Comparative Effectiveness and Safety of New-Generation Versus Early-Generation Drug-Eluting Stents According to Complexity of Coronary Artery Disease: A Patient-Level Pooled Analysis of 6,081 Patients.

OBJECTIVES The purpose of this study was to compare the 2-year safety and effectiveness of new- versus early-generation drug-eluting stents (DES) according to the severity of coronary artery disease (CAD) as assessed by the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score. BACKGROUND New-generation DES are considered the standard-of-care in patients with CAD undergoing percutaneous coronary intervention. However, there are few data investigating the effects of new- over early-generation DES according to the anatomic complexity of CAD. METHODS Patient-level data from 4 contemporary, all-comers trials were pooled. The primary device-oriented clinical endpoint was the composite of cardiac death, myocardial infarction, or ischemia-driven target-lesion revascularization (TLR). The principal effectiveness and safety endpoints were TLR and definite stent thrombosis (ST), respectively. Adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated at 2 years for overall comparisons, as well as stratified for patients with lower (SYNTAX score ≤11) and higher complexity (SYNTAX score >11). RESULTS A total of 6,081 patients were included in the study. New-generation DES (n = 4,554) compared with early-generation DES (n = 1,527) reduced the primary endpoint (HR: 0.75 [95% CI: 0.63 to 0.89]; p = 0.001) without interaction (p = 0.219) between patients with lower (HR: 0.86 [95% CI: 0.64 to 1.16]; p = 0.322) versus higher CAD complexity (HR: 0.68 [95% CI: 0.54 to 0.85]; p = 0.001). In patients with SYNTAX score >11, new-generation DES significantly reduced TLR (HR: 0.36 [95% CI: 0.26 to 0.51]; p < 0.001) and definite ST (HR: 0.28 [95% CI: 0.15 to 0.55]; p < 0.001) to a greater extent than in the low-complexity group (TLR pint = 0.059; ST pint = 0.013). New-generation DES decreased the risk of cardiac mortality in patients with SYNTAX score >11 (HR: 0.45 [95% CI: 0.27 to 0.76]; p = 0.003) but not in patients with SYNTAX score ≤11 (pint = 0.042). CONCLUSIONS New-generation DES improve clinical outcomes compared with early-generation DES, with a greater safety and effectiveness in patients with SYNTAX score >11.

Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial.

BACKGROUND Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent. METHODS AND RESULTS Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively. CONCLUSIONS In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.

Efficacy and safety of calcium channel blocker/diuretics combination therapy in hypertensive patients: a meta-analysis.

Although recent guidelines recommend the combination of calcium channel blockers (CCBs) and thiazide (-like) diuretics, this combination is not widely used in clinical practice. The aim of this meta-analysis was to assess the efficacy and safety of this combination regarding the following endpoints: all-cause and cardiovascular mortality, myocardial infarction, and stroke. Four studies with a total of 30,791 of patients met the inclusion criteria. The combination CCB/thiazide (-like) diuretic was associated with a significant risk reduction for myocardial infarction (risk ratio [RR], 0.83; 95% confidence interval [CI], 0.73-0.95) and stroke (RR, 0.77; CI, 0.64-0.92) compared with other combinations, whereas it was similarly effective compared with other combinations in reducing the risk of all-cause (RR, 0.89; CI, 0.75-1.06) and cardiovascular (RR, 0.89; CI 0.71-1.10) mortality. Elderly patients with isolated systolic hypertension may particularly benefit from such a combination, since both drug classes have been shown to confer cerebrovascular protection.

Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial

OBJECTIVES To prove non-inferiority of the first non-hormonal vaginal cream in Germany, Vagisan(®) Moisturising Cream (CREAM), compared to a non-hormonal vaginal gel (GEL) for vulvovaginal atrophy (VVA) symptom relief. METHOD This was a 12-week multicenter, open-label, prospective, randomized, two-period, cross-over phase-III trial. The primary endpoint was the cumulative VVA subjective symptom score of the respective treatment period. Secondary endpoints were assessment of single VVA subjective and objective symptoms, VVA objective symptom score, vaginal pH, safety parameters, overall assessment of efficacy, tolerability and evaluation of product properties. In total, 117 women were randomly allocated to either one of the two treatments, each administered for 4 weeks; 92 women were included in the per-protocol analysis (primary analysis). The main outcome measure was cumulative VVA subjective symptom score. RESULTS Regarding VVA symptom relief, results confirmed non-inferiority of CREAM compared to GEL and even indicated superiority of CREAM. Frequency and intensity of subjective symptoms and objective findings were clearly reduced, with CREAM showing better results compared to GEL. Mean VVA objective symptom score significantly decreased; improvement was significantly greater with CREAM. Vaginal pH decreased only following CREAM treatment. Tolerability was superior for CREAM: burning and itching, mostly rated as mild, occurred markedly less often with CREAM than with GEL. Overall satisfaction with treatment efficacy, tolerability and most product properties were rated significantly superior for CREAM. CONCLUSIONS Subjective and objective VVA symptoms were reliably and safely reduced by both non-hormonal topical products. However, efficacy and tolerability of CREAM were shown to be superior to GEL.

A double-blind randomised study to evaluate the efficacy and safety of bindarit in preventing coronary stent restenosis.

AIMS Bindarit (BND) is a selective inhibitor of monocyte chemotactic protein-1 (MCP-1/CCL2), which plays an important role in generating intimal hyperplasia. Our aim was to explore the efficacy and safety of bindarit in preventing restenosis following percutaneous coronary intervention. METHODS AND RESULTS A phase II, double-blind, multicentre randomised trial included 148 patients randomised into three arms (BND 600 mg, n=48; BND 1,200 mg, n=49; PLB, n=51). Bindarit was given following PCI and continued for 180 days. Monthly clinical follow-up and six-month coronary angiography were conducted. The primary endpoint was in-segment late loss; the main secondary endpoints were in-stent late loss and major adverse cardiovascular events. Efficacy analysis was carried out on two populations, ITT and PP. There were no significant differences in the baseline characteristics among the three treatment groups. In-segment and in-stent late loss at six months in BND 600, BND 1,200 and PLB were: (ITT 0.54 vs. 0.52 vs. 0.72; p=0.21), (PP 0.46 vs. 0.53 vs. 0.72; p=0.12) and (ITT 0.74 vs. 0.74 vs. 1.05; p=0.01), (PP 0.66 vs. 0.73 vs. 1.06; p=0.003), respectively. The MACE rates at nine months among treatment groups were 20.8% vs. 28.6% vs. 25.5% (p=0.54), respectively. CONCLUSIONS This was a negative study with the primary endpoint not being met. However, significant reduction in the in-stent late loss suggests that bindarit probably exerts a favourable action on the vessel wall following angioplasty. Bindarit was well tolerated with a compliance rate of over 90%. A larger study utilising a loading dose and targeting a specific patient cohort may demonstrate more significant results.

Three-year efficacy and safety of new- versus early-generation drug-eluting stents for unprotected left main coronary artery disease insights from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 trials.

BACKGROUND In percutaneous coronary intervention (PCI) patients new-generation drug-eluting stent (DES) has reduced adverse events in comparison to early-generation DES. The aim of the current study was to investigate the long-term clinical efficacy and safety of new-generation DES versus early-generation DES for PCI of unprotected left main coronary artery (uLMCA) disease. METHODS The patient-level data from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 randomized trials were pooled. The clinical outcomes of PCI patients assigned to new-generation DES (everolimus- or zotarolimus-eluting stent) versus early-generation DES (paclitaxel- or sirolimus-eluting stent) were studied. The primary endpoint was the composite of death, myocardial infarction (MI), target lesion revascularization and stroke (MACCE, major adverse cardiac and cerebrovascular event). RESULTS In total, 1257 patients were available. At 3 years, the risk of MACCE was comparable between patients assigned to new-generation DES or early-generation DES (28.2 versus 27.5 %, hazard ratio-HR 1.03, 95 % confidence intervals-CI 0.83-1.26; P = 0.86). Definite/probable stent thrombosis was low and comparable between new-generation DES and early-generation DES (0.8 versus 1.6 %, HR 0.52, 95 % CI 0.18-1.57; P = 0.25); in patients treated with new-generation DES no cases occurred beyond 30 days. Diabetes increased the risk of MACCE in patients treated with new-generation DES but not with early-generation DES (P interaction = 0.004). CONCLUSIONS At 3-year follow-up, a PCI with new-generation DES for uLMCA disease shows comparable efficacy to early-generation DES. Rates of stent thrombosis were low in both groups. Diabetes significantly impacts the risk of MACCE at 3 years in patients treated with new-generation DES for uLMCA disease. ClinicalTrials.gov Identifiers: NCT00133237; NCT00598637.

The association between mental health and hypertension in the 2005 Department of Defense Population Survey

Major objectives within Healthy People 2010 include improving hypertension and mental health management of the American population. Both mental health issues and hypertension exist in the military which may decrease the health status of military personnel and diminish the ability to complete assigned missions. Some cases may be incompatible with military service even with optimum treatment. In the interest of maintaining a fit fighting force, the Department of Defense regularly conducts a survey of health related behaviors among active duty military personnel. The 2005 DoD Survey was conducted to obtain information regarding health and behavioral readiness among active duty military personnel to assess progress toward selected Healthy People 2010 objectives. ^ This study is a cross-sectional prevalence design looking at the association of hypertension treatment with mental health issues (either treatment or perceived need for treatment) within the military population sampled in the 2005 DoD Survey. There were 16,946 military personnel in the final cross-sectional sample representing 1.3 million active duty service members. The question is whether there is a significant association between the self-reported occurrence of hypertension and the self-reported occurrence of mental health issues in the 2005 DoD Survey. In addition to these variables, this survey examined the contribution of various sociodemographic, occupational, and behavioral covariates. An analysis of the demographic composition of the study variables was followed by logistic analysis, comparing outcome variables with each of the independent variables. Following univariate regression analysis, multivariate regression was performed with adjustment (for those variables with an unadjusted alpha level less than or equal to 0.25). ^ All the mental health related indicators were associated with hypertension treatment. The same relationship was maintained after multivariate adjustment. The covariates remaining as significant (p < 0.05) in the final model included gender, age, race/ethnicity and obesity. There is a need to recognize and treat co-morbid medical diagnoses among mental health patients and to improve quality of life outcomes, whether in the military population or the general population. Optimum health of the individual can be facilitated through discovery of treatable cases, to minimize disruptions of military missions, and even allow for continued military service. ^

Texas Health & Safety Code, Section 165.002 - Right to Breastfeed in Texas

The language used in Section 165.002 of the Texas Health and Safety Code renders breastfeeding women vulnerable and susceptible to harassment, discrimination, and persecution via the Texas Penal Code, Sec. 30.05 (Criminal Trespassing), Sec. 21.08 (Indecent Exposure), and Sec. 21.22 (Indecency with a Child). ^ The overall goal of this paper is to develop a solution to this problem via a proposed law or legislative action that offers protection and support for breastfeeding women who choose to nurse in public. Data to inform these recommendations were collected through a literature review and structured interviews with several breastfeeding stakeholders. A literature review of state and federal breastfeeding legislation was conducted to compare and contrast differences between existing legislation in the United States. Interviews were conducted with breastfeeding legislation stakeholders, which included state legislators who have been active in breastfeeding legislation, breastfeeding mothers, and representatives from the Central Texas Healthy Mothers Healthy Babies Coalition (Centex HMHB Coalition), Texas Breastfeeding Coalition (TXBF coalition), La Leche League International, and the Texas Business Association. Data from the literature and legislation reviews and interviews were transcribed and examined for common themes using qualitative data techniques. ^ Overall, most of the stakeholders came to a general consensus on three points, (1) breastfeeding women are supported by stakeholders within the community, (2) other legislation or penal codes should not override the right to breastfeed, and (3) the current breastfeeding legislation needs to be improved to adequately support breastfeeding women. The interviews with breastfeeding legislation stakeholders yielded two major recommendations for the improvement of Section 165.002 of the Texas Health and Safety Code: advocacy efforts to change the wording of the legislation and education to inform people about the legislation. ^ The right to breastfeed is an important public health issue in that it provides a host of health benefits for mothers and children, and is more economical and environmentally superior to alternative feeding methods. While breastfeeding in public is not illegal nor ever has been, adequate legislation is important to affirm this right for women so that they can confidently feed their children without embarrassment or harassment.^

Analysis of participation in the federally mandated coal workers' health surveillance program

The Federal Coal Mine Health and Safety Act of 1969 required that periodic chest radiographs be offered to underground coal miners to protect the miners from the development of Coal Workers' Pneumoconiosis (CWP) and progression of the disease to progressive massive fibrosis (PMF). These examinations are administered by the National Institute for Occupational Safety and Health (NIOSH) through the Coal Workers' Health Surveillance Program (CWHSP). The mine operator is required to provide each miner with the opportunity to have the chest radiograph at no cost to the miner.^ Three rounds of examinations have been conducted since 1969 and the fourth is underway. The decrease in participation over rounds is of great concern if the incidence and progression of CWP are to be understood and controlled.^ This study developed rates of participation for each of 558 West Virginia underground coal mines who submitted or had NIOSH assigned plans for making chest radiographs available during the third round, July 1978 through December 1980. These rates were analyzed in relation to desired levels of participation and to reinforcing, predisposing and enabling factors presumed to affect rates of participation in disease prevention and surveillance programs.^ Two reinforcing factors, size of mine and inclusion of the mine in the National Coal Study (NCS) epidemiology research program, and the enabling factor, use of an on-site radiograph facility, demonstrated highly significant relationships to participation rates.^ The major findings of the study were: (1) Participation in the CWHSP is even lower than previously estimated; (2) CWHSP program evaluation is not systematic and program data base is not complete and comprehensive; and (3) NIOSH program policy is not clear and administration of the CWHSP is fragmented and lacks adequate fiscal and personnel resources. ^

Occupational class and cause specific mortality in middle aged men in 11 European countries: comparison of population based studies

Objectives: To compare countries in western Europe with respect to class differences in mortality from specific causes of death and to assess the contributions these causes make to class differences in total mortality.

Identifying and implementing corridor safety improvements: a highway safety improvement process and safety analysis tools for Arizona.

Arizona Department of Transportation, Phoenix

A review of current information on some ecological and health related aspects of the release of trace metals into the environment associated with the combustion of coal /

Issued June 1977.

Social security rulings on Federal old-age, survivors, disability, health insurance, supplemental security income, and black lung benefits.

Reproduces in full part I of all quarterly issues for the year. The rulings contain precedential case decisions, statements of policy and interpretations of titles II, XVI, and XVIII of the Social security act, title IV of the Federal coal mine health and safety act of 1969, as amended, and related laws.