotripsy.

BACKGROUND: Coronary calcification negatively impacts optimal stenting. Intravascular lithotripsy (IVL) is a new calcium modification technique. AIMS: We aimed to assess the impact of different calcium morphologies on IVL efficacy. METHODS: This was a prospective, multicentre study (13 tertiary referral centres). Optical coherence tomography (OCT) was performed before and after IVL, and after stenting. OCT-defined calcium morphologies were concentric (mean calcium arc >180°) and eccentric (mean calcium arc ≤180°). The primary outcomes were angiographic success (residual stenosis <20%) and the presence of fracture by OCT in concentric versus eccentric lesions. RESULTS: Ninety patients were included with a total of 95 lesions: 47 concentric and 48 eccentric. The median number of pulses was 60 (p=1.00). Following IVL, the presence of fracture was not statistically different between groups (79.0% vs 66.0% for concentric vs eccentric; p=0.165). The number of fractures/lesion (4.2±4.4 vs 2.3±2.8; p=0.018) and ≥3 fractures/lesion (57.1% vs 34.0%; p=0.029) were more common in concentric lesions. Angiographic success was numerically but not statistically higher in the concentric group (87.0% vs 76.6%; p=0.196). By OCT, no differences were noted in final minimum lumen area (5.9±2.2 mm2 vs 6.2±2.1 mm2; p=0.570), minimum stent area (5.9±2.2 mm² vs 6.25±2.4 mm2; p=0.483), minimum stent expansion (80.9±16.7% vs 78.2±19.8%), or stent expansion at the maximum calcium site (100.6±24.2% vs 95.8±27.3%) (p>0.05 for all comparisons of concentric vs eccentric, respectively). Calcified nodules were found in 29.5% of lesions; these were predominantly non-eruptive (57%). At the nodule site, dissection was more common than fracture with stent expansion of 103.6±27.2%. CONCLUSIONS: In this prospective, multicentre study, the effectiveness of IVL followed by stenting was not significantly affected by coronary calcium morphology.

Sex differences in delay times in ST-segment elevation myocardial infarction: A cohort study.

BACKGROUND: The present study analyzes a cohort of consecutive patients with ST-segment elevation acute myocardial infarction (STEMI), evaluating the ischemia-reperfusion times from the perspective of gender differences (females versus males), with a long-term follow-up. METHODS: Single-center analytical cohort study of patients with STEMI in a tertiary hospital, between January 2015 and December 2020. RESULTS: A total of 2668 patients were included, 2002 (75%) men and 666 (25%) women. The time elapsed from the onset of symptoms to the opening of the artery was 197min (IQR 140-300) vs 220min (IQR 152-340), p=0.004 in men and women respectively. A delay in health care significantly impacts the occurrence of cardiovascular adverse events at follow-up, HR 1.34 [95%CI 1.06-1.70]; p=0.015. CONCLUSIONS: Women took longer to go to health care services and had a longer delay both in the diagnosis of STEMI and in coronary reperfusion. It is imperative to emphasize the necessity of educating women about the recognition of ischemic heart disease symptoms, empowering them to raise early alarms and seek timely medical attention.

Impacto pronóstico a diez años del fallo del vaso diana tras un IAMCEST. Perspectivas del ensayo EXAMINATION-EXTEND / Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial

Introducción y objetivos Se desconoce el impacto pronóstico de los diferentes tipos de eventos adversos tras el infarto agudo de miocardio con elevación del segmento ST (IAMCEST). El objetivo de este trabajo es evaluar los predictores a largo plazo del objetivo combinado orientado al paciente (POCE) y si tener un fallo del vaso diana (FVD) como primer evento puede influir en los resultados. Métodos El ensayo EXAMINATION-EXTEND aleatorizó a pacientes con IAMCEST a tratamiento con stents liberadores de everolimus o a stents convencionales, con un seguimiento de hasta 10 años. En la población del estudio, se evaluaron los predictores de POCE (combinado de mortalidad por cualquier causa, infarto de miocardio y cualquier revascularización). Se clasificó a los pacientes según el tipo de primer evento (FVD primero o FDV no primero) y comparado en términos de POCE posterior. El FVD se definió como el compuesto de muerte cardiaca, IAMCEST del vaso diana y revascularización del vaso diana. Resultados De los 1.498 pacientes del estudio, 529 (35,3%) tuvieron POCE durante el seguimiento a los 10 años. Los predictores independientes de POCE fueron la edad, la diabetes mellitus, el infarto de miocardio previo, la enfermedad arterial periférica y la enfermedad coronaria multivaso. El primer evento fue un FVD o no FVD en 296 y 233 casos respectivamente. No hubo diferencias estadísticamente significativas entre quienes tuvieron primero un FVD y los que tuvieron un evento no FVD en cuanto a POCE (el 21,7 frente al 39,3%; razón de tiempo, 1,79; IC95%, 0,87-3,67; p=0,12) o sus componentes individuales. Conclusiones En el seguimiento a 10 años, alrededor de un tercio de los pacientes con IAMCEST tuvo al menos 1 evento de POCE, cuyos predictores independientes fueron la edad, la diabetes mellitus y una mayor extensión de la enfermedad ateroesclerótica... (AU)

Introduction and objectivesAfter ST-segment myocardial infarction (STEMI), the impact of different adverse events on prognosis remains unknown. We aimed to assess very long-term predictors of patient-oriented composite endpoints (POCE) and investigate whether the occurrence of target vessel failure (TVF) vs a non-TVF event as the first event could potentially influence subsequent outcomes. Methods The EXAMINATION.EXTEND trial randomized STEMI patients to receive either an everolimus-eluting stent or a bare-metal stent. The follow-up period was 10 years. Predictors of POCE (a composite of all-cause death, any myocardial infarction, or any revascularization) were evaluated in the overall study population. The patients were stratified based on the type of first event (TVF-first vs non–TVF-first) and were compared in terms of subsequent POCE. TVF was defined as a composite of cardiac death, TV myocardial infarction, or TV revascularization. Results Out of the 1498 enrolled patients, 529 (35.3%) experienced a POCE during the 10-year follow-up. Independent predictors of POCE were age, diabetes mellitus, previous myocardial infarction, peripheral arterial disease, and multivessel coronary disease. The first event was a TVF in 296 patients and was a non-TVF in 233 patients. No significant differences were observed between TVF-first and non–TVF-first patients in terms of subsequent POCE (21.7% vs 39.3%, time ratio 1.79; 95%CI, 0.87-3.67; P=.12) or its individual components. Conclusions At the 10-year follow-up, approximately one-third of STEMI patients had experienced at least 1 POCE. Independent predictors of these events were age, diabetes, and more extensive atherosclerotic disease. The occurrence of a TVF or a non-TVF as the first event did not seem to influence subsequent outcomes. Trial registration number: NCT04462315. (AU)

Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial.

INTRODUCTION AND OBJECTIVES: After ST-segment myocardial infarction (STEMI), the impact of different adverse events on prognosis remains unknown. We aimed to assess very long-term predictors of patient-oriented composite endpoints (POCE) and investigate whether the occurrence of target vessel failure (TVF) vs a non-TVF event as the first event could potentially influence subsequent outcomes. METHODS: The EXAMINATION-EXTEND trial randomized STEMI patients to receive either an everolimus-eluting stent or a bare-metal stent. The follow-up period was 10 years. Predictors of POCE (a composite of all-cause death, any myocardial infarction, or any revascularization) were evaluated in the overall study population. The patients were stratified based on the type of first event (TVF-first vs non-TVF-first) and were compared in terms of subsequent POCE. TVF was defined as a composite of cardiac death, TV myocardial infarction, or TV revascularization. RESULTS: Out of the 1498 enrolled patients, 529 (35.3%) experienced a POCE during the 10-year follow-up. Independent predictors of POCE were age, diabetes mellitus, previous myocardial infarction, peripheral arterial disease, and multivessel coronary disease. The first event was a TVF in 296 patients and was a non-TVF in 233 patients. No significant differences were observed between TVF-first and non-TVF-first patients in terms of subsequent POCE (21.7% vs 39.3%, time ratio 1.79; 95%CI, 0.87-3.67;P=.12) or its individual components. CONCLUSIONS: At the 10-year follow-up, approximately one-third of STEMI patients had experienced at least 1 POCE. Independent predictors of these events were age, diabetes, and more extensive atherosclerotic disease. The occurrence of a TVF or a non-TVF as the first event did not seem to influence subsequent outcomes. TRIAL REGISTRATION NUMBER: NCT04462315.

Automatic Assessment of Transcatheter Aortic Valve Implantation Results on Four-Dimensional Computed Tomography Images Using Artificial Intelligence.

Transcatheter aortic valve implantation (TAVI) is a procedure to treat severe aortic stenosis. There are several clinical concerns related to potential complications after the procedure, which demand the analysis of computerized tomography (CT) scans after TAVI to assess the implant's result. This work introduces a novel, fully automatic method for the analysis of post-TAVI 4D-CT scans to characterize the prosthesis and its relationship with the patient's anatomy. The method enables measurement extraction, including prosthesis volume, center of mass, cross-sectional area (CSA) along the prosthesis axis, and CSA difference between the aortic root and prosthesis, all the variables studied throughout the cardiac cycle. The method has been implemented and evaluated with a cohort of 13 patients with five different prosthesis models, successfully extracting all the measurements from each patient in an automatic way. For Allegra patients, the mean of the obtained inner volume values ranged from 10,798.20 mm3 to 18,172.35 mm3, and CSA in the maximum diameter plane varied from 396.35 mm2 to 485.34 mm2. The implantation of this new method could provide information of the important clinical value that would contribute to the improvement of TAVI, significantly reducing the time and effort invested by clinicians in the image interpretation process.

Cerebral embolic protection during transcatheter heart interventions.

Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), with the incidence of clinically apparent stroke seemingly fixed at around 3% despite TAVR's significant evolution during the past decade. Embolic showers of debris (calcium, atheroma, valve material, foreign material) are captured in the majority of patients who have TAVR using a filter-based cerebral embolic protection device (CEPD). Additionally, in systematic brain imaging studies, the majority of patients receiving TAVR exhibit new cerebral lesions. Mechanistic studies have shown reductions in the volume of new cerebral lesions using CEPDs, yet the first randomised trial powered for periprocedural stroke within 72 hours of a transfemoral TAVR failed to meet its primary endpoint of showing superiority of the SENTINEL CEPD. The present review summarises the clinicopathological rationale for the development of CEPDs, the evidence behind these devices to date and the emerging recognition of cerebral embolisation in many non-TAVR transcatheter procedures. Given the uniqueness of each of the various CEPDs under development, specific trials tailored to their designs will need to be undertaken to broaden the CEPD field, in addition to evaluating the role of CEPD in non-TAVR transcatheter heart interventions. Importantly, the cost-effectiveness of these devices will require assessment to broaden the adoption of CEPDs globally.

Relationship between stent length and very long-term target lesion failure following percutaneous coronary intervention for ST-elevation myocardial infarction in the drug-eluting stents era: insights from the EXAMINATION-EXTEND study.

BACKGROUND: Little data exist on the relationship between total stent length (TSL) and cardiovascular outcomes at very-long follow-up in patients with ST-elevation myocardial infarction (STEMI) in the 2nd generation drug-eluting stents (DES) era. AIM: To analyze the relationship between TSL and 10-year target-lesion failure (TLF) in STEMI patients treated with percutaneous coronary intervention enrolled in the EXAMINATION-EXTEND. METHODS: The EXAMINATION-EXTEND was an extended-follow-up study of the EXAMINATION trial, which randomized 1:1 STEMI patients to receive DES or bare metal stent (BMS). The primary endpoint was TLF, defined as a composite of target lesion revascularization (TLR), target vessel myocardial infarction (TVMI), or definite/probable stent thrombosis (ST). Relationship between stent length and TLF was evaluated in the whole study group in a multiple-adjusted Cox regression model with TSL as a quantitative variable. Subgroup analysis was also performed according to stent type, diameter, and overlap. RESULTS: A total of 1,489 patients with a median TSL of 23 mm (Q1-Q318-35 mm) were included. TSL was associated with TLF at 10 years (adjusted HR per 5 mm increase of 1.07; 95% CI, 1.01-1.14; P = .02). This effect was mainly driven by TLR and was consistent regardless of stent type, diameter, or overlap. There was no significant relationship between TSL and TV-MI or ST. CONCLUSIONS: In STEMI patients, there is a direct relationship between TSL implanted in the culprit vessel and the risk of TLF at 10 years, mainly driven by TLR. The use of DES did not modify this association.

Wellens syndrome as an independent predictor of in-hospital cardiovascular complications.

INTRODUCTION: Wellens Syndrome was described for the first time in the eighties, as an equivalent pattern of a critical lesion of the anterior descending artery. Different risk factors have been associated with a worse prognosis during hospitalisation in patients with non-ST segment elevation acute coronary syndrome. However, it is unknown whether the presence of Wellens Syndrome alone contributes to an increase in in-hospital cardiovascular complications. MATERIAL AND METHOD: Analytical prospective cohort study in 141 patients with the diagnosis of acute coronary syndrome without ST segment elevation who underwent coronary angiography between 2016 and 2020. RESULTS: Wellens syndrome was diagnosed in 64 patients with a mean age of 66.31 ± 12.54, of which 21 patients had a cardiac event during hospitalisation: hemodynamic complication 14 (21.9%), refractory or recurrent angina 4 (6.3%) and Acute myocardial infarction 3 (4.7%) confirming a relative risk (RR): 4.88 (95% confidence interval (CI) 1.92-12.45) p = 0.001. CONCLUSIONS: The presence of Wellens Syndrome is independently associated with the appearance of cardiac complications during hospitalisation.Key pointsSW is now known to be a relatively frequent presentation of ACS, not addressed in depth in clinical practice guidelines for NSTEACS. This syndrome is generally caused by a severe ADA occlusion that, if not adequately treated, could evolve into a large infarction. According to the results of the different series published, the incidence of cardiovascular risk factors in SW is similar to other forms of presentation of ischaemic heart disease.At present, the exact relationship between the main cardiovascular risk factors and SW is unknown; in addition to the possible associations of this syndrome with in-hospital cardiovascular complications and its value as a predictor of the occurrence of cardiac complications, elements that are included in the results of the present study.

Impact of Age at the Time of the First ST-Elevation Myocardial Infarction on 10-Year Outcomes (from the EXAMINATION-EXTEND Trial).

The aim of this substudy of the EXAMINATION-EXTEND was to analyze 10-year outcomes according to the patient's age at the time of the first ST-elevation myocardial infarction (STEMI). Of 1,498 patients with STEMI included in the EXAMINATION-EXTEND study, those with a previous history of coronary ischemic even or ischemic stroke were excluded from this analysis. The remaining 1,375 patients were divided into 4 age groups: <55, 55 to 65, 65 to 75, and >75 years. The primary end point was 10-year patient-oriented composite end point (POCE) of all-cause death, any MI, or any revascularization. At 10-year follow-up, patients aged <55 years (adjusted hazard ratio [HR] 0.24, 95% confidence interval [CI] 0.18 to 0.31, p = 0.001), 55 to 65 years (adjusted HR 0.26, 95% CI 0.20 to 0.34, p = 0.001), and 65 to 75 years (adjusted HR 0.38, 95% CI 0.30 to 0.50, p = 0.001) showed lower risk of POCE than those aged >75 years, led by a lower incidence of all-cause death (<55 : 6% vs 55 to 65: 11.9% vs 65 to 75: 25.7% vs >75 years: 61.6%, p = 0.001). Cardiac death was more prevalent in the older group (<55: 3.7% vs 55 to 65: 5.8% vs 65 to 75: 10.9% vs >75 years: 35.5%, p = 0.001). In the landmark analyses, between 5- and 10-year follow-up, young patients exhibited a higher incidence of any revascularization (<55: 7.4% vs 55 to 65: 4.9% vs 65 to 75: 1.8% vs >65 years: 1.6%, p = 0.001). In conclusion, in patients with a first STEMI, advanced age was associated with high rates of POCE at 10-year follow-up due to all-cause and cardiac death. Conversely, younger patients exhibited a high risk of revascularization at long-term follow-up.

Geographic Variations on the Safety and Efficacy of the Supreme Biodegradable Polymer DES: Results From PIONEER III.

Background: The PIONEER III trial showed the 12-month safety and efficacy of the Supreme drug-eluting stent (DES) vs the durable polymer everolimus-eluting stent. We sought to assess whether the characteristics and clinical outcomes of the Supreme DES in PIONEER III were consistent among patients by enrollment location. Methods: This subgroup analysis of the PIONEER III trial compared the characteristics and outcomes of patients recruited from North America, Europe, and Japan and the relative differences in patient outcomes according to the site recruitment volume. Results: From October 2017 to July 2019, 1629 patients were recruited in North America (816, 50.1%), Europe (650, 39.9%), and Japan (163, 10%). Procedural success was achieved in 1556 of 1611 procedures (96.6%), with no difference by the geographic location. Target lesion failure at 12 months for combined groups was observed in 84 of 1629 patients (5.2%), with no significant geographic differences (4.7%, 6.5%, and 2.5%, respectively; P =.08), with similar results in the Supreme DES group alone (4.4%, 6.8%, and 3.7%, respectively, P =.20). Cardiac death at 12 months occurred in 0.4%, 0.2%, and 0.0% (P =.79), target vessel-related myocardial infarction occurred in 2.2%, 4.7%, and 3.7%, (P =.10), and clinically driven target lesion revascularization was required in 2.1%, 3.1%, and 0%, respectively (P =.15). Compared with those from high-recruiting sites, results from low-recruiting sites were similar for target lesion failure, major adverse cardiac events, stent thrombosis, and mortality, with a nonsignificant trend for higher rates of myocardial infarction. Conclusions: Despite regional differences in patient characteristics, the clinical outcomes between Supreme DES and durable polymer everolimus-eluting stent in the PIONEER III trial were not different, supporting the generalizability and robustness of the findings from this multicenter controlled trial.

The Supreme Biodegradable Polymer DES in Acute and Chronic Coronary Syndromes: A PIONEER III Substudy.

Background: The PIONEER III trial demonstrated noninferiority of 12-month target lesion failure (TLF) with the Supreme DES (Sinomed), a thin-strut cobalt-chromium, biodegradable polymer, sirolimus-eluting stent, compared with a durable polymer, everolimus-eluting (XIENCE/PROMUS) stent (DP-EES). The relative safety and effectiveness of the Supreme DES in patients with acute coronary syndromes (ACS) and those with chronic coronary syndromes (CCS) is not known. Methods: PIONEER III was a prospective, multicenter, international, 2:1 randomized trial stratified by clinical presentation. The primary end point was TLF at 12 months (a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization). Results: A total of 1628 patients were enrolled, including 41% of patients with ACS (unstable angina and non-ST-elevation myocardial infarction) randomized to Supreme DES (n = 441) versus DP-EES (n = 232) and 59% of patients with CCS randomized to Supreme DES (n = 645) versus DP-EES (n = 310). Patients with ACS were younger, fewer presented with less diabetes, hypertension, and previous revascularization, but more were current smokers. The primary end point of TLF (6.4% vs 4.4%; P = .1), major adverse cardiac events (8.5% vs 6.5%; P = .16), and stent thrombosis (0.4% vs 0.9%; P = .25) at 12 months were similar in the ACS and CCS groups. There was no difference in TLF at 12 months between Supreme DES and DP-EES among patients with ACS (6.6% vs 6.0%; P = .89) and those with CCS (4.5% vs 4.3%; P = .83); interaction P = .51 for TLF by clinical presentation. Conclusions: Compared with the DP-EES, the Supreme DES seemed safe and effective with a similar TLF at 12 months in both patients with ACS and those with CCS.

Validation of Quantitative Flow Ratio-Derived Virtual Angioplasty with Post-Angioplasty Fractional Flow Reserve-The QIMERA-I Study.

Background: Quantitative flow ratio (QFR) virtual angioplasty with pre-PCI residual QFR showed better results compared with an angiographic approach to assess post-PCI functional results. However, correlation with pre-PCI residual QFR and post-PCI fractional flow reserve (FFR) is lacking. Methods: A multicenter prospective study including consecutive patients with angiographically 50-90% coronary lesions and positive QFR results. All patients were evaluated with QFR, hyperemic and non-hyperemic pressure ratios (NHPR) before and after the index PCI. Pre-PCI residual QFR (virtual angioplasty) was calculated and compared with post-PCI fractional flow reserve (FFR), QFR and NHPR. Results: A total of 84 patients with 92 treated coronary lesions were included, with a mean age of 65.5 ± 10.9 years and 59% of single vessel lesions being the left anterior descending artery in 69%. The mean vessel diameter was 2.82 ± 0.41 mm. Procedural success was achieved in all cases, with a mean number of implanted stents of 1.17 ± 0.46. The baseline QFR value was 0.69 ± 0.12 and baseline FFR and NHPR were 0.73 ± 0.08 and 0.82 ± 0.11, respectively. Mean post-PCI FFR increased to 0.87 ± 0.05 whereas residual QFR had been estimated as 0.95 ± 0.05, showing poor correlation with post-PCI FFR (0.163; 95% CI:0.078-0.386) and low diagnostic accuracy (30.9%, 95% CI:20-43%). Conclusions: In this analysis, the results of QFR-based virtual angioplasty did not seem to accurately correlate with post-PCI FFR.

One-year cardiovascular outcomes after coronavirus disease 2019: The cardiovascular COVID-19 registry.

BACKGROUND: The long-term cardiovascular (CV) outcomes of COVID-19 have not been fully explored. METHODS: This was an international, multicenter, retrospective cohort study conducted between February and December 2020. Consecutive patients ≥18 years who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 were included. Patients were classified into two cohorts depending on the nasopharyngeal swab result and clinical status: confirmed COVID-19 (positive RT-PCR) and control (without suggestive symptoms and negative RT-PCR). Data were obtained from electronic records, and clinical follow-up was performed at 1-year. The primary outcome was CV death at 1-year. Secondary outcomes included arterial thrombotic events (ATE), venous thromboembolism (VTE), and serious cardiac arrhythmias. An independent clinical event committee adjudicated events. A Cox proportional hazards model adjusted for all baseline characteristics was used for comparing outcomes between groups. A prespecified landmark analysis was performed to assess events during the post-acute phase (31-365 days). RESULTS: A total of 4,427 patients were included: 3,578 (80.8%) in the COVID-19 and 849 (19.2%) control cohorts. At one year, there were no significant differences in the primary endpoint of CV death between the COVID-19 and control cohorts (1.4% vs. 0.8%; HRadj 1.28 [0.56-2.91]; p = 0.555), but there was a higher risk of all-cause death (17.8% vs. 4.0%; HRadj 2.82 [1.99-4.0]; p = 0.001). COVID-19 cohort had higher rates of ATE (2.5% vs. 0.8%, HRadj 2.26 [1.02-4.99]; p = 0.044), VTE (3.7% vs. 0.4%, HRadj 9.33 [2.93-29.70]; p = 0.001), and serious cardiac arrhythmias (2.5% vs. 0.6%, HRadj 3.37 [1.35-8.46]; p = 0.010). During the post-acute phase, there were no significant differences in CV death (0.6% vs. 0.7%; HRadj 0.67 [0.25-1.80]; p = 0.425), but there was a higher risk of deep vein thrombosis (0.6% vs. 0.0%; p = 0.028). Re-hospitalization rate was lower in the COVID-19 cohort compared to the control cohort (13.9% vs. 20.6%; p = 0.001). CONCLUSIONS: At 1-year, patients with COVID-19 experienced an increased risk of all-cause death and adverse CV events, including ATE, VTE, and serious cardiac arrhythmias, but not CV death. STUDY REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04359927.

Impact of Diabetes on 10-Year Outcomes Following ST-Segment-Elevation Myocardial Infarction: Insights From the EXAMINATION-EXTEND Trial.

Background Long-term outcomes of ST-segment-elevation myocardial infarction in patients with diabetes have been barely investigated. The objective of this analysis from the EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION trial) trial was to compare 10-year outcomes of patients with ST-segment-elevation myocardial infarction with and without diabetes. Methods and Results Of the study population, 258 patients had diabetes and 1240 did not. The primary end point was patient-oriented composite end point of all-cause death, any myocardial infarction, or any revascularization. Secondary end points were the individual components of the primary combined end point, cardiac death, target vessel myocardial infarction, target lesion revascularization, and stent thrombosis. All end points were adjusted for potential confounders. At 10 years, patients with diabetes showed a higher incidence of patient-oriented composite end point compared with those without (46.5% versus 33.0%; adjusted hazard ratio [HR], 1.31 [95% CI, 1.05-1.61]; P=0.016) mainly driven by a higher incidence of any revascularization (24.4% versus 16.6%; adjusted HR, 1.61 [95% CI, 1.19-2.17]; P=0.002). Specifically, patients with diabetes had a higher incidence of any revascularization during the first 5 years of follow-up (20.2% versus 12.8%; adjusted HR, 1.57 [95% CI, 1.13-2.19]; P=0.007) compared with those without diabetes. No statistically significant differences were found with respect to the other end points. Conclusions Patients with ST-segment-elevation myocardial infarction who had diabetes had worse clinical outcome at 10 years compared with those without diabetes, mainly driven by a higher incidence of any revascularizations in the first 5 years. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04462315.

Stroke prevention during and after transcatheter aortic valve implantation: From cerebral protection devices to antithrombotic management.

Since its conception, transcatheter aortic valve implantation (TAVI) has undergone important improvements both in the implantation technique and in transcatheter devices, allowing an enthusiastic adoption of this therapeutic approach in a wide population of patients previously without a surgical option and managed conservatively. Nowadays, patients with severe symptomatic aortic stenosis are typically managed with TAVI, regardless of their risk to surgery, improving the prognosis of patients and thus achieving an exponential global expansion of its use. However, thromboembolic and hemorrhagic complications remain a latent concern in TAVI recipients. Both complications can appear simultaneously in the periprocedural period or during the follow-up, and when minor, they resolved without apparent sequelae, but in a relevant percentage of cases, they are devastating, overshadowing the benefit achieved with TAVI. Our review outlines the etiology and incidence of thromboembolic complications associated with TAVI, the main current strategies for their prevention, and the implications of its pharmacological management at the follow-up in a TAVI population, mostly frail and predisposed to bleeding complications.

Patients' knowledge about their involvement in clinical trials. A non-randomized controlled trial.

Background: Nowadays, good clinical practice should be established in human research. Patient's rights and autonomy must be respected above the interest of the researcher, making mandatory to raise patient's awareness on the implications of participating in a clinical study. Contrary to popular belief, this is not always the case. This means that, after signing the informed consent form, some patients have difficulties understanding their responsibilities as participants. Materials and methods: This study is a prospective, multicenter, non-randomized controlled trial comparative survey conducted on patients enrolled in a clinical trial to evaluate and improve their understanding after an educational intervention was applied to the research staff. Results: Females were underrepresented in the clinical trials performed in this study, 21.5%. Most of the participants had a low educational level (74.4%). Around 5 and 10% of the research participants were not aware they were part of a clinical study, and more 24% just trusted in the medical decision to be enrolled. After the interventional education, the following items: "given time and resolution of the patient doubts" (p-value = 0.003), "enough written information" (p-value = 0.006), "explanation of the risks of participating in the study," (p-value = 0.047) and understanding of the information provided to them showed an improvement regarding the study in which they were participating. Conclusion: The research participants understanding of their involvement in clinical trials is limited. An educational intervention on the research team can improve the process of empowerment and transit of information.