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Guideline Meeting report ESC forum on drug eluting stents, European Heart House, Nice, 27-28 September 2007. 2009
Daemen J, Simoons ML, Wijns W, Bagust A, Bos G, Bowen JM, Braunwald E, Camenzind E, Chevaliers B, DiMario C, Fajadeto J, Gitt A, Guagliumi G, Hillege HL, James S, Jüni P, Kastrati A, Kloth S, Kristensen SD, Krucoff M, Legrand V, Pfisterer M, Rothman M, Serruys PW, Silber S, Steg PG, Tariah I, Wallentin L, Windecker SW, Aimonetti A, Allocco D, Berenger M, Boam A, Calle JP, Campo G, Carlier S, de Schepper J, Di Bisceglie G, Dobbels H, Farb A, Ghislain JC, Hellbardt S, ten Hoedt R, Isaia C, de Jong P, Lekehal M, LeNarz L, Mhullain FN, Nagai H, Patteet A, Paunovic D, Potgieter A, Purdy I, Raveau-Landon C, Ternstrom S, Van Wuytswinkel J, Waliszewski M, Anonymous00071. · Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands. · EuroIntervention. · Pubmed #19284063 No free full text.
This publication has no abstract.
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Guideline Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. free! 2005
Silber S, Albertsson P, Avilés FF, Camici PG, Colombo A, Hamm C, Jørgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W, Anonymous00028. · Kardiologische Praxis und Praxisklinik, München, Germany. <> · Eur Heart J. · Pubmed #15769784 links to free full text
Abstract: In patients with stable CAD, PCI can be considered a valuable initial mode of revascularization in all patients with objective large ischaemia in the presence of almost every lesion subset, with only one exception: chronic total occlusions that cannot be crossed. In early studies, there was a small survival advantage with CABG surgery compared with PCI without stenting. The addition of stents and newer adjunctive medications improved the outcome for PCI. The decision to recommend PCI or CABG surgery will be guided by technical improvements in cardiology or surgery, local expertise, and patients' preference. However, until proved otherwise, PCI should be used only with reservation in diabetics with multi-vessel disease and in patients with unprotected left main stenosis. The use of drug-eluting stents might change this situation. Patients presenting with NSTE-ACS (UA or NSTEMI) have to be stratified first for their risk of acute thrombotic complications. A clear benefit from early angiography (<48 h) and, when needed, PCI or CABG surgery has been reported only in the high-risk groups. Deferral of intervention does not improve outcome. Routine stenting is recommended on the basis of the predictability of the result and its immediate safety. In patients with STEMI, primary PCI should be the treatment of choice in patients presenting in a hospital with PCI facility and an experienced team. Patients with contra-indications to thrombolysis should be immediately transferred for primary PCI, because this might be their only chance for quickly opening the coronary artery. In cardiogenic shock, emergency PCI for complete revascularization may be life-saving and should be considered at an early stage. Compared with thrombolysis, randomized trials that transferred the patients for primary PCI to a 'heart attack centre' observed a better clinical outcome, despite transport times leading to a significantly longer delay between randomization and start of the treatment. The superiority of primary PCI over thrombolysis seems to be especially clinically relevant for the time interval between 3 and 12 h after onset of chest pain or other symptoms on the basis of its superior preservation of myocardium. Furthermore, with increasing time to presentation, major-adverse-cardiac-event rates increase after thrombolysis, but appear to remain relatively stable after primary PCI. Within the first 3 h after onset of chest pain or other symptoms, both reperfusion strategies seem equally effective in reducing infarct size and mortality. Therefore, thrombolysis is still a viable alternative to primary PCI, if it can be delivered within 3 h after onset of chest pain or other symptoms. Primary PCI compared with thrombolysis significantly reduced stroke. Overall, we prefer primary PCI over thrombolysis in the first 3 h of chest pain to prevent stroke, and in patients presenting 3-12 h after the onset of chest pain, to salvage myocardium and also to prevent stroke. At the moment, there is no evidence to recommend facilitated PCI. Rescue PCI is recommended, if thrombolysis failed within 45-60 min after starting the administration. After successful thrombolysis, the use of routine coronary angiography within 24 h and PCI, if applicable, is recommended even in asymptomatic patients without demonstrable ischaemia to improve patients' outcome. If a PCI centre is not available within 24 h, patients who have received successful thrombolysis with evidence of spontaneous or inducible ischaemia before discharge should be referred to coronary angiography and revascularized accordingly--independent of 'maximal' medical therapy.
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Review [Drug-eluting stents for diabetic patients. A critical appraisal of the currently available data from randomized trials] 2008
Silber S, Herdeg C. · Kardiologische Praxis und Praxisklinik, Akademische Lehrpraxis der Ludwig-Maximilians-Universität München, München. · Herz. · Pubmed #18568314 No free full text.
Abstract: BACKGROUND AND PURPOSE: Patients with coronary artery disease (CAD) and diabetes mellitus represent a peculiar high-risk population because of their specific characteristics of atherosclerotic disease. In conjunction with the diabetes-related comorbidities, percutaneous coronary intervention (PCI) often leads not only to a worse acute result but - also as compared to nondiabetics - to significantly worse long-term results due to the higher restenosis rates. The rapid introduction of effective drug-eluting stents (DES), which undoubtedly reduce the restenosis rates as compared with bare-metal stents (BMS), brought great hope of providing diabetic patients better and longer-lasting interventional solutions. This overview compiles the currently available data from randomized trials and meta-analyses. METHODS: Altogether, 86 randomized DES studies were identified in 34,677 patients. None of these with an adequate primary clinical endpoint had diabetes as an inclusion criterion. The high standard of an adequate primary clinical endpoint for comparing BMS versus DES in patients with predominantly stable CAD and de novo lesions was met by only five pivotal trials: SIRIUS (Cypher stent), TAXUS-IV, -V, -VI (Taxus stent) and ENDEAVOR II (Endeavor stent). Patients with diabetes were represented in these trials only in smaller subgroups. Three studies with a primary surrogate endpoint had diabetes as an inclusion criterion (DIABETES, SCORPIUS and ISAR-DIABETES, totaling 610 patients). The efficacy parameter TLR (target lesion revascularization) was chosen to compare these studies and the subgroup analyses. RESULTS: In the subgroup analyses for diabetic patients in the pivotal trials, TLR was reduced at the time of the primary endpoint after 9 months as compared with BMS as follows (p < 0.05): Cypher stent (279 patients): 22.3% versus 6.9%; Taxus stent (318 patients): 16.0% versus 5.2%; Endeavor stent (239 patients): 15.2% versus 7.5%. 5-year follow-up data are available only for the Cypher and Taxus stents with 33.1% versus 13.7% and 26.9% versus 13.4%. As compared with BMS, the three above-mentioned studies studies with a primary surrogate endpoint and diabetes as an inclusion criterion showed a significant reduction of TLR after 9 months of 31.3% versus 7.3% and after 8 months of 25.0% versus 5.3%, respectively. The TLR between Taxus (12.0%) and Cypher (6.4%), however, was not statistically different. Meta-analyses of 627 Cypher patients and 814 Taxus patients corroborated these findings with 1-year TLR of 24.8% versus 7.9% and 20.5% versus 8.0%. CONCLUSION: Of the 22 DES having received a CE certificate, long-term data over 5 years for patients with diabetes are available only for the Cypher and the Taxus stents. Compared with BMS, patients with diabetes and their characteristically small vessels and long lesions predominantly benefit from effective DES. The sometimes postulated differences between Cypher and Taxus in diabetic patients could not be convincingly demonstrated; larger randomized trials with a primary clinical endpoint are required for this. PCI cannot be considered a scientifically sound and evidence- based alternative to bypass surgery in diabetic patients with multivessel disease and/or unprotected left main stenosis until we have the results of the SYNTAX, COMBAT and FREEDOM trials.
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Review [Evidence-based application of cardiac magnetic resonance and cardiac computed tomography for primary diagnosis of stable coronary artery disease with special attention to disease management programs and the German National Medical Care Guidelines] 2007
Silber S, Richartz BM. · Kardiologische Praxis, Herzdiagnostikzentrum und Praxisklinik, Akademische Lehrpraxis der Ludwig-Maximilians-Universität München, Am Isarkanal 36, 81379, München, Germany. · Herz. · Pubmed #17401756 No free full text.
Abstract: BACKGROUND AND PURPOSE: Despite all the progress made in diagnosis and treatment, cardiovascular diseases remain the no. 1 cause of death worldwide. In 2005, 27.9% of males and 24.1% of females (eight times more than for mammary carcinoma) in Germany died of coronary artery disease (CAD). Although mortality rates following acute myocardial infarction have considerably dropped, morbidity has increased--people are getting older, but they are getting older sick. The resulting need for reduction of CAD morbidity can only be achieved by truly early detection of patients at high coronary risk before occurrence of a coronary event. Modern imaging techniques like cardiac magnetic resonance (MR) and cardiac computed tomography (CT) are being increasingly utilized. The goal of this review is the practical application of evidence-based recommendations by relevantly and cost-effectively implementing cardiac MR and cardiac CT with special attention to current national and international guidelines and recommendations. THE PATIENT WITH STABLE CHEST PAIN: The primary objective here is to ascertain if the described symptoms can be attributed to a stenosing CAD with inducible myocardial ischemia or if they are effected by extracardial sources. As always, patients' history, examination findings and the stress ECG play the major roles. The conventional approach prescribes that an abnormal resting ECG compromising the interpretation of a stress ECG, should immediately be followed by an imaging ischemia diagnosis technique, like stress echocardiography, myocardial scintigraphy or cardiac MR (recommendation I B). This also holds true when a stress ECG is assessable and the probability of a stenosing CAD is between 10% and 90% (recommendation I B or "appropriate"). Alternatively, "modern" procedures allow imaging ischemia diagnosis to be replaced by noninvasive coronary angiography using a CTA (recommendation IIa B). If the image quality by CTA is assessable (free of artifacts and no disruptive calcified plaques) and no coronary stenosis can be found, the coronary diagnosis process may at this point be terminated, avoiding superfluous cardiac catheterizations. If the CTA shows the possibility of a higher-grade coronary stenosis, a cardiac catheterization examination with stand-by PCI (percutaneous coronary intervention) can be performed. THE ASYMPTOMATIC PREVENTION PATIENT: The prim ary objective in cardiovascular primary prevention is the avoidance of a first myocardial infarction and/or a first stroke. Current guidelines for prevention of cardiovascular diseases recommend administration of acetylsalicylic acid (ASA) and a statin when risk>20%/10 years (recommendation I A). The coronary calcium score has a strong predictive power which is independent of conventional risk factors and thus offers the most relevant information in addition to Framingham, PROCAM or ESC scores regarding coronary risk. For patients initially showing "intermediate" coronary risk (10-20%), guidelines suggest the determination of the coronary calcium score, which leads to better risk assessment and to identification of patients needing more aggressive lipid lowering (recommendation IIb B). Thus, the cardiac CT, on the one hand, aims the intense risk reduction needed in primary prevention to the high-risk patients, on the other hand, it avoids "superfluous" cardiac catheterizations, unnecessary statin therapies and potentially harmful ASA administrations. However, the proof of coronary calcium must not be confused with the presence of coronary artery stenoses: a positive calcium score in an asymptomatic person does not by itself indicate the need for a cardiac catheterization.
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Review Capturing circulating endothelial progenitor cells: a new concept tested in the HEALING studies. 2006
Silber S. · Cardiology Practice and Hospital, Munich, Germany. · Minerva Cardioangiol. · Pubmed #16467737 No free full text.
This publication has no abstract.
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Review [Immediate hemostasis of the femoral artery after heart catheterization: the present situation of closure systems] 2004
Lochow P, Silber S. · Kardiologische Gemeinschaftspraxis und Praxisklinik in der Klinik Dr. Müller, München. · Dtsch Med Wochenschr. · Pubmed #15295687 No free full text.
Abstract: The femoral approach is the most commonly used route for diagnostic cardiac catheterization and coronary interventions today. Manual compression and pressure bandages usually lead to immobilisation of the patient for several hours and may result in significant discomfort. Since the introduction of the first femoral closure device in 1991, many devices have proven their efficacy in significantly reducing time to hemostasis while simultaneously improving patient comfort. Twenty four closure device systems with different concepts are on the market, e. g. pure collagen, collagen + thrombin, collagen + anchor, vascular suture, hemostatic patches and pads, staples and more. The four predominantly used are Angio-Seal (46 %), Perclose (32 %), VasoSeal (14 %) and Duett (3 %). The effectiveness of all four systems has been proven in a prospective, randomized, controlled multicenter trial each. Efficacy and safety were analyzed using data from ten comparative studies in 8832 predominantly or exclusively interventional patients, however none of the closure systems proved to be superior. Fortunately, recent years have shown a trend toward a reduction in local complications by vascular closure devices compared to manual compression. Closure devices are thus becoming increasingly cost effective. Vascular closure systems should be preferred when the prolonged supine position is not tolerated, a protein IIb/IIIa-inhibitor was used during the procedure, or early discharge of patient is anticipated. In the presence of peripheral vascular disease, small diameter of the femoral vessels or stenotic lesions in the femoral artery, closure devices should be used with caution. Closure systems for immediate femoral puncture site hemostasis are now an important tool of invasive cardiology today.
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Review [Detection of coronary calcifications by electron beam tomography and multislice spiral CT: clinical relevance] 2003
Achenbach S, Schmermund A, Erbel R, Silber S, Haberl R, Moshage W, Daniel WG. · CIMIT, Massachusetts General Hospital, 100 Charles River Plaza, Suite 400, Boston, MA 02114, USA. · Z Kardiol. · Pubmed #14634759 No free full text.
Abstract: Coronary calcifications can be detected and quantified using electron beam tomography (EBT) or newer generation multi-slice spiral CT (MSCT) scanners. An abundance of data has been acquired by EBT. It could be shown that the amount of coronary calcium correlates to the coronary plaque burden. The detection of coronary calcium with CT imaging methods therefore provides a unique opportunity to detect and quantify coronary atherosclerosis in a subclinical stage. Consequently, the presence and amount of coronary calcium has been shown to be indicative for an increased coronary event risk in symptomatic and asymptomatic individuals. Several clinical studies found a predictive value that was superior to conventional risk factors. Clinically, the use of coronary calcification assessment may therefore be beneficial in patients who, based on traditional risk factors, seem to be at "intermediate risk" for coronary events (10-year event risk 10-20%) in order to decide on the aggressiveness of risk factor modification. The role of coronary calcium quantification to monitor the progression of disease has not been clarified yet. Large, ongoing trials will provide further data as to the relative merit of coronary calcium assessment for risk stratification and will help to more clearly define its clinical role. The relationship between coronary calcium and coronary stenoses is more complex. While the absence of coronary calcifications makes significant coronary stenoses unlikely, even large amounts of coronary calcium do not necessarily indicate the presence of coronary artery stenoses. Pronounced coronary calcifications as an isolated finding should therefore not be the motivation for invasive diagnostic procedures in the absence of other evidence of ischemic heart disease.
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Clinical Conference Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. free! 2003
Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME, Anonymous00087. · Ospedale San Raffaele, Milano, Italy. · Circulation. · Pubmed #12900339 links to free full text
Abstract: BACKGROUND: Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations. METHODS AND RESULTS: We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients. CONCLUSIONS: Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.
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Clinical Conference TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. free! 2003
Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME. · Department of Cardiology/Angiology, Heart Center Siegburg, Siegburg, Germany. · Circulation. · Pubmed #12515740 links to free full text
Abstract: BACKGROUND: The TAXUS NIRx stent (Boston Scientific Corp) provides local delivery of paclitaxel via a slow-release polymer coating. The TAXUS I trial was the first in-human experience evaluating safety and feasibility of the TAXUS NIRx stent system compared with bare NIR stents (control) (Boston Scientific Corp) for treatment of coronary lesions. METHODS AND RESULTS: METHODS AND RESULTS: The TAXUS I trial was a prospective, double-blind, three-center study randomizing 61 patients with de novo or restenotic lesions (< or =12 mm) to receive a TAXUS (n=31) versus control (n=30) stent (diameter 3.0 or 3.5 mm). Demographics, lesion characteristics, clinical outcomes were comparable between the groups. The 30-day major adverse cardiac event (MACE) rate was 0% in both groups (P=NS). No stent thromboses were reported at 1, 6, 9, or 12 months. At 12 months, the MACE rate was 3% (1 event) in the TAXUS group and 10% (4 events in 3 patients) in the control group (P=NS). Six-month angiographic restenosis rates were 0% for TAXUS versus 10% for control (P=NS) patients. There were significant improvements in minimal lumen diameter (2.60+/-0.49 versus 2.19+/-0.65 mm), diameter stenosis (13.56+/-11.77 versus 27.23+/-16.69), and late lumen loss (0.36+/-0.48 versus 0.71+/-0.48 mm) in the TAXUS group (all P<0.01). No evidence of edge restenosis was seen in either group. Intravascular ultrasound analysis showed significant improvements in normalized neointimal hyperplasia in the TAXUS (14.8 mm3) group compared with the control group (21.6 mm3) (P<0.05). CONCLUSIONS: In this feasibility trial, the TAXUS slow-release stent was well tolerated and showed promise for treatment of coronary lesions, with significant reductions in angiographic and intravascular ultrasound measures of restenosis.
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Clinical Conference Age and gender distribution of coronary artery calcium measured by four-slice computed tomography in 2,030 persons with no symptoms of coronary artery disease. 2002
Schmermund A, Erbel R, Silber S, Anonymous00069. · Department of Cardiology, University Clinic, Essen, Germany. · Am J Cardiol. · Pubmed #12106852 No free full text.
This publication has no abstract.
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Clinical Conference Rotational atherectomy does not reduce recurrent in-stent restenosis: results of the angioplasty versus rotational atherectomy for treatment of diffuse in-stent restenosis trial (ARTIST). free! 2002
vom Dahl J, Dietz U, Haager PK, Silber S, Niccoli L, Buettner HJ, Schiele F, Thomas M, Commeau P, Ramsdale DR, Garcia E, Hamm CW, Hoffmann R, Reineke T, Klues HG. · Medizinische Klinik I, Universitätsklinikum, Rheinisch-Westfaelische Technische Hochschule Aachen, Germany. · Circulation. · Pubmed #11827923 links to free full text
Abstract: BACKGROUND: Aim of this trial was to compare rotational atherectomy followed by balloon angioplasty (rotablation [ROTA] group) with balloon angioplasty (percutaneous transluminal coronary angioplasty [PTCA] group) alone in patients with diffuse in-stent restenosis. METHODS AND RESULTS: The ARTIST study is a multicenter, randomized, prospective European trial with 298 patients with in-stent restenosis>70% (mean lesion length, 14 +/- 8 mm) in stents, implanted in coronary arteries for >/= 3 months. In the PTCA group, angioplasty was performed at the discretion of the local investigator, and rotablation was performed by using a stepped-burr approach followed by adjunctive PTCA with low (</= 6 atm) inflation pressure. Intravascular ultrasound during the intervention and at follow-up was used in a substudy in 86 patients (45 PTCA, 41 ROTA). Angiography demonstrated no difference regarding the short-term outcome, with equivalent procedural success rates defined as remaining stenosis <30% (89% PTCA, 88% ROTA). However, the results showed that, in the long term, PTCA was a significantly better strategy than ROTA. Mean net gain in minimal lumen diameter was 0.67 mm and 0.45 mm for PTCA and ROTA, respectively (P=0.0019). Mean gain in diameter stenosis was 25% and 17% (P=0.002), resulting in restenosis (>/= 50%) rates of 51% (PTCA) and 65% (ROTA) (P=0.039). By intravascular ultrasound, the major difference was the missing stent over-expansion during PTCA after ROTA. Six-month event-free survival was significantly higher after PTCA (91.3%) compared with ROTA (79.6%, P=0.0052). CONCLUSIONS: In terms of the primary objective of the study, PTCA produced a significantly better long-term outcome than ROTA followed by adjunctive low-pressure PTCA.
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Article Impact of vessel size, lesion length and diabetes mellitus on angiographic restenosis outcomes: insights from the NIRTOP study. 2008
Kornowski R, Fort S, Almagor Y, Silber S, Lewis BS, Anonymous00069. · Rabin Medical Center, Petach Tikva, Israel. · Acute Card Care. · Pubmed #18568572 No free full text.
Abstract: BACKGROUND: The primary objective of the current analysis was to define the impact of vessel size, lesion length, and diabetes on clinical and angiographic restenosis following implantation of the NIRFLEX stent. METHODS AND RESULTS: Clinical and angiographic restenosis outcomes and multivariate predictors were compared between patients treated in 'small' (<3 mm, n=113 pts/133 lesions) versus 'large' (> or =3 mm, n=41 pts/53 lesions) vessels; between 'tubular' (10-20 mm lesion length n=49 pts/51 lesions) versus 'discrete' (<10 mm lesion length n=103 pts/133 lesions) lesions; and between 'diabetic' (n=30/35 lesions) versus 'non-diabetic' (n=128/156 lesions) patients using the flexible closed-cell design 'bare-metal' NIRFLEX stent in patients with native coronary artery disease. At six month follow-up, target vessel revascularization (TVR) and target lesion revascularization (TLR) rates were significantly less frequent in the 'large' versus 'small' vessel group (2.4% versus 16.8% for TVR, P=0.016, 0% versus 12.4% for TLR, P=0.022). Likewise, angiographic late loss was lower in 'large' versus 'small' vessels (0.54 versus 0.70 mm, P=0.05). Lesion length affected MACE rates but not angiographic restenosis. Angiographic late loss was greater in diabetics compared to the non-diabetic group (0.89 versus 0.60 mm, P=0.003). Using a multivariate model, diabetes mellitus (odds ratio=2.65, P=0.047) and post-procedure in-stent MLD (mm) (odds ratio=0.178, P=0.0019) were major determinants of restenosis. CONCLUSION: Clinical and angiographic restenosis outcomes following NIRFLEX stent implantation were dependent upon vessel size, lesions length, post-procedural stent lumen dimensions, and the diabetic status.
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Article Associations of age-dependent IGF-I SDS with cardiovascular diseases and risk conditions: cross-sectional study in 6773 primary care patients. free! 2008
Schneider HJ, Klotsche J, Saller B, Böhler S, Sievers C, Pittrow D, Ruf G, März W, Erwa W, Zeiher AM, Silber S, Lehnert H, Wittchen HU, Stalla GK. · Institute of Clinical Psychology and Psychotherapy, Technical University of Dresden, 01187, Dresden, Germany. · Eur J Endocrinol. · Pubmed #18230821 links to free full text
Abstract: OBJECTIVE: We aimed at investigating the association of age-dependent IGF-I SDS with diabetes, dyslipidemia, hypertension, and heart diseases, in a large patient sample. BACKGROUND: IGF-I has been suggested to be associated with several diseases and a prognostic marker for the development of cardiovascular diseases and risk factors. The findings, though, have been inconsistent possibly due to the methodological factors. METHODS: We studied 6773 consecutive primary care patients, aged 18+ years, in a cross-sectional, epidemiological study in primary care, Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment study. All patients underwent a standardized clinical diagnostic and laboratory assessment. IGF-I levels were measured with an automated chemiluminescence assay system. We calculated the odds ratios (OR) for diseases in quintiles of IGF-I, and additionally analyzed the association of age-dependent IGF-I SDS with these conditions. RESULTS: After multiple adjustments for confounders, we found increased ORs for coronary artery disease in patients with high IGF-I. Women, but not men, with low IGF-I also showed increased ORs for coronary artery disease. Dyslipidemia was positively associated with IGF-I. Type 2 diabetes showed a curvilinear association with IGF-I SDS. CONCLUSIONS: The findings suggest the existence of multiple and complex interactions between IGF-I and several health conditions. The complex nature of disease- and subgroup-specific associations along with the methodological factors can be held responsible for divergent findings in previous studies.
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Article Aberrant origin of the left main coronary artery arising from the right coronary artery associated with coronary artery disease: a case report. 2007
Beiras-Fernandez A, Kur F, Kazmarek I, Eifert S, Oberhoffer M, Silber S, Reichart B, Vicol C. · Department of Cardiac Surgery, Klinikum Grosshadern, LM-University, Munich, Germany. · Heart Surg Forum. · Pubmed #17597047 No free full text.
Abstract: Coronary artery anomalies are not frequent, nevertheless they are associated with increased and potentially lethal cardiac events. Recognition of these anomalies is fundamental in patients undergoing diagnostic or interventional coronary angiography. Most patients presenting with coronary anomalies are asymptomatic, but the risk of myocardial ischemia and sudden death requires the treatment of those patients. Different therapeutic options have been discussed, including surgery, conservative therapy, and interventional approaches. In this report, an aberrant origin of the left main coronary artery arising from the right coronary artery associated with coronary artery atherosclerosis and its surgical correction is described.
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Article [The European Society of Cardiology (ESC) guidelines for percutaneous coronary interventions (PCI). Three case reports] 2006
Silber S, Richartz BM, Brilmayer M, Anonymous00817. · Kardiologische Praxis und Praxisklinik in der Klinik Dr. Müller, München, Deutschland. · Herz. · Pubmed #17180646 No free full text.
Abstract: The European Society of Cardiology (ESC) for the first time issued guidelines for percutaneous coronary interventions (PCI) in spring 2005. The strengths of recommendations stated in the ESC guidelines (as in those of the AHA/ACC [American Heart Association/American College of Cardiology]) are traditionally a combination of recommendation classes (I, IIa, and IIb) and a level of evidence (A, B, or C). This paper explains and discusses selected focal points of the ESC PCI guidelines based on three representative cases from daily practice. 1. Stable coronary artery disease (CAD): PCI in a 53-year-old patient without angina pectoris and proof of myocardial ischemia. With a clear indication of ischemia in the anterior myocardial wall, the ESC PCI guidelines indicated coronary angiography with possible PCI, even without angina pectoris symptoms. Cardiac catheterization showed a 99% proximal LAD stenosis, which was immediately dilated and stented based on the indicated ischemia. According to the ESC PCI guidelines, an intervention is indicated for CAD when a larger ischemic area is clearly evident even in the absence of typical angina (recommendation class I A). 2. ST segment elevation myocardial infarction (STEMI): PCI even after successful thrombolysis. A 70-year-old patient experienced acute substernal pain and immediately went to his nearby hospital. The ECG clearly showed anterior myocardial wall STEMI, which in this hospital without a cardiac cath lab indicated thrombolysis, since it could be initiated within 3 h after the onset of chest pain. Pain relief was evident soon after thrombolysis, combined with a resolution of the ST segment elevations. As suggested by the ESC PCI guidelines, a transfer to a cardiac cath lab took place the next day, where the 50% residual stenosis of the LAD was stented. The ESC PCI guidelines suggest coronary angiography with possible PCI within 1-2 days following successful thrombolysis (recommendation class I A). Thus, even "successful" thrombolysis is not regarded as the final treatment for STEMI. 3. Premature termination of clopidogrel after stent implantation: stent thrombosis with acute myocardial infarction. A 46-year-old patient visited the practice due to increasing dyspnea. 4 months earlier, a Taxus stent had been implanted at a heart center into the second RPLS of the RCX; 3 days later, a Cypher stent was implanted in the LAD. Upon being discharged on a Friday at noon, the patient was advised to see his general practitioner soon to attain a prescription for clopidogrel. The patient was given an appointment at his general practitioner for the following Wednesday afternoon. But on that Wednesday morning the patient went into cardiogenic shock. Although the occluded LAD (stent thrombosis) could be quickly reopened, left ventricular myocardium became severely damaged. Until a cardiac transplantation will be performed, a defibrillator was implanted. This "organizational" gap in clopidogrel administration did not conform to the ESC PCI guidelines: after implantation of any coronary stent, dual antiplatelet treatment (acetylsalicylic acid and clopidogrel) must be consistently administered for at least 4 weeks. After implantation of drug-eluting stents (DES), the ESC PCI guidelines call for clopidogrel administration for at least 6 months; when small vessels, long lesions or a complex anatomy (e. g., bifurcation stenting) are involved, a duration of 1 year or even longer is recommended. The optimal duration of platelet aggregation inhibition following PCI with DES of unprotected left main stem stenoses is unknown at this time.The traditional levels of evidence according to ESC, AHA and ACC criteria (levels A, B, or C) do no longer meet the actual requirements to assess the scientific evidence of randomized PCI trials and registry studies. For example, only two small randomized studies with few patients and insufficient statistical power utilizing a clinically insignificant surrogate endpoint would be enough to attain level of evidence A. Consequently, a new scoring system will be proposed, which considers criteria such as the importance of a primary clinical endpoint, the statistical power achieved, and the presence of an independent external data review and safety monitoring board.
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Article A double-blind, randomized, placebo-controlled multicenter clinical trial to evaluate the effects of the angiotensin II receptor blocker candesartan cilexetil on intimal hyperplasia after coronary stent implantation. 2006
Radke PW, Figulla HR, Drexler H, Klues HG, Mügge A, Silber S, Daniel W, Schmeisser A, Reifart N, Motz W, Büttner HJ, Fischer D, Ortlepp JR, Schaefers K, Hoffmann R, Hanrath P, Anonymous00398. · Medical Clinic I, RWTH University Hospital Aachen, Aachen, Germany. · Am Heart J. · Pubmed #16996855 No free full text.
Abstract: BACKGROUND: Preclinical data suggest beneficial effects of angiotensin II receptor blockers (ARBs) on neointima formation after vascular injury. Preliminary clinical data, however, revealed conflicting results. The AACHEN trial was a double-blind, randomized, placebo-controlled clinical multicenter trial to evaluate the effects of candesartan cilexetil on intimal hyperplasia after coronary stent implantation. METHODS: A total of 120 patients (61 +/- 9 years, 83% male) were randomized to receive either 32 mg candesartan cilexetil (active) or placebo starting 7 to 14 days before elective coronary stent implantation. A follow-up angiography including intravascular ultrasound assessment of the target lesion was performed 24 +/- 2 weeks after stent implantation. The primary end point was defined as the difference in neointimal area between groups as assessed by intravascular ultrasound. Secondary end points included differences in angiographic parameters (ie, restenosis rate) and incidence of major cardiac events. RESULTS: The mean stent length measured 15.0 +/- 4.9 mm in the active and 14.6 +/- 5.7 mm in the placebo group (P = .81). There was no significant difference in neointimal area between groups (2.1 +/- 1.0 vs 2.1 +/- 1.5 mm2, P = 1.00), nor were there differences in angiographic end point parameters. Major cardiac event rates were not significantly different between treatment groups (8% vs 11%, P = .75). CONCLUSIONS: High-dose candesartan cilexetil therapy in patients with symptomatic coronary artery disease undergoing coronary stent implantation does not reduce clinical event rates, restenosis rates, or neointimal proliferation after elective stent implantation.
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Article Inadequate medical treatment of patients with coronary artery disease by primary care physicians in Germany. 2006
Bischoff B, Silber S, Richartz BM, Pieper L, Klotsche J, Wittchen HU, Anonymous00146. · Cardiology Practice and Heart Diagnostic Center, Am Isarkanal 36, 81379 Munich, Germany. · Clin Res Cardiol. · Pubmed #16799879 No free full text.
Abstract: AIMS: The DETECT study was performed to obtain representative data about the frequency, distribution, and treatment of patients with coronary artery disease (CAD) in the primary care setting in Germany. METHODS AND RESULTS: The DETECT study was a cross-sectional clinical- epidemiological survey of a nationally representative sample of 3795 primary care offices and 55,518 patients. Overall, 12.4% of patients were diagnosed with CAD. Stable angina pectoris and myocardial infarction were the most frequent (4.2%) subgroups, followed by status post (s/p) percutaneous coronary interventions (PCI, 3.0%) and s/p coronary bypass surgery (2.2%). Patients with CAD were prescribed AT1 receptor antagonists (in 19.4% of cases), beta blockers (57.2%), ACE inhibitors (49.9%), antiplatelet agents (52.7%), statins (43.0%), and long-term nitrates (24.5%). When comparing all CAD patients with social health care insurance to those who had private insurance, private patients had significantly higher rates of revascularisation procedures and use of preventive medications. CONCLUSION: Great potential remains for improving secondary prevention in primary care in Germany to reduce the risk of further coronary or vascular events, especially in patients with social health care insurance.
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Article Unmet needs in the diagnosis and treatment of dyslipidemia in the primary care setting in Germany. 2007
Böhler S, Scharnagl H, Freisinger F, Stojakovic T, Glaesmer H, Klotsche J, Pieper L, Pittrow D, Kirch W, Schneider H, Stalla GK, Lehnert H, Zeiher AM, Silber S, Koch U, Ruf G, März W, Wittchen HU, Anonymous00294. · Institute for Clinical Psychology and Psychotherapy, Technical University of Dresden, Germany. · Atherosclerosis. · Pubmed #16546194 No free full text.
Abstract: OBJECTIVES AND METHODS: DETECT is a cross-sectional study of 55,518 unselected consecutive patients in 3188 representative primary care offices in Germany. In a random subset of 7519 patients, an extensive standardized laboratory program was undertaken. The study investigated the prevalence of cardiovascular disease, known risk factors (such as diabetes, hypertension and dyslipidemia and their co-morbid manifestation), as well as treatment patterns. The present analysis of the DETECT laboratory dataset focused on the prevalence and treatment of dyslipidemia in primary medical care in Germany. Coronary artery disease (CAD), risk categories and LDL-C target achievement rates were determined in the subset of 6815 patients according to the National Cholesterol Education Program (NCEP) ATP III Guidelines. RESULTS: Of all patients, 54.3% had dyslipidemia. Only 54.4% of the NCEP-classified dyslipidemic patients were diagnosed as 'dyslipidemic' by their physicians. Only 27% of all dyslipidemic patients (and 40.7% of the recognized dyslipidemic patients) were treated with lipid-lowering medications, and 11.1% of all dyslipidemic patients (41.4% of the patients treated with lipid-lowering drugs) achieved their LDL-C treatment goals. In conclusion, 80.3% of patients in the sample with dyslipidemia went undiagnosed, un-treated or under-treated.
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Article [Impact of both cardiac-CT and cardiac-MR on the assessment of coronary risk] 2005
Silber S, Richartz BM. · Kardiologische Praxis und Praxisklinik, Am Isarkanal 36, 81379 München. · Z Kardiol. · Pubmed #16416070 No free full text.
Abstract: Today's definition of coronary artery disease (CAD) comprises two forms: obstructive and non-obstructive CAD. The 31-72% chance of a life-threatening event-like a myocardial infarction-with non-obstructive CAD is well documented in numerous studies. The objective in modern strategies of diagnosis and therapy should therefore be expedient identification of patients at high risk for coronary events, who will benefit from a customized therapy. Before initiating diagnostic procedures of CAD, a well defined strategy should be pursued. There are two possible primary objectives: ASSESSMENT OF THE INDIVIDUAL RISK FOR A CORONARY EVENT: Assessment of the individual "absolute" risk for a coronary event is not possible using single traditional risk factors. The individual risk can be estimated by integrating several of the traditional risk factors into a scoring system. These so-called risk scores (e.g. Framingham score and Procam score), however, have been associated with shortcomings: insufficient discrimination of high-risk from low-risk individuals. The calcium score has therefore become increasingly established; this Agatston score is independent of the traditional risk factors, so there is no correlation between Agatston and Procam scores. Today, the calcium score is considered the superior test for identifying individuals at high risk for a coronary event and its use is recommended by the European Society of Cardiology (ESC) guidelines for prevention of cardiovascular diseases. PROOF OR EXCLUSION OF A HEMODYNAMICALLY SIGNIFICANT CORONARY STENOSIS: Another concept is the definitive proof or exclusion of a hemodynamically "significant" coronary narrowing. The probability of an obstructive CAD is traditionally assessed by the type of chest pain, age, gender and stress-ECG. In patients with a low probability of an obstructive CAD, cardiac catheterization is not indicated, whereas in patients with a high probability of a hemodynamically significant coronary stenosis, an invasive strategy should be performed. Since non-invasive coronary angiography (CTA) with cardiac-CT has been shown to provide a high negative predictive value, CTA (with good imaging quality) is suitable for ruling out a significant obstructive CAD in the group at intermediate risk for an obstructive CAD. Another approach could be a functional test to initially prove a relevant, inducible myocardial ischemia: In a large cohort it was shown that patients will only prognostically benefit from revascularization procedures if the ischemic myocardial area is greater than 10%. Therefore, the assessment of the extent of myocardial ischemia is the domain of modern stress imaging tests. Stress-echocardiography and myocardial scintigraphy have almost the same sensitivity (74-80%, 84-90%, respectively) and specificity (84-89%, 77-86%, respectively), which are considerably higher than for stress-ECG. Cardiac MR is most suitable for the assessment of myocardial perfusion, because it traces the first pass dynamics of gadolinium at rest and during stress in reproducible slices at an acceptable spatial and a high temporal resolution without ionizing radiation. Whether the non-invasive coronary angiography with cardiac-CT and the Adenosin-perfusion imaging with cardiac-MR will completely replace diagnostic cardiac catheterization and stress-echocardiography as well as myocardial scintigraphy remains to be evaluated in further studies.
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Article [Can PCI with drug-eluting stents replace coronary artery bypass surgery? A comparative economic analysis regarding both therapeutic options based on clinical 12-month data reflecting the German social health care insurance system] 2005
Fricke FU, Silber S. · Fricke & Pirk GmbH, Nürnberg. · Herz. · Pubmed #15965811 No free full text.
Abstract: BACKGROUND AND PURPOSE: It is generally known and accepted that percutaneous coronary intervention (PCI) has undergone a patient-relevant innovation with the introduction of drug-eluting stents (DES): prospective, randomized, controlled studies with a primary clinical endpoint have shown that DES, especially those releasing sirolimus from a polymer (SES) or those releasing paclitaxel from a polymer (PES), significantly and relevantly reduce the restenosis rate and hence the number of needed reinterventions in the target vessel (target vessel revascularization [TVR]) as compared to bare metal stents (BMS). For this improvement of quality of life, cost-effectiveness analyses comparing DES and BMS in the US and German health care systems have been reported. For the comparison of DES and coronary artery bypass graft surgery (CABG), no economic data regarding the German health care system have been published. The goal of the present study is to provide such an economic analysis investigating the question whether DES can reduce costs as compared to CABG within the German health care system. METHODS: Based on the clinical data for PCI with a PES for long and complex lesions (TAXUS VI) and for CABG (ARTS I), the comparison was calculated for the time interval of 1 year. The analysis of the PCI group was derived from a TVR of 11% including a CABG rate of 1%; the CABG group analysis was based on a TVR of 3.8% including a PCI rate of 3.1% and a re-CABG rate of 0.7%. At a stent factor of 2.75, the costs per stent were calculated to be 250 Euro for the BMS and 1,500 Euro for the PES. The total costs for 12 months included the follow-up costs for reinterventions. The results were tested for stability according to a sensitivity analysis. RESULTS: Patients' demographics were well comparable between the PCI and the CABG groups. The primary costs, including the reinterventions, were 7,841 Euro for PCI and 12,415 Euro for CABG. The sensitivity analysis revealed that only at more than eight stents per patient and a need for reintervention of ca. 10% did the cost of PCI with PES reach the level of the cost for CABG. CONCLUSION: Within the German health care system, in patients with a social insurance, PCI of long and complex lesions with PES significantly reduces costs as compared to CABG to the amount of 4,574 Euro per patient. The cost-effectiveness analyses of currently ongoing prospective, randomized trials (SYNTAX und FREEDOM) will provide more insight into the economic comparison of PCI with DES and CABG.
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Article Cardiovascular risk factors in primary care: methods and baseline prevalence rates--the DETECT program. 2005
Wittchen HU, Glaesmer H, März W, Stalla G, Lehnert H, Zeiher AM, Silber S, Koch U, Böhler S, Pittrow D, Ruf G, Anonymous00332. · Institute of Clinical Psychology and Psychotherapy, Technical University of Dresden, Germany. · Curr Med Res Opin. · Pubmed #15899112 No free full text.
Abstract: OBJECTIVES: DETECT is an epidemiological study in primary care to examine (a) the prevalence rates and comorbidity of diabetes mellitus, hypertension, hyperlipidaemia and coronary heart disease (CHD), and associated conditions; (b) the frequency of behavioural and clinical risk factors for onset and progression; (c) the 12-month course and outcome; and (d) the met and unmet needs for these patients. METHODS: Three-stage, cross-sectional clinical-epidemiological study with a prospective-longitudinal component in a nationally representative sample of N = 3795 primary care settings [response rate (RR): 60.2%] and N = 55518 patients (RR: 95.5%). Patients completed a standardized assessment, including questionnaires for patients and the physician and diagnostic screening measures (i.e. blood pressure, heart rate, body mass index and waist circumference assessments). A subsample of patients (N = 7519) also completed a standardized laboratory screening program and was followed-up after 12 months. Data were weighted to adjust for non-response, regional distribution and attrition. RESULTS: (1) Doctors and patients sample can be regarded as representative for primary care settings in Germany. (2) The clinician-rated point prevalence of hypertension is highest (35.5%), followed by hyperlipidaemia (29.1%), diabetes (14.1%) and CHD (12.1%); prevalence rates of each disorder as well as their co-incidence rates increase markedly with age. (3) The vast majority (78%) of all patients revealed multiple (3+) behavioural and clinical risk factors. CONCLUSION: The findings of DETECT underline the considerable burden for primary care doctors in managing a highly morbid patient population, with predominantly complex risk factor constellations, in routine care. Our data provide, in unprecedented detail, a basis for calculating age-, gender- and risk-group-adjusted risk-factor profiles in routine care.
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Article [Early detection of myocardial infarct risk with cardio-CT. Can coronary calcium calculation prevention sudden cardiac death?] 2003
Silber S. · Kardiologische Gemeinschaftspraxis und Herzdiagnostikzentrum, München. · MMW Fortschr Med. · Pubmed #12808802 No free full text.
Abstract: The measurement of the calcium score with the cardio-CT is an option for determination of the individually elevated risk of a heart attack. In contrast to cardiac catheterization, the calcium score does not assess the coronary lumen, but rather the coronary vessel wall. Therefore, cardiac catheterization and calcium scoring are not competing but complementary tests: cardiac catheterization is performed to prove coronary stenoses, i.e. in patients with angina pectoris, while cardio-CT is used for the prognostic evaluation in asymptomatic patients. Cardio-CT should not be used to determine if cardiac catheterization should be performed. Also, in patients with angina pectoris, known coronary artery disease, s/p myocardial infarction or high absolute coronary risk, there is no indication for calcium scoring with cardio-CT. The prevailing indication for cardio-CT is detection of patients at high risk of a heart attack defined as > 2% annually. The recently presented St. Francis Heart Study has shown that calcium scoring provides a significantly higher prognostic value than the traditional Framingham score.
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Article [Noninvasive angiography of coronary bypass grafts with cardio-CT in a cardiology practice] 2003
Silber S, Finsterer S, Krischke I, Lochow P, Mühling H. · Kardiologische Gemeinschaftpraxis and Herzdiagnostikzentrum, Munich, Germany. · Herz. · Pubmed #12669226 No free full text.
Abstract: BACKGROUND: The role of coronary artery bypass surgery as a key foundation in the therapy of coronary artery disease remains unchanged: in Germany in 2001, 75,537 coronary bypass procedures were performed. However, the endurance of coronary bypass grafts is limited: after 3 years, 20-30% of the bypass grafts have occluded. The myocardial infarct rate significantly increases 8 years after bypass surgery. Since the clinical outcome of the patients is closely related to the patency rate of their bypass grafts, it would be important for the patients to have the patency rate of their bypass grafts assessed on time to detect any occluded bypass grafts before the majority of the grafts become occluded. Recently, multi-slice computed tomography (MSCT) offers an attractive tool for this purpose. This paper describes our first experiences with MSCT in our cardiology practice and regards whether this new method provides relevant information for a cardiology practice. PATIENTS AND METHODS: Studies were performed at the Heart Diagnostic Center in Munich with an Mx 8000 four-row spiral CT with an effective slice thickness of 1.3 mm, 120 kV at 300 mA and approximately 120 ml of contrast medium in double bolus technique. Image reconstruction was performed for 5 heart phases between 50% and 70% of the RR intervals. Thus, a total of over 1,500 slices were reconstructed. 74 patients without angina or proof of myocardial ischemia had noninvasive bypass angiography at a mean of 5 years after surgery. RESULTS: Of the total of 220 investigated bypass grafts, 132 were venous and 88 were arterial. 177 bypass grafts were classified as open, 42 as occluded; and one venous bypass graft was highly narrowed. Compared with cardiac catheterization, the sensitivity of the cardio-CT regarding the occlusion of a bypass graft was 100% with a specificity of 96%. The only "false positive" occlusion was a LIMA with a small lumen. CONCLUSIONS: Our results show that noninvasive bypass angiography with the ultrafast multi-slice CT (MSCT) provides relevant information for the practicing cardiologist. Noninvasive bypass angiography with a cardio-CT predominantly aims at asymptomatic patients without proof of myocardial ischemia ("bypass check") for the detection of asymptomatic occluded bypass grafts as early as possible. In patients with asymptomatic bypass occlusion, considering a coronary or bypass intervention for prognostic reasons is an option. It is important to note that in our study in a mean of 5 years after bypass surgery almost every third patient had an unexpected bypass graft occlusion.
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Article [Quantification of coronary artery calcifications in the risk stratification of cardiac events] 2002
Silber S. · Herzkatheterlabor, München, Germany. · Dtsch Med Wochenschr. · Pubmed #12457329 No free full text.
This publication has no abstract.
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Article Intracoronary beta-radiation to reduce restenosis after balloon angioplasty and stenting; the Beta Radiation In Europe (BRIE) study. 2002
Serruys PW, Sianos G, van der Giessen W, Bonnier HJ, Urban P, Wijns W, Benit E, Vandormael M, Dörr R, Disco C, Debbas N, Silber S, Anonymous00109. · Department of Interventional Cardiology, Thoraxcenter, Heartcenter, Erasmus Medical Center, Academisch Ziekenhuis Dijkzigt Rotterdam, The Netherlands. · Eur Heart J. · Pubmed #12191746 No free full text.
Abstract: AIMS: The BRIE trial is a registry evaluating the safety and performance of (90)Sr delivered locally (Beta-Cath TM system of Novoste) to de-novo and restenotic lesions in patients with up to two discrete lesions in different vessels. METHODS AND RESULTS: In total, 149 patients (175 lesions) were enrolled; 62 treated with balloons and 113 with stents. The restenosis rate, the minimal luminal diameter and the late loss were determined in three regions of interest: (a) in a subsegment of 5mm containing the original minimal luminal diameter pre-intervention termed target segment; (b) the irradiated segment, 28 mm in length, and (c) the entire analysed segment, 42 mm in length, termed the vessel segment. Binary restenosis was 9.9% for the target segment, 28.9% for the irradiated segment, and 33.6% for the vessel segment. These angiographic results include 5.3% total occlusions. Excluding total occlusions binary restenosis was 4.9%, 25% and 29.9%, respectively. At 1 year the incidence of major adverse cardiac events placed in a hierarchical ranking were: death 2%, myocardial infarction 10.1%, CABG 2%, and target vessel revascularization 20.1%. The event-free survival rate was 65.8%. Non-appropriate coverage of the injured segment by the radioactive source termed geographical miss affected 67.9% of the vessels, and increased edge restenosis significantly (16.3% vs 4.3%, P=0.004). It accounted for 40% of the treatment failures. CONCLUSION: The results of this registry reflect the learning process of the practitioner. The full therapeutic potential of this new technology is reflected by the restenosis rate at the site of the target segment. It can only be unravelled once the incidence of late vessel occlusion and geographical miss has been eliminated by the prolonged use of thienopyridine, the appropriate training of the operator applying this new treatment for restenosis prevention, and the use of longer sources.
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