The Asia Renal Denervation Consortium consensus conference of Asian physicians actively performing renal denervation (RDN) was recently convened to share up-to-date information and regional ...perspectives, with the goal of consensus on RDN in Asia. First- and second-generation trials of RDN have demonstrated the efficacy and safety of this treatment modality for lowering blood pressure in patients with resistant hypertension. Considering the ethnic differences of the hypertension profile and demographics of cardiovascular disease demonstrated in the SYMPLICITY HTN (Renal Denervation in Patients With Uncontrolled Hypertension)-Japan study and Global SYMPLICITY registry data from Korea and Taiwan, RDN might be an effective hypertension management strategy in Asia. Patient preference for device-based therapy should be considered as part of a shared patient-physician decision process. A practical population for RDN treatment could consist of Asian patients with uncontrolled essential hypertension, including resistant hypertension. Opportunities to refine the procedure, expand the therapy to other sympathetically mediated diseases, and explore the specific effects on nocturnal and morning hypertension offer a promising future for RDN. Based on available evidence, RDN should not be considered a therapy of last resort but as an initial therapy option that may be applied alone or as a complementary therapy to antihypertensive medication.
The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB).
There is increasing clinical ...evidence for the treatment of coronary de novo disease using drug-coated balloons. However, it is unclear whether paclitaxel remains the drug of choice or if sirolimus is an alternative, in analogy to drug-eluting stents.
Seventy patients with coronary de novo lesions were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, B. Braun Melsungen; 4 μg/mm2) with a PCB (SeQuent Please, B. Braun Melsungen; 3 μg/mm2). The primary endpoint was angiographic late lumen loss (LLL) at 6 months. Secondary endpoints included major adverse cardiovascular events and individual clinical endpoints such as cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis.
Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment LLL was 0.01 ± 0.33 mm in the PCB group versus 0.10 ± 0.32 mm in the SCB group. The mean difference between SCB and PCB was 0.08 (95% CI: −0.07 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. However, negative LLL was more frequent in the PCB group (60% of lesions vs 32% in the SCB group; P = 0.019). Major adverse cardiovascular events up to 12 months also did not differ between the groups.
This first-in-human comparison of a novel SCB with a crystalline coating showed similar angiographic outcomes in the treatment of coronary de novo disease compared with a clinically proven PCB. However, late luminal enlargement was more frequently observed after PCB treatment. (Treatment of Coronary De-Novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia SCBDNMAL; NCT04017364)
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Routine coagulation tests do not enable rapid, accurate determination of direct oral anticoagulant (DOAC) therapy. The ecarin clotting assay (ECA), performed on the ClotPro viscoelastic testing ...device, may enable sensitive and specific detection of dabigatran. We assessed the association between trough plasma dabigatran concentration and clotting time (CT) in the ClotPro ECA, in patients with non-valvular atrial fibrillation (NVAF). Each patient provided a single venous blood sample, ∼1 hour before dabigatran dosing. The study included 118 patients, of whom 64 were receiving dabigatran 110 mg twice daily and 54 were receiving 150 mg twice daily. ECA CT was moderately correlated with trough plasma dabigatran concentration (r = 0.80, p < 0.001). Slight trends toward increased plasma dabigatran concentration and prolonged ECA CT were apparent with 150 mg versus the 110 mg dose (differences not statistically significant). Individuals with creatinine clearance below 50 mL/minute had significantly higher plasma dabigatran concentrations and significantly prolonged ECA CT versus those with creatinine clearance ≥50 mL/minute. In conclusion, this preliminary study has demonstrated that CT in the ClotPro ECA reflects the plasma concentration of dabigatran in patients with NVAF. The ECA could potentially be used to assess the impact of dabigatran on a patient’s coagulation status.
Cardiovascular diseases account for approximately half of all deaths in Asia. The present analysis aimed to evaluate characteristics, antithrombotic management patterns (AMPs), and outcomes in ...patients with acute coronary syndrome (ACS) who underwent in-hospital percutaneous coronary intervention (PCI) and survived to hospital discharge, using data from the EPICOR Asia registry (NCT01361386).
Two-year post-discharge follow-up data were analyzed from 8757 ACS PCI patients from EPICOR Asia (218 centers, eight countries). Major adverse cardiovascular events (MACE; death, non-fatal myocardial infarction MI, non-fatal ischemic stroke), PCI characteristics, and AMPs were recorded. For MACE, time - to - event was analyzed using Cox regression.
Primary PCI was performed in 62.0% of ST-segment elevation MI (STEMI), 38.7% of non-STEMI (NSTEMI), and 24.2% of unstable angina (UA) patients. At 12 months, 88.1% of patients were on dual antiplatelet therapy (DAPT), with no differences by index event. Most (61.5%) still received DAPT at 2 years. Two-year incidences of mortality, composite MACE, and bleeding were 3.6%, 6.2%, and 6.6%, respectively. Risk of death and MACE was increased with STEMI and NSTEMI vs. UA. Patients from East Asia showed lower mortality and more bleeding vs. Southeast Asia/India.
Many patients in EPICOR Asia underwent PCI and received DAPT up to 2 years post-discharge. These real-world findings improve our understanding of AMP impact on outcomes in Asian patients with ACS undergoing PCI.
•In EPICOR Asia, primary PCI was performed in 8757 ACS survivors, mostly for STEMI.•At 1 and 2 years post discharge, 88.1% and 61.5%, respectively, were on DAPT.•Two-year risk of death and MACE was increased with STEMI and NSTEMI vs. UA.•East Asia patients showed lower mortality and more bleeding vs. Southeast Asia/India.
The COMBO stent (OrbusNeich Medical, Ft. Lauderdale, Florida) is a new-generation bio-engineered drug eluting stent, combining an abluminal coating of a bioabsorbable polymer matrix for sustained ...release of sirolimus and luminal anti-CD34 coating for endothelial progenitor cell capture and rapid endothelialization.
The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014–May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization.
A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12).
The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST.
NCT02183454.
•The COMBO stent is a new-generation drug eluting stent (DES) combining sirolimus elution and endothelial progenitor cell capture for rapid endothelialization.•The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry enrolled 2614 patients with attempted COMBO stent implantation across 60 centers globally.•COMBO DES was associated with low rates of 1-year TLF, ST and MACE with high rates of device and procedural success.
BACKGROUND AND OBJECTIVESHeart failure (HF) poses substantial economic burden, primarily driven by high hospitalization and mortality rates. This study aimed to understand the economic burden of HF ...in 4 Asian countries under varying healthcare systems. METHODSThis was a non-interventional, retrospective study conducted in South Korea, Taiwan, Thailand and Malaysia through medical chart review. Eligible patients included those who had either ≥1 hospitalization or ≥2 outpatient visits from January 1st to December 31st, 2014, and at least one year of follow-up. Resource use and direct healthcare costs (adjusted to 2015 USD) of HF were assessed. HF costs for subgroups stratified by age and sex were assessed. RESULTSA total of 568 patients were recruited from South Korea (n=200), Taiwan (n=200), Thailand (n=100) and Malaysia (n=68). The proportion of patients hospitalized ranged from 20.0% to 93.5% (South Korea 20.0%, Thailand 49.0%, Malaysia 70.6%, and Taiwan 93.5%). The overall annual HF cost per patient was $2,357, $4,513, $3,513 and $1,443 in South Korea, Taiwan, Thailand, and Malaysia, respectively; hospitalized HF care costs were $10,714, $4,790, $7,181 and $1,776, respectively. The length of stay was more than 12.2 days except in Malaysia. No specific trend was observed in subgroup analysis. CONCLUSIONSIn Asia, HF poses significant economic burden and hospitalization has emerged as the major cost driver among healthcare costs. A streamlined treatment strategy reducing hospitalization rate can minimize the economic burden.
Long-term comparative outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stents and coronary artery bypass grafting (CABG) are limited in patients with multivessel ...coronary artery disease.
This prospective, multicenter, randomized controlled trial was conducted in 27 international heart centers and was designed to randomly assign 1776 patients with angiographic multivessel coronary artery disease to receive PCI with everolimus-eluting stents or CABG. After inclusion of 880 patients (438 in the PCI group and 442 in the CABG group) between July 2008 and September 2013, the study was terminated early because of slow enrollment. The primary end point was the composite of death from any cause, myocardial infarction, or target vessel revascularization.
During a median follow-up of 11.8 years (interquartile range, 10.6-12.5 years; maximum, 13.7 years), the primary end point occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio HR, 1.18 95% CI, 0.88-1.56;
=0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%; HR, 1.07 95% CI, 0.75-1.53;
=0.70), as well as the occurrence of death from any cause (20.5% and 19.9%; HR, 1.04 95% CI, 0.65-1.67;
=0.86). However, spontaneous myocardial infarction (7.1% and 3.8%; HR, 1.86 95% CI, 1.06-3.27;
=0.031) and any repeat revascularization (22.6% and 12.7%; HR, 1.92 95% CI, 1.58-2.32;
<0.001) were more frequent after PCI than after CABG.
In patients with multivessel coronary artery disease, there were no significant differences between PCI and CABG in the incidence of major adverse cardiac events, the safety composite end point, and all-cause mortality during the extended follow-up.
URL: https://www.
gov; Unique identifiers: NCT05125367 and NCT00997828.
Coronary artery disease (CAD) is currently the leading cause of death globally, and the prevalence of this disease is growing more rapidly in the Asia-Pacific region than in Western countries. ...Although the use of metal coronary stents has rapidly increased thanks to the advancement of safety and efficacy of newer generation drug eluting stent (DES), patients are still negatively affected by some the inherent limitations of this type of treatment, such as stent thrombosis or restenosis, including neoatherosclerosis, and the obligatory use of dual antiplatelet therapy (DAPT) with unknown optimal duration. Drug-coated balloon (DCB) treatment is based on a leave-nothing-behind concept and therefore it is not limited by stent thrombosis and long-term DAPT; it directly delivers an anti-proliferative drug which is coated on a balloon after improving coronary blood flow. At present, DCB treatment is recommended as the first-line treatment option in metal stent-related restenosis linked to DES and bare metal stent. For de novo coronary lesions, the application of DCB treatment is extended further, for conditions such as small vessel disease, bifurcation lesions, and chronic total occlusion lesions, and others. Recently, several reports have suggested that fractional flow reserve guided DCB application was safe for larger coronary artery lesions and showed good long-term outcomes. Therefore, the aim of these recommendations of the consensus group was to provide adequate guidelines for patients with CAD based on objective evidence, and to extend the application of DCB to a wider variety of coronary diseases and guide their most effective and correct use in actual clinical practice.
The increasing disease burden of coronary artery disease (CAD) calls for sustainable cardiac service. Teaching hospitals and general hospitals in Malaysia are main providers of percutaneous coronary ...intervention (PCI), a common treatment for CAD. Few studies have analyzed the contemporary data on local cardiac facilities. Service expansion and budget allocation require cost evidence from various providers. We aim to compare the patient characteristics, procedural outcomes, and cost profile between a teaching hospital (TH) and a general hospital (GH).
This cross-sectional study was conducted from the healthcare providers' perspective from January 1st to June 30th 2014. TH is a university teaching hospital in the capital city, while GH is a state-level general hospital. Both are government-funded cardiac referral centers. Clinical data was extracted from a national cardiac registry. Cost data was collected using mixed method of top-down and bottom-up approaches. Total hospitalization cost per PCI patient was summed up from the costs of ward admission and cardiac catheterization laboratory utilization. Clinical characteristics were compared with chi-square and independent t-test, while hospitalization length and cost were analyzed using Mann-Whitney test.
The mean hospitalization cost was RM 12,117 (USD 3,366) at GH and RM 16,289 (USD 4,525) at TH. The higher cost at TH can be attributed to worse patients' comorbidities and cardiac status. In contrast, GH recorded a lower mean length of stay as more patients had same-day discharge, resulting in 29% reduction in mean cost of admission compared to TH. For both hospitals, PCI consumables accounted for the biggest proportion of total cost.
The high PCI consumables cost highlighted the importance of cost-effective purchasing mechanism. Findings on the heterogeneity of the patients, treatment practice and hospitalization cost between TH and GH are vital for formulation of cost-saving strategies to ensure sustainable and equitable cardiac service in Malaysia.
Key Clinical Message
The high‐risk “Shark Fin” electrocardiogram (ECG) pattern has been associated with transmural ischemia but can also result from electrolyte anomalies. Therefore, the decision for ...invasive coronary catheterization requires a detailed history and dedicated biochemical tests.
Pseudo‐infarction ECG pattern resembling “Shark Fin” was demonstrated in a 76‐year‐old lady with a previous total thyroidectomy who presented with unspecific symptoms. An incidental finding of hypokalemia and hypocalcemia was thought to be related to delayed onset hypoparathyroidism. Potential etiologies like coronary vasospasm and catecholamine‐associated myocardial injury were suggested.
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