Abstract Background We sought to compare the prognosis of patients with spontaneous coronary artery dissection (SCAD) and atherosclerosis as the cause of acute myocardial infarction (AMI), especially in young females. Methods and results A total of 20,195 patients with AMI at 20 institutions between 2000 and 2013 were retrospectively studied. Major adverse cardiac event (MACE: cardiac death, AMI or urgent revascularization) was the endpoint. The overall prevalence of SCAD was 0.31% (n = 63; female, 94%). SCAD developed following emotional stress in 29% of patients. Revascularization was performed in 56% (35 of 63 patients), and SCAD recurrence developed in the originally involved vessel in 6 of 35 patients with revascularization, compared to none among 28 patients after conservative therapy (p = 0.002). We compared the clinical characteristics of young female AMI patients aged ≤ 50 years in the SCAD (n = 45) and no-SCAD groups (atherosclerotic AMI, n = 55). During a median follow-up of 50 months, SCAD recurred in 27% of patients, of which 42% was in the first 30 days. Kaplan–Meier analysis showed a significantly higher incidence of MACE in the SCAD group compared to the no-SCAD group (hazard ratio, 6.91; 95% confidence interval, 2.5 to 24.3; p < 0.001), although the rate of successful percutaneous coronary intervention for SCAD was as high as 92%. Conclusions Young female patients with SCAD represent a high-risk subgroup of patients with AMI and require close follow-up.
Abstract Background In this study, we tested the hypothesis that a combined adipose-derived mesenchymal stem cell (ADMSC) and ADMSC-derived exosome therapy protected rat kidney from acute ischemia–reperfusion (IR) injury (i.e., ligation both renal arteries for 1 h and reperfusion for 72 h prior to euthanization). Methods and Results Adult-male SD rats (n = 40) were equally categorized into group 1 (sham control), group 2(IR), group 3[IR + exosome (100 μg)], group 4 [IR + ADMSC (1.2 × 106 cells)], and group 5 (IR-exosome-ADMSC). All therapies were performed at 3 h after IR procedure from venous administration. By 72 h, the creatinine level and kidney injury score were lowest in group 1 and highest in group 2, significantly higher in group 3 than in groups 4 and 5, and significantly higher in group 4 than in group 5 (all P < 0.0001). The protein expression of inflammatory (TNF-α/NF-κB/IL-1β/MIF/PAI-1/Cox-2), oxidative-stress (NOX-1/NOX-2/oxidized protein), apoptotic (Bax/caspase-3/PARP), and fibrotic (Smad3/TGF-β) biomarkers showed an identical pattern, whereas the anti-apoptotic (Smad1/5, BMP-2) and angiogenesis (CD31/vWF/angiopoietin) biomarkers and mitochondrial cytochrome-C showed an opposite pattern of creatinine level among the five groups (all P < 0.001). The microscopic findings of glomerular-damage (WT-1), renal tubular-damage (KIM-1), DNA-damage (γ-H2AX), inflammation (MPO/MIF/CD68) exhibited an identical pattern, whereas the podocyte components (podocin/p-cadherin/synaptopodin) displayed a reversed pattern of creatinine level (all P < 0.0001). Conclusion Combined exosome-ADMSC therapy was superior to either one for protecting kidney from acute IR injury.
Abstract Background Successful reperfusion is the most effective strategy to reduce ischemic injury in acute myocardial infarction (AMI). Ischemic injury, however, also triggers a secondary ischemia–independent injury, known as reperfusion injury, contributing to the overall infarct size. We hypothesize that inhibition of the Nod-like Receptor Protein-3 (NLRP3) inflammasome limits infarct size following myocardial ischemia/reperfusion (I/R), by inhibiting the inflammatory component of the reperfusion injury. Methods CD-1 male mice underwent transient ligation of the left anterior descending coronary artery for 30 or 75 min followed by reperfusion. Infarct size was measured at 1, 3 and 24 h. A NLRP3 inflammasome inhibitor (NLRP3inh) or vehicle was administrated immediately at time of reperfusion or with a delay of 1 or 3 h of reperfusion. Results A time-dependent increase in infarct size was measured at 1, 3, and 24 h after reperfusion (11 ± 2%, 30 ± 5% and 43 ± 4% of the area at risk respectively; P < 0.001 for trend). NLRP3 myocardial expression was significantly increased at 24 h and 6 h vs 3 h (P < 0.01). Administration of the NLRP3inh at reperfusion did not reduce infarct size at 3 h, while it significantly reduced infarct size at 24 h (− 56% vs vehicle, P < 0.01). The NLRP3inh given 1 h after reperfusion also significantly decreased caspase-1 activity and infarct size measured at 24 h, whereas the NLRP3inh did not when given with a delay of 3 h. Conclusions Pharmacological inhibition of the NLRP3 inflammasome within 1 h of reperfusion limits the secondary inflammatory injury and infarct size following myocardial ischemia–reperfusion in the mouse.
Abstract Background Due to the great advances in the care of patients with congenital heart disease (CHD), mortality has decreased significantly over the last decades. Nonetheless, mortality for adults with congenital heart disease (ACHD) is still higher than for the general population. An analysis regarding causes of death in a nationwide contemporary cohort of ACHD is lacking. Methods A well-characterized cohort of the German National Register for Congenital Heart Defects was screened for patients over the age of 18 years who died between January 2001 and January 2015. Data relating to the cardiac diagnosis, symptoms, operations, interventions, comorbidities, and causes of death were analyzed. Results During a median follow-up of 3.67 years (IQR 1.32–9.41), 239 (9.2%) out of 2596 patients died during the study period (110 female (46%), mean age at death 39.8 ± 17.8 years). The majority of those who died were CHD-related (171 patients (71.5%)). Leading causes of death were heart failure (n = 66, 27.6%), and sudden cardiac death (n = 55, 23.0%). Deceased patients had a more complex CHD and more extracardiac comorbidities compared with living patients. Conclusions Causes of death of ACHD patients in a large contemporary cohort from a national register are in the majority still CHD-related, with heart failure being the leading cause of death. Additionally, extracardiac comorbidities gain increasing importance.
Abstract Aims To conduct a prospective, individual participant data (IPD) meta-analysis of randomised controlled trials comparing a polypill-based approach with usual care in high risk individuals. Methods and results Three trials comparing polypill-based care with usual care in individuals with CVD or high calculated cardiovascular risk contributed IPD. Primary outcomes were self-reported adherence to combination therapy (anti-platelet, statin and ≥ two blood pressure (BP) lowering agents), and difference in mean systolic BP (SBP) and LDL-cholesterol at 12 months. Analyses used random effects models. Among 3140 patients from Australia, England, India, Ireland, New Zealand and The Netherlands (75% male, mean age 62 years), median follow-up was 15 months. At baseline, 84%, 87% and 61% respectively were taking a statin, anti-platelet agent and at least two BP lowering agents. At 12 months, compared to usual care, participants in the polypill arm had higher adherence to combination therapy (80% vs. 50%, RR 1.58; 95% CI, 1.32 to 1.90; p < 0.001), lower SBP (− 2.5 mmHg; 95% CI, − 4.5 to − 0.4; p = 0.02) and lower LDL-cholesterol (− 0.1 mmol/L; 95% CI, − 0.2 to 0.0; p = 0.04). Baseline treatment levels were a major effect modifier for adherence and SBP (p-homog < 0.0001 and 0.02 respectively) with greatest improvements seen among those under-treated at baseline. Conclusions Polypill therapy significantly improved adherence, SBP and LDL-cholesterol in high risk patients compared with usual care, especially among those who were under-treated at baseline.
Abstract Background To describe the prevalence of sarcopenia in ambulatory patients with heart failure with preserved ejection fraction (HFpEF) and its relation to reduced exercise capacity, muscle strength, and quality of life (QoL). Methods and results A total of 117 symptomatic outpatients with HFpEF were prospectively enrolled in Germany, England, and Slovenia as part of the Studies Investigating Co-morbidities Aggravating Heart Failure (SICA-HF). Appendicular skeletal muscle (ASM) mass (the sum of muscle mass in both arms and legs) was assessed by DEXA. Echocardiography, 6-minute walk testing (6-MWT), muscle strength assessment, spiroergometry and QoL evaluation using EQ-5D Questionnaire were performed. Sarcopenia was defined as ASM 2 standard deviations below the mean of a healthy reference group aged 18–40 years. Patients were divided into 3 groups according to the E/e′ value: ≤ 8, 9–14, and ≥ 15. Sarcopenia was detected in 19.7% of all patients. These patients performed worse during 6-MWT (404 ± 116 vs. 307 ± 145 m, p = 0.003) and showed lower absolute peak oxygen consumption (1579 ± 474 vs. 1211 ± 442 mL/min, p 15 (p < 0.05). Higher values of muscle strength/ASM were associated with a better QoL (r = 0.5, p < 0.0005). Logistic regression showed ASM to be independently associated with reduced distance walked during the 6-MWT adjusted for NYHA, height, left atrium diameter, ferritin and forced expiratory volume in 1 s (FEV1) (odds ratio 1.2, p = 0.02). Conclusion Sarcopenia affects a clinically relevant proportion of patients with HFpEF. Low ASM is strongly linked to reduced muscle strength, exercise capacity and QoL in these patients.
Abstract Background Diabetes promotes progressive loss of cardiac cells, which are replaced by a fibrotic matrix, resulting in the loss of cardiac function. In the current study we sought to identify if excessive autophagy plays a major role in inducing this progressive loss. Methods and results Immunofluorescence and western blotting analysis of the right atrial appendages collected from diabetic and non-diabetic patients undergoing coronary artery bypass graft surgery showed a marked increase in the level of autophagy in the diabetic heart, as evidenced by increased expression of autophagy marker LC3B-II and its mediator Beclin-1 and decreased expression of p62, which incorporates into autophagosomes to be efficiently degraded. Moreover, a marked activation of pro-apoptotic caspase-3 was observed. Electron microscopy showed increased autophagosomes in the diabetic heart. In vivo measurement of autophagic flux by choloroquine injection resulted in further enhancement of LC3B-II in the diabetic myocardium, confirming increased autophagic activity in the type-2 diabetic heart. Importantly, in-vitro genetic depletion of beclin-1 in high glucose treated adult rat cardiomyocytes markedly inhibited the level of autophagy and subsequent apoptotic cell death. Conclusions These findings demonstrate the pathological role of autophagy in the type-2 diabetic heart, opening up a potentially novel therapeutic avenue for the treatment of diabetic heart disease.
Abstract Background Hypertension is a major cause of cardiovascular disease. Periodic nationwide surveys are essential for monitoring secular trend of hypertension and its control in population. We assessed prevalence of hypertension and related awareness, treatment and control rates in Chinese adults in 2013–14. Methods A nationally representative survey recruited 174,621 adults aged > 18 years from 31 provinces in mainland China between 2013 and 2014. Population-weighted prevalence of hypertension and related rates of awareness, treatment and control were calculated and compared by age, sex, region and other factors of interest. Results Overall, 27.8% of Chinese adults were hypertensive, with the adjusted prevalence higher in men than in women and increasing steeply with rising age. Of those with hypertension, 31.9% were previously diagnosed, of those diagnosed, 82.9% were treated, and of those treated, 34.6% had their blood pressure properly controlled, resulting in an overall control rates of 9.7% among those with hypertension. Despite similar prevalence, the awareness, treatment and control were much better in urban areas than in rural areas. Among hypertensive individuals, older age, higher levels of education or household income tended to be associated with better awareness, treatment and control rates. During 2013–14, 292 million adults in China had hypertension, representing an absolute increase of 139 million individuals since year 2002. Conclusions Among Chinese adults, more than one forth had hypertension and the prevalence has increased significantly during recent decades. Despite huge efforts, the levels of awareness, treatment and control rates of hypertension remain extremely low, foreshadowing substantial unnecessary disease burden.
Abstract Background This prospective study aims to assess early clinical outcomes in patients undergoing Transapical Off-Pump Mitral Valve Intervention with Neochord Implantation (TOP-MINI). Methods and results Forty-nine patients with severe symptomatic degenerative mitral regurgitation (MR) were treated. Median age was 72 years (IQR 58-78) and median Euroscore-I was 3.26% (IQR 0.88–8.15). Forty-four patients (89.8%) presented with posterior leaflet prolapse (LP), 4 (8.2%) with anterior LP and 1 (2%) with combined disease. Acute procedure success (defined as successful placement of at least 3 neochords with reduction of residual MR to less than 2 +) was achieved in all patients. In-hospital mortality was 2%. At 30 days major adverse events included one AMI (2%) successfully treated percutaneously and one sepsis (2%), no stroke or bleeding events occurred. At 3 months overall survival was 98%. MR was absent in 16 patients (33.4%), was grade 1 + in 15 (31.2%), and was grade 2 + in 12 (25%). Five patients (10.4%) developed recurrent severe MR due to anterior native chordae rupture. Four of them were successfully re-operated. At 3 months follow-up freedom from reoperation was 91.7 ± 4%. Conclusions Early results with Neochord procedure indicate that TOP-MINI is feasible and safe. Efficacy is maintained up to 3 months follow-up with significant clinical benefit for the patients.
Abstract Background Stroke patients have a high risk for recurrence, which is positively correlated with the number of risk factors. The assessment of risk factors is essential in both stroke outcomes research and the surveillance of stroke burden. However, methods for assessment of risk factors using claims data are not well developed. Methods We enrolled 6469 patients with acute ischemic stroke, transient ischemic attack, or intracerebral hemorrhage from hospital-based stroke registries, which were linked with Taiwan's National Health Insurance (NHI) claims database. We developed algorithms using diagnosis codes and prescription data to identify stroke risk factors including hypertension, diabetes, hyperlipidemia, atrial fibrillation (AF), and coronary artery disease (CAD) in the claims database using registry data as reference standard. We estimated the kappa statistics to quantify the agreement of information on the risk factors between claims and registry data. Results The prevalence of risk factors in the registries was: hypertension 77.0%, diabetes 39.1%, hyperlipidemia 55.6%, AF 10.1%, and CAD 10.9%. The highest kappa statistics were 0.552 (95% confidence interval 0.528–0.577) for hypertension, 0.861 (0.836–0.885) for diabetes, 0.572 (0.549–0.596) for hyperlipidemia, 0.687 (0.663–0.712) for AF, and 0.480 (0.455–0.504) for CAD. Algorithms based on diagnosis codes alone could achieve moderate to high agreement in identifying the selected risk factors, whereas prescription data helped improve identification of hyperlipidemia. Conclusions We tested various claims-based algorithms to ascertain important risk factors in stroke patients. These validated algorithms are useful for assessing stroke risk factors in future studies using Taiwan's NHI claims data.
Abstract Background Dipeptidyl Peptidase 4 Inhibitors (DPP4-I) and Sodium-Glucose Linked coTransporter-2 Inhibitors (SGLT2-I) improve glycemic control in patients with type 2 diabetes mellitus (DM). However, only few studies were designed to assess the efficacy and safety of these drugs on cardiovascular (CV) events and mortality. The purpose of the current study was to evaluate the effects of DPP4-Is and SGLT2-Is on CV events and mortality by meta-analysis. Methods Randomized trials enrolling more than 200 patients, comparing DPP-4-Is or SGLT2-Is versus placebo or active treatments in patients with DM, and reporting at least one event among all-cause and CV mortality, stroke, myocardial infarction (MI) and new onset of heart failure (HF), were included. Results 157 randomized trials (114 on DPP4-Is and 43 on SGLT2-Is) enrolling 140,470 patients (107,100 in DPP4-I and 33,370 in SGLT2-I studies) were included in the analysis. Compared to control, treatment with DPP4-Is did not affect all-cause (RR:1.010; 95% CI:0.935–1.091) and CV (RR:0.975; CI: 0.887–1.073) mortality as well as risk of MI (RR:0.915; CI:0.835–1.002), stroke (RR:0.933; CI:0.820–1.062) and HF (RR:1.083; CI:0.973–1.205). Treatment with SGLT2-Is significantly reduced the risk of all-cause death by 28% (RR:0.718; CI:0.613–0.840), CV death by 33% (RR:0.668; CI:0.544–0.821), MI by 20% (RR:0.803; CI:0.668–0.965) and HF by 35% (RR:0.652; CI:0.517–0.823) without effect on stroke (RR:1.158; CI: 0.912–1.469). Conclusions DPP4-Is show a safe CV profile as they do not affect mortality and CV events, including HF, in patients with type 2 DM. SGLT2-Is are associated with improved CV outcome and survival in DM patients.
Abstract Background Obesity is a well-known risk factor for development of atrial fibrillation (AF). However, the impact of underweight on AF has not been previously recognized. We sought to determine the risk of AF in subjects with underweight in this study. Methods We analyzed clinical data from a total of 132,063 individuals with the age of 40 years or older who received health care checkups arranged by the national insurance program between 2003 and 2004. Newly diagnosed nonvalvular AF was identified using claim data during a median follow-up duration of 9.0 years. Results The mean body mass index (BMI) of patients was 23.9 kg/m2 , and 3,323 individuals (2.5%) were classified as being underweight (BMI < 18.5 kg/m2 ). During the study period, 3,237 individuals (2.5%) developed AF. There was a U-shaped relationship between BMI and AF occurrence: Each 1.0 kg/m2 increase of BMI above 20 kg/m2 was associated with a 6% increased risk of AF (p < 0.001), while each 1.0 kg/m2 lower BMI below 20 kg/m2 was associated with a 13% increased risk of AF (p < 0.001) after multivariable adjustment. Underweight was significantly associated with 23% increased risk of AF, while obesity classes I and II were with 26% and 120% increased risk of AF, respectively. Excess risk of AF in the underweight was independent of thyroid disease, chronic lung disease, or history of malignancy, and was not attributable to cigarette smoking, low socioeconomic status, excessive physical activity, or heavy alcohol consumption. Conclusion BMI has a U-shaped relationship with the risk of AF. Underweight was an independent risk factor for AF independent of confounding factors such as chronic lung disease and malignancy. These findings suggest that underweight is associated with biological effects that contribute to the development of AF.
Abstract Background Stroke is the most serious clinical consequence of atrial fibrillation, which is the most common cardiac arrhythmia. Non-vitamin K antagonist oral anticoagulants (NOACs) have emerged as efficacious, safe and convenient stroke prevention agents. This updated network meta-analysis focused on the relative efficacy and safety of apixaban compared with dabigatran, rivaroxaban and edoxaban for stroke prevention in (i) patients with CHADS2 score ≥ 2, (ii) secondary stroke prevention, and (iii) patients with high quality anticoagulation control with warfarin. Methods and results A fixed-effects network meta-analysis was conducted, including data from four Phase III randomised controlled trials (> 70,000 patients with non-valvular atrial fibrillation). The results of the base-case analysis comparing NOACs with warfarin were broadly in line with the results from the individual trials. Results from the three subgroup analyses were broadly similar to the base case results. For example in patients with CHADS2 score ≥ 2, apixaban, high-dose dabigatran, rivaroxaban, and high-dose edoxaban had significantly lower hazards of stroke/systemic embolism compared with low-dose edoxaban. Apixaban and low-dose edoxaban were associated with significantly lower hazards of major bleeding compared with rivaroxaban and dabigatran 150 mg. However, several treatment comparisons that were significant in the base-case analysis were not significant in the patient subgroups, due to the reduced sample size of the subgroups compared with the overall population. Conclusions Among the NOACs, apixaban offered the most favourable efficacy and safety profile in the overall patient population as well as in the three subgroups investigated.
Abstract Background Doxorubicin (DOXO) is an effective anti-neoplastic drug but its clinical benefits are hampered by cardiotoxicity. Oxidative stress, apoptosis and myocardial fibrosis mediate the anthracycline cardiomyopathy. ROS trigger TGF-β pathway that activates cardiac fibroblasts promoting fibrosis. Myocardial stiffness contributes to diastolic dysfunction, less studied aspect of anthracycline cardiomyopathy. Considering the role of SIRT1 in the inhibition of the TGF-β/SMAD3 pathway, resveratrol (RES), a SIRT1 activator, might improve cardiac function by interfering with the development of cardiac fibrosis in a model of DOXO-induced cardiomyopathy. Methods F344 rats received a cumulative dose of 15 mg/kg of DOXO in 2 weeks or DOXO + RES (DOXO and RES, 2.5 mg/kg/day, concomitantly for 2 weeks and then RES alone for 1 more week). The effects of RES on cardiac fibroblasts were also tested in vitro. Results Along with systolic dysfunction, DOXO was also responsible of diastolic abnormalities. Myocardial stiffness correlated with fibroblast activation and collagen deposition. DOXO + RES co-treatment significantly improved ± dP/dt and, more interestingly, ameliorated end-diastolic pressure/volume relationship. Treatment with RES resulted in reduced fibrosis and fibroblast activation and, most importantly, the mortality rate was significantly reduced in DOXO + RES group. Fibroblasts isolated from DOXO + RES-treated rats, in which SIRT1 was upregulated, showed decreased levels of TGF-β and pSMAD3/SMAD3 when compared to cells isolated from DOXO-exposed hearts. Conclusions Our findings reveal a key role of SIRT1 in supporting animal survival and functional parameters of the heart. SIRT1 activation by interfering with fibrogenesis can improve relaxation properties of myocardium and attenuate myocardial remodeling related to chemotherapy.
Abstract Objectives To evaluate the impact of age- and gender-specific cut-offs for high-sensitivity cardiac troponin T (hs-cTnT) compared to the general 99th percentile hs-cTnT cut-off on diagnosis and prognosis of acute myocardial infarction (AMI). Methods 1282 unselected patients presenting to the emergency department with suspected AMI were enrolled as part of the TRAPID-AMI study. In the present sub-analysis, reclassification of AMI diagnosis was performed by comparing the general hs-cTnT cut-off of 14 ng/L to previously proposed age- and gender-dependent hs-cTnT 99th percentile cut-offs (28 ng/L for ≥ 65 years, 9 ng/L for female and 15.5 ng/L for male patients). Patients were further clinically adjudicated into acute coronary syndrome (ACS) and non-ACS. Results For patients ≥ 65 years, application of age-specified cut-offs resulted in a decrease of AMI from 29.8% to 18.3% in the entire cohort (n = 557) and 54.7% to 40.9% in the ACS subcohort (n = 225). Using gender-specific cut-offs, AMI-rate increased from 16.6% to 22.6% (entire cohort, n = 477) and 62.6% to 71.7% (ACS subcohort, n = 99) in women, whereas in men, rates decreased from 23.1% to 21.1% (entire cohort, n = 805) and 48.8% to 45.9% (ACS, n = 281), respectively. Age-specified cut-offs significantly reclassified patients for outcomes of 1-month and 3-month mortality in the entire and ACS cohort (14.2% net reclassification improvement, p < 0.001, respectively). Contrary, no significant differences in outcomes could be found using gender-specific cut-offs. Conclusions While influence of gender-specific hs-cTnT cut-offs on diagnostic and prognostic reclassification was only modest in patients with suspected AMI, age-specific cut-offs showed a significant impact and may be considered for further validation.
Abstract Objectives Despite maximally tolerated statin therapy, many patients with high cardiovascular risk, with or without heterozygous familial hypercholesterolemia may require additional low-density lipoprotein cholesterol (LDL-C) reduction. We report pooled alirocumab (ALI) efficacy and safety data from eight Phase 3 trials in 4629 hypercholesterolemia patients, receiving background statin therapy. Material and methods Studies were pooled by ALI dose and control: ALI 75/150 mg every 2 weeks (Q2W; dose increased to 150 mg Q2W at Week 12 based on Week 8 LDL-C) versus ezetimibe (EZE; Pool 1) or placebo (PBO; Pool 2), and ALI 150 mg Q2W versus PBO (Pool 3). Results Mean baseline LDL-C was 109 vs. 105 mg/dL (Pool 1), 129 vs. 130 mg/dL (Pool 2) and 126 vs. 125 mg/dL (Pool 3). ALI 75/150 mg Q2W reduced LDL-C by 48.9% (vs. − 19.3% EZE) and 48.6% (vs. + 4.2% PBO) from baseline to Week 24, and ALI 150 mg Q2W reduced LDL-C by 60.4% (vs. + 0.5% PBO; all p < 0.0001). LDL-C reductions were sustained to Week 104. Risk-based LDL-C goals (< 70 mg/dL or < 100 mg/dL) were achieved by 78.0%, 75.2%, and 79.0% (Pool 1–3) of ALI-treated patients (vs. 52.4%, 6.4%, and 8.4%, respectively, for controls) at Week 24. Consistent reductions were observed in apolipoprotein B, non-high-density lipoprotein cholesterol, and lipoprotein (a) (p < 0.0001 vs. control). Common adverse events in ALI-treated patients were nasopharyngitis, injection-site reactions, upper respiratory tract infections, and influenza. Conclusions Alirocumab treatment significantly reduced LDL-C in high cardiovascular risk patients, enabling most to achieve risk-based LDL-C goals.
Abstract Objective To compare the distribution of international normalized ratios (INRs) in patients receiving vitamin K antagonist (VKA) for newly diagnosed atrial fibrillation in Eastern and Southeastern Asia and in other regions of the world (ORW) represented in the ongoing, global observational study GARFIELD-AF. Methods and Results 3621 and 13,541 patients were recruited prospectively in 2010–2013 from Asia and ORW, respectively. At baseline, excluding patients with unknown antithrombotic treatment, 1356 (37.8%) in Asia and 7081 (53.3%) in ORW received VKA (± antiplatelets). INR readings during 1-year follow-up were analyzed for VKA-treated patients with ≥ 3 measurements (878 [64.7%] patients in Asia, 4452 [62.9%] in ORW). VKA-treated patients in Asia were younger than those in ORW (mean 67.1 vs 71.3 years), with a lower CHA2 DS2 -VASc score (3.0 vs 3.5), but a similar HAS-BLED score (1.3 vs 1.4). Mean INR was lower in Asia than in ORW (2.0 vs 2.4). The proportion of time in the therapeutic range, defined using the multinational target of 2.0–3.0, was substantially lower in Asia (31.1% vs 54.1%). In Asia and ORW, 59.3% and 28.2% of INRs were 3, respectively. The same trend was found in different age groups (< 65, 65–74, ≥ 75 years). Conclusion GARFIELD-AF data demonstrate a difference in the distribution of INRs in patients from Asia versus other regions under current real-world practice. Clinical Trial Registration—URL: http://www.clinicaltrials.gov . Unique identifier: NCT01090362.
Abstract Background Randomized clinical trials on bioresorbable scaffolds (BRS) enrolled patients with simple coronary lesions. The present study was sought to give preliminary findings about safety of BRS implantation in overlap in long coronary lesions. Methods From June 2012 to January 2015, we prospectively collected data from 162 consecutive patients receiving overlapping BRS implantation in the 16 participating institutions. We applied a propensity-score to match BRS-treated patients with 162 patients receiving second generation drug eluting stents (DES) in overlap. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization. Results DOCE rate did not significantly differ between the two groups (5.6% in BRS group vs. 7.4% in DES group, HR 0.79, 95%CI 0.37–3.55, p = 0.6). Also stent/scaffold thrombosis did not differ between groups (1.2% in BRS group vs. 1.9% in DES group, p = 0.6). Occurrence of procedural-related myocardial injury was significantly higher in the BRS group (25% vs. 12%, p = 0.001), although it was not related to DOCE (HR 1.1, 95%CI 0.97–1.2, p = 0.2). Imaging techniques and enhanced stent visualization systems were significantly more employed in the BRS group (p = 0.0001 for both). Procedure length, fluoroscopy time and contrast dye amount were significantly higher in the BRS group (p = 0.001, p = 0.001 and p = 0.01, respectively). Conclusions Overlapping BRS utilization in long coronary lesions showed a comparable DOCE rate at 1 year if compared to second generation DES. Further and larger studies are on demand to confirm our findings.