Asia Pacific TAVI registry (an APSIC initiative): initial report of early outcomes: Asia Pacific TAVI registry.

AIMS: The aim of the study was to report the clinical experience, 30-day mortality and acute outcomes of patients undergoing transcatheter aortic valve implantation (TAVI) in the Asia Pacific region. METHODS AND RESULTS: The Asia Pacific TAVI registry is an international, multicentre, prospective, observational registry managed under the auspices of the Asian Pacific Society of Interventional Cardiology (APSIC). Patients undergoing TAVI in seven centres from Hong Kong, Japan, Philippines, Singapore and Taiwan, treated with TAVI devices for severe symptomatic aortic stenosis, were assessed. This first review presents the acute results and 30-day mortality. A multivariable analysis was also performed to identify independent predictors of early all-cause mortality. The enrolment was from 2009 to 2017 and a total of 1,125 patients were recruited. The 30-day mortality rate was 2.5%. Baseline logistic EuroSCORE more than 16 was independently associated with a 2.8-times increased risk of 30-day all-cause mortality (p=0.016). Post-procedural stroke (HR 4.9, p=0.008) was also associated with increased mortality. CONCLUSIONS: This initial report of the Asia Pacific TAVI registry demonstrated good acute success and low 30-day mortality. The preprocedural logistic EuroSCORE and post-procedural stroke incidence were strongly associated with acute mortality. Further attempts to reduce post-procedural stroke should be explored.

Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials.

OBJECTIVES: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. METHODS: The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups. CONCLUSION: In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc.

Propensity score matched all comers population treated with ultra-thin strut bare metal and sirolimus-probucol coated drug-eluting stents of identical stent architecture.

OBJECTIVE: The objective of this study was to compare the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug eluting stent (PF-SES) to its uncoated bare-metal stent (BMS) platform of identical stent architecture. BACKGROUND: Recently published randomized trials comparing BMS to DES with a focus on shortened dual-antiplatelet therapy reported incidences of stent thrombosis (ST) and bleeding complications (LEADERS FREE) in favor of drug eluting stents (DES). METHODS: Data of previously published large-sale, international, single-armed, multicenter, observational studies of ultra-thin PF-SES, and BMS were propensity score (PS) matched for selected lesion morphological and cardiovascular risk factors to compare target lesion revascularization (TLR), myocardial infarction, cardiac death, major adverse cardiac events (MACE), bleeding complications and ST rates. Primary endpoint in both studies was TLR at 9 months. RESULTS: At 9 months the rates of TLR was significantly lower in the PF-SES group as compared with patients treated with the BMS analogue of identical stent design (1.4% vs. 4.6%, P = 0.005). Likewise the 9-month MACE rates were lower in the PF-SES group (3.2% vs. 8.7%, P = 0.001) whereas there were no differences in the accumulated ST rates (0.5% vs. 1.5%, P = 0.109). Overall accumulated bleeding incidences (BARC 1-5) were not significantly different between PF-SES and BMS patients (1.8% vs. 2.7%, p = 0.388). CONCLUSIONS: PF-SES are superior over analogue BMS of identical stent architecture in daily clinical routine with lower rates of TLR and MACE in a PS-matched, unselected patient population without differences in accumulated ST rates and bleeding frequencies given the currently favored postprocedural comedication (ClinicalTrials.gov Identifier NCT02629575).

Updates in the management of Dyslipidaemia in the high and very high risk individual for CV risk reduction

mortality and an important cause of morbidity in Malaysiafor several years. To reduce global cardiovascular (CV) riskin the population, primary preventive strategies need to beimplemented. Hypercholesterolaemia is one of the majorrisk factors for CVD. This paper is an expert review on themanagement of hypercholesterolemia focusing on high andvery high risk individuals. In low and Intermediate riskindividuals, therapeutic lifestyle changes (TLC) and ahealthy lifestyle alone may suffice. In high and very high riskindividuals, drug therapy in conjunction with TLC arenecessary to achieve the target LDL-C levels which havebeen shown to slow down progression and sometimes evenresult in regression of atherosclerotic plaques. Statins arefirst-line drugs because they have been shown in numerousrandomized controlled trials to be effective in reducing CVevents and to be safe. In some high risk individuals, despitemaximally tolerated statin therapy, target Low DensityLipoprotein Cholesterol (LDL-C) levels are not achieved.These include those with familial hypercholesterolaemia andstatin intolerance. This paper discusses non-statintherapies, such as ezetimibe and the newer Proproteinconvertase subtilisin/kexin type 9 Inhibitors (PCSK9-i).

Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials

OBJECTIVES: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. METHODS:The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups...

Acute coronary syndrome in the elderly: the Malaysian National Cardiovascular Disease Database-Acute Coronary Syndrome registry

<p><b>INTRODUCTION</b>The elderly are often underrepresented in clinical trials for acute coronary syndrome (ACS), and cardiologists commonly face management dilemmas in the choice of treatment for this group of patients, particularly concerning the use of invasive revascularisation. This study analysed the characteristics of hospitalised elderly patients with ACS, and compared the outcomes of treatments.</p><p><b>METHODS</b>From 29 December 2005 to 26 April 2010, 13,545 patients were admitted for ACS in 16 hospitals across Malaysia. These patients were divided into two groups - elderly (≥ 65 years) and non-elderly (< 65 years). The clinical characteristics, treatment received (invasive or non-invasive) and outcomes (in-hospital and 30-day all-cause mortality) of the two groups were compared. The elderly patients were then grouped according to the type of treatment received, and the outcomes of the two subgroups were compared.</p><p><b>RESULTS</b>Elderly patients had a higher cardiovascular risk burden and a higher incidence of comorbidities. They were less likely to receive urgent revascularisation for acute ST-segment elevation myocardial infarction (elderly: 73.9% vs. non-elderly: 81.4%) and had longer door-to-needle time (elderly: 60 minutes vs. non-elderly: 50 minutes, p = 0.004). The rate of cardiac catheterisation was significantly lower in the elderly group across all ACS strata. Elderly patients had poorer outcomes than non-elderly patients, but those who received invasive treatment appeared to have better outcomes than those who received non-invasive treatment.</p><p><b>CONCLUSION</b>Elderly patients with ACS tend to be undertreated, both invasively and pharmacologically. Invasive treatment seems to yield better outcomes for this group of patients.</p>

Prevalence And Risk Factors Of Premature Coronary Artery Disease: A Comparative Cross-Sectional Study Between Two Time Frames In Malaysia

Limited studies on prevalence and risk factors of Premature Coronary Artery Disease (PCAD) were done in Malaysia, primarily on lipid profile. This cross sectional study aims to identify any changing patterns in prevalence and risk factors of Premature CAD between 2000 and 2012. From 2000 to 2012 we included 21862 patients who underwent the first Percutaneous Coronary Intervention (PCI). Analysis of risk factors was done to 1660 and 2098 patients from year 2007 and 2012 respectively. Age of less than 45 years was taken as PCAD. Data was collected from PCI database of National Heart Institute (NHI), NHI TrakCare System, and patients’ medical records. PCAD significantly decreased from 18.8% (2000) to 11.6% (2012). Malay ethnicity showed increasing trend over the years from 55.1% to 66.9%. Multiple logistic regression analysis in 2007 showed that smoking had the higher risk (AOR=2.52), followed by male gender (AOR=2.06), family history of PCAD (AOR=1.96), Indian ethnicity, (AOR=1.65), triglycerides level (AOR=1.20) and BMI (AOR=1.06). In 2012, family history of PCAD had the highest risk (AOR=2.00) followed by smoking (AOR=1.91) and BMI (AOR=1.11). There are changes in risk factors patterns of premature CAD between 2007 and 2012. Most of them are preventable at earlier stage.

The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture stent with a paclitaxel-eluting stent.

OBJECTIVES: This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months. BACKGROUND: Drug-eluting stents have limited restenosis and reintervention but are complicated by especially late and very late stent thrombosis and accelerated neoatherosclerosis. Alternative or adjunct technologies should address these limitations. METHODS: One hundred eighty-three patients with de novo native coronary artery stenoses were randomized 2:1 to Combo stent or PES implantation. The primary endpoint is the angiographic in-stent late lumen loss at 9 months, which was tested for noninferiority between the 2 stent groups. Secondary endpoints include the occurrence of major adverse cardiac events. RESULTS: The Combo stent was found to be noninferior to the PES in 9-month angiographic in-stent late lumen loss with 0.39 ± 0.45 mm versus 0.44 ± 0.56 mm (pnoninferiority = 0.0012). At 12 months, the occurrence of major adverse cardiac events was 8.9% in the Combo group and 10.2% in the PES group (p = 0.80) with no difference in mortality, occurrence of myocardial infarction, or target lesion revascularization. No stent thrombosis was reported in either group. CONCLUSIONS: In the REMEDEE trial the Combo stent has shown to be effective by meeting the primary noninferiority angiographic endpoint and safe, with an overall low rate of clinical events in both stent groups, including no stent thrombosis up to 12 months.

Recurrent in-stent restenosis with total occlusion remedied with drug-eluting balloon angioplasty.

We report a 69 year old female who presented with chest pain to the Emergency Department of the National Heart Institute Malaysia. Her history revealed that she had had 2 separate episodes of chest pain beginning in 2002, resulting in total occlusion of her mid left anterior descending artery (LAD) requiring percutaneous coronary intervention and stenting on both occasions. Cine angiogram on her current admission revealed recurrent target lesion in-stent restenosis with total occlusion of the distal LAD. Intravascular ultrasound revealed multilayered suboptimally deployed stents in the LAD. Successive drug-eluting balloon deployments resulted in sustained patency of the LAD after 1 year.