Evaluating the budget impact of Empagliflozin in managing heart failure with reduced ejection fraction: Proposing strategic policies for Malaysian public healthcare.

Sodium-glucose co-transporter-2 (SGLT2) inhibitors such as Empagliflozin, are increasingly recommended as part of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) in many developed nations. This recommendation is based on robust clinical evidence showing that adding Empagliflozin to GDMT improves heart failure symptoms, clinical outcomes, functional status, and overall quality of life. In Malaysia, where healthcare is predominantly public and heavily subsidized, the introduction of new treatments can significantly impact costs, requiring detailed economic assessments. This study evaluates the budget impact of incorporating Empagliflozin into GDMT for HFrEF from the perspective of the public healthcare system. A five-year budget impact model was developed, integrating local data such as population, drug use, costs, clinical outcomes, and healthcare expenses. In the current scenario (GDMT alone), the projected five-year expenditure is MYR 6.12 billion (USD 3.92 billion). With Empagliflozin, the total cost rises by 0.71% to MYR 6.16 billion (USD 3.95 billion), driven by drug acquisition costs of MYR 160.12 million (USD 102.64 million) and adverse event costs of MYR 211,543 (USD 135,604). However, these costs are offset by savings from reduced HF hospitalizations, fewer cardiovascular deaths, and improved renal outcomes. Sensitivity analysis identified hospitalization costs, the price of Empagliflozin, and cardiovascular deaths in diabetic patients as key factors influencing the budget impact. Policymakers can improve the affordability of Empagliflozin through strategies like price negotiations, cost-sharing, and focusing on high-risk groups to optimize healthcare expenditure while ensuring effective treatment access.

Risk factors for mortality in post-myocardial infarction patients: insights from the improve SCA bridge study.

BACKGROUND: Underutilization of implantable cardioverter defibrillators (ICD) to prevent sudden cardiac death (SCD) in post-myocardial infarction (MI) patients remains an issue across several geographies. A better understanding of risk factors for SCD in post-MI patients from regions with low ICD adoption rates will help identify those who will benefit from an ICD. This analysis assessed risk factors for all-cause and cardiovascular-related mortality in post-MI patients from the Improve Sudden Cardiac Arrest (SCA) Bridge Trial. RESULTS: For the entire cohort, the overall 1-year mortality rate was 5.9% (88/1491) and 3.4% (51/1491) for all-cause and cardiovascular mortality, respectively, with 76.5% of all cardiac deaths being from SCD. A multivariate model determined increased age, reduced left ventricular ejection fraction (LVEF), increased time from myocardial infarction to hospital admission, being female, being from Southeast Asia (SEA), and having coronary artery disease to be significant risk factors for all-cause mortality. The risk factors for cardiovascular-related mortality revealed increased age, reduced LVEF, and being from SEA as significant risk factors. CONCLUSIONS: We show several characteristics as being predictors of cardiovascular-related mortality in post-MI patients from the Improve SCA Bridge study. Patients who experience an MI and present with these characteristics would benefit from a referral to an electrophysiologist for further SCD risk stratification and management and possible subsequent ICD implantation to reduce unnecessary death.

Impact of Drug-Coated Balloon-Based Revascularization in Patients with Chronic Total Occlusions.

Background: Percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) for chronic total coronary occlusions (CTOs) improves clinical symptoms and quality of life. However, data on drug-coated balloon (DCB)-based PCI in CTO lesions are limited. Methods: A total of 200 patients were successfully treated for CTO lesions, either with DCB alone or in combination with DES (DCB-based PCI). They were compared with 661 patients who underwent second-generation DES implantation for CTO from the PTRG-DES registry (DES-only PCI). The endpoint was major adverse cardiovascular events (MACEs), which included a composite of cardiac death, myocardial infarction, stent or target lesion thrombosis, target vessel revascularization, and major bleeding at 2 years. Results: In the DCB-based PCI group, 49.0% of patients were treated with DCB only and 51.0% underwent the hybrid approach combining DCB with DES. Bailout stenting was performed in seven patients (3.5%). The DCB-based PCI group exhibited fewer stents (1.0; IQR: 0.0-1.0 and 2.0; IQR: 1.0-3.0, p < 0.001), shorter stent lengths (6.5 mm; IQR: 0.0-38.0 mm and 42.0 mm; IQR: 28.0-67.0 mm, p < 0.001), and lower usage of small stents with a diameter of 2.5 mm or less (9.8% and 36.5%, p < 0.001). Moreover, the DCB-based PCI group had a lower rate of MACEs than the DES-only PCI group (3.1% and 13.2%, p = 0.001) at 2-year follow-up. Conclusions: The DCB-based PCI approach significantly reduced the stent burden, particularly in the usage of small stent diameters, and resulted in a lower risk of MACEs compared to DES-only PCI in CTO lesions.

Characteristics of patients admitted with heart failure: Insights from the first Malaysian Heart Failure Registry.

AIMS: Heart failure (HF) is a growing health problem, yet there are limited data on patients with HF in Malaysia. The Malaysian Heart Failure (MY-HF) Registry aims to gain insights into the epidemiology, aetiology, management, and outcome of Malaysian patients with HF and identify areas for improvement within the national HF services. METHODS AND RESULTS: The MY-HF Registry is a 3-year prospective, observational study comprising 2717 Malaysian patients admitted for acute HF. We report the description of baseline data at admission and outcomes of index hospitalization of these patients. The mean age was 60.2 ± 13.6 years, 66.8% were male, and 34.3% had de novo HF. Collectively, 55.7% of patients presented with New York Heart Association (NYHA) Class III or IV; ischaemic heart disease was the most frequent aetiology (63.2%). Most admissions (87.3%) occurred via the emergency department, with 13.7% of patients requiring intensive care, and of these, 21.8% needed intubation. The proportion of patients receiving guideline-directed medical therapy increased at discharge (84.2% vs. 93.6%). The median length of stay (LOS) was 5 days, and in-hospital mortality was 2.9%. Predictors of LOS and/or in-hospital mortality were age, NYHA class, estimated glomerular filtration rate, and comorbid anaemia. LOS and in-hospital mortality were similar regardless of ejection fraction. CONCLUSIONS: The MY-HF Registry showed that the HF population in Malaysia is younger, predominantly male, and ischaemic-driven and has good prospects with hospitalization for optimization of treatment. These findings suggest a need to reassess current clinical practice and guide resource allocation to improve patient outcomes.

From Primary to Tertiary Care: Expert Position Statements to Guide Heart Failure with Preserved Ejection Fraction Diagnosis.

Globally, heart failure with preserved ejection fraction (HFpEF) is quickly becoming the dominant form of heart failure (HF) in ageing populations. However, there are still multiple gaps and challenges in making a firm diagnosis of HFpEF in many low-to-middle income Asian countries. In response to this unmet need, the Malaysian HFpEF Working Group (MY-HPWG) gathered and reviewed evidence surrounding the use of different diagnostic modalities indicated for patients with HFpEF to identify diagnostic tools that could be conveniently accessed across different healthcare settings. As a result, five recommendation statements were proposed and an accompanying algorithm was developed, with the aim of improving the diagnostic rate of HFpEF. The MY-HPWG recommends using more easily accessible and non-invasive tools, such as natriuretic peptide (NP) biomarkers and basic echocardiogram (ECHO), to ensure timely HFpEF diagnosis in the primary and secondary care settings, and prompt referral to a tertiary care centre for more comprehensive assessments in uncertain cases.

Improve the Prevention of Sudden Cardiac Arrest in Patients With Post-Acute Myocardial Infarction.

Background: Implantable cardioverter-defibrillator (ICD) implantation to prevent sudden cardiac death (SCD) in post-myocardial infarction (MI) patients varies by geography but remains low in many regions despite guideline recommendations. Objectives: This study aimed to characterize the care pathway of post-MI patients and understand barriers to referral for further SCD risk stratification and management in patients meeting referral criteria. Methods: This prospective, nonrandomized, multi-nation study included patients ≥18 years of age, with an acute MI ≤30 days and left ventricular ejection fraction <50% ≤14 days post-MI. The primary endpoint was defined as the physician's decision to refer a patient for SCD stratification and management. Results: In total, 1,491 post-MI patients were enrolled (60.2 ± 12.0 years of age, 82.4% male). During the study, 26.7% (n = 398) of patients met criteria for further SCD risk stratification; however, only 59.3% of those meeting criteria (n = 236; 95% CI: 54.4%-64.0%) were referred for a visit. Of patients referred for SCD risk stratification and management, 94.9% (n = 224) attended the visit of which 56.7% (n =127; 95% CI: 50.1%-63.0%) met ICD indication criteria. Of patients who met ICD indication criteria, 14.2% (n = 18) were implanted. Conclusions: We found that ∼40% of patients meeting criteria were not referred for further SCD risk stratification and management and ∼85% of patients who met ICD indications did not receive a guideline-directed ICD. Physician and patient reasons for refusing referral to SCD risk stratification and management or ICD implant varied by geography suggesting that improvement will require both physician- and patient-focused approaches. (Improve Sudden Cardiac Arrest [SCA] Bridge Study; NCT03715790).

Cost analysis of chronic heart failure management in Malaysia: A multi-centred retrospective study.

Background: Estimation of the economic burden of heart failure (HF) through a complete evaluation is essential for improved treatment planning in the future. This estimation also helps in reimbursement decisions for newer HF treatments. This study aims to estimate the cost of HF treatment in Malaysia from the Ministry of Health's perspective. Materials and methods: A prevalence-based, bottom-up cost analysis study was conducted in three tertiary hospitals in Malaysia. Chronic HF patients who received treatment between 1 January 2016 and 31 December 2018 were included in the study. The direct cost of HF was estimated from the patients' healthcare resource utilisation throughout a one-year follow-up period extracted from patients' medical records. The total costs consisted of outpatient, hospitalisation, medications, laboratory tests and procedure costs, categorised according to ejection fraction (EF) and the New York Heart Association (NYHA) functional classification. Results: A total of 329 patients were included in the study. The mean ± standard deviation of total cost per HF patient per-year (PPPY) was USD 1,971 ± USD 1,255, of which inpatient cost accounted for 74.7% of the total cost. Medication costs (42.0%) and procedure cost (40.8%) contributed to the largest proportion of outpatient and inpatient costs. HF patients with preserved EF had the highest mean total cost of PPPY, at USD 2,410 ± USD 1,226. The mean cost PPPY of NYHA class II was USD 2,044 ± USD 1,528, the highest among all the functional classes. Patients with underlying coronary artery disease had the highest mean total cost, at USD 2,438 ± USD 1,456, compared to other comorbidities. HF patients receiving angiotensin-receptor neprilysin-inhibitor (ARNi) had significantly higher total cost of HF PPPY in comparison to patients without ARNi consumption (USD 2,439 vs. USD 1,933, p < 0.001). Hospitalisation, percutaneous coronary intervention, coronary angiogram, and comorbidities were the cost predictors of HF. Conclusion: Inpatient cost was the main driver of healthcare cost for HF. Efficient strategies for preventing HF-related hospitalisation and improving HF management may potentially reduce the healthcare cost for HF treatment in Malaysia.

Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions.

BACKGROUND: Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis. METHODS: One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 µg/mm²) with the clinically proven PCB (SeQuent Please, 3 µg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. RESULTS: Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups. CONCLUSIONS: This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02996318, NCT03242096.

Clinical recommendations to diagnose and monitor patients with transthyretin amyloid cardiomyopathy in Asia.

Transthyretin amyloid cardiomyopathy (ATTR-CM) is a debilitating and life-threatening condition with a heterogeneous clinical presentation. Recent guidelines from the United States and Europe have been published to guide clinical practice and to facilitate management conformity by covering current diagnostic and treatment strategies for patients with ATTR-CM. These guidelines highlight the importance of an early diagnosis to optimize therapeutic outcomes, specifying the use of tests and imaging techniques to allow accurate, noninvasive diagnosis of ATTR-CM. However, as regional practice variations across Asia may limit access to healthcare, availability of specific tests, and expertise in assessing diagnostic images, there is an ongoing need to provide an Asian perspective on these clinical guidelines. This review article provides practical recommendations for the diagnosis and monitoring of patients with ATTR-CM in Asia, highlighting the need for additional guidelines to support a broad and diverse population, consider differing healthcare systems and diagnostic testing availability, and provide a flexible yet robust algorithm.

Clinical Outcomes of Drug-Coated Balloon Treatment After Successful Revascularization of de novo Chronic Total Occlusions.

Background: The safety and efficacy of drug-coated balloon (DCB) treatment for de novo coronary chronic total occlusion (CTO) remain uncertain. The aim of this study was to evaluate the outcomes of DCB only treatment for de novo CTO. Methods: In this retrospective study, 101 vessels with de novo CTO lesions dilated by balloon angioplasty with thrombolysis in myocardial infarction flow grade 3 were included. Among them, 93 vessels successfully treated with DCB only treatment were analyzed. The study endpoint was major adverse cardiac events (MACE) at 2 years, a composite of cardiac death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR), and target vessel thrombosis. The secondary endpoint was late lumen loss (LLL) on follow-up coronary angiography. Results: All 84 patients were followed up clinically, and 67 vessels underwent scheduled coronary angiography after 6 months. There were no procedural complications, and three vessels required bailout-stenting. The median follow-up was 720 days (interquartile range [IQR]; 406-1,268 days). MACE occurred in 8.3% of the patients after 1 year, including cardiac death (1.2%), TVR (7.1%), and no non-fatal MI and target vessel thrombosis. Two years after treatment, MACE occurred in 16.7% of the patients, including cardiac death (2.4%), non-fatal MI (3.6%), TVR (13.1%), and no target vessel thrombosis. The mean LLL was 0.03 ± 0.53 mm. Binary restenosis occurred in 14.9% of the treated vessels, and 3.0% of the vessels had late re-occlusion on follow-up coronary angiography. Conclusions: If the result of revascularization using balloon angioplasty is good, the clinical outcomes of DCB only treatment of de novo CTOs at the 2-year follow-up are encouraging, with a low rate of hard endpoints and acceptable MACE rates (Clinical Trial Registration Information; Impact of Drug-coated Balloon Treatment in de novo Coronary Lesion; NCT04619277).

Trends for Readmission and Mortality After Heart Failure Hospitalisation in Malaysia, 2007 to 2016.

Background and objectives: Data on population-level outcomes after heart failure (HF) hospitalisation in Asia is sparse. This study aimed to estimate readmission and mortality after hospitalisation among HF patients and examine temporal variation by sex and ethnicity. Methods: Data for 105,399 patients who had incident HF hospitalisations from 2007 to 2016 were identified from a national discharge database and linked to death registration records. The outcomes assessed here were 30-day readmission, in-hospital, 30-day and one-year all-cause mortality. Results: Eighteen percent of patients (n = 16786) were readmitted within 30 days. Mortality rates were 5.3% (95% confidence interval (CI) 5.1-5.4%), 11.2% (11.0-11.4%) and 33.1% (32.9-33.4%) for in-hospital, 30-day and 1-year mortality after the index admission. Age, sex and ethnicity-adjusted 30-day readmissions increased by 2% per calendar year while in-hospital and 30-day mortality declined by 7% and 4% per year respectively. One-year mortality rates remained constant during the study period. Men were at higher risk of 30-day readmission (adjusted rate ratio (RR) 1.16, 1.13-1.20) and one-year mortality (RR 1.17, 1.15-1.19) than women. Ethnic differences in outcomes were evident. Readmission rates were equally high in Chinese and Indians relative to Malays whereas Others, which mainly comprised Indigenous groups, fared worst for in-hospital and 30-day mortality with RR 1.84 (1.64-2.07) and 1.3 (1.21-1.41) relative to Malays. Conclusions: Short-term survival was improving across sex and ethnic groups but prognosis at one year after incident HF hospitalisation remained poor. The steady increase in 30-day readmission rates deserves further investigation.

Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon.

OBJECTIVES: 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). BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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).

Coronary artery aneurysm formation after paclitaxel-coated balloon-only intervention for de novo coronary chronic total occlusion.

Background: Although coronary artery aneurysm (CAA) is an uncommon complication of drug-coated balloon (DCB) treatment, the incidence and mechanisms CAA formation after DCB intervention for chronic total occlusion (CTO) remains to be clarified. The aim of this study was to investigate the incidence of CAA after DCB intervention for the treatment of CTO of coronary arteries. Materials and methods: This was a retrospective analysis of 82 patients, contributing 88 vessels, who underwent successful DCB-only treatment for de novo CTO lesions. Follow-up angiography was performed in all cases, at a mean 208.5 (interquartile range [IQR]: 174.8 to 337.5) days after the index procedure. Results: CAA was identified in seven vessels, in seven patients, at the site of previous successful DCB-only treatment. Of these, six were fusiform in shape and one saccular, with a mean diameter of 4.2 ± 1.0 mm and length of 6.7 ± 2.6 mm. Six CAAs developed at the CTO inlet site, and all CAAs occurred at the lesions following dissection immediately after DCB treatment. CAAs were not associated with an increased risk of major clinical events over the median follow-up of 676.5 (IQR: 393.8 to 1,304.8) days. Conclusion: The incidence of CAA after DCB-only treatment for CTO lesions was 8.0% in this study. Further research is warranted, using intravascular imaging, to clarify the mechanism of DCB-related CAA formation and prognosis.

Economic Burden of Heart Failure in Asian Countries with Different Healthcare Systems.

BACKGROUND AND OBJECTIVES: Heart 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. METHODS: This 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. RESULTS: A 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. CONCLUSIONS: In 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.

Incidence and Determinants of Acute Mountain Sickness in Mount Kinabalu, Malaysia.

Background: Acute mountain sickness (AMS) is the most common type of high-altitude sickness. The incidence of AMS varies by mountain location, trail characteristics, and study design. The lack of local epidemiology data has driven us to investigate the incidence and severity of AMS and its associated factors at Mount Kinabalu, Malaysia. Methods: A cohort study was conducted to collect data from climbers after days 1 (3272 m) and 2 (4095 m) of ascent. A self-administered questionnaire was used to explore climbers' demographic and climb characteristics, history of AMS, alcohol exposure, and AMS prevention measures. The Lake Louis score 2018 was used to assess the presence and severity of AMS (cutoff ≥3). Univariate and multivariable logistic regressions were performed to determine the factors associated with the development of AMS on day 2. Results: Data from 345 climbers were analyzed. The incidence of AMS was 23.9% (95% confidence interval [CI] 19.5%-28.7%) and 21.7% (95% CI 17.5%-26.3%) on days 1 and 2, respectively. The majority were mild cases. Experiencing AMS on day 1 (odds ratio [OR] = 12.88; 95% CI 6.71-24.75), alcohol consumption (OR = 3.73; 95% CI 1.66-8.39), receiving guide advice on day 1 (OR = 0.49; 95% CI 0.26-0.93), and age (OR = 0.96; 95% CI 0.93-0.99) were significant determinants of AMS at Mount Kinabalu. Gender, history of AMS, past exposure to high altitude, ascending time, water intake, acetazolamide use, physical fitness, pulse rate, and peripheral capillary oxygen saturation (SpO2) were not associated with AMS at Mount Kinabalu. Conclusion: Future analysis with age strata is required to ascertain the association of age with AMS. Our research has signposted a strong call for collaborative efforts to improve the provision of hiking advice and discourage alcohol sales to mitigate the risk of AMS among Mount Kinabalu climbers.

Comparison of One-Year Outcomes in Patients >75 Versus ≤75 Years With Coronary Artery Disease Treated With COMBO Stents (From The MASCOT Registry).

Older patients who undergo coronary interventions are at greater risk of ischemic events and less likely to tolerate prolonged dual antiplatelet therapy (DAPT) due to bleeding risk. The COMBO biodegradable polymer sirolimus-eluting stent promotes rapid endothelialization through endothelial progenitor cell capture technology which may be advantageous in elderly patients. We compared 1-year clinical outcomes and DAPT cessation events in patients >75 versus ≤75 years from the MASCOT registry. MASCOT was a prospective, multicenter cohort study of all-comers undergoing attempted COMBO stenting. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a nontarget vessel or clinically driven target lesion revascularization. Bleeding was adjudicated using the Bleeding Academic Research Consortium criteria. Adjusted outcomes were analyzed using Cox regression methods. The study included 18% (n = 479) patients >75 years and 72% (n = 2,135) patients ≤75 years. One-year TLF occurred in 4.6% patients >75 years versus 3.1% patients ≤75years of age, p = 0.10; adj hazard ratio 1.36, 95% confidence intervals 0.77 to 2.38, p = 0.29. There were no significant differences in cardiac death (1.7% vs 1.3%, p = 0.55), MI (2.1% vs 1.2%, p = 0.14), target lesion revascularization (1.7% vs 1.4%, p = 0.60) and definite stent thrombosis (0.8% vs 0.4%, p = 0.19). Major Bleeding Academic Research Consortium 3,5 bleeding (3.1% vs 1.5%, p = 0.01) and DAPT cessation rates (32.4% vs 23.0%, p <0.001) were significantly higher in elderly patients. In conclusion, elderly patients >75 years treated with COMBO stents had similar TLF but significantly greater incidence of bleeding than younger patients and DAPT cessation in one-third of patients over 1 year.

1-year results after PCI with the COMBO stent in all-comers in Asia versus Europe: Geographical insights from the COMBO collaboration.

BACKGROUND: The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer with an anti-CD34+ antibody coating for early endothelialization. OBJECTIVE: We investigated for geographical differences in outcomes after percutaneous coronary intervention (PCI) with the COMBO stent among Asians and Europeans. METHODS: The COMBO Collaboration is a pooled patient-level analysis of the MASCOT and REMEDEE registries of all-comers undergoing attempted COMBO stent PCI. The primary outcome was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR). RESULTS: This study included 604 Asians (17.9%) and 2775 Europeans (82.1%). Asians were younger and included fewer females, with a higher prevalence of diabetes mellitus but lower prevalence of other comorbidities than Europeans. Asians had a higher prevalence of ACC/AHA C type lesions and received longer stent lengths. More Asians than Europeans were discharged on clopidogrel (86.5% vs 62.8%) rather than potent P2Y12 inhibitors. One-year TLF occurred in 4.0% Asians and 4.1% of Europeans, p = 0.93. The incidence of cardiac death was higher in Asians (2.8% vs. 1.3%, p = 0.007) with similar rates of TV-MI (1.5% vs. 1.2%, p = 0.54) and definite stent thrombosis (0.3% vs. 0.5%, p = 0.84) and lower incidence of TLR than Europeans (1.0% vs. 2.5%, p = 0.025). After adjustment, differences for cardiac death and TLR were no longer significant. CONCLUSIONS: In the COMBO collaboration, although 1-year TLF was similar regardless of geography, Asians experienced higher rates of cardiac death and lower TLR than Europeans, while incidence of TV-MI and ST was similar in both regions. Adjusted differences did not reach statistical significance. CLINICALTRIAL. GOV IDENTIFIER-NUMBERS: NCT01874002 (REMEDEE Registry), NCT02183454 (MASCOT registry).

Drug Coated Balloon-Only Strategy in De Novo Lesions of Large Coronary Vessels.

OBJECTIVES: We analyzed the efficacy of drug coated balloons (DCB) as a stand-alone-therapy in de novo lesions of large coronary arteries. DCBs seem to be an attractive alternative for the stent-free interventional treatment of de novo coronary artery disease (CAD). However, data regarding a DCB-only approach in de novo CAD are currently limited to vessels of small caliber. METHODS: By means of propensity score (PS) matching 234 individuals with de novo CAD were identified with similar demographic characteristics. This patient population was stratified in a 1:1 fashion according to a reference vessel diameter cut-off of 2.75 mm in small and large vessel disease. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 9 months. RESULTS: Patients with small vessel disease had an average reference diameter of 2.45 ± 0.23 mm, while the large vessel group averaged 3.16 ± 0.27 mm. Regarding 9-month major adverse cardiac event (MACE), 5.7% of the patients with small and 6.1% of the patients with large vessels had MACE (p=0.903). Analysis of the individual MACE components revealed a TLR rate of 3.8% in small and 1.0% in large vessels (p=0.200). Of note, no thrombotic events in the DCB treated coronary segments occurred in either group during the 9-month follow-up. CONCLUSIONS: Our data demonstrate for the first time that DCB-only PCI of de novo lesions in large coronary arteries (>2.75 mm) is safe and as effective. Interventional treatment for CAD without permanent or temporary scaffolding, demonstrated a similar efficacy for large and small vessels.

Final results of the randomised evaluation of short-term dual antiplatelet therapy in patients with acute coronary syndrome treated with a new-generation stent (REDUCE trial).

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.