Harmonising Individual Patient Level Cardiac Registry Data Across the Asia Pacific Region-A Feasibility Study of In-Hospital Outcomes of STEMI Patients From the Asia Pacific Evaluation of Cardiovascular Therapies (ASPECT) Network.

OBJECTIVE: The Asia-Pacific Evaluation of Cardiovascular Therapies (ASPECT) collaboration was established to inform on percutaneous coronary intervention (PCI) in the Asia-Pacific Region. Our aims were to (i) determine the operational requirements to assemble an international individual patient dataset and validate the processes of governance, data quality and data security, and subsequently (ii) describe the characteristics and outcomes for ST-elevation myocardial infarction (STEMI) patients undergoing PCI in the ASPECT registry. METHODS: Seven (7) ASPECT members were approached to provide a harmonised anonymised dataset from their local registry. Patient characteristics were summarised and associations between the characteristics and in-hospital outcomes for STEMI patients were analysed. RESULTS: Six (6) participating sites (86%) provided governance approvals for the collation of individual anonymised patient data from 2015 to 2017. Five (5) sites (83%) provided >90% of agreed data elements and 68% of the collated elements had <10% missingness. From the registry (n=12,620), 84% were male. The mean age was 59.2±12.3 years. The Malaysian cohort had a high prevalence of previous myocardial infarction (34%), almost twice that of any other sites (p<0.001). Adverse in-hospital outcomes were the lowest in Hong Kong whilst in-hospital mortality varied from 2.7% in Vietnam to 7.9% in Singapore. CONCLUSIONS: Governance approvals for the collation of individual patient anonymised data was achieved with a high level of data alignment. Secure data transfer process and repository were established. Patient characteristics and presentation varied significantly across the Asia-Pacific region with this likely to be a major predictor of variations in the clinical outcomes observed across the region.

Health related quality of life assessment in acute coronary syndrome patients: the effectiveness of early phase I cardiac rehabilitation.

BACKGROUND: Acute Coronary Syndrome (ACS) is one of the most burdensome cardiovascular diseases in terms of the cost of interventions. The Cardiac Rehabilitation Programme (CRP) is well-established in improving clinical outcomes but the assessment of actual clinical improvement is challenging, especially when considering pharmaceutical care (PC) values in phase I CRP during admission and upon discharge from hospital and phase II outpatient interventions. This study explores the impact of pharmacists' interventions in the early stages of CRP on humanistic outcomes and follow-up at a referral hospital in Malaysia. METHODS: We recruited 112 patients who were newly diagnosed with ACS and treated at the referral hospital, Sarawak General Hospital, Malaysia. In the intervention group (modified CRP), all medication was reviewed by the clinical pharmacists, focusing on drug indication; understanding of secondary prevention therapy and adherence to treatment strategy. We compared the "pre-post" quality of life (QoL) of three groups (intervention, conventional and control) at baseline, 6 months and 12 months post-discharge with Malaysian norms. QoL data was obtained using a validated version of Short-Form 36 Questionnaire (SF-36). Analysis of variance (ANOVA) with repeated measure tests was used to compare the mean differences of scores over time. RESULTS: A pre-post quasi-experimental non-equivalent group comparison design was applied to 112 patients who were followed up for one year. At baseline, the physical and mental health summaries reported poor outcomes in all three groups. However, these improved gradually but significantly over time. After the 6-month follow-up, the physical component summary reported in the modified CRP (MCRP) participants was higher, with a mean difference of 8.02 (p = 0.015) but worse in the mental component summary, with a mean difference of -4.13. At the 12-month follow-up, the MCRP participants performed better in their physical component (PCS) than those in the CCRP and control groups, with a mean difference of 11.46 (p = 0.008), 10.96 (p = 0.002) and 6.41 (p = 0.006) respectively. Comparing the changes over time for minimal important differences (MICD), the MCRP group showed better social functioning than the CCRP and control groups with mean differences of 20.53 (p = 0.03), 14.47 and 8.8, respectively. In role emotional subscales all three groups showed significant improvement in MCID with mean differences of 30.96 (p = 0.048), 31.58 (p = 0.022) and 37.04 (p < 0.001) respectively. CONCLUSION: Our results showed that pharmaceutical care intervention significantly improved HRQoL. The study also highlights the importance of early rehabilitation in the hospital setting. The MCRP group consistently showed better QoL, was more highly motivated and benefitted most from the CRP. TRIAL REGISTRATION: Medical Research and Ethics Committee (MREC) Ministry of Health Malaysia, November 2007, NMRR-08-246-1401.

Apixaban in patients with atrial fibrillation.

BACKGROUND: Vitamin K antagonists have been shown to prevent stroke in patients with atrial fibrillation. However, many patients are not suitable candidates for or are unwilling to receive vitamin K antagonist therapy, and these patients have a high risk of stroke. Apixaban, a novel factor Xa inhibitor, may be an alternative treatment for such patients. METHODS: In a double-blind study, we randomly assigned 5599 patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable to receive apixaban (at a dose of 5 mg twice daily) or aspirin (81 to 324 mg per day), to determine whether apixaban was superior. The mean follow up period was 1.1 years. The primary outcome was the occurrence of stroke or systemic embolism. RESULTS: Before enrollment, 40% of the patients had used a vitamin K antagonist. The data and safety monitoring board recommended early termination of the study because of a clear benefit in favor of apixaban. There were 51 primary outcome events (1.6% per year) among patients assigned to apixaban and 113 (3.7% per year) among those assigned to aspirin (hazard ratio with apixaban, 0.45; 95% confidence interval [CI], 0.32 to 0.62; P<0.001). The rates of death were 3.5% per year in the apixaban group and 4.4% per year in the aspirin group (hazard ratio, 0.79; 95% CI, 0.62 to 1.02; P=0.07). There were 44 cases of major bleeding (1.4% per year) in the apixaban group and 39 (1.2% per year) in the aspirin group (hazard ratio with apixaban, 1.13; 95% CI, 0.74 to 1.75; P=0.57); there were 11 cases of intracranial bleeding with apixaban and 13 with aspirin. The risk of a first hospitalization for cardiovascular causes was reduced with apixaban as compared with aspirin (12.6% per year vs. 15.9% per year, P<0.001). The treatment effects were consistent among important subgroups. CONCLUSIONS: In patients with atrial fibrillation for whom vitamin K antagonist therapy was unsuitable, apixaban reduced the risk of stroke or systemic embolism without significantly increasing the risk of major bleeding or intracranial hemorrhage. (Funded by Bristol-Myers Squibb and Pfizer; ClinicalTrials.gov number, NCT00496769.).

Dronedarone in high-risk permanent atrial fibrillation.

BACKGROUND: Dronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular antiarrhythmic effects. We hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation. METHODS: We assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death. RESULTS: After the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29; 95% confidence interval [CI], 1.34 to 3.94; P=0.002). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11; 95% CI, 1.00 to 4.49; P=0.046), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26; 95% CI, 1.06 to 10.00; P=0.03). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32; 95% CI, 1.11 to 4.88; P=0.02). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81; 95% CI, 1.10 to 2.99; P=0.02). CONCLUSIONS: Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients. (Funded by Sanofi-Aventis; PALLAS ClinicalTrials.gov number, NCT01151137.).

Duration of dual antiplatelet therapy and outcomes after coronary stenting with the Genous™ bio-engineered R stent™ in patients from the e-HEALING registry.

OBJECTIVE: We investigated the relation between duration of dual antiplatelet therapy (DAPT) and clinical outcomes up to 12 months after Genous™ endothelial progenitor cell capturing R stent™ placement in patients from the e-HEALING registry. BACKGROUND: Cessation of (DAPT) has been shown to be associated with the occurrence of stent thrombosis (ST). After Genous placement, 1 month of DAPT is recommended. METHODS: Patients were analyzed according to continuation or discontinuation of DAPT at a 30-day and 6-month landmark, excluding patients with events before the landmark. Each landmark was a new baseline, and outcomes were followed up to 12 months after stenting. The main outcome for our current analysis was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction and target vessel revascularization. Secondary outcomes included ST. (Un)adjusted hazard ratios (HR) for TVF were calculated with Cox regression. RESULTS: No difference was observed in the incidence of TVF [HR: 1.03; 95% confidence intervals (CI): 0.65-1.65, P = 0.89] in patients continuing DAPT (n = 4,249) at 30 days versus patients stopped (n = 309), and HR: 0.82 (95% CI: 0.55-1.23, P = 0.34) in patients continuing DAPT (n = 2,654) at 6 months versus patients stopped [n = 1,408] DAPT). Furthermore, no differences were observed in ST. Even after addition of identified independent predictors for TVF, adjusted TVF hazards were comparable. CONCLUSIONS: In a post-hoc analysis of e-HEALING, duration of DAPT was not associated with the occurrence of the outcomes TVF or ST. The Genous stent may be an attractive treatment especially in patients at increased risk for (temporary) cessation of DAPT or bleeding.

Applying the National Institute for Clinical Excellence criteria to patients treated with the Genous™ Bio-engineered R stent™: a sub-study of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry.

The National Institute for Clinical Excellence (NICE) guidelines recommend the use of bare-metal stents (BMS) in non-complex lesions with a low risk of restenosis (diameter ≥3 mm and lesion length ≤15 mm) and the use of drug-eluting stents (DES) in more complex lesions with a high risk of restenosis (diameter <3.0 mm or lesion length >15 mm). However, the guidelines were created based on studies evaluating BMS and DES only. We performed an analysis of patients undergoing non-urgent percutaneous coronary intervention with the novel endothelial cell capturing stent (ECS). The ECS is coated with CD34(+) antibodies that attract circulating endothelial progenitor cells to the stent surface, thereby accelerating the endothelialization of the stented area. We analyzed all patients enrolled in the worldwide e-HEALING registry that met the NICE criteria for either low-risk or high-risk lesions and were treated with ≥1 ECS. The main study outcome was target vessel failure (TVF) at 12-month follow-up, defined as the composite of cardiac death or MI and target vessel revascularization (TVR). A total of 4,241 patients were assessed in the current analysis. At 12-month follow-up, TVF occurred in 7.0% of the patients with low-risk lesions and in 8.8% of the patients with high-risk lesions (p = 0.045). When evaluating the diabetic patients versus the non-diabetic patients per risk group, no significant differences were found in TVF, MI or TVR in either risk group. The ECS shows good clinical outcomes in lesions carrying either a high or a low risk of restenosis according to the NICE guidelines with comparable rates of cardiac death, myocardial infarction, and stent thrombosis. The TVF rate with ECS was slightly higher in patients with high-risk lesions, driven by higher clinically driven TLR. The risk of restenosis with ECS in patients carrying high-risk lesions needs to be carefully considered relative to other risks associated with DES. Furthermore, the presence of diabetes mellitus did not influence the incidence of TVF in either risk group.

Twelve-month outcomes after coronary stenting with the Genous™ bio-engineered R Stent™ in diabetic patients from the e-HEALING registry.

OBJECTIVES: We compared 12-month outcomes, regarding ischemic events, repeat intervention, and ST, between diabetic and nondiabetic patients treated with the Genous™ EPC capturing R stent™ during routine nonurgent percutaneous coronary intervention (PCI) using data from the multicenter, prospective worldwide e-HEALING registry. BACKGROUND: Diabetic patients have an increased risk for restenosis and stent thrombosis (ST). METHODS: In the 4,996 patient e-HEALING registry, 273 were insulin requiring diabetics (IRD), 963 were non-IRD (NIRD), and 3,703 were nondiabetics. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularization. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularization (TLR), and individual outcomes including ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test. RESULTS: TVF rates were respectively 13.4% in IRD, 9.0% in NIRD, and 7.9% in nondiabetics (P < 0.01). This was mainly driven by a higher mortality hazard in IRD (P < 0.001) and NIRD (P = 0.07), compared with nondiabetics. TLR rates were comparable in NIRD and nondiabetics, but significantly higher in IRD (P = 0.04). No difference was observed in ST. CONCLUSION: The 1-year results of the Genous stent in a real-world population of diabetics show higher TVF rates in diabetics compared with nondiabetics, mainly driven by a higher mortality hazard. IRD is associated with a significant higher TLR hazard. Definite or probable ST in all diabetic patients was comparable with nondiabetics. (J Interven Cardiol 2011;24:285-294).

Coronary stenting with the Genous™ Bio-Engineered R Stent™ in elderly patients.

BACKGROUND: We evaluated the Genous™ Bio-engineered R stent™ in elderly patients undergoing non-urgent percutaneous coronary intervention. The elderly have an increased risk of (temporary) discontinuation of clopidogrel, which is associated with a higher risk of developing stent thrombosis (ST). METHODS AND RESULTS: In the e-HEALING registry, 2,651 patients were <65, 1,403 were 65-74 and 869 were ≥ 75 years old. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related car-diac death or myocardial infarction and target vessel revascularization. Secondary outcomes included target lesion revascularization (TLR) and ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test. TVF occurred significantly more often in elderly patients compared with younger patients (7.0% in patients aged < 65, 8.8% in patients aged 65-74 and 11.7% in patients aged ≥ 75 years, P<0.001). There was a trend to higher TLR with increasing age (log-rank P=0.06) and no difference in ST. CONCLUSIONS: The 1-year results of the Genous stent in a population of elderly patients show a significantly higher TVF rate compared with younger patients, mainly driven by a higher mortality. Although there was a trend to higher TLR rates with increasing age, there was no difference in ST. This attests to the safety of this therapy for the elderly, in whom there could be concerns with administering long-term dual antiplatelet therapy.

Risk for radiation-induced cataract for staff in interventional cardiology: is there reason for concern?

OBJECTIVES: To examine the prevalence of radiation-associated lens opacities among interventional cardiologists and nurses and correlate with occupational radiation exposure. BACKGROUND: Interventional cardiology personnel are exposed to relatively high levels of X-rays and based on recent findings of radiation-associated lens opacities in other cohorts, they may be at risk for cataract without use of ocular radiation protection. METHODS: Eyes of interventional cardiologists, nurses, and age- and sex-matched unexposed controls were screened by dilated slit lamp examination and posterior lens changes graded using a modified Merriam-Focht technique. Individual cumulative lens X-ray exposure was calculated from responses to a questionnaire and personal interview. RESULTS: The prevalence of radiation-associated posterior lens opacities was 52% (29/56, 95% CI: 35-73) for interventional cardiologists, 45% (5/11, 95% CI: 15-100) for nurses, and 9% (2/22, 95% CI: 1-33) for controls. Relative risks of lens opacity was 5.7 (95% CI: 1.5-22) for interventional cardiologists and 5.0 (95% CI: 1.2-21) for nurses. Estimated cumulative ocular doses ranged from 0.01 to 43 Gy with mean and median values of 3.4 and 1.0 Gy, respectively. A strong dose-response relationship was found between occupational exposure and the prevalence of radiation-associated posterior lens changes. CONCLUSIONS: These findings demonstrate a dose dependent increased risk of posterior lens opacities for interventional cardiologists and nurses when radiation protection tools are not used. While study of a larger cohort is needed to confirm these findings, the results suggest ocular radio-protection should be utilized.

Assessment of global right ventricular function on 64-MDCT compared with MRI.

OBJECTIVE: The aim of this study was to compare ECG-gated 64-MDCT with MRI for the assessment of global right ventricular (RV) function from coronary CT angiography data. SUBJECTS AND METHODS: Thirty-eight patients (25 men, 13 women; mean age +/- SD, 55.0 +/- 8.8 years) with suspected coronary artery disease underwent contrast-enhanced 64-MDCT (64 x 0.6 mm, 120 kV, 770 mAs(eff)) and 1.5-T MRI (balanced fast-field echo; TR/TE, 3.3/1.6; flip angle, 60 degrees ; 50 phases). Double oblique short-axis MDCT and MR images were used for further analysis. End-diastolic volume (EDV), end-systolic volume (ESV), stroke volume (SV), and ejection fraction (EF) were computed from manually drawn endocardial contours of the right ventricle. For statistical analysis, repeated-measures analysis of variance and Pearson's correlation coefficients were calculated. Bland-Altman plots were computed. RESULTS: In general, RV volumes calculated from 64-MDCT agreed well with those calculated from MRI. The mean EF (+/- SD) calculated from MDCT and MRI was 51.0% +/- 7.8% and 51.4% +/- 7.3%, respectively. An excellent correlation was observed for EDV (r = 0.99), ESV (r = 0.98), SV (r = 0.98), and EF (r = 0.97). Bland-Altman plots showed no systematic variation between MDCT and MRI data. No statistically significant differences (p < or = 0.05) between the techniques were found. CONCLUSION: Although contrast injection is optimized for visualization of the coronary arteries, retrospectively ECG-gated 64-MDCT permits reliable assessment of global RV function.

Assessment of global and regional left ventricular function using 64-slice multislice computed tomography and 2D echocardiography: a comparison with cardiac magnetic resonance.

OBJECTIVES: To compare the assessment of global and regional left ventricular (LV) function using 64-slice multislice computed tomography (MSCT), 2D echocardiography (2DE) and cardiac magnetic resonance (CMR). METHODS: Thirty-two consecutive patients (mean age, 56.5+/-9.7 years) referred for evaluation of coronary artery using 64-slice MSCT also underwent 2DE and CMR within 48h. The global left ventricular function which include left ventricular ejection fraction (LVEF), left ventricular end diastolic volume (LVdV) and left ventricular end systolic volume (LVsV) were determine using the three modalities. Regional wall motion (RWM) was assessed visually in all three modalities. The CMR served as the gold standard for the comparison between 64-slice MSCT with CMR and 2DE with CMR. Statistical analysis included Pearson correlation coefficient, Bland-Altman plots and kappa-statistics. RESULTS: The 64-slice MSCT agreed well with CMR for assessment of LVEF (r=0.92; p<0.0001), LVdV (r=0.98; p<0.0001) and LVsV (r=0.98; p<0.0001). In comparison with 64-slice MSCT, 2DE showed moderate correlation with CMR for the assessment of LVEF (r=0.84; p<0.0001), LVdV (r=0.83; p<0.0001) and LVsV (r=0.80; p<0.0001). However in RWM analysis, 2DE showed better accuracy than 64-slice MSCT (94.3% versus 82.4%) and closer agreement (kappa=0.89 versus 0.63) with CMR. CONCLUSION: 64-Slice MSCT correlates strongly with CMR in global LV function however in regional LV function 2DE showed better agreement with CMR than 64-slice MSCT.

Accuracy of 64-row multidetector computed tomography in detecting coronary artery disease in 134 symptomatic patients: influence of calcification.

BACKGROUND: The new 64-row multidetector computed tomography (CT)-assisted angiography can now detect coronary artery disease with shorter breath-hold time and at faster heart rates for symptomatic patients. We aim to determine if the 64-row scanner can also overcome limitations due to mild to moderate calcification. METHODS: Scheduled for conventional coronary angiography, 134 symptomatic patients underwent multidetector CT-assisted angiography within 3 months. Patients were divided into those with low or high calcium score (median score 142) by modified Agatston formula: group A calcium score <142 Agatston score (68 patients, mean age 53 years, heart rate 62 beat/min) and group B calcium score > or = 142 Agatston score (66 patients, mean age 57 years, heart rate 62 beat/min). Eleven major coronary segments were evaluated. RESULTS: In group A, 93.6% of segments were evaluable with 97.3% correlation. Segment-by-segment analyses for sensitivity, specificity, and positive and negative predictive values were 85.4%, 98.1%, 76.7%, and 99.2%, respectively. For group B, 86.9% of segments were evaluable with 90.5% correlation. Sensitivity, specificity, and positive and negative predictive values were 79.9%, 92.8%, 78.8%, and 93.5%, respectively. CONCLUSIONS: The 64-slice multidetector CT coronary angiography can reliably detect the presence of significant coronary stenosis in symptomatic patients with mild calcification, but remains limited by moderate to heavy calcification.

Direct stenting compared to conventional stenting in Diabetic Patients Undergoing Elective Angioplasty for Coronary Artery Disease (DECIDE): a multicenter, open label, randomized, controlled efficacy study.

BACKGROUND: Direct stenting (DS) has been shown to be associated with reduced radiation exposure and procedural costs but has a restenosis rate and clinical outcomes similar to conventional stenting (CS) with balloon predilatation. Whether DS confers benefit in diabetic patients, who have been shown to have high restenosis risk after stent implantation, remains unknown. METHODS: In a multicenter randomized trial, diabetic patients undergoing elective coronary stent implantation for a de novo lesion in a native coronary artery between April 2001 and October 2002 were randomized into DS or CS treatment groups. All patients received NirElite stents (SciMed, Boston Scientific, Maple Grove, Minn). They were scheduled to undergo a 6-month angiographic follow-up with quantitative coronary analysis evaluation. The primary end point was a 6-month binary restenosis rate and the secondary end point involved 6-month all-cause mortality, nonfatal acute myocardial infarction, or target vessel revascularization rates. RESULTS: A total of 128 diabetic patients were randomized into DS or CS treatment groups (n = 64, both groups). The 2 groups were well matched in baseline and lesion characteristics. The procedural success rate was similar (DC vs CS; 98.4% vs 96.9%). Nineteen patients (29.7%) crossed over from DS to CS. Six-month angiographic follow-up showed similar restenosis rates, minimum luminal diameter and late lumen loss. The binary restenosis rate was 43% in DS and 52% in CS groups (P = NS). The 6-month all-cause mortality, nonfatal acute myocardial infarction, or target vessel revascularization rates were also similar in both groups. CONCLUSIONS: Among diabetic patients undergoing elective coronary stent implantation, DS is safe and feasible. However, it is not associated with reduction in restenosis rate or improvement in clinical outcomes when compared with CS.

Coronary intervention with a heparin-coated stent and aspirin only.

OBJECTIVES: To determine the safety and efficacy of a post-stenting anti-platelet regimen of aspirin without additional ticlopidine or clopidogrel after successful heparin-coated stent implantation. METHODS: A prospective, non-randomized, multi-center pilot study of patients undergoing percutaneous coronary intervention, including those with acute coronary syndromes and small vessels with one-month clinical follow-up, was undertaken. Patients received a heparin-coated stent and were treated with aspirin only. RESULTS: Over a period of 6 months, a total of 122 patients were recruited in 6 centers. Their mean age was 57.2 10.0 years, 79% were male and 31% had unstable angina. Most (75%) had single-vessel disease, predominantly of the left anterior descending artery (51%), with a mean reference diameter of 2.44 mm 0.44 mm at baseline and 2.48 0.41 mm post stenting. At a 1-month clinical follow-up, no major adverse cardiovascular events (including subacute stent thrombosis) had occurred. Five patients were readmitted to hospital for symptoms unrelated to the interventional procedure. CONCLUSIONS: Heparin-coated stent implantation using an antiplatelet regimen of aspirin only, appears to be safe and feasible. A randomized trial of a larger number of patients appears warranted.

Sex differences in acute coronary syndrome in a multiethnic asian population: results of the malaysian national cardiovascular disease database-acute coronary syndrome (NCVD-ACS) registry.

BACKGROUND: Sex differences in acute coronary syndrome (ACS) have been well studied in major registries and clinical trials in Western populations. Limited studies have examined the sex differences in ACS using a large number of Asian women as the subjects. OBJECTIVES: The aim was to study the sex differences in ACS using the NCVD-ACS (National Cardiovascular Disease Database-Acute Coronary Syndrome) registry. METHODS: We analyzed 13,591 ACS patients, of which 75.8% were men and 24.2% were women, from March 2006 to February 2010. Data were collected on demographic characteristics, risk factors, anthropometrics, treatments, procedures, mortalities, and complications. The results were compared among 3 cohorts of ACS (ST-segment elevation myocardial infarction [STEMI], non-STEMI, and unstable angina). RESULTS: Women were older and more likely to have diabetes, hypertension, previous heart failure, and cerebral vascular accidents than men were. Women were less likely to receive in-hospital administration of aspirin, beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers, and they were less likely to undergo angiography and percutaneous coronary intervention. In STEMI, a significantly lower proportion of women than men received primary percutaneous coronary intervention (6.2% vs. 6.7%, respectively, p = 0.000) and fibrinolysis (64.4% vs. 74.6%, respectively, p = 0.000). In addition, with regard to STEMI, women had a significantly higher unadjusted in-hospital mortality rate than men did (15.0% vs. 8.1%, respectively, p < 0.000). There was no statistically significant in-hospital mortality difference between sexes for non-STEMI and unstable angina. After adjustment for age and other covariates, a multivariate analysis showed no sex differences in the in-hospital mortality in all spectrums of ACS. CONCLUSIONS: Our study showed significant sex differences in the demographic characteristics, risk factors, treatments, and outcomes of ACS. More importantly, in ACS patients, we found evidence of suboptimal treatments and interventions in women versus men. Our findings provide an opportunity to narrow the sex gap in the care of women with ACS in Malaysia.

Survey of atherosclerotic disease in Asian subjects with cardiovascular disease risk factors who were not receiving lipid-lowering agents.

BACKGROUND: Carotid intima media thickness (CIMT) is a surrogate marker for atherosclerosis, used to identify asymptomatic individuals at increased risk of cardiovascular events. The primary objective of this study was to obtain the distribution of CIMT measurements in Asian individuals with cardiovascular disease (CVD) risk factors who were not receiving lipid-lowering agents. METHODS: Mean CIMT based on ultrasonographic measurement of 12 sites within the common carotid artery was recorded for 2726 subjects across eight Asian countries who had two or more CVD risk factors but were not receiving lipid-lowering therapy. CVD risk factors and lipid and glucose profiles were analyzed with respect to distribution of CIMT and high-sensitivity C-reactive protein (hs-CRP) values. RESULTS: The overall mean (SD) of mean CIMT (mean-mean CIMT) was 0.662 (0.16) mm. There was a significant variation in mean-mean CIMT across countries (P<0.0001). Mean-mean CIMT values (mm) by age were: 0.485, 0.527, 0.614, 0.665, 0.715 and 0.797 for ≤ 29, 30-39, 40-49, 50-59, 60-69 and ≥ 70 years, respectively. Multivariate analyses confirmed a significant association between increasing mean-mean CIMT and increasing age, male gender, low high-density lipoprotein-cholesterol (HDL-C) levels and elevated fasting blood glucose levels. Analysis of log-transformed hs-CRP levels showed significant association with increasing waist circumference, low-density lipoprotein-cholesterol, body-mass index, high blood glucose levels and low HDL-C. CONCLUSIONS: Our data show normative mean-mean CIMT data for Asian subjects with two or more CVD risk factors who are not receiving lipid-lowering therapy, which may guide CVD risk-stratification of asymptomatic individuals in Asia.

Are there gender differences in coronary artery disease? The Malaysian National Cardiovascular Disease Database - Percutaneous Coronary Intervention (NCVD-PCI) Registry.

OBJECTIVES: To assess whether gender differences exist in the clinical presentation, angiographic severity, management and outcomes in patients with coronary artery disease (CAD). METHODS: The study comprised of 1,961 women and 8,593 men who underwent percutaneous coronary intervention (PCI) and were included in the Malaysian NCVD-PCI Registry from 2007-2009. Significant stenosis was defined as ≥70% stenosis in at least one of the epicardial vessels. RESULTS: Women were significantly older and had significantly higher rates of diabetes mellitus, hypertension, chronic renal failure, new onset angina and prior history of heart failure whereas smokers and past history of myocardial infarction were higher in men. In the ST-elevation myocardial infarction (STEMI) cohort, more women were in Killip class III-IV, had longer door-to-balloon time (169.5 min. vs 127.3 min, p<0.052) and significantly longer transfer time (300.4 min vs 166.3 min, p<0.039). Overall, women had significantly more left main stem (LMS) disease (1.3% vs 0.6%, p<0.003) and smaller diameter vessels (<3.0 mm: 45.5% vs 34.8%, p<0.001). In-hospital mortality rates for all PCI, STEMI, Non-STEMI (NSTEMI) and unstable angina for women and men were 1.99% vs 0.98%, Odds ratio (OR): 2.06 (95% confidence interval (CI): 1.40 to 3.01), 6.19% vs 2.88%, OR: 2.23 (95% CI: 1.31 to 3.79), 2.90% vs 0.79%, OR: 3.75 (95% CI: 1.58 to 8.90) and 1.79% vs 0.29%, OR: 6.18 (95% CI: 0.56 to 68.83), respectively. Six-month adjusted OR for mortality for all PCI, STEMI and NSTEMI in women were 2.18 (95% CI: 0.97 to 4.90), 2.68 (95% CI: 0.37 to 19.61) and 2.66 (95% CI: 0.73 to 9.69), respectively. CONCLUSIONS: Women who underwent PCI were older with more co-morbidities. In-hospital and six-month mortality for all PCI, STEMI and NSTEMI were higher due largely to significantly more LMS disease, smaller diameter vessels, longer door-to-balloon and transfer time in women.