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Background: Erythropoietin (EPO) has been suggested to promote cardiac repair after MI. However, the randomized, double-blind, placebo controlled REVIVAL-3 trial showed that short term high dose EPO in timely reperfused myocardium does not improve left ventricular ejection fraction after 6 months. Moreover, the study raised safety concerns due to a trend towards a higher incidence of adverse clinical events as well as a increase in neointima formation after treatment with EPO. The present study therefore aimed to assess the 5-year clinical outcomes.Methods: After successful reperfusion 138 patients with STEMI were randomly assigned to receive epoetin beta (3.33×104 U, n = 68) or placebo (n = 70) immediately, 24 and 48 h after percutaneous coronary intervention. The primary outcome of the present study- the combined incidence of MACE 5 years after randomization - occurred in 25% of the patients assigned to epoetin beta and 17% of the patients assigned to placebo (RR 1.5; 95% CI 0.8-3.5; p = 0.26). Target lesion revascularization was required in 15 patients (22.1%) treated with epoetin-ß and 9 patients (12.9%) treated with placebo (p = 0.15). Analysis of patients in the upper and lower quartile of baseline hemoglobin as an indirect estimate of endogenous erythropoietin levels revealed no significant impact of endogenous erythropoietin on efficiency of exogen administered epoetin-ß in terms of death and MACE.Conclusion: These long-term follow-up data show that epoetin beta does not improve clinical outcomes of patients with acute myocardial infarction.Trial Registration: URL www.clinicaltrials.gov ; Unique identifier NCT00390832; trial registration date October 19th 2006. [ABSTRACT FROM AUTHOR]

The article presents the study which examined the effectiveness of paclitaxel-eluting balloons (PEB), paclitaxel-eluting stents (PES) and balloon angioplasty in patients who previously received a drug-eluting stent (DES). The randomised, open-label trial was conducted in Germany. Based on the results, PEB could be an effective treatment for patients with restenosis following the implantation of a DES.

Introduction and Objectives: Long-term outcomes of unselected patients treated with bioresorbable vascular scaffold (BVS) implantation are lacking, especially for the period after complete dissolution of the BVS. This study sought to evaluate 5-year outcomes in patients treated with BVS in routine practice., Methods: Consecutive patients who underwent implantation of everolimus-eluting BVS during routine clinical practice at 2 high-volume centres in Germany were studied. The patients were followed-up for up to 5 years. The primary endpoints of interest were the composite of death, myocardial infarction and target lesion revascularization, as well as definite scaffold thrombosis., Results: A total of 419 patients (mean age 66.6 ± 10.9 years; 31.5% had diabetes) were included, of whom 38.9% presented with an acute coronary syndrome. Of the 527 lesions treated, 49.0% were classified as complex and 13.1% were bifurcation lesions. At 5 years, the composite clinical endpoint occurred in 33.1% of patients and definite scaffold thrombosis occurred in 4.7%. Most definite scaffold thrombosis occurred within 2 years after BVS implantation., Conclusions: In patients treated with BVS implantation in routine clinical practice the rates of adverse clinical events at 5 years were high, including a considerable incidence of scaffold thrombosis., (Copyright © 2020 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background Extended long-term follow-up data of new-generation drug-eluting stents in patients with diabetes mellitus is scant. The aim of this study is to assess the 10-year clinical outcome of new-generation biodegradable polymer-based sirolimus-eluting stents (Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (XIENCE) in patients with and without diabetes mellitus. Methods and Results In a prespecified subgroup analysis, outcomes of patients with or without diabetes mellitus treated with drug-eluting stents were compared. The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The analysis includes a total of 1951 patients (560 patients with and 1391 patients without diabetes mellitus) randomized to treatment with Yukon Choice PC (n=1299) or Xience (n=652). Regarding the primary end point, at 10 years patients with diabetes mellitus showed significantly higher major adverse cardiac event rates than patients without diabetes mellitus ( P <0.001; hazard ratio [HR], 1.41; 95% CI, 1.22-1.63). There was no significant difference between patients treated with Yukon Choice PC versus Xience, neither in the subgroup of patients with ( P =0.91; HR, 1.01; 95% CI, 0.79-1.30) nor without diabetes mellitus ( P =0.50; HR, 0.94; 95% CI, 0.79-1.21). Rates of definite/probable stent thrombosis were 2.3% in patients with and 1.9% in patients without diabetes mellitus (HR, 1.27; 95% CI, 0.34-2.60; P =0.52), without significant differences between study devices. Conclusions The clinical outcome of patients with diabetes after percutaneous coronary intervention with different new-generation drug-eluting stents is considerably worse than that of patients without diabetes mellitus, with event rates constantly increasing out to 10 years. Registration URL: https://clinicaltrials.gov. Unique Identifier: NCT00598676.

Background: Since the outbreak of the COVID-19 pandemic, a number of risk factors for a poor outcome have been identified. Thereby, cardiovascular comorbidity has a major impact on mortality. We investigated whether coronary calcification as a marker for coronary artery disease (CAD) is appropriate for risk prediction in COVID-19., Methods: Hospitalized patients with COVID-19 (n = 109) were analyzed regarding clinical outcome after native computed tomography (CT) imaging for COVID-19 screening. CAC (coronary calcium score) and clinical outcome (need for intensive care treatment or death) data were calculated following a standardized protocol. We defined three endpoints: critical COVID-19 and transfer to ICU, fatal COVID-19 and death, composite endpoint critical and fatal COVID-19, a composite of ICU treatment and death. We evaluated the association of clinical outcome with the CAC. Patients were dichotomized by the median of CAC. Hazard ratios and odds ratios were calculated for the events death or ICU or a composite of death and ICU., Results: We observed significantly more events for patients with CAC above the group's median of 31 for critical outcome (HR: 1.97[1.09,3.57], p = 0.026), for fatal outcome (HR: 4.95[1.07,22.9], p = 0.041) and the composite endpoint (HR: 2.31[1.28,4.17], p = 0.0056. Also, odds ratio was significantly increased for critical outcome (OR: 3.01 [1.37, 6.61], p = 0.01) and for fatal outcome (OR: 5.3 [1.09, 25.8], p = 0.02)., Conclusion: The results indicate a significant association between CAC and clinical outcome in COVID-19. Our data therefore suggest that CAC might be useful in risk prediction in patients with COVID-19., Competing Interests: The authors have declared that no competing interests exists.

Disturbed wound healing (DWH) following elective foot and ankle surgery is associated with a number of known risk factors. The purpose of this study was to determine if peripheral artery disease (PAD) is a potential risk factor that contributes to an increase in postoperative DWH. In a case-control study, we analyzed all patients undergoing elective foot and ankle surgery between January 1, 2014 and December 31, 2017 at two institutions and identified 51 patients with postoperative DWH. After matching with 51 control patients without DWH, all 102 patients were evaluated for PAD. The prevalence of PAD was significantly higher in the DWH group compared to the control group (41.2% vs 19.6%, p < 0.01). This difference was even more distinctive for patients with any abnormal ankle-brachial index (ABI) (51.0% vs 19.6%, p < 0.001). After adjustment for diabetes, hypertension, hypercholesterolemia, and smoking, any abnormal ABI or a history of PAD remained an independent risk factor for DWH (odds ratio 3.28; 95% CI 1.24-8.71). In this dual-center study, postoperative DWH was associated with significantly higher rates of PAD. These findings suggest that preoperative evaluation for PAD could be a helpful tool to identify patients at high risk for postoperative wound complications undergoing foot and ankle surgery. This trial is registered with drks.de, number DRKS00012580.

Objectives: We aimed to assess the impact of omitting aspirin on clinical outcomes in a real-world collective of patients receiving oral anticoagulation (OAC) therapy who were treated with a current-generation drug-eluting stent (DES) or an everolimus-eluting bioresorbable vascular scaffold (BVS)., Background: Limited data are available regarding the clinical benefit of triple antithrombotic therapy (TAT) with aspirin compared with dual antithrombotic therapy (DAT) without aspirin in patients undergoing percutaneous coronary intervention (PCI) and requiring OAC., Methods: In total, 237 patients were analyzed. The primary outcome was a composite of major adverse cardiac and cerebrovascular events (MACCE) within 1 year after PCI. Secondary outcomes were the individual components of the primary endpoint, cardiovascular death, and any bleeding according to Bleeding Academic Research Consortium (BARC) or Thrombolysis in Myocardial Infarction (TIMI) criteria., Results: Eighty-nine patients (37.6%) received DAT, and 148 (62.4%) received TAT. The rate of MACCE was significantly higher in DAT patients than in TAT patients (16 (18%) vs. 11 (7.4%); hazard ratio [HR] 2.73, 95% confidence interval [CI] 1.24-6.03; P = 0.01). The results of the multivariable Cox proportional hazards model including corrections for imbalances in baseline characteristics confirmed a significant independent association between DAT and MACCE (HR adj 3.14, 95% CI 1.31-7.54; P = 0.01). Major bleeding did not differ significantly between treatment groups., Conclusion: DAT was associated with a significantly higher rate of MACCE than TAT after DES or BVS implantation. Further studies are required to evaluate the safety and efficacy of dual versus TAT after PCI in clinical practice., (© 2018 Wiley Periodicals, Inc.)

Background: Hemodynamic monitoring plays a pivotal role in the treatment of patients in the cardiac intensive care unit (CICU). The innovative radial artery applanation tonometry technology allows for continuous noninvasive arterial blood pressure (AP) measurement. By closing the gap between continuous invasive AP monitoring (arterial catheter) and intermittent noninvasive AP monitoring (oscillometry) this technology might improve CICU patient monitoring. We therefore aimed to evaluate the measurement performance of radial artery applanation tonometry in comparison with a radial arterial catheter in CICU patients., Methods: In this prospective method comparison study, we simultaneously recorded AP noninvasively with radial artery applanation tonometry (T-line 200 pro device; Tensys Medical Inc., San Diego, CA, USA) and invasively with an arterial catheter (criterion standard) in 30 patients treated in the CICU of a German university hospital. We statistically analyzed 7,304 averaged 10-beat epochs of measurements of mean AP, systolic AP, and diastolic AP by using Bland-Altman analysis for repeated measurements., Results: Our study revealed a mean difference ± standard deviation (95% limits of agreement; percentage error) between radial artery applanation tonometry and the criterion standard method (radial arterial catheter) of +2 ± 6 mmHg (-10 to +14 mmHg; 17%) for mean AP, -6 ± 11 mmHg (-28 to +15 mmHg; 20%) for systolic AP, and +4 ± 7 mmHg (-9 to +17 mmHg; 23%) for diastolic AP., Conclusions: In CICU patients, continuous noninvasive measurement of AP using radial artery applanation tonometry is feasible. The technology showed reasonable accuracy and precision in comparison with radial arterial catheter-derived AP values.

Background: Inhospital stent thrombosis (ST) and cerebrovascular accidents (CVA) are rare but serious adverse events after percutaneous coronary intervention (PCI). The association of ST or CVA with long-term outcome after PCI remains poorly investigated., Methods: The study included 18,334 consecutive patients who underwent PCI. Patients were divided into 3 groups: the group with ST, the group with CVA, and the group without these events. The primary outcome was all-cause mortality at 3-year follow-up., Results: Inhospital ST or CVA occurred in 59 patients (0.32%) and in 90 patients (0. 49%), respectively. There were 2,149 deaths (11.7%) during the follow-up: 26 deaths among patients with ST, 32 deaths among patients with CVA, and 2,091 deaths among patients without ST or CVA (Kaplan-Meier estimates of 3-year mortality 45.3%, 38.0%, and 12.9%, odds ratio 6.1, 95% CI 3.6-10.2, P < .001 for ST group vs the group without ST or CVA and odds ratio 4.2 [2.7-6.6], P < .001 for CVA group vs the group without ST or CVA). There was no significant difference in the 3-year mortality between CVA and ST groups (P = .29). The Cox proportional hazards model showed that ST (adjusted hazard ratio 4.97, 95% CI 2.58-9.56, P < .001) and CVA (adjusted hazard ratio 2.25 [1.25-4.04], P = .006) were independently associated with the increased risk of 3-year mortality., Conclusion: Inhospital ST and CVA after PCI are associated with the increased risk of 3-year mortality. Both events seem to have a similar impact on long-term survival., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Aims: Vascular closure devices (VCD) have been introduced into clinical practice with the aim of increasing the procedural efficiency and clinical safety of coronary angiography. However, clinical studies comparing VCD and manual compression have yielded mixed results, and large randomised clinical trials comparing the two strategies are missing. Moreover, comparative efficacy studies between different VCD in routine clinical use are lacking., Methods and Results: The Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial is a prospective, randomised clinical trial designed to compare the outcomes associated with the use of VCD or manual compression to achieve femoral haemostasis. The test hypothesis is that femoral haemostasis after coronary angiography achieved using VCD is not inferior to manual compression in terms of access-site-related vascular complications. Patients undergoing coronary angiography via the common femoral artery will be randomised in a 1:1:1 fashion to receive FemoSeal VCD, EXOSEAL VCD or manual compression. The primary endpoint is the incidence of the composite of arterial access-related complications (haematoma ≥5 cm, pseudoaneurysm, arteriovenous fistula, access-site-related bleeding, acute ipsilateral leg ischaemia, the need for vascular surgical/interventional treatment or documented local infection) at 30 days after randomisation. According to power calculations based on non-inferiority hypothesis testing, enrolment of 4,500 patients is planned. The trial is registered at www.clinicaltrials.gov (study identifier: NCT01389375)., Conclusions: The safety of VCD as compared to manual compression in patients undergoing transfemoral coronary angiography remains an issue of clinical equipoise. The aim of the ISAR-CLOSURE trial is to assess whether femoral haemostasis achieved through the use of VCD is non-inferior to manual compression in terms of access-site-related vascular complications.

Objectives: This study sought to compare the risk of stent thrombosis among patients treated with bare-metal stents (BMS), first-generation drug-eluting stents (G1-DES), and second-generation drug-eluting stents (G2-DES) for a period of 3 years., Background: In patients undergoing coronary stenting, there is a scarcity of long-term follow-up data on cohorts large enough to compare rates of stent thrombosis across the stent generations., Methods: A total of 18,334 patients undergoing successful coronary stent implantation from 1998 to 2011 at 2 centers in Munich, Germany, were included in this study. Patients were stratified into 3 groups according to treatment with BMS, G1-DES, and G2-DES., Results: The cumulative incidence of definite stent thrombosis at 3 years was 1.5% with BMS, 2.2% with G1-DES, and 1.0% with G2-DES. On multivariate analysis, G1-DES compared with BMS showed a significantly higher risk of stent thrombosis (odds ratio [OR]: 2.05; 95% confidence interval [CI]: 1.47 to 2.86; p < 0.001). G2-DES were associated with a similar risk of stent thrombosis compared with BMS (OR: 0.82; 95% CI: 0.56 to 1.19; p = 0.30). Beyond 1 year, the risk of stent thrombosis was significantly increased with G1-DES compared with BMS (OR: 4.72; 95% CI: 2.01 to 11.1; p < 0.001), but not with G2-DES compared with BMS (OR: 1.01; 95% CI: 0.32 to 3.25; p = 0.98)., Conclusions: In a large cohort of unselected patients undergoing coronary stenting, compared with BMS, there was a significant excess risk of stent thrombosis at 3 years with G1-DES, driven by an increased risk of stent thrombosis events beyond 1 year. G2-DES were associated with a similar risk of stent thrombosis compared with BMS., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Endovascular therapy of carotid artery disease has emerged as a potential alternative to endarterectomy and its clinical practise dramatically increased in many parts of the world. This study aims to determine the safety and mid-term outcome of carotid artery stenting (CAS) within a 15-year carotid program at a single-centre institution., Patients and Methods: We retrospectively analysed all CAS-procedures performed at our institution between 1995 and 2009., Results: During the observation period, a total of 497 CAS procedures were attempted in 460 patients with stenoses of the internal carotid artery of which 187 (37.6 %) were symptomatic and 310 (62.4 %) were asymptomatic. CAS was successful in 479 (96.4 %) cases and success rate significantly increased throughout the study (p < 0.001). The periprocedural complication rate for death, stroke, and transient ischemic attack (TIA) was 0.4 %, 1.2 %, and 2.6 %, respectively, and the cumulative event rate did not differ between symptomatic and asymptomatic patients (4.8 % vs. 3.9 %; p = 0.62). Age was the only significant predictor for the occurrence of any periprocedural adverse event (OR 2.08 [1.22 - 3.54]; p = 0.007). During a median follow-up of 24 [1; 141] months, the rate of stroke, TIA, and in-stent restenosis was 1.0 %, 2.2 %, and 2.7 %, respectively., Conclusions: Data from this large observation in everyday clinical patients demonstrate that endovascular therapy in carotid artery disease can be performed safely and with mid-term outcomes comparable to carotid endarterectomy.

Background: It is the general perception, that ST-elevation myocardial infarction is associated with transmural ischemia while Non-ST elevation myocardial infarction is found in non-transmural subendocardial ischemia. This association, however, derives primarily from post mortem studies., Methods: A total of 220 patients with acute myocardial infarction (MI) who had PCI on admission and contrast-enhanced cardiac magnetic resonance imaging (CMR) within one week were included into the study. Size and transmural extent of MI was quantified by CMR and correlated with the ECG on admission., Results: Based on the ECG findings, 57% were classified as STEMI and 43% as NSTEMI. CMR infarct size was significantly larger in STEMI than NSTEMI (23.2 vs. 14.2 LV%, p<0.001). As assessed by CMR, STEMI patients were transmural in 63% as compared to 27% of patients with NSTEMI (p<0.001). In a multivariable logistic regression model, total infarct size was significantly associated with presence of STEMI (OR: 1.045, 95% CI [1.014-1.077], p=0.004) whereas the number of transmural segments did not significantly add further information for a STEMI/NSTEMI classification (p=0.054, change of c-index from 0.69 to 0.70)., Conclusions: The electrocardiographic STEMI/NSTEMI classification does rather characterize the total size of MI than the transmural extent as assessed by CMR., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Besides different risk profiles for cardiovascular events in men and women, several studies reported gender differences in mortality after acute myocardial infarction (AMI). As infarct size has been shown to correlate with mortality, it is widely accepted as surrogate marker for clinical outcome. Currently, cardiovascular imaging studies covering the issue of gender differences are rare. As magnetic resonance scar characterization parameters are emerging as additional prognostic factors after acute myocardial infarction, we sought to evaluate gender differences in CMR infarct characteristics in patients after acute myocardial infarction. We prospectively analyzed patients (n = 448) with AMI and primary angioplasty, who underwent contrast-enhanced cardiac magnetic resonance (CMR) imaging on a 1.5 T scanner in median 5 [4, 6] days after the acute event. [corrected]. CMR scar size was measured 15 min after gadolinium injection. In addition presence and extent of microvascular obstruction (MVO) was assessed. A matched pair analysis was performed in order to exclude confounding by gender related co-morbidities and gender differences in established clinical risk factors. Matching process according to clinical risk defined by GRACE score resulted in 93 mixed gender couples. Women were significantly older than men (64.4 ± 11.9 vs. 60.5 ± 12.3, p = 0.03) and presented with a significantly better ejection fraction before angioplasty (48.9 ± 8.4 vs. 46.2 ± 8.9, p = 0.04). Infarct size did not differ significantly between women and men (13.5 ± 10.7 vs. 15.1 ± 11.8, p = 0.32). Size of MVO was significantly smaller in women than in men (0.48 ± 1.3 vs. 1.2 ± 3.0, p = 0.03). Comparing scar characterization between women and men with similar risk profiles revealed no gender differences in scar size. Size of MVO, however, was significantly smaller in women and might reflect better cardioprotective mechanisms in women. Whether these changes have prognostic implications has to be tested on a larger patient population.