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Major Adverse Cardiac Events (major + adverse_cardiac_event)
Selected AbstractsBeneficial Effect of Preventative Intra-Aortic Balloon Pumping in High-Risk Patients Undergoing First-Time Coronary Artery Bypass Grafting,A Single Center ExperienceARTIFICIAL ORGANS, Issue 8 2009Qingcheng Gong Abstract Although intra-aortic balloon pumping (IABP) has been used widely as a routine cardiac assist device for perioperative support in coronary artery bypass grafting (CABG), the optimal timing for high-risk patients undergoing first-time CABG using IABP is unknown. The purpose of this investigation is to compare preoperative and preventative IABP insertion with intraoperative or postoperative obligatory IABP insertion in high-risk patients undergoing first-time CABG. We reviewed our IABP patients' database from 2002 to 2007; there were 311 CABG patients who received IABP treatment perioperatively. Of 311 cases, 41 high-risk patients who had first-time on-pump or off-pump CABG (presenting with three or more of the following criteria: left ventricular ejection fraction less than 0.45, unstable angina, CABG combined with aneurysmectomy, or left main stenosis greater than 70%) entered the study. We compared perioperatively the clinical results of 20 patients who underwent preoperative IABP placement (Group 1) with 21 patients who had obligatory IABP placement intraoperatively or postoperatively during CABG (Group 2). There were no differences in preoperative risk factors, except left ventricular aneurysm resection, between the two groups. There were no differences in indications for high-risk patients between the two groups. The mean number of grafts was similar. There were no significant differences in the need for inotropes, or in cerebrovascular, gastrointestinal, renal, and infective complications postoperatively. There were no IABP-related complications in either group. Major adverse cardiac event (severe hypotension and/or shock, myocardial infarction, and severe hemodynamic instability) was higher in Group 2 (14 [66.4%] vs. 1 [5%], P < 0.0001) during surgery. The time of IABP pumping in Group 1 was shorter than in Group 2 (72.5 ± 28.9 h vs. 97.5 ± 47.7 h, P < 0.05). The duration of ventilation and intensive care unit stay in Group 1 was significantly shorter than in Group 2, respectively (22.0 ± 1.6 h vs. 39.6 ± 2.1 h, P < 0.01 and 58.0 ± 1.5 h vs. 98.5 ± 1.9 h, P < 0.005). There were no differences in mortality between the two groups (n = 1 in Group 1 and n = 3 in Group 2). Preoperative and preventative insertion of IABP can be performed safely in selected high-risk patients undergoing CABG, with results comparable to those in patients who received obligatory IABP intraoperatively and postoperatively. Therefore, earlier IABP support as part of surgical strategy may help to improve the outcome in high-risk first-time CABG patients. [source] Initial clinical experience with distal protection using the FilterWire in patients undergoing coronary artery and saphenous vein graft percutaneous interventionCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2002Jeffrey J. Popma MD Abstract Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) and native coronary arteries may be associated with embolization of particulate debris into the distal microcirculation. The FilterWire uses a polyurethane filter bag contained on a radiopaque loop to trap embolic debris during native vessel and SVG intervention. The objectives of this study were to assess the feasibility and safety of the FilterWire during PCI and to examine the size and content of the particulate debris captured during SVG and native vessel intervention. Early angiographic, in-hospital, and 30-day clinical outcomes were reviewed in 35 patients with 36 lesions treated with the FilterWire during PCI. Lesions were located in 22 (61%) native coronary arteries and in 14 (39%) SVGs. Multivessel coronary artery disease was present in 75% of patients. Lesions were complex (ACC/AHA complexity B2 or C) in 81% of cases. The FilterWire was successfully delivered and deployed distal to the site of coronary intervention in 92% of lesions, including 95% of native vessels and 82% of SVG lesions. Embolic debris was entrapped in 82% of these cases. The average particulate debris had a mean major axis of 490 ,m (range, 45,3,302 ,m) and minor axis of 226 ,m (range, 33,1,677 ,m). Although reduced flow was common (36.1%) when the FilterWire was in place, there were no sustained episodes of abrupt closure and only one (2.8%) patient developed sustained no-reflow after FilterWire removal. Distal branch vessel embolization was found in four (11.1%) cases. Major adverse cardiac events occurred in 5 (14%) of 35 patients treated with the device, although 2 of these patients were evolving an acute myocardial infarction at the time of the procedure; in patients meeting the prospectively defined inclusion criteria, the major adverse cardiac event was 6%. These results suggest that the FilterWire is a feasible and safe method of collecting particulate debris released during SVG and native vessel coronary intervention. Its benefit over conventional therapy and other distal protection devices is currently under study. Cathet Cardiovasc Intervent 2002;57:125,134. © 2002 Wiley-Liss, Inc. [source] Prognostic significance of asymptomatic coronary artery disease in patients with diabetes and need for early revascularization therapyDIABETIC MEDICINE, Issue 9 2007E.-K. Choi Abstract Aims, Information on the clinical outcome of patients with diabetes with silent myocardial ischaemia is limited. We compared the clinical and angiographic characteristics, and the clinical outcomes of diabetic patients with asymptomatic or symptomatic coronary artery disease (CAD). Methods, Three hundred and ten consecutive diabetic patients with CAD were divided into two groups according to the presence of angina and followed for a mean of 5 years. Fifty-six asymptomatic patients with a positive stress test and CAD on coronary angiography were compared with 254 symptomatic patients, 167 with unstable angina and 87 with chronic stable angina. Results, Although the severity of coronary atherosclerosis was similar in asymptomatic and symptomatic patients, revascularization therapy was performed less frequently in the asymptomatic than the symptomatic patients (26.8 vs. 62.0%; P < 0.001). Asymptomatic patients experienced a similar number of major adverse cardiac events (MACEs; death, non-fatal myocardial infarction, and revascularization; 32 vs. 28%; P = 0.57), but had higher cardiac mortality than symptomatic patients (26 vs. 9%; P < 0.001). However, patients who underwent revascularization therapy at the time of CAD diagnosis in these two groups showed similar MACE and cardiac mortality (20.0 vs. 22.5%, 6.7 vs. 5.3%, respectively; all P > 0.05). Conclusions, This study suggests that diabetic patients with asymptomatic CAD have a higher cardiac mortality risk than those with symptomatic CAD, and that lack of revascularization therapy may be responsible for the poorer survival. [source] Significance of white blood cell count and its subtypes in patients with acute coronary syndromeEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 5 2009G. Huang Abstract Background, Inflammation plays a role in the pathogenesis of coronary atherosclerosis. Materials and methods, Six hundred twenty-three patients with acute coronary syndrome (ACS) referred for coronary angiography for the first time in our hospital were enrolled in this study. White blood cell and its subtypes were measured on admission. The study population was divided into three groups based on total white blood cell count and followed up. Clinical end points were major adverse cardiac events (MACEs), including cardiogenic death, stroke, heart failure, non-fatal myocardial infarction, rehospitalization for angina pectoris. Results, The median age was 68 years (range 31,92) and 64·2% of the patients were men. The median white blood cell count was 6·48 × 109 L,1 (range 2·34,27·10 × 109 L,1). The median follow-up duration was 21 months (range 1,116) and MACEs occurred in 167 patients. The multivariable Cox proportional hazards regression model revealed that neutrophil count [Relative risk = 1·098, 95% Confidence interval (CI): 1·010,1·193, P = 0·029) was a risk factor for MACEs. The logistic regression model revealed that lymphocyte count [Odds ratio (OR) = 1·075, 95% CI: 1·012,1·142, P = 0·018] and monocyte count (OR = 8·578, 95% CI: 2·687,27·381, P < 0·001) were predictive of stenosis , 75%; Neutrophil proportion (OR = 1·060, 95% CI: 1·007,1·115, P = 0·026), monocyte count (OR = 12·370, 95% CI: 1·298,118·761, P = 0·029) were predictive of the presence of multivessel disease. Kaplan,Meier analysis of short-term and long-term cumulative survival showed no significant statistical differences among three groups. Conclusions, Neutrophil count adds prognostic information to MACEs in ACS. Monocyte count and lymphocyte count are predictive of severity of coronary atherosclerosis. [source] Meta-analysis comparing clinical effectiveness of drug-eluting stents, bare metal stents and coronary artery bypass surgeryINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 3 2007Eun-Hwan Oh PhD MPH MHA BA Abstract Objective, To compare clinical outcomes among patients receiving drug-eluting stents, bare metal stents, or coronary artery bypass grafting surgery (CABG) to treat coronary artery disease. Data sources, Randomised controlled trials were systematically selected from electronic database for head-to-head comparisons. The results from these head-to-head comparisons were used for an adjusted indirect comparison. Methods, Published randomised controlled trials were reviewed for outcome data in patients treated for coronary artery disease with drug-eluting stents, bare metal stents, or CABG. Head-to-head comparisons were conducted for drug-eluting stents versus bare metal stents and for CABG versus bare metal stents. Adjusted indirect comparison was used to compare drug-eluting stents and CABG. Mid-term clinical outcomes (range: 6,12 months) were investigated and included rates of mortality, myocardial infarction, thrombosis, target lesion revascularisation, target vessel revascularisation, restenosis and major adverse cardiac events. Results, Systematic literature search identified 23 randomised controlled trials (15 for drug-eluting stents vs. bare metal stents, 8 for CABG vs. bare metal stents). Head-to-head comparisons for both single and multiple vessel disease demonstrated that compared with bare metal stents, drug-eluting stents had better outcomes for target lesion revascularisation, target vessel revascularisation, restenosis and major adverse cardiac events. Except target lesion revascularisation, data were similarly favourable for CABG when compared with bare metal stents. Adjusted indirect comparison between drug-eluting stents and CABG in single vessel disease failed to detect significant differences in any of the measured outcomes. Multiple vessel disease data analysis demonstrated that target vessel revascularisation (odds ratio 3.41 [95% CI 2.29,5.08]) and major adverse cardiac events (1.89 [1.28,2.79]) were superior to drug-eluting stents in patients undergoing CABG. Conclusions, Drug-eluting stents and CABG were superior to bare metal stents in terms of target lesion revascularisation (drug-eluting stents only), target vessel revascularisation, restenosis and major adverse cardiac events. There was no difference in clinical outcomes when comparing CABG and drug-eluting stents in patients with single vessel disease, and CABG may be superior to drug-eluting stents for target vessel revascularisation and major adverse cardiac events in patients with multiple vessel disease. However, results may vary between subpopulations with different clinical or socioeconomic differences. [source] Predictors of cardiac events in high-risk patients undergoing emergency surgeryACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 8 2009A. OSCARSSON Background: The aim of this study was to determine the incidence of myocardial damage and left ventricular myocardial dysfunction and their influence on outcome in high-risk patients undergoing non-elective surgery. Methods: In this prospective observational study, 211 patients with American Society of Anesthesiologists classification III or IV undergoing emergent or urgent surgery were included. Troponin I (TnI) was measured pre-operatively, 12 and 48 h post-operatively. Pre-operative N-terminal fragment of B-type natriuretic peptide (NT-proBNP), as a marker for left ventricular systolic dysfunction, was analyzed. The diagnostic thresholds were set to TnI >0.06 ,g/l and NT-proBNP >1800 pg/ml, respectively. Post-operative major adverse cardiac events (MACE), 30-day and 3-months mortality were recorded. Results: Elevated TnI levels were detected in 33% of the patients post-operatively. A TnI elevation increased the risk of MACE (35% vs. 3% in patients with normal TnI levels, P<0.001) and 30-day mortality (23% vs. 7%, P=0.003). Increased concentrations of NT-proBNP were seen in 59% of the patients. Elevated NT-proBNP was an independent predictor of myocardial damage post-operatively, odds ratio, 6.2 [95% confidence interval (CI) 2.1,18.0] and resulted in an increased risk of MACE (21% vs. 2.5% in patients with NT-proBNP ,1800 pg/ml, P<0.001). Conclusion: Myocardial damage is common in a high-risk population undergoing unscheduled surgery. These results suggest a close correlation between myocardial damage in the post-operative period and increased concentration of NT-proBNP before surgery. The combinations of TnI and NT-proBNP are reliable markers for monitoring patients at risk in the peri-operative period as well as useful tools in our risk assessment pre-operatively in emergency surgery. [source] Two-Year Clinical Registry Follow-up of Endothelial Progenitor Cell Capture Stent Versus Sirolimus-Eluting Bioabsorbable Polymer-Coated Stent Versus Bare Metal Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Elevation Myocardial InfarctionJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2010ERIC CHONG M.B.B.S., F.A.M.S., M.R.C.P. Background: Endothelial progenitor cell (EPC) capture stent is designed to promote rapid endothelization and healing and is potentially useful in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). We studied the intermediate-term efficacy and safety of EPC stent and compared that with sirolimus-eluting bioabsorbable polymer stent (CURA) and bare metal stent (BMS) in AMI patients. Methodology: Patients presenting with AMI who underwent primary PCI with the respective stents between January 2004 and June 2006 were enrolled in the single-center clinical registry. The study end-points were major adverse cardiac events (MACE) and stent thrombosis. Results: A total of 366 patients (EPC = 95, CURA = 53, BMS 218) were enrolled. Baseline demographics including age, gender, diabetes, renal impairment, predischarge left ventricular ejection fraction, and creatinine kinase level were comparable among the groups. Procedural success rate was 99.5%. Post-procedural thrombolysis in myocardial infarction (TIMI) 3 flow was achieved in EPC 91.6%, CURA 96.2%, and BMS 88.5% (P = 0.209). At 2 years, the MACE rate was EPC 13.7%, CURA 15.1%, and BMS 19.7% (P = 0.383). Target vessel revascularizations (TVR) were EPC 4.2%, CURA 9.4%, and BMS 6.0% (P = 0.439). Nonfatal myocardial infarctions were EPC 1.1%, CURA 3.8%, and BMS 4.1% (P = 0.364). One patient in the EPC group had acute stent thrombosis. There was no late stent thrombosis in the EPC group. Conclusion: EPC stent appeared to be safe and had comparable clinical efficacy with a BMS when used in the AMI setting. At 2-year follow-up, the EPC group showed favorable, single-digit TVR rate and stent thrombosis remained a low-event occurrence. (J Interven Cardiol 2010;23:101-108) [source] Drug-Eluting Stents Versus Bare Metal Stents Following Rotational Atherectomy for Heavily Calcified Coronary Lesions: Late Angiographic and Clinical Follow-Up ResultsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2007AHMED A. KHATTAB M.D. Objectives: To study the effectiveness of drug-eluting stents following rotablation of severely calcified lesions. Background: Drug-eluting stents are increasingly showing promising results in complex lesions and high-risk patients. Heavily calcified stenoses have not been adequately studied, and form a challenge both for the immediate and late outcomes. Methods: Single-center prospective study among 27 patients treated by rotablation followed by a drug-eluting stent implantation for angiographically heavily calcified lesions, compared with a historical control of 34 patients treated by rotablation followed by bare stent implantation for the same indication. The primary endpoint was the late lumen loss at 9 months; secondary endpoints were binary restenosis and major adverse cardiac events at 9 months. A 2-year follow-up directed to death and myocardial infarction was added. Results: Both groups were comparable regarding baseline and procedural characteristics. Angiographic success was 100% for both groups. At 9 months, there was a significant difference in the late lumen loss (0.11 ± 0.7 mm in the DES group and 1.11 ± 0.9 mm in the BMS group, P = 0.001). This difference was manifest in the clinical event rates at late follow-up (combined incidence of death due to any cause, MI, and TLR was 7.4% in the DES group and 38.2% in the BMS group; P = 0.004). At 2 years, there were 5 deaths in each group (P = 0.5) and 2 infarctions in the BMS group versus none in the DES group (P = 1.0). Conclusion: The combination of rotablation and drug-eluting stent implantation (Rota-DES) has a favorable effect on clinical and angiographic outcomes at 9 months when treating heavily calcified lesions compared to rotablation followed by bare metal stent implantation. No safety concerns are observed at 2 years. [source] Predictors of Clinical Outcome Following NIR Stent Implantation for Coronary Artery Disease: Analysis of the Results of the First International New Intravascular Rigid-Flex Endovascular Stent Study (FINESS Trial)JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2002STEVEN FELD M.D. Background: Patient and procedural characteristics associated with major adverse cardiac events following balloon angioplasty have been identified. Factors predictive of angiographic restenosis following coronary stent implantation have been reported, although patient variables associated with adverse clinical outcome are not well defined. Hypothesis and Methods: To identify predictors of adverse clinical outcome following NIR stent implantation, clinical and angiographic characteristics of patients enrolled in the FINESS Trial were subjected to stepwise logistic regression analysis. From December 1995 through March 1996, NIR stent implantation was attempted in 255 patients (341 lesions) enrolled prospectively in a multicenter registry with broad entry criteria. Results: On stepwise logistic regression analysis, the presence of multivessel disease, diabetes, and the total length of the stented segment were predictive of major adverse cardiac events during 6-month follow-up. For every 1 mm increase in stent length, the risk for the combined end point of death or myocardial infarction increased by 3%. Lesion length was not predictive of clinical events on multivariate analysis. Conclusions: Our data raise the possibility that an attempt to use shorter stents to cover significant stenoses, but not adjacent areas of visible narrowing, may improve outcome. [source] Three-dimensional MRI assessment of regional wall stress after acute myocardial infarction predicts postdischarge cardiac eventsJOURNAL OF MAGNETIC RESONANCE IMAGING, Issue 3 2008Fabrice Prunier MD Abstract Purpose To determine the prognostic significance of systolic wall stress (SWS) after reperfused acute myocardial infarction (AMI) using MRI. Materials and Methods A total of 105 patients underwent MRI 7.8 ± 4.2 days after AMI reperfusion. SWS was calculated by using a three-dimensional (3D) MRI approach to left ventricular (LV) wall thickness and to the radius of curvature. Between hospital discharge and the end of follow-up, an average of 4.1 ± 1.7 years after AMI, 19 patients experienced a major cardiac event, including cardiac death, nonfatal reinfarction or heart failure (18.3%). Results The results were mainly driven by heart failure outcome. In univariate analysis the following factors were predictive of postdischarge major adverse cardiac events: 1) at the time of AMI: higher heart rate, previous calcium antagonist treatment, in-hospital congestive heart failure, proximal left anterior descending artery (LAD) occlusion, a lower ejection fraction, higher maximal ST segment elevation before reperfusion, and ST segment reduction lower than 50% after reperfusion; 2) MRI parameters: higher LV end-systolic volume, lower ejection fraction, higher global SWS, higher SWS in the infarcted area (SWS MI) and higher SWS in the remote myocardium (SWS remote). In the final multivariate model, only SWS MI (odds ratio [OR]: 1.62; 95% confidence interval [CI]: 1.01,2.60; P = 0.046) and SWS remote (OR: 2.17; 95% CI: 1.02,4.65; P = 0.046) were independent predictors. Conclusion Regional SWS assessed by means of MRI a few days after AMI appears to be strong predictor of postdischarge cardiac events, identifying a subset of at risk patients who could qualify for more aggressive management. J. Magn. Reson. Imaging 2008. © 2008 Wiley-Liss, Inc. [source] Ventricular Dyssynchrony and Risk Markers of Ventricular Arrhythmias in Nonischemic Dilated Cardiomyopathy:PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 1p2 2003A Study with Phase Analysis of Angioscintigraphy FAUCHIER, L.,et al.: Ventricular Dyssynchrony and Risk Markers of Ventricular Arrhythmias in Nonischemic Dilated Cardiomyopathy: A Study with Phase Analysis of Angioscintigraphy.Biventricular pacing is a new form of treatment for patients with dilated cardiomyopathy and ventricular dyssynchrony. Limited information is available regarding the relationship between ventricular dyssynchrony and risk markers of ventricular arrhythmias in idiopathic dilated cardiomyopathy (IDC). In 103 patients with IDC, Fourier phase analysis of both ventricles was performed from equilibrium radionuclide angiography (ERNA). The difference between the mean phase of the LV and RV was a measure of interventricular dyssynchrony, and the standard deviations of the mean phases in each ventricle measured intraventricular dyssynchrony. There were no significant differences in inter- and intraventricular dyssynchrony between patients with versus without histories of sustained VT or VF, nonsustained VT, abnormal signal-averaged ECG, or induced sustained monomorphic VT. Dyssynchrony was not related to decreased heart rate variability (HRV). LV and interventricular dyssynchrony were weakly related to QT duration and QT dispersion. During a follow-up of27 ± 23 months, 21 patients had major adverse cardiac events (MACE), including 7 cardiac deaths, 11 progression of heart failure leading to cardiac transplantation, and 3 sustained VT/VF. The only independent predictors of MACE were an increased standard deviation of LV mean phase (P = 0.003), a decreased HRV (standard deviation of normal-to-normal intervals, P = 0.004), and histories of previous VT/VF (P = 0.03) or nonsustained VT (P = 0.04). In conclusion, left intraventricular dyssynchrony evaluated with ERNA was an independent predictor of MACE in IDC and was not related to usual risk markers of ventricular arrhythmias. This may have implications for resynchronization therapy and/or the use of implantable cardioverter defibrillators in IDC. (PACE 2003; 26[Pt. II]:352,356) [source] A meta-analysis of the utility of C-reactive protein in predicting early, intermediate-term and long term mortality and major adverse cardiac events in vascular surgical patientsANAESTHESIA, Issue 4 2009L. Padayachee Summary We conducted a meta-analysis of the utility of pre-operative C reactive protein (CRP) in predicting early (< 30 days), intermediate (30,180 days) and long term (> 180 days) mortality and major adverse cardiac events (MACE; cardiac mortality and nonfatal myocardial infarction (MI) combined) following vascular surgery. Of 291 studies identified, ten prospective patient cohorts were identified. A pre-operative CRP > 3 mg.l,1 was not associated with 30-day all-cause mortality, cardiac mortality, nonfatal myocardial infarction or MACE. Intermediate-term all-cause mortality, cardiac death and MACE showed a trend to a worse outcome (odds ratio (OR) 9.07, 95% confidence interval (CI) 0.86,96.28, p = 0.07; OR 8.71, 95% CI 0.5,153.1, p = 0.14 and OR 2.81, 95% CI 0.78,5.18, p = 0.15 respectively). Long term all cause mortality (OR 2.40, 95% CI 1.15,5.02, p = 0.02), cardiac death (OR 5.66, 95% CI 1.71,18.73, p = 0.005) and MACE (OR 2.76, 95% CI 1.38,5.55, p = 0.004) were significantly increased. [source] An everolimus-eluting stent versus a paclitaxel-eluting stent in small vessel coronary artery disease: A pooled analysis from the SPIRIT II and SPIRIT III trials,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2010Antonio L. Bartorelli MD Abstract Objectives: To evaluate the safety and efficacy of the XIENCE V everolimus-eluting stent compared to the TAXUS paclitaxel-eluting stent in small vessels. Backgroud: The XIENCE V everolimus-eluting stent (EES) has been shown to improve angiographic and clinical outcomes after percutaneous myocardial revascularization, but its performance in small coronary arteries has not been investigated. Methods: In this pooled analysis, we studied a cohort of 541 patients with small coronary vessels (reference diameter <2.765 mm) by using patient and lesion level data from the SPIRIT II and SPIRIT III studies. TAXUS Express (73% of lesions) and TAXUS Liberté (27% of lesions) paclitaxel-eluting stents (PES) were used as controls in SPIRIT II. In SPIRIT III, Taxus Express2 PES was the control. Results: Mean angiographic in-stent and in-segment late loss was significantly less in the EES group compared with the PES group, (0.15 ± 0.37 mm vs. 0.30 ± 0.44 mm; P = 0.011 for in-stent; 0.10 ± 0.38 mm vs. 0.21 ± 0.34 mm; P = 0.034 for in-segment). EES also resulted in a significant reduction in composite major adverse cardiac events at 1 year (19/366 [5.2%] vs. 17/159 [10.7%]; P = 0.037), due to fewer non-Q-wave myocardial infarctions and target lesion revascularizations. At 1 year, the rate of non-Q-wave myocardial infarction was significantly lower in the EES group compared with that of the PES group (6/366 [1.6%] vs. 8/159 [5.0%]; P = 0.037). Conclusions: In patients with small vessel coronary arteries, the XIENCE V EES was superior to the TAXUS PES. © 2010 Wiley-Liss, Inc. [source] Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-Year results of the PAINT trial,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2009Pedro A. Lemos MD Abstract Objectives: We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective). Background: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. Methods: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months. Results: Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54,0.44 mm, 0.32,0.43 mm, vs. 0.90,0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. Conclusion: Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.© 2009 Wiley-Liss, Inc. [source] Outcomes with drug-eluting stents versus bare metal stents in acute ST-elevation myocardial infarction: Results from the Strategic Transcatheter Evaluation of New Therapies (STENT) Group,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2008Bruce R. Brodie MD Abstract Objectives: This study compares outcomes with drug-eluting stents (DES) versus bare metal stents (BMS) in patients with ST-elevation myocardial infarction (STEMI). Background: DESs have been effective in elective percutaneous coronary intervention (PCI), but their safety and efficacy in patients with STEMI have not been well studied. Methods: The STENT Registry is a multicenter United States registry evaluating outcomes of DES. Our study population includes patients with STEMI treated with either a DES or BMS who completed 9-month or 2-year follow-up. Outcomes were adjusted using propensity score analysis. Results: DES patients were younger, had less prior infarction and prior bypass surgery, but had smaller vessels and longer lesions. After adjusting for differences in baseline variables, there were no significant differences between DES and BMS in death, reinfarction, or major adverse cardiac events (MACE). DES had lower rates of stent thrombosis at 9 months (1.0% vs. 2.7%, HR 0.40 [0.17,0.95]) and lower rates of target vessel revascularization (TVR) at 9 months (4.0% vs. 7.5%, HR 0.55 [0.34,0.88]) and 2 years (8.0% vs. 11.3%, HR 0.57 [0.35,0.92]). There was a nonsignificant increase in stent thrombosis with DES versus BMS from 1 to 2 years (1.1% vs. 0.3%, P = 0.28). Conclusions: Our data suggest that DES used with primary PCI for STEMI are more effective than BMS in reducing TVR and are safe for up to 2 years. Whether DES are safe beyond 2 years and whether the reduction in TVR is enough to justify their use in STEMI will have to wait for the results of large randomized trials. 2008 Wiley-Liss, Inc. [source] A randomized comparison of sirolimus-eluting versus bare metal stents in the treatment of diabetic patients with native coronary artery lesions: The DECODE study,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2008Charles Chan MD Abstract Objective: To compare the effects of sirolimus-eluting (SES) versus bare metal stents (BMS) on 6-month in-stent late luminal loss (LLL) and 1-year major adverse cardiac events (MACE) in diabetics undergoing percutaneous coronary interventions. Background: In studies of unselected patients, coronary restenosis rates have been lower with SES than with BMS. Comparisons of SES versus BMS in diabetics with more than one stenosis or more than one vessel disease are few. Methods: This open-label trial randomly assigned 200 diabetics with de novo coronary artery stenoses to receive up to three SES versus BMS in a 2:1 ratio. The patients underwent repeat coronary angiography at 6 months after the index procedure and were followed-up for 1 year. The primary study endpoint was in-stent LLL at 6 months. Results: Between August 2002 and May 2004, 83 patients (mean age = 60 years) with 128 lesions (mean = 1.5 per patient) were enrolled at four U.S. and seven Asian medical centers. Enrollment was terminated early by the Safety Monitoring Board because of a statistically significant difference in rates of clinical endpoints. The mean in-stent LLL at 6 months was 0.23 mm in SES versus 1.10 mm in BMS recipients (P < 0.001). At 12 months, 8 patients (15%) assigned to SES had experienced MACE versus 12 patients (41%) assigned to BMS (P = 0.006). Conclusions: In diabetics, the mean 6-month in-stent LLL was significantly smaller, and 12-month MACE rate significantly lower, after myocardial revascularization with SES than with BMS. © 2008 Wiley-Liss, Inc. [source] Adjunctive use of the Rinspiration system for fluidic thrombectomy during primary angioplasty: The Rinspiration international registry,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2008Marco De Carlo MD Abstract Background: Atherothrombotic embolization during primary percutaneous coronary intervention (PCI) induces microvascular obstruction and reduces myocardial tissue reperfusion. A variety of thrombectomy devices have been evaluated as an adjunct to primary PCI in patients with ST-elevation myocardial infarction (STEMI) to reduce distal embolization. Results have been inconsistent and difficult to predict. The aim of this study was to investigate the safety and efficacy of an innovative thrombectomy device, the Rinspiration System, which simultaneously "rinses" the vessel with turbulent flow and aspirates thrombus. Methods: We prospectively enrolled 109 patients at six academic institutions in three countries referred for primary or rescue PCI for STEMI presenting within 12 hr of symptom onset. The primary endpoint was ,50% ST-segment elevation resolution (STR) measured 60 min after PCI by continuous elctrocardiographic recording, Secondary end points included STR > 70% at 60 min, final TIMI flow, myocardial blush score, and 30-day major adverse cardiac events (MACE). Results: Mean symptom-to-PCI time was 4.7 ± 2.7 hr. Rinspiration was successfully delivered in 98% of cases. Final TIMI three flow was achieved in 89% of patients and myocardial blush ,2 in 78%. Rates of STR , 50% and >70% at 60 min were 97 and 80%, respectively. No device-related complications were observed. Thirty-day MACE rate was 4.6%. Conclusions: This international multicenter registry demonstrates that the adjunctive use of Rinspiration during primary PCI is safe and feasible. The excellent STR data compare favorably with results of previous trials using different devices for thrombus management, indicating a potential clinical benefit. © 2008 Wiley-Liss, Inc. [source] The AST petal dedicated bifurcation stent: First-in-human experienceCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2007John Ormiston MBChB Abstract The aim of this first-in-human study was to evaluate the feasibility and safety of the novel AST petal side-access bifurcation stent. Outcomes following percutaneous coronary intervention for bifurcations remain inferior to those of nonbifurcated lesions. Even with drug-eluting stents, restenosis occurs especially at the side-branch (SB) ostium. The petal stent uniquely deploys strut elements into the SB, supporting the ostium and carina. The primary endpoint of this 13-patient prospective registry was in-hospital major adverse cardiac events (MACE). Secondary end points included acute minimum lumen diameter (MLD) at the SB ostium, lesion success, device success, procedural success, 30-day MACE, and 4-month SB ostial MLD. The study lesion was successfully treated in 13 patients with the study stent being successfully implanted in 12. Target lesions were left anterior descending coronary artery in nine subjects, left circumflex in three, and right coronary artery in one. In-hospital MACE were limited to two non-Q-wave myocardial infarctions. In-stent main branch MLD increased from a mean of 0.63 ± 0.45 mm to 2.61 ± 0.47 mm at the index procedure and for this initial bare metal version of the stent, 4-month mean MLD measured 1.02 ± 0.42mm and there was target vessel revascularization on two patients. The feasibility of safely deploying this first-generation petal stent was demonstrated in selected patients with challenging coronary bifurcation lesions. It is a promising platform for drug delivery, with unique scaffolding of the side-branch ostium. © 2007 Wiley-Liss, Inc. [source] Long-term outcomes of bifurcation lesions after implantation of drug-eluting stents with the "mini-crush technique"CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2007Alfredo R. Galassi MD, FSCAI Abstract Objectives: To evaluate clinical and angiographic long-term outcome of "the mini-crush" technique for treating bifurcation lesions. Background: Despite proven efficacy of drug-eluting stent (DES) within most lesions subsets, bifurcation lesions continue to exhibit high restenosis rate using current DES stenting technique. Methods: We report a new stenting technique which was employed in 45 consecutive patients (52 lesions) between April 2004 and July 2005 to treat true bifurcation lesions using DES in both branches. Results: Using this technique procedural success was obtained in 100% of cases, without complications and with excellent angiographic result in 96.1% and 98.1% of main vessel and side branch. Preprocedure reference vessel diameter and minimal lumen diameter (MLD) were 2.68 ± 0.48 and 0.90 ± 0.55 mm for the main branch, respectively and 2.28 ± 0.34 and 1.14 ± 0.47 mm for the side branch, respectively. Postprocedure MLD was 2.56 ± 0.39 mm for the main branch and 2.16 ± 0.29 mm for the side branch. There were no in-hospital major adverse cardiac events (MACE). At 72 days after procedure there was one case of side branch stent thrombosis (2.2%), which resulted in non Q-wave MI. Angiographic follow up was obtained in 100% of patients at 7.5 ± 1.3 months. Target lesion revascularization (TLR) was 12.2%; no death and Q-wave MI were observed; reference vessel diameter and MLD for the main branch were 2.79 ± 0.51 and 1.99 ± 0.65 mm respectively and for the side branch 2.28 ± 0.40 and 1.63 ± 0.48 mm respectively. Restenosis rate in the main branch was 12.2% while in the side branch was 2.0%. Conclusions: In-hospital outcome indicates that the mini-crush technique for bifurcation lesions with DES can be easily performed. It provides very low total MACE rate and restenosis at 8-month follow-up. These results confirmed the advantage of this specific technique to give complete coverage of the ostium of the side branch using two stents technique. © 2007 Wiley-Liss, Inc. [source] Outcome in the real-world of coronary high-risk intervention with drug-eluting stents (ORCHID),A single-center study comparing CypherÔ sirolimus-eluting with TaxusÔ paclitaxel-eluting stentsCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2006S. Kumar MRCP Abstract Objective: We present real world experience from a single center registry comparing the 6-month outcome of percutaneous coronary intervention (PCI) in unselected high-risk individuals using either sirolimus-eluting (SES) or paclitaxel-eluting stents (PES). Methods/Results: We compared clinical outcome at 6 months follow-up in two cohorts of 156 consecutive patients(total n = 312) who underwent SES (June 2002,Februrary 2003) and PES(march 2003,July 2003) implantation. The primary endpoint was a composite of major adverse cardiac events (MACE). Baseline clinical characteristics were well matched. The 6-month target vessel revascularization (TVR) rates were 1.9% (SES) and 2.6% (PES) and MACE rates were similar in the two groups (SES 4.5% vs. PES 3.2%, P = NS). In the PES group, intervention for multivessel disease, bifurcation lesions and in small vessels was more common, and for in-stent restenosis less common, reflecting the impact of drug eluting stents on indications for PCI. The incidence of sub-acute stent thrombosis, related to inadequate antiplatelet therapy in 3 of the 6 cases, was 0.95% with no difference between the two groups. Conclusion: This study confirms the safety and efficacy of SES and PES in unselected high risk patients undergoing PCI. Clinical outcomes of both stents are equivalent at 6 months with low rates of MACE and TVR. These data provide important complementary information to forthcoming randomized studies. © 2006 Wiley-Liss., Inc. [source] Improved survival with drug-eluting stent implantation in comparison with bare metal stent in patients with severe left ventricular dysfunctionCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2006FACC, Giuseppe Gioia MD Abstract OBJECTIVE: We examined the efficacy of drug-eluting stent (DES) implantation (Sirolimus or Paclitaxel) in patients with ischemic cardiomyopathy and severe left ventricular (LV) dysfunction and compared the outcome with a similar group of patients undergoing bare metal stent (BMS) implantation. BACKGROUND: Patients with severe LV dysfunction are a high risk group. DES may improve the long term outcomes compared with BMS. METHODS: One hundred and ninety one patients (23% women) with severe LV dysfunction (LV ejection fraction ,35%) underwent coronary stent implantation between May 2002 and May 2005 and were available for follow-up. One hundred and twenty eight patients received DES (Sirolimus in 72 and Paclitaxel in 54) and 63 patients had BMS. Patients with acute S-T elevation myocardial infarction (STEMI) were excluded. The primary endpoint was cardiovascular mortality. A composite endpoint of major adverse cardiac events (MACE) including cardiovascular mortality, myocardial infarction (MI), and target vessel revascularization (TVR) was the secondary endpoint. RESULTS: Mean follow-up was 420 ± 271 days. No differences were noted in age (69 ± 10 years vs. 70 ± 10 years, P = NS), number of vessel disease (2.3 ± 0.7 vs. 2.2 ± 0.8, P = NS), history of congestive heart failure (47% vs. 46%, P = NS), MI (60% vs. 61%, P = NS), or number of treated vessels (1.3 ± 0.5 vs. 1.3 ± 0.6, P = NS) for the DES and BMS group, respectively. Diabetes was more common among DES patients (45% vs. 25%, P = 0.01). The left ventricular ejection fraction (LVEF) was similar between the two groups (28% ± 6% vs. 26% ± 8%, P = NS for the DES and BMS, respectively). During the follow-up, there were a total of 25 deaths of which two were cancer related (2 in DES group). There were 23 cardiac deaths, 8/126 (6%) which occurred in the DES group and 15/63 (24%) in the BMS group (P = 0.05 by log-rank test). MACE rate was 10% for the DES group and 41% for the BMS group (P = 0.003). NYHA class improved in both groups (from 2.5 ± 0.8 to 1.7 ± 0.8 in DES and from 2 ± 0.8 to 1.4 ± 0.7 in the BMS, P = NS). CONCLUSION: Compared with bare-metal stents, DES implantation reduces mortality and MACE in high risk patients with severe left ventricular dysfunction. © 2006 Wiley-Liss, Inc. [source] Elective sirolimus-eluting stent implantation for multivessel disease involving significant LAD stenosis: One-year clinical outcomes of 99 consecutive patients,the Rotterdam experienceCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 1 2004Chourmouzios A. Arampatzis MD Abstract The aim of this study was to evaluate the effectiveness of sirolimus-eluting stent (SES) implantation for patients with multivessel disease, which included left anterior descending artery (LAD) treatment. Since April 2002, SES has been utilized as the device of choice for all interventions in our institution as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Hospital (RESEARCH) registry. In the first 6 months of enrolment, 99 consecutive patients (17.6% of the total population) were treated for multivessel disease involving the LAD. The impact of SES implantation on major adverse cardiac events (MACE) was evaluated. All the patients received SES in the LAD. Additional stent implantation in the right coronary artery, the left circumflex, or in all three major vessels was attempted successfully in 32 (32%), 51 (52%), and 16 (16%) of the treated patients respectively. During a mean follow-up of 360 ± 59 days (range, 297,472 days), we had one death, one non-Q-wave myocardial infarction, and eight patients required subsequent intervention. The event-free survival of MACE at 1 year was 85.6%. SES implantation for multivessel disease in a consecutive series of patients is associated with low incidence of adverse events. The reported results are related predominantly to the reduction in repeat revascularization. Catheter Cardiovasc Interv 2004;63:57,60. © 2004 Wiley-Liss, Inc. [source] Clinical outcomes for sirolimus-eluting stent implantation and vascular brachytherapy for the treatment of in-stent restenosisCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2004Francesco Saia MD Abstract The purpose of this study was to compare the mid-term clinical outcome of sirolimus-eluting stent (SES) implantation and vascular brachytherapy (VBT) for in-stent restenosis (ISR). We assessed the 9-month occurrence of major adverse cardiac events (MACE) in 44 consecutive patients with ISR treated with SES implantation and 43 consecutive patients treated with VBT in the period immediately prior. Baseline clinical and angiographic characteristics of the two groups were similar. During follow-up, three patients (7%) died in the VBT group and none in the SES group. The incidence of myocardial infarction was 2.3% in both groups. Target lesion revascularization was performed in 11.6% of the VBT patients and 16.3% of the SES patients (P = NS). The 9-month MACE-free survival was similar in both groups (79.1% VBT vs. 81.5% SES; P = 0.8 by log rank). The result of this nonrandomized study suggests that sirolimus-eluting stent implantation is at least as effective as vascular brachytherapy in the treatment of in-stent restenosis. Catheter Cardiovasc Interv 2004;62:283,288. © 2004 Wiley-Liss, Inc. [source] Clinical Outcomes for Single Stent and Multiple Stents in Contemporary PracticeCLINICAL CARDIOLOGY, Issue 9 2009Qiao Shu Bin MD Background Stents had been demonstrated to be safe and effective in the treatment of severe coronary artery disease (CAD); however, the current knowledge on percutaneous coronary intervention (PCI) in treating patients requiring 2 or more stents placements is still limited. Hypothesis Patients who required 2 or more stents might have worse clinical outcomes. Methods A total of 2371 patients who underwent stenting were divided into a single stenting group (n = 1233) and a multiple stenting group (n = 1138). We assessed the cumulative incidence of major adverse cardiac events (death, acute myocardial infarction, and target-vessel revascularization) and stent thrombosis during 1-year follow-up. Results The 1-year unadjusted cumulative incidence of major adverse cardiac events was 7.7% in the multiple stenting group and 5.4% in the single stenting group (P = 0.02 by log-rank test). After adjustment, there was a trend toward a lower rate of 1-year major adverse cardiac events in the single stenting group than in the multiple stenting group (P = 0.09). A nonsignificant trend was also detected in favor of the single stenting group, as compared with the multiple stenting group, at the rate of acute myocardial infarction (1.3% vs 1.7%, P = 0.89) and at the rate of target-vessel revascularization (4.5% vs 5.4%, P = 0.08). Conclusions Although the use of a single stent in coronary artery disease has less incidence of adverse cardiac events at 1 year as compared with the use of multiple stents, the difference was not statistically significant. Copyright © 2009 Wiley Periodicals, Inc. [source] Efficacy and Safety of Tirofiban in High-Risk Patients With Non-ST-Segment Elevation Acute Coronary SyndromesCLINICAL CARDIOLOGY, Issue 9 2009Zhenxian Yan MD Objective To evaluate the safety and efficacy of tirofiban in high risk patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) after percutaneous coronary intervention (PCI). Methods A total of 240 patients were randomized to either a tirofiban group or a control group. Results Compared with the control group, the platelet aggregation rate in the tirofiban group was lower (P < 0.01); the plasma levels of CK-MB and troponin I, cardiac form (cTnI) were lower (P < 0.05); ECG improved significantly (P < 0.05); the incidence of major adverse cardiac events (MACE) was lower (P < 0.05); and there was no difference in bleeding complications between the 2 groups (P = 0.1). Conclusions The administration of tirofiban in high risk patients with NSTE-ACS after PCI is safe and effective. Copyright © 2009 Wiley Periodicals, Inc. [source] Metabolic syndrome and cardiovascular risk in renal transplant recipients: effects of statin treatmentCLINICAL TRANSPLANTATION, Issue 6 2009Inga Soveri Abstract:, Background:, Renal transplant recipients (RTR) have high risk for cardiovascular disease (CVD). They also have high prevalence of insulin resistance and metabolic syndrome (MS). Statin treatment reduces CVD risk in RTR. The aim was to study MS as CVD risk factor in RTR, and to investigate the effect of statin treatment in RTR with MS. Methods:, In total, 1706 non-diabetic RTR from the Assessment of Lescol in Renal Transplantation trial were followed for 7,8 yr. The captured endpoints included major adverse cardiac events [MACE, defined as cardiac death (CD), non-fatal myocardial infarction or coronary revascularization procedure], and CD. MS was defined at baseline according to Adult Treatment Panel III definition with waist girth replaced by body mass index ,30 kg/m2. Results:, MS was diagnosed in 32% of the patients. During the follow-up, MACE incidence was 16% in those with MS and 11% in those without MS (p < 0.001). Statin treatment reduced MACE risk by 53% in the group with MS. CD risk was 74% higher in RTR with MS (p = 0.012), and statin treatment reduced CD risk in those with MS (p = 0.03). Conclusions:, RTR with MS have increased risk for CVD. RTR with MS are an easily identifiable group of patients who benefit from statin treatment. [source] | |||||||||||||||||||||||||