Cardiac troponin is associated with cardiac outcomes in men and women with atrial fibrillation, insights from the ARISTOTLE trial.

BACKGROUND: Cardiac troponin T (cTnT) and I (cTnI) concentrations provide strong prognostic information in anticoagulated patients with atrial fibrillation (AF). Whether the associations between cardiac troponin concentrations and mortality and morbidity differ by sex is not known. OBJECTIVES: To assess whether men and women have different concentrations and prognostic value of cTnT and cTnI measurements in anticoagulated patients with AF. METHODS: cTnT and cTnI concentrations were measured with high-sensitivity (hs) assays in EDTA plasma samples obtained from the multicentre ARISTOTLE trial, which randomized patients with AF and at least one risk factor for stroke or systemic embolic event to warfarin or apixaban. Patients were stratified according to sex and the associations between hs-troponin concentrations, and all-cause death, cardiac death, myocardial infarction, stroke or systemic embolic event and major bleeding were assessed in multivariable regression models. RESULTS: We found higher cardiac troponin concentrations in men (n = 9649) compared to women (n = 5331), both for hs-cTnT (median 11.8 [Q1-3 8.1-18.0] vs. 9.6 [6.7-14.3] ng L-1 , P < 0.001) and hs-cTnI (5.8 [3.4-10.8] vs. 4.9 [3.1-8.8] ng L-1 , P < 0.001). Adjusting for baseline demographics, comorbidities and medications, men still had significantly higher hs-troponin concentrations than women. C-reactive protein and N-terminal pro-B-type natriuretic peptide concentrations were higher in female patients. Both hs-cTnT and hs-cTnI concentrations were associated with all clinical outcomes similarly in men and women (p-value for interaction >0.05 for all end-points). CONCLUSION: Men have higher hs-troponin concentrations than women in AF. Regardless of sex, hs-troponin concentrations remain similarly associated with adverse clinical outcomes in anticoagulated patients with AF.

Photoprotection of the future: challenges and opportunities.

The use of sunscreens is an important and essential component of photoprotection. Since their introduction during the first half of the last century, sunscreens have benefited enormously from major technological advances such as the development of novel UV filters; as a result, their efficacy in preventing UV-induced erythema is unequivocal. More recently, however, new challenges have appeared, which have prompted a robust discussion about the safety of sunscreens. These include topics directly related to photoprotection of human skin such as improved/alternative methods for standardization of assessment of the efficacy of sunscreens, but also many others such as photoprotection beyond UV, concerns about human toxicity and ecological safety, the potential of oral photoprotective measures, consequences of innovative galenic formulations. On a first glance, some of these might raise questions and doubts among dermatologists, physicians and the general public about the use sunscreens as a means of photoprotection. This situation has prompted us to critically review such challenges, but also opportunities, based on existing scientific evidence. We conclude by providing our vision about how such challenges can be met best in the future in an attempt to create the ideal sunscreen, which should provide adequate and balanced protection and be easy and safe to use.

Psychosocial stress and major cardiovascular events in patients with stable coronary heart disease.

OBJECTIVES: Assess the risk of ischaemic events associated with psychosocial stress in patients with stable coronary heart disease (CHD). METHODS: Psychosocial stress was assessed by a questionnaire in 14 577 patients (median age 65.0, IQR 59, 71; 81.6% males) with stable CHD on optimal secondary preventive therapy in the prospective randomized STABILITY clinical trial. Adjusted Cox regression models were used to assess associations between individual stressors, baseline cardiovascular risk factors and outcomes. RESULTS: After 3.7 years of follow-up, depressive symptoms, loss of interest and financial stress were associated with increased risk (hazard ratio, 95% confidence interval) of CV death (1.21, 1.09-1.34; 1.15, 1.05-1.27; and 1.19, 1.08-1.30, respectively) and the primary composite end-point of CV death, nonfatal MI or nonfatal stroke (1.21, 1.13-1.30; 1.19, 1.11-1.27; and 1.17, 1.10-1.24, respectively). Living alone was related to higher risk of CV death (1.68, 1.38-2.05) and the primary composite end-point (1.28, 1.11-1.48), whereas being married as compared with being widowed, was associated with lower risk of CV death (0.64, 0.49-0.82) and the primary composite end-point (0.81, 0.67-0.97). CONCLUSIONS: Psychosocial stress, such as depressive symptoms, loss of interest, living alone and financial stress, were associated with increased CV mortality in patients with stable CHD despite optimal medical secondary prevention treatment. Secondary prevention of CHD should therefore focus also on psychosocial issues both in clinical management and in future clinical trials.

A hospital and home-based exercise program to address functional decline in people following allogeneic stem cell transplantation.

PURPOSE: The aims of this study are to investigate the feasibility of an exercise program commencing 60 days following allogeneic stem cell transplantation (alloSCT), to investigate changes in physical function and health-related quality of life (HRQoL) in patients from pre- to post-alloSCT and to explore changes in patient outcomes before and after the program. METHODS: This study is a single site, prospective case series including 43 adults undergoing alloSCT. The intervention was an 8-week outpatient and home-based exercise and education program. Outcomes included feasibility (consent, attendance, compliance and completion rates), functional exercise capacity (incremental shuttle walk test), muscle strength (hand-held dynamometry), self-efficacy for physical activity (Physical Activity Assessment Inventory) and HRQoL (Functional Assessment of Cancer Therapy-Bone Marrow Transplant). Outcomes were measured pre-alloSCT, 60 days post-alloSCT (pre-intervention) and 100 days post-alloSCT (post-intervention). RESULTS: The consent rate was 93%. From baseline to 60 days post-alloSCT, there was significant decline in functional exercise capacity (mean difference 224 m, 95% CI 153-295, p < 0.0005), self-efficacy for physical activity (294 points, 95% CI 136-452, p = 0.001) and HRQoL (15 points, 95% CI 8-21, p < 0.0005). Ten participants did not commence the exercise program due to death (n = 5), illness (n = 1) or cancellation of alloSCT (n = 4). The intervention was feasible in those not affected by major medical complications or death. No adverse events occurred. From pre- to post-intervention, there was significant improvement in functional exercise capacity (p = 0.001) and HRQoL (p = 0.001). CONCLUSIONS: AlloSCT results in significant decline in functional exercise capacity, self-efficacy for physical activity and HRQoL, which may be improved through an exercise program. This pilot demonstrated safety, feasibility and high patient interest. Further randomised research is required.

The Effect of Complete Denture Occlusion on Function and Patient Quality of Life: Systematic Review.

Edentulism presents an ongoing challenge for prosthodontic dentistry. Many aspects of complete denture construction lack contemporary evidence. One such aspect is denture occlusion. Balanced occlusion (BO) has become the prevailing occlusal scheme. It has been suggested that canine guidance (CG) is unsuitable for complete denture occlusion due to an increased risk for tipping of the prostheses. However it may be indicated in patients with minimal alveolus resorption. There has been limited evidence suggesting the superiority of either occlusal scheme over another. This article investigates the available literature assessing complete denture occlusion by means of clinical trials or reviews of evidence. We utilised PRISMA guidelines to investigate the effect of complete denture occlusal scheme (balance occlusion vs. canine guidance) on functional or quality of life. Seven studies were included for review. All studies were poor to moderate quality with the majority lacking randomisation, blinding and demographic data from the study sample. The available evidence suggests that the differences between occlusal schemes may be small, challenging the notion that BO may be the optimal occlusal scheme. There is a need for high-quality clinical research, investigating both chewing ability and quality of life in complete denture wearers in the long-term.

Ergonomic assessment of enhanced protection under body armour combat shirt neck collars.

INTRODUCTION: Combat neck injury due to explosively propelled fragments is a significant cause of mortality and long-term morbidity in UK soldiers deployed on current operations. Reinforcing the collar of the existing under body armour combat shirt (UBACS) has been suggested as a potential method for reducing the incidence of combat neck injury. METHOD: 20 soldiers serving in Afghanistan objectively compared three designs of enhanced protection UBACS (EP-UBACS) using 10 representative military tasks against a baseline of a standard UBACS. Each EP-UBACS design was trialled using three constituent materials: two layers of para-aramid felt, one layer of ultra high molecule weight polyethylene (UHMWPE) felt or two layers of a silk fabric. Subjective assessment of these nine configurations in terms of comfort, heat dissipation and overall acceptability were compared with the standard UBACS using a χ² test. RESULTS: All military tasks could be performed with all nine configurations of EP-UBACS. Although silk was the most comfortable material, it was not functionally practical in any of the three designs. Crossover collars incorporating UHMWPE or para-aramid were the only two of the nine configurations to demonstrate similar user acceptability to a standard UBACS. CONCLUSIONS: The EP-UBACS has the potential to provide neck protection without reducing performance incorporating materials analogous to either of the felts assessed in this study. The collar should provide stand-off from the skin to improve heat dissipation and comfort, which can be maximised by changing the current UBACS collar shape to one that crosses over at the front. Should a zip be desired, it should be moved to one side of the midline to reduce rubbing on the chin and be covered with ballistic protective material. Additional semi-circles of silk beneath the collar at the front and back would improve protection without affecting comfort.

The acute respiratory management of cervical spinal cord injury in the first 6 weeks after injury: a systematic review.

STUDY DESIGN: Systematic review. OBJECTIVES: Identify, evaluate, and synthesize evidence regarding the effectiveness of various treatment strategies for the respiratory management of acute tetraplegia. SETTING: Melbourne, Australia. METHODS: A search of multiple electronic databases (Medline, Cinahl, EMBASE, Cochrane Library, Web of Science, http://www.guideline.gov and http://www.icord.org/scire) was undertaken accompanied by the reference lists of all relevant articles identified. Methodological quality was assessed using the Newcastle-Ottawa Scale and the PEDro Scale. Descriptive analysis was performed. RESULTS: Twenty-one studies including 1263 patients were identified. The majority of the studies were case series (n = 13). A variety of interventions were used for the management of respiratory complications. Mortality (ARR = 0.4, 95% confidence interval (CI) 0.18, 0.61), the incidence of respiratory complications (ARR = 0.36, 95% CI (0.08, 0.58)), and requirement for a tracheostomy (ARR = 0.18, 95% CI (-0.05, 0.4)) were significantly reduced by using a respiratory protocol. A clinical pathway reduced duration of mechanical ventilation by 6 days 95% CI (-0.56, 12.56), intensive care unit length of stay by 6.8 days 95% CI (0.17-13.77) and costs. Intubation, mechanical ventilation, and tracheostomy are the mainstay of respiratory management for complete injuries above the level of C5. CONCLUSION: This review showed a clinical pathway with a structured respiratory protocol that includes a combination of treatment techniques provided regularly is effective in reducing respiratory complications and cost. The overall study quality was moderate and further studies using specific interventions that target respiratory complications are associated with specific regions of the cervical spine using more methodologically rigorous designs are required.

Postoperative pulmonary complications following major head and neck cancer surgery.

The primary aim of this observational study was to describe the incidence of postoperative pulmonary complications (PPCs) in 60 consecutive, surgically treated head and neck cancer patients requiring free flap reconstruction and tracheostomy, using both a prospective and a retrospective outcome measure. Secondary aims were to identify risk factors for PPC development, explore the effects of PPC on outcomes, and describe the provision of postoperative physiotherapy in this population. Postoperative pulmonary complications occurred in nine (15%) patients based on the Melbourne Group Scale and 27 (45%) patients based on Health Information Service coding data. The occurrence of a PPC was not statistically correlated with age, smoking history, comorbidities, operative time, or type of resection or free flap. Patients who developed a PPC, compared to those who did not, had a higher preoperative body mass index (P=0.022) and were more likely to be sat out of bed earlier post-surgery (P=0.038). Overall, patients required a median of 9.0 (interquartile range 7.0-11.0) physiotherapy sessions. Patients developing a PPC required significantly more physiotherapy sessions (P=0.007) and additional days of supplemental oxygen (P=0.022) as compared to those without a PPC, despite a similar hospital length of stay. In future, targeted physiotherapy interventions may reduce PPCs in this population.

Patient and caregiver reported facilitators of self-care among patients with chronic heart failure: report from a formative qualitative study.

Background: Adherence to a complex, yet effective medication regimen improves clinical outcomes in patients with chronic heart failure (CHF). However, patient adherence to an agreed upon plan for medication-taking is sub-optimal and continues to hover at 50% in developed countries. Studies to improve medication-taking have focused on interventions to improve adherence to guideline-directed medication therapy, yet few of these studies have integrated patients' perceptions of what constitutes effective strategies for improved medication-taking and self-care in everyday life. The purpose of this formative study was to explore patient perceived facilitators of selfcare and medication-taking. Methods: We conducted in-depth interviews of patients with long standing heart failure admitted to the cardiology and internal medicine wards of a South Indian tertiary care hospital. We purposively sampled using the following criteria: sex, socio-economic status, health literacy and patient reported medication adherence in the month prior to hospitalization. We employed inductive coding to identify facilitators. At the end of 15 interviews (eight patients and seven caregivers; seven patient-caregiver dyads), we arrived at theoretical saturation for facilitators. Results: Facilitators could be classified into intrinsic (patient traits - situational awareness, self-efficacy, gratitude, resilience, spiritual invocation and support seeking behavior) and extrinsic (shaped by the environment - financial security and caregiver support, company of children, ease of healthcare access, trust in provider/hospital, supportive environment and recognizing the importance of knowledge). Conclusions: We identified and classified a set of key patient and caregiver reported self-care facilitators among Indian CHF patients. The learnings from this study will be incorporated into an intervention package to improve patient engagement, overall self-care and patient-caregiver-provider dynamics.

PRP­1 significantly decreases the ALDHhigh cancer stem cell population and regulates the aberrant Wnt/ß­catenin pathway in human chondrosarcoma JJ012 cells.

Chondrosarcomas are malignant bone tumors refractory to chemotherapy and radiation treatment; thus, novel therapeutic strategies are required. Proline­rich polypeptide 1 (PRP­1) has previously demonstrated antitumor properties in chondrosarcoma. To further investigate the role of PRP­1 in chondrosarcoma cells, its effects on cancer stem cell (CSC) populations were determined by analyzing aldehyde dehydrogenase (ALDH) activity, an established marker of CSCs, in association with regulation of the Wnt/ß­catenin signaling. A significant decrease in ALDHhigh CSCs was observed following treatment of chondrosarcoma JJ012 cells with PRP­1. For RT2 profiler PCR array analysis of Wnt/ß­catenin signaling genes, cells were sorted into: i) Bulk JJ012 cells; ii) ALDHhigh cells sorted from untreated JJ012 cells (ALDHhigh­untreated); and iii) ALDHlow cells sorted from PRP­1­treated JJ012 cells (ALDHlow­PRP­1). The expression levels of Wnt/ß­catenin signaling genes were determined to be downregulated in the ALDHhigh­untreated cells and upregulated in ALDHlow­PRP­1 cells when compared to the bulk JJ012 cells. Additionally, two important oncogenes involved in this pathway, MMP7 and CCND2, were found to be downregulated in the ALDHlow­PRP­1 cells. Immunocytochemistry demonstrated the localization of ß­catenin in the nuclei of the PRP­1­treated cells. Western blotting indicated increased ß­catenin expression in the ALDHlow­PRP­1 cells compared with the bulk JJ012 cells. Analysis of the cytoplasmic and nuclear fractions of cells treated with increasing concentrations of PRP­1 and ß­catenin nuclear translocation inhibitor CGP57380, suggested the nuclear translocation of ß­catenin following PRP­1 treatment. In addition, treatment of JJ012 cells with a specific ALDH inhibitor, diethylaminobenzaldehyde, and PRP­1 resulted in a significant decrease in cytoplasmic ß­catenin protein expression. This indicated that ALDH inactivation may be associated with the nuclear translocation of ß­catenin. Derivation of sarcomas from mesenchymal stem cells via inactivation of the Wnt pathway has been previously documented. The findings of the present study support the notion that Wnt/ß­catenin activation may serve a differential role in sarcomas, limiting tumor progression in association with decreased CSC activity.

The effect of instrument lubricant on the diametral tensile strength and water uptake of posterior composite restorative material.

OBJECTIVES: This in-vitro study investigated the effect of 'instrument lubricants' used during placement of composite restorative material, on the diametral tensile strength (DTS) and water uptake of composite specimens. METHODS: 300 posterior composite cylindrical specimens were manufactured: 60 with each instrument lubricant (ethanol, 3-step, 2-step and 1-step 'bonding agent') and 60 with no lubricant (controls). Each set of 60 specimens was evenly allocated to one of the following test groups (n=100/group): Group 1 - tested for DTS immediately after manufacture; Groups 2 and 3 - tested for DTS after immersion in phosphate-buffered saline (PBS) for 1 and 12-weeks respectively, using a Universal Instron machine. Water uptake was assessed gravimetrically. Data were statistically analysed with two-way ANOVA and Tukey's post hoc test (α=0.05). RESULTS: The mean DTS and percentage weight change of composite specimens ranged between 32.49-53.14MPa and 0.51-1.36% and varied with lubricant used and time incubated in PBS. All control groups exhibited significantly higher DTS (MPa) (groups 1-3: 53.17±1.78; 50.64±1.85; 45.17±1.77) and lower percentage weight change (groups 2-3: 0.51±0.03; 0.61±0.01) than specimens placed with an instrument lubricant, with significant differences between certain lubricant groups. CONCLUSION: Data from the present study suggest that the use of instrument lubricant may adversely effect the DTS and water uptake of composite restorative material. CLINICAL SIGNIFICANCE: The use of instrument lubricants to aid composite placement is widespread however based on the data obtained it is suggested that discontinuing or limiting the use of instrument lubricants, and if necessary using the 'bonding agent' from a 3-step adhesive system is recommended as results suggest this has the least deleterious effect upon material properties.​.

Rationale and design of ACTIVE: the atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events.

BACKGROUND: Atrial fibrillation (AF) is the most frequently occurring cardiac arrhythmia with often serious clinical consequences. Many patients have contraindications to anticoagulation, and it is often underused in clinical practice. The addition of clopidogrel to aspirin (ASA) has been shown to reduce vascular events in a number of high-risk populations. Irbesartan is an angiotensin receptor-blocking agent that reduces blood pressure and has other vascular protective effects. METHODS AND RESULTS: ACTIVE W is a noninferiority trial of clopidogrel plus ASA versus oral anticoagulation in patients with AF and at least 1 risk factor for stroke. ACTIVE A is a double-blind, placebo-controlled trial of clopidogrel in patients with AF and with at least 1 risk factor for stroke who receive ASA because they have a contraindication for oral anticoagulation or because they are unwilling to take an oral anticoagulant. ACTIVE I is a partial factorial, double-blind, placebo-controlled trial of irbesartan in patients participating in ACTIVE A or ACTIVE W. The primary outcomes of these studies are composites of vascular events. A total of 14000 patients will be enrolled in these trials. CONCLUSIONS: ACTIVE is the largest trial yet conducted in AF. Its results will lead to a new understanding of the role of combined antiplatelet therapy and the role of blood pressure lowering with an angiotensin II receptor blocker in patients with AF.

Deterioration in physical activity and function differs according to treatment type in non-small cell lung cancer - future directions for physiotherapy management.

OBJECTIVES: To investigate in non-surgically and surgically treated non-small cell lung cancer (NSCLC): (1) changes in physical activity, function, health-related quality of life (HRQoL) and symptoms after diagnosis; and (2) the association between physical activity and outcomes. DESIGN: Prospective observational study. SETTING: Three acute tertiary hospitals. PARTICIPANTS: Sixty-nine individuals (43 male, median [IQR] age 68 [61 to 74] years) with stage I-IV NSCLC. MAIN OUTCOME MEASURES: The primary outcome (Physical Activity Scale for the Elderly) and secondary outcome (six-minute walk test and questionnaires assessing HRQoL, function, symptoms, mood) were measured at diagnosis (pre-treatment), and eight to ten weeks post-diagnosis (post-operative and/or during chemotherapy/radiotherapy). RESULTS: Individuals treated surgically (n=27) experienced a deterioration in physical activity levels (baseline median [IQR]=74 [51 to 135]; follow-up median [IQR]=29 [24 to 73]; median difference=45, effect size=0.3). At follow-up physical activity was inversely related to depression, pain and appetite loss (rho>0.5, p<0.05). In contrast non-surgical individuals (n=42) did not experience a change in physical activity, however did experience deterioration in function, functional capacity, global HRQoL, fatigue and dyspnoea. Physical activity levels were low in this group and at follow-up the strongest relationships with physical activity levels were global HRQoL, function, fatigue and mood (inverse, rho>0.5, p<0.05). CONCLUSIONS: Surgically treated individuals experienced a reduction in physical activity levels after diagnosis, which was not seen in the non-surgical group. Lower physical activity levels were associated with poorer outcomes, particularly in non-surgically treated individuals. Further research is required to establish the optimal intervention to improve physical activity levels in these cohorts.

Exercise interventions for patients with gynaecological cancer: a systematic review and meta-analysis.

BACKGROUND: People with gynaecological cancer commonly suffer from physical and psychological symptoms related to their cancer and cancer treatment. OBJECTIVE: To evaluate and synthesise the evidence examining the effect of interventions with an exercise component for females with gynaecological cancer. DATA SOURCES: Medline, CINAHL, EMBASE, PubMed, PEDro, PsycINFO and Cochrane Library were searched systematically in September 2014. STUDY SELECTION: Randomised controlled trials were included if they investigated the effects of interventions with an exercise component in patients with gynaecological cancer. STUDY APPRAISAL: Two reviewers independently assessed the risk of bias of studies using the PEDro scale. RESULTS: Seven randomised controlled trials on five patient groups involving 221 participants were included. The mean PEDro score was 5.3 (standard deviation 1.5) out of 10. Compared with control groups, the intervention groups showed significantly greater improvements in physical activity levels and body mass index. No significant effects were found for fatigue, depression and health-related quality of life. A meta-analysis of functional exercise capacity and muscle strength was not possible due to insufficient data in the included trials. LIMITATIONS: The majority of studies provided exercise as part of multicomponent intervention programmes. CONCLUSIONS: Interventions with an exercise component appear to be effective at improving physical activity levels and body mass index among patients with gynaecological cancer. Further research is required to examine the effects of exercise interventions alone in this population. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42014014019.

Time to treatment influences the impact of ST-segment resolution on one-year prognosis: insights from the assessment of the safety and efficacy of a new thrombolytic (ASSENT-2) trial.

BACKGROUND: Early ST resolution after reperfusion is a prognostic indicator in acute myocardial infarction. Little information exists regarding the prognostic utility of ST resolution beyond 4 hours after fibrinolysis. Furthermore, the relation between time to treatment, ST resolution at 24 to 36 hours, and 1-year outcome has not been well studied. Accordingly, we undertook a prospective ECG substudy in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) trial to examine this. METHODS AND RESULTS: Patients (n=13 100) were stratified into 3 ST-resolution categories, based on baseline and 24- to 36-hour ECGs: complete resolution (>/=70%) in 6698 (51.1%) patients, partial resolution (30% to 70%) in 4610 (35.2%) patients, and no resolution (<30%) in 1792 (13.7%) patients; 1-year mortality rate was 5.1%, 8.0%, and 9.7%, respectively (P<0.001). Among patients treated <2 hours after symptom onset, 55.6% had complete ST resolution, whereas 52.1% and 43% of patients treated between 2 to 4 hours and 4 to 6 hours, respectively, had complete ST resolution (P<0.001). Within each category of ST resolution, patients treated <2 hours had lower 1-year mortality rates as compared with patients treated between 2 to 4 hours or >4 hours (3.8% versus 5.2% and 6.6%, P=0.002 in complete ST resolution; 5.7% versus 8.4% and 9.9%, P=0.001 in partial ST resolution; 7.1% versus 8.7% and 13%, P=0.006 in no resolution). The extent of ST resolution was closely and inversely correlated with 1-year mortality rates (r=-0.963, P<0.001). CONCLUSIONS: ST resolution at 24 to 36 hours after fibrinolysis is influenced by time to treatment and inversely related to 1-year mortality rates. Time to treatment further differentiates between high- and low-risk patients and further highlights the importance of reducing time delay to initiation of fibrinolysis in acute myocardial infarction.

Canadian-American differences in the management of acute coronary syndromes in the GUSTO IIb trial: one-year follow-up of patients without ST-segment elevation. Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) II Investigators.

BACKGROUND: Little information exists concerning practice patterns between Canada and the United States in the management of myocardial infarction (MI) patients without ST-segment elevation and unstable angina. METHODS AND RESULTS: We examined the practice patterns and 1-year outcomes of 2250 US and 922 Canadian patients without ST-elevation acute coronary syndromes in the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIb trial. The US hospitals more commonly had on-site facilities for angiography and revascularization. These procedures were performed more often and sooner in the United States than Canada, whereas Canadian patients were more likely to undergo noninvasive stress testing. The length of initial hospital stay was 1 day longer for Canadian than US patients. Recurrent and refractory ischemia was more common in Canada. One-year mortality was comparable between the 2 countries. However, at 6 months, even after baseline differences were accounted for, the (re)MI rate was significantly higher in Canadian than US patients with unstable angina (8.8% versus 5.8%, P:=0.039), as was the composite rate of death or (re)MI (13.1% versus 9.1%, P:=0.016). CONCLUSIONS: One-year mortality was comparable between Canada and the United States in both MI and unstable angina cohorts despite higher intervention rates in the United States. However, outcomes at 6 months among patients with unstable angina differed. Whereas more frequent coronary interventions were not associated with reduced recurrent MI or death among MI patients without ST elevation, they may favorably affect outcomes in patients with unstable angina.

Relationship between delay in performing direct coronary angioplasty and early clinical outcome in patients with acute myocardial infarction: results from the global use of strategies to open occluded arteries in Acute Coronary Syndromes (GUSTO-IIb) trial.

BACKGROUND: Time to treatment with thrombolytic therapy is a critical determinant of mortality in acute myocardial infarction. Little is known about the relationship between the time to treatment with direct coronary angioplasty and clinical outcome. The objectives of this study were to determine both the time required to perform direct coronary angioplasty in the Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes (GUSTO-IIb) trial and its relationship to clinical outcome. METHODS AND RESULTS: Patients randomized to direct coronary angioplasty (n=565) were divided into groups based on the time between study enrollment and first balloon inflation. Patients randomized to angioplasty who did not undergo the procedure were also analyzed. The median time from study enrollment to first balloon inflation was 76 minutes; 19% of patients assigned to angioplasty did not undergo an angioplasty procedure. The 30-day mortality rate of patients who underwent balloon inflation /=91 minutes after enrollment, 6.4%. The mortality rate of patients assigned to angioplasty who never underwent the procedure was 14.1% (P=0.001). Logistic regression analysis revealed that the time from enrollment to first balloon inflation was a significant predictor of mortality within 30 days; after adjustment for differences in baseline characteristics, the odds of death increased 1.6 times (P=0.008) for a movement from each time interval to the next. CONCLUSIONS: The time to treatment with direct PTCA, as with thrombolytic therapy, is a critical determinant of mortality.