Short-term clinical outcome of drug-eluting coronary stent

Objective To evaluate short-term outcome of coronary drug-eluting stent (DES) in patients with coronary artery disease (CAD) by comparing with standard bare stents.     

Ongoing clinical outcome studies of calcium antagonists

Calcium antagonists continue to have a place in the treatment of hypertension, despite recent concerns regarding their safety and long-term capacity to alter the natural history of cardiovascular disease. Results of a well-designed cohort study concerning a very elderly population suggested that administration of shorft-acting nifedipine is linked to an increase in mortality, particularly when a high dose is administered and when the initiaol blood pressure is below 160/90 mmHg. The risk of using short-acting verapamil, however, was no greater than that of beta-blockade. These differences can be attributed at least in part to the low catecholamine profile of verapamil and to the marked rapid adrenergic activation with short-acting nifedipine. Current evidence sujggests that less catecholamine activation occurs during the chronic use of long-acting dihydropyridine agents. Two recent studies have shown that the combination of verapamil and an angiotensin converting enzyme inhibitor reduces numbers of cardiovascular disease events among postinfarct patients with heart failure, and that the dihydropyridine nitrendipine reduces poor outcome measures, such as stroke incidence, in treating systolic hypertension in the elderly. In my view, apparent hazards such as the precipitation of myocardial infarction and cancer are discounted by the available evidence. While we await further major trials concerning outcomes, general safety can be related to a preference for administering those long-acting agents that do not stimulate and may even inhibit adrenergic responses, and the avoidance of possible adverse effects through the use of combination therapies, such as verapamil plus an angiotensin converting enzyme inhibitor or nifedipine plus a beta-blocker.     

Responsiveness of fibromyalgia clinical trial outcome measures

OBJECTIVE: To assess the responsiveness of the Fibromyalgia Impact Questionnaire (FIQ), patient ratings of pain intensity, number of tender points, and total tender point pain intensity score to perceived changes in clinical status in patients with fibromyalgia (FM). METHODS: Using data from a randomized placebo controlled study evaluating efficacy of magnetic therapy in patients with FM, the ability of primary outcomes to detect clinically meaningful changes over a 6 month period was assessed by: (1) degree of association between outcome change scores and patient global ratings of symptom change (Spearman rank-order correlations); (2) ability of these scores to discriminate among groups of patients whose perceived health status had changed to varying degrees (ANOVA); (3) ability of these scores, individually and jointly, to discriminate between patients who had reported improvement and those who did not (logistic regression); (4) effect size, standardized response mean, and Guyatt's statistic were calculated to quantify responsiveness. RESULTS: Correlations showed the outcome measures were moderately responsive to perceived symptomatic change. For FIQ, pain intensity ratings and number of tender points, differences in change scores between globally improved and unchanged groups and between globally improved and worsened groups were significant; for total tender point pain intensity, the globally improved differed from worsened group. FIQ outperformed the other measures in discriminating between patients who reported improvement from those who did not. Summary statistics were consistent with discriminatory analyses, indicating the measures were sensitive to improvement, but relatively unresponsive to decline. CONCLUSION: The FIQ was the most responsive measure to perceived clinical improvement and we recommend its inclusion as a primary endpoint in FM clinical trials.     

Source of funding and outcome of clinical trials

Because of recent concerns about conflicts of interest and published research, the author analyzed 107 controlled clinical trials. Studies were classified as favoring either a new therapy or a traditional therapy, and as being supported by a pharmaceutical manufacturer or as being generally supported. Seventy-one per cent of the trials favored new therapies; 43% of these were funded by pharmaceutical firms. Of the 31 trials favoring traditional therapy, only four (13%) were supported by a pharmaceutical firm. There was a statistically significant association between the source of funding and the outcome of the study (p = 0.002). Few trials supported by pharmaceutical manufacturers favored traditional therapy; some reasons for this finding may include selection of drugs likely to be proven efficacious, Type II errors (false-negative studies), and fear of discontinuation of funding should such studies be submitted. Important clinical information may be lost if negative studies are not published.     

Cystic fibrosis: Benefits and clinical outcome

Summary Diagnosis of cystic fibrosis (CF), the most common life-limiting recessive genetic condition in the caucasian population, via NBS is now occurring in many regions of the world. There is evidence that newborn screening (NBS) for CF may prevent malnutrition in infants with pancreatic-insufficient CF and may have an impact upon later growth and development. Progression of lung disease in CF is the major determinant of quality of life and of survival. There is no clear evidence of an advantage for those diagnosed by NBS programmes in terms of the progression of lung disease as measured by lung function. Some studies show better preservation of lung function, while others fail to show such an outcome. This is also true for respiratory infections and acquisition of the most significant respiratory pathogen in CF—Pseudomonas aeruginosa. There is, however, evidence that an advantage may be accrued by early diagnosis made possible by NBS in terms of lung disease as measured by pulmonary imaging. Those diagnosed via NBS have an apparent advantage in terms of a reduction in the number and duration of hospitalizations, particularly in infancy, as well as the need for antibiotic usage. There is also evidence from a number of sources for a lifetime survival advantage for those with CF diagnosed via NBS programmes, with the most significant advantage being for survival during infancy. Competing interests: None declared     

Determinants of clinical outcome and survival in acromegaly

OBJECTIVE The extent to which treatment modifies the excess in morbidity and mortality in acromegaly remains uncertain. This study investigates the determinants of final outcome following therapy for acromegaly. DESIGN A retrospective analysis of patients treated at the Departments of Endocrinology and Neurosurgery, Auckland Hospital, New Zealand. PATIENTS One hundred and fifty-one patients (63 females and 88 males) with acromegaly or gigantism treated between the years 1964 and 1989. The mean duration of follow-up was 12 years (median 11 years). MEASUREMENTS Patients had their age, estimated duration of symptoms preceding diagnosis, serum GH at diagnosis, presence of diabetes mellitus, cardiovascular disease, hypertension and/or osteoarthritis at diagnosis and the last known serum GH documented. The final outcome at the time of study was graded under three classes: dead (n = 32), those with major complications (n = 47) and those with minor/no complications (n = 67). RESULTS The mean age at diagnosis of acromegaly was 41 years and the average estimated duration of symptoms prior to diagnosis was 7 years, with older patients showing longer duration of symptoms preceding diagnosis (P= 0.0002). Final outcome (dead, alive with major complications, alive and well) was significantly worse in those with older age at diagnosis (P= 0.008), longer duration of symptoms before diagnosis (P= 0.03) and higher GH at last follow-up (P= 0.0001). In multivariate analysis, survival was significantly Influenced by the last known GH (P = 0.0001), presence of hypertension (P = 0.02) or cardiac disease (P = 0.03) at diagnosis, and duration of symptoms prior to diagnosis (P = 0.04). Survival In the acromegalic group, irrespective of treatment, was reduced by an average of 10 years compared with the non-acromegalic population. CONCLUSIONS Acromegaly has a significant adverse effect on well-being and survival. The predominant determinant of outcome is the final serum GH level following treatment.     

Intermittent tepid blood cardioplegia improves clinical outcome

Intermittent antegrade cold blood cardioplegia is the predominant method of myocardial protection, but recent studies suggest that warm or tepid blood cardioplegia may improve the return of myocardial metabolic and contractile function. Data were collected prospectively on 1,533 patients undergoing cardiopulmonary bypass in a single surgeon's practice. The use of intermittent antegrade cold (4 degrees C) blood cardioplegia in 951 consecutive patients from September 1994 to November 1997 was compared with intermittent antegrade tepid (28 degrees C) blood cardioplegia in 582 consecutive patients from July 1998 to July 2000. The two groups were similar, but the symptom class was more severe and there were more redo and combined procedures and more operations within 7 days of myocardial infarction in the tepid group. Significant clinical benefits identified in the tepid group included reduced usage of intraaortic balloon pumping postoperatively (4.4% versus 2.2%) and reduced incidence of postoperative atrial fibrillation (25.7% versus 20.6%). There was no significant difference in mortality, perioperative myocardial infarction, cerebrovascular events, or use of inotropics between the groups. Intermittent tepid blood cardioplegia is clinically appropriate and safe to use in patients undergoing cardiac surgery.     

Effect of MRI on clinical outcome of recurrent fistula-in-ano

Recurrent fistula-in-ano is usually due to sepsis missed at surgery, which can be identified by MRI. We aimed to establish the therapeutic effect of MRI in patients with fistula-in-ano. We did MRI in 71 patients with recurrent fistula, with further surgery done at the discretion of the surgeon. Surgery and MRI agreed in 40 patients, five (13%) of whom had further recurrence, compared with 16 (52%) of 31 in whom surgery and MRI disagreed (p=0.0005). Further recurrence in all 16 was at the site predicted by MRI. For surgeons who always acted on MRI, further recurrences arose in four of 25 (16%) operations versus eight of 14 (57%) operations for those who ignored imaging (p=0.008). Surgery guided by MRI reduces further recurrence of fistula-in-ano by 75% and should be done in all patients with recurrent fistula.     

活动衬垫膝关节假体行关节置换的中长期报告

目的 对应用可活动衬垫膝关节假体行关节置换术后的临床中长期效果进行评价.方法 对我院1997年11月～2007年12月应用可活动衬垫膝关节假体行膝关节表面置换的住院患者746膝(653例)进行临床及X线随访,根据HSS评分标准进行临床评价.结果 HSS评分从术前平均51.2分提高到术后平均92.1分,优良率达92.3%.活动范围从术前平均伸-7.5°、屈64.3°到术后平均伸-1.1°、屈103.5°.术后12例感染,5例假体周围骨折,其他未发现有骨溶解、假体松动或活动衬垫脱位等并发症.结论 活动衬垫膝关节增加了股骨与聚乙烯衬垫之间的匹配,减少了接触应力和聚乙烯的磨损,其术后短期及中长期临床效果令人满意.     

Randomized clinical outcome trials of statins in heart failure

Morbidity and mortality in patients who have heart failure (HF) remains substantial, and new therapies are needed. Tantalizing evidence from experimental studies, retrospective analyses, and limited prospective clinical investigations have suggested that statin therapy may improve ventricular function, HF status, and clinical outcomes independently of HF etiology and through mechanisms other than statin effects on dyslipidemia. The Controlled Rosuvastatin in Multinational Trial in Heart Failure (CORONA) is the first prospective randomized clinical outcome trial with statins focused specifically on HF. Over a median follow-up of 33 months, there were no significant differences in the primary end point or in all-cause mortality, the rate of coronary events, effects on New York Heart Association class, or the rate of newly diagnosed diabetes. There were significant reductions in the number of cardiovascular hospitalizations and, in a post hoc analysis, in nonfatal ischemic events. The discrepancy between the results from previous observational studies and the results of the CORONA trial emphasizes the importance of prospective randomized clinical outcome trials.     

Endocarditis: clinical outcome and benefit of trans-oesophageal echocardiography

The improved prognosis for infective endocarditis (IE) seen in the last decade is due partly to more active surgical treatment and partly to improved diagnosis by echocardiography. To evaluate the clinical value of repeated trans-oesophageal echocardiography (TEE) 34 patients with 35 episodes of suspected IE were included in a prospective part of the study (group A). TEE was carried out for diagnosis, at discharge and about 5 months after hospitalization. Endocarditis was classified using Duke's criteria. In a retrospective part of the study 32 other patients with 34 episodes of IE were included (group B). Both groups were analysed regarding mortality, frequency of surgery and classification according to Duke. The diagnosis was regarded as definite in 49 and possible in 20 episodes. Vegetation-size decreased significantly (p < 0.001) during treatment. In contrast, no significant changes in valvular insufficiency were found. In episodes diagnosed as definite, the mortality was 2/49 (4.1%). The low mortality might be explained by the high frequency of surgery (22%), the inclusion of patients with right-sided IE, and 'early diagnosis'. The first TEE was important for correct diagnosis in patients with small vegetations and for those needing surgery. The clinical value of the additional investigations was low in native valve endocarditis.