Impact of coronary calcification assessed by coronary CT angiography on treatment decision in patients with three-vessel CAD: insights from SYNTAX III trial.

OBJECTIVES: The aim of this study was to determine Syntax scores based on coronary computed tomography angiography (CCTA) and invasive coronary angiography (ICA) and to assess whether heavy coronary calcification significantly limits the CCTA evaluation and the impact of severe calcification on heart team's treatment decision and procedural planning in patients with three-vessel coronary artery disease (CAD) with or without left main disease. METHODS: SYNTAX III was a multicentre, international study that included patients with three-vessel CAD with or without left main disease. The heart teams were randomized to either assess coronary arteries with coronary CCTA or ICA. We stratified the patients based on the presence of at least 1 lesion with heavy calcification defined as arc of calcium >180° within the lesion using CCTA. Agreement on the anatomical SYNTAX score and treatment decision was compared between patients with and without heavy calcifications. RESULTS: Overall, 222 patients with available CCTA and ICA were included in this trial subanalysis (104 with heavy calcification, 118 without heavy calcification). The mean difference in the anatomical SYNTAX score (CCTA derived-ICA derived) was lower in patients without heavy calcifications [mean (-1.96 SD; +1.96 SD) = 1.5 (-19.3; 22.4) vs 5.9 (-17.5; +29.3), P = 0.004]. The agreement on treatment decision did not differ between patients with (Cohen's kappa 0.79) or without coronary calcifications (Cohen's kappa 0.84). The agreement on the treatment planning did not differ between patients with (concordance 80.3%) or without coronary calcifications (concordance 82.8%). CONCLUSIONS: An overall good correlation between CCTA- and ICA-derived Syntax score was found. The presence of heavy coronary calcification moderately influenced the agreement between CCTA and ICA on the anatomical SYNTAX score. However, agreement on the treatment decision and planning was high and irrespective of the presence of calcified lesions.

Site vs. core laboratory variability in computed tomographic angiography-derived SYNTAX scores in the SYNTAX III trial.

AIMS: To investigate the variability between site and core laboratory (CL) calculation of the anatomical SYNTAX score (SS) based on coronary computed tomography angiography (CTA) alone and functional SS based on coronary CTA and fractional flow reserve derived from computed tomography (FFRCT) in the SYNTAX III trial. METHODS AND RESULTS: The SYNTAX III trial was a multicentre, international study that included 223 patients with three-vessel disease with or without left main involvement. Functional SS was computed by subtracting non-flow limiting stenoses (FFRCT > 0.80) from anatomical SS. SS was combined with clinical information to generate the SYNTAX score II (SS II) that provides treatment recommendations. The mean anatomical SS based on coronary CTA alone was 33.4 ± 12.7 by sites and 37.1 ± 13.4 by CL (P < 0.001). The mean functional SS based on coronary CTA and FFRCT was 30.5 ± 13.0 by sites and 33.3 ± 13.6 by CL (P < 0.001). The intraclass correlation coefficient was 0.49 [95% confidence interval (CI) 0.37-0.59) in anatomical SS and 0.62 (95% CI 0.52-0.70) in functional SS. The Cohen's κ comparing treatment recommendation between sites and CL was 0.68 (95% CI 0.58-0.78) based on anatomical SS and 0.71 (95% CI 0.60-0.82) based on functional SS. CONCLUSION: The mean anatomical SS derived from coronary CTA alone and functional SS based on coronary CTA and FFRCT were higher when assessed by the CL than by the sites themselves. However, substantial agreement in treatment recommendation by SS II between sites and CL was demonstrated. CLINICAL TRIALS.GOV IDENTIFIER: NCT02385279.

Impact of Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography on Heart Team Treatment Decision-Making in Patients With Multivessel Coronary Artery Disease: Insights From the SYNTAX III REVOLUTION Trial.

BACKGROUND: Fractional flow reserve (FFR) is a reliable tool for the functional assessment of coronary stenoses. FFR computed tomography (CT) derived (FFRCT) has shown to be accurate, but its clinical usefulness in patients with complex coronary artery disease remains to be investigated. The present study sought to determine the impact of FFRCT on heart team's treatment decision-making and selection of vessels for revascularization in patients with 3-vessel coronary artery disease. METHODS: The trial was an international, multicenter study randomizing 2 heart teams to make a treatment decision between percutaneous coronary interventions and coronary artery bypass grafting using either coronary computed tomography angiography or conventional angiography. The heart teams received the FFRCT and had to make a treatment decision and planning integrating the functional component of the stenoses. Each heart team calculated the anatomic SYNTAX score, the noninvasive functional SYNTAX score and subsequently integrated the clinical information to compute the SYNTAX score III providing a treatment recommendation, that is, coronary artery bypass grafting, percutaneous coronary intervention, or equipoise coronary artery bypass grafting-percutaneous coronary intervention. The primary objective was to determine the proportion of patients in whom FFRCT changed the treatment decision and planning. RESULTS: Overall, 223 patients were included. Coronary computed tomography angiography assessment was feasible in 99% of the patients and FFRCT analysis in 88%. FFRCT was available for 1030 lesions (mean FFRCT value 0.64±13). A treatment recommendation of coronary artery bypass grafting was made in 24% of the patients with coronary computed tomography angiography with FFRCT. The addition of FFRCT changed the treatment decision in 7% of the patients and modified selection of vessels for revascularization in 12%. With conventional angiography as reference, FFRCT assessment resulted in reclassification of 14% of patients from intermediate and high to low SYNTAX score tertile. CONCLUSIONS: In patients with 3-vessel coronary artery disease, a noninvasive physiology assessment using FFRCT changed heart team's treatment decision-making and procedural planning in one-fifth of the patients. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02813473.

Coronary computed tomography angiography for heart team decision-making in multivessel coronary artery disease.

Aims: Coronary computed tomography angiography (CTA) has emerged as a non-invasive diagnostic method for patients with suspected coronary artery disease, but its usefulness in patients with complex coronary artery disease remains to be investigated. The present study sought to determine the agreement between separate heart teams on treatment decision-making based on either coronary CTA or conventional angiography. Methods and results: Separate heart teams composed of an interventional cardiologist, a cardiac surgeon, and a radiologist were randomized to assess the coronary artery disease with either coronary CTA or conventional angiography in patients with de novo left main or three-vessel coronary artery disease. Each heart team, blinded for the other imaging modality, quantified the anatomical complexity using the SYNTAX score and integrated clinical information using the SYNTAX Score II to provide a treatment recommendations based on mortality prediction at 4 years: coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or equipoise between CABG and PCI. The primary endpoint was the agreement between heart teams on the revascularization strategy. The secondary endpoint was the impact of fractional flow reserve derived from coronary CTA (FFRCT) on treatment decision and procedural planning. Overall, 223 patients were included. A treatment recommendation of CABG was made in 28% of the cases with coronary CTA and in 26% with conventional angiography. The agreement concerning treatment decision between coronary CTA and conventional angiography was high (Cohen's kappa 0.82, 95% confidence interval 0.74-0.91). The heart teams agreed on the coronary segments to be revascularized in 80% of the cases. FFRCT was available for 869/1108 lesions (196/223 patients). Fractional flow reserve derived from coronary CTA changed the treatment decision in 7% of the patients. Conclusion: In patients with left main or three-vessel coronary artery disease, a heart team treatment decision-making based on coronary CTA showed high agreement with the decision derived from conventional coronary angiography suggesting the potential feasibility of a treatment decision-making and planning based solely on this non-invasive imaging modality and clinical information. Trial registration number: NCT02813473.

Undiagnosed and uncontrolled hypertension among the adults in rural Bangladesh: findings from a community-based study.

OBJECTIVES: This article reports the prevalence and prediction factors of undiagnosed and uncontrolled hypertension among the adults in rural Bangladesh. METHODS: A cross-sectional study of the major noncommunicable disease risk factors was conducted in rural surveillance sites of Bangladesh in 2005. In addition to the self-report questions on risk factors, height, weight, and blood pressure were measured using standard protocols of the WHO STEPwise approach to Surveillance. Undiagnosed hypertension was defined when people reported no hypertension but were found hypertensive when measured, and uncontrolled hypertension was defined when people reported receiving antihypertensive treatment but their blood pressure was above the normal range when measured. RESULTS: The prevalence of undiagnosed hypertension was 11.1%, increasing with age to 22.7% among those aged 60 years and above. Among the hypertensive patients receiving treatment, 54.9% were found to be uncontrolled (34.5% among 25-39 years and 67.9% among 60+ years). Increasing age and higher BMI were significantly positively associated with undiagnosed hypertension in multivariate analysis. Increasing age and more wealth have significant independent association with uncontrolled hypertension. CONCLUSION: High prevalence of undiagnosed hypertension, and more than 50% of the treated hypertension being uncontrolled puts a great challenge ahead for Bangladesh, a resource-poor setting. Regular health check or health screening along with implementation of hypertensive guidelines should be reinforced.

Prevalence and determinants of pre-hypertension and hypertension among the adults in rural Bangladesh: findings from a community-based study.

BACKGROUND: The people of low and middle income countries bear about 80% of the global burden of diseases that are attributable to high blood pressure. Hypertensive people contribute half of this burden; the rest is among the people with lesser degrees of high blood pressure. Prehypertension elevates the risk of CVD, and that of end-stage renal disease. Bangladesh is a developing country, with more than 75% of the population live in rural area. This study aims to determine the prevalence and predictors of pre-hypertension and hypertension among the adults in rural Bangladesh. METHODS: A cross-sectional study of major non-communicable disease risk factors (tobacco and alcohol use, fruit and vegetable intake, physical activity) was conducted in rural surveillance sites of Bangladesh. In addition to the self-reported information on risk factors, height and weight, and blood pressure were measured during household visits using standard protocols of the WHO STEPwise approach to Surveillance. The study population included 6,094 men and women aged 25 years and above. Adjusted and unadjusted logistic regression analyses were performed to evaluate the association of prehypertension and hypertension with various factors. RESULTS: The prevalence of pre-hypertension and hypertension was 31.9% and 16.0%, respectively. The men had a higher prevalence (33.6%) of pre-hypertension compared to the women (30.3%). Multivariate analysis showed that increasing age [OR 2.30 (1.84-2.87)] and higher BMI [OR 4.67 (3.35-6.51) were positively associated with pre-hypertension. For hypertension, multivariate analysis showed that increasing age [OR 4.48 (3.38-5.94)] and higher BMI (specially the overweight category) was positively associated. Significant linear relationships of prehypertension were found with age [P for trend < 0.0001] and BMI [P for trend < 0.0001]. Linear regression for hypertension shows significant association with age [P for trend < 0.0001] but not with BMI [P for trend 0.3783]. CONCLUSION: Approximately one third and one-sixth of the adult population of rural Bangladesh are affected with pre-hypertension and hypertension, respectively. This poses a great challenge ahead, as most of the people with pre-hypertension will progress towards hypertension until otherwise undergo in any pharmacological or lifestyle intervention.

Hypertension: adherence to treatment in rural Bangladesh--findings from a population-based study.

BACKGROUND: Poor adherence has been identified as the main cause of failure to control hypertension. Poor adherence to antihypertensive treatment is a significant cardiovascular risk factor, which often remains unrecognized. There are no previous studies that examined adherence with antihypertensive medication or the characteristics of the non-adherent patients in Bangladesh. OBJECTIVE: This paper aims to describe hypertension and factors affecting adherence to treatment among hypertensive persons in rural Bangladesh. DESIGN: The study population included 29,960 men and women aged 25 years and older from three rural demographic surveillance sites of the International Center for Diarrheal Disease Research, Bangladesh (icddr,b): Matlab, Abhoynagar, and Mirsarai. Data was collected by a cross-sectional design on diagnostic provider, initial, and current treatment. Discontinuation of medication at the time of interview was defined as non-adherence to treatment. RESULTS: The prevalence of hypertension was 13.67%. Qualified providers diagnosed only 53.5% of the hypertension (MBBS doctors 46.1 and specialized doctors 7.4%). Among the unqualified providers, village doctors diagnosed 40.7%, and others (nurse, health worker, paramedic, homeopath, spiritual healer, and pharmacy man) each diagnosed less than 5%. Of those who started treatment upon being diagnosed with hypertension, 26% discontinued the use of medication. Age, sex, education, wealth, and type of provider were independently associated with non-adherence to medication. More men discontinued the treatment than women (odds ratio [OR] 1.74, confidence interval [CI] 1.48-2.04). Non-adherence was greater when hypertension was diagnosed by unqualified providers (OR 1.52, CI 1.31-1.77). Hypertensive patients of older age, least poor quintile, and higher education were less likely to be non-adherent. Patients with cardiovascular comorbidity were also less likely to be non-adherent to antihypertensive medication (OR 0.79, CI 0.64-0.97). CONCLUSIONS: Although village doctors diagnose 40% of hypertension, their treatments are associated with a higher rate of non-adherence to medication. The hypertension care practices of the village doctors should be explored by additional research. More emphasis should be placed on men, young people, and people with low education. Health programs focused on education regarding the importance of taking continuous antihypertensive medication is now of utmost importance.

Sources and prevalence of self-reported asthma diagnoses in adults in urban and rural settings of Bangladesh.

This study provides data on the sources of asthma diagnoses in the adult Bangladeshi population in urban and rural settings. The paper also reports the prevalence of self-reported asthma diagnoses and associated socio-demographic factors. A cross-sectional study was conducted in three communities: two rural settings and one urban setting, with a total sample size of 32,665 subjects. Pre-existing surveillance data provided individual socio-demographic factors. Provider categories were based on previous research describing provider plurality in Bangladesh. Descriptive statistics, univariate regression and multivariate regression analyses were performed. Bachelor of Medicine, Bachelor of Surgery (MBBS) generalists provided the largest proportion of diagnoses in both urban (54.6%) and rural (42.4%) sites. The largest proportion of non-MBBS-trained healthcare workers providing diagnoses of asthma was spiritual healers (13.3%) in the urban settings and village doctors (42.4%) in rural settings. The overall prevalence of self-reported asthma diagnoses was 5.0% in the urban population and 3.5% in the rural population. The results highlight the importance of non-MBBS doctors in serving the healthcare needs of the Bangladeshi population. This study reveals a higher prevalence of self-reported asthma diagnoses in the urban setting than in rural ones, which is consistent with international literature on the topic.

A randomised study of dabigatran in elective percutaneous coronary intervention in stable coronary artery disease patients.

AIMS: Patients receiving long-term anticoagulant treatment with dabigatran may need to undergo a percutaneous coronary intervention (PCI). We studied markers of coagulation activation during elective PCI in patients using dabigatran in order to investigate whether coagulation activation upon balloon inflation and stenting is suppressed by dabigatran without additional heparin treatment. METHODS AND RESULTS: This phase IIa, exploratory, multicentre, randomised, open-label study included 50 stable patients having an elective PCI. Patients on standard dual antiplatelet therapy (DAPT) were randomised (2:2:1) to either pre-procedural dabigatran 110 mg BID (n=19) or 150 mg BID (n=21), as compared to standard intraprocedural unfractionated heparin (UFH) (n=10). Following PCI, a significant increase in the levels of prothrombin fragment 1+2 (F1+2) in the combined dabigatran group was observed compared to the level just before the start of PCI (159.1 [1.4] pmol/l; geometric mean [gSD]). Levels at 0.5, 1.0, 1.5 and 2 hrs after the start of PCI ranged from 193.5 (1.4) to 270.6 pmol/l (1.7); (p-value for paired analysis=0.015, 0.022, 0.2342, 0.0379, respectively). Also, thrombin-antithrombin (TAT) complexes were increased significantly in the combined dabigatran group compared to pre-PCI levels (4.2 [2.2] ug/l). Levels ranged from 5.2 (2.5) to 8.5 (2.3) (p=0.0497, 0.0343, 0.005 and 0.1628, respectively). In contrast, in the control group of patients treated with UFH, no increase was observed in F1+2 and TAT complexes during PCI. Five out of 40 (12.5%) patients required bail-out anticoagulation in the dabigatran group, of whom four experienced a procedural myocardial infarction (MI), versus one out of 10 in the UFH group, who had a stent thrombosis without MI prior to the study-PCI. One minor access-site bleeding occurred in the dabigatran group. CONCLUSIONS: Dabigatran treatment (110 mg or 150 mg BID) may not provide sufficient anticoagulation during PCI. EudraCT. No: 2007-007536-25.

The association of weather and mortality in Bangladesh from 1983-2009.

INTRODUCTION: The association of weather and mortality have not been widely studied in subtropical monsoon regions, particularly in Bangladesh. This study aims to assess the association of weather and mortality (measured with temperature and rainfall), adjusting for time trend and seasonal patterns in Abhoynagar, Bangladesh. MATERIAL AND METHODS: A sample vital registration system (SVRS) was set up in 1982 to facilitate operational research in family planning and maternal and child health. SVRS provided data on death counts and population from 1983-2009. The Bangladesh Meteorological Department provided data on daily temperature and rainfall for the same period. Time series Poisson regression with cubic spline functions was used, allowing for over-dispersion, including lagged weather parameters, and adjusting for time trends and seasonal patterns. Analysis was carried out using R statistical software. RESULTS: Both weekly mean temperature and rainfall showed strong seasonal patterns. After adjusting for seasonal pattern and time trend, weekly mean temperatures (lag 0) below the 25th percentile and between the 25th and 75th percentiles were associated with increased mortality risk, particularly in females and adults aged 20-59 years by 2.3-2.4% for every 1°C decrease. Temperature above the 75th percentile did not increase the risk. Every 1 mm increase in rainfall up to 14 mm of weekly average rainfall over lag 0-4 weeks was associated with decreased mortality risks. Rainfall above 14 mm was associated with increased mortality risk. CONCLUSION: The relationships between temperature, rainfall and mortality reveal the importance of understanding the current factors contributing to adaptation and acclimatization, and how these can be enhanced to reduce negative impacts from weather.

The association of meteorological factors and mortality in rural Bangladesh, 1983-2009.

INTRODUCTION: While the association of weather and mortality has been well documented for moderate climate zones, little is known about sub-tropical zones, particularly Bangladesh. This study aims to assess the short-term relationship of temperature and rainfall on daily mortality after controlling for seasonality and time-trends. The study used data from Matlab, Bangladesh, where a rigorous health and demographic surveillance system (HDSS) has been operational since 1966. MATERIAL AND METHODS: Matlab HDSS data on mortality and population for the period 1983-2009 were used. Weather data for the same period were obtained from a nearby government weather station. Time series Poisson regression with cubic spline functions was applied allowing for lagged effects of weather and extreme weather events on mortality, and controlling for time trends and seasonal patterns. Analysis was carried out using R statistical software. RESULTS: Both temperature and rainfall showed strong seasonal patterns, explaining a significant part of mortality in all age groups. After adjusting for seasonality and trend, mortality and temperature show a U-shaped pattern; below a temperature of around 29°C, a decrease in temperature resulted in an increase in mortality, whereas above 29°C, increased temperature resulted in increased mortality. The strongest negative mortality temperature association was observed in the elderly (5.4% increase with every 1°C decrease in temperature at temperatures below 23°C), and the opposite trend was observed in the age groups 1-4 and 5-19 years old. At aggregate level, the rainfall-mortality association is statistically weak. However in the age group 5-19, a 0.6% increase in mortality per 1 mm additional rainfall was found, at rainfall levels over 100 mm per day. Multivariate analysis showed high mortality risks for women aged 20-59 years of age during cyclone episodes. DISCUSSION: Weather and extreme weather were associated with mortality with differential impacts in age and sex sub-groups. Further studies should investigate these findings more closely and develop policy recommendations targeted at improving public health and protecting population groups susceptible to environmental stressors.

Informal allopathic provider knowledge and practice regarding hypertension in urban and rural Bangladesh.

OBJECTIVES: Describe informal allopathic practitioner (IAP) knowledge and practice about management of hypertension and identify gaps in IAP knowledge and practice amenable to interventions. METHODS: A cross sectional descriptive survey of 642 IAPs in Kamalapur (urban) and Mirsarai (rural) Bangladesh was conducted from March to April, 2011. Using a structured, pre-tested questionnaire sociodemographic, training, knowledge and practice data about management of hypertension was collected. Comparative statistics were preformed to show differences between urban and rural practitioners using SAS 8.0. FINDINGS: 99.4% of IAPs were male, mean age was 37.5 (12.5 SD) years. Greater than 65% correctly identified the upper limit of normal blood pressure. 50.2% underestimated lower limit of systolic hypertension. 79.8% allowed age to affect their treatment approach. As blood pressure increased, willingness to treat with medication decreased and tendency to refer increased. Sedative/sleeping pills, antidepressants, and beta blockers were the most commonly prescribed medications for prehypertension (58.7%, 50.3% and 53.7% respectively), stage I hypertension (55.0%, 38.6%, 49.8% respectively) and stage II hypertension (42.4%, 23.7%, and 28.8% respectively). Rural IAPs were more likely than urban IAPs to treat (84.7% vs 77.7%), order tests (27.1% vs 6.0%) and write prescriptions (60.4% vs 18.7%). CONCLUSION: While IAPs are crucial to Bangladesh's pluralistic healthcare system, gaps in knowledge and practice could cause unnecessary harm. To include IAPs in the public sector's fight against the chronic disease epidemic, interventions aimed at standardizing IAPs knowledge and practice will be essential. Successfully utilizing IAPs will have beneficial implications not only for Bangladesh, but for all developing countries.

Diagnosis of chronic conditions with modifiable lifestyle risk factors in selected urban and rural areas of Bangladesh and sociodemographic variability therein.

BACKGROUND: Bangladesh suffers from a lack of healthcare providers. The growing chronic disease epidemic's demand for healthcare resources will further strain Bangladesh's limited healthcare workforce. Little is known about how Bangladeshis with chronic disease seek care. This study describes chronic disease patients' care seeking behavior by analyzing which providers diagnose these diseases. METHODS: During 2 month periods in 2009, a cross-sectional survey collected descriptive data on chronic disease diagnoses among 3 surveillance populations within the International Center for Diarrheal Disease Research, Bangladesh (ICDDR, B) network. The maximum number of respondents (over age 25) who reported having ever been diagnosed with a chronic disease determined the sample size. Using SAS software (version 8.0) multivariate regression analyses were preformed on related sociodemographic factors. RESULTS: Of the 32,665 survey respondents, 8,591 self reported having a chronic disease. Chronically ill respondents were 63.4% rural residents. Hypertension was the most prevalent disease in rural (12.4%) and urban (16.1%) areas. In rural areas chronic disease diagnoses were made by MBBS doctors (59.7%) and Informal Allopathic Providers (IAPs) (34.9%). In urban areas chronic disease diagnoses were made by MBBS doctors (88.0%) and IAP (7.9%). Our analysis identified several groups that depended heavily on IAP for coverage, particularly rural, poor and women. CONCLUSION: IAPs play important roles in chronic disease care, particularly in rural areas. Input and cooperation from IAPs are needed to minimize rural health disparities. More research on IAP knowledge and practices regarding chronic disease is needed to properly utilize this potential healthcare resource.

The metabolic syndrome: prevalence, associated factors, and impact on survival among older persons in rural Bangladesh.

OBJECTIVES: To describe the prevalence of the metabolic syndrome (MetS) among older persons in rural Bangladesh, to investigate whether the prevalence varies by age, sex, literacy, marital status, nutritional status and socio-economic status, and to assess the impact of MetS on survival. METHODS: The study consisted of 456 persons who were aged ≥60 years living in a rural area of Bangladesh during July 2003-March 2004. Data were collected through interview, clinical examination, and laboratory tests, and their survival status until 30(th) June 2009 was ascertained through the Matlab surveillance system. We defined MetS following the NCEP ATP III criteria, with minor modifications, i.e., presence of any three of the following: hypertension (BP ≥130/85 mm Hg); random blood glucose (RBG) level ≥7.0 mmol/L; hyper-triglyceridemia (≥2.28 mmol/L); low level of HDL-cholesterol (<1.04 mmol/L for men and <1.29 mmol/L for women); and BMI ≥25.0 kg/m(2). Data were analysed with logistic regressions for the influential factors of MetS, and with Cox models for the association of MetS with the survival status. FINDINGS: The overall prevalence of MetS was 19.5%, 20.8% in women, and 18.0% in men. Asset-index and nutritional status were independently associated with MetS. During 4.93 years of follow-up, 18.2% died. In the presence of high RBG, MetS has a significant negative effect on survival (69.4% vs 95.2%, log rank p = 0.02). CONCLUSION: This study highlights the importance of the metabolic syndrome in rural Bangladesh. Our findings suggest that there is a need for screening programmes involving the metabolic syndrome to prevent diabetes and cardiovascular diseases.

Sex differences and their impact on clinical outcome after percutaneous or surgical revascularisation: a report from the Arterial Revascularisation Therapies Study (ARTS).

AIMS: To determine whether women have an unfavorable outcome after coronary interventions compared with men, we evaluated patients undergoing revascularisation within the Arterial Revascularisation Therapies Study (ARTS). METHODS AND RESULTS: We evaluated 1205 patients (23% women) with multivessel disease randomised to percutaneous or surgical coronary revascularisation. The in-hospital results, and clinical outcome at five years were evaluated. Women were older, with a higher prevalence of hypertension, hypercholesterolaemia, family history for coronary artery disease (all p<0.001), diabetes mellitus (p=0.05) and stable angina (p<0.05) than men, but had a lower incidence of history of myocardial infarction or smoking (both p<0.001). More major bleeding complications, even after adjusting for baseline clinical characteristics (OR 29.4, 95% CI: 5.3-500, p<0.005) were observed in women following percutaneous coronary intervention. During clinical follow-up freedom from major adverse cardiac and cerebrovascular events was similar in men and women, regardless of treatment strategy. Men assigned to bypass surgery had a better quality of life, but women reported more frequently angina. CONCLUSION: The clinical outcome of women with multivessel disease undergoing coronary revascularisation was similar to that in men. However, women presented more bleeding complications before hospital discharge, and had less favourable assessment in specific domain of daily life at follow-up.

Association of chronic kidney disease with clinical outcomes after coronary revascularization: the Arterial Revascularization Therapies Study (ARTS).

BACKGROUND: Chronic kidney disease (CKD) is associated with adverse outcomes after coronary artery bypass graft surgery (CABG) and percutaneous coronary interventions (PCI), but it is unclear which of these revascularization strategies is associated with lower risk for morbidity and mortality in this population. In the Arterial Revascularization Therapies Study (ARTS), we compared long-term clinical outcomes after CABG or PCI with multivessel stenting in patients with CKD. METHODS: The ARTS randomly assigned 1205 participants with and without CKD to CABG or PCI with multivessel stenting. We defined CKD as creatinine clearance < or =60 mL/min, estimated by the Cockroft-Gault equation. The primary outcome was the composite of death, myocardial infarction (MI), or stroke; and, a secondary outcome was repeat revascularization. Participants were followed for a mean of 3 years after their intervention. We evaluated whether randomization to CABG or PCI was associated with different outcomes among participants with CKD. RESULTS: Two hundred ninety participants (25%) had CKD at entry into ARTS. One hundred fifty-one received PCI, and 139 received CABG. No difference was observed in the primary endpoint with CABG or PCI among CKD participants (adjusted Hazard Ratio [HR] CABG vs PCI = 0.93; 95% CI 0.54-1.60; P = .97). However, CABG was associated with a reduced risk for repeat revascularization (HR = 0.28; 95% CI 0.14-0.54; P < .01). Compared with participants with normal renal function, CKD was associated with a nearly 2-fold risk for the primary outcome (unadjusted HR = 1.9; 95% CI 1.4-2.7; P < .01). After multivariate adjustment, this association remained significant (HR 1.6; 95% CI 1.1-2.4). CONCLUSIONS: In patients with multivessel CAD and CKD, treatment with CABG or PCI with multivessel stenting led to similar outcomes of death, MI, or stroke, but CABG was associated with decreased repeat revascularizations. When compared with ARTS participants with normal renal function, those with CKD had substantially elevated risk of adverse clinical outcomes after coronary revascularization.

Five year clinical effect of coronary stenting and coronary artery bypass grafting in renal insufficient patients with multivessel coronary artery disease: insights from ARTS trial.

AIMS: To compare coronary stent implantation and bypass surgery for multivessel coronary disease in patients with renal insufficiency. METHODS AND RESULTS: In the ARTS trial, 142 moderate renal insufficient patients (Ccr<60 mL/min) with multivessel coronary disease were randomly assigned to stent implantation (n=69) or CABG (n=73). At 5 years, there was no significant difference between the two groups in terms of mortality (14.5% in the stent group vs. 12.3% in the CABG group, P=0.81), or combined endpoint of death, cerebrovascular accident (CVA), or myocardial infarction (MI) (30.4% in the stent group vs. 23.3% in the CABG group, P=0.35). Among patients who survived without CVA or MI, 18.8% in the stent group underwent a second revascularization procedure when compared with 8.2% in the surgery group (P=0.08). The event-free survival at 5 years was 50.7% in the stent group and 68.5% in the surgery group (P=0.04). CONCLUSION: At 5 years, the differences in mortality and combined incidence of death, CVA, and MI between coronary stenting and surgery did not reach statistically significant level. However, the occurrence of MACCE in the stent group was higher than in the CABG group, mainly driven by the higher incidence of repeat revascularization in the stent group.

Five year clinical effect of coronary stenting and coronary artery bypass grafting in renal insufficient / patients with multivessel coronary artery disease: insights from ARTS trial

Aims to compare coronary stent implantation and bypass surgery for multivessel coronary disease in patients with renal insufficiency. Methods and results In the ARTS trial, 142 moderate renal insufficient patients (Ccr , 60 mL/min) with multivessel coronary disease were randomly assigned to stent implantation (n » 69) or CABG (n » 73).At 5 years, there was no significant difference between the two groups in terms of mortality (14.5% in the stent group vs. 12.3% in the CABG group, P » 0.81), or combined endpoint of death, cerebrovascular accident (CVA), or myocardial infarction (MI) (30.4% in the stent group vs. 23.3% in the CABG group, P » 0.35). Among patients who survived without CVA or MI, 18.8% in the stent group underwent a second revascularization procedure when compared with 8.2% in the surgery group (P » 0.08). Theevent-free survival at 5 years was 50.7% in the stent group and 68.5% in the surgery group (P » 0.04).Conclusion At 5 years, the differences in mortality and combined incidence of death, CVA, and MI between coronary stenting and surgery did not reach statistically significant level. However, the occurrence of MACCE in the stent group was higher than in the CABG group, mainly driven by the higher incidence of repeat revascularization in the stent group...

Three-year outcome after coronary stenting versus bypass surgery for the treatment of multivessel disease.

BACKGROUND: The primary results of Arterial Revascularization Therapy Study reported a greater need for repeated revascularization after percutaneous coronary intervention with stenting (PCI). However, PCI was less expensive than coronary artery bypass grafting (CABG) and offered the same degree of protection against death, stroke, and myocardial infarction. METHODS AND RESULTS: Patients with multivessel disease (n=1205) were randomly assigned to either CABG or PCI and followed up for up to 3 years. Survival rates without stroke or myocardial infarction were similar in each group at 1 year and 3 years (90.5% versus 91.4% for PCI versus CABG at 1 year and 87.2% versus 88.4% for PCI versus CABG at 3 years). However, the respective repeat revascularization rates were 21.2% and 26.7% at 1 and 3 years in patients allocated to PCI, compared with 3.8% and 6.6% in patients allocated to CABG (P<0.0001). Diabetes (P<0.0009) and maximal pressure for stent deployment (P<0.002) are the strongest independent predictors of events at 3 years after PCI, whereas left anterior descending coronary artery grafting (P<0.006) is the best predictor of event-free survival at 3 years after CABG. The incremental cost of surgery compared with PCI for an event-free patient was 19 257 at 1 year but decreased to 10 492 at 3 years. It remained at 142 391 at 3 years when revascularization procedures were excluded in the efficacy end point, however. CONCLUSIONS: Three-year survival rates without stroke and myocardial infarction are identical in both groups, and the cost/benefit ratio of stenting is determined primarily by the increasing need for revascularization in the PCI group.

Clinical and angiographic predictors of restenosis after stent deployment in diabetic patients.

BACKGROUND: Restenosis and consequent adverse cardiac events are increased in diabetics undergoing percutaneous coronary intervention. Use of intracoronary stents may ameliorate such risks; however, factors influencing the likelihood of restenosis after stent deployment in this high-risk patient subgroup are unknown. METHODS AND RESULTS: We retrospectively analyzed all stented diabetic patients in 16 studies of percutaneous coronary intervention, all of which underwent core angiographic analysis at Cardialysis, Rotterdam. Univariate and multivariate analyses, with 37 clinical and angiographic variables, compared those with and without restenosis and predicted restenosis rates calculated through the use of reference charts derived from angiographic data. Within the studies, 418 of 3090 (14%) stented patients with 6-month angiographic follow-up had diabetes. Restenosis (> or =50% diameter stenosis at follow-up) occurred in 550 of 2672 (20.6%) nondiabetic and 130 of 418 (31.1%) diabetic patients (P<0.001). Univariate predictors of restenosis in diabetics were smaller vessel reference diameter (RD) (P<0.001), smaller minimal luminal diameter before stenting (P=0.01), smaller minimal luminal diameter and percent diameter stenosis after stenting (P<0.001, P=0.04), greater stented length of vessel (P<0.001), and reduced body mass index (BMI) (P=0.04). With the use of multivariate analysis, only smaller RD (P=0.003), greater stented length of vessel (P=0.04), and reduced BMI (P=0.04) were associated with restenosis. Reference charts demonstrated an incremental risk of restenosis that appears solely dependent on vessel RD. CONCLUSIONS: Restenosis after stent deployment is significantly increased in diabetic patients. Vessel caliber, stented length of vessel, and lower BMI are predictors of in-stent restenosis in patients with diabetes. Furthermore, vessel caliber affected the predicted risk of restenosis incrementally.