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Background: Gender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). The impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) in ACS patients is still unexplored and was, therefore, the aim of the present sub-study., Methods: REDUCE was a prospective, multicenter, randomized investigator-initiated study designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months., Results: From June 2014 to May 2016 300 women and 1196 men were included in the study. Among them, 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, with the exception of a lower rate of TIMI flow < 3 (p = 0.04), lower systolic blood pressure (p = 0.05) and use of spironolactone (p = 0.006) among women and a more advanced age (p = 0.05) among men receiving a short-term DAPT. At a mean follow-up of 525 (± 198) days, no difference in the primary endpoint was observed according to DAPT duration in both females [6.9% vs 5.9%, HR (95% CI) = 1.19 (0.48-2.9), p = 0.71] and males [8.2% vs 9%, HR (95% CI) = 0.92 (0.63-1.35), p = 0.67; p INT = 0.20]. Results were confirmed after correction for baseline differences [females: adjusted HR (95% CI) = 1.12 (0.45-2.78), p = 0.81; males: adjusted HR (95% CI) = 0.90 (0.61-1.32), p = 0.60]. Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of gender., Conclusions: The present study shows that among ACS patients randomized in the REDUCE trial, a 3 months DAPT strategy offers comparable results as compared to a standard 12 months DAPT at 2-years follow-up in both male and female gender., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Gender disparities in ST-segment elevation myocardial infarction (STEMI) outcomes continue to be reported worldwide; however, the magnitude of this gap remains unknown. To evaluate gender-based discrepancies in clinical outcomes and identify the primary driving factors a global meta-analysis was performed. Studies were selected if they included all comers with STEMI, reported gender specific patient characteristics, treatments, and outcomes, according to the registered PROSPERO protocol: CRD42020161469. A total of 56 studies (705,098 patients, 31% females) were included. Females were older, had more comorbidities and received less antiplatelet therapy and primary percutaneous coronary intervention (PCI). Females experienced significantly longer delays to first medical contact (mean difference 42.5 min) and door-to-balloon time (mean difference 4.9 min). In-hospital, females had increased rates of mortality (odds ratio [OR] 1.91, 95% confidence interval [CI] 1.84 to 1.99, p <0.00001), repeat myocardial infarction (MI) (OR 1.25, 95% CI 1.00 to 1.56, p=0.05), stroke (OR 1.67, 95% CI 1.27 to 2.20, p <0.001), and major bleeding (OR 1.82, 95% CI 1.56 to 2.12, p <0.00001) compared with males. Older age at presentation was the primary driver of excess mortality in females, although other factors including lower rates of primary PCI and aspirin usage, and longer door-to-balloon times contributed. In contrast, excess rates of repeat MI and stroke in females appeared to be driven, at least in part, by lower use of primary PCI and P2Y12 inhibitors, respectively. In conclusion, despite improvements in STEMI care, women continue to have in-hospital rates of mortality, repeat MI, stroke, and major bleeding up to 2-fold higher than men. Gender disparities in in-hospital outcomes can largely be explained by age differences at presentation but comorbidities, delays to care and suboptimal treatment experienced by women may contribute to the gender gap., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background and Aims: The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy., Methods: The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT. The study population was divided according to age (

Aims: The optimal duration of DAPT in ACS patients treated with DES is still unclear. Therefore, the aim of the current study was to investigate a short versus a standard 12-month DAPT regimen in ACS patients undergoing new-generation DES implantation., Methods and Results: REDUCE was a prospective, open-label, multicentre, investigator-initiated study that randomised 1,496 ACS patients after treatment with the COMBO stent to either three (n=751) or 12 months (n=745) of DAPT. The primary study endpoint was a composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target vessel revascularisation and bleeding at 12 months. No difference was observed in the demographic and clinical characteristics between the two groups, except for gender (p=0.01). At one-year follow-up, non-inferiority of three- versus 12-month DAPT in the primary endpoint was met (8.2% vs 8.4%, pnon-inferiority<0.001). The similar outcome between the two groups was confirmed at two-year follow-up (11.6% vs 12.1%, p=0.76), with no significant difference in overall mortality (3.1% vs 2.2%, p=0.27), cardiac mortality (1.8% vs 1.1%, p=0.28), stent thrombosis (1.6% vs 0.8%, p=0.16) and major bleeding (3.3% vs 4.0%, p=0.46)., Conclusions: The results show that, among ACS patients treated with the COMBO stent, three months is non-inferior to 12 months of DAPT. However, given the numerically higher rates of mortality and ST in the three-month DAPT group, one-year DAPT should still be recommended in ACS until more information becomes available. A three-month DAPT strategy should be considered only if clinically mandated.

Aims: The LEADERS FREE trial has demonstrated that a polymer-free Biolimus A9-coated stent (BA9-DCS) is superior to a bare metal stent (BMS) for high bleeding risk (HBR) patients when treated with one month of dual antiplatelet therapy (DAPT). This analysis aimed to determine the impact of PCI procedure complexity on the two-year results., Methods and Results: Six hundred and sixty-seven (667) patients enrolled in the LEADERS FREE (BA9-DCS 346, BMS 321) underwent a complex PCI, defined by one or more of eight characteristics: total stent length ≥60 mm, ≥3 vessels or lesions treated, ≥3 stents implanted, bifurcation lesion treated with ≥2 stents, chronically occluded, restenotic or saphenous vein graft lesion. Patients undergoing complex PCI were older, more often male, and presented with more ACS, diabetes, renal insufficiency, anaemia and multivessel disease. They derived major benefit from DCS over BMS for safety (16.2% vs. 21.7%, HR 0.70 [0.49-0.99], p<0.05) and for efficacy (10.8% vs. 18.1%, HR 0.54 [0.35-0.83], p<0.005). For the 1,746 patients with non-complex PCI, DCS demonstrated superior efficacy (5.3% vs. 9.9%, HR 0.52 [0.36-0.75], p<0.001, p for interaction NS) and similar safety to BMS (11.1% vs. 12.6%, NS, p for interaction NS)., Conclusions: Compared to BMS, the BA9-DCS maintained both efficacy and safety benefits when used in complex PCI procedures.

Aims: We assessed long-term outcomes in patients with extra-small (XS) (≤2.25 mm) and small vessels (SV) (>2.25-2.75 mm) treated with the Resolute zotarolimus-eluting stent (R-ZES)., Methods and Results: Data from eight studies including patients with XS or SV were pooled for this analysis. Among 2,141 patients (837 XS, 1,304 SV), three-year cumulative major adverse cardiac events (15.4% vs. 11.5%; adj. HR [95% CI]: 1.3 [1.0, 1.7], p=0.12), target lesion failure (12.4% vs. 9.3%, adj. HR: 1.1 [0.8, 1.5], p=0.56), and target lesion revascularisation (TLR: 6.9% vs. 4.5%, adj. HR 1.4 [0.9, 2.1], p=0.17) were greater in the XS cohort but were not significantly different after propensity adjustment. Target vessel revascularisation occurred more frequently in XS patients in both unadjusted and adjusted analyses (11.2% vs. 7.6%, adj. HR: 1.5 [1.1, 2.1], p=0.02). Stent thrombosis was low in both cohorts (1.2% vs. 0.6%, p=0.09). In the XS cohort, insulin-dependent diabetics had over twofold higher rates of TLR than non-diabetics (13.6% vs. 6.0%, p=0.02)., Conclusions: Long-term lesion-specific results among patients with XS vessels treated with the R-ZES were not significantly different from those among patients with SV, but specific patients with XS vessels (e.g., insulin-dependent diabetics) may remain at high risk for TLR.

Objectives: The objective of this study is to describe and compare the use of the MitraClip therapy in mitral regurgitation (MR) patients with degenerative MR (DMR) and functional MR (FMR)., Introduction: Percutaneous edge-to-edge repair of severe MR using the MitraClip device is approved for use in the USA for high risk DMR while European guidelines include its use in FMR patients as well., Methods: The MitraClip in the Asia-Pacific Registry (MARS) is a multicenter retrospective registry, involving eight sites in five Asia-Pacific countries. Clinical and echocardiographic characteristics, procedural outcomes and 1-month outcomes [death and major adverse events (MAE)] were compared between FMR and DMR patients treated with the MitraClip., Results: A total of 163 patients were included from 2011 to 2014. The acute procedural success rates for FMR (95.5%, n = 84) and DMR (92%, n = 69) were similar (P = 0.515). 45% of FMR had ≥2 clips inserted compared to 60% of those with DMR (P = 0.064).The 30-day mortality rate for FMR and DMR was similar at 4.5% and 6.7% respectively (P = 0.555). The 30-day MAE rate was 9.2% for FMR and 14.7% for DMR (P = 0.281). Both FMR and DMR patients had significant improvements in the severity of MR and NYHA class after 30 days. There was a significantly greater reduction in left ventricular end-diastolic diameter (P = 0.002) and end systolic diameter (P = 0.017) in DMR than in FMR., Conclusions: The MitraClip therapy is a safe and efficacious treatment option for both FMR and DMR. Although, there is a significantly greater reduction in LV volumes in DMR, patients in both groups report clinical benefit with improvement in functional class. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Background: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month., Methods: In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization., Results: We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001)., Conclusions: Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.).

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., (Copyright © 2014 World Heart Federation (Geneva). Published by Elsevier B.V. All rights reserved.)

Aims: Percutaneous MitraClip therapy has been shown to be safe and efficacious in mitral regurgitation (MR). Our aim was to describe early outcomes in patients from the Asia- Pacific region., Methods and Results: The MitraClip Asia-Pacific Registry (MARS) includes data from eight different centres in five countries in the Asia-Pacific region. The primary efficacy outcome was reduction in MR to ≤2+ at 30 days. The safety outcome was 30-day freedom from major adverse events (MAE), defined as the composite of death, myocardial infarction, non-elective cardiac surgery, renal failure, transfusion of ≥2 units of blood, ventilation for >48 hours, septicaemia, and new onset atrial fibrillation. A total of 142 patients underwent the MitraClip procedure from February 2011 to October 2013. Fifty-three point five percent (76) of patients had functional MR, 45.8% (65) had degenerative MR and 0.7% (1) had mixed MR. The acute procedural success rate was 93.7% (133). Thirty-one point seven percent of the patients were in NYHA Class I-II at baseline, compared to 82.1% at 30 days (p<0.001). Zero percent (0) of the patients had ≤2+ MR at baseline compared to 76.8% (109) at 30 days (p<0.001)., Conclusions: Results from the Asia-Pacific region show that the MitraClip procedure is effective in reducing mitral regurgitation and has favourable short-term safety outcomes.

This study was designed to prospectively evaluate the safety and efficacy of the 38-mm Resolute zotarolimus-eluting stent (R-ZES). Drug-eluting stents with long lengths are needed to ensure coverage of long lesions in some patients. Patients recruited from the RESOLUTE US and RESOLUTE Asia studies were implanted with at least one 38-mm R-ZES. Up to 2 lesions (in separate vessels) could be implanted with length ≤35 mm and a reference vessel diameter of 3.0 to 4.2 mm. The primary end point was 1-year target lesion failure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. The 1-year target lesion failure rate using 1 vessel per patient was compared with a performance goal (19%) derived from historical data. There were 223 patients enrolled (n = 269 lesions). The mean age was 60.9 ± 10.9 years, 79% were men, and 38% had diabetes. Target lesion failure rate using a single-vessel analysis was 4.5%, and the upper limit of the 1-sided 95% confidence interval (7.5%) was less than the performance goal of 19%. A secondary analysis using all lesions resulted in a target lesion failure rate of 5.4% (upper limit of 1-sided 95% confidence interval, 8.6%). Baseline characteristics and clinical outcomes were similar between patients with and without diabetes. The rate of probable or definite stent thrombosis was 0.9%. In conclusion, the 38-mm length of the R-ZES was found to be safe and effective with a low rate of target lesion failure and stent thrombosis and no differences in outcomes between patients with and without diabetes., (Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.)

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.

Introduction: The Malaysian National Cardiovascular Disease Database (NCVD) team presents Percutaneous Coronary Intervention (PCI) Registry report for the year 2007 to 2009. It provides comprehensive information regarding practice and outcome of PCI in Malaysia., Methodology: It was a voluntary, multi-centered, observational, cohort study and included patients of 18 years or above who underwent PCI at eleven participating centers in Malaysia from the year 2007 to 2009., Result: Ten thousand six hundred and two patients underwent 11,498 PCI procedures with 18,116 stents for 15,538 lesions. Mean age of the patients was 57 years and more than 98% of patients had at least one cardiovascular risk factor. A significant number of our patients were diabetic (50%) and had renal impairment (44.7% had ≤ stage 3 chronic kidney disease) at the time of procedure. Fifty eight percent of the lesions were type B2 or type C lesion. Twenty eight percent of the lesions had high risk characteristics. Procedural success rate was about 97% and post-procedural complications were low. Overall in-hospital, all cause mortality was 1%, of which 85% were cardiac related deaths. The poor prognostic factors for in-hospital mortality were acute coronary syndrome cases, higher Killip class and increasing age., Conclusion: Compared to other registries, Malaysian patients undergoing PCI were much younger with high prevalence of risk factors. In spite of complex and high risk lesions, procedural success was high, with overall low mortality rate. NCVD-PCI Registry aims to improve over-all cardiac services in Malaysia through its ongoing journey., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Cardiovascular disease (CVD) is an under-recognized major health problem among women in South-East Asia. The prevalence of cardiovascular risk factors such as hypertension, diabetes mellitus, dyslipidemia, physical inactivity, and being overweight or obese has shown a significantly increasing trend among women in the region, with the exception of Singapore. The problem is compounded by low awareness that CVD is a health problem for women as well as for men, by misconceptions about the disease, and by the lack of suitable, locally available health literature. Efforts have been made by the national heart associations and other organizations to increase heart health awareness and promote healthy lifestyles. Singapore initiated these prevention programs in the early 1990s and has been successful in reducing the prevalence of cardiovascular risk factors. The governments of the region, in accordance with the Noncommunicable Disease Alliance, have begun implementing appropriate preventive strategies and improving health-delivery systems. However, psychological, social, and cultural barriers to cardiovascular health awareness in women need to be addressed before these programs can be fully and successfully implemented.

Background: Asian patients have a uniquely high risk for heart disease compared to other ethnicities. Past drug eluting stent trials have examined mainly populations of European heritage. As a significant proportion of the real world population in the SPIRIT V single arm study is Asian, the study provides insight into how this population responds to stenting with the XIENCE V Everolimus Eluting Coronary Stent (EES)., Methods and Results: 2,700 patients were enrolled at 93 sites in Europe, Asia Pacific and Canada between November 2006 and November 2007. 698 (26%) patients were recruited from Asian sites in India, China, Hong Kong, Malaysia, Singapore and Thailand. De novo coronary artery lesions of all patients were to be treated with up to 4 planned EES. Up to 2 year follow-up, major adverse cardiac events, myocardial infarction and target lesion revascularization rates were lower in the Asian subgroup than in the non-Asian subgroup. These results were mainly driven by better clinical outcomes in the Indian population. All populations showed similar low stent thrombosis rates., Conclusion: These findings demonstrate the safety and efficacy of the EES when used in a real-world Asian population, known to be at higher risk for heart disease.

Introduction: The ACute CORonary syndromes Descriptive study (ACCORD) is a prospective observational study that evaluates the management of acute coronary syndrome (ACS) in clinical practice and the use of antiplatelet agents in acute settings and after discharge. The secondary objective of this study was to obtain information on risk factors in a large cohort of patients with ACS., Methods: The study population included subjects aged at least 21 years who had unstable angina or non-ST elevation myocardial infarction. The patients had four follow-up visits over a one-year period., Results: A total of 525 patients from Malaysia were enrolled into the study. The mean age of the patients was 58.14 +/- 11.3 years, and the mean body mass index was 25.4 +/- 4.3 kg/m2. 96.8 percent of subjects had at least one cardiovascular risk factor. Following hospitalisation, 83.6 percent of patients were managed medically. During the follow-up visits, 62.7-77.6 percent of patients received aspirin only, 5.0-6.8 percent received clopidogrel only and 15.6-32.3 percent received dual antiplatelet medications. Compliance with aspirin was 93.5-96.5 percent. Clopidogrel compliance was above 80 percent of the prescribed tablets for more than 88 percent of patients., Conclusion: Patients in the Malaysia-ACCORD registry were much younger compared to those in the Global Registry of Acute Coronary Events. The majority of patients had cardiovascular risk factors at presentation and were treated medically, and those on dual antiplatelet therapy had a relatively high level of compliance.

Aims: Coronary lesions in diabetics (DM) are associated with a high recurrence following percutaneous coronary intervention (PCI), even after drug-eluting stent (DES) deployment. Encouraging clinical data of the drug-eluting balloon catheter (DEB) SeQuent Please warrant its investigation in these patients., Methods and Results: Eighty-four diabetic patients (60.8 ± 9.1 years, 76.2% male) were randomised to either the DEB SeQuent Please or the DES Taxus Liberté to compare the 9-month clinical and angiographic outcome of PCI in native coronary arteries. Comparing the DEB vs. the DES the 9-month results (follow-up DEB 39/45 [86.7%], DES 36/39 [92.3%]) are statistically not different at the 0.05 level for the primary endpoint of in-segment (0.37 ± 0.59 mm vs. 0.35 ± 0.63 mm) and in-stent (0.51 ± 0.61 mm vs. 0.53 ± 0.67 mm) late lumen loss, overall and cardiac deaths (2/45 [4.4%] and 3/45 [6.7%] vs. 0), target lesion revascularisation (3/45 [8.9%] vs. 4/39 [10.3%]), the total MACE rate (6/45 [13.3%] vs. 6/39 [15.4%]), and the event free survival after 10.2 ± 3.8 months (Kaplan-Meier analysis, p<0.80, log rank test)., Conclusions: The clinical and angiographic outcome of the combination of the drug-eluting balloon SeQuent Please with a cobalt chromium stent compared to the drug eluting Taxus stent are similar.

Aims: Assess clinical, angiographic, and intravascular ultrasound results in lesions treated with the PROMUS Element platinum chromium everolimus-eluting stent (EES)., Methods and Results: Patients (N=100) with one de novo target lesion ≤ 34 mm long and reference vessel diameter (RVD) ≥ 2.25-≤ 4.25 mm were enrolled at 14 sites. The primary endpoint was the 30-day composite of cardiac death, myocardial infarction, target lesion revascularisation (TLR), or definite/probable stent thrombosis (ST). The efficacy endpoint of 9 month in-stent late loss in workhorse lesions (defined as RVD ≥ 2.5-≤ 4.25 mm, lesion ≤ 24 mm) was compared to a performance goal based on historical results with TAXUS Express paclitaxel-eluting stents. Post-procedure incomplete stent apposition (ISA) was compared to a performance goal based on results with the PROMUS/XIENCE V EES in SPIRIT III. Mean age was 61.8 ± 9.9 years; 77.0% were male; 19% had medically treated diabetes. Baseline RVD was 2.72 ± 0.53 mm; lesion length was 15.4 ± 7.0 mm. The primary endpoint occurred in one patient (periprocedural ST with TLR) with no additional major clinical events through one year. Nine-month in-stent late loss in workhorse lesions (0.17 ± 0.25 mm, N=73) and post-procedure ISA (5.7%, 5/88) were below performance goals (p<0.001)., Conclusions: Through one year, PROMUS Element EES had an acceptable safety and efficacy profile with low in-stent late loss and post-procedure ISA.

Background: There is scarce or no data on prevalence and presentation of acute coronary syndrome (ACS) among women of reproductive age. Furthermore, whether women of reproductive age presenting with ACS have the same risk factors as men and older women is not known., Objective: To analyze factors associated with ACS in women of reproductive age in comparison with older women and men of a similar age group., Methodology: A total of 9702 cases of acute coronary syndrome over a 3-year period ( 2006-2008) from the National Cardiovascular Disease database were analyzed, with focus on women of reproductive age (20-<40 years), looking into association with ethnicity, comorbid illness, and the ACS stratum. Comparison with older women (40-<60 years; Control 1) and men of similar age group (Control 2) was made and analyzed using Fisher's exact test and chi-square test when necessary., Results: From a total of 9702 cases, 2344 (24.2%) were women. Of these, 45 (1.9%) were women between 20 and <40 years, which is significantly lower than the two controls (older women 30.8%, and men of same age 6.2%, respectively; P < 0.0001). The distribution of ethnicity shows a similar pattern between the study group and the controls, but patients of Indian ethnicity were over-represented when compared with the Malaysian demographics of general population (31.3% versus 7.1%; P < 0.0001). ACS in women of reproductive age was associated with diabetes mellitus in 37.8%, hypertension in 40.0%, and dyslipidemia in 24.4% of cases, similar to men of the same age but significantly lower than the older women (P < 0.0001). Smoking is not a major risk factor in the study group, where only 6.7% ever smoked, similar to older women (6.8%, P = 1.000) and significantly much less compared with men of the same age (84.1%; P < 0.0001). Regarding the ACS stratum, a significantly higher percentage of women in the study group had ST-segment elevation myocardial infarction compared with older women (P = 0.0085) but less than that of men of similar age (P = 0.0187)., Conclusion: ACS is rare in women of reproductive age. Diabetes, hypertension, and Indian ethnicity were identified as important contributors.

Objective: To retrospectively evaluate the 12-month effectiveness of the Endeavor zotarolimus-eluting stent (ZES) in diabetic versus non-diabetic patients enrolled in the E-Five Registry., Design and Setting: The E-Five Registry is a prospective, multicentre registry of 8314 patients presenting with symptomatic coronary artery disease treated with the Endeavor (ZES). Patients were treated at 188 centres located in 37 countries across Europe, Latin America and Asia Pacific., Patients: There were 2721 (32.7%) patients with diabetes (DM) and among these patients 682 were insulin-treated (ITDM) and 2039 were non-insulin-treated diabetic patients (NITDM). Interventions All enrolled patients received an Endeavor ZES and were followed for 12 months., Main Outcome Measurements: The primary outcome measure was major adverse cardiac event (MACE) at 12 months. Secondary endpoints included target lesion revascularisation (TLR), target vessel revascularisation (TVR), target vessel failure (TVF) and stent thrombosis., Results: Compared with non-DM patients, DM patients had higher rates of MACE (9.7% vs 6.4%, p<0.001), TLR (5.3% vs 4.0%, p=0.028) and Academic Research Consortium (ARC) definite and probable stent thrombosis (1.5% vs 0.9%, p=0.041). Compared with non-DM patients, ITDM patients had higher rates of MACE (12.6% vs 6.4%, p<0.001). ITDM patients had higher rates of death (6.7% vs 1.7%, p<0.001), cardiac death (4.5% vs 1.2%, p<0.001) and TLR (6.5% vs 4.0%, p=0.011) than non-DM patients., Conclusions: The Endeavor ZES performed well in DM patients; however, DM patients experienced higher rates of adverse clinical events compared with non-DM patients. TRIAL REG NO:, Clinical Trial Registration Information: http://www.clinicaltrials.gov; Unique identifier: NTC00623441.

Background: The Taxus Olympia registry is a prospective, postapproval registry collecting clinical outcomes data on patients receiving the Taxus Liberté paclitaxel-eluting stent during routine interventional cardiology practice., Methods: Between February and July 2005, 529 patients receiving the Taxus Liberté stent at 16 centers in the Middle East, South/Central America, and Asia/Pacific regions were enrolled in Phase I of Olympia. The primary end-point was Taxus Liberté stent-related cardiac events (cardiac death, MI, and revascularization) at 30 days postimplant. Additional clinical assessment was conducted at 6 and 12 months. Olympia phases II and III are in clinical follow-up and will be reported separately., Results: One-year clinical follow-up is available for 98% of patients. Complex patients and lesions were prevalent, including: 50% diabetes mellitus, 49% multivessel disease, 30% multiple stenting, 48% AHA/ACC type B2/C lesions, 19% long lesions (>26 mm), and 40% small vessels (30 days postprocedure. One-year cardiac event rates among complex subpopulations (diabetics 5.0%, multiple stents 3.8%, long lesions 3.1%, and small vessels 2.9%) were comparable to the overall study population., Conclusions: In conclusion, this first report of real-world experience with the Taxus Liberté stent demonstrates the safety and clinical utility of this stent in the broader spectrum of coronary disease treated in everyday practice.

Objective: To compare the effects of sirolimus-eluting (SES) versus bare metal stents (BMS) on 6-month in-stent late luminal loss (LLL) and 1-year major adverse cardiac events (MACE) in diabetics undergoing percutaneous coronary interventions., Background: In studies of unselected patients, coronary restenosis rates have been lower with SES than with BMS. Comparisons of SES versus BMS in diabetics with more than one stenosis or more than one vessel disease are few., Methods: This open-label trial randomly assigned 200 diabetics with de novo coronary artery stenoses to receive up to three SES versus BMS in a 2:1 ratio. The patients underwent repeat coronary angiography at 6 months after the index procedure and were followed-up for 1 year. The primary study endpoint was in-stent LLL at 6 months., Results: Between August 2002 and May 2004, 83 patients (mean age = 60 years) with 128 lesions (mean = 1.5 per patient) were enrolled at four U.S. and seven Asian medical centers. Enrollment was terminated early by the Safety Monitoring Board because of a statistically significant difference in rates of clinical endpoints. The mean in-stent LLL at 6 months was 0.23 mm in SES versus 1.10 mm in BMS recipients (P < 0.001). At 12 months, 8 patients (15%) assigned to SES had experienced MACE versus 12 patients (41%) assigned to BMS (P = 0.006)., Conclusions: In diabetics, the mean 6-month in-stent LLL was significantly smaller, and 12-month MACE rate significantly lower, after myocardial revascularization with SES than with BMS., ((c) 2008 Wiley-Liss, Inc.)

Background: Data on achieving National Cholesterol Education Program Adult Treatment Panel III (ATP III) goals in Asia are limited., Objective: To examine treatment patterns, goal attainment, and factors influencing treatment among patients in 6 Asian countries who were taking statins., Methods: A retrospective cohort study was conducted in China, Korea, Malaysia, Singapore, Taiwan, and Thailand, where 437 physicians (41% cardiologists) recruited adults with hypercholesterolemia newly initiated on statin monotherapy., Results: Of 2622 patients meeting inclusion and exclusion criteria, approximately 66% had coronary heart disease (CHD)/diabetes mellitus, 24% had no CHD but > or =2 risk factors, and 10% had no CHD and <2 risk factors. Most patients ( approximately 90%) received statins at medium or lower equipotency doses. Across all cardiovascular risk categories, 48% of patients attained ATP III targets for low-density lipoprotein cholesterol (LDL-C), including 38% of those with CHD/diabetes (goal: <100 mg/dL), 62% of those without CHD but with > or =2 risk factors (goal: <130 mg/dL), and 81% of those without CHD and <2 risk factors (goal: <160 mg/dL). Most patients who achieved goals did so within the first 3 months. Increasing age (odds ratio (OR)=1.015 per 1-year increment; 95% confidence interval (CI)=1.005-1.206; p=0.0038) and initial statin potency (OR=2.253; 95% CI=1.364-3.722; p=0.0015) were directly associated with goal attainment, whereas increased cardiovascular risk (OR=0.085; 95% CI=0.053-0.134; p<0.0001 for CHD/diabetes mellitus at baseline compared with <2 risk factors,) and baseline LDL-C (OR=0.990; 95% CI=0.987-0.993); p<0.0001 per 1-mg/dL increment) were inversely associated with LDL-C goal achievement. Limitations of this study include potential differences in treatment settings and cardiovascular risk factors between different countries and centers. In addition, the effects on cholesterol goal achievement of concomitant changes in lifestyle were not assessed., Conclusion: LDL-C goal attainment is low in Asians, particularly those with CHD/diabetes. More effective patient monitoring, treatments, including combining regimens and dose titration, and adherence to these treatments along with therapeutic lifestyle counseling may facilitate goal attainment.

Several therapeutic approaches have been developed to improve the outcome among patients with acute coronary syndrome (ACS). However, treatment with antithrombotic therapies such as oral glycoprotein IIb/IIIa inhibitors has been limited by the lack of efficacy and excess bleeding complications. As the publication of the landmark study Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE), the clinical benefit of early and intermediate-term use of combined antiplatelet agents--clopidogrel plus aspirin--in non-ST-segment elevation myocardial infarction (NSTEMI) patients became evident. Pretreatment and intermediate-term therapy with clopidogrel in NSTEMI ACS patients undergoing percutaneous coronary intervention (PCI) was further supported by the PCI-CURE trial. Recently, the results of two major trials Clopidogrel as Adjunctive Reperfusion Therapy-Thrombolysis in Myocardial Infarction 28, Clopidogrel and Metoprolol in Myocardial Infarction Trial established the pivotal role of clopidogrel in the other spectrum of ACS-STEMI. Coupled with the results from previous multicentre trials, these two studies provide a guide for the early and long-term use of clopidogrel in the whole spectrum of ACS. A review summarising the results of the recent clinical trials and a discussion on its implications for the clinical management of ACS is presented.

Objective: We compared the result of radiofrequency (RF)-assisted valvotomy and balloon dilation with closed surgical valvotomy and Blalock Taussig (BT) shunt as primary treatment in selected patients with pulmonary atresia and intact ventricular septum (PA-IVS)., Background: Patients with PA-IVS who have mild to moderate hypoplasia of the right ventricle (RV) and patent infundibulum have the greatest potential for complete biventricular circulation. The use of RF or laser wires to perforate the atretic valve followed by balloon dilation provides an alternative to surgery., Methods: Between May 1990 and March 1998, 33 selected patients underwent either percutaneous RF valvotomy and balloon dilation (group 1, n = 21; two crossed over to group 2) or surgical valvotomy with concomitant BT shunt (group 2, n = 14). Second RV decompression by balloon dilation or right ventricular outflow tract (RVOT) reconstruction were performed if necessary. Patients who remained cyanosed were subjected to transcatheter trial closure of the interatrial communication. Partial biventricular repair was offered to those with inadequate growth of the RV., Results: The primary procedure was successful in 19 patients in group 1. There was one in-hospital death and two late deaths. Of the remaining 16 survivors, 12 achieved complete biventricular circulation, 7 of whom required no further interventions. Two patients required repeat balloon dilation, 1 RVOT reconstruction and 2 transcatheter closure of interatrial communication. Two patients underwent partial biventricular repair. In group 2, there were 3 in-hospital deaths after the primary procedure and 1 patient died four months later. All survivors (n = 10) required a second RV decompression, 8 by balloon dilation and 2 by RVOT reconstruction, after which, two patients died. Of the final 8 survivors, 7 achieved complete biventricular circulation, 5 after coil occlusion of the BT shunt and 2 after closure of interatrial communication., Conclusions: Radiofrequency valvotomy and balloon dilation is more efficacious and safe compared with closed pulmonary valvotomy and BT shunt in selected patients with PA-IVS.

A 10-month-old boy underwent operation to close a large secundum atrial septal defect and multiple muscular ventricular septal defects. Closure of the ventricular septal defects was unsuccessful and led to worsening cardiac failure and inability to wean the patient from mechanical ventilation. Transcatheter closure of the ventricular septal defects using Gianturco coils was undertaken. This technique is an effective alternative for closure of multiple muscular ventricular septal defects in infants and small children.

Two hundred eleven patients with small- to moderate-sized native patent ductus arteriosus underwent closure using Gianturco coils, employing the transvenous multiple catheter approach. Short-term results showed a high rate of complete occlusion and a potential long-term complication of mild left pulmonary artery stenosis in a small number of patients.

Because transseptal catheterization is felt to be contraindicated in patients with severe kyphoscoliosis, there have been no reports of percutaneous transvenous mitral commissurotomy performed in such patients. This report describes percutaneous transvenous mitral commissurotomy in three patients with severe thoracic kyphoscoliosis, with special emphasis on the transseptal puncture technique. Biplane right atrial angiography and the contrast septal flush method are very useful in landmark selection for a safe transseptal puncture.

Continuous wave Doppler recordings of the turbulent jet through the restrictive orifice of a left atrial partition in a patient with corrected transposition of the great arteries and cor triatriatum showed alternate bands of high intensity diastolic and low intensity systolic signals with preservation of the normal configuration of the diastolic E and A peaks. It is thought that Doppler studies in cor triatriatum will provide useful complementary haemodynamic information in the echocardiographic diagnosis of this anomaly.

A successful retrieval of a detached segment of a CVP catheter by percutaneous right transfemoral venous route, using a Dotter intravascular retriever basket, is reported. The procedure was monitored under fluoroscopy. Only local anaesthesia, which was infiltrated around the puncture site, was given to the patient. No significant complication was encountered. Successful retrieval of the detached catheter fragment by percutaneous means obviates the need for thoracotomy.