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PubMed2002

Frequency and correlates of coronary stent thrombosis in the modern era: analysis of a single center registry.

OBJECTIVES: The study examined the frequency, correlates, and outcome of patients with stent thrombosis within 30 days of stent placement. BACKGROUND: Patients in trials evaluating stents or dual antiplatelet therapy to prevent coronary stent thrombosis have generally had narrow inclusion criteria; the extent to which stent thrombosis rates in such trials represent current practice, particularly with the availability of newer stents, is unclear. METHODS: We performed a retrospective analysis of the Mayo Clinic Percutaneous Coronary Intervention database and identified all patients who received at least one coronary stent and dual antiplatelet therapy (aspirin and ticlopidine or clopidogrel for two to four weeks). RESULTS: Four thousand five hundred nine patients underwent successful coronary stent implantation and were treated with dual antiplatelet therapy between July 1, 1994, and April 30, 2000. Stent thrombosis occurred in 23 patients (0.51%; 95% confidence interval 0.32%, 0.76%) within 30 days of stent placement. Multivariate analysis using bootstrap model selection to avoid over-fitting the model indicated that only the number of stents placed was an independent correlate of stent thrombosis (odds ratio 1.80, p < 0.001). The frequency of death and frequency of nonfatal myocardial infarction (MI) among the 23 patients with stent thrombosis were 48% and 39%, respectively. CONCLUSIONS: Stent thrombosis is even more rare in the current era than in earlier trials. Number of stents placed was an independent correlate of stent thrombosis. Most patients who suffer stent thrombosis either die or suffer MI.

Aged↗

PubMed2004

Variability in respiratory protection and the assigned protection factor.

The workplace protection factor (WPF) for a given respirator wearer shows substantial variability from wearing to wearing; this variability is commonly assumed to be lognormal in nature. Further, when multiple WPFs are measured for each of multiple wearers, the aggregated WPFs appear to follow a lognormal distribution. However, the analysis typically applied to WPF data does not apportion variability within versus between wearers. We present an analytical framework based on a normal random effects model of log-transformed penetration P values (P = 1/WPF). Data from seven studies of negative-pressure air-purifying half-mask respirators, and from two studies of hemlet-and-visor type powered air-purifying respirators were analyzed by the method of maximum likelihood in the context of the model. More specifically, analyses were performed for log-transformed P values and for logit-transformed P values. Parameter estimates included within-wearer and between-wearer variance components. In general, the within-wearer component dominated the between-wearer component. We also propose a method for establishing an assigned protection factor, APF, that properly accounts for these variance components. Our method provides an APF satisfying two criteria: (1) for a given wearer, an acceptable WPF distribution has no more than 5% of WPFs below the APF value; and (2) for a wearer population, no more than 5% of wearers have unacceptable WPF distributions. The method incorporates an one-sided confidence limit to account for sampling variability. Alternative confidence limits were computed based on large sample variance estimates of random effects model parameters versus a bootstrap method. In general, there was good agreement between the APF values based on log-transformed versus logit-transformed P data, and between APF values based on the large sample variance estimates versus the bootstrap method. Based on large sample variance estimates for the logit-transformed P data from the seven half-mask studies, estimated APFs ranged from 1.4 to 250, with 5/7 studies yielding an APF </= 5.3. Given these results and related considerations, we recommend that the current half-mask APF be reduced from 10 to 5.

Air Pollution, Indoor↗

PubMed2004

Long branch attraction, taxon sampling, and the earliest angiosperms: Amborella or monocots?

BACKGROUND: Numerous studies, using in aggregate some 28 genes, have achieved a consensus in recognizing three groups of plants, including Amborella, as comprising the basal-most grade of all other angiosperms. A major exception is the recent study by Goremykin et al. (2003; Mol. Biol. Evol. 20:1499-1505), whose analyses of 61 genes from 13 sequenced chloroplast genomes of land plants nearly always found 100% support for monocots as the deepest angiosperms relative to Amborella, Calycanthus, and eudicots. We hypothesized that this conflict reflects a misrooting of angiosperms resulting from inadequate taxon sampling, inappropriate phylogenetic methodology, and rapid evolution in the grass lineage used to represent monocots. RESULTS: We used two main approaches to test this hypothesis. First, we sequenced a large number of chloroplast genes from the monocot Acorus and added these plus previously sequenced Acorus genes to the Goremykin et al. (2003) dataset in order to explore the effects of altered monocot sampling under the same analytical conditions used in their study. With Acorus alone representing monocots, strongly supported Amborella-sister trees were obtained in all maximum likelihood and parsimony analyses, and in some distance-based analyses. Trees with both Acorus and grasses gave either a well-supported Amborella-sister topology or else a highly unlikely topology with 100% support for grasses-sister and paraphyly of monocots (i.e., Acorus sister to "dicots" rather than to grasses). Second, we reanalyzed the Goremykin et al. (2003) dataset focusing on methods designed to account for rate heterogeneity. These analyses supported an Amborella-sister hypothesis, with bootstrap support values often conflicting strongly with cognate analyses performed without allowing for rate heterogeneity. In addition, we carried out a limited set of analyses that included the chloroplast genome of Nymphaea, whose position as a basal angiosperm was also, and very recently, challenged. CONCLUSIONS: These analyses show that Amborella (or Amborella plus Nymphaea), but not monocots, is the sister group of all other angiosperms among this limited set of taxa and that the grasses-sister topology is a long-branch-attraction artifact leading to incorrect rooting of angiosperms. These results highlight the danger of having lots of characters but too few and, especially, molecularly divergent taxa, a situation long recognized as potentially producing strongly misleading molecular trees. They also emphasize the importance in phylogenetic analysis of using appropriate evolutionary models.

Artifacts↗

PubMedDate not supplied

Cost-effectiveness of antiplatelet agents in secondary stroke prevention: the limits of certainty.

UNLABELLED: Which of the available antiplatelet therapies should be preferred for secondary prevention of recurrent ischemic stroke has been contentious. OBJECTIVE: We applied the Duke Stroke Policy Model (DSPM) to reconsider this issue, paying particular attention to the degree of uncertainty in the estimates of their efficacy. The DSPM is a continuous-time simulation model of stroke development and outcome. METHODS: We modified the inputs to reflect the cost of the drugs aspirin (ASA), extended release dipyridamole/aspirin (DP/A) and clopidogrel (CLO), as well as their relative risk in preventing subsequent ischemic stroke in comparison with placebo (PBO). These relative risks were derived from published reports from the second European Stroke Prevention Study (ESPS-2) and Clopidogrel Versus Aspiring in Patients at Risk of Ischemic Events studies. Precision was addressed by applying bootstrapping to the above estimates of relative risk. The target population was 70-year-old men with nondisabling stroke. The outcome measures were quality-adjusted life-years (QALYs), costs, and costs per QALY. RESULTS: Results of Base Case Analysis: In large part because of its modest drug cost, ASA was cost-effective in comparison with PBO. DP/A tended to have improved outcomes, but at increased costs. CLO was dominated in the base case. RESULTS OF SENSITIVITY ANALYSIS: ASA and DP/A cannot be differentiated on a statistical basis alone. In probabilistic sensitivity analysis, CLO was rarely preferred. CONCLUSIONS: Either DP/A or ASA appear to be a good value in comparison with no treatment, but there is no clear winner between the two. In the absence of a definitive randomized trial, simulation modeling can help clarify the trade-offs between the various antiplatelet agents, but not beyond the constraints imposed by the imprecision in the estimates that can be obtained from the current evidence base.

Aged↗

PubMed2006

Reduced 6-month resource use and costs associated with cilostazol in patients after successful coronary stent implantation: results from the Cilostazol for RESTenosis (CREST) trial.

BACKGROUND: The CREST trial demonstrated that after successful coronary stent implantation, the 6-month rate of target vessel revascularization (TVR) was similar (15.4% vs 16%, P = .90) for the 2 treatment groups, but restenosis rate was lower (22.0% vs 34.5%, P = .002) in cilostazol-treated patients. We sought to evaluate resource use, cost, and cost-effectiveness of cilostazol in CREST. METHODS: A total of 705 patients were randomized to cilostazol 100 mg twice daily (n = 354) versus placebo (n = 351) for 6 months. Resources included rehospitalizations, medications, and outpatient services. Costs were determined from the Medicare fee schedule. Cilostazol was priced at 1.64 dollars a day. Base-case cost and cost-effectiveness analysis was performed for the entire population using TVR as a measure of effectiveness. Sensitivity analysis was conducted among 526 patients because restenosis data were available only for this patient population. A bootstrap resample approach (5000 samples) was used to obtain confidence intervals for cost differences. RESULTS: For the entire population, costs of rehospitalizations, concomitant medications, outpatient tests, and physician or emergency department visits were lower during follow-up for cilostazol-treated patients. Overall, total 6-month follow-up costs remained 447 dollars lower for cilostazol (4178 dollars vs 4625 dollars), although this difference did not reach significance (95% CI -1458 dollars to 515 dollars). Cilostazol is likely a cost-saving strategy (similar rate of TVR and lower costs). Sensitivity analysis showed that cilostazol is likely a dominant strategy (lower restenosis rate and costs, 85% dominant, 88.9% <1000 dollars per restenosis averted). CONCLUSIONS: Treatment with cilostazol is likely a cost-saving or dominant strategy in patients with successful coronary bare metal stent implantation. Cilostazol may offer a low-cost alternative to restenosis prevention in patients who do not receive drug-eluting stents.

Adult↗

PubMed2000

Predictors of outcome in patients with acute coronary syndromes without persistent ST-segment elevation. Results from an international trial of 9461 patients. The PURSUIT Investigators.

BACKGROUND: Appropriate treatment policies should include an accurate estimate of a patient's baseline risk. Risk modeling to date has been underutilized in patients with acute coronary syndromes without persistent ST-segment elevation. METHODS AND RESULTS: We analyzed the relation between baseline characteristics and the 30-day incidence of death and the composite of death or myocardial (re)infarction in 9461 patients with acute coronary syndromes without persistent ST-segment elevation enrolled in the PURSUIT trial [Platelet glycoprotein IIb/IIIa in Unstable angina: Receptor Suppression Using Integrilin (eptifibatide) Therapy]. Variables examined included demographics, history, hemodynamic condition, and symptom duration. Risk models were created with multivariable logistic regression and validated by bootstrapping techniques. There was a 3.6% mortality rate and 11.4% infarction rate by 30 days. More than 20 significant predictors for mortality and for the composite end point were identified. The most important baseline determinants of death were age (adjusted chi(2)=95), heart rate (chi(2)=32), systolic blood pressure (chi(2)=20), ST-segment depression (chi(2)=20), signs of heart failure (chi(2)=18), and cardiac enzymes (chi(2)=15). Determinants of mortality were generally also predictive of death or myocardial (re)infarction. Differences were observed, however, in the relative prognostic importance of predictive variables for mortality alone or the composite end point; for example, sex was a more important determinant of the composite end point (chi(2)=21) than of death alone (chi(2)=10). The accuracy of the prediction of the composite end point was less than that of mortality (C-index 0.67 versus 0.81). CONCLUSIONS: The occurrence of adverse events after presentation with acute coronary syndromes is affected by multiple factors. These factors should be considered in the clinical decision-making process.

Age Distribution↗