Home About us Contact
|
Home About us Contact | ||
|
|
||
Composite Endpoint (composite + endpoint)
Selected AbstractsThiazolidinediones: effects on the development and progression of type 2 diabetes and associated vascular complicationsDIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue 2 2009Andrew Krentz Abstract In addition to reducing hyperglycaemia, the metabolic actions of TZDs (pioglitazone and rosiglitazone) in theory might improve the prognosis of patients with type 2 diabetes. However, it appears from recent data that pioglitazone and rosiglitazone have different cardiovascular risk profiles. The scope of this paper is to examine the benefits and risks of pioglitazone and rosiglitazone. Three large clinical studies (DREAM, and ADOPT with rosiglitazone; PROactive with pioglitazone) have recently been reported. A lower annual rate of decline of ß-cell function observed with rosiglitazone in the ADOPT study, compared with metformin and glyburide (glibenclamide), along with a reduced progression to insulin use seen with pioglitazone in the PROactive study, provides evidence that TZDs are effective in treating progressive hyperglycaemia. In PROactive, although the primary endpoint was not met, pioglitazone was associated with a reduction in a secondary composite endpoint of clinical cardiovascular events in high-risk patients with existing macrovascular disease who were already receiving other glycaemic and cardiovascular medications. Further evidence supporting an anti-atherogenic effect of pioglitazone was gained from the PERISCOPE study of carotid intima-media thickness. Recent controversy concerning a possible increased risk of myocardial infarction associated with rosiglitazone has fuelled uncertainty about the risk,benefit profile of this agent. In 2008, an update of an American Diabetes Association,European Association for the Study of Diabetes consensus statement on initiation and adjustment of therapy in patients with type 2 diabetes advised clinicians against using rosiglitazone. Skeletal fractures have recently emerged as a side effect of both TZDs. Available data suggest that cardiovascular benefits observed with pioglitazone might not be a class effect of TZDs. Copyright © 2009 John Wiley & Sons, Ltd. [source] A Short-Term, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Dronedarone versus Amiodarone in Patients with Persistent Atrial Fibrillation: The DIONYSOS StudyJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 6 2010JEAN-YVES LE HEUZEY M.D. Dronedarone versus Amiodarone in Patients with AF.,,Introduction: We compared the efficacy and safety of amiodarone and dronedarone in patients with persistent atrial fibrillation (AF). Methods: Five hundred and four amiodarone-naïve patients were randomized to receive dronedarone 400 mg bid (n = 249) or amiodarone 600 mg qd for 28 days then 200 mg qd (n = 255) for at least 6 months. Primary composite endpoint was recurrence of AF (including unsuccessful electrical cardioversion, no spontaneous conversion and no electrical cardioversion) or premature study discontinuation. Main safety endpoint (MSE) was occurrence of thyroid-, hepatic-, pulmonary-, neurologic-, skin-, eye-, or gastrointestinal-specific events, or premature study drug discontinuation following an adverse event. Results: Median treatment duration was 7 months. The primary composite endpoint was 75.1 and 58.8% with dronedarone and amiodarone, respectively, at 12 months (hazard ratio [HR] 1.59; 95% confidence interval [CI] 1.28,1.98; P < 0.0001), mainly driven by AF recurrence with dronedarone compared with amiodarone (63.5 vs 42.0%). AF recurrence after successful cardioversion was 36.5 and 24.3% with dronedarone and amiodarone, respectively. Premature drug discontinuation tended to be less frequent with dronedarone (10.4 vs 13.3%). MSE was 39.3 and 44.5% with dronedarone and amiodarone, respectively, at 12 months (HR = 0.80; 95% CI 0.60,1.07; P = 0.129), and mainly driven by fewer thyroid, neurologic, skin, and ocular events in the dronedarone group. Conclusion: In this short-term study, dronedarone was less effective than amiodarone in decreasing AF recurrence, but had a better safety profile, specifically with regard to thyroid and neurologic events and a lack of interaction with oral anticoagulants. (J Cardiovasc Electrophysiol, Vol. 21, pp. 597-605, June 2010) [source] Efficacy of Spironolactone on Survival in Dogs with Naturally Occurring Mitral Regurgitation Caused by Myxomatous Mitral Valve DiseaseJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 2 2010F. Bernay Background: Spironolactone, an aldosterone antagonist, has been demonstrated to decrease mortality in human patients when added to other cardiac therapies. Hypothesis: Spironolactone in addition to conventional therapy increases survival compared with conventional therapy in dogs with naturally occurring myxomatous mitral valve disease (MMVD). Animals: Between February 2003 and March 2005, 221 dogs were recruited in Europe. Nine dogs were excluded from analysis, leaving 212 dogs with moderate to severe mitral regurgitation (MR) caused by MMVD (International Small Animal Cardiac Health Council classification classes II [n = 190] and III [n = 21]). Methods: Double-blinded, field study conducted with dogs randomized to receive either spironolactone (2 mg/kg once a day) or placebo in addition to conventional therapy (angiotensin converting enzyme inhibitor, plus furosemide and digoxin if needed). Primary endpoint was a composite of cardiac-related death, euthanasia, or severe worsening of MR. Results: Primary endpoint reached by 11/102 dogs (10.8%) in the spironolactone group (6 deaths, 5 worsening) versus 28/110 (25.5%) in control group (14 deaths, 8 euthanasia, 6 worsening). Risk of reaching the composite endpoint significantly decreased by 55% (hazard ratio [HR] = 0.45; 95% confidence limits [CL], 0.22,0.90; log rank test, P= .017). Risk of cardiac- related death or euthanasia significantly reduced by 69% (HR = 0.31; 95% CL, 0.13,0.76; P= .0071). Number of dogs not completing the study for cardiac and other miscellaneous reasons similar in spironolactone (67/102) and control groups (66/110). Conclusion and Clinical Importance: Spironolactone added to conventional cardiac therapy decreases the risk of reaching the primary endpoint (ie, cardiac-related death, euthanasia, or severe worsening) in dogs with moderate to severe MR caused by MMVD. [source] Determinants of Mortality in Patients Undergoing Cardiac Resynchronization Therapy: Baseline Clinical, Echocardiographic, and Angioscintigraphic Evaluation Prior to ResynchronizationPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 12 2005ANTONIO DE SISTI Background: In dilated cardiomyopathy (DCM) patients (pts) with cardiac resynchronization therapy (CRT) for ventricular dyssynchrony, long-term predictors of mortality and morbidity remain poorly investigated. Method and Results: We reviewed data of 102 pts, 68 ± 10 years, NYHA Class II,IV (14 Class II, 67 Class III, 21 Class IV), who benefited from CRT (69 CRT, 33 CRT-ICD). Fifty-two patients had an ischemic DCM, 36 a previously implanted conventional PM/ICD, 29 a permanent atrial fibrillation, and 19 needed dobutamine in the month preceding implant. QRS duration was 187 ± 35 ms, left ventricular end-diastolic diameter 72 ± 10 mm, mitral regurgitation severity 1.9 ± 0.8, echographic aorto-pulmonary electromechanical delay 61.5 ± 25 ms and septo-lateral left intraventricular delay 86 ± 56 ms, pulmonary artery pressure (PAP) 43 ± 11 mmHg, angioscintigraphic left ventricular ejection fraction (EF) 20 ± 9%, and right ventricular EF 30.5 ± 14%. Over a mean follow-up of 23 ± 20 months, 26 pts died (18 heart failures (HFs), 1 arrhythmic storm, 7 noncardiac deaths). Positive univariate predictors of death from any cause were NYHA Class IV (P < 0.001), and need for dobutamine the month preceding CRT (P < 0.008), while use of ,-blocking agents (P < 0.08) and left ventricular EF (P < 0.09) were negative ones. NYHA Class IV was the only independent predictor at multivariate analysis (P < 0.01). Survival at 24 months was 85% in Class II, 80% in Class III, and 37% in Class IV (II vs III, P = ns; III vs IV, P < 0.001). When using a composite endpoint of death from any cause and unplanned rehospitalization for a major cardiovascular event, there were 48 events (14 HF deaths, 3 noncardiac deaths, 26 HF rehospitalizations, 2 paroxysmal atrial fibrillation, 2 sustained ventricular tachycardia, 1 nonfatal pulmonary embolism). Predictors of death from any cause/unplanned rehospitalization for a major cardiovascular event in the follow-up were NYHA Class IV (P < 0.001), need for dobutamine during the month preceding CRT (P < 0.002), and PAP (<0.02). NYHA Class IV was the only independent predictor at multivariate analysis (P < 0.05). Event-free proportion at 24 months was 70% in Class II, 64% in Class III, and 37% in Class IV (II vs III, P = ns; III vs IV, P < 0.01). When considering determinants of mortality only in NYHA Class IV patients, no variable was significantly correlated to mortality. Need for dobutamine during the last month preceding CRT did not add an adjunctive mortality risk. Conclusion: Baseline NYHA Class IV at implantation appears as the most important determinant of a poor clinical outcome in terms of both mortality and morbidity. No predictive criteria seem available for NYHA Class IV patients, in order to discriminate who will die after CRT and who will not. NYHA Class IV strongly influences the clinical outcome, suggesting that, in future studies planned on mortality and rehospitalization as major endpoints, baseline NYHA Class IV should be separately taken into account. [source] A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 10 2007Charles M. Gerrits PharmD Abstract Background Recent studies have raised concerns about potential increased cardiovascular (CV) risk in type 2 diabetes patients treated with some peroxisome proliferator-activated receptor gamma (PPAR-gamma) agonists. Objective To ascertain the risk of hospitalization for acute myocardial infarction (AMI) in type 2 diabetes patients treated with pioglitazone relative to rosiglitazone. Methodology Using data covering 2003,2006 from a large health care insurer in the US, a retrospective cohort study was conducted in patients who initiated treatment with pioglitazone or rosiglitazone. The hazard ratio (HR) of incident hospitalization for AMI after initiation of treatment with these drugs was estimated from multivariate Cox's proportional hazards survival analysis; similarly, the HR was ascertained for hospitalization for the composite endpoint of AMI or coronary revascularization (CR). Results A total of 29,911 eligible patients were identified in the database; 14,807 in the pioglitazone and 15,104 in the rosiglitazone group. Baseline demographics, medical history, and dispensed medications were generally well balanced between groups. The unadjusted HR for hospitalization for AMI was 0.82, 95%CI: 0.67,1.01. After adjustment for baseline covariates the HR was 0.78, 95%CI: 0.63,0.96. The adjusted HR for the composite of AMI or CR was 0.85, 95%CI: 0.75,0.98. Conclusion This retrospective cohort study showed that pioglitazone, in comparison with rosiglitazone, is associated with a 22% relative risk reduction of hospitalization for AMI in patients with type 2 diabetes. Copyright © 2007 John Wiley & Sons, Ltd. [source] Thrombophilic Factors Do Not Predict Outcomes in Renal Transplant Recipients Under Prophylactic Acetylsalicylic AcidAMERICAN JOURNAL OF TRANSPLANTATION, Issue 1 2010L. Ghisdal A cohort of recipients of renal transplant after 2000 (N = 310) was prospectively screened on the day of transplantation and 1 month later for a panel of 11 thrombophilic factors to assess their effect on posttransplant outcomes. All patients received prophylactic acetylsalicylic acid, started before transplantation. The rate of thromboembolic events or acute rejection episodes during the first posttransplant year (primary composite endpoint) was 16.7% among patients free of thrombophilic factor (N = 60) and 17.2% in those with ,1 thrombophilic factor (N = 250) (p > 0.99). The incidence of the primary endpoint was similar among patients free of thrombophilic factors and those with ,2 (N = 135), or ,3 (N = 53) factors (16.3% and 15.1% respectively; p = 1) and in patients who remained thrombophilic at 1 month (15.7%; p = 0.84). None of the individual thrombophilic factor present at the day of transplantation was associated with the primary endpoint. The incidence of cardiovascular events at 1-year, serum creatinine at 1-year, 4-year actuarial graft and patient survival were not influenced by the presence of ,1 thrombophilic factor at baseline (p = NS). In conclusion, the presence of thrombophilic factors does not influence thromboembolic events, acute rejection, graft or patient survival in patients transplanted after 2000 and receiving prophylactic acetylsalicylic acid. [source] Re-Formulating Non-inferiority Trials as Superiority Trials: The Case of Binary OutcomesBIOMETRICAL JOURNAL, Issue 1 2009Valerie L. Durkalski Abstract Non-inferiority trials are conducted for a variety of reasons including to show that a new treatment has a negligible reduction in efficacy or safety when compared to the current standard treatment, or a more complex setting of showing that a new treatment has a negligible reduction in efficacy when compared to the current standard yet is superior in terms of other treatment characteristics. The latter reason for conducting a non-inferiority trial presents the challenge of deciding on a balance between a suitable reduction in efficacy, known as the non-inferiority margin, in return for a gain in other important treatment characteristics/findings. It would be ideal to alleviate the dilemma on the choice of margin in this setting by reverting to a traditional superiority trial design where a single p -value for superiority of both the most important endpoint (efficacy) and the most important finding (treatment characteristic) is provided. We discuss how this can be done using the information-preserving composite endpoint (IPCE) approach and consider binary outcome cases in which the combination of efficacy and treatment characteristics, but not one itself, paints a clear picture that the novel treatment is superior to the active control (© 2009 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source] The management of heparin-induced thrombocytopeniaBRITISH JOURNAL OF HAEMATOLOGY, Issue 3 2006David Keeling Abstract The Haemostasis and Thrombosis Task Force of the British Committee for Standards in Haematology has produced a concise practical guideline to highlight the key issues in the management of heparin-induced thrombocytopenia (HIT) for the practicing physician in the UK. The guideline is evidence-based and levels of evidence are included in the body of the article. All patients who are to receive heparin of any sort should have a platelet count on the day of starting treatment. For patients who have been exposed to heparin in the last 100 d, a baseline platelet count and a platelet count 24 h after starting heparin should be obtained. For all patients receiving unfractionated heparin (UFH), alternate day platelet counts should be performed from days 4 to 14. For surgical and medical patients receiving low-molecular-weight heparin (LMWH) platelet counts should be performed every 2,4 d from days 4 to 14. Obstetric patients receiving treatment doses of LMWH should have platelet counts performed every 2,4 d from days 4 to 14. Obstetric patients receiving prophylactic LMWH are at low risk and do not need routine platelet monitoring. If the platelet count falls by 50% or more, or falls below the laboratory normal range and/or the patient develops new thrombosis or skin allergy between days 4 and 14 of heparin administration HIT should be considered and a clinical assessment made. If the pretest probability of HIT is high, heparin should be stopped and an alternative anticoagulant started at full dosage unless there are significant contraindications while laboratory tests are performed. Platelet activation assays using washed platelets have a higher sensitivity than platelet aggregation assays but are technically demanding and their use should be restricted to laboratories experienced in the technique. Non-expert laboratories should use an antigen-based assay of high sensitivity. Only IgG class antibodies need to be measured. Useful information is gained by reporting the actual optical density, inhibition by high concentrations of heparin, and the cut-off value for a positive test rather than simply reporting the test as positive or negative. In making a diagnosis of HIT the clinician's estimate of the pretest probability of HIT together with the type of assay used and its quantitative result (enzyme-linked immunosorbent assay, ELISA, only) should be used to determine the overall probability of HIT. Clinical decisions should be made following consideration of the risks and benefits of treatment with an alternative anticoagulant. For patients with strongly suspected or confirmed HIT, heparin should be stopped and full-dose anticoagulation with an alternative, such as lepirudin or danaparoid, commenced (in the absence of a significant contraindication). Warfarin should not be used until the platelet count has recovered. When introduced in combination with warfarin, an alternative anticoagulant must be continued until the International Normalised Ratio (INR) is therapeutic for two consecutive days. Platelets should not be given for prophylaxis. Lepirudin, at doses adjusted to achieve an activated partial thromboplastin time (APTT) ratio of 1·5,2·5, reduces the risk of reaching the composite endpoint of limb amputation, death or new thrombosis in patients with HIT and HIT with thrombosis (HITT). The risk of major haemorrhage is directly related to the APTT ratio, lepirudin levels and serum creatinine levels. The patient's renal function needs to be taken into careful consideration before treatment with lepirudin is commenced. Severe anaphylaxis occurs rarely in recipients of lepirudin and is more common in previously exposed patients. Danaparoid in a high-dose regimen is equivalent to lepirudin in the treatment of HIT and HITT. Danaparoid at prophylactic doses is not recommended for the treatment of HIT or HITT. Patients with previous HIT who are antibody negative (usually so after >100 d) who require cardiac surgery should receive intraoperative UFH in preference to other anticoagulants that are less validated for this purpose. Pre- and postoperative anticoagulation should be with an anticoagulant other than UFH or LMWH. Patients with recent or active HIT should have the need for surgery reviewed and delayed until the patient is antibody negative if possible. They should then proceed as above. If deemed appropriate early surgery should be carried out with an alternative anticoagulant. We recommend discussion of these complex cases requiring surgery with an experienced centre. The diagnosis must be clearly recorded in the patient's medical record. [source] Feasibility of randomized controlled trials in liver surgery using surgery-related mortality or morbidity as endpoint,BRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 9 2009M. A. J. van den Broek Background: There is a shortage of randomized controlled trials (RCTs) on which to base guidelines in liver surgery. The feasibility of conducting an adequately powered RCT in liver surgery using the dichotomous endpoints surgery-related mortality or morbidity was examined. Methods: Articles published between January 2002 and November 2007 with mortality or morbidity after liver surgery as primary endpoint were retrieved. Sample size calculations for a RCT aiming to show a relative reduction of these endpoints by 33, 50 or 66 per cent were performed. Results: The mean operative mortality rate was 1·0 per cent and the total morbidity rate 28·9 per cent; mean rates of bile leakage and postresectional liver failure were 4·4 and 2·6 per cent respectively. The smallest numbers of patients needed in each arm of a RCT aiming to show a 33 per cent relative reduction were 15 614 for operative mortality, 412 for total morbidity, 3446 for bile leakage and 5924 for postresectional liver failure. Conclusion: The feasibility of conducting an adequately powered RCT in liver surgery using outcomes such as mortality or specific complications seems low. Conclusions of underpowered RCTs should be interpreted with caution. A liver surgery-specific composite endpoint may be a useful and clinically relevant solution to pursue. Copyright © 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] Improved survival with drug-eluting stent implantation in comparison with bare metal stent in patients with severe left ventricular dysfunctionCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2006FACC, Giuseppe Gioia MD Abstract OBJECTIVE: We examined the efficacy of drug-eluting stent (DES) implantation (Sirolimus or Paclitaxel) in patients with ischemic cardiomyopathy and severe left ventricular (LV) dysfunction and compared the outcome with a similar group of patients undergoing bare metal stent (BMS) implantation. BACKGROUND: Patients with severe LV dysfunction are a high risk group. DES may improve the long term outcomes compared with BMS. METHODS: One hundred and ninety one patients (23% women) with severe LV dysfunction (LV ejection fraction ,35%) underwent coronary stent implantation between May 2002 and May 2005 and were available for follow-up. One hundred and twenty eight patients received DES (Sirolimus in 72 and Paclitaxel in 54) and 63 patients had BMS. Patients with acute S-T elevation myocardial infarction (STEMI) were excluded. The primary endpoint was cardiovascular mortality. A composite endpoint of major adverse cardiac events (MACE) including cardiovascular mortality, myocardial infarction (MI), and target vessel revascularization (TVR) was the secondary endpoint. RESULTS: Mean follow-up was 420 ± 271 days. No differences were noted in age (69 ± 10 years vs. 70 ± 10 years, P = NS), number of vessel disease (2.3 ± 0.7 vs. 2.2 ± 0.8, P = NS), history of congestive heart failure (47% vs. 46%, P = NS), MI (60% vs. 61%, P = NS), or number of treated vessels (1.3 ± 0.5 vs. 1.3 ± 0.6, P = NS) for the DES and BMS group, respectively. Diabetes was more common among DES patients (45% vs. 25%, P = 0.01). The left ventricular ejection fraction (LVEF) was similar between the two groups (28% ± 6% vs. 26% ± 8%, P = NS for the DES and BMS, respectively). During the follow-up, there were a total of 25 deaths of which two were cancer related (2 in DES group). There were 23 cardiac deaths, 8/126 (6%) which occurred in the DES group and 15/63 (24%) in the BMS group (P = 0.05 by log-rank test). MACE rate was 10% for the DES group and 41% for the BMS group (P = 0.003). NYHA class improved in both groups (from 2.5 ± 0.8 to 1.7 ± 0.8 in DES and from 2 ± 0.8 to 1.4 ± 0.7 in the BMS, P = NS). CONCLUSION: Compared with bare-metal stents, DES implantation reduces mortality and MACE in high risk patients with severe left ventricular dysfunction. © 2006 Wiley-Liss, Inc. [source] Biomarkers on Admission for the Prediction of Cardiovascular Events After Primary Stenting in Patients with ST-Elevation Myocardial InfarctionCLINICAL CARDIOLOGY, Issue 12 2008Young-Hoon Jeong MD Abstract Background Several cardiac biomarkers have been shown to have predictive values for the development of cardiovascular disease and clinical outcome after events, and are now broadly used by clinicians. Little is known about the utility of these biomarker values on admission in ST-elevation myocardial infarction (STEMI) cases of primary drug-eluting stent (DES) implantation and intense medical therapy. Hypothesis Because little is known about the utility of these biomarkers on admission in ST-elevation myocardial infarction (STEMI) in cases primary drug-eluting stent (DES) implantation and intense medical therapy, we evaluated clinical outcomes. Methods We enrolled 207 consecutive STEMI patients treated with primary stenting (mean age, 57.3 ± 12.0 y). We evaluated the association between B-type natriuretic peptide (BNP), cardiac troponin I (cTnI), high-sensitivity C-reactive protein (hs-CRP) on admission, and death, reinfarction, and new or worsening congestive heart failure (CHF) through 1 y. Results In backward-elimination models including all biomarkers, only the cTnI level was retained as a predictor of 1-y CHF (odds ratio [OR]: 1.017, 95% confidence interval [CI]: 1.001,1.034, p = 0.039). There were no predictors in terms of 1-y death, reinfarction, and composite endpoint. When we applied a simple score system, in which patients were categorized on the basis of the number of elevated biomarkers, the 1-y risks of death (p = 0.600), reinfarction (p = 0.185), and composite endpoint (p = 0.620) did not increase in proportion to the number of elevated biomarkers on admission. One-y CHF only tended to increase according to the number of elevated biomarkers (p = 0.067). Conclusions The use of cardiac biomarkers on admission, in each or in combination, had only a minimal impact for the prediction of long-term cardiovascular events after primary stenting in STEMI patients. Copyright © 2008 Wiley Periodicals, Inc. [source] Continuous 12-lead electrocardiographic ST monitoring adds prognostic information to the thrombolysis in myocardial infarction risk score in patients with non-ST-elevation acute coronary syndromesCLINICAL CARDIOLOGY, Issue 4 2005Michael N. Zairis M.D. Abstract Background: Continuous 12-lead electrocardiographic (ECG) ST monitoring and the Thrombolysis In Myocardial Infarction Risk Score (TIMI-RS), both have been shown to be useful for early risk stratification in patients with non-ST elevation acute coronary syndromes (NSTACS). Hypothesis: Transient ST ischemic events, detected by continuous 12-lead ECG ST monitoring, early in the course of NSTACS, may add prognostic information to the TIMI-RS. Methods: In all, 567 consecutive patients with a NSTACS underwent 24-h continuous 12-lead ECG ST monitoring. An ST ischemic event was defined as a transient ST shift in any lead of , 0.10 mV compared with the reference ECG, lasting for ,l min. Results: The incidence of the composite of death, nonfatal myocardial infarction (or reinfarction) and recurrent ischemia by Day 14 was 22.2%. By Day 30, the incidence of the composite of death and nonfatal myocardial infarction (or reinfarction) was 14.7%. There was a significantly increased risk of 14-day (p value for trend < 0.001) or 30-day (p value for trend <0.001) composite endpoint with increasing of TIMI-RS. Moreover, the occurrence of , 1 ST shifts during ST monitoring was associated with a significantly increased risk of 14-(p value < 0.001) or 30-day (p value < 0.001) composite end-point, and this was true throughout the groups of TIMI-RS. Conclusions: The present study suggests that continuous 12-lead ECG ST monitoring, early in the course of NSTACS, may serve as an affordable tool to add prognostic information to the TIMI-RS. [source] How to deal with multiple endpoints in clinical trialsFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 6 2006Markus Neuhäuser Abstract Multiple endpoints are common in clinical trials. This article discusses statistical methods that can be applied to control the rate of false positive conclusions at an acceptable level. The considered methods include the Bonferroni adjustment and related methods, the intersection-union test, ordered hypotheses and gatekeeper procedures, composite endpoints and global assessment measures, closed testing procedures, and combinations of different approaches. [source] | ||||||||||||||||||||||