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Combined Endpoint (combined + endpoint)
Selected AbstractsEffect of Statin (HMG-Co-A-Reductase Inhibitor) Use on 1-Year Mortality and Hospitalization Rates in Older Patients with Cardiovascular Disease Living in Nursing HomesJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 8 2002Charles B. Eaton MD OBJECTIVES: To quantify the effect of statins on 1-year mortality, hospitalizations, and decline in physical function among patients with cardiovascular disease (CVD) aged 65 and older living in nursing homes. DESIGN: Retrospective cohort study. SETTING: All Medicare/Medicaid certified nursing homes (N = 1,492) in Maine, New York, Mississippi, and South Dakota. PARTICIPANTS: We identified 51,559 older patients with CVD from a population database that merged sociodemographic data and functional, clinical, and drug treatments from more than 300,000 newly admitted nursing home residents from 1992 to 1997. Statin users (n = 1,313) were matched with nonusers (n = 1,313) in the same facilities. MEASUREMENTS: All-cause mortality, hospitalization, combined endpoint of mortality or hospitalization, and decline in physical function were determined at 1 year, and survival analysis was performed. RESULTS: Prevalence of statin use in this frail older cohort with CVD was 2.6%. Statin use varied by age, gender, comorbid condition, medication use, and cognitive and physical function. One-year mortality was 229/1,000 person-years in the statin group and 404/1,000 person-years in the nonusers, with an adjusted hazard rate ratio (HRR) of 0.69, 95% confidence interval (CI) = 0.58,0.81. The estimated number needed to treat was seven (95% CI = 5,13). This association with improved all-cause mortality was evident for women and men and for age groups 75 to 84, and 85 and older. CONCLUSION: Statin therapy is associated with improved clinical outcomes, including reduction in 1-year all-cause mortality, and the combined endpoint of death or hospitalization in a frail older population with CVD. Some caution should be taken in interpreting these results because potential bias from residual confounding could affect these results. [source] Obesity As a Risk Factor for Sustained Ventricular Tachyarrhythmias in MADIT II PatientsJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 2 2007GRZEGORZ PIETRASIK M.D. Background: Obesity, as defined by body mass index ,30 kg/m2, has been shown to be a risk factor for cardiovascular disease. However, data on the relationship between body mass index (BMI) and the risk of ventricular arrhythmias and sudden cardiac death are limited. The aim of this study was to evaluate the risk of ventricular tachyarrhythmias and sudden death by BMI in patients after myocardial infarction with severe left ventricular dysfunction. Methods: The risk of appropriate defibrillator therapy for ventricular tachycardia or ventricular fibrillation (VT/VF) by BMI status was analyzed in 476 nondiabetic patients with left ventricular dysfunction who received an implantable cardioverter defibrillator (ICD) in the Multicenter Automatic Defibrillator Implantation Trial-II (MADIT II). Results: Mean BMI was 27 ± 5 kg/m2. Obese patients comprised 25% of the study population. After 2 years of follow-up, the cumulative rates of appropriate ICD therapy for VT/VF were 39% in obese and 24% in nonobese patients, respectively (P = 0.014). In multivariate analysis, there was a significant 64% increase in the risk for appropriate ICD therapy among obese patients as compared with nonobese patients, which was attributed mainly to an 86% increase in the risk of appropriate ICD shocks (P = 0.006). Consistent with these results, the risk of the combined endpoint of appropriate VT/VF therapy or sudden cardiac death (SCD) was also significantly increased among obese patients (Hazard Ratio 1.59; P = 0.01). Conclusions: Our findings suggest that in nondiabetic patients with ischemic left ventricular dysfunction, a BMI ,30 kg/m2 is an independent risk factor for ventricular tachyarrhythmias. [source] Left Ventricular Lead Proximity to an Akinetic Segment and Impact on Outcome of Cardiac Resynchronization TherapyJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 6 2006DANIEL ARZOLA-CASTANER M.D. Background: Previous studies report that the optimal pacing site for cardiac resynchronization therapy (CRT) is along the left ventricular (LV) lateral and postero-lateral (PL) wall. However, little is known regarding whether pacing over an akinetic site impacts the contractile response and long-term outcome from CRT. Methods and Results: A total of 38 patients with ischemic cardiomyopathy were studied for their acute hemodynamic and 12-month clinical response to CRT. The intraindividual percentage change in dP/dt (%,dP/dt), over baseline, was derived from the mitral regurgitation (MR) Doppler profile with CRT on versus off. Two-dimensional echocardiography was used for myocardial segmentation and determinination of akinetic sites. LV lead implant site was determined using angiographic and radiographic data and categorized as being "on" (group 1) or "off" (group 2) an akinetic site. Long-term response was measured as a combined endpoint of hospitalization for heart failure and/or all cause mortality at 12 months. Time to primary endpoint was estimated by the Kaplan-Meier method. Clinical characteristics and acute hemodynamic response was similar in both (group 1 [n = 14]; %,dP/dt 48.8 ± 67.4% vs group 2 [n = 24]; %,dP/dt 32.2 ± 40.1%, P = 0.92). No difference in long-term outcome was observed (P = 0.59). In contrast, lead placement in PL or mid-lateral (ML) positions was associated with a better acute hemodynamic response when compared to antero-lateral (AL) positions (PL, %,dP/dt 45.7 ± 50.7% and ML, %,dP/dt 45.1 ± 58.8% vs AL, %,dP/dt 2.9 ± 30.9%, respectively, P = 0.014). Conclusion: LV lead proximity to an akinetic segment does not impact acute hemodynamic or 12-month clinical response to CRT. [source] The Clinical Implications of Cumulative Right Ventricular Pacing in the Multicenter Automatic Defibrillator Trial IIJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 4 2005JONATHAN S. STEINBERG M.D. Introduction: This study was designed to assess whether right ventricular pacing in the implantable cardioverter defibrillator (ICD) arm of the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II was associated with an unfavorable outcome. Methods and Results: Data on the number of ventricular paced beats were available in 567 (76%) of 742 MADIT II patients with ICDs. The number of ventricular paced beats over the total number of beats showed a bimodal distribution with patients being predominantly paced or nonpaced. Therefore, patients were dichotomized at 0,50% and 51,100% of cumulative pacing with median pacing rate 0.2% and 95.6%, respectively. Endpoints included new or worsening heart failure, appropriate ICD therapy for VT/VF, and the combined endpoint of heart failure or death. Clinical features associated with frequent ventricular pacing included age ,65 years, advanced NYHA heart failure class, LVEF < 0.25, first degree AV and bundle branch block, and amiodarone use. During follow-up, 119 patients (21%) had new or worsened heart failure, 130 (23%) had new or worsened heart failure or death, and 142 (25%) had appropriate therapy for VT/VF. In comparison to patients with infrequent pacing, those with frequent pacing had significantly higher risk of new or worsened heart failure (hazard ratio = 1.93; P = 0.002) and VT/VF requiring ICD therapy (HR = 1.50; P = 0.02). Conclusions: Patients in MADIT II who were predominantly paced had a higher rate of new or worsened heart failure and were more likely to receive therapy for VT/VF. These results suggest the deleterious consequences of RV pacing, particularly in the setting of severe LV dysfunction. [source] Mortality Benefit of Beta Blockade in Patients with Acute Coronary Syndromes Undergoing Coronary Intervention:JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2003Capture, Epilog, Epistent, Pooled Results from the Epic, Rapport Trials The effects of beta blocker therapy in the settings of heart failure and coronary artery disease have been well described, although little data exist in patients presenting with acute coronary syndromes undergoing percutaneous coronary intervention. The current study will attempt to evaluate the efficacy of beta blocker therapy in this setting. Pooled data from five randomized, controlled trials of abciximab during coronary intervention were used to analyze the clinical efficacy of beta blocker therapy. The pooled analysis evaluated the end points of all-cause mortality, myocardial infarction, repeat revascularization, and the combined endpoint of death and myocardial infarction in 2,894 patients. At 30 days, death occurred in 12 of 1,939 (0.6%) patients receiving beta blocker therapy and in 19 of 955 (2.0%) patients not receiving beta blocker therapy, (P < 0.001). At 6 months, death occurred in 33 of 1,939 (1.7%) patients receiving beta blocker therapy and 35 of 955 (3.7%) not receiving beta blocker therapy, (P < 0.001). After creating a propensity model and adjusting for variables predictive of mortality in the multivariable analysis, beta blocker therapy continued to be associated with a significant reduction in mortality. The findings were similar to those shown for the effects of beta blocker therapy in separate subgroups of patients with unstable angina and acute myocardial infarction. This analysis demonstrates a lower short-term mortality in patients receiving beta blocker therapy who undergo percutaneous coronary intervention for unstable angina or acute myocardial infarction. (J Interven Cardiol 2003;16:299,305) [source] Rationale and Design of the OPTION Study: Optimal Antitachycardia Therapy in ICD Patients without Pacing IndicationsPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 9 2010CHRISTOF KOLB M.D. Background:,Implantable cardioverter-defibrillators (ICDs) represent the treatment of choice for primary and secondary prevention of sudden cardiac death but ICD therapy is also plagued by inappropriate shocks due to supraventricular tachyarrhythmias. Dual-chamber (DC) ICDs are considered to exhibit an enhanced discrimination performance in comparison to single-chamber (SC) ICDs, which results in reduction of inappropriate detections in a short- to mid-term follow-up. Comparative data on long-term follow-up and especially on inappropriate shocks are limited. Methods:,The aim of the OPTION study is to assess whether an optimized treatment with DC ICDs improves patient outcome and decreases the rate of inappropriate shocks in comparison to SC ICDs. DC ICD therapy optimization is achieved by optimal customizing of antitachycardia therapy parameters, activation of discrimination algorithms, antitachycardia pacing in the slow ventricular tachycardia zone, and avoidance of right ventricular pacing with the SafeR algorithm mode. The OPTION study, a prospective, multicenter, randomized, single-blinded, parallel study, will randomize 450 patients on a 1:1 allocation to either an SC arm with backup pacing at VVI 40 beats per minute (bpm) or to the DC arm with SafeR pacing at 60 bpm. Patients will be followed for 27 months. Primary outcome measure is the time to first occurrence of inappropriate shock and a combined endpoint of cardiovascular morbidity and all-cause mortality. Conclusion:,The study will evaluate the relative performance of DC in comparison to SC ICDs in terms of inappropriate shock reduction and patient outcome. (PACE 2010; 33:1141,1148) [source] Latest news and product developmentsPRESCRIBER, Issue 8 2007Article first published online: 23 JUL 200 Lamotrigine for partial, valproate for generalised A large UK trial has shown that lamotrigine is the most effective choice in the treatment of partial epilepsy (Lancet 2007;369: 1000-15). The SANAD trial, commissioned by the National Institute for Health Research's Health Technology Assessment programme, randomised 1721 patients (for whom carbamazepine monotherapy would have been the treatment of choice) to treatment with carbamazepine, gabapentin, lamotrigine, oxcarbazepine (Trileptal) or topiramate (Topamax). Lamotrigine was associated with a longer time to treatment failure, though time to 12-month remission favoured carbamazepine. Over four years' follow-up, lamotrigine was numerically but not significantly superior. The authors concluded lamotrigine is clinically superior to carbamazepine for partial epilepsy A second arm of the trial, yet to be published, evaluated the treatment of generalised epilepsy and found valproate to be clinically most effective, though topiramate was cost effective for some patients. Chronic pain common in nursing homes Most residents in nursing homes say they have long- term pain but only one in seven say a health professional has ever discussed its treatment with them, according to a report by the Patients' Association (www.patients-association.org.uk). Pain in Older People ,A Hidden Problem was a qualitative study of 77 older residents in care homes in England. Most were frail and suffered long-term illness. The study found that 85 per cent of residents said they were often troubled by aches or pains and these lasted over a year in 74 per cent. Most described their pain as moderate (33 per cent) or severe (38 per cent) but 8 per cent said it was excruciating. Many reported limitations on mobility and social activities despite a high level of stoicism. All but one were taking medication to relive pain; one-third experienced adverse effects but 78 per cent believed drugs offered the most effective treatment. One-quarter said a doctor or nurse had discussed how to stop their pain worsening, and 15 per cent said they had discussed how to treat their pain. Visits from GPs appeared to be uncommon. Atherothrombotic events despite treatment Between one in five and one in seven of high-risk patients experience atherothrombotic events despite evidence-based treatment, the REACH study has shown (J Am Med Assoc 2007;297:1197-1206). REACH (REduction of Atherothrombosis for Continued Health) is an international observational study involving 68 236 patients with atherothrombotic disease or at least three risk factors. Most were taking conventional evidence-based medication. After one year, the incidence of the combined endpoint of cardiovascular death, myocardial infarction, stroke or hospitalisation for atherothrombotic events was approximately 15 per cent for patients with coronary artery disease or cardiovascular disease, and 21 per cent in patients with peripheral artery disease and established coronary disease. Event rates increased with the number of vascular beds affected, rising to 26 per cent in patients with three symptomatic arterial disease locations. Extended CD prescribing by nurses and pharmacists The Medicines and Healthcare products Regulatory Agency (MHRA) is consulting on expanding the prescribing of controlled drugs (CDs) by nonmedical prescribers. Currently, nurse independent prescribers can prescribe 12 CDs, including diamorphine and morphine, but pharmacist independent prescribers may not prescribe any CDs. The proposal is to allow both professions to prescribe any CDs within their competence, with the exception of cocaine, diamorphine or dipipanone for the management of addiction. The closing date for consultation is 15 June. Consultation is also underway on expanding the range of CDs nurses and pharmacists can prescribe under a patient group direction (PGD), and their use for pain relief. The closing date for consultation is 20 April. Intrinsa: transdermal testosterone for women A transdermal formulation of testosterone has been introduced for the treatment of low sexual desire associated with distress in women who have experienced an early menopause following hysterectomy involving a bilateral oophorectomy and are receiving concomitant oestrogen therapy. Manufacturer Procter & Gamble says that Intrinsa, a twice-weekly patch, delivers testosterone 300µg every 24 hours, achieving premenopausal serum testosterone levels. Clinical trials showed that Intrinsa reduced distress in 65-68 per cent and increased satisfying sexual activity in 51-74 per cent of women. A month's treatment (eight patches) costs £28.00. Fish oil for secondary ,not primary ,prevention of CHD Supplementing statin therapy with eicosapentaenoic acid (EPA) reduces the risk of major coronary events in patients with coronary heart disease (CHD) ,but not in patients with no history of CHD Lancet 2007;369:1090-8). The five-year study in 18 645 patients with total cholesterol levels of 6.5mmol per litre or greater found that the incidence of sudden cardiac death, fatal and nonfatal myocardial infarction in CHD patients treated with EPA plus a statin was 8.7 per cent compared with 10.7 per cent with a statin alone (relative risk reduction 19 per cent). A similar relative risk reduction in patients with no CHD was not statistically significant. There was no difference in mortality between the groups but EPA did reduce unstable angina and nonfatal coronary events. Department pilots information prescriptions The Department of Health has announced 20 sites to pilot information prescriptions prior to a nationwide roll-out in 2008. The prescriptions will guide people with long-term conditions such as diabetes and cancer to sources of support and information about their condition. The Department hopes the project will increase patients' understanding of their discussions with health professionals, empower them to locate the information they need, and provide long-term support. NPSA guidelines for safer prescribing The National Patient Safety Agency (www.npsa.nhs.uk) has published five guidelines to improve medication safety in the NHS. Targeting ,high-risk issues', the guidance covers anticoagulant prescribing, liquid medicines for oral or enteral administration, injectable medicines, epidural injections and infusions, and paediatric intravenous infusions. The implementation of each guide is supported by additional tools and resources. Better adherence not matched to outcomes A systematic review has found that interventions can increase adherence to prescribed medication but there is no evidence that clinical outcomes also improve (Arch Intern Med 2007;167:540-9). The review of 37 trials identified 20 reporting increased adherence. The most effective interventions were behavioural changes to reduce dose demands and those involving monitoring and feedback. Improvements in clinical outcomes were variable and did not correspond to changes in adherence. Antidepressant plus mood stabiliser no better US investigators have found that combining a mood stabiliser with an antidepressant is no more effective than a mood stabiliser alone in preventing mood changes (N Engl J Med 2007; published online 28 March, doi.10.1056/NEJMoa064135). The study found durable recovery occurred in 23.5 per cent of patients treated with a mood stabiliser and adjunctive antidepressant therapy for six months compared with 27.3 per cent of those taking a mood stabiliser plus placebo. [source] Transplantation of Kidneys from Donors at Increased Risk for Blood-Borne Viral Infection: Recipient Outcomes and Patterns of Organ UseAMERICAN JOURNAL OF TRANSPLANTATION, Issue 10 2009P. P. Reese Kidney transplantation from deceased donors classified as increased risk for viral infection by the Centers for Disease Control (CDC) is controversial. Analyses of Organ Procurement and Transplantation Network (OPTN) data from 7/1/2004 to 7/1/2006 were performed. The primary cohort included 48 054 adults added to the kidney transplant wait list. Compared to receiving a standard criteria donor (SCD) kidney or remaining wait-listed, CDC recipients (HR 0.80, p = 0.18) had no significant difference in mortality. In a secondary cohort of 19 872 kidney recipients at 180 centers, SCD (reference) and CDC (HR 0.91, p = 0.16) recipients had no difference in the combined endpoint of allograft failure or death. Among centers performing >10 kidney transplants during the study period, the median proportion of CDC transplants/total transplants was 7.2% (range 1.1,35.6%). Higher volume transplant centers were more likely to use CDC kidneys compared to low and intermediate volume centers (p < 0.01). An analysis of procured kidneys revealed that 6.8% of SCD versus 7.8% of CDC (p = 0.13) kidneys were discarded. In summary, center use of CDC kidneys varied widely, and recipients had good short-term outcomes. OPTN should collect detailed data about long-term outcomes and recipient viral testing so the potential risks of CDC kidneys can be fully evaluated. [source] | ||||||||||