Publications by authors named "Sigmund Silber"

176 Publications

Identification of the type of stent with three-dimensional optical coherence tomography: the SPQR study.

EuroIntervention 2020 Sep 15. Epub 2020 Sep 15.

Klinikum Frankfurt (Oder), Frankfurt (Oder), Germany.

Aims: The ability of optical coherence tomography (OCT) to identify specific types of stent has never been systematically studied.

Methods And Results: A series of 212 consecutive patients with OCT from six international centres were retrospectively screened, finding 294 metallic stents or scaffolds in 146 patients. The sample was analysed by two blinded operators, applying a dedicated protocol in 4 steps to identify the type of stent: 1) 3D and automatic strut detection (ASD), 2) 3D in direct tissue view, 3) Longitudinal view with ASD, 4) Mode "stent only" and ASD. The protocol correctly identified 285 stents (96.9%, kappa 0.965), with excellent interobserver agreement (kappa 0.988). The performance tended to be better in recently implanted stents (kappa 0.993) than in stents implanted ≥3 months before (kappa 0.915), and in pullback speed 18mm/s as compared with 36 mm/s (kappa 0.969 vs. 0.940, respectively).

Conclusions: The type of stent platform can be accurately identified in OCT by trained analysts following a dedicated protocol, combining 3D-OCT, ASD and longitudinal view. This might be clinically helpful in scenarios of device failure and for the quantification of apposition. The blinding of analysts in OCT studies should be revisited.
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http://dx.doi.org/10.4244/EIJ-D-20-00598DOI Listing
September 2020

Percutaneous Coronary Intervention in Stable Coronary Heart Disease -Is Less More?

Dtsch Arztebl Int 2020 Feb;117(9):137-144

Jena University Hospital; Department of Cardiology (CBF), Charité - Universitätsmedizin Berlin; Department of Internal Medicine II, University Hospital Regensburg; Cardiologicum Stuttgart; Cardiology practice, Munich and Stent Therapy at the Isar Heart Center, Munich; Department of Internal Medicine/Cardiology, Leipzig Heart Center.

Background: This review concerns the putative benefit of percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) for symptomatic patients with stable angina pectoris, or for asymptomatic persons in whom screening tests have revealed coronary heart disease (CHD; this entity has been newly designated chronic coronary syndrome, or CCS). Moreover, it addresses the question whether the indications for which PCI is now performed in Germany on patients with CCS are consistent with current scientific knowledge.

Methods: The pathophysiological concept of CHD and ischemia induction is discussed in the light of the scientific literature. This concept implies that PCI might be beneficial in the treatment of CCS. The benefit of PCI over OMT has now been evaluated in seven randomized trials (the so-called milestone trials). The current situation in Germany is presented here as well, on the basis of the available data.

Results: The pathophysiological concept of CHD implies that the particular coronary artery stenoses that are likely to give rise to a myocardial infarction (the so-called vulnerable plaques) cannot be identified prospectively with current methods. Moreover, a coronary artery stenosis will not necessarily cause myocardial ischemia. All of the randomized trials carried out to date that have compared OMT to PCI-plus-OMT in patients with CCS have led to the conclusion that PCI, because it focuses on individual coronary artery stenoses, cannot prolong survival or lower the incidence of myocardial infarction over the long term. This remains the case even if a single coronary artery stenosis is known to be causing moderate or severe myocardial ischemia (a conclusion of the ISCHEMIA trial). A PCI performed only because the coronary stenosis or stenoses meet certain morphological criteria, without any demonstration of a resulting functional disturbance, is generally detrimental to the health of the patient, with rare exceptions, and is inconsistent with the recommendations of current guidelines. The number of PCIs being performed in Germany at present is high compared to other countries; this arouses concern that the indications for it may be dubious in many cases.

Conclusion: Current data imply that PCI for CCS does not improve outcomes in a large percentage of cases. A symptomatic benefit exists only in patients with frequent angina pectoris. The selection of CCS patients for PCI needs to be more strictly bound to the recommendations of current guidelines, particularly in Germany.
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http://dx.doi.org/10.3238/arztebl.2020.0137DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7132080PMC
February 2020

Author Correction: Cardiovascular risk algorithms in primary care: Results from the DETECT study.

Sci Rep 2020 Mar 31;10(1):5945. Epub 2020 Mar 31.

University of Heidelberg, Mannheim Medical Faculty, Department of Internal Medicine V (Nephrology, Hypertensiology, Rheumatology, Endocrinology, Diabetology), Mannheim, Germany.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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http://dx.doi.org/10.1038/s41598-020-59763-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7105487PMC
March 2020

Five-year clinical outcomes for the Resolute zotarolimus-eluting stent in total coronary occlusions.

EuroIntervention 2019 Nov 19. Epub 2019 Nov 19.

Department of Cardiology, Zealand University Hospital, Roskilde, Denmark, Denmark.

Aims: Reports of long-term outcomes of patients treated with drug-eluting stents in total coronary occlusions are limited. We analyzed clinical outcomes of patients treated with the zotarolimus-eluting Resolute stent (R-ZES) implanted in total coronary versus non-occluded lesions.

Methods And Results: Patients treated with R-ZES and included in 4 trials (RESOLUTE All Comers, RESOLUTE International, RESOLUTE China RCT, and RESOLUTE China Registry) were pooled and divided in 3 groups: patients with chronic total occlusions (CTO), patients with total occlusions that had occurred recently (rec-TO), and patients without total occlusions (non-TO). Clinical outcomes at 5-years were analyzed. Of 5,487 patients treated with R-ZES in these trials, 8.0% had CTO's, 8.5% rec-TO's and 83.5% non-TO's. Patients had a mean age of 62.8 years, approximately 25% were female and 30% diabetics. TLF was similar in the 3 groups at 5 years (TLF was 13.2%, 12.5% and 13.3% in the CTO, rec-TO and non-TO groups, respectively, p=0.96). Stent thrombosis tended to occur more frequently for rec-TO compared to CTO and non-TO patients (2.6% vs 1.2% and 1.3%, respectively, p=0.11).

Conclusions: In this large population of patients who had R-ZES implanted, 5-year clinical outcomes were similar whether or not the stents were implanted in total occlusions.
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http://dx.doi.org/10.4244/EIJ-D-19-00866DOI Listing
November 2019

[ESC guidelines 2019 on chronic coronary syndrome (CCS, previously "stable coronary artery disease") : What is new? What is particularly important?]

Authors:
Sigmund Silber

Herz 2019 Dec;44(8):676-683

Kardiologische Praxis und Herzkatheter, Tal 21, 80331, München, Deutschland.

After an unusually long period of time of 6 years, in August 2019 the updated version of the European Society of Cardiology (ESC) guidelines from 2013 on the management of stable coronary artery disease was published. The course of "stable" coronary artery disease is only assumed to be stable and pathologically is often progressive but initially goes unnoticed. In order to raise awareness for the progressive character of "stable" coronary artery disease, the term chronic coronary syndrome (CCS) was introduced. In this overview the various phenotypes of CCS are divided into three groups. 1) Suspected obstructive coronary artery disease: the emphasis here is on functional, noninvasive imaging diagnostics of ischemia and cardiac computed tomography (CT). These diagnostic options have become even more important in the light of the decreasing prevalence of coronary artery disease. 2) Known obstructive coronary artery disease: here there are many new practice-relevant recommendations, particularly in the field of pharmaceutical treatment with antithrombotic drugs. 3) Microvascular disease: in symptomatic patients the exclusion of epicardial coronary stenoses using invasive coronary angiography should not signify the end of the diagnostic procedure. Functional tests in the catheter laboratory should be initiated in order not to overlook a microvascular cause of the complaints and do an injustice to the patient.
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http://dx.doi.org/10.1007/s00059-019-04862-6DOI Listing
December 2019

Impact of Periprocedural Myocardial Biomarker Elevation on Mortality Following Elective Percutaneous Coronary Intervention.

JACC Cardiovasc Interv 2019 10;12(19):1954-1962

Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis & Faculty of Medicine and Life Sciences Hasselt University, Hasselt, Belgium.

Objectives: This study sought to explore the association between biomarker elevation, with creatine kinase-myocardial band (CK-MB) or cardiac troponin (cTn), following percutaneous coronary intervention (PCI) and mortality in patients undergoing PCI for stable angina with normal baseline values.

Background: Several studies have shown a strong association between post-PCI CK-MB elevation and subsequent mortality. However, the prognostic significance of troponin elevation following coronary intervention is still debated.

Methods: Patient-level data from 5 contemporary coronary stent trials and 1 large registry were pooled. Mortality of patients with stable angina, with normal baseline biomarkers, was compared between patients with and those without different cutoff values of cTn and CK-MB.

Results: A total of 13,452 patients were included in this pooled analysis. The overall percentage of patients with elevated biomarkers following PCI was 23.9% for CK-MB and 68.4% for cTn. In the patient cohort for whom both assays were available (n = 8,859), 2.4% had both CK-MB ≥5 × the upper limit of normal (ULN) and cTn ≥35 × ULN, while 92% had both CK-MB <5 × ULN and cTn <35 × ULN. Among patients with CK-MB ≥5 × ULN (n = 315), 212 (67.3%) also had cTn ≥35 × ULN. Conversely, 390 of patients (64.8%) who had cTn ≥35 × ULN did not have CK-MB ≥5 × ULN. A total of 259 patients (1.9%) died at 1 year; 20 (7.7%) had CK-MB ≥5 × ULN, and 23 (8.8%) had cTn ≥35 × ULN. In the Cox multivariate analysis, in which the CK-MB and cTn ratios post-procedure were forced into the model, age, prior myocardial infarction, lesion complexity, hyperlipidemia, and CK-MB ratio (≥10) post-procedure were associated with increased 1-year mortality.

Conclusions: Following elective PCI in patients in stable condition treated with second-generation drug-eluting stent, CK-MB and cTn elevations remain common. After multivariate adjustment, there was an increased mortality rate with elevation of CK-MB after PCI, whereas cTn elevation was not independently associated with mortality at 1 year.
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http://dx.doi.org/10.1016/j.jcin.2019.07.014DOI Listing
October 2019

[The new Disease Management Program (DMP) for patients with chronic systolic heart failure in Germany: Goals and limitations].

Authors:
Sigmund Silber

MMW Fortschr Med 2019 Sep;161(16):40-44

, Tal 21, D-80331, München, Deutschland.

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http://dx.doi.org/10.1007/s15006-019-0902-0DOI Listing
September 2019

The REMEDEE trial: 5-Year results on a novel combined sirolimus-eluting and endothelial progenitor cells capturing stent.

Catheter Cardiovasc Interv 2020 05 5;95(6):1076-1084. Epub 2019 Sep 5.

Cardiovascular Research Foundation, New York, New York.

Objectives: To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial.

Background: Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations.

Methods: A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up.

Results: Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%.

Conclusion: At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.
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http://dx.doi.org/10.1002/ccd.28483DOI Listing
May 2020

Impact of left ventricular function on clinical outcomes among patients with coronary artery disease.

Eur J Prev Cardiol 2019 08 9;26(12):1273-1284. Epub 2019 Apr 9.

1 Department of Cardiology, University Hospital of Bern, Inselspital, Switzerland.

Aims: To investigate the clinical relevance of contemporary cut-offs of left ventricular ejection fraction (LVEF) including an intermediate phenotype with mid-range reduced ejection fraction among patients with coronary artery disease undergoing percutaneous coronary intervention.

Methods And Results: Patient-level data were summarized from five randomized clinical trials in which 6198 patients underwent clinically indicated percutaneous coronary intervention in different clinical settings. We assessed all-cause mortality as primary endpoint at five-year follow-up. According to the proposed LVEF cut-offs, 3816 patients were included in the preserved LVEF group (LVEF ≥ 50%), 1793 in the mid-range reduced LVEF group (LVEF 40-49%) and 589 patients in the reduced LVEF group (LVEF < 40%). Patients in the reduced LVEF group were at increased risk for the primary outcome of all-cause mortality compared with both, preserved and mid-range LVEF throughout five years of follow-up (adjusted hazard ratio 2.39 (95% confidence interval 1.75-3.28,  < 0.001) and 1.68 (95% confidence interval 1.34-2.10,  < 0.001), respectively). The risk of cardiac death and the composite endpoint of cardiac death, myocardial infarction, or stroke were higher for patients in the reduced LVEF group compared with the preserved and mid-range reduced LVEF groups, but also for the mid-range LVEF compared with preserved LVEF group (adjusted  < 0.05 for all comparisons) throughout five years. Irrespective of clinical presentation at baseline (stable coronary artery disease or acute coronary syndrome), patients with reduced or mid-range LVEF were at increased risk of all-cause mortality and cardiac death up to five years compared with the other group (adjusted  < 0.05 for all comparisons).

Conclusion: Patients with reduced LVEF <40% or mid-range LVEF 40-49% in the context of coronary artery disease undergoing clinically indicated percutaneous coronary intervention are at increased risk of all-cause mortality, cardiac death and the composite of cardiac death, stroke and myocardial infarction throughout five years of follow-up. The recently proposed LVEF cut-offs contribute to the differentiation and risk stratification of patients with ischaemic heart disease.
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http://dx.doi.org/10.1177/2047487319841939DOI Listing
August 2019

Cardiovascular risk algorithms in primary care: Results from the DETECT study.

Sci Rep 2019 01 31;9(1):1101. Epub 2019 Jan 31.

University of Heidelberg, Mannheim Medical Faculty, Department of Internal Medicine V (Nephrology, Hypertensiology, Rheumatology, Endocrinology, Diabetology), Mannheim, Germany.

Guidelines for prevention of cardiovascular diseases use risk scores to guide the intensity of treatment. A comparison of these scores in a German population has not been performed. We have evaluated the correlation, discrimination and calibration of ten commonly used risk equations in primary care in 4044 participants of the DETECT (Diabetes and Cardiovascular Risk Evaluation: Targets and Essential Data for Commitment of Treatment) study. The risk equations correlate well with each other. All risk equations have a similar discriminatory power. Absolute risks differ widely, in part due to the components of clinical endpoints predicted: The risk equations produced median risks between 8.4% and 2.0%. With three out of 10 risk scores calculated and observed risks well coincided. At a risk threshold of 10 percent in 10 years, the ACC/AHA atherosclerotic cardiovascular disease (ASCVD) equation has a sensitivity to identify future CVD events of approximately 80%, with the highest specificity (69%) and positive predictive value (17%) among all the equations. Due to the most precise calibration over a wide range of risks, the large age range covered and the combined endpoint including non-fatal and fatal events, the ASCVD equation provides valid risk prediction for primary prevention in Germany.
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http://dx.doi.org/10.1038/s41598-018-37092-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6355969PMC
January 2019

[Policy paper nuclear cardiology - update 2018 - Current status of clinical practice].

Nuklearmedizin 2018 Aug 24;57(4):146-152. Epub 2018 Jul 24.

The joint position paper of the working community "Cardiovascular Nuclear Medicine" of the German Society of Nuclear Medicine (DGN) and the working group "Nuclear Cardiology Diagnostics" of the German Cardiac Society (DKG) updates the former 2009 paper. It is the purpose of this paper to provide an overview about the application fields, the state-of-the-art and the current value of nuclear cardiology imaging. The topics covered are chronic coronary artery disease, including viability imaging, furthermore cardiomyopathies, infective endocarditis, cardiac sarcoidosis and amyloidosis.
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http://dx.doi.org/10.3413/2018-06-0001DOI Listing
August 2018

Adjusted Troponin I for Improved Evaluation of Patients with Chest Pain.

Sci Rep 2018 05 24;8(1):8087. Epub 2018 May 24.

Department of Internal Medicine III, Cardiology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.

The use of cardiac troponins (cTn) is the gold standard for diagnosing myocardial infarction. Independent of myocardial infarction (MI), however, sex, age and kidney function affect cTn levels. Here we developed a method to adjust cTnI levels for age, sex, and renal function, maintaining a unified cut-off value such as the 99 percentile. A total of 4587 individuals enrolled in a prospective longitudinal study were used to develop a model for adjustment of cTn. cTnI levels correlated with age and estimated glomerular filtration rate (eGFR) in males/females with r = 0.436/0.518 and with r = -0.142/-0.207. For adjustment, these variables served as covariates in a linear regression model with cTnI as dependent variable. This adjustment model was then applied to a real-world cohort of 1789 patients with suspected acute MI (AMI) (N = 407). Adjusting cTnI showed no relevant loss of diagnostic information, as evidenced by comparable areas under the receiver operator characteristic curves, to identify AMI in males and females for adjusted and unadjusted cTnI. In specific patients groups such as in elderly females, adjusting cTnI improved specificity for AMI compared with unadjusted cTnI. Specificity was also improved in patients with renal dysfunction by using the adjusted cTnI values. Thus, the adjustments improved the diagnostic ability of cTnI to identify AMI in elderly patients and in patients with renal dysfunction. Interpretation of cTnI values in complex emergency cases is facilitated by our method, which maintains a single diagnostic cut-off value in all patients.
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http://dx.doi.org/10.1038/s41598-018-26120-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5967336PMC
May 2018

[Do you know your risk of getting a heart attack?]

Authors:
Sigmund Silber

MMW Fortschr Med 2018 Mar;160(4):38-44

, Tal 21, D-80331, München, Deutschland.

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http://dx.doi.org/10.1007/s15006-018-0243-4DOI Listing
March 2018

Longitudinal change instead of baseline testosterone predicts depressive symptoms.

Psychoneuroendocrinology 2018 03 21;89:7-12. Epub 2017 Dec 21.

European University of Applied Sciences, Faculty of Applied Public Health, Rostock, Germany; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Background: The association between total testosterone (T) and depression mostly relies on single sex hormone assessment and remains inconclusive. Thus, we investigated the comparative predictive performance of baseline T and change in T with development of depressive symptoms and incident depressive episodes.

Methods: We used data from 6493 primary care patients (2653 men and 3840 women) of the DETECT study (Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment), including four-year follow-up, repeated immunoassay-based measurement of serum T and depressive symptoms assessed by the Depression Screening Questionnaire (DSQ). Cross-sectional and longitudinal associations of baseline T and one-year change in T with prevalent and incident depression were investigated using age- and multivariable-adjusted regression models.

Results: Baseline T showed no association with prevalent or incident depressive symptoms and episodes in both sexes. In men, a positive change in T (higher T at one-year follow-up compared to baseline) was associated with a lower burden of depressive symptoms (β-coefficient per unit change in T: -0.17; 95% CI: -0.31 to -0.04) and lower risk of incident depressive symptoms (odds ratio per unit change in T: 0.84; 95% CI: 0.72-0.98) at four-year follow-up. In women, the association of T change with incident depressive episodes was rendered non-significant after multivariable adjustment.

Discussion: The present study observed a sex-specific inverse association of T change, but not baseline T, with increased depressive symptom burden in men. Future studies should assess longitudinal changes in sex hormone status as predictor of adverse health outcomes related to low T.
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http://dx.doi.org/10.1016/j.psyneuen.2017.12.013DOI Listing
March 2018

The Diagnosis of Chronic Coronary Heart Disease.

Dtsch Arztebl Int 2017 Oct;114(42):712-719

Department of Psychosomatics and Psychotherapy, University Hospital Cologne, Cologne, Germany; Department of Radiology and Nuclear Medicine, Schleswig-Holstein University Hospital (UK-SH), Campus Lübeck, Lübeck, Germany; Internal Medicine/Cardiology, German Society of Cardiology (DGK), DGK Capital Office, Berlin, Germany; Philipps University Marburg, Department of General Medicine, Preventive and Rehabilitative Medicine, Marburg, Germany; Institute of Radiology, Nuclear Medicine and Molecular Imaging, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany; Cardiology Practice, Munich, Germany.

Background: Chronic coronary heart disease (CHD) and acute myocardial infarction are endemic conditions. In Germany, an estimated 900 000 cardiac catheterizations were performed in the year 2014, and a percutaneous intervention was carried out in 40% of these procedures. It would be desirable to lessen the number of invasive diagnostic procedures while preserving the reliability of diagnosis. In this article, we present the updated recommendations of the German National Care Guideline for Chronic CHD with regard to diagnostic evaluation.

Methods: Updated recommendations for the diagnostic evaluation of chronic CHD were developed on the basis of existing guidelines and a systematic literature review and approved by a formal consensus process.

Results: 8-11% of patients with chest pain who present to a general practitioner and 20-25% of those who present to a cardiologist have chronic CHD. General practitioners should estimate the probability of CHD with the Marburg Heart Score. Specialists can use detailed tables for determining the pre-test probability of CHD; if this lies in the range of 15% to 85%, then non-invasive tests should be primarily used for evaluation and treatment planning. If the pretest probability is less than 15%, other potential causes should be ruled out first. If it is over 85%, the presence of CHD should be presumed and treatment planning should be initiated. Coronary angiography is needed only if therapeutic implications are expected (revascularization). Psychosocial risk factors for the development and course of CHD and the patient's quality of life should be regularly assessed as well.

Conclusion: Non-invasive testing and invasive coronary angiography should be used only if their findings are expected to have therapeutic implications. Psychosocial risk factors, the quality of life, and adherence to treatment are important components of these patients' diagnostic evaluation and long-term care.
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http://dx.doi.org/10.3238/arztebl.2017.0712DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5686296PMC
October 2017

Improved risk stratification in prevention by use of a panel of selected circulating microRNAs.

Sci Rep 2017 07 3;7(1):4511. Epub 2017 Jul 3.

Department of Internal Medicine III, Cardiology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.

Risk stratification is crucial in prevention. Circulating microRNAs have been proposed as biomarkers in cardiovascular disease. Here a miR panel consisting of miRs related to different cardiovascular pathophysiologies, was evaluated to predict outcome in the context of prevention. MiR-34a, miR-223, miR-378, miR-499 and miR-133 were determined from peripheral blood by qPCR and combined to a risk panel. As derivation cohort, 178 individuals of the DETECT study, and as validation cohort, 129 individuals of the SHIP study were used in a case-control approach. Overall mortality and cardiovascular events were outcome measures. The Framingham Risk Score(FRS) and the SCORE system were applied as risk classification systems. The identified miR panel was significantly associated with mortality given by a hazard ratio(HR) of 3.0 (95% (CI): 1.09-8.43; p = 0.034) and of 2.9 (95% CI: 1.32-6.33; p = 0.008) after adjusting for the FRS in the derivation cohort. In a validation cohort the miR-panel had a HR of 1.31 (95% CI: 1.03-1.66; p = 0.03) and of 1.29 (95% CI: 1.02-1.64; p = 0.03) in a FRS/SCORE adjusted-model. A FRS/SCORE risk model was significantly improved to predict mortality by the miR panel with continuous net reclassification index of 0.42/0.49 (p = 0.014/0.005). The present miR panel of 5 circulating miRs is able to improve risk stratification in prevention with respect to mortality beyond the FRS or SCORE.
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http://dx.doi.org/10.1038/s41598-017-04040-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5495799PMC
July 2017

5-Year Safety and Efficacy of Resolute Zotarolimus-Eluting Stent: The RESOLUTE Global Clinical Trial Program.

JACC Cardiovasc Interv 2017 02 18;10(3):247-254. Epub 2017 Jan 18.

Division of Cardiovascular Medicine, Baim Institute for Clinical Research, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts.

Objectives: The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation.

Background: Individual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication.

Methods: The RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated.

Results: The 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5.0% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual-antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively. The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual-antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe.

Conclusions: In the largest group of R-ZES patients examined to date, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation with much lower risks of these events out to 5 years.
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http://dx.doi.org/10.1016/j.jcin.2016.11.004DOI Listing
February 2017

9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System.

JACC Cardiovasc Interv 2017 01;10(2):160-167

CeloNova BioSciences, San Antonio, Texas.

Objectives: The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions.

Background: Polyzene-F-coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies.

Methods: Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis.

Results: Of 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events.

Conclusions: The COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.
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http://dx.doi.org/10.1016/j.jcin.2016.10.037DOI Listing
January 2017

Long-term outcomes after Resolute zotarolimus-eluting stent implantation in patients with ST-segment elevation acute myocardial infarction: insights from the RESOLUTE All Comers Trial and the RESOLUTE Global Clinical Trial Program.

EuroIntervention 2016 Nov;12(10):1207-1214

National Institute of Health Research Cardiovascular BRU, Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom.

Aims: We examined long-term outcomes after implantation of the Resolute zotarolimus-eluting stent (R-ZES) in ST-segment elevation acute myocardial infarction (STEMI) patients.

Methods And Results: We compared long-term outcomes of STEMI patients undergoing primary angioplasty <12 hours from symptom onset who were randomised to the R-ZES (n=122) or the everolimus-eluting stent (EES, n=158) in the RESOLUTE All Comers Trial after propensity score adjustment. The five-year cumulative incidence of target lesion failure (TLF) was 7.6% versus 10.4% among patients treated with R-ZES versus EES, respectively, (adjusted p=0.304), and comprised clinically driven target lesion revascularisation (TLR, 2.5% versus 2.0%, adjusted p=0.766) and cardiac death/target vessel MI (5.1% versus 9.1%, adjusted p=0.123). The five-year cumulative incidence of stent thrombosis was 0.8% for R-ZES patients versus 1.3% for EES patients (adjusted p=0.868). In the RESOLUTE Global Clinical Trial Program, excluding RESOLUTE All Comers, the three-year cumulative incidence of TLF with R-ZES was 9.8% and comprised 7.0% clinically driven TLR and 4.5% cardiac death/target vessel MI.

Conclusions: Patients with STEMI who received R-ZES had excellent long-term clinical outcomes which were similar to those of patients who received EES.
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http://dx.doi.org/10.4244/EIJV12I10A199DOI Listing
November 2016

Twelve-month results of a prospective, multicentre trial to assess the everolimus-eluting coronary stent system (PROMUS Element): the PLATINUM PLUS all-comers randomised trial.

EuroIntervention 2017 Jan;12(13):1595-1604

Clinique Pasteur, Toulouse, France.

Aims: The aim of the study was to compare the safety and efficacy of the platinum-chromium-based everolimus-eluting stent (EES) with a cobalt-chromium EES.

Methods And Results: We performed a prospective, multicentre, single-blind non-inferiority all-comers study randomising patients with stable or unstable coronary artery disease (2:1) to treatment with the platinum-chromium EES (n=1,952) or the control cobalt-chromium EES (n=1,028) in Europe (PLATINUM PLUS trial). The primary endpoint was target vessel failure (TVF) at 12 months, a composite of target vessel-related cardiac death, myocardial infarction (MI), and ischaemia-driven target vessel revascularisation (TVR). Among 2,980 patients, 33% presented with acute coronary syndromes, and 48% with multivessel disease. At 12 months, the intention-to-treat analysis determined that the platinum-chromium EES was non-inferior to the cobalt-chromium EES for the primary endpoint (86 [4.6%] patients vs. 32 [3.2%], absolute difference 1.4%, 95% confidence interval [CI]: -0.1-2.9; upper limit of the one-sided 95% CI: 2.57%; non-inferiority p=0.012; superiority analysis: hazard ratio [HR] 1.44, 95% CI: 0.96-2.16, p=0.08). In the per protocol analysis, however, the primary endpoint was significantly more common in the platinum-chromium EES (HR 1.64, 95% CI: 1.05-2.55, p=0.03). There were no significant differences in the rates of cardiac death (1.1% vs. 1.0%, p=0.78), MI (1.6% vs. 0.8%, p=0.09), or ischaemia-driven TLR (2.0% vs. 1.6%, p=0.49). The rates of ARC definite or probable stent thrombosis were comparable between platforms (0.8% vs. 0.5%, p=0.44).

Conclusions: At one year, the platinum-chromium EES satisfied the pre-specified criteria for non-inferiority relative to the control cobalt-chromium EES in this all-comers trial.
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http://dx.doi.org/10.4244/20150112-07DOI Listing
January 2017

[Consensus statement: Management of oral anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation].

Herzschrittmacherther Elektrophysiol 2016 Sep;27(3):295-306

Klinik für Kardiologie, Abteilung für Rhythmologie und invasive Elektrophysiologie, Zentralklinik Bad Berka, Robert-Koch-Allee 9, 99437, Bad Berka, Deutschland.

With the introduction of edoxaban last year in Germany, four nonvitamin K antagonist oral anticoagulants are now available for stroke prevention in patients with nonvalvular atrial fibrillation. These novel oral anticoagulants (NOAC) represent an attractive new option compared to vitamin K antagonists (e.g., warfarin or phenprocoumon) due to simple use and fewer interactions with other drugs or food. Therefore, no INR monitoring and dosage adjustments are required for NOAC. The compelling clinical advantage of NOAC is the dramatic risk reduction of hemorhagic stroke and intracranial bleeding compared to current standard. In addition, total mortality is significantly reduced by 10 %. These effects are demonstrated for all four NOAC (dabigatran, rivaroxaban, apixaban and edoxaban). Therefore, current national and international guidelines recommend NOAC as the preferred option or at least as an attractive alternative compared to the former standard of vitamin K antagonists. The economic impact and reimbursement by Statutory Health Insurance (GKV) is of major importance for treatment in an outpatient setting. For apixaban and edoxaban, an additional benefit was granted by the institution of G‑BA and IQWiG in this clinical setting, whereas dabigatran and rivaroxaban were not assessed due to market entrance prior to 2011 before the AMNOG procedure was initiated. The members of this consensus paper recommend NOAC as the preferred option for patients with nonvalvular atrial fibrillation who are currently not treated with anticoagulant drugs in spite of clear indication for anticoagulation. For new patients with nonvalvular fibrillation, it should be decided on an individual basis which treatment option is adequate for the patient with their respective comorbidities.
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http://dx.doi.org/10.1007/s00399-016-0447-1DOI Listing
September 2016

Effect of Diabetes Mellitus on Frequency of Adverse Events in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention.

Am J Cardiol 2016 08 14;118(3):345-52. Epub 2016 May 14.

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address:

Few data are available on the timing of adverse events in relation to the status of diabetes mellitus and the type of acute coronary syndrome (ACS). We investigated this issue in diabetic and nondiabetic patients admitted with a diagnosis of non-ST-segment elevation ACS (NSTE-ACS) or ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention. Patient-level data from 6 studies (n = 16,601) were pooled and only patients with ACS are included (n = 9,492). Early (0 to 30 days), late (31 to 365 days), and overall (0 to 365 days) events were analyzed. Diabetes mellitus was present in 1,927 patients (20.3%). At 1 year, all-cause mortality was highest for diabetic patients with STEMI (13.4%), followed by diabetic patients with NSTE-ACS (10.3%), nondiabetic patients with STEMI (6.4%) and nondiabetic patients with NSTE-ACS (4.4%; p <0.001). Among patients with diabetes, there was a significant interaction (p <0.001) for STEMI versus NSTE-ACS in early compared with late mortality, due to an excess of early mortality associated with STEMI (9.3% vs 3.7%; hazard ratio 2.31, 95% CI 1.52 to 3.54, p <0.001). Compared with diabetic NSTE-ACS patients, diabetic patients with STEMI had an increased risk of early stent thrombosis (hazard ratio 2.26, 95% CI 1.48 to 3.44, p <0.001), as well as a significant interaction (p = 0.009) in the risk of target lesion revascularization between the early and late follow-up. The distribution of fatal and nonfatal events according to the type of ACS was not influenced by diabetic status. In conclusion, diabetes in ACS setting confers a worse prognosis with 1-year mortality >10% in both STEMI and NSTE-ACS. Notwithstanding the high absolute rates, the temporal distribution of adverse events related to the type of ACS is similar between diabetic and nondiabetic patients.
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http://dx.doi.org/10.1016/j.amjcard.2016.05.005DOI Listing
August 2016

Risk and timing of recurrent ischemic events among patients with stable ischemic heart disease, non-ST-segment elevation acute coronary syndrome, and ST-segment elevation myocardial infarction.

Am Heart J 2016 May 23;175:56-65. Epub 2016 Feb 23.

Department of Cardiology, Bern University Hospital, Bern, Switzerland.

Background: We aimed to compare differences in risk and timing of recurrent ischemic events among patients with stable ischemic heart disease (SIHD), non-ST-segment elevation acute coronary syndrome (NSTE-ACS), and ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).

Methods: We performed an individual data pooled analysis of 5 randomized controlled all-comer trials including a total of 8,859 patients and investigated the risk and timing of recurrent ischemic events among patients with SIHD (n = 3,543), NSTE-ACS (n = 3,364), and STEMI (n = 1,952) throughout 2 years of follow-up.

Results: At 2 years, all-cause mortality was higher among patients with STEMI (6.4%) and NSTE-ACS (6.1%) compared with those with SIHD (4.2%) (STEMI vs SIHD: hazard ratio [HR] 1.40, 95% CI 1.09-1.78, P = .007; NSTE-ACS vs SIHD: 1.40, 95% CI 1.13-1.73, P = .002). In a landmark analysis, the risk of mortality among patients with STEMI compared with those with SIHD was confined to the first 30 days after PCI (HR 6.19, 95% CI 3.15-12.16, P < .001) but was similar between 30 days and 2 years (HR 1.00, 95% CI 0.76-1.33, P = .974) (Pinteraction < .001). Conversely, patients with NSTE-ACS had a higher risk of mortality compared with those with SIHD both within the first 30 days (HR 2.19, 95% CI 1.08-4.47, P = .031) and beyond (HR 1.34, 95% CI 1.07-1.67, P = .012) (Pinteraction < .001). A similar pattern in the differential timing of events was observed for cardiac death. Beyond 30 days, the risk of myocardial infarction was comparable in patients with STEMI and SIHD, whereas the risk in patients with NSTE-ACS was increased (HR 1.65, 95% CI 1.23-2.21, P = .001).

Conclusion: Whereas patients with NSTE-ACS are at increased risk for death at any time after PCI, the mortality of STEMI patients is higher during the first 30 days after PCI but not thereafter compared with patients with SIHD.
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http://dx.doi.org/10.1016/j.ahj.2016.01.021DOI Listing
May 2016

A case report of the new Polyzene™-F COBRA PzF™ Nanocoated Coronary Stent System (NCS): Addressing an unmet clinical need.

Cardiovasc Revasc Med 2016 Apr-May;17(3):209-11. Epub 2016 Jan 22.

Heart Center at the Isar, Am Isarkanal 30, 81379 Munich, Germany. Electronic address:

Because of anticipated antiplatelet medication risks, patients who are not DES candidates or who are at particularly high risk for bleeding events have been targeted initially for treatment with the COBRA PzF Coronary Stent System. We report the case of a successful experience with a new, Polyzene™-F COBRA PzF™ Coronary Stent System, designed to impart thrombo-resistance and reduce inflammation, to achieve shorter dual antiplatelet therapy duration while reducing restenosis incidence in a high risk patient with atrial fibrillation.
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http://dx.doi.org/10.1016/j.carrev.2016.01.007DOI Listing
February 2017

Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients.

Circ Cardiovasc Interv 2016 Feb;9(2):e003255

From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (K.C.K., G.C.M.S., R.P., A.F., T.P., L.R., S.W.); Institute of Social and Preventive Medicine and Clinical Trials Unit (A.H., J.R.-W., D.H., S.W.) and Institute of Primary Health Care (BIHAM) (P.J.), University of Bern, Bern, Switzerland; Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and International Centre for Circulatory Health, National Heart & Lung Institute, Imperial College London, London, United Kingdom (P.S.).

Background: Diabetes mellitus and angiographic coronary artery disease complexity are intertwined and unfavorably affect prognosis after percutaneous coronary interventions, but their relative impact on long-term outcomes after percutaneous coronary intervention with drug-eluting stents remains controversial. This study determined drug-eluting stents outcomes in relation to diabetic status and coronary artery disease complexity as assessed by the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score.

Methods And Results: In a patient-level pooled analysis from 4 all-comers trials, 6081 patients were stratified according to diabetic status and according to the median SYNTAX score ≤11 or >11. The primary end point was major adverse cardiac events, a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization within 2 years. Diabetes mellitus was present in 1310 patients (22%), and new-generation drug-eluting stents were used in 4554 patients (75%). Major adverse cardiac events occurred in 173 diabetics (14.5%) and 436 nondiabetic patients (9.9%; P<0.001). In adjusted Cox regression analyses, SYNTAX score and diabetes mellitus were both associated with the primary end point (P<0.001 and P=0.028, respectively; P for interaction, 0.07). In multivariable analyses, diabetic versus nondiabetic patients had higher risks of major adverse cardiac events (hazard ratio, 1.25; 95% confidence interval, 1.03-1.53; P=0.026) and target lesion revascularization (hazard ratio, 1.54; 95% confidence interval, 1.18-2.01; P=0.002) but similar risks of cardiac death (hazard ratio, 1.41; 95% confidence interval, 0.96-2.07; P=0.08) and myocardial infarction (hazard ratio, 0.89; 95% confidence interval, 0.64-1.22; P=0.45), without significant interaction with SYNTAX score ≤11 or >11 for any of the end points.

Conclusions: In this population treated with predominantly new-generation drug-eluting stents, diabetic patients were at increased risk for repeat target-lesion revascularization consistently across the spectrum of disease complexity. The SYNTAX score was an independent predictor of 2-year outcomes but did not modify the respective effect of diabetes mellitus.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00297661, NCT00389220, NCT00617084, and NCT01443104.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003255DOI Listing
February 2016