Paclitaxel drug-eluting balloons to recurrent in-stent stenoses in autogenous dialysis fistulas: a retrospective study.

PURPOSE: To assess the effect of the Medtronic paclitaxel drug-eluting balloon (DEB) on re-intervention to in-stent stenoses in autogenous dialysis arteriovenous fistulas (AVFs). BACKGROUND: AVF is the optimum haemodialysis access. The commonest problem is stenosis, preventing maturation, causing inadequate dialysis or precipitating occlusion. Conventional angioplasty has a high recurrence rate. Successful drug elution in the coronary circulation led us to use DEBs in recurrent AVF stenoses since 2010. METHODS: This is a retrospective study, based on prospective audit data, using DEBs on recurrent in-stent stenotic lesions in the AVF circuit of our haemodialysis population. To analyse the effect of DEBs on re-intervention, we created two Kaplan-Meier curves. The first curve compares the last "disease-free-interval" pre-DEB intervention to the first "disease-free interval" post-DEB, giving us "re-intervention-free percentage at 12 months" pre- and post-DEB. The second curve takes into account the multiple pre- and post-DEB interventions to the index lesion, and uses a marginal proportional hazards model to estimate the hazard ratio for "DEBpresent vs. DEBabsent". RESULTS: From 1 September 2010 to 1 December 2013, we treated 625 AVF stenoses with endovascular techniques. In 86 of these stenoses, DEBs were used. Of the 86 DEB interventions, 37 were included for this study, 49 were excluded. In the study group, there was a significant difference in "re-intervention-free percentage at 12 months" before and after DEB: 19% vs. 69%. The hazard ratio for "DEBpresent" vs. "DEBabsent" was 0.23 (95% CI 0.14 to 0.36, p<0.001). CONCLUSIONS: This retrospective study suggests that DEBs significantly reduce re-intervention on recurrent in-stent AVF stenoses.

Predictive value of ST resolution analysis performed immediately versus at ninety minutes after primary percutaneous coronary intervention.

ST segment resolution (STR) predicts epicardial and microvascular reperfusion after primary percutaneous coronary intervention (PPCI) or thrombolysis for ST-elevation myocardial infarction. Immediate restoration of epicardial coronary flow, with improved microvascular perfusion, is much more likely with PPCI. However, the predictive value of immediate STR compared to 90 minutes after PPCI remains unknown. In 622 consecutive patients with ST-elevation myocardial infarction (mean age 59 +/- 13 years), 217 had complete STR immediately after PPCI (group A), 188 had complete STR only at 90 minutes (group B), and 217 had incomplete STR at either point (group C). The primary end point was mortality and adverse cardiovascular events ([MACE] death, nonfatal repeat myocardial infarction, and heart failure). Group A had a greater left ventricular ejection fraction (53%, 47%, and 46%, p <0.001) and lower all-cause mortality (1.8%, 3.2%, and 6%, p = 0.07), lower heart failure (1.8%, 4.3%, and 7.8%, p <0.001), and MACE (5.1%, 9.6%, and 16.1%, p = 0.001) at 30 days compared to groups B and C, respectively. The rate of MACE at 1 year was 7.6%, 17.1%, and 20.2% in groups A, B, and C, respectively (p <0.001). Immediate STR independently predicted MACE (adjusted hazard ratio 0.36, 95% confidence interval 0.21 to 0.61, p = 0.001, group A vs C), and STR at 90 minutes did not. In conclusion, STR analysis performed immediately after PPCI provided superior differentiation for adverse cardiovascular events compared to STR at 90 minutes. Immediate STR should be the contemporary goal of reperfusion with PPCI.

Incidence and predictors of silent myocardial infarction in type 2 diabetes and the effect of fenofibrate: an analysis from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study.

AIMS: To determine the incidence and predictors of, and effects of fenofibrate on silent myocardial infarction (MI) in a large contemporary cohort of patients with type 2 diabetes in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. METHODS AND RESULTS: Routine electrocardiograms taken throughout the study were assessed by Minnesota-code criteria for the presence of new Q-waves without clinical presentation and analysed with blinding to treatment allocation and clinical outcome. Of all MIs, 36.8% were silent. Being male, older age, longer diabetes duration, prior cardiovascular disease (CVD), neuropathy, higher HbA(1c), albuminuria, high serum creatinine, and insulin use all significantly predicted risk of clinical or silent MI. Fenofibrate reduced MI (clinical or silent) by 19% [hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.69-0.94; P = 0.006], non-fatal clinical MI by 24% (P = 0.01), and silent MI by 16% (P = 0.16). Among those having silent MI, fenofibrate reduced subsequent clinical CVD events by 78% (HR 0.22, 95% CI 0.08-0.65; P = 0.003). CONCLUSION: Silent and clinical MI have similar risk factors and increase the risk of future CVD events. Fenofibrate reduces the risk of a first MI and substantially reduces the risk of further clinical CVD events after silent MI, supporting its use in type 2 diabetes.

Interventions for prevention of post-operative atrial fibrillation and its complications after cardiac surgery: a meta-analysis.

AIMS: Atrial fibrillation (AF) is the most common complication after cardiac surgery. We aimed to evaluate, by meta-analysis, all randomized trials testing interventions for preventing AF. METHODS AND RESULTS: Ninety-four trials of prevention of post-operative AF were identified, by standard search methods, and analysed by standard meta-analysis techniques. All five commonly tested interventions, beta-blockers (BBs), sotalol, amiodarone, magnesium, and atrial pacing, were effective in preventing AF. The odds ratio (OR) for the effect of BB on the incidence of AF was 0.36 (95% CI 0.28-0.47, P<0.001), but after trials confounded by post-operative non-study BB withdrawal were excluded was 0.69 (95% CI 0.54-0.87, P=0.002). Sotalol reduced AF, compared with placebo (OR 0.34, 95% CI 0.26-0.45, P<0.001) and compared with conventional BB (OR 0.42, 95% CI 0.26-0.65, P<0.001). Amiodarone reduced AF (OR 0.48, 95% CI 0.40-0.57, P<0.001). Magnesium (Mg) also had an effect (OR 0.57 95% CI 0.42-0.77) but there was significant heterogeneity (P<0.001), partly explained by concomitant BB. The effect of Mg with BB was less (OR 0.83, 95% CI 0.60-1.16). Pacing reduced AF (OR 0.60, 95% CI 0.47-0.77, P<0.001), despite wide variations in techniques. Only amiodarone and pacing significantly reduced length of stay, average -0.60 days (95% CI -0.92 to -0.29) and -1.3 days (95% CI -2.55 to -0.08), respectively. Collectively, all treatments analysed together reduced stroke (OR 0.63, 95% CI 0.41-0.98). Amiodarone was the only intervention that alone significantly reduced stroke rate (OR 0.54, 95% CI 0.30-0.95). CONCLUSION: All five interventions reduced the incidence of AF, though the effect of BBs is less than previously thought. The significant reductions in length of stay and stroke in meta-analysis suggest that there are worthwhile benefits from aggressive prevention. Larger studies to confirm these clinical benefits and evaluate their cost-effectiveness would be worthwhile.

The MMR vaccination and autism controversy in United Kingdom 1998-2005: inevitable community outrage or a failure of risk communication?

BACKGROUND: The report of an hypothesised link between measles-mumps-rubella (MMR) vaccination and autism in 1998 became a major public health issue in the United Kingdom (UK), leaving most experts surprised by the overwhelming influence it had on public opinion about MMR vaccination. Coverage rates fell dramatically, and did not start to recover until 2004. Could this public reaction have been predicted? METHODS: We used Sandman's model of components predicting community outrage to assess the MMR controversy. RESULTS: The controversy fulfilled all of Sandman's 12 primary components and six of the eight additional components. CONCLUSIONS: The Sandman model provided a useful framework to analyse this controversy and explained a significant portion of the community reaction and subsequent fall in vaccination coverage rates.

A systematic review and economic analysis of drug-eluting coronary stents available in Australia.

OBJECTIVES: To compare the safety, effectiveness and cost-effectiveness of drug-eluting coronary stents used in Australia with bare-metal stents and determine whether the benefits are greater for high-risk subgroups. DATA SOURCES: MEDLINE, Pre-Medline, EMBASE, Current Contents, CINAHL and the Cochrane Library database were searched to identify eligible randomised controlled trials and systematic reviews published in English between January 1966 and June 2004. STUDY SELECTION: Seven randomised controlled trials that assessed polymer-based paclitaxel- or sirolimus-eluting stents versus bare-metal stents in patients with coronary atherosclerosis and reported on stent thrombosis, mortality, myocardial infarction, coronary artery bypass grafting or target lesion revascularisation. DATA EXTRACTION: Two independent reviewers appraised eligible studies and extracted data. Relative risks (RRs) were calculated for each outcome and pooled using the Mantel-Haenszel method. DATA SYNTHESIS: Rates of stent thrombosis, mortality, myocardial infarction and bypass grafts did not differ by stent type. Drug-eluting stents (DESs) resulted in a 71%-80% lower risk of revascularisation at 12 months (RR 0.29 [95% CI, 0.20-0.43] for paclitaxel-eluting stents [n = 1593 patients]; RR 0.20 [95% CI, 0.13-0.29] for sirolimus-eluting stents [n = 1296 patients]). Similar benefits were seen in several high-risk subgroups of patients: those with diabetes, lesion length > 20 mm and target-vessel diameter < or = 2.5 mm. The benefits of DESs in these high-risk groups over lower-risk groups were inconclusive because of low numbers. The cost per revascularisation avoided by using DESs was 3,750-6,100 Australian dollars, with an estimated cost per quality-adjusted-life-year (QALY) gained of 46,829-76,467 Australian dollars. In sensitivity analyses, estimates varied from DESs being cost-saving to costing an additional 314,385 Australian dollars per QALY gained. CONCLUSIONS: DESs are effective in reducing revascularisation. Estimates of cost-effectiveness are very sensitive to changes in estimates of their true effects in clinical practice, market price and the number of stents used per patient. Decisions to limit DESs to only patients at the highest risk of restenosis may improve their cost-effectiveness but will need to be reassessed when evidence is available to compare absolute benefits between patient groups.