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Despite prompt epicardial recanalization in patients presenting with ST-segment elevation myocardial infarction (STEMI), coronary microvascular obstruction and dysfunction (CMVO) is still fairly common and is associated with poor prognosis. Various pharmacological and mechanical strategies to treat CMVO have been proposed, but the positive results reported in preclinical and small proof-of-concept studies have not translated into benefits in large clinical trials conducted in the modern treatment setting of patients with STEMI. Therefore, the optimal management of these patients remains a topic of debate. In this Review, we appraise the pathophysiological mechanisms of CMVO, explore the evidence and provide future perspectives on strategies to be implemented to reduce the incidence of CMVO and improve prognosis in patients with STEMI., (© 2023. Springer Nature Limited.)

Background: The impact on age on the short-term and long-term prognosis in patients with Takotsubo syndrome (TTS) is unclear. We aimed to evaluate whether age has prognostic implications during hospital stay and long-term follow-up of TTS patients., Methods: 688 consecutive patients were admitted for TTS in 7 tertiary centers from January-2008 to June-2021. We divided our cohort into two groups (patients <75 years and ≥75 years). Clinical, analytical, and hemodynamic variables as well as in-hospital management were registered and compared between groups. Mortality rates during hospital stay and follow-up were assessed. Adverse cardiovascular events (ACE) were defined as the composite of cardiovascular death, heart failure event, acute myocardial infarction, stroke and symptomatic arrhythmia., Results: Median age was 74.7 years and 49.4 % were ≥75 years. 86.9 % were women and 22.3 % were secondary forms of TTS. In-hospital mortality was 3.6 % (1.5 % cardiovascular). Median clinical follow-up was 4.3 years. Mortality during the follow-up period was 23 % (5.0 % cardiovascular) while ACE were 22.5 %, mainly due to heart failure events. Kaplan-Meier curves showed both higher rates of mortality and ACE in ≥75 years group (30.2 % vs 15.8 %; p < 0.001 and 28.3 % vs 16.7 %; p < 0.001). Age was independently associated with higher rates of overall mortality and ACE in patients with TTS. Hypertension, absence of sinus rhythm, Killip class > I and a more impaired coronary microvascular resistance were also associated to ACE in TTS patients., Conclusions: Advanced age was associated with higher rate of overall mortality and ACE during long-term follow-up in TTS patients., Competing Interests: Declaration of competing interest Dr. Hector M. Garcia-Garcia reports the following institutional grant support: Biotronik, Boston Scientific, Medtronic, Abbott, Neovasc, Shockwave, Phillips and Corflow. The following is the supplementary data related to this article. Supplementary data to this article can be found online at https://doi.org/10.1016/j.carrev.2023.10.018., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Complete revascularization of the culprit and all significant nonculprit lesions in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and multivessel disease (MVD) reduces major adverse cardiac events, but optimal timing of revascularization remains unclear., Objectives: This study aims to compare immediate complete revascularization (ICR) and staged complete revascularization (SCR) in patients presenting with NSTE-ACS and MVD., Methods: This prespecified substudy of the BIOVASC (Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndrome and Multivessel Disease) trial included patients with NSTE-ACS and MVD. Risk differences of the primary composite outcome of all-cause mortality, myocardial infarction (MI), unplanned ischemia-driven revascularization (UIDR), or cerebrovascular events and its individual components were compared between ICR and SCR at 1 year., Results: The BIOVASC trial enrolled 1,525 patients; 917 patients presented with NSTE-ACS, of whom 459 were allocated to ICR and 458 to SCR. Incidences of the primary composite outcome were similar in the 2 groups (7.9% vs 10.1%; risk difference 2.2%; 95% CI: -1.5 to 6.0; P = 0.15). ICR was associated with a significant reduction of MIs (2.0% vs 5.3%; risk difference 3.3%; 95% CI: 0.9 to 5.7; P = 0.006), which was maintained after exclusion of procedure-related MIs occurring during the index or staged procedure (2.0% vs 4.4%; risk difference 2.4%; 95% CI: 0.1 to 4.7; P = 0.032). UIDRs were also reduced in the ICR group (4.2% vs 7.8%; risk difference 3.5%; 95% CI: 0.4 to 6.6; P = 0.018)., Conclusions: ICR is safe in patients with NSTE-ACS and MVD and was associated with a reduction in MIs and UIDRs at 1 year., Competing Interests: Funding Support and Author Disclosures The BIOVASC trial was funded by the Erasmus University Medical Center, Rotterdam, and Biotronik SE & Co KG, Berlin. Dr Diletti has received institutional research grants from Biotronik, Medtronic, ACIST Medical Systems, and Boston Scientific. Dr den Dekker has received institutional research grants from Biotronik. Dr Van Mieghem has received institutional research grants from Biotronik, Abbott, Medtronic, Edwards Lifesciences, PulseCath, Abiomed, and Daiichi-Sankyo; speaker fees from Abiomed and Amgen; and a travel grant from JenaValve. Dr Bennett has received institutional grants from Biotronik, Abbott Vascular, and Shockwave Medical. Dr Daemen has received institutional grant/research support from Abbott Vascular, Boston Scientific, ACIST Medical Systems, Medtronic, Microport, Pie Medical, and ReCor Medical; and consultancy and speaker fees from Abbott Vascular, Abiomed, ACIST Medical Systems, Boston Scientific, Cardialysis BV, CardiacBooster, Kaminari Medical, ReCor Medical, PulseCath, Pie Medical, Sanofi, Siemens Healthineers, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2023 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Aims: Women have historically been disadvantaged in terms of care and outcomes for non-ST-segment elevation myocardial infarction (NSTEMI). We describe patterns of presentation, care, and outcomes for NSTEMI by sex in a contemporary and geographically diverse cohort., Methods and Results: Prospective cohort study including 2947 patients (907 women, 2040 men) with Type I NSTEMI from 287 centres in 59 countries, stratified by sex. Quality of care was evaluated based on 12 guideline-recommended care interventions. The all-or-none scoring composite performance measure was used to define receipt of optimal care. Outcomes included acute heart failure, cardiogenic shock, repeat myocardial infarction, stroke/transient ischaemic attack, BARC Type ≥3 bleeding, or death in-hospital, as well as 30-day mortality. Women admitted with NSTEMI were older, more comorbid, and more frequently categorized as at higher ischaemic (GRACE >140, 54.0% vs. 41.7%, P < 0.001) and bleeding (CRUSADE >40, 51.7% vs. 17.6%, P < 0.001) risk than men. Women less frequently received invasive coronary angiography (ICA; 83.0% vs. 89.5%, P < 0.001), smoking cessation advice (46.4% vs. 69.5%, P < 0.001), and P2Y12 inhibitor prescription at discharge (81.9% vs. 90.0%, P < 0.001). Non-receipt of ICA was more often due to frailty for women than men (16.7% vs. 7.8%, P = 0.010). At ICA, more women than men had non-obstructive coronary artery disease or angiographically normal arteries (15.8% vs. 6.3%, P < 0.001). Rates of in-hospital adverse outcomes and 30-day mortality were low and did not differ by sex., Conclusion: In contemporary practice, women presenting with NSTEMI, compared with men, less frequently receive antiplatelet prescription, smoking cessation advice, or are considered eligible for ICA., Competing Interests: Conflict of interest: H.B., K.H., P.L., R.N., and V.K. report no conflict of interest. C.P.G. reports personal fees from AstraZeneca, Amgen, Bayer, Boehrinher-Ingelheim, Daiichi Sankyo, Vifor, Pharma, Menarini, Wondr Medical, Raisio Group, and Oxford University Press. He has received educational and research grants from BMS, Abbott Inc., the British Heart Foundation, National Institute of Health Research, Horizon 2020, and from the European Society of Cardiology, outside the submitted work. S.B. reports personal fees from Boston Scientific, Insight, Lifetech, iVascular, and Abbott Vascular. D.M. reports personal fees from Abbott, Boston Scientific, Biosensors and Terumo. He has participated on Data Safety Monitoring Boards or Advisory Boards for Abbott and Boston Scientific. A.B. reports personal and institutional investigator fees from AstraZeneca, Bristol Myers Squibb/Pfizer, sanofi-aventis, Novartis, Amgen, Novo Nordisk, and Bayer. He reports personal fees from AstraZeneca, Bristol Myers Squibb/Pfizer, sanofi-aventis, Novartis, and Bayer. He has participated in Data Safety Monitoring Boards or Advisory Boards for AstraZeneca, Bristol Myers Squibb/Pfizer, sanofi-aventis, and Bayer. He has received support for attending meetings by Astra Zeneca, Bristol Myers Squibb/Pfizer, sanofi-aventis, and Bayer. S.L. reports personal fees from ICON, Chiesi, AstraZeneca, Daiichi Sankyo, Bayer, Bristol Myers Squibb/Pfizer, and Novo Nordisk. M.L. reports speaker fees from Bristol Myers Squibb/Pfizer, Boehrinher-Ingelheim, Novartis and sanofi, and manuscript writing fees from Edwards Lifesciences. She has also participated as an advisory board member for sanofi, Bristol Myers Squibb/Pfizer, and Boehrinher-Ingelheim. Y.A. reports a research grant from the Dutch Heart Foundation. Signed COIs available for all authors., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: In the prospective, multicentre, randomised TARGET All Comers study, percutaneous coronary intervention (PCI) with the FIREHAWK biodegradable-polymer sirolimus-eluting stent (BP-SES) was non-inferior to the durable-polymer everolimus-eluting stent (DP-EES) for the primary endpoint of target lesion failure (TLF) at 12 months., Aims: We aimed to report the final study outcomes at 5 years., Methods: Patients referred for PCI were randomised to receive either a BP-SES or DP-EES in a 1:1 ratio in 10 European countries. Randomisation was stratified by centre and ST-elevation myocardial infarction (STEMI) presentation, and clinical follow-up extended to 5 years. The primary endpoint was TLF (composite of cardiac death, target vessel myocardial infarction [MI], or ischaemia-driven target lesion revascularisation). Secondary endpoints included patient-oriented composite events (POCE; composite of all-cause death, all MI, or any revascularisation and its components)., Results: From December 2015 to October 2016, 1,653 patients were randomly assigned to the BP-SES or DP-EES groups, of which 93.8% completed 5-year clinical follow-up or were deceased. At 5 years, TLF occurred in 17.1% of the BP-SES group and in 16.3% of the DP-EES group (p=0.68). POCE occurred in 34.0% of the BP-SES group and 32.7% of the DP-EES group (p=0.58). Revascularisation was the most common POCE, occurring in 19.3% of patients receiving BP-SES and 19.2% receiving DP-EES, of which less than one-third was ischaemia-driven target lesion-related. In the landmark analysis, there were no differences in the rates of TLF and POCE between groups from 1 to 5 years, and these results were consistent across all subgroups., Conclusions: In an all-comers population requiring stent implantation for myocardial ischaemia, the BP-SES was non-inferior to the DP-EES for the primary endpoint of TLF at 12 months, and results were sustained at 5 years, confirming the long-term safety and efficacy of the FIREHAWK BP-SES.

Introduction and Objectives: Data on the clinical profile and outcomes of younger patients with ST-elevation myocardial infarction (STEMI) is scarce. This study compared clinical characteristics and outcomes between patients aged<45 years and those aged ≥ 45 years with STEMI managed by the acute myocardial infarction code (AMI Code) network. Sex-based differences in the younger cohort were also analyzed., Methods: This multicenter study collected individual data from the Catalonian AMI Code network. Between 2015 and 2020, we enrolled patients with an admission diagnosis of STEMI. Primary endpoints were all-cause mortality within 30 days, 1 year, and 2 years., Results: Overall, 18 933 patients (23% female) were enrolled. Of them, 1403 participants (7.4%) were aged<45 years. Younger patients with STEMI were more frequently smokers (P<.001) and presented with cardiac arrest and TIMI flow 0 before pPCI (P<.05), but the time from first medical contact to wire crossing was shorter than in the older group (P<.05). All-cause mortality rates were lower in patients aged<45 years (P<.001). Among younger patients, cardiogenic shock was most prevalent in women than in their male counterparts (P=.002), with the time from symptom onset to reperfusion being longer (P<.05). Compared with men aged<45 years, younger women were less likely to undergo pPCI (P=.004)., Conclusions: Despite showing high-risk features on admission, young patients exhibit better outcomes than older patients. Differences in ischemia times and treatment were observed between men and women., (Copyright © 2023 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background ST-segment-elevation myocardial infarction complicated with no reflow after primary percutaneous coronary intervention is associated with adverse outcomes. Although several hyperemic drugs have been shown to improve the Thrombolysis in Myocardial Infarction flow, optimal treatment of no reflow remains unsettled. Saline infusion at 20 mL/min via a dedicated microcatheter causes (flow-mediated) hyperemia. The objective is to compare the efficacy of pharmacologic versus flow-mediated hyperemia in patients with ST-segment-elevation myocardial infarction complicated with no reflow. Methods and Results In the RAIN-FLOW (Treatment of Slow-Flow After Primary Percutaneous Coronary Intervention With Flow-Mediated Hyperemia) study, 67 patients with ST-segment-elevation myocardial infarction and no reflow were randomized to receive either pharmacologic-mediated hyperemia with intracoronary adenosine or nitroprusside (n=30) versus flow-mediated hyperemia (n=37). The angiographic corrected Thrombolysis in Myocardial Infarction frame count and the minimal microcirculatory resistance, as assessed with intracoronary pressure-thermistor wire, dedicated microcatheter, and thermodilution techniques, were compared after study interventions. Both Thrombolysis in Myocardial Infarction frame count(40.2±23.1 versus 39.2±20.7; P =0.858) and minimal microcirculatory resistance (753.6±661.5 versus 993.3±740.8 Wood units; P =0.174) were similar between groups. Thrombolysis in Myocardial Infarction 3 flow was observed in 26.7% versus 27.0% ( P =0.899). Flow-mediated hyperemia showed 2 different thermodilution patterns during saline infusion indicative of the severity of the no reflow phenomenon. In-hospital death and nonfatal heart failure were observed in 10.4% and 26.9%, respectively. Conclusions Both treatments showed similar (and limited) efficacy restoring coronary flow. Flow-mediated hyperemia with thermodilution pattern assessment allowed the simultaneous characterization of the no reflow degree and response to hyperemia. No reflow was associated with a high rate of adverse outcomes. Further research is warranted to prevent and to treat no reflow in patients with ST-segment-elevation myocardial infarction. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04685941.

Background: In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non-culprit lesions should be attempted during the index procedure or staged., Methods: This prospective, open-label, non-inferiority, randomised trial was done at 29 hospitals across Belgium, Italy, the Netherlands, and Spain. We included patients aged 18-85 years presenting with ST-segment elevation myocardial infarction or non-ST-segment elevation acute coronary syndrome and multivessel (ie, two or more coronary arteries with a diameter of 2·5 mm or more and ≥70% stenosis based on visual estimation or positive coronary physiology testing) coronary artery disease with a clearly identifiable culprit lesion. A web-based randomisation module was used to randomly assign patients (1:1), with a random block size of four to eight, stratified by study centre, to undergo immediate complete revascularisation (PCI of the culprit lesion first, followed by other non-culprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularisation (PCI of only the culprit lesion during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator within 6 weeks after the index procedure). The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1 year after the index procedure. Secondary outcomes included all-cause mortality, myocardial infarction, and unplanned ischaemia-driven revascularisation at 1 year after the index procedure. Primary and secondary outcomes were assessed in all randomly assigned patients by intention to treat. Non-inferiority of immediate to staged complete revascularisation was considered to be met if the upper boundary of the 95% CI of the hazard ratio (HR) for the primary outcome did not exceed 1·39. This trial is registered with ClinicalTrials.gov, NCT03621501., Findings: Between June 26, 2018, and Oct 21, 2021, 764 patients (median age 65·7 years [IQR 57·2-72·9] and 598 [78·3%] males) were randomly assigned to the immediate complete revascularisation group and 761 patients (median age 65·3 years [58·6-72·9] and 589 [77·4%] males) were randomly assigned to the staged complete revascularisation group, and were included in the intention-to-treat population. The primary outcome at 1 year occurred in 57 (7·6%) of 764 patients in the immediate complete revascularisation group and in 71 (9·4%) of 761 patients in the staged complete revascularisation group (HR 0·78, 95% CI 0·55-1·11, p non-inferiority =0·0011). There was no difference in all-cause death between the immediate and staged complete revascularisation groups (14 [1·9%] vs nine [1·2%]; HR 1·56, 95% CI 0·68-3·61, p=0·30). Myocardial infarction occurred in 14 (1·9%) patients in the immediate complete revascularisation group and in 34 (4·5%) patients in the staged complete revascularisation group (HR 0·41, 95% CI 0·22-0·76, p=0·0045). More unplanned ischaemia-driven revascularisations were performed in the staged complete revascularisation group than in the immediate complete revascularisation group (50 [6·7%] patients vs 31 [4·2%] patients; HR 0·61, 95% CI 0·39-0·95, p=0·030)., Interpretation: In patients presenting with acute coronary syndrome and multivessel disease, immediate complete revascularisation was non-inferior to staged complete revascularisation for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischaemia-driven revascularisation., Funding: Erasmus University Medical Center and Biotronik., Competing Interests: Declaration of interests RD has received institutional research grants from Biotronik, Medtronic, ACIST Medical Systems, and Boston Scientific. WKdD has received institutional research grants from Biotronik. NMVM has received institutional research grants from Biotronik, Abbott, Medtronic, Edwards Lifesciences, PulseCath, Abiomed, and Daiichi Sankyo; speaker fees from Abiomed and Amgen; and a travel grant from JenaValve. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: Time between Emergency Department (ED) and ST-segment elevation acute myocardial infarction (STEMI) activation time is a good indicator of ED quality. STEMI delays are of particular importance in some subgroups, such as women and the elderly., Objective: To determine the association of sex and age with activation time in STEMI patients admitted to the ED., Methods: An observational retrospective study was conducted including all patients admitted to the ED activated as a STEMI. The main variable was activation time. To evaluate the independent predictors of activation time, a multivariate logistic regression analysis was carried out, variables were sex, age, sex and age combined, chest pain, ST elevation in the electrocardiogram, and first medical contact (FMC) at the hospital's ED., Results: A total of 330 patients were included. They were classified by sex: 23.9% (78) women and 76.1% (249) men; and age: 51.1% (167) <65 yo and 48.9% (160) ≥65 yo. Women and elderly patients exhibited a more atypical presentation. Multivariate analysis shows that showed that elderly age (OR=1.976 95%; CI=1.257-3.104; p = 0.003) and FMC prior to attending the ED (OR=1.762; 95% CI=1.117-2.779; p = 0.015) were associated with a longer activation time. Women older than 65 years old showed the longest activation time., Conclusion: STEMI delays are longer in women and the elderly with atypical presentation. Age ≥65 and FMC outside the ED were associated with an increase in the activation time. This highlights the need to develop strategies to improve activation time for these specific patient groups., Competing Interests: Conflict of Interest The authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Although some studies have investigated sex-related outcomes up to 5 years after percutaneous coronary intervention (PCI), analyses at longer follow-up (ie, to 10 years) in large cohorts treated exclusively with drug-eluting stent (DES) platforms are lacking. Therefore, this study aimed to define whether sex-related differences in long-term outcomes after PCI persist both in the DES era and at longer-term follow-up., Methods: Individual data of patients treated with DES in 5 randomized controlled trials with 10-year follow-up were pooled. Patients were divided into 2 groups by sex. The analysis of individual participant data was performed using a 1-stage approach by entering a clustering effect by parent study in all univariable and multivariable models focusing on sex. The main outcomes of interest for this analysis included cardiovascular death, myocardial infarction, repeat revascularization, and definite stent thrombosis to 10 years after PCI. Survival was analyzed by the Kaplan-Meier method to estimate the time to first event, and differences between the 2 groups were tested with the log-rank test. Hazard ratios (HRs) and 95% CIs were calculated with a Cox proportional hazards model. Conventional multivariable analyses with adjustment for relevant variables were performed., Results: Among 9700 patients undergoing PCI with DES implantation included in the present analysis, 2296 were women and 7404 were men. Through to 10 years, cardiovascular death occurred in 407 of the 2296 female patients and 1012 of the 7404 male patients (adjusted HR [HR adj ], 0.94 [95% CI, 0.80-1.11]). Female sex was associated with a lower risk of repeat revascularization of the target lesion (HR adj , 0.80 [95% CI, 0.74-0.87]), target vessel (HR adj , 0.81 [95% CI, 0.76-0.87]), and nontarget vessels (HR adj , 0.69 [95% CI, 0.62-0.77]). Compared with male patients, female patients displayed an increased risk of myocardial infarction in the first 30 days after PCI with DES (HR adj , 1.65 [95% CI, 1.24-2.19]) but a comparable risk of myocardial infarction thereafter. The risk of definite stent thrombosis was not significantly different between female and male patients (HR adj , 1.14 [95% CI, 0.89-1.47])., Conclusions: Through to 10-year follow-up after PCI with DES, female patients are at increased risk of early myocardial infarction, receive fewer repeat revascularizations, and have no difference in cardiovascular mortality compared with male patients.

Background: The occurrence of acute kidney injury (AKI) among patients with acute coronary syndrome (ACS) undergoing invasive management is associated with worse outcomes. However, the prognostic implications of transient or in-hospital persistent AKI may differ., Objectives: The aim of this study was to evaluate the prognostic implications of transient or in-hospital persistent AKI in patients with ACS., Methods: In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial, 203 subjects were excluded because of incomplete information or end-stage renal disease, with a study population of 8,201 patients. Transient and persistent AKI were defined as renal dysfunction no longer or still fulfilling the AKI criteria (>0.5 mg/dL or a relative >25% increase in creatinine) at discharge, respectively. Thirty-day coprimary outcomes were the out-of-hospital composite of death, myocardial infarction, or stroke (major adverse cardiovascular events [MACE]) and net adverse cardiovascular events (NACE), defined as the composite of MACE or Bleeding Academic Research Consortium type 3 or 5 bleeding., Results: Persistent and transient AKI occurred in 750 (9.1%) and 587 (7.2%) subjects, respectively. After multivariable adjustment, compared with patients without AKI, the risk for 30-day coprimary outcomes was higher in patients with persistent AKI (MACE: adjusted HR: 2.32; 95% CI: 1.48-3.64; P < 0.001; NACE: adjusted HR: 2.29; 95% CI: 1.48-3.52; P < 0.001), driven mainly by all-cause mortality (adjusted HR: 3.43; 95% CI: 2.03-5.82; P < 0.001), whereas transient AKI was not associated with higher rates of MACE or NACE. Results remained consistent when implementing the KDIGO (Kidney Disease Improving Global Outcomes) criteria., Conclusions: Among patients with ACS undergoing invasive management, in-hospital persistent but not transient AKI was associated with higher risk for 30-day MACE and NACE. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox [MATRIX]; NCT01433627)., Competing Interests: Funding Support and Author Disclosures The trial was sponsored by Società Italiana di Cardiologia Invasiva (a nonprofit organization), which received grant support from The Medicines Company and Terumo. This substudy did not receive any direct or indirect funding. Prof Leonardi has received grants and personal fees from AstraZeneca; and has received personal fees from Daiichi Sankyo, Bayer, Pfizer/Bristol Myers Squibb, ICON, Chiesi, and Novo Nordisk (all outside the submitted work). Prof Vranckx has received personal fees from Bayer, Daiichi Sankyo, and CLS Behring (all outside the submitted work). Dr Tebaldi has received research grants from GADA and Abbott Vascular; and has received personal fees from Abbott (all outside the submitted work). Prof Andò has received personal fees and nonfinancial support from Daiichi Sankyo, Boeringer Ingelheim, and Amgen; and has received personal fees from AstraZeneca, Chiesi, and Biosensors (all outside the submitted work). Dr Brugaletta has received a research grant to the institution from AstraZeneca; has received personal fees from Abbott Vascular (outside the submitted work); and has served as an advisory board member for Boston Scientific, iVascular, and Teleflex. Dr Adamo has received speaker fees from Abbott Vascular and Medtronic (all outside the submitted work). Prof Windecker has received research and educational grants to the institution from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Biotronik, Boston Scientific, Cardinal Health, Cardiovalve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, Infraredx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave; has served as an unpaid advisory board member and/or unpaid member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, Terumo, V-Wave, and Xeltis (but has not received personal payments from pharmaceutical companies or device manufacturers); and is a member of the steering or executive committee groups of several investigator-initiated trials that receive funding from industry without impact on his personal remuneration. Prof Valgimigli has received grants and personal fees from Abbott, Terumo, and AstraZeneca; has received personal fees from Chiesi, Bayer, Daiichi Sankyo, Amgen, Alvimedica, Biosensors, and Idorsia; and has received grants from Medicure (outside the submitted work). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

Background: Short-term outcomes following ST-segment elevation myocardial infarction (STEMI) in women are worse than in men, with a higher mortality rate. It is unknown whether sex plays a role in very long term outcomes., Objectives: The aim of this study was to assess whether very long term outcomes following STEMI treatment are influenced by sex., Methods: EXAMINATION-EXTEND (10-Year Follow-Up of the EXAMINATION Trial) was an investigator-driven 10-year follow-up of the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial, which randomly 1:1 assigned 1,498 patients with STEMI to receive either everolimus-eluting stents or bare-metal stents. The present study was a subanalysis according to sex. The primary endpoint was the composite patient-oriented endpoint (all-cause death, any myocardial infarction, or any revascularization) at 10 years. Secondary endpoints were individual components of the primary endpoint. All endpoints were adjusted for age., Results: Among 1,498 patients with STEMI, 254 (17%) were women. Overall, women were older, with more arterial hypertension and less smoking history than men. At 10 years, no difference was observed between women and men for the patient-oriented composite endpoint (40.6% vs 34.2%; adjusted HR: 1.14; 95% CI: 0.91-1.42; P = 0.259). There was a trend toward higher all-cause death in women vs men (27.6% vs 19.4%; adjusted HR: 1.30; 95% CI: 0.99-1.71; P = 0.063), with no difference in cardiac death or other endpoints., Conclusions: At very long term follow-up, there were no differences in the combined patient-oriented endpoint between women and men, with a trend toward higher all-cause death in women not driven by cardiac death. The present findings underline the need for focused personalized medicine in women after percutaneous revascularization aimed at both cardiovascular and sex-specific risk factor control and targeted treatment. (10-Years Follow-Up of the EXAMINATION Trial [EXAMINAT10N]; NCT04462315)., Competing Interests: Funding Support and Author Disclosures This study was an investigator-driven clinical trial conducted by the Hospital Clinic of Barcelona. The EXAMINATION-EXTEND study was funded by an unrestricted grant from Abbott Vascular to the Spanish Heart Foundation (promoter). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

MicroRNAs (miRNA) are major regulators of intercellular communication and key players in the pathophysiology of cardiovascular disease. This study aimed to determine the miRNA fingerprint in a cohort of 53 patients with acute myocardial infarction (AMI) with non-ST-segment elevation (NSTEMI) relative to miRNA expression in healthy controls (n = 51). miRNA expression was initially profiled by miRNA array in the serum of patients undergoing cardiac catheterization during NSTEMI (n = 8) and 1 year past the event (follow-up, n = 8) and validated in the entire cohort. In total, 58 miRNAs were differentially expressed during AMI (p < 0.05), while 36 were modified at follow-up (Fisher’s exact test: p = 0.0138). Enrichment analyses revealed differential regulation of biological processes by miRNA at each specific time point (AMI vs. follow-up). During AMI, the miRNA profile was associated mainly with processes involved in vascular development. However, 1 year after AMI, changes in miRNA expression were partially related to the regulation of cardiac tissue morphogenesis. Linear correlation analysis of miRNA with serum levels of cytokines and chemokines revealed that let-7g-5p, let-7e-5p, and miR-26a-5p expression was inversely associated with serum levels of pro-inflammatory cytokines TNF-α, and the chemokines MCP-3 and MDC. Transient transfection of human endothelial cells (HUVEC) with let-7e-5p inhibitor or mimic demonstrated a key role for this miRNA in endothelial function regulation in terms of cell adhesion and angiogenesis capacity. HUVEC transfected with let-7e-5p mimic showed a 20% increase in adhesion capacity, whereas transfection with let-7e-5p inhibitor increased the number of tube-like structures. This study pinpoints circulating miRNA expression fingerprint in NSTEMI patients, specific to the acute event and changes at 1-year follow-up. Additionally, given its involvement in modulating endothelial cell function and vascularization, altered let-7e-5p expression may constitute a therapeutic biomarker and target for ischemic heart disease.

Background: Patients presenting with the coronavirus-2019 disease (COVID-19) may have a high risk of cardiovascular adverse events, including death from cardiovascular causes. The long-term cardiovascular outcomes of these patients are entirely unknown. We aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and to determine their long-term cardiovascular outcomes., Study and Design: This is a multicenter, observational, retrospective registry to be conducted at 17 centers in Spain and Italy (ClinicalTrials.gov number: NCT04359927). Consecutive patients older than 18 years, who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 in the participating institutions, will be included since March 2020, to August 2020. Patients will be classified into two groups, according to the results of the RT-PCR: COVID-19 positive or negative. The primary outcome will be cardiovascular mortality at 1 year. The secondary outcomes will be acute myocardial infarction, stroke, heart failure hospitalization, pulmonary embolism, and serious cardiac arrhythmias, at 1 year. Outcomes will be compared between the two groups. Events will be adjudicated by an independent clinical event committee., Conclusion: The results of this registry will contribute to a better understanding of the long-term cardiovascular implications of the COVID19., Competing Interests: The authors have declared that no competing interests exist.

Objective: Relationship between STEMI time of presentation, its circadian pattern and cardiovascular outcomes is unclear. Our objective is to analyze clinical outcomes of STEMI according to time of presentation and circadian pattern., Methods: We analyzed data from patients treated within the regional STEMI Network from January 2010 to December 2015. On-hour group included patients treated between 8:00 h and 19:59 h on weekdays, the rest were catalogued as off-hour group. The primary endpoint was 1-year all-cause mortality. Secondary endpoints were 30-day all-cause mortality and in-hospital complications., Results: A total of 8608 patients were included, 44.1% in the on-hour group and 55.9% in the off-hour group. We observed a shorter patient delay and longer system delay in the off-hour group compared to on-hour group with no difference in total ischemic time. At 30-day and 1-year follow-up there were no differences in adjusted all-cause mortality between groups [OR 0.91 (CI95%: 0.73-1.12; p = 0.35) and OR 0.99 (CI95%: 0.83-1.17; p = 0.87), respectively]. A circadian pattern was observed between 9:00 am and 12:30 pm, with no differences in 30-day and 1-year mortality between patients included in this time interval [OR 1.02 (IC95%: 0.81-1.30; p = 0.85) and OR 1.12 (IC95%: 0.92-1.36; p = 0.25) respectively]., Conclusions: Off-hour STEMI presentation was associated with a shorter patient delay and longer system delay without an increase in total ischemic time. The off-hour presentation was not related to an increase in 1-year all-cause mortality when compared to on-hour. A circadian pattern was found, without differences in 30-day and 1-year mortality., Competing Interests: Declaration of competing interest The authors report no relationships that could be construed as a conflict of interest., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Despite the promising value of miRNAs in the diagnostic and prognostic of cardiovascular disease (CVD), recent meta-analyses did not support their potential. Methodological variances in studies may interfere with miRNA profile and affect their results. This study determines if the blood starting material is a source of variance in miRNA profile by performing a paired comparison in plasma and serum of the expression of primary miRNAs associated with CVD. Circulating miRNA yield was similar in both plasma and serum, although a significant increase was observed in patients with Non-ST-elevation myocardial infarction (NSTEMI) compared to control volunteers. When normalized by the expression of miR-484, different patterns of miRNA expression between serum and plasma. Although NSTEMI modified the expression of miR-1 and miR-208 in both serum and plasma, plasma displayed a higher variance than serum (Levene's test p < 0.01). For miR-133a and miR-26a, differences were only detected in serum (p = 0.0240), and conversely, miR-499a showed differences only in plasma of NSTEMI (p = 0.001). Interestingly, miR-21 showed an opposite pattern of expression, being increased in serum (2 -ΔΔCt : 5.7, p = 0.0221) and decreased in plasma (2 -ΔΔCt : 0.5, p = 0.0107). Plasma and serum exhibit different patterns of circulating miRNA expression in NSTEMI and suggest that results from studies with different starting material could not be comparable.

Aims: The aim of this study was to compare five-year clinical outcomes between an everolimus-eluting bioresorbable scaffold (BRS) and an everolimus-eluting metallic stent (EES) in STEMI patients., Methods and Results: This observational and retrospective study included 235 consecutive STEMI patients treated with BRS, compared with 235 STEMI patients treated with EES from the EXAMINATION trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction and target lesion revascularisation at five-year follow-up. Device thrombosis, according to the ARC criteria, was also evaluated. Optical coherence tomography (OCT) analysis was also performed at five years in event-free BRS patients. The cumulative incidence of five-year DOCE was higher in the BRS group as compared to the EES group (13.2% vs 7.6%, HR 1.87, 95% CI: 0.94-3.44, p=0.071), mainly driven by a higher rate of TLR (7.6% vs 1.7%, HR 1.15, 95% CI: 0.44-2.30, p=0.004). The five-year definite BRS thrombosis rate was also higher as compared to EES (4.2% vs 1.2%, HR 3.49, 95% CI: 0.95-12.82, p=0.054). OCT analysis showed a high incidence of neoatherosclerosis in the BRS group., Conclusions: The five-year event risk was higher with BRS versus EES in STEMI. This suggests that the probability of obtaining favourable results at very long-term follow-up is low. Whether better results will be obtained with new-generation BVS remains to be determined.

Importance: Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been fully investigated., Objective: To compare 1-year clinical outcomes of iFR-guided or FFR-guided treatment in patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial., Design, Setting, and Participants: The DEFINE-FLAIR trial is a multicenter, international, randomized, double-blinded trial that randomly assigned 2492 patients in a 1:1 ratio to undergo either iFR-guided or FFR-guided coronary revascularization. Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015., Interventions: According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred., Main Outcomes and Measures: The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. The incidence of MACE was compared according to the presence of diabetes in iFR-guided and FFR-guided groups., Results: Among the total trial population (2492 patients), 758 patients (30.4%) had diabetes. Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465). In the nondiabetes population (68.5%; 1707 patients), iFR guidance was associated with a significantly higher rate of deferral of revascularization than the FFR-guided group (56.5% [n = 477 of 844] vs 46.6% [n = 402 of 863]; P < .001). However, it was not different between the 2 groups in the diabetes population (42.1% [n = 161 of 382] vs 47.1% [n = 177 of 376]; P = .15). At 1 year, the diabetes population showed a significantly higher rate of MACE than the nondiabetes population (8.6% vs 5.6%; adjusted hazard ratio [HR], 1.88; 95% CI, 1.28-2.64; P < .001). However, there was no significant difference in MACE rates between iFR-guided and FFR-guided groups in both the diabetes (10.0% vs 7.2%; adjusted HR, 1.33; 95% CI, 0.78-2.25; P = .30) and nondiabetes population (4.7% vs 6.4%; HR, 0.83; 95% CI, 0.51-1.35; P = .45) (interaction P = .25)., Conclusions and Relevance: The diabetes population showed significantly higher risk of MACE than the nondiabetes population, even with the iFR-guided or FFR-guided treatment. The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes., Trial Registration: ClinicalTrials.gov identifier: NCT02053038.

Objectives: The study sought to compare the vasomotor and microcirculatory function of the infarct-related artery (IRA) between bioresorbable vascular scaffolds (BVS) and everolimus-eluting stents (EES) at 3 years., Background: The ABSORB STEMI TROFI II study showed similar outcomes between BVS and EES in the context of ST-segment elevation myocardial infarction at 3 years., Methods: Sixty-three consecutive event-free patients of the randomized TROFI II study were screened to undergo coronary angiography with vasomotor, microcirculatory, and optical coherence tomography (OCT) examination at 3 years. Vasomotion was defined as >4% change in mean lumen diameter to acetylcholine (ACH) and nitroglycerin as assessed by quantitative angiography. Microcirculatory examination was performed with pressure or thermodilution techniques., Results: A total of 38 patients (20 BVS and 18 EES) were included. At 3 years, ≥60% of patients exhibited paradoxical vasoconstriction to ACH in the periscaffold or stent segments. Vasoconstriction to ACH and vasodilatation to nitroglycerin were more often observed in the scaffold or stent segment with BVS than with EES (77.8% vs. 25.0%; p = 0.008 and 61.1% vs. 18.8%; p = 0.018). The IRA-depending microcirculation showed similar index of resistance (23.8 vs. 22.4; p = 0.781), coronary flow reserve (2.4 vs. 1.9; p = 0.523), fractional flow reserve (0.91 vs. 0.93; p = 0.317), and absolute flow (135.5 ml/min vs. 147.3 ml/min; p = 0.791). OCT showed remaining strut footprints and larger number of intraluminal scaffold dismantling (26.3% vs. 0%; p = 0.049) in the BVS group., Conclusions: Both endothelium-dependent and -independent vasomotion of the IRA were more evident with BVS, as compared with EES, at 3 years. Functional microcirculatory parameters were mostly adequate and similar between BVS and EES. Clinical implications of these findings warrant further investigations., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

In patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), lack of ST-segment resolution (STR) is associated with poor prognosis at short- and long-term follow-up. The aim of this study was to evaluate the role of STR on very long-term outcomes in patients with STEMI treated with pPCI included in the EXAMINATION (Evaluation of the Xience-V Stent in Acute Myocardial Infarction) trial. Patients were stratified according to the presence of STR < 50% and STR < 70% at the 30-minute post-pPCI electrocardiogram. Primary end point was the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization at 5-year follow-up. Both baseline and post-PCI 30-minute electrocardiograms were available for STR assessment in 1,351 patients. Of these patients, 228 (16.9%) and 500 (37.0%) exhibited STR < 50% and STR < 70%, respectively. At 5-year follow-up, the POCE was observed more frequently in patients with STR < 50% (hazard ratio [HR] 1.556; 95% confidence interval [CI] 1.194 to 2.027; p <0.001) and in patients with STR < 70% (HR 1.460, 95% CI 1.169 to 1.824, p <0.001) compared with patients with STR > 50% and STR ≥ 70%, respectively. In both cases, this difference was mainly driven by a significant increase in the rate of all-cause death and any revascularization. After multivariable adjustment, STR < 70%, but not STR < 50%, resulted as a 5-year independent predictor of POCE (adjusted HR 1.338, 95% CI 1.008 to 1.778, p = 0.044). In conclusion, in patients with STEMI, the evaluation of 70% STR after pPCI provides independent prognostic information at 5-year follow-up and it can be used to identify patients at high risk of very long-term cardiovascular events., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Aims: Our aim was to assess the safety and efficacy of paclitaxel-eluting balloon (PTX-B) treatment after bare metal stent (BMS) implantation in patients undergoing primary angioplasty., Methods and Results: After BMS implantation, patients were randomised (1:1) to treatment with a PTX-B or no PTX-B treatment (BMS group). The primary endpoint was in-stent late luminal loss (LLL) at nine-month follow-up. OCT was carried out on the first 20% of consecutive patients included in the study. Two hundred and twenty-three patients were randomised (BMS: 112, PTX-B: 111). At nine months, median LLL was 0.80 mm (interquartile range [IQR] 0.36-1.26) in the BMS group vs. 0.31 mm (IQR 0.00-0.58) in the PTX-B group, p<0.0001. Binary restenosis was significantly lower in the PTX-B group: 29.8% vs. 2.2%, p<0.0001, 95% confidence interval (CI): 3.2-54.2. Nine-month OCT showed good strut coverage in both groups but greater in the BMS group (100±0.0% vs. 99.52±1.11%, p=0.03) with very low rates of malapposed struts per lesion. One-year MACE was significantly lower in the PTX-B group (12.5% vs. 3.6%, p=0.016)., Conclusions: PTX-B after successful BMS implantation resulted in less LLL and better clinical outcomes as compared with a BMS-only strategy. This was associated with good stent strut coverage and very low rates of malapposed struts.

Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p <0.001) due mostly by minor vascular events (89 [15%] vs 25 [4.1%], RR 3.56, 95% CI 2.32 to 5.47, p <0.001). Bleeding rates were lower in the puncture group (18 [3%] vs 40 [6.6%], RR 0.45, 95% CI 0.26 to 0.78, p = 0.003) mainly driven by major bleeding (9 [1.5%] vs 21 [3.4%], RR 0.43, 95% CI 0.20 to 0.93, p = 0.03). At a mean follow-up of 323 days, complication rates remained significantly different between groups (minor vascular complications 90 [15%] vs 31 [5.1%], hazard ratio 2.99, 95% CI 1.99 to 4.50, p <0.001 and major bleeding 10 [1.6%] vs 21 [3.4%], hazard ratio 0.47, 95% CI 0.22 to 1.0, p = 0.04, puncture versus cutdown group, respectively). In conclusion, percutaneous approach yielded higher rates of minor vascular complications but lower rates of major bleeding compared with the surgical cutdown, both at 30-day and at mid-term follow-up in our population., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Aims: We aimed to investigate the outcomes of bioresorbable vascular scaffolds (BVS) in coronary ostial lesions. Ostial lesions represent a challenging angiographic subset, with higher event rates compared with non-ostial lesions. BVS might be associated with advantages over the long term, but their safety in this setting remains to be explored., Methods and Results: Procedural and 12-month follow-up data from consecutive patients treated with BVS for lesions located at the ostium of the right (RCA), left anterior (LAD) or circumflex (LCX) coronary in 11 European centres were collected. The primary device-oriented endpoint was defined as a combination of cardiovascular death, target vessel myocardial infarction or target lesion revascularisation. The database included a total of 1,549 lesions in 1,304 patients with a mean age of 62±11years. There were 90 ostial lesions (5.8%) in 84 patients (6.4%) located at the ostial RCA (14; 16%), LCX (29; 32%), or LAD (47; 52%). Patients presenting with ostial lesions did not differ from the remaining cohort except for a higher incidence of prior revascularisation. Predilation was performed in 97% of the lesions (vs. 96% in non-ostial, p=0.618), post-dilation in 43% (versus 58% in the non-ostial group, p=0.008). At quantitative coronary angiography, treatment of ostial lesions was associated with higher residual stenosis (30% [23-41] vs. 26% [20-37], p=0.035), but no difference in minimum lumen diameter existed (p=0.447). Follow-up data were available at 385 [362-465] days. The 12-month Kaplan-Meier estimated rates of scaffold thrombosis were 4.9% and 2.0% (ostial and non-ostial lesion groups, respectively, log-rank p=0.005). The device-oriented composite endpoint occurred, respectively, in 12.6% and 4.6% at 12 months (log-rank p=0.001). Treatment of ostial lesions was an independent predictor of this endpoint (p=0.0025, HR 2.65 [1.41-4.97])., Conclusions: In combination with a suboptimal implantation technique, treatment of coronary ostial lesions was an independent predictor of clinical events in a cohort of patients treated with BVS.

Aims: The Absorb bioresorbable vascular scaffold (Absorb BVS) provides similar clinical outcomes compared with a durable polymer-based everolimus-eluting metallic stent (EES) in stable coronary artery disease patients. ST-elevation myocardial infarction (STEMI) lesions have been associated with delayed arterial healing and impaired stent-related outcomes. The purpose of the present study is to compare directly the arterial healing response, angiographic efficacy and clinical outcomes between the Absorb BVS and metallic EES., Methods and Results: A total of 191 patients with acute STEMI were randomly allocated to treatment with the Absorb BVS or a metallic EES 1:1. The primary endpoint is the neointimal healing (NIH) score, which is calculated based on a score taking into consideration the presence of uncovered and malapposed stent struts, intraluminal filling defects and excessive neointimal proliferation, as detected by optical frequency domain imaging (OFDI) six months after the index procedure. The study will provide 90% power to show non-inferiority of the Absorb BVS compared with the EES., Conclusions: This will be the first randomised study investigating the arterial healing response following implantation of the Absorb BVS compared with the EES. The healing response assessed by a novel NIH score in conjunction with results on angiographic efficacy parameters and device-oriented events will elucidate disease-specific applications of bioresorbable scaffolds.

Background: Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial., Methods: In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087., Findings: 1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047)., Interpretation: Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction., Funding: Spanish Heart Foundation., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Objectives: The aim of the study was to evaluate the healing process at 12 months after ABSORB™ bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI)., Background: There is currently no data on long-term BVS performance in the acute thrombotic setting. The underlying altered plaque pathomorphology may impact the neointima healing pattern, potentially making it different to that observed in stable coronary artery disease (CAD)., Methods: We have performed an angiographic and optical coherence tomography (OCT) 12-month follow-up of 19 STEMI patients who were treated with a BVS implantation (23 scaffolds). An independent core laboratory performed a paired analysis of the corresponding frames at baseline and follow-up., Results: At 12 months, the OCT follow-up showed a decrease in the mean lumen area (8.29 ± 1.53 mm(2) vs. 6.82 ± 1.57 mm(2) , P < 0.001), but no significant change in the mean scaffold area (8.49 ± 1.53 mm(2) vs. 8.90 ± 1.51 mm(2) ). Significant decreases in malapposed strut ratio (4.9 ± 8.65% vs. 0.4 ± 1.55%, P < 0.001) and malapposition area (0.29 ± 0.60 mm(2) 0.08 ± 0.32 mm(2) , P = 0.002) were observed. A nonhomogenous proliferation of neointima was revealed with a symmetry index of 0.15 (0.08-0.27), a mean neointima thickness of 203 μm (183-249) and mean neointima area of 2.07 ± 0.51 mm(2) . The quantitative coronary angiography showed late lumen loss of 0.08 ± 0.23 mm and no significant change in the minimal lumen diameter (P = 0.11). There were no major adverse cardiovascular events (MACE), except for one nontarget vessel revascularization., Conclusions: The OCT revealed a favorable healing pattern after BVS implantation in a STEMI population., (© 2015 Wiley Periodicals, Inc.)

Aims: The aim of this study was to identify predictors of adverse events among patients with ST-elevation myocardial infarction (STEMI) undergoing contemporary primary percutaneous coronary intervention (PCI)., Methods and Results: Individual data of 2,655 patients from two primary PCI trials (EXAMINATION, N=1,504; COMFORTABLE AMI, N=1,161) with identical endpoint definitions and event adjudication were pooled. Predictors of all-cause death or any reinfarction and definite stent thrombosis (ST) and target lesion revascularisation (TLR) outcomes at one year were identified by multivariable Cox regression analysis. Killip class III or IV was the strongest predictor of all-cause death or any reinfarction (OR 5.11, 95% CI: 2.48-10.52), definite ST (OR 7.74, 95% CI: 2.87-20.93), and TLR (OR 2.88, 95% CI: 1.17-7.06). Impaired left ventricular ejection fraction (OR 4.77, 95% CI: 2.10-10.82), final TIMI flow 0-2 (OR 1.93, 95% CI: 1.05-3.54), arterial hypertension (OR 1.69, 95% CI: 1.11-2.59), age (OR 1.68, 95% CI: 1.41-2.01), and peak CK (OR 1.25, 95% CI: 1.02-1.54) were independent predictors of all-cause death or any reinfarction. Allocation to treatment with DES was an independent predictor of a lower risk of definite ST (OR 0.35, 95% CI: 0.16-0.74) and any TLR (OR 0.34, 95% CI: 0.21-0.54)., Conclusions: Killip class remains the strongest predictor of all-cause death or any reinfarction among STEMI patients undergoing primary PCI. DES use independently predicts a lower risk of TLR and definite ST compared with BMS. The COMFORTABLE AMI trial is registered at: http://www.clinicaltrials.gov/ct2/show/NCT00962416. The EXAMINATION trial is registered at: http://www.clinicaltrials.gov/ct2/show/NCT00828087.

Introduction and Objectives: The use of second-generation drug-eluting stents compared with bare-metal stents in patients with ST-segment elevation myocardial infarction reduces the rate of major adverse cardiac events. We aimed to evaluate the impact of sex on the performance of everolimus-eluting stents vs bare-metal stents in ST-segment elevation myocardial infarction at 2-year follow-up., Methods: This is a sub-study of the EXAMINATION trial that randomized 1498 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention to everolimus-eluting or bare-metal stents. Primary end point was combined all-cause death, any recurrent myocardial infarction, and any revascularization. All end points were analyzed according to sex at 2-year follow-up., Results: Of 1498 patients included in the trial, 254 (17.0%) were women. Women were older and had higher prevalence of hypertension and lower prevalence of smoking compared with men. In contrast with men, stent diameter was smaller in women. After multivariate analysis, the primary end point was similar between women and men (hazard ratio=0.95; 95% confidence interval, 0.66-1.37), and among women, between those treated with bare-metal vs everolimus-eluting stents (hazard ratio=2.48; 95% confidence interval, 0.95-6.46). Women showed a lower rate of repeat revascularization than men (hazard ratio=0.55; 95% confidence interval, 0.32-0.95) despite worse baseline characteristics. This difference was driven by better performance of the everolimus-eluting stent in women., Conclusions: Despite poorer baseline clinical characteristics, women with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention showed outcomes similar to men. The use of everolimus-eluting stents may represent an added value in women as it showed a reduced rate of repeated revascularization compared to men., (Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Objective: The ST-segment elevation myocardial infarction network "Codi Infart" was implemented in Catalonia (Spain) in June 2009. The objective of this study was to evaluate the impact of the implementation of the Codi Infart on women., Method: Women referred for primary percutaneous coronary intervention, were divided into two groups according to Codi Infart: Non-Codi Infart group (January 2003 to May 2009) and Codi Infart group (June 2009 to December 2012). Place of first medical contact, time intervals in diagnosis and treatment, treatments received and rate of major cardiovascular adverse events defined as all-cause death, reinfarction or stroke in-hospital, at 30 and 180 days were compared., Results: From a total population of 2,426 patients, 501 (20.7%) were women. One-hundred eighty-six women (2.09 cases/month) belonged to Non-Codi Infart group and 315 women (10.16 cases/month) to Codi Infart group. The percentage of women attended increased since the introduction of CI (22.2% vs. 18.5%, P=.028). In addition, the Codi Infart group had a higher percentage of women initially attended outside our institution (84.1% vs. 16.7%, P<.001), and lower total ischemia time (220 [155-380] vs. 272 [196-456], P=.003). However, no differences in 180-day major cardiovascular adverse events were detected (14.2% vs. 15.6%, P=.692)., Conclusions: The implementation of the major cardiovascular adverse events allowed to increase the rate and the percentage of women with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention and reducing total ischemic time., (Copyright © 2014 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.)

Aims: Residual thrombus accumulation around stent struts has been observed after the end of primary PCI and may represent a risk factor for acute stent thrombosis. The aim of this study is to test whether a strategy of prolonged bivalirudin infusion may reduce thrombosis of stent struts as compared to an intraprocedural only administration in subjects undergoing primary PCI., Methods and Results: One hundred and sixty patients will be selected from the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) study with all the following inclusion criteria: a) STEMI patients undergoing primary PCI with stent implantation, b) randomisation to standard or prolonged bivalirudin treatment arm, and c) at least one critical (>70%) stenosis of non-infarct-related coronary vessels suitable for staged PCI. Optical coherence tomography (OCT) of the infarct-related artery will be performed at the end of primary PCI and at the time of staged PCI which will be performed three to five days after the index procedure. The percentage difference in minimal flow area and in the number of stent cross-sections with a thrombotic area >5% will be measured at the end of primary PCI and at the time of staged PCI., Conclusions: The MATRIX OCT substudy will establish whether prolonging the infusion of bivalirudin after the end of primary PCI may reduce the amount of residual thrombotic material on stent struts. The effect of the long-infusion strategy on clinical outcome will be elucidated by the MATRIX study.

Background: The elderly (≥75years) constitute a high-risk subset of patients who continue to have a poorer prognosis than non-elderly (<75years). Whether the effects of everolimus-eluting stent (EES) in ST-segment elevation myocardial infarction (STEMI) are independent of age has not been reported. We investigated the outcomes following primary PCI (PPCI) with bare-metal stent (BMS) or EES in elderly vs. non-elderly STEMI patients., Methods: The EXAMINATION trial randomized 1498 STEMI patients to BMS or EES. The primary patient-oriented endpoint (POCE) was the combined of all-cause death, any-recurrent myocardial infarction (MI) and any-revascularization at 1-year. The secondary endpoint included the device-oriented combined (DOCE) of cardiac death, target-vessel MI and target-lesion revascularization. These endpoints and their components were compared between elderly and non-elderly., Results: Among patients enrolled in the trial, 245 (16.3%) were elderly, allocated to BMS (n=132) or EES (n=113), while the remaining 1253 (83.7%) were non-elderly, allocated to BMS (n=615) or EES (n=638). At 1-year, both the POCE and DOCE were observed more frequently in elderly vs. non-elderly group (24.5% vs. 10.5%, p<0.001 and 15.9% vs. 5.1%, p<0.001). Whereas in non-elderly, both POCE and DOCE were lower in EES vs. BMS (12.4% vs. 8.8%, p=0.03 and 6.7% vs. 3.6%, p=0.01), no differences were found in elderly, with a tendency for interaction between age and stent type for POCE (p=0.05). On multivariate analysis age ≥75 years was an independent predictor of POCE (HR 2.19 [95%CI 1.59-3.01], p<0.0001) and DOCE (HR 2.42 [95%CI 1.60-3.7], p<0.001) at 1-year., Conclusions: In STEMI patients undergoing PPCI, advanced age (≥75 years) is associated with worse outcomes. The beneficial effects of EES over BMS tended to be age-dependent., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Bioresorbable vascular scaffolds (BVS) represent a breakthrough technology for percutaneous coronary intervention (PCI). In this context, because of the unique properties of bioresorbable devices, ST-segment elevation myocardial infarction (STEMI) may represent the ideal scenario for BVS implantation. Consistently, 57% of physicians declare they currently use BVS in this group of patients. However, continuous and growing evidence on the good performance of these devices has been actually shown only in small studies with short- and mid-term follow-up. For these reasons, we need data from sufficiently large observational studies, with long-term follow-up, to confirm that BVS can deliver the same results as 2nd-generation drug-eluting stents when using an appropriate implantation technique. In this review, we discuss the potential advantages of BVS implantation in STEMI patients, together with the most recent evidence from clinical studies, highlighting safety and procedural concerns.

Objectives: The purpose of this study was to compare the 1-year outcome between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic stent (EES) in ST-segment elevation myocardial infarction (STEMI) patients., Background: The Absorb BVS (Abbott Vascular, Santa Clara, California) is a polymeric scaffold approved for treatment of stable coronary lesions. Limited and not randomized data are available on its use in ST-segment elevation myocardial infarction (STEMI) patients., Methods: This study included 290 consecutive STEMI patients treated by BVS, compared with either 290 STEMI patients treated with EES or 290 STEMI patients treated with bare-metal stents (BMS) from the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction) trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization, at 1-year follow-up. Device thrombosis, according to the Academic Research Consortium criteria, was also evaluated., Results: The cumulative incidence of DOCE did not differ between the BVS and EES or BMS groups either at 30 days (3.1% vs. 2.4%, hazard ratio [HR]: 1.31 [95% confidence interval (CI): 0.48 to 3.52], p = 0.593; vs. 2.8%, HR: 1.15 [95% CI: 0.44 to 2.30], p = 0.776, respectively) or at 1 year (4.1% vs. 4.1%, HR: 0.99 [95% CI: 0.23 to 4.32], p = 0.994; vs. 5.9%, HR: 0.50 [95% CI: 0.13 to 1.88], p = 0.306, respectively). Definite/probable BVS thrombosis rate was numerically higher either at 30 days (2.1% vs. 0.3%, p = 0.059; vs. 1.0%, p = 0.324, respectively) or at 1 year (2.4% vs. 1.4%, p = 0.948; vs. 1.7%, p = 0.825, respectively), as compared with EES or BMS., Conclusions: At 1-year follow-up, STEMI patients treated with BVS showed similar rates of DOCE compared with STEMI patients treated with EES or BMS, although rate of scaffolds thrombosis, mostly clustered in the early phase, was not negligible. Larger studies with longer follow-up are needed to confirm our findings., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction and Objectives: Invasive and pharmacological treatment of ST-segment elevation acute myocardial infarction reduces the rate of ischemic events but not bleeding complications. The objective of this study was to compare clinical results and bleeding complications between femoral and radial access routes in patients with ST-segment elevation acute myocardial infarction., Methods: An evaluation was performed of the population of the Examination study, a randomized, multicenter, clinical trial that included 1498 patients with ST-segment elevation acute myocardial infarction who underwent emergency angioplasty. Subanalysis of this population was conducted to compare patients by type of access (femoral vs radial). The primary end point was a composite of: all-cause death, myocardial infarction, revascularization, and bleeding., Results: Femoral and radial access routes were used in 825 (55%) and 673 (45%) patients, respectively. More bleeding complications (major and minor) were seen with femoral access than radial access (5.9% vs 2.8%; P<.004), largely due to a greater incidence of minor bleeding with femoral access (4.6% vs 1.9%; P=.005). After adjustment for confounders, survival analysis showed a reduction in the primary composite end point in patients with radial access (hazard ratio=0.73; 95% confidence interval, 0.56-0.96; P=.022)., Conclusions: In patients with ST-segment elevation acute myocardial infarction, the radial approach is an effective technique that improves prognosis and reduces bleeding complications., (Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.)

Objectives: To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents., Design: Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported., Data Sources and Study Selection: Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients., Primary Outcomes: The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death., Results: The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P<0.001), and target vessel revascularisation (0.29, 0.20 to 0.41; P<0.001) at a median follow-up of 720 days. There was no significant difference in all cause death between groups (0.83, 0.65 to 1.06; P=0.14). Findings remained unchanged at multivariable regression after adjustment for the acuity of clinical syndrome (for instance, acute coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets., Conclusions: This meta-analysis offers evidence that compared with bare metal stents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis., (© Valgimigli et al 2014.)

Background: Manual thrombus aspiration (TA) is effective to reduce the thrombus burden during primary percutaneous coronary intervention for ST-elevation myocardial infarction. The objective of this study is to assess the impact of manual TA on stent implantation during primary percutaneous coronary intervention., Methods and Results: Population of the EXAMINATION trial (n=1498) was divided into 2 groups according to the use of TA. Immediate angiographic results, primary patient-oriented end point (combination of all-cause death, myocardial infarction, and any revascularization) and secondary device-oriented end point (combination of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization), definite/probable stent thrombosis, and major/minor bleeding were evaluated at 2 years. A total of 976 (65.2%) patients were classified into TA group and 522 (34.8%) patients into nonthrombus aspiration group. Manual TA was most frequently used in patients with worse initial thrombolysis in myocardial infarction flow. The TA group received less number of stents implanted (1.35 ± 0.62 versus 1.45 ± 0.71, P = 0.005) with bigger size (3.25 ± 0.44 versus 3.11 ± 0.46 mm, P < 0.001) compared with the nonthrombus aspiration group. A higher rate of direct stenting (69.2% versus 43.3%, P < 0.001) with lower rate of postdilatation (13.0% versus 18.0%, P < 0.009) was also present in the TA group compared with the nonthrombus aspiration group. At 2-year follow-up, no differences in clinical end point were observed between groups., Conclusions: Manual TA during primary percutaneous coronary intervention is associated with a higher rate of direct stenting, a lower rate of postdilatation, and larger and less stents in comparison with conventional primary percutaneous coronary intervention. Conversely, manual TA had no apparent impact on clinical outcomes at long-term follow-up., Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT00828087., (© 2014 American Heart Association, Inc.)

Objectives: This study sought to assess the 2-year outcomes of the population included in the EXAMINATION (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction) trial beyond the 1-year prescription period of dual antiplatelet therapy., Background: The EXAMINATION trial compared the performance of everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population., Methods: This was a multicenter, multinational, prospective, randomized, single-blind, controlled trial in patients with STEMI. The primary endpoint, which was the combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularization, and the endpoints target lesion revascularization and stent thrombosis were assessed at 2 years., Results: Between December 31, 2008, and May 15, 2010, 1,498 patients were randomized to receive EES (n = 751) or BMS (n = 747). Compliance with dual antiplatelet regimen was reduced at 2 years to a similar degree (17.3% vs. 17.2%, p = 0.91). At 2 years, the primary endpoint occurred in 108 (14.4%) patients of the EES group and in 129 (17.3%) patients of the BMS group (p = 0.11). Rate of target lesion revascularization was significantly lower in the EES group than in the BMS group (2.9% vs. 5.6%; p = 0.009). Rates of definite and definite or probable stent thrombosis were also significantly reduced in the EES group (0.8% vs. 2.1%; p = 0.03, and 1.3% vs. 2.8%; p = 0.04, respectively)., Conclusions: The 2-year follow-up of the EXAMINATION trial confirms the safety and efficacy of the EES compared with BMS in the setting of STEMI. Specifically, both rates of target lesion revascularization and stent thrombosis were reduced in recipients of EES without any signs of late attrition for either of these endpoints. (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction: EXAMINATION Study; NCT00828087)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI)., Background: Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES., Methods: Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year., Results: Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p < 0.0001) and a lower risk of target-vessel infarction (RR: 0.36; 95% CI: 0.14 to 0.92; p = 0.03). Newer-generation DES also reduced the risk of definite stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS., Conclusions: Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Few data are available about safety of second generation drug eluting stents in an all-comer ST elevation myocardial infarction (STEMI) population. We sought to investigate the predictors and clinical implications of 1-year stent thrombosis (ST) in patients with STEMI, included in the EXAMINATION trial., Methods and Results: The EXAMINATION trial is an all-comer prospective, randomized 1:1 controlled trial, testing everolimus-eluting stent (EES) vs. cobalt chromium bare metal stent (BMS) in STEMI patients. It included 1498 patients, randomized to EES (n = 751) or BMS (n = 747). At 1 year, definite/probable stent thrombosis, defined according to ARC criteria, occurred in 26 patients (1.73%), including 18 definite and 8 probable events. The incidence of ST was lower in patients treated with EES than in those treated with BMS (HR 0.16, 95% CI 0.03-0.29, p = 0.017). Patients with ST have higher 1-year rates of cardiac death (30.8% vs. 2.5%, p<0.001), myocardial infarction (30.8% vs. 0.5%, p<0.001) and target vessel revascularization (65.4% vs. 4.2%, p<0.001) compared with those without. Independent predictors of 1-year definite/probable ST were BMS implantation at the index procedure (HR 3.41, 95% CI 1.35-8.60), ST segment resolution of at least 70% in the EKG post-PCI (HR 0.30, 95% CI 0.13-0.70) and Killip class on admission (HR 2.57, 95% CI 1.70-3.90)., Conclusions: ST had low frequency in the first year after implantation of EES/BMS in STEMI patients, but it is associated with adverse events. BMS implantation, lack of ST-segment resolution and high Killip class on admission were independent predictors of 1-year ST., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Background: ST-elevation myocardial infarctions (STEMI) caused by proximal left-anterior descending (LAD) lesions have more myocardium at risk and worse outcomes than those located in other segments. The aim is to compare outcomes of patients with STEMI and proximal-LAD lesions treated with bare-metal stents (BMS) versus everolimus-eluting stents (EES)., Methods: The EXAMINATION trial randomized 1498 STEMI patients to BMS versus EES. The primary end point was the patient-oriented combined of all-cause death, any-recurrent myocardial infarction (MI) and any-revascularization. The secondary end point included the device-oriented combined of cardiac death, target-vessel MI and target-lesion revascularization (TLR)., Results: STEMI with a proximal-LAD occlusion was observed in 290 patients (BMS = 132 and EES = 158). Both groups were similar except for diabetes (12.9% vs 24.1%; P = .016). At 1 year, the primary end point was observed in 18.9% and 9.5% of patients treated with BMS and EES, respectively (P = .023). The secondary end point was observed in 11.4% and 5.1%, respectively (P = .053). There were no differences in cardiac death (4.5% vs 3.8%; P = .750) and MI (1.5% vs 0%; P = .121). BMS had higher rate of TLR compared to EES (6.8% vs 1.3%; P = .014). Patients with proximal-LAD STEMI had higher mortality than patients with non proximal-LAD STEMI (5.5% vs 2.9%; P = .027). Proximal-LAD lesions treated with BMS tended to increase the risk of the primary end point compared with other segments (18.9% vs 13.0%; P = .079). However, EES implanted in proximal-LAD had similar outcomes compared with other locations (9.5% vs 12.0%; P = .430). Adjusting for confounders, the interaction between BMS and proximal-LAD location was associated with the primary end point., Conclusion: Patients with STEMI and proximal-LAD lesions treated with EES have better outcomes compared with BMS at 1 year. Although further investigations are required, it seems reasonable to consider EES for proximal-LAD STEMI-lesions., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Background: Everolimus-eluting stent (EES) reduces the risk of restenosis in elective percutaneous coronary intervention. However, the use of drug-eluting stent in patients with ST-segment elevation myocardial infarction (STEMI) is still controversial. Data regarding the performance of second-generation EES in this setting are scarce. We report the 1-year result of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) trial, comparing EES with bare-metal stents (BMS) in patients with STEMI., Methods: This multicentre, prospective, randomised, all-comer controlled trial was done in 12 medical centres in three countries. Between Dec 31, 2008, and May 15, 2010, we recruited patients with STEMI up to 48 h after the onset of symptoms requiring emergent percutaneous coronary intervention. Patients were randomly assigned (ratio 1:1) to receive EES or BMS. Randomisation was in blocks of four or six patients, stratified by centre and centralised by telephone. Patients were masked to treatment. The primary endpoint was the patient-oriented combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularisation at 1 year and was analysed by intention to treat. The secondary endpoints of the study included the device-oriented combined endpoint of cardiac death, target vessel myocardial infarction or target lesion revascularisation, and rates of all cause or cardiac death, recurrent myocardial infarction, target lesion or target vessel revascularisation, stent thrombosis, device and procedure success, and major and minor bleeding. This trial is registered with ClinicalTrials.gov, number NCT00828087., Findings: Of the 1504 patients randomised, 1498 patients were randomly assigned to receive EES (n=751) or BMS (n=747). The primary endpoint was similar in both groups (89 [11·9%] of 751 patients in the EES group vs 106 [14·2%] of 747 patients in the BMS group; difference -2·34 [95% CI -5·75 to 1·07]; p=0·19). Device-oriented endpoint (44 [5·9%] in the EES group vs 63 [8·4%] in the BMS group; difference -2·57 [95% CI -5·18 to 0·03]; p=0·05) did not differ between groups, although rates of target lesion and vessel revascularisation were significantly lower in the EES group (16 [2·1%] vs 37 [5·0%], p=0·003, and 28 [3·7%] vs 51 [6·8%], p=0·0077, respectively). Rates of all cause (26 [3·5%] for EES vs 26 [3·5%] for BMS, p=1·00) or cardiac death (24 [3·2%] for EES vs 21 [2·8%] for BMS, p=0·76) or myocardial infarction (10 [1·3%] vs 15 [2·0%], p=0·32) did not differ between groups. Stent thrombosis rates were significantly lower in the EES group (4 [0·5%] patients with definite stent thrombosis in the EES group vs 14 [1·9%] in the BMS group and seven [0·9%] patients with definite or probable stent thrombosis in the EES group vs 19 [2·5%] in the BMS group, both p=0·019). Although device success rate was similar between groups, procedure success rate was significantly higher in the EES group (731 [97·5%] vs 705 [94·6%]; p=0·0050). Finally, Bleeding rates at 1 year were comparable between groups (29 [3·9%] patients in the EES group vs 39 [5·2%] in the BMS group; p=0·19)., Interpretation: The use of EES compared with BMS in the setting of STEMI did not lower the patient-oriented endpoint. However, at the stent level both rates of target lesion revascularisation and stent thrombosis were reduced in recipients of EES., Funding: Spanish Heart Foundation., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Aims: To assess the performance of the everolimus-eluting stent (EES) versus cobalt chromium bare-metal stent (BMS) in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI). The implantation of a drug-eluting stent in the setting of an acute myocardial infarction is still controversial. In several registries this clinical scenario has been associated with the development of stent thrombosis. The EES has demonstrated to reduce the stent thrombosis rate as compared to paclitaxel-eluting stent in randomised controlled trials, mainly performed in patients in stable clinical conditions. There are however few data regarding the effectiveness of EES in the context of STEMI., Methods and Results: This is an investigator-driven, prospective, multicentre, multinational, randomised, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT00828087). This trial, with an all comer design, randomises approximately 1,500 patients 1:1 to EES or BMS. Overall, any patient presenting with STEMI up to 48 hours who requires emergent percutaneous coronary intervention can be included. The primary endpoint is the patient-oriented combined endpoint of all-cause death, any myocardial infarction and any revascularisation at 1-year according to the Academic Research Consortium. Clinical follow-up will be scheduled at 30 days, six months, one year and yearly up to five years. No angiographic follow-up is mandated per protocol., Conclusions: This trial with broad inclusion and few exclusion criteria will shed light on the performance of the second generation EES in the complex scenario of STEMI.