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The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparincoated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12·8%) of 413 patients in the stent group and 79 (19·3%) of 410 in the angioplasty group (p=0·013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1·89 [SD 0·65] vs 1·66 [0·57] mm, p=0·0002), which corresponds to restenosis rates (diameter stenosis ≥50%) of 16% and 31% (p=0·0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0·89 vs 0·79, p=0·004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient. Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.

Bivalirudin is a new direct thrombin inhibitor. In patients undergoing PCI for stable coronary disease, bivalirudin and unfractionated heparin resulted in similar overall outcomes, but there was less major bleeding with bivalirudin. Bivalirudin is a new direct thrombin inhibitor. In patients undergoing PCI for stable coronary disease, bivalirudin and unfractionated heparin resulted in similar overall outcomes, but there was less major bleeding with bivalirudin. Percutaneous coronary intervention (PCI) is commonly used to treat patients with coronary artery disease. To minimize the risk of thrombotic complications during and shortly after the procedure, many different antithrombotic regimens have been investigated and are currently in use. Increasing evidence of the adverse consequences of periprocedural bleeding suggests that protection from thrombotic complications should not be the sole measure by which antithrombotic therapies are evaluated. 1 Aspirin, clopidogrel, and heparin are established antithrombotic drugs that are widely recommended according to current guidelines on PCI. 2 Pretreatment with 300 to 600 mg of clopidogrel increasingly is used before PCI because of mounting . . .

ObjectiveTo assess the long-term effect of spinal cord stimulation (SCS) on angina symptoms and quality of life in patients with refractory angina pectoris defined as severe angina due to coronary artery disease resistant to conventional pharmacological therapy and/or revascularisation.MethodsDuring 2003–2005, all patients with refractory angina referred for SCS treatment at 10 European centres were consecutively included in the European registry for refractory angina (European Angina Registry Link, EARL), a prospective, 3-year follow-up study. In the present study, the SCS-treated patients were followed-up regarding angina symptoms and quality of life assessed was with a generic (Short Form 36, SF-36) and a disease-specific (Seattle Angina Questionnaire, SAQ) quality of life questionnaire.ResultsIn total, 235 patients were included in the study. After screening, 121 patients were implanted and followed up 12.1 months after implantation. The implanted patients reported fewer angina attacks (p<0.0001), reduced short-acting nitrate consumption (p<0.0001) and improved Canadian Cardiovascular Society class (p<0.0001). Furthermore, quality of life was significantly improved in all dimensions of the SF-36 and the SAQ. Seven (5.8%) of the implanted patients died within 1 year of follow up.ConclusionsSCS treatment is associated with symptom relief and improved quality of life in patients with refractory angina pectoris suffering from severe coronary artery disease.

In addition to its anti-ischaemic effects, the antianginal drug nicorandil is thought to have cardioprotective properties. We did a randomised trial to find out whether nicorandil could reduce the frequency of coronary events in men and women with stable angina and additional risk factors. 5126 patients were randomly assigned 20 mg nicorandil twice daily (n=2565) or identical placebo (n=2561) in addition to standard antianginal therapy. The primary composite endpoint was coronary heart disease death, non-fatal myocardial infarction, or unplanned hospital admission for cardiac chest pain. The secondary endpoint was the combined outcome of coronary heart disease death or nonfatal myocardial infarction. Other outcomes reported include all-cause mortality, all cardiovascular events, and acute coronary syndromes. Mean follow-up was 1·6 years (SD 0·5). Analysis was by intention to treat. There were 398 (15·5%) primary endpoint events in the placebo group and 337 (13·1%) in the nicorandil group (hazard ratio 0·83, 95% Cl 0·72–0·97; p=0·014). The frequency of the secondary endpoint was not significantly different between the groups (134 events [5·2%] vs 107 events [4·2%]; 0·79, 0·61–1·02; p=0·068). The rate of acute coronary syndromes was 195 (7·6%) in the placebo group and 156 (6·1%) in the nicorandil group (0·79, 0·64–0·98; p=0·028), and the corresponding rates for all cardiovascular events were 436 (17·0%) and 378 (14·7%; 0·86, 0·75–0·98; p=0·027). We showed a significant improvement in outcome due to a reduction in major coronary events by antianginal therapy with nicorandil in patients with stable angina.

Objective : To see whether mortality among men with angina can be reduced by dietary advice. Design : A randomized controlled factorial trial. Setting : Male patients of general practitioners in south Wales. Subjects : A total of 3114 men under 70 y of age with angina. Interventions : Subjects were randomly allocated to four groups: (1) advised to eat two portions of oily fish each week, or to take three fish oil capsules daily; (2) advised to eat more fruit, vegetables and oats; (3) given both the above types of advice; and (4) given no specific dietary advice. Mortality was ascertained after 3–9 y. Results : Compliance was better with the fish advice than with the fruit advice. All-cause mortality was not reduced by either form of advice, and no other effects were attributable to fruit advice. Risk of cardiac death was higher among subjects advised to take oily fish than among those not so advised; the adjusted hazard ratio was 1.26 (95% confidence interval 1.00, 1.58; P =0.047), and even greater for sudden cardiac death (1.54; 95% CI 1.06, 2.23; P =0.025). The excess risk was largely located among the subgroup given fish oil capsules. There was no evidence that it was due to interactions with medication. Conclusion : Advice to eat more fruit was poorly complied with and had no detectable effect on mortality. Men advised to eat oily fish, and particularly those supplied with fish oil capsules, had a higher risk of cardiac death. This result is unexplained; it may arise from risk compensation or some other effect on patients' or doctors' behaviour. Sponsorship : British Heart Foundation, Seven Seas Limited, Novex Pharma Limited, The Fish Foundation.

It is unknown if baseline angiographic findings can be used to estimate residual risk of patients with chronic stable angina treated with both optimal medical therapy (OMT) and protocol-assigned or symptom-driven percutaneous coronary intervention (PCI). Death, myocardial infarction (MI), and hospitalization for non–ST-segment elevation acute coronary syndrome were adjudicated in 2,275 COURAGE patients. The number of vessels diseased (VD) was defined as the number of major coronary arteries with ≥50% diameter stenosis. Proximal left anterior descending, either isolated or in combination with other disease, was also evaluated. Depressed left ventricular ejection fraction (LVEF) was defined as ≤50%. Cox regression analyses included these anatomical factors as well as interaction terms for initial treatment assignment (OMT or OMT + PCI). Percutaneous coronary intervention and proximal left anterior descending did not influence any outcome. Death was predicted by low LVEF (hazard ratio [HR] 1.86, CI 1.34-2.59, P < .001) and VD (HR 1.45, CI 1.20-1.75, P < .001). Myocardial infarction and non–ST-segment elevation acute coronary syndrome were predicted only by VD (HR 1.53, CI 1.30-1.81 and HR 1.24, CI 1.06-1.44, P = .007, respectively). In spite of OMT and irrespective of protocol-assigned or clinically driven PCI, LVEF and angiographic burden of disease at baseline retain prognostic power and reflect residual risk for secondary ischemic events.

Background To decrease the morbidity burden of cardiovascular disease and to avoid the development of potentially preventable complications, early assessment and treatment of acute coronary syndrome (ACS) are important. The aim of this study has therefore been to explore the possible association between patients’ estimated intensity of chest pain when first seen by the ambulance crew in suspected ACS, and the subsequent outcome before and after arrival in hospital. Methods Data was collected both prospectively and retrospectively. The inclusion criteria were chest pain raising suspicion of ACS and a reported intensity of pain ≥4 on the visual analogue scale. Results All in all, 1603 patients were included in the study. Increased intensity of chest pain was related to: 1) more heart-related complications before hospital admission; 2) a higher proportion of heart failure, anxiety and chest pain after hospital admission; 3) a higher proportion of acute myocardial infarction and 4) a prolonged hospitalisation. However, there was no significant association with mortality neither in 30 days nor in three years. Adjustment for possible confounders including age, a history of smoking and heart failure showed similar results. Conclusion The estimated intensity of chest pain reported by the patients on admission by the ambulance team was associated with the risk of complications prior to hospital admission, heart failure, anxiety and chest pain after hospital admission, the final diagnosis and the number of days in hospital. Trial registration ClinicalTrials.gov 151:2008/4564 Identifier: NCT00792181. Registred 17 November 2008 ‘retrospectively registered’.

Despite the success of current medical and surgical management of ischemic heart disease, a growing number of patients have diffuse obstructive coronary artery disease that is not amenable to coronary-artery bypass grafting or catheter-based interventions. This problem has stimulated interest in developing alternative therapeutic approaches. Early attempts at indirect myocardial revascularization had limited success. Beck's use of omentopexy, reported in 1935, 1 and Vinberg's use of thoracic-artery implantation, reported in 1954, 2 were attempts to provide direct myocardial perfusion and were based on the description by Wearn et al., in 1933, 3 of a sinusoidal network in the human heart. In 1965, Sen . . .

In the 1950s, Goldman and associates 1 and Massimo and Boffi 2 proposed that natural or artificial conduits could be implanted in the subendocardium to direct left ventricular blood through the coronary sinusoids and into ischemic areas of the myocardium. In 1968, after extensive experiments in animals, Sen and colleagues 3 described transmyocardial revascularization through transmural channels created with a 16-gauge intravenous cannula. In 1981, Mirhoseini and Cayton 4 used a laser to create transmyocardial channels in animals; five years later, Okada and colleagues 5 did the same in humans. Investigators have continued to test transmyocardial revascularization in both animals 6 – 9 and humans. 10 In a . . .

Summary Drug therapy for hypercholesterolaemia has remained controversial mainly because of insufficient clinical trial evidence for improved survival. The present trial was designed to evaluate the effect of cholesterol lowering with simvastatin on mortality and morbidity in patients with coronary heart disease (CHD). 4444 patients with angina pectoris or previous myocardial infarction and serum cholesterol 5·5-8·0 mmol/L on a lipid-lowering diet were randomised to double-blind treatment with simvastatin or placebo. Over the 5·4 years median follow-up period, simvastatin produced mean changes in total cholesterol, low-density-lipoprotein cholesterol, and high-density-lipoprotein cholesterol of -25%, -35%, and +8%, respectively, with few adverse effects. 256 patients (12%) in the placebo group died, compared with 182 (8%) in the simvastatin group. The relative risk of death in the simvastatin group was 0·70 (95% Cl 0·58-0·85, p=0·0003). The 6-year· probabilities of survival in the placebo and simvastatin groups were 87·6% and 91·3%, respectively. There were 189 coronary deaths in the placebo group and 111 in the simvastatin group (relative risk 0·58, 95% Cl 0·46-0·73), while noncardiovascular causes accounted for 49 and 46 deaths, respectively. 622 patients (28%) in the placebo group and 431 (19%) in the simvastatin group had one or more major coronary events. The relative risk was 0·66 (95% Cl 0·59-0·75, p<0·00001), and the respective probabilities of escaping such events were 70·5% and 79·6%. This risk was also significantly reduced in subgroups consisting of women and patients of both sexes aged 60 or more. Other benefits of treatment included a 37% reduction (p<0·00001) in the risk of undergoing myocardial revascularisation procedures. This study shows that long-term treatment with simvastatin is safe and improves survival in CHD patients.