A no-prophylaxis platelet-transfusion strategy for hematologic cancers.

BACKGROUND: The effectiveness of platelet transfusions to prevent bleeding in patients with hematologic cancers remains unclear. This trial assessed whether a policy of not giving prophylactic platelet transfusions was as effective and safe as a policy of providing prophylaxis. METHODS: We conducted this randomized, open-label, noninferiority trial at 14 centers in the United Kingdom and Australia. Patients were randomly assigned to receive, or not to receive, prophylactic platelet transfusions when morning platelet counts were less than 10×10(9) per liter. Eligible patients were persons 16 years of age or older who were receiving chemotherapy or undergoing stem-cell transplantation and who had or were expected to have thrombocytopenia. The primary end point was bleeding of World Health Organization (WHO) grade 2, 3, or 4 up to 30 days after randomization. RESULTS: A total of 600 patients (301 in the no-prophylaxis group and 299 in the prophylaxis group) underwent randomization between 2006 and 2011. Bleeding of WHO grade 2, 3, or 4 occurred in 151 of 300 patients (50%) in the no-prophylaxis group, as compared with 128 of 298 (43%) in the prophylaxis group (adjusted difference in proportions, 8.4 percentage points; 90% confidence interval, 1.7 to 15.2; P=0.06 for noninferiority). Patients in the no-prophylaxis group had more days with bleeding and a shorter time to the first bleeding episode than did patients in the prophylaxis group. Platelet use was markedly reduced in the no-prophylaxis group. A prespecified subgroup analysis identified similar rates of bleeding in the two study groups among patients undergoing autologous stem-cell transplantation. CONCLUSIONS: The results of our study support the need for the continued use of prophylaxis with platelet transfusion and show the benefit of such prophylaxis for reducing bleeding, as compared with no prophylaxis. A significant number of patients had bleeding despite prophylaxis. (Funded by the National Health Service Blood and Transplant Research and Development Committee and the Australian Red Cross Blood Service; TOPPS Controlled-Trials.com number, ISRCTN08758735.).

Evaluation of enteropathy-associated T-cell lymphoma comparing standard therapies with a novel regimen including autologous stem cell transplantation.

Enteropathy associated T-cell lymphoma (EATL) is a rare type of peripheral T-cell lymphoma. At present, there are no standardized diagnostic or treatment protocols for EATL. We describe EATL in a population-based setting and evaluate a new treatment with aggressive chemotherapy and autologous stem cell transplantation (ASCT). From 1979 onward the Scotland and Newcastle Lymphoma Group prospectively collected data on all patients newly diagnosed with lymphoma in the Northern Region of England and Scotland. Between 1994 and 1998, records of all patients diagnosed with EATL were reviewed, and 54 patients had features of EATL. Overall incidence was 0.14/100 000 per year. Treatment was systemic chemotherapy (mostly anthracycline-based chemotherapy) with or without surgery in 35 patients and surgery alone in 19 patients. Median progression-free survival (PFS) was 3.4 months and overall survival (OS) was 7.1 months. The novel regimen IVE/MTX (ifosfamide, etoposide, epirubicin/methotrexate)-ASCT [corrected] was piloted from 1998 for patients eligible for intensive treatment, and 26 patients were included. Five-years PFS and OS were 52% and 60%, respectively, and were significantly improved compared with the historical group treated with anthracycline-based chemotherapy (P = .01 and P = .003, respectively). EATL is a rare lymphoma with an unfavorable prognosis when treated with conventional therapies. The IVE/MTX-ASCT regimen is feasible with acceptable toxicity and significantly improved outcome.

Tissue Doppler E/E' ratio is a powerful predictor of primary cardiac events in a hypertensive population: an ASCOT substudy.

AIMS: Patients with controlled hypertension are at risk of future cardiac events, but predicting first events remains difficult. We hypothesized that modern echocardiographic measures of left ventricular diastolic function may be more sensitive than traditional echocardiographic methods of risk prediction and set out to test this in a cohort of patients with well-controlled hypertension. METHODS AND RESULTS: Conventional and tissue Doppler echocardiography was performed on 980 participants in the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT). All subjects had hypertension, but no known cardiac disease. Cardiac events were defined as fatal and non-fatal myocardial infarction (including silent myocardial infarction), coronary revascularization procedures, new-onset angina (stable or unstable), fatal and non-fatal heart failure, and life-threatening arrhythmias. Analysis was performed by a single, blinded observer. There were 56 primary cardiac events during 4.2 +/- 0.7 years follow-up. The ratio of transmitral Doppler early filling velocity to tissue Doppler early diastolic mitral annular velocity (E/E') was the strongest predictor of first cardiac events in Cox-proportional hazards models. Following adjustment for covariates, a unit rise in the E/E' ratio was associated with a 17% increment in risk of a cardiac event (HR 1.17, CI 1.05-1.29; P = 0.003). CONCLUSION: Tissue Doppler E/E', a non-invasive estimate of left atrial filling pressure, independently predicts primary cardiac events in a hypertensive population and out-performed traditional echocardiographic measures in this moderately sized, well-treated hypertensive population. E/E' represents a simple, effective tool for assessing cardiac risk in a hypertensive population.

Validation of the TONOPORT V ambulatory blood pressure monitor according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults.

BACKGROUND: It is now accepted that blood pressure measuring devices should be subjected to an independent evaluation of their accuracy before they are marketed for clinical use. The results of validation of the TONOPORT V blood pressure monitor for the measurement of ambulatory blood pressure according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults are presented in this paper. POPULATION: Thirty-three subjects were recruited from among staff and patients at Beaumont Hospital, Dublin, Ireland. METHODS: The TONOPORT V monitor was connected to the Sphygmocorder, an audiovisual system for validation, which records blood pressure on tape and video for later analysis. Nine sequential same-arm measurements between the device and a standard mercury sphygmomanometer were recorded using the Sphygmocorder. RESULTS: In phase 1, the TONOPORT V monitor produced 28 measurements within 5 mmHg, 37 within 10 mmHg and 40 within 15 mmHg for systolic blood pressure (SBP), and 26 within 5 mmHg, 38 within 10 mmHg and 44 within 15 mmHg for diastolic blood pressure (DBP). The mean differences were -2.2 (8.6) [mean (SD)] mmHg for SBP and +0.5 (7.2) mmHg for DBP. The TONOPORT V monitor passed all the criteria for both SBP and DBP. In phase 2.1, the TONOPORT V monitor had 56 measurements within 5 mmHg, 78 within 10 mmHg and 88 within 15 mmHg for SBP, and 60 measurements within 5 mmHg, 83 within 10 mmHg and 97 within 15 mmHg for DBP. The mean differences were -1.4 (8.7) mmHg for SBP and -0.2 (6.8) mmHg for DBP. The TONOPORT V monitor passed the criteria for DBP but failed to meet any of the criteria for SBP. In phase 2.2, 19 subjects had at least two of the differences within 5 mmHg and six subjects had no differences within 5 mmHg for SBP, and 22 subjects had at least two of the differences within 5 mmHg and six subjects no differences within 5 mmHg for DBP. The TONOPORT V monitor failed to meet the criteria for SBP and for DBP. CONCLUSIONS: The TONOPORT V monitor cannot be recommended for clinical use in an adult population because it records SBP inaccurately and because it records DBP inaccurately in an unacceptably high proportion of people.

Validation of the ROSSMAX blood pressure measuring monitor according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults.

BACKGROUND: It is now accepted that blood pressure measuring devices should be subjected to an independent evaluation of their accuracy before they are marketed for clinical use. The results of validation of the ROSSMAX Blood Pressure Measuring Monitor for self-measurement according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults are presented in this paper. POPULATION: Thirty-three subjects were recruited from among staff and patients at Beaumont Hospital, Dublin, Ireland. METHODS: The ROSSMAX monitor was connected to the Sphygmocorder, an audiovisual system for validation, which records blood pressure on tape and video for later analysis. Nine sequential same-arm measurements between the device and a standard mercury sphygmomanometer were recorded using the Sphygmocorder. RESULTS: In phase 1, the ROSSMAX monitor produced 21 measurements within 5 mmHg, 31 within 10 mmHg and 38 within 15 mmHg for systolic blood pressure (SBP), and 36 within 5 mmHg, 43 within 10 mmHg and 45 within 15 mmHg for diastolic blood pressure (DBP). The mean differences were -5.6 (10.2) [mean (SD)] mmHg for SBP and -0.5 (4.5) mmHg for DBP. The ROSSMAX monitor failed to meet any of the criteria for SBP but comfortably passed all of the criteria for DBP. In phase 2.1, the ROSSMAX monitor had 51 measurements within 5 mmHg, 73 within 10 mmHg and 86 within 15 mmHg for SBP, and 71 measurements within 5 mmHg, 93 within 10 mmHg and 98 within 15 mmHg for DBP. The mean differences were -4.5. (9.5) mmHg for SBP and -1.8 (5.0) mmHg for DBP. The ROSSMAX monitor failed to meet any of the criteria for SBP but comfortably passed all of the criteria for DBP. In phase 2.2, 16 subjects had at least two of the differences lying within 5 mmHg and 10 subjects had no differences within 5 mmHg for SBP; 26 subjects had at least two of the differences falling within 5 mmHg and three subjects no differences within 5 mmHg for DBP. The ROSSMAX monitor failed to meet the criteria for SBP but passed the criteria for DBP. CONCLUSIONS: The ROSSMAX monitor cannot be recommended for clinical use in an adult population because it records SBP inaccurately.

Hypertensive target-organ damage in the very elderly.

In people aged >80 years, the so-called very elderly, there is uncertainty about the relation between hypertension and cardiovascular morbidity. The aims of this study were to investigate whether hypertension in people aged >80 years is associated with target-organ damage, over and above the effects of age, and to determine whether ambulatory blood pressure monitoring (ABPM) could improve on conventional blood pressure monitoring (CBPM) in predicting target-organ damage. Investigations included echocardiographic measurement of left ventricular mass index (LVMI), brain magnetic resonance imaging assessment of periventricular hyperintensity (PVH), urinary albumin-creatinine ratio (ACR), aortic pulse wave velocity (PWV), and 24-hour ABPM. Forty-three subjects, at a mean age 84.3 years, were studied, 22 normotensive (NT) and 21 hypertensive (HT). CBP was 184/89 and 145/76 mm Hg in the HT and NT groups, respectively. In men, LVMI was significantly greater in HT subjects, 157+/-37 vs 123+/-15 g/m2 in NT subjects (P<0.05). In women, LVMI was similar in both groups. Urinary ACR was greater in HT than in NT subjects (log ACR, 1.21+/-0.50 vs 0.95+/-0.23; P<0.05). Cerebral PVH grade was higher in the HT subjects (2.6+/-0.8 vs 2.2+/-0.9), although this difference was not significant. Aortic PWV did not differ between the 2 groups. ABPM was positively associated with urinary ACR and cerebral PVH, independent of its correlation with CBPM. In advanced old age, HT is associated with evidence of target-organ damage. ABPM can improve on CBPM in predicting very elderly subjects with HT target-organ damage.

Silent myocardial ischaemia in treated hypertensives with and without left ventricular hypertrophy.

BACKGROUND: Silent ischaemia has been reported to be associated with an increased risk of myocardial infarction and sudden death in a wide range of patient groups. The aim of this study was to examine the prevalence of silent ischaemia in hypertensive patients with and without left ventricular hypertrophy (LVH). METHODS: Twenty hypertensive patients participating in the Anglo-Scandinavian Cardiac Outcomes Trial with echocardiographic LVH (11 males, nine females), and 20 age, sex, blood pressure, and drug treatment-matched hypertensive patients without LVH underwent 24-h combined ambulatory blood pressure and electrocardiographic (ECG) monitoring. Ischaemic events were defined by the 'rule of 3 x 1'-asymptomatic ST-depression >/= 1 mm (0.1 mV), lasting at least 1 min, and with a duration of at least 1 min between two events. RESULTS: Thirteen patients with LVH had ischaemic events, whilst only four without LVH demonstrated ischaemia. Median numbers of events (seven versus zero; P < 0.01) and median total ischaemic area (0.25 versus 0 mV*min/day; P < 0.01) were significantly increased amongst hypertensive patients with LVH by comparison to those without LVH. CONCLUSION: Despite similar levels of established risk factors for atherosclerotic coronary artery disease, the prevalence of silent ischaemia was markedly increased amongst hypertensive patients with LVH by comparison to those with normal left ventricular dimensions. Ambulatory ECG monitoring may have a use in the identification of those at greatest risk of cardiovascular complications and sudden death, amongst hypertensive patients with persistent cardiac hypertrophy despite anti-hypertensive therapy.