Routine use of fondaparinux in acute coronary syndromes: A 2-year multicenter experience.

Am Heart J. 2010 Feb;159(2):190-198

Authors: Schiele F, Meneveau N, Seronde MF, Descotes-Genon V, Dutheil J, Chopard R, Ecarnot F, Bassand JP,

BACKGROUND: Fondaparinux has recently been approved in patients with acute coronary syndromes. The primary aim of this study was to describe the changes in use of anticoagulants between January 2006 and December 2007. The secondary aim was to compare 30-day mortality and rate of a combined end point (30-day death or major bleeding) according to the initial and final anticoagulant agent used. METHODS: The rates of use of unfractionated heparin (UFH), enoxaparin, and fondaparinux were compared by periods of 1 month in a multicenter registry. The initial anticoagulant (first used at admission), the final anticoagulant (last used during hospitalization), and switches in anticoagulation were recorded. Temporal trends in monthly use of each anticoagulant were assessed; 30-day mortality rates and the combined end point were compared according to initial and final anticoagulant. RESULTS: Among 2,874 patients included, the first anticoagulant used was UFH in 26%, enoxaparin in 59%, and fondaparinux in 15%. Respective figures for final anticoagulant were 17%, 56%, and 27%. Although 3 centers did not use fondaparinux (community centers with catheterization laboratory), the overall rate of use of fondaparinux, as initial and final anticoagulant, increased at the expense of the use of enoxaparin. We observed a growing proportion of patients with a switch from UFH to either enoxaparin or fondaparinux, ranging from 5% at the beginning to 25% at the end of the study. Patients treated with UFH were older, had more comorbidities, were at higher risk, and received fewer guidelines-recommended treatments. In patients submitted to angioplasty and treated with fondaparinux, a bolus of 60 IU/kg of UFH was added. After adjustment, 30-day mortality and combined end point rates were higher in patients treated with UFH. Irrespective of the type of acute coronary syndromes, patients treated with enoxaparin or fondaparinux had similar outcomes. CONCLUSIONS: Between 2006 and 2007, the use of fondaparinux in patients with acute coronary syndromes increased considerably, either because it was used instead of enoxaparin or because of a switch from UFH. Adjusted mortality in patients treated with fondaparinux was lower than with UFH and similar to enoxaparin.

PMID: 20152216 [PubMed - as supplied by publisher]

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Randomized comparison between clinical evaluation plus N-terminal pro-B-type natriuretic peptide versus exercise testing for decision making in acute chest pain of uncertain origin.

Am Heart J. 2010 Feb;159(2):176-182

Authors: Sanchis J, Bosch X, Bodí V, Núñez J, Doltra A, Heras M, Mainar L, Santas E, Bragulat E, García-Alvarez A, Carratalá A, Llácer A

BACKGROUND: Exercise testing constitutes the usual tool for decision making in chest pain units. This policy implies logistical constrains. Our aim was to evaluate a new strategy, combining a clinical risk score and N-terminal pro-B-type natriuretic peptide (NT-proBNP), in patients presenting to the emergency department with chest pain, without ischemic electrocardiogram changes or troponin elevation. METHODS: A total of 320 patients were randomized to either usual management, involving exercise testing, or a new strategy combining a clinical risk score and NT-proBNP without exercise testing. In the usual management, discharge decision was guided by the result of exercise test. In the new strategy, those patients with low clinical risk score and NT-proBNP were directly discharged. The primary outcome was hospitalization at the index episode. Secondary outcomes were cardiac events at 1 year. RESULTS: A total of 110 patients (69%) were hospitalized using usual management in comparison with 90 (56%) in the new strategy (P = .03). There were no differences in death or myocardial infarction (n = 11, 6.9% vs n = 6, 3.8%, P = .3) or cardiac events (n = 38, 24% vs n = 28, 18%, P = .2). Revascularizations at the index episode were more frequent under usual management (18% vs 8%, P = .01), although the new strategy was associated with higher rate of planned postdischarge revascularizations (0.6% vs 5%, P = .04). CONCLUSIONS: A strategy combining clinical history and NT-proBNP is simpler and reduced initial emergency hospitalizations in patients with chest pain, in comparison with the usual strategy involving exercise testing. Larger studies to assess its impact on long-term hard end points are needed. (ClinicalTrials.govNCT00493844).

PMID: 20152214 [PubMed - as supplied by publisher]

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Safety and feasibility of early hospital discharge in ST-segment elevation myocardial infarction-A prospective and randomized trial in low-risk primary percutaneous coronary intervention patients (the Safe-Depart Trial).

Am Heart J. 2010 Jan;159(1):117.e1-117.e6

Authors: Kotowycz MA, Cosman TL, Tartaglia C, Afzal R, Syal RP, Natarajan MK

BACKGROUND: Patients with ST-segment elevation myocardial infarction (STEMI) have traditionally been hospitalized for 5 to 7 days to monitor for serious complications such as heart failure, arrhythmias, reinfarction, and death. The Zwolle Primary Percutaneous Coronary Intervention (PCI) Index is an externally validated risk score that has been used to identify low-risk STEMI patients who have undergone primary PCI and can safely be discharged from hospital within 72 hours. Previous studies have shown that many low-risk patients remain in hospital significantly longer. METHODS: We randomly assigned 54 low-risk STEMI patients treated with primary or rescue PCI to 1 of 2 groups. Patients in the intervention group (n = 27) were actively targeted for early hospital discharge (48-72 hours) and received outpatient follow-up with an advanced practice nurse (APN). In the control group (n = 27), discharge planning and follow-up were left to the treating physician, and there was no added nursing intervention. The 2 primary outcomes of this pilot study were to demonstrate feasibility and safety. Secondary outcomes included compliance with medications, smoking cessation, attendance at cardiac rehabilitation, and quality of life, measured in both groups at 6 weeks time. RESULTS: In the intervention group, 74% of patients were discharged within 72 hours, 100% had follow-up with the APN within 3 days (74% in person, 26% by phone), and 100% had >/= 3 APN follow-ups in total, meeting our prespecified criteria for feasibility. The median length of stay was 55 hours in both groups. There were no deaths in either group, and there was no difference in rehospitalization between patients in the intervention and control groups (8% vs 4%, P = .56). There was no difference in rates of medication compliance, smoking cessation, attendance at cardiac rehabilitation, or quality of life between the 2 groups, although our small pilot study was not powered to detect a difference in these outcomes. CONCLUSION: In low-risk STEMI patients treated with primary or rescue PCI, a strategy of early hospital discharge facilitated by close nursing follow-up is feasible. Although our study did not identify differences in compliance or quality of life between the 2 groups, it did provide a functional study design for a larger trial powered to detect these important clinical end points.

PMID: 20102876 [PubMed - as supplied by publisher]

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Prognostic role of highly sensitive cardiac troponin I in patients with systolic heart failure.

Am Heart J. 2010 Jan;159(1):63-7

Authors: Tsutamoto T, Kawahara C, Nishiyama K, Yamaji M, Fujii M, Yamamoto T, Horie M

BACKGROUND: Cardiac troponin T (cTnT) and cardiac troponin I (cTnI) are useful biomarkers in patients with chronic heart failure (CHF). However, the clinical use has limitations due to the low sensitivity of a conventional commercial assay system. Recently, a high sensitive-cTnI (hs-cTnI) commercial assay has become available. METHODS: To compare the prognostic value of cTnT and hs-cTnI, we measured hemodynamic parameters and serum levels of cTnT, hs-cTnI and N-terminal pro-brain natriuretic peptide (NT-proBNP)in 258 consecutive CHF patients and then followed these patients for a mean period of 2.6 years. In both assays of cTnT and hs-cTnI, the lowest concentration at which the coeffi cient of variation was < or =10% were 0.03 ng/mL, respectively. Therefore, in the present study, an elevated cTnT or cTnI test was defined as a level of > or =0.03 ng/mL. RESULTS: During long-term follow up, there were 20 cardiac deaths. In 258 CHF patients, serum cTnT were elevated (> or =0.03 ng/mL) in 32 patients (12%) and serum hs-cTnI was elevated (> or =0.03 ng/mL) in 112 patients (43%). On stepwise multivariate analyses, high plasma NT-proBNP (> or =627 pg/mL, P = .0063) and hs-cTnI (> or =0.03 ng/mL) (P = .016) were independent significant prognostic predictors but cTnT (> or =0.03 ng/mL) was not. The hazard ratio for mortality of patients with high plasma NT-proBNP (> or =627 pg/mL) and hs-cTnI (> or =0.03 ng/mL) was 5.74 (95% CI, 2.33-14.28, P < .0001) compared to that of those with low NT-proBNP (<627 pg/mL) or hs-cTnI (<0.03 ng/mL). CONCLUSIONS: These findings indicate that a high plasma concentration of hs-cTnI is an independent and useful prognostic predictor in patients with CHF.

PMID: 20102868 [PubMed - in process]

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Noninvasive assessment of left ventricular filling pressure after acute myocardial infarction: A prospective study of the relative prognostic utility of clinical assessment, echocardiography, and B-type natriuretic peptide.

Am Heart J. 2010 Jan;159(1):47-54

Authors: Kruszewski K, Scott AE, Barclay JL, Small GR, Croal BL, Møller JE, Oh JK, Hillis GS

BACKGROUND: Elevated left ventricular filling pressure after acute myocardial infarction (AMI) may be identified using clinical assessment, echocardiography, and B-type natriuretic peptide (BNP) levels. All of these predict outcome in this setting. There are, however, no data assessing their relative prognostic value. The current study addresses this. METHODS: Four hundred patients underwent detailed echocardiography and measurement of BNP levels after AMI (median 1 day). The study end points were (1) a composite of death, recurrent AMI, and/or admission to hospital with heart failure within 1 year and (2) all-cause mortality during medium-term follow-up (median 2.9 years). RESULTS: Both an elevated ratio of early transmitral flow to early mitral annulus velocity (E/e') and higher BNP levels were associated with an increased risk of an adverse event within the first year (odds ratio 6.14 for E/e' >15, P < .001; odds ratio 1.19 per 50-pg/mL increase in BNP, P < .001) and medium-term mortality (hazard ratio 4.67 for E/e' >15, P < .001; hazard ratio 1.10 per 50-pg/mL increase in BNP, P < .001). Among patients with BNP levels higher than the median or in the upper quartile, an E/e' ratio >15 identified a subgroup at greatest risk of mortality (P < .001 for both). CONCLUSIONS: The E/e' ratio and BNP levels play important and complementary roles in the risk stratification of patients after AMI.

PMID: 20102866 [PubMed - in process]

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Management patterns of non-ST segment elevation acute coronary syndromes in relation to prior coronary revascularization.

Am Heart J. 2010 Jan;159(1):40-6

Authors: Elbarasi E, Goodman SG, Yan RT, Welsh RC, Kornder J, Wong GC, Déry JP, Anderson F, Gore JM, Fox KA, Yan AT, ,

BACKGROUND: Contemporary guidelines support an early invasive strategy for non-ST elevation acute coronary syndrome (NSTE-ACS) patients who had prior coronary revascularization. However, little is known about the management pattern of these patients in "real world." METHODS: We analyzed 3 consecutive Canadian registries (ACS I, ACS II, and Global Registry of Acute Coronary Events [GRACE]/expanded-GRACE) that recruited 12,483 NSTE-ACS patients from June 1999 to December 2007. We stratified the study population according to prior coronary revascularization status into 4 groups and compared their clinical characteristics, in-hospital use of medications, and cardiac procedures. RESULTS: Of the 12,483 NSTE-ACS patients, 71.2% had no prior revascularization, 14.2% had percutaneous coronary intervention (PCI) only, 9.5% had coronary artery bypass graft surgery (CABG) only, and 5% had both PCI and CABG. Compared to their counterparts without prior revascularization, patients with previous PCI and/or CABG were more likely to be male, to have diabetes, myocardial infarction, and heart failure but less likely to have ST-segment deviation or positive cardiac biomarker on presentation. Early use of evidence-based medications was higher among patients with previous PCI only and lower among patients with previous CABG only. After adjusting for possible confounders including GRACE risk score, prior PCI was independently associated with in-hospital use of cardiac catheterization (adjusted odds ratio [OR] 1.18, 95% CI 1.04-1.34, P = .008). In contrast, previous CABG was an independent negative predictor (adjusted OR .77, 95% CI 0.68-0.87, P < .001). There was no significant interaction (P = .93) between previous PCI and CABG. CONCLUSIONS: The NSTE-ACS patients with previous PCI were more likely to be treated invasively. Conversely, patients with prior CABG less frequently received invasive therapy. Future studies should determine the appropriateness of this treatment discrepancy.

PMID: 20102865 [PubMed - in process]

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Safety and feasibility of adjunctive antiplatelet therapy with intravenous elinogrel, a direct-acting and reversible P2Y12 ADP-receptor antagonist, before primary percutaneous intervention in patients with ST-elevation myocardial infarction: The Early Rapid ReversAl of Platelet ThromboSis with Intravenous Elinogrel before PCI to Optimize REperfusion in Acute Myocardial Infarction (ERASE MI) pilot trial.

Am Heart J. 2009 Dec;158(6):998-1004.e1

Authors: Berger JS, Roe MT, Gibson CM, Kilaru R, Green CL, Melton L, Blankenship JD, Metzger DC, Granger CB, Gretler DD, Grines CL, Huber K, Zeymer U, Buszman P, Harrington RA, Armstrong PW

BACKGROUND: Inhibition of the P2Y12 ADP-receptor with oral antiplatelet agents given to patients undergoing primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is associated with improved outcomes, but this strategy is limited by the time required for maximal antiplatelet effect after administration. We examined the safety and tolerability of a novel, direct-acting, reversible, intravenous P2Y12 ADP-receptor antagonist, elinogrel, versus placebo when administered to STEMI patients before primary PCI. METHODS: The ERASE MI trial was a pilot, phase IIA, randomized, double-blind, placebo-controlled, dose-escalation study designed to evaluate the safety and tolerability of escalating doses (10, 20, 40, and 60 mg) of elinogrel administered as a single intravenous bolus before the start of the diagnostic angiogram preceding primary PCI. Patients were randomly assigned in a 1:1 manner to either elinogrel or placebo within each dosing group; and all patients received a 600-mg clopidogrel loading dose, followed by a second 300-mg clopidogrel loading dose 4 hours after PCI. The major outcome, in-hospital bleeding, was assessed with the Thrombolysis in Myocardial Infarction and Global Strategies to Open Occluded Coronary Arteries bleeding scales. Pre-PCI corrected Thrombolysis in Myocardial Infarction frame count and ST-segment resolution were also evaluated. RESULTS: Seventy patients were randomized in the dose-escalation study, but the dose-confirmation phase was not started because the trial was prematurely terminated for administrative reasons. The incidence of bleeding events was infrequent and appeared to be similar in patients treated with all doses of elinogrel versus placebo. No differences in serious adverse events, laboratory values, corrected Thrombolysis in Myocardial Infarction frame count, or ST resolution were demonstrated between elinogrel and placebo. CONCLUSIONS: With the limitations of a small study sample size, this pilot study provided preliminary data on the feasibility and tolerability of escalating doses of a direct-acting, reversible, intravenous P2Y12 ADP-receptor antagonist, elinogrel, as an adjunctive therapy for primary PCI for STEMI.

PMID: 19958867 [PubMed - in process]

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Admission and fasting plasma glucose for estimating risk of death of diabetic and nondiabetic patients with acute coronary syndrome: nonlinearity of hazard ratios and time-dependent comparison.

Am Heart J. 2009 Dec;158(6):989-97

Authors: Cid-Alvarez B, Gude F, Cadarso-Suarez C, Gonzalez-Babarro E, Rodriguez-Alvarez MX, Garcia-Acuna JM, Gonzalez-Juanatey JR

BACKGROUND: In patients with acute coronary syndrome (ACS), increased plasma glucose levels are associated with worse outcome. Our aim is to ascertain the values of admission and fasting glucose for prediction of death among patients with ACS; and to compare their predictive capacities. METHODS: The relationships of mortality to plasma glucose levels among 811 consecutive patients hospitalized with ACS were estimated using spline Cox models. Blood samples were obtained upon admission and after overnight fast. The predictive capacities of fasting and admission glucose were compared using time-dependent receiver operating characteristic curves. RESULTS: Fasting and admission glucose levels were higher among the 151 patients who died (18.6%) than among survivors (P < .001). Among the 558 patients with no history of diabetes (68.8%) there was a J-shaped dependence of the all-time mortality hazard ratio on fasting glucose that persisted when adjusted for covariates: hazard was lowest at 110 mg/dL (6.1 mmol/L), and significantly greater at levels <90 mg/dL (5.0 mmol/L) or >117 mg/dL (6.5 mmol/L). Likewise among non-diabetic patients, the predictive capacities of admission and fasting glucose were similar for forecast times of up to about 1 year, but for later times the area under the receiver operating characteristic curve was larger for fasting glucose than admission glucose (P < .05). Neither admission nor fasting glucose levels discriminated among diabetic patients in regard to risk of death. CONCLUSIONS: Both admission and fasting glucose may be used for triage of nondiabetic ACS patients; fasting glucose may additionally be useful for long-term management, for which the relationship with the all-time mortality hazard ratio is J-shaped.

PMID: 19958866 [PubMed - in process]

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Coronary heart disease in moderately hypercholesterolemic, hypertensive black and non-black patients randomized to pravastatin versus usual care: The Antihypertensive and Lipid Lowering to Prevent Heart Attack Trial (ALLHAT-LLT).

Am Heart J. 2009 Dec;158(6):948-955

Authors: Margolis KL, Dunn K, Simpson LM, Ford CE, Williamson JD, Gordon DJ, Einhorn PT, Probstfield JL,

BACKGROUND: In previous analyses in ALLHAT, blacks had a significantly lower risk of coronary heart disease (CHD) in the pravastatin group compared to the usual care group, whereas non-blacks had no benefit from pravastatin. No previous statin trial has reported results separately in blacks. OBJECTIVES: The study aimed to determine if apparent racial differences in CHD in ALLHAT are explained by differences in baseline characteristics, adherence during the trial, or achieved blood pressure and lipid lowering. METHODS: This was a prespecified subgroup analysis of a randomized controlled trial. Hypertensive, moderately hypercholesterolemic participants were assigned to open-label pravastatin (40 mg/d) or usual care. The outcome was a composite of nonfatal myocardial infarction and fatal CHD. We performed intention-to-treat survival analyses using Cox proportional hazards models, adjusting for baseline covariates (age, sex, aspirin use, history of CHD and diabetes, and baseline hypertension treatment) and time-varying levels of blood pressure and total cholesterol. RESULTS: After adjustment for baseline characteristics, there remained a significant interaction between race and treatment group (P = .02). In stratified models, blacks in the pravastatin group had a 29% lower risk of CHD (hazard ratio [HR] 0.71, 95% CI 0.57-0.90, P = .005) compared to those in the usual care group, whereas non-blacks had no benefit (HR 1.00, 95% CI 0.85-1.19, P = .95). With further adjustment for achieved blood pressure and total cholesterol, the HR in blacks was 0.65 (95% CI 0.45-0.96, P = .03) and in non-blacks was 1.07 (95% CI 0.81-1.41, P = .65). CONCLUSIONS: Our results suggest that pravastatin is effective in preventing CHD in blacks.

PMID: 19958861 [PubMed - as supplied by publisher]

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The clinical significance of hematocrit values before and after percutaneous coronary intervention.

Am Heart J. 2009 Dec;158(6):1024-30

Authors: Maluenda G, Lemesle G, Collins SD, Ben-Dor I, Syed AI, Torguson R, Kaneshige K, Xue Z, Pakala R, Suddath WO, Satler LF, Kent KM, Lindsay J, Pichard AD, Waksman R

BACKGROUND: The presence of anemia before percutaneous coronary intervention (PCI) and/or the development of bleeding or anemia after PCI has been shown to increase mortality and morbidity rates. However, the definition of severe anemia varies among reports. In this context, the roles of hematocrit at baseline and hematocrit drop after PCI, both treated as continuous variables, have not yet been described in the risk assessment of patients undergoing PCI. METHODS: We analyzed 6,025 consecutive patients who underwent PCI from 2003 to 2007 at our institution. In the entire population, we analyzed by multivariable Cox analysis the clinical value of both hematocrit at baseline and hematocrit drop after PCI as continuous variables. The primary end point was the composite of death and myocardial infarction at 1-year follow-up. RESULTS: The rate of the 1-year composite end point death/myocardial infarction increased continuously every time hematocrit at baseline decreased and/or hematocrit dropped after PCI. After multivariable adjustment using the relevant covariables, both hematocrit at baseline (hazard ratio = 0.92, P < .001) and hematocrit drop after PCI (hazard ratio = 1.11, P < .001) strongly predicted the primary end point at 1-year follow-up. CONCLUSION: Hematocrit at baseline and the drop after PCI should be recognized as important risk factors for adverse outcomes after PCI. The inclusion of hematocrit or hemoglobin values as continuous variables in a risk-stratification scheme should be strongly considered.

PMID: 19958871 [PubMed - in process]

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Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial.

Am Heart J. 2009 Oct;158(4):e43-50

Authors: Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G

BACKGROUND: Drug-eluting stent (DES) may offer benefits in terms of repeat revascularization, which may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with STEMI. No data have been reported so far on the long-term benefits and safety of DES in STEMI. The aim of the current study was to evaluate the short- and long-term benefits of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) as compared to bare-metal stent (BMS) in patients undergoing primary angioplasty. METHODS: Consecutive patients with STEMI admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, and SES. All patients received upstream glycoprotein IIb-IIIa inhibitors. Primary end point was target-lesion revascularization at 1-year follow-up. Secondary end points were (1) cumulative combined incidence of death and/or reinfarction; (2) cumulative incidence of in-stent thrombosis; and (3) major adverse cardiac events (MACE) (combined death and/or reinfarction and/or target lesion revascularization [TLR]) at long-term follow-up (up to 4 years). No patient was lost to follow-up. RESULTS: From October 1, 2003, to December 2005, 270 patients with STEMI were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. As compared to BMS (14.4%), both PES (4.4%, hazard ratio [HR] 0.29, 95% CI 0.095-0.89, P = .023) and SES (3.3%, HR 0.21, 95% CI 0.06-0.75, P = .016) were associated with a significant reduction in TLR at 1-year follow-up (primary study end point). At long-term follow-up (1,233 +/- 215 days), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared to BMS (21.1%), both PES (6.7%, HR 0.29, 95% CI 0.12-0.73, P = .008) and SES (5.6%, HR 0.24, 95% CI 0.09-0.63, P = .002), respectively, were associated with a significant reduction in TLR. CONCLUSIONS: This study shows that among patients with STEMI undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of TLR up to 4 years’ follow-up, as compared to BMS. Thus, until the results of further large randomized trials with long-term follow-up become available, DES may be considered among patients with STEMI undergoing primary angioplasty.

PMID: 19781402 [PubMed - in process]

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Treatment of stable angina pectoris by ivabradine in every day practice: the REDUCTION study.

Am Heart J. 2009 Oct;158(4):e51-7

Authors: Köster R, Kaehler J, Meinertz T,

BACKGROUND: The antianginal efficacy of ivabradine was studied in controlled clinical trials. Strict patient selection criteria may cause a discrepancy between the results of highly controlled clinical trials and everyday routine practice. The objective of this study was to evaluate the efficacy and safety of ivabradine in everyday routine practice. METHODS: In this multicenter study, 4,954 patients with stable angina pectoris received ivabradine in everyday routine practice and underwent follow-up for 4 months. The heart rate (HR), angina pectoris attacks, nitrate consumption, overall efficacy, and tolerance were evaluated. RESULTS: Within 4 months of treatment with ivabradine, HR was reduced by 12.4 +/- 12.2 beat/min from 82.9 +/- 15.3 to 70.4 +/- 9.2 beat/min (P < .0001). Angina pectoris attacks were reduced from 2.4 +/- 3.1 to 0.4 +/- 1.5 per week (P < .0001). Consumption of short-acting nitrates was reduced from 3.3 +/- 4.4 to 0.6 +/- 1.6 U/wk (P < .0001). Seventy-eight cases of adverse drug reactions were reported. The most common adverse drug reactions were nausea (n = 11, 0.22%) and dizziness (n = 9, 0.18%). Efficacy and tolerance were graded by physicians as being "excellent/very good" for 97% and 98% of the patients treated. CONCLUSION: Ivabradine reduces the HR and is highly effective and well tolerated in the treatment of patients with symptomatic coronary artery disease. The results confirm the findings of controlled clinical trials in a broad patient population in everyday routine practice.

PMID: 19781403 [PubMed - in process]

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Hospital performance recognition with the Get With The Guidelines Program and mortality for acute myocardial infarction and heart failure.

Am Heart J. 2009 Oct;158(4):546-53

Authors: Heidenreich PA, Lewis WR, LaBresh KA, Schwamm LH, Fonarow GC

BACKGROUND: Many hospitals enrolled in the American Heart Association's Get With The Guidelines (GWTG) Program achieve high levels of recommended care for heart failure, acute myocardial infarction (MI) and stroke. However, it is unclear if outcomes are better in those hospitals recognized by the GWTG program for their processes of care. METHODS: We compared hospitals enrolled in GWTG and receiving achievement awards for high levels of recommended processes of care with other hospitals using data on risk-adjusted 30-day survival for heart failure and acute MI reported by the Center for Medicare and Medicaid Services. RESULTS: Among the 3,909 hospitals with 30-day data reported by Center for Medicare and Medicaid Services 355 (9%) received GWTG achievement awards. Risk-adjusted mortality for hospitals receiving awards was lower for both heart failure (11.0% vs 11.2%, P = .0005) and acute MI (16.1% vs 16.5%, P < .0001) compared to those not receiving awards. After additional adjustment for hospital characteristics and noncardiac performance measures, the reduction in mortality remained significantly lower for GWTG award hospitals for acute myocardial infraction (-0.19%, 95% CI -0.33 to -0.05), but not for heart failure (-0.11%, 95% CI -0.25 to 0.02). Additional adjustment for cardiac processes of care reduced the benefit of award hospitals by 28% for heart failure mortality and 43% for acute MI mortality. CONCLUSIONS: Hospitals receiving achievement awards from the GWTG program have modestly lower risk adjusted mortality for acute MI and to a lesser extent, heart failure, explained in part by better process of care.

PMID: 19781413 [PubMed - in process]

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Timing of clopidogrel loading before percutaneous coronary intervention in clopidogrel-naive patients with stable or unstable angina: a comparison of two strategies.

Am Heart J. 2009 Oct;158(4):585-91

Authors: Davlouros PA, Arseniou A, Hahalis G, Chiladakis J, Mazarakis A, Damelou A, Karakantza M, Paliogianni F, Karogiannis N, Alexopoulos D

BACKGROUND: Clopidogrel-naive patients subjected to coronary angiography may be candidates for percutaneous coronary intervention (PCI). Clopidogrel loading with 600 mg at least 2 hours before the procedure is advised for such patients. However, there is no direct evidence that delaying PCI for 2 hours after clopidogrel loading is superior to ad hoc PCI. METHODS: After coronary angiography, clopidogrel-naive patients (N = 199) with stable or unstable angina, candidates for PCI, were loaded with 900 mg of clopidogrel and then randomized to ad hoc PCI (ad hoc group, n = 103) or delayed PCI 2 hours after loading (delayed group, n = 96). Combined primary end point was death/periprocedural myocardial infarction (MI)/stroke/reintervention within 30 days post-PCI. Secondary end points were periprocedural MI; periprocedural creatine kinase-MB elevation >3 x upper limit of normal; any periprocedural increase of creatine kinase-MB, troponin-I, or myoglobin above upper limit of normal; Thrombolysis in Myocardial Infarction flow <3 after PCI; thrombocytopenia with platelet count of <70,000/mL; major bleeding defined according to the Thrombolysis in Myocardial Infarction criteria; and elevation of high-sensitivity C-reactive protein and soluble P selectin. RESULTS: Primary end point occurred in 12.6% ad hoc group versus 15.6% delayed group patients (P = .34). High-sensitivity C-reactive protein increased in both groups post-PCI (analysis of variance P < .0001) without difference between groups (P = .5). Major bleeding occurred in 2.9% ad hoc group versus 3.1% delayed group patients (P = .9). No significant difference was observed in any other secondary end point. CONCLUSIONS: In clopidogrel-naive patients, a strategy of delaying PCI for 2 hours after high-dose clopidogrel loading does not seem to confer any benefit compared to ad hoc PCI.

PMID: 19781418 [PubMed - in process]

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Practice patterns, outcomes, and end-organ dysfunction for patients with acute severe hypertension: the Studying the Treatment of Acute hyperTension (STAT) registry.

Am Heart J. 2009 Oct;158(4):599-606.e1

Authors: Katz JN, Gore JM, Amin A, Anderson FA, Dasta JF, Ferguson JJ, Kleinschmidt K, Mayer SA, Multz AS, Peacock WF, Peterson E, Pollack C, Sung GY, Shorr A, Varon J, Wyman A, Emery LA, Granger CB,

BACKGROUND: Limited data are available on the care of patients with acute severe hypertension requiring hospitalization. We characterized contemporary practice patterns and outcomes for this population. METHODS: STAT is a 25-institution, US registry of consecutive patients with acute severe hypertension (>180 mm Hg systolic and/or >110 mm Hg diastolic; >140 and/or >90 for subarachnoid hemorrhage) treated with intravenous therapy in a critical care setting. RESULTS: One thousand five hundred eighty-eight patients were enrolled (January 2007 to April 2008). Median age was 58 years (interquartile range 49-70 years), 779 (49%) were women, and 892 (56%) were African American; 27% (n = 425) had a prior admission for acute hypertension and 486 (31%) had chronic kidney disease. Median qualifying blood pressure (BP) was 200 (186, 220) systolic and 110 (93, 123) mm Hg diastolic. Initial intravenous antihypertensive therapies used to control BP varied, with 1,009 (64%) patients requiring multiple drugs. Median time to achieve a systolic BP <160 mm Hg (<140 mm Hg for subarachnoid hemorrhage) was 4.0 (0.8, 12) hours; 893 (60%) had reelevation to >180 (>140 for subarachnoid hemorrhage) after initial control; and 63 (4.0%) developed iatrogenic hypotension. Hospital mortality was 6.9% (n = 109) with an aggregate 90-day mortality rate of 11% (174/1,588); 59% (n = 943) had acute/worsening end-organ dysfunction during hospitalization. The 90-day readmission rate was 37% (523/1,415), of which one quarter (132/523) was due to recurrent acute severe hypertension. CONCLUSION: This study highlights heterogeneity in care, BP control, and outcomes of patients hospitalized with acute severe hypertension.

PMID: 19781420 [PubMed - in process]

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