13154 articles - 08.09.10
1: Am J Cardiol. 2010 Sep 15;106(6):905-9.
Demazumder D, Hasan RK, Blumenthal RS, Michos ED, Jones S.
The Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, Baltimore, Maryland.
Current clinical guidelines recommend the use of a global risk assessment tool, such as those pioneered by the Framingham Heart Study, to determine eligibility for statin therapy in patients with absolute risk levels greater than a certain threshold. In support of this approach, several randomized trials have reported that patients with high absolute risk clearly benefit from statin therapy. Therefore, the guideline recommendations would seem intuitive and effective, albeit on the core assumption that the mortality and morbidity benefits associated with statin therapy would be greatest in those with high predicted absolute risk. However, if this assumption is incorrect, using predicted absolute risk to guide statin therapy could easily result in underuse in some groups and overuse in others. Herein, the authors question the utility of global risk assessment strategies based on the Framingham risk score for guiding statin therapy in light of current data that have become available from more recent and robust prospective randomized clinical trials since the publication of the National Cholesterol Education Program Adult Treatment Panel III guidelines. Moreover, the Adult Treatment Panel III guidelines do not support treatment of some patients who may benefit from statin therapy. In conclusion, the authors propose an alternative approach for incorporating more recent randomized trial data into future statin allocation algorithms and treatment guidelines. Copyright (c) 2010 Elsevier Inc. All rights reserved.
Publication Types: Editorial
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PMID: 20816135 [PubMed - in process]2: Am J Cardiol. 2010 Sep 15;106(6):757-63. Epub 2010 Aug 1.
Carey VJ, Bishop L, Laranjo N, Harshfield BJ, Kwiat C, Sacks FM.
Channing Laboratory, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
To determine the relative contributions of triglycerides (TGs) and high-density lipoprotein (HDL) cholesterol in the residual risk of coronary heart disease (CHD) after the reduction of low-density lipoprotein (LDL) cholesterol to guideline-recommended levels, we conducted a hospital-based, case-control study with optimal matching in the strata of LDL cholesterol, gender, ethnicity, and age. The 170 cases and 175 controls were patients at Brigham and Women's Hospital (Boston, Massachusetts) from 2005 to 2008 who had an LDL cholesterol level <130 mg/dl. The cases had incident CHD, and the controls had diagnoses unrelated to CHD. The 170 cases and 175 controls had a mean LDL cholesterol level of 73 and 87 mg/dl, respectively. The association between TG and HDL cholesterol levels and CHD risk was assessed using conditional and unconditional logistic regression analysis. The models investigated accommodated the possibility of an interaction between lipid factors. The odds of CHD increased by approximately 20% per 23-mg/dl increase in TGs and decreased by approximately 40% per 7.5-mg/dl decrease in HDL cholesterol. High TGs and low HDL cholesterol interacted synergistically to increase the odds ratio to 10 for the combined greatest TG (>/=190 mg/dl) and lowest HDL cholesterol quintiles (<30 mg/dl). High TG levels were more strongly associated with CHD when the HDL cholesterol was low than average or high; and low HDL cholesterol levels were more strongly associated with CHD when the TGs were high. TGs and HDL cholesterol were associated with CHD in patients with a LDL cholesterol level of </=70 mg/dl, with a risk similar to, or greater than, those in the total group. In conclusion, high TG and low HDL cholesterol levels contribute strongly and synergistically to CHD when LDL cholesterol is well controlled. Thus, high TGs might have greater importance in patients with optimal rather than greater LDL cholesterol concentrations. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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PMID: 20816113 [PubMed - in process]3: Circ Cardiovasc Qual Outcomes. 2010 Aug 31; [Epub ahead of print]
Chen ST, Maruthur NM, Appel LJ.
Division of General Internal Medicine, The Johns Hopkins University School of Medicine, Baltimore, Md; Welch Center for Prevention, Epidemiology, and Clinical Research, The Johns Hopkins University School of Medicine, Baltimore, Md; and the Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Md.
Background The Dietary Approaches to Stop Hypertension (DASH) diet is recommended in the 2005 US Dietary Guidelines. To understand the potential benefits of DASH on coronary heart disease (CHD), we applied the Framingham risk equations to calculate 10-year risk of developing CHD using data from the DASH trial. Methods and Results In the DASH trial, 459 individuals with prehypertension or stage-1 hypertension not taking antihypertensive medication were randomly assigned to 1 of 3 diets: control, fruits and vegetables (F/V), or DASH (rich in fruits, vegetables, low-fat dairy, and reduced in fats and cholesterol). Weight was held constant. Estimated 10-year CHD risk was the primary outcome of this secondary analysis. Among 436 participants with complete data, mean (SD) age was 44.7 (10.7) years, 51% were male, and 60% were African-American. Median 10-year CHD risk was 0.98% at baseline and decreased in all groups. Compared with control, the relative risk ratio comparing 8-week with baseline 10-year CHD risk was 0.93 (95% confidence interval, 0.85 to 1.02; P=0.12) for F/V and 0.82 (95% confidence interval, 0.75 to 0.90; P<0.001) for DASH. Comparing DASH with F/V, the relative risk ratio was 0.89 (95% confidence interval, 0.81 to 0.97; P=0.012). With the exception of an interaction between dietary pattern and race suggesting a greater risk reduction in blacks than whites (P for interaction=0.038), results were similar across subgroups. Conclusions Compared with control and F/V, the DASH diet reduced estimated 10-year CHD risk by 18% and 11%, respectively. In addition to reducing blood pressure, the DASH diet should substantially reduce the risk of CHD. Clinical Trial Registration URL: http://clinicaltrials.gov". Unique identifier: NCT00000544.">Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20807884&dopt=ExternalLink
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PMID: 20807884 [PubMed - as supplied by publisher]4: Circulation. 2010 Aug 30; [Epub ahead of print]
Guo N, Maehara A, Mintz GS, He Y, Xu K, Wu X, Lansky AJ, Witzenbichler B, Guagliumi G, Brodie B, Kellett MA Jr, Dressler O, Parise H, Mehran R, Stone GW.
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY.
BACKGROUND: -The incidence and mechanisms of acute and late stent malapposition after primary stent implantation in ST-segment elevation myocardial infarction remain unclear. Methods and Results-The Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial was a dual-arm, factorial, randomized trial comparing paclitaxel-eluting stents (PES) and otherwise equivalent bare metal stents (BMS) in ST-segment elevation myocardial infarction patients. The intravascular ultrasound substudy enrolled 241 patients with 263 native coronary lesions (201 PES, 62 BMS) with baseline and 13-month follow-up imaging. Postintervention acute stent malapposition (ASM) occurred in 34.3% PES- and 40.3% BMS-treated lesions. Of these, 39.1% PES- and 40.0% BMS-treated lesions resolved at follow-up, especially within the stent body (66.7%); complete resolution was accompanied by a reduction in external elastic membrane area. An ASM area >1.2 mm(2) best separated persistent from resolved ASM. At follow-up, a higher frequency of late stent malapposition was detected in PES-treated lesions (46.8%) mainly because of more late acquired stent malapposition (30.8%) compared with BMS-treated lesions. Late acquired stent malapposition area correlated to the decrease of peri-stent plaque in the subset of lesions without positive remodeling and only to change in external elastic membrane in the group with positive remodeling. Independent predictors of late acquired stent malapposition were plaque/thrombus protrusion (odds ratio, 5.60; 95% confidence interval [CI], 2.32 to 13.54) and PES use (odds ratio, 6.32; 95% CI, 2.15 to 18.62). Conclusions-The incidence of ASM was similar in PES- and BMS-treated lesions, but late acquired stent malapposition was more common in PES-treated lesions. The reason for resolved ASM was negative remodeling, with larger ASM areas separating persistent from resolved ASM. Late acquired stent malapposition was due mainly to positive remodeling and plaque/thrombus resolution. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.">Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20805433&dopt=ExternalLink
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PMID: 20805433 [PubMed - as supplied by publisher]5: Circulation. 2010 Aug 30; [Epub ahead of print]
James S, Budaj A, Aylward P, Buck KK, Cannon CP, Cornel JH, Harrington RA, Horrow J, Katus H, Keltai M, Lewis BS, Parikh K, Storey RF, Szummer K, Wojdyla D, Wallentin L.
Uppsala Clinical Research Center, Uppsala, Sweden.
BACKGROUND: -Reduced renal function is associated with a poorer prognosis and increased bleeding risk in patients with acute coronary syndromes and may therefore alter the risk-benefit ratio with antiplatelet therapies. In the Platelet Inhibition and Patient Outcomes (PLATO) trial, ticagrelor compared with clopidogrel reduced the primary composite end point of cardiovascular death, myocardial infarction, and stroke at 12 months but with similar major bleeding rates. Methods and Results-Central laboratory serum creatinine levels were available in 15 202 (81.9%) acute coronary syndrome patients at baseline, and creatinine clearance, estimated by the Cockcroft Gault equation, was calculated. In patients with chronic kidney disease (creatinine clearance <60 mL/min; n=3237), ticagrelor versus clopidogrel significantly reduced the primary end point to 17.3% from 22.0% (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.65 to 0.90) with an absolute risk reduction greater than that of patients with normal renal function (n=11 965): 7.9% versus 8.9% (HR, 0.90; 95% CI, 0.79 to 1.02). In patients with chronic kidney disease, ticagrelor reduced total mortality (10.0% versus 14.0%; HR, 0.72; 95% CI, 0.58 to 0.89). Major bleeding rates, fatal bleedings, and non-coronary bypass-related major bleedings were not significantly different between the 2 randomized groups (15.1% versus 14.3%; HR, 1.07; 95% CI, 0.88 to 1.30; 0.34% versus 0.77%; HR, 0.48; 95% CI, 0.15 to 1.54; and 8.5% versus 7.3%; HR, 1.28; 95% CI, 0.97 to 1.68). The interactions between creatinine clearance and randomized treatment on any of the outcome variables were nonsignificant. Conclusions-In acute coronary syndrome patients with chronic kidney disease, ticagrelor compared with clopidogrel significantly reduces ischemic end points and mortality without a significant increase in major bleeding but with numerically more non-procedure-related bleeding. Clinical Trial Registration-URL:http://www.clinicatrials.gov. Unique identifier: NCT00391872.">Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20805430&dopt=ExternalLink
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PMID: 20805430 [PubMed - as supplied by publisher]6: J Vasc Surg. 2010 Aug 27; [Epub ahead of print]
Antoniou GA, Riga CV, Mayer EK, Cheshire NJ, Bicknell CD.
BACKGROUND:: Emerging robotic technologies are increasingly being used by surgical disciplines to facilitate and improve performance of minimally invasive surgery. Robot-assisted intervention has recently been introduced into the field of vascular surgery to potentially enhance laparoscopic vascular and endovascular capabilities. The objective of this study was to review the current status of clinical robotic applications in vascular surgery. METHODS:: A systematic literature search was performed in order to identify all published clinical studies related to robotic implementation in vascular intervention. Web-based search engines were searched using the keywords "surgical robotics," "robotic surgery," "robotics," "computer assisted surgery," and "vascular surgery" or "endovascular" for articles published between January 1990 and November 2009. An evaluation and critical overview of these studies is reported. In addition, an analysis and discussion of supporting evidence for robotic computer-enhanced telemanipulation systems in relation to their applications in laparoscopic vascular and endovascular surgery was undertaken. RESULTS:: Seventeen articles reporting on clinical applications of robotics in laparoscopic vascular and endovascular surgery were detected. They were either case reports or retrospective patient series and prospective studies reporting laparoscopic vascular and endovascular treatments for patients using robotic technology. Minimal comparative clinical evidence to evaluate the advantages of robot-assisted vascular procedures was identified. Robot-assisted laparoscopic aortic procedures have been reported by several studies with satisfactory results. Furthermore, the use of robotic technology as a sole modality for abdominal aortic aneurysm repair and expansion of its applications to splenic and renal artery aneurysm reconstruction have been described. Robotically steerable endovascular catheter systems have potential advantages over conventional catheterization systems. Promising results from applications in cardiac interventions and preclinical studies have urged their use in vascular surgery. Although successful applications in endovascular repair of abdominal aortic aneurysm and lower extremity arterial disease have been reported, published clinical experience with the endovascular robot is limited. CONCLUSIONS:: Robotic technology may enhance vascular surgical techniques given preclinical evidence and early clinical reports. Further clinical studies are required to quantify its advantages over conventional treatments and define its role in vascular and endovascular surgery. Crown Copyright (c) 2010. Published by Mosby, Inc. All rights reserved.
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PMID: 20801611 [PubMed - as supplied by publisher]7: J Vasc Surg. 2010 Aug 25; [Epub ahead of print]
Greenberg RK, Qureshi M.
A great deal of attention has been given to the use of endografts in anatomy that involves critical aortic branches, such as the visceral segment and the aortic arch. Hybrid techniques and other methods to preserve flow into such vessels have been met with questionable success. The recent publication of the endovascular aneurysm repair (EVAR) trial data, particularly their screening registry, indicates that the number of patients with aneurysms involving critical vessels is considerable compared with aneurysms with adequate infrarenal neck. This has renewed corporate interest in developing devices that will address these complex problems. Branches designed to preserve iliac flow, fenestrated and branched devices for the visceral aortic segment, and arch branch devices have all been used clinically with a variety of platforms. This article reviews the devices and treatment strategies that are being proposed or studied by both large and small companies. Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
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PMID: 20800422 [PubMed - as supplied by publisher]8: J Am Coll Cardiol. 2010 Aug 18; [Epub ahead of print]
Bellemain-Appaix A, Brieger D, Beygui F, Silvain J, Pena A, Cayla G, Barthelemy O, Collet JP, Montalescot G.
OBJECTIVES: The purpose of this study was to perform a meta-analysis of randomized trials that compare new P2Y12 inhibitors with clopidogrel to determine whether they improve clinical outcomes after percutaneous intervention (PCI). BACKGROUND: Ticlopidine/clopidogrel prevents major adverse cardiac events after PCI, but no trials have shown an effect on mortality. New P2Y12 inhibitors are more potent and evaluated in PCI. Whether they decrease mortality after PCI compared with clopidogrel is unknown. METHODS: MEDLINE and Cochrane Controlled Trials Register databases were searched from January 1980 through January 2010. Randomized, placebo-controlled trials that compared new P2Y12 antagonists with clopidogrel in PCI were selected. Data from 8 studies were evaluated and analyses performed for all randomized patients, PCI patients (any PCI), and PCI for ST-segment elevation myocardial infarction (STEMI) patients. All-cause mortality was the primary efficacy end point. Thrombolysis In Myocardial Infarction major bleeding was the primary safety end point. RESULTS: A total of 48,599 patients were included with 94% of patients with acute coronary syndrome and 84% of patients undergoing PCI. New P2Y12 inhibitors significantly decreased death (odds ratio [OR]: 0.83, 95% confidence interval [CI]: 0.75 to 0.92, p < 0.001 for the whole cohort; OR: 0.85, 95% CI: 0.75 to 0.96, p = 0.008 for any PCI; and OR: 0.78, 95% CI: 0.66 to 0.92, p = 0.003 for PCI for STEMI). In PCI patients, new P2Y12 inhibitors also significantly decreased major adverse cardiac events by 18% (p < 0.001) and stent thrombosis by 40% (p < 0.001). Although there was an increase in Thrombolysis In Myocardial Infarction major bleeding for any PCI (OR: 1.23, 95% CI: 1.04 to 1.46, p = 0.01), no difference was observed in PCI for STEMI (OR: 0.98, 95% CI: 0.85 to 1.13, p = 0.76), with similar outcomes in primary PCI for STEMI. Results were confirmed in sensitivity analyses that removed the largest study. CONCLUSIONS: New P2Y12 inhibitors decrease mortality after PCI compared with clopidogrel. The risk/benefit ratio is particularly favorable in PCI for STEMI patients. Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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PMID: 20800407 [PubMed - as supplied by publisher]9: J Am Coll Cardiol. 2010 Aug 31;56(10):766-73.
Fein AS, Wang Y, Curtis JP, Masoudi FA, Varosy PD, Reynolds MR; National Cardiovascular Data Registry.
Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
OBJECTIVES: The purpose of the study was to define the extent and nature of cardiac resynchronization therapy (CRT) device usage outside consensus guidelines using national data. BACKGROUND: Recent literature has shown that the application of CRT in clinical practice frequently does not adhere to evidence-based consensus guidelines. Factors underlying these practices have not been fully explored. METHODS: From the National Cardiovascular Data Registry's Implantable Cardiac-Defibrillator Registry, we defined a cohort of 45,392 cardiac resynchronization therapy-defibrillator (CRT-D) implants between January 2006 and June 2008 with a primary prevention indication. We defined "off-label" implants as those in which the ejection fraction was >35%, the New York Heart Association functional class was below III, or the QRS interval duration was <120 ms in the absence of a documented need for ventricular pacing. The relationships between patient, implanting physician, and hospital characteristics with off-label use were explored with multivariable hierarchical logistic regression models. RESULTS: Overall, 23.7% of devices were placed without meeting all 3 implant criteria, most often due to New York Heart Association functional class below III (13.1% of implants) or QRS interval duration <120 ms (12.0%). Atrial fibrillation/flutter, previous percutaneous coronary intervention, and the performance of an electrophysiology study before implant were independently associated with increased odds of off-label use, whereas diabetes mellitus, increasing age, and female sex were associated with decreased odds. Physician training and insurance payer were weakly associated with the likelihood of off-label use. CONCLUSIONS: Nearly 1 in 4 patients receiving CRT devices in the study time frame did not meet guideline-based indications. Given the evolving evidence base supporting the use of CRT, these practices require careful scrutiny. Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Publication Types: Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, P.H.S.
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PMID: 20797489 [PubMed - in process]10: J Am Coll Cardiol. 2010 Aug 31;56(10):754-62.
Van Bommel RJ, Delgado V, Schalij MJ, Bax JJ.
Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.
Cardiac resynchronization therapy (CRT) is an effective treatment for patients with drug-refractory, chronic heart failure. Multiple single-center and multicenter studies have shown significant reductions in left ventricular (LV) volumes and an increase in LV systolic function. More importantly, CRT reduces mortality and morbidity during long-term follow-up. Current guidelines consider CRT as a Class I indication for heart failure patients in New York Heart Association (NYHA) functional class III to IV with depressed LV ejection fraction <or=35% and a wide QRS complex (>or=120 ms). However, the benefits of this therapy could possibly be extended to selected subgroups of patients who do not fulfill these criteria. These subgroups include patients with mildly symptomatic heart failure and patients with a narrow QRS complex (<120 ms). Results from recent multicenter controlled clinical trials including heart failure patients in NYHA functional class I to II or with a narrow QRS complex are equivocal. Although expanding CRT to patients with a narrow QRS complex seems currently not likely, the benefits of CRT in mildly symptomatic patients are more evident. Perhaps attenuation of disease progression will prove to be a successful new treatment strategy in heart failure patients in the future. In addition, multimodality cardiac imaging will allow optimizing responder rate in patients undergoing CRT according to current guidelines. Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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PMID: 20797487 [PubMed - in process]11: Circ Cardiovasc Interv. 2010 Aug 24; [Epub ahead of print]
Frelinger AL 3rd, Barnard MR, Fox ML, Michelson AD.
Center for Platelet Research Studies, Division of Hematology/Oncology, Children's Hospital Boston, Harvard Medical School, Boston, Mass; and the Center for Platelet Function Studies, Department of Pediatrics, University of Massachusetts Medical School, Worcester, Mass.
Background-"Rebound" platelet hyperreactivity after discontinuation of clopidogrel has been proposed to lead to increased thrombotic risk, including late stent thrombosis. However the hypothesis that discontinuation of clopidogrel results in platelet hyperreactivity has never been rigorously tested. We therefore performed a randomized, double-blind, placebo-controlled, crossover study: the Platelet Activity after Clopidogrel Termination (PACT) study. Methods and Results-Platelet reactivity in 15 healthy subjects was measured at baseline, during clopidogrel 75 mg or placebo daily for 14 days, and on days 1, 4, 8, 11, 15, and 45 after discontinuation of clopidogrel or placebo. Platelet reactivity was assessed by (1) platelet surface activated GPIIb-IIIa and surface P-selectin (by whole blood flow cytometry) in response to ADP 0.5, 1, and 20 mu mol/L; thrombin receptor activating peptide (TRAP) 1 and 20 mu mol/L; and collagen/epinephrine 5 mu g/mL/5 mu mol/L, (2) light transmission aggregation with ADP 2.5, 5, and 20 mu mol/L; TRAP 2 and 20 mu mol/L; and collagen 6 mu g/mL, (3) whole blood impedance aggregation with ADP 1.6 and 6.5 mu mol/L; TRAP 4 and 32 mu mol/L; and collagen 3.2 mu g/mL, and (4) plasma soluble CD40 ligand (by ELISA). Immature platelet fraction was measured in the Sysmex XE-2100. At no time point after discontinuation of clopidogrel was platelet reactivity, as determined by any assay end point, or the immature platelet fraction significantly greater than after discontinuation of placebo. Conclusions-This randomized, double-blind, placebo-controlled, crossover study demonstrates that discontinuation of clopidogrel does not result in "rebound" platelet hyperreactivity, as determined by multiple time points, assays, agonists, and agonist concentrations. Clinical Trial Registration-URL: http://clinicaltrials.gov. Unique identifier: NCT00619073.">Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20736449&dopt=ExternalLink
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PMID: 20736449 [PubMed - as supplied by publisher]12: Circ Cardiovasc Interv. 2010 Aug 24; [Epub ahead of print]
Ott I, Schulz S, Mehilli J, Fichtner S, Hadamitzky M, Hoppe K, Ibrahim T, Martinoff S, Massberg S, Laugwitz KL, Dirschinger J, Schwaiger M, Kastrati A, Schomig A; for the REVIVAL-3 Study Investigators.
Deutsches Herzzentrum, 1. Medizinische Klinik rechts der Isar, and Nukearmedizinische Klinik rechts der Isar, Munich, Germany.
Background-Erythropoietin improves myocardial function in experimental models of myocardial infarction. The aim of the present study was to determine the value of erythropoietin in patients with acute ST-elevation myocardial infarction. METHODS AND RESULTS: =0.92). Five days after percutaneous coronary intervention, left ventricular ejection fraction was 49.4+/-8.0% in the erythropoietin group and 50.8+/-7.3% in the placebo group (P=0.32); infarct size was 26.8+/-20.9% and 28.3+/-24.4% (P=0.76) and decreased to 17.3+/-14.3% and 20.9+/-16.4% at 6-month follow-up (P=0.27). The cumulative 6-month incidence of death, recurrent myocardial infarction, stroke or target vessel revascularization was 13.2% in the erythropoietin group and 5.7% in the placebo group (hazard ratio, 2.36; 95% confidence interval, 0.73 to 7.66; P=0.15). Conclusions-In patients with acute ST-elevation myocardial infarction treated with primary percutaneous coronary intervention, erythropoietin treatment did not improve left ventricular ejection fraction or reduce infarct size but may increase clinical adverse events. Clinical Trial Registration-URL: http://clinicaltrials.gov. Unique identifier: NCT00390832.">Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20736448&dopt=ExternalLink
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PMID: 20736448 [PubMed - as supplied by publisher]13: Circ Cardiovasc Interv. 2010 Aug 24; [Epub ahead of print]
Gotberg M, Olivecrona GK, Koul S, Carlsson M, Engblom H, Ugander M, van der Pals J, Algotsson L, Arheden H, Erlinge D.
Department of Coronary Heart Disease, the Department of Clinical Physiology, and the Department of Cardiothoracic Anesthesia, Skane University Hospital, Lund University, Lund, Sweden.
Background-Experimental studies have shown that induction of hypothermia before reperfusion of acute coronary occlusion reduces infarct size. Previous clinical studies, however, have not been able to show this effect, which is believed to be mainly because therapeutic temperature was not reached before reperfusion in the majority of the patients. We aimed to evaluate the safety and feasibility of rapidly induced hypothermia by infusion of cold saline and endovascular cooling catheter before reperfusion in patients with acute myocardial infarction. METHODS AND RESULTS: =0.12). Despite similar duration of ischemia (174+/-51 minutes versus 174+/-62 minutes, hypothermia versus control, P=1.00), infarct size normalized to myocardium at risk was reduced by 38% in the hypothermia group compared with the control group (29.8+/-12.6% versus 48.0+/-21.6%, P=0.041). This was supported by a significant decrease in both peak and cumulative release of Troponin T in the hypothermia group (P=0.01 and P=0.03, respectively). Conclusions-The protocol demonstrates the ability to reach a core body temperature of <35 degrees C before reperfusion in all patients without delaying primary percutaneous coronary intervention and that combination hypothermia as an adjunct therapy in acute myocardial infarction may reduce infarct size at 3 days as measured by MRI. Clinical Trial Registration-URL: http://clinicaltrials.gov. Unique identifier: NCT00417638.">Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20736446&dopt=ExternalLink
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PMID: 20736446 [PubMed - as supplied by publisher]14: Circ Cardiovasc Qual Outcomes. 2010 Aug 24; [Epub ahead of print]
Ridker PM, Macfadyen JG, Nordestgaard BG, Koenig W, Kastelein JJ, Genest J, Glynn RJ.
Center for Cardiovascular Disease Prevention and the Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass; the Department of Clinical Biochemistry, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark; the University of Ulm, Ulm, Germany; Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; and McGill University Health Center, Montreal Canada.
Background Recent primary prevention guidelines issued in Canada endorse the use of statin therapy among individuals at "intermediate risk" who have elevated levels of high-sensitivity C-reactive protein (hsCRP). However, trial data directly addressing whether this recommendation defines a patient population in which statin therapy is effective have not previously been published. Methods and Results In the Justification for Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) trial, which demonstrated a 44% reduction in first vascular events when rosuvastatin 20 mg was compared with placebo among 17 802 primary prevention patients with LDL cholesterol <130 mg/dL and hsCRP >/=2 mg/L, 6091 participants (2525 women, 3566 men) had baseline estimated 10-year Framingham risks of 5% to 10% and 7340 participants (1404 women, 5936 men) had baseline estimated Framingham risk of 11% to 20%. In these 2 "intermediate risk" subgroups, relative risk reductions consistent with the overall trial treatment effect were observed (hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.84; 5-year number needed to treat=40, P=0.005 for those with 5% to 10% risk; hazard ratio, 0.51; 95% confidence interval, 0.39 to 0.68, 5-year number needed to treat=18, P<0.0001 for those with 11% to 20% risk). Use of the Reynolds Risk Score to stratify the study population gave similar results but reclassified large numbers of individuals into lower- or higher-risk groups. The majority of women with elevated hsCRP who benefited from rosuvastatin were at 5% to 10% 10-year risk at study entry using either global risk scoring system. Conclusions Consistent with recent evidence-based Canadian Cardiovascular Society guidelines for primary prevention, the JUPITER trial demonstrates that rosuvastatin 20 mg significantly reduces major cardiovascular events among men and women with elevated hsCRP and "intermediate risk" defined either as 5% to 10% or 10% to 20% 10-year risk. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00239681.">Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20736443&dopt=ExternalLink
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PMID: 20736443 [PubMed - as supplied by publisher]15: Circulation. 2010 Aug 23; [Epub ahead of print]
Lubitz SA, Sinner MF, Lunetta KL, Makino S, Pfeufer A, Rahman R, Veltman CE, Barnard J, Bis JC, Danik SP, Sonni A, Shea MA, Del Monte F, Perz S, Muller M, Peters A, Greenberg SM, Furie KL, van Noord C, Boerwinkle E, Stricker BH, Witteman J, Smith JD, Chung MK, Heckbert SR, Benjamin EJ, Rosand J, Arking DE, Alonso A, Kaab S, Ellinor PT.
Cardiac Arrhythmia Service and Cardiovascular Research Center, Massachusetts General Hospital, Boston, MA 02114. pellinor@partners.org.
BACKGROUND: Genetic variants on chromosome 4q25 are associated with atrial fibrillation (AF). We sought to determine whether there is more than 1 susceptibility signal at this locus. METHODS AND RESULTS: Thirty-four haplotype-tagging single-nucleotide polymorphisms (SNPs) at the 4q25 locus were genotyped in 790 case and 1177 control subjects from Massachusetts General Hospital and tested for association with AF. We replicated SNPs associated with AF after adjustment for the most significantly associated SNP in 5066 case and 30 661 referent subjects from the German Competence Network for Atrial Fibrillation, Atherosclerosis Risk In Communities Study, Cleveland Clinic Lone AF Study, Cardiovascular Health Study, and Rotterdam Study. All subjects were of European ancestry. A multimarker risk score composed of SNPs that tagged distinct AF susceptibility signals was constructed and tested for association with AF, and all results were subjected to meta-analysis. The previously reported SNP, rs2200733, was most significantly associated with AF (minor allele odds ratio 1.80, 95% confidence interval 1.50 to 2.15, P=1.2x10(-20)) in the discovery sample. Adjustment for rs2200733 genotype revealed 2 additional susceptibility signals marked by rs17570669 and rs3853445. A graded risk of AF was observed with an increasing number of AF risk alleles at SNPs that tagged these 3 susceptibility signals. CONCLUSIONS: We identified 2 novel AF susceptibility signals on chromosome 4q25. Consideration of multiple susceptibility signals at chromosome 4q25 identifies individuals with an increased risk of AF and may localize regulatory elements at the locus with biological relevance in the pathogenesis of AF.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733104&dopt=ExternalLink
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PMID: 20733104 [PubMed - as supplied by publisher]16: Circulation. 2010 Aug 23; [Epub ahead of print]
Hueb W, Lopes N, Gersh BJ, Soares PR, Ribeiro EE, Pereira AC, Favarato D, Rocha AS, Hueb AC, Ramires JA.
BACKGROUND: This study compared the 10-year follow-up of percutaneous coronary intervention (PCI), coronary artery surgery (CABG), and medical treatment (MT) in patients with multivessel coronary artery disease, stable angina, and preserved ventricular function. METHODS AND RESULTS: The primary end points were overall mortality, Q-wave myocardial infarction, or refractory angina that required revascularization. All data were analyzed according to the intention-to-treat principle. At a single institution, 611 patients were randomly assigned to CABG (n=203), PCI (n=205), or MT (n=203). The 10-year survival rates were 74.9% with CABG, 75.1% with PCI, and 69% with MT (P=0.089). The 10-year rates of myocardial infarction were 10.3% with CABG, 13.3% with PCI, and 20.7% with MT (P<0.010). The 10-year rates of additional revascularizations were 7.4% with CABG, 41.9% with PCI, and 39.4% with MT (P<0.001). Relative to the composite end point, Cox regression analysis showed a higher incidence of primary events in MT than in CABG (hazard ratio 2.35, 95% confidence interval 1.78 to 3.11) and in PCI than in CABG (hazard ratio 1.85, 95% confidence interval 1.39 to 2.47). Furthermore, 10-year rates of freedom from angina were 64% with CABG, 59% with PCI, and 43% with MT (P<0.001). CONCLUSIONS: Compared with CABG, MT was associated with a significantly higher incidence of subsequent myocardial infarction, a higher rate of additional revascularization, a higher incidence of cardiac death, and consequently a 2.29-fold increased risk of combined events. PCI was associated with an increased need for further revascularization, a higher incidence of myocardial infarction, and a 1.46-fold increased risk of combined events compared with CABG. Additionally, CABG was better than MT at eliminating anginal symptoms. Clinical Trial Registration Information- URL: http://www.controlled-trials.com. Registration number: ISRCTN66068876.">Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733102&dopt=ExternalLink
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PMID: 20733102 [PubMed - as supplied by publisher]17: Circulation. 2010 Aug 23; [Epub ahead of print]
Solomon SD, Foster E, Bourgoun M, Shah A, Viloria E, Brown MW, Hall WJ, Pfeffer MA, Moss AJ; for the MADIT-CRT Investigators.
Cardiovascular Division, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115. ssolomon@rics.bwh.harvard.edu.
BACKGROUND: Cardiac resynchronization therapy (CRT) plus implantation of an implantable cardioverter defibrillator (ICD) reduced the risk of death or heart failure event in patients with mildly symptomatic heart failure, left ventricular dysfunction, and wide QRS complex compared with an ICD only. We assessed echocardiographic changes in patients enrolled in the MADIT-CRT trial (Multicenter Automatic Defibrillator Implantation Trial: Cardiac Resynchronization Therapy) to evaluate whether the improvement in outcomes with CRT plus an ICD was associated with favorable alterations in cardiac size and function. METHODS AND RESULTS: A total of 1820 patients were randomly assigned to CRT plus an ICD or to an ICD only in a 3:2 ratio. Echocardiographic studies were obtained at baseline and 12 months later in 1372 patients. We compared changes in cardiac size and performance between treatment groups and assessed the relationship between these changes over the first year, as well as subsequent outcomes. Compared with the ICD-only group, the CRT-plus-ICD group had greater improvement in left ventricular end-diastolic volume index (-26.2 versus -7.4 mL/m(2)), left ventricular end-systolic volume index (-28.7 versus -9.1 mL/m(2)), left ventricular ejection fraction (11% versus 3%), left atrial volume index (-11.9 versus -4.7 mL/m(2)), and right ventricular fractional area change (8% versus 5%; P<0.001 for all). Improvement in end-diastolic volume at 1 year was predictive of subsequent death or heart failure, with adjustment for baseline covariates and treatment group; each 10% decrease in end-diastolic volume was associated with a 40% reduction in risk (P<0.001). CONCLUSIONS: CRT resulted in significant improvement in cardiac size and performance compared with an ICD-only strategy in patients with mildly symptomatic heart failure. Improvement in these measures accounted for the outcomes benefit. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180271.">Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733097&dopt=ExternalLink
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PMID: 20733097 [PubMed - as supplied by publisher]18: Circulation. 2010 Aug 23; [Epub ahead of print]
Reriani M, Raichlin E, Prasad A, Mathew V, Pumper GM, Nelson RE, Lennon R, Rihal C, Lerman LO, Lerman A.
Division of Cardiovascular Diseases, Mayo Clinic Rochester, 200 First St SW, Rochester, MN 55905. lerman.amir@mayo.edu.
BACKGROUND: Endothelin (ET-1) is one of the most potent vasoconstrictors and plays a seminal role in the pathogenesis of atherosclerosis. The present study was designed to test the hypothesis that long-term treatment with an endothelin-A (ET(A)) receptor antagonist improves coronary endothelial function in patients with early coronary atherosclerosis. METHODS AND RESULTS: Forty-seven patients with multiple cardiovascular risk factors, nonobstructive coronary artery disease, and coronary endothelial dysfunction were randomized in a double-blind manner to either the ET(A) receptor antagonist atrasentan (10 mg) or placebo for 6 months. Coronary endothelium-dependent vasodilation was examined by infusing acetylcholine (10(-6) to 10(-4) mol/L) in the left anterior descending coronary artery. N(G)-monomethyl-l-arginine was administered to a subgroup of patients. Endothelium-independent coronary flow reserve was examined by use of intracoronary adenosine and nitroglycerin. Baseline characteristics and incidence of adverse effects were similar between the 2 groups. There was a significant improvement in percent change of coronary blood flow in response to acetylcholine at 6 months from baseline in the atrasentan group compared with the placebo group (39.67%, 95% confidence interval 23.23% to 68.21%, versus -2.22%, 95% confidence interval -27.37% to 15.28%; P<0.001). No significant difference in the percent change of coronary artery diameter or change in coronary flow reserve was demonstrated. Coronary blood flow, coronary artery diameter, and the effect of N(G)-monomethyl-l-arginine were similar between the groups at baseline and at 6 months. CONCLUSIONS: This study demonstrates that 6-month treatment with atrasentan improves coronary microvascular endothelial function and supports the role of the endogenous endothelin system in the regulation of endothelial function in early atherosclerosis in humans. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00271492.">Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20733096&dopt=ExternalLink
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PMID: 20733096 [PubMed - as supplied by publisher]19: J Vasc Surg. 2010 Aug 21; [Epub ahead of print]
Kurtoglu M, Koksoy C, Hasan E, Akcali Y, Karabay O, Filizcan U; TROMBOTEK Study Group.
Department of General Surgery, Istanbul University, Istanbul School of Medicine, Istanbul, Turkey.
OBJECTIVE: The present study was designed to evaluate the long-term efficacy and safety of once-daily enoxaparin plus warfarin for the outpatient ambulatory treatment of lower-limb deep venous thrombosis (DVT). METHODS: A total of 246 patients, comprising 128 men (mean age, 54.28 +/- 16.48 years) and 118 women (mean age, 50.11 +/- 16.47 years) with symptomatic lower extremity DVT, were included in this open-label, single-arm, multicenter, phase IV clinical trial conducted at 14 centers in Turkey. All patients were administered subcutaneous enoxaparin (1.5 mg/kg, once-daily) until international normalized ratio (INR) levels reached to 2 to 3, followed by oral warfarin (5 mg/d) for at least 3 months and elastic compression stockings (30-40 mm Hg). Clinical signs (leg circumference), symptoms (edema, pain, tenderness), recanalization rates upon duplex ultrasound examination, laboratory findings (D-dimer and INR levels), and postthrombotic syndrome status with CEAP classification were the efficacy parameters evaluated every 3 months during 18 months of follow-up. Safety end points included minor and major bleeding as well as serious adverse events. RESULTS: Ambulatory treatment with enoxaparin plus warfarin significantly reduced physical symptoms, including tenderness, edema, pain (P < .001), and the circumference of the affected leg (P < .001). The leg circumference difference in almost all patients was <1.5 cm at the end of 18 months (P < .001). Recanalization rates for occluded iliofemoral vein were 76.1% at 3 months and 86.5% at 18 months (P < .001). An early and significant decrease obtained in D-dimer levels on day 10 continued to decline significantly until month 6 and remained unchanged afterwards (P < .001). Of four patients diagnosed with major bleeding during oral anticoagulant use, three recovered with conservative treatment (reduction in hemoglobin levels in 2 developed at visit 2 [day 10] and intracranial bleeding in 1 developed at visit 3 [day 30]), and one patient required a hysterectomy after menorrhagia developed at visit 7 (month 18). Two of the 65 (9.9%) adverse events documented were serious adverse events, but none of the serious adverse events leading to death were related to the study medications. CONCLUSION: Ambulatory treatment with enoxaparin plus warfarin seems to be effective in symptomatic healing and in clinical improvement by reducing thrombus formation and organization at all levels of lower extremity venous system with DVT, without a significant major bleeding risk. Therefore, the results of our conventional conservative treatment are in line with 1A level evidence reported in the recent American College of Chest Physicians guideline. Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20732787&dopt=ExternalLink
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PMID: 20732787 [PubMed - as supplied by publisher]20: Angiology. 2010 Aug 18; [Epub ahead of print]
Elkaffas KH, Elkashef O, Elbaz W.
Introduction: Chronic venous insufficiency is the most common vascular disease in the adult population. However, randomized clinical trials (RCTs) comparing therapeutic options are limited. Patients and Methods: A total of 180 patients with saphenofemoral junction and great saphenous reflux detected on duplex were randomized to either ultrasound-guided radiofrequency ablation (RFA) or standard surgical treatment. The study participants blindly chose an assignment card that placed them in either group A (ultrasound-guided RFA of the great saphenous vein [GSV]; n = 90); or group B (surgical management n = 90). Patients were followed up for 24 months. Results: The primary occlusion rate in group A was 94.5% versus 100% in group B. Radiofrequency ablation had a lower overall complication rate (P = .02) and shorter post-intervention hospital stay (P = .001). Kaplan-Meier analysis showed no significant differences in recurrence rates at 24 months follow-up (P = .45). Radiofrequency ablation was significantly more expensive (P = .003). Conclusion: Great saphenous vein occlusion was achieved efficiently in 94% of our group using RFA with minimal complications and obvious advantages as compared to standard surgery.
Links http://www.ncbi.nlm.nih.gov/entrez/queryd.fcgi?cmd=Retrieve&db=PubMed&list_uids=20724299&dopt=ExternalLink
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PMID: 20724299 [PubMed - as supplied by publisher]