scholarly journals Potential eligibility for low dose rivaroxaban treatment in a “real world” population of Spanish patients with stable coronary artery disease: a subanalysis of the CICCOR registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Ruiz Ortiz ◽  
J.J Sanchez Fernandez ◽  
C Ogayar Luque ◽  
E Romo Penas ◽  
M Delgado Ortega ◽  
...  

Abstract Background In the COMPASS trial, low dose rivaroxaban (2.5 mg/12h) on top of aspirin showed a 26% reduction in major cardiovascular events in patients with stable coronary artery disease (sCAD). However, information about external applicability of these results is limited. Our objective was to assess potential eligibility for this treatment in a “real world” cohort of Spanish patients with sCAD and to evaluate the incidence of major events in the long-term follow up in this population. Methods The CICCOR registry (“Chronic ischemic heart disease in Cordoba”, in Spanish “Cardiopatía isquémica crόnica en Cordoba”) is a prospective, monocentric study. From February 1, 2000 to January 31, 2004, all consecutive patients with sCAD attended at two outpatient cardiology clinics in a city of the south of Spain were included in the study and prospectively followed. The COMPASS inclusion and exclusion criteria were applied to this cohort, and the proportion of patients potentially eligible for this trial was described. The rate of the main COMPASS end-point (the composite of acute myocardial infarction, stroke, or cardiovascular death), as well as mortality rates, were investigated in this subset of patients, and compared with those of sCAD patients included in the aspirin alone group of the COMPASS trial. Results From a total population of 1268 patients, 1246 subjects presented enough data to assess eligibility. Among these, 575 patients (46%) had exclusion criteria, and another 229 (18%) did not fulfill the inclusion criteria and were not eligible. The main reasons for exclusion were requirement for dual antiplatelet therapy within 1 year of an acute coronary syndrome or coronary stent implantation (70%), high-bleeding risk (33%), other non-aspirin antiplatelet therapy (13%), atrial fibrillation (12%), anticoagulant use (11%), history of ischemic stroke (5%) and heart failure with severe left ventricular dysfunction (4%). The reason for not fulfilling inclusion criteria was the absence of additional high risk factors in patients younger than 65 years. The potentially eligible population included 442 patients (35% of evaluable patients), with up to 17 years of follow-up (median 9 years, IQR 4–15 years, only 1 patient lost in follow-up, 4174 patients-years of observation). These patients experienced higher primary outcome event rates than coronary patients actually enrolled in the aspirin alone arm of COMPASS (5.1% versus 2.9% per year), and higher rates of cardiovascular (4.0% versus 1.1%) and all-cause mortality (6.3 versus 2.1%, p<0.00005 for all comparisons). Conclusion More than one third of “real world” patients with sCAD of this prospective Spanish registry could be potentially eligible for low dose rivaroxaban therapy, according to COMPASS inclusion and exclusion criteria. This population had a higher risk of cardiovascular events and mortality than COMPASS participants with sCAD in the reference aspirin group. Funding Acknowledgement Type of funding source: None

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Nagai ◽  
I Yokota ◽  
K Omote ◽  
I Sakuma ◽  
Y Nakagawa ◽  
...  

Abstract Background The relation between high-density lipoprotein cholesterol (HDL-C) level after statin therapy and cardiovascular events in patients with stable coronary artery disease remains unclear. Purpose We sought to determine the association of the HDL-C level after statin therapy with cardiovascular events in stable coronary artery disease patients. Methods This study was a post-hoc analysis of the Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy with Pitavastatin in Coronary Artery Disease (REAL-CAD) study, which is randomised, open-label, blinded endpoint, physician-initiated, superiority clinical trial. Enrollment was from January 2010 to March 2013, and follow-up was through January 2016. From the main study, we excluded the patients without either HDL-C data at baseline or 6 months, with occurrence of the primary outcome at 6 months and reported poor adherence for pitavastatin. The primary outcome of interest was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or unstable angina requiring emergent admission after 6 months from randomisation, consistent with the primary analysis of the trial. We constructed landmark Cox proportional hazards regression models with the 18 selected clinically relevant risk-adjusting variables during the entire follow-up period starting at 6 months after randomisation. Absolute and relative changes of HDL-C level were defined as (6 months value – baseline value) and (absolute change / baseline value) × 100, respectively. Results Among 14,774 participants in the REAL-CAD study, 9,221 patients were included in this analysis (7652 [83.0%] male; median [IQR] age, 70 [63–75] years; median [IQR] HDL-C, 49 [42–57] mg/dL; median [IQR] low-density lipoprotein cholesterol [LDL-C], 88 [75–101] mg/dL). During a median follow-up period of 4.0 (IQR 3.2–4.7) years, the primary outcome occurred in 417 (4.5%) patients. There was no significant difference in crude and adjusted cumulative incidence of the primary outcome among the quartiles of HDL-C level at 6 months (Figure 1). The adjusted risks of all the HDL-C related variables (baseline value, 6 months value, absolute and relative changes) for the primary outcome were not significant (Figure 2). Furthermore, the adjusted hazard ratio (HR) as HDL-C level at 6 months increased by 10 mg/dL remained non-significant for the primary outcome for each on-treatment LDL-C level at 6 months (<70 mg/dL [HR 0.97, 95% CI 0.82–1.15], 70–100 mg/dL [HR 1.10, 95% CI 0.98–1.24], and ≥100 mg/dL [HR 0.94, 95% CI 0.78–1.13]). There was also no significant association between HDL-C level at 6 months and the primary outcome both in the low (1 mg/day [HR 1.02, 95% CI 0.91–1.14], increased by 10 mg/dL) dose and high (4 mg/day [HR 1.04, 95% CI 0.91–1.19]) dose pitavastatin groups Conclusion After statin therapy with modestly controlled LDL-C, HDL-C level has little prognostic value in patients with stable coronary artery disease. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): The Comprehensive Support Project for Clinical Research of Lifestyle-Related Disease of the Public Health Research Foundation


Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 426-P
Author(s):  
YUQIAN BAO ◽  
YUN SHEN ◽  
XUELI ZHANG ◽  
YITING XU ◽  
QIN XIONG ◽  
...  

Author(s):  
Tomonori Itoh ◽  
◽  
Hiromasa Otake ◽  
Takumi Kimura ◽  
Yoshiro Tsukiyama ◽  
...  

AbstractThe purpose of this study was to assess early and late vascular healing in response to bioresorbable-polymer sirolimus-eluting stents (BP-SESs) for the treatment of patients with ST-elevation myocardial infarction (STEMI) and stable coronary artery disease (CAD). A total of 106 patients with STEMI and 101 patients with stable-CAD were enrolled. Optical frequency-domain images were acquired at baseline, at 1- or 3-month follow-up, and at 12-month follow-up. In the STEMI and CAD cohorts, the percentage of uncovered struts (%US) was significantly and remarkably decreased during early two points and at 12-month (the STEMI cohort: 1-month: 18.75 ± 0.78%, 3-month: 10.19 ± 0.77%, 12-month: 1.80 ± 0.72%; p < 0.001, the CAD cohort: 1-month: 9.44 ± 0.78%, 3-month: 7.78 ± 0.78%, 12-month: 1.07 ± 0.73%; p < 0.001 respectively). The average peri-strut low-intensity area (PLIA) score in the STEMI cohort was significantly decreased during follow-up period (1.90 ± 1.14, 1.18 ± 1.25, and 1.01 ± 0.72; p ≤ 0.001), whereas the one in the CAD cohort was not significantly changed (0.89 ± 1.24, 0.67 ± 1.07, and 0.64 ± 0.72; p = 0.59). In comparison with both groups, differences of %US and PLIA score at early two points were almost disappeared or close at 12 months. The strut-coverage and healing processes in the early phase after BP-SES implantation were significantly improved in both cohorts, especially markedly in STEMI patients. At 1 year, qualitatively and quantitatively consistent neointimal coverage was achieved in both pathogenetic groups.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Hack-Lyoung Kim ◽  
Jung Pyo Lee ◽  
Nathan Wong ◽  
Woo-Hyun Lim ◽  
Jae-Bin Seo ◽  
...  

AbstractThe role of ST2 in stable coronary artery disease (CAD) has not yet been well defined. This study was performed to investigate baseline serum soluble ST2 (sST2) level can predict clinical outcomes in patients with stable CAD. A total of 388 consecutive patients with suspected CAD (65 years and 63.7% male) in stable condition referred for elective invasive coronary angiography (ICA) was prospectively recruited. Major adverse cardiovascular event (MACE), including cardiac death, non-fatal myocardial infarction, coronary revascularization (90 days after ICA), and ischemic stroke during clinical follow-up was assessed. Most of the patients (88.0%) had significant CAD (stenosis ≥ 50%). During median follow-up of 834 days, there was 29 case of MACE (7.5%). The serum sST2 level was significantly higher in patients with MACE than those without (47.3 versus 30.6 ng/ml, P < 0.001). In multiple Cox regression model, higher sST2 level (≥ 26.8 ng/ml) was an independent predictor of MACE even after controlling potential confounders (hazard ratio, 13.7; 95% confidence interval 1.80–104.60; P = 0.011). The elevated level of baseline sST2 is associated with an increased risk of adverse clinical events in stable CAD patients. Studies with larger sample size are needed to confirm our findings.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Darmon ◽  
G Ducrocq ◽  
A Jasilek ◽  
J M Juliard ◽  
E Sorbets ◽  
...  

Abstract Background The COMPASS trial demonstrated that a combination of rivaroxaban and aspirin improved cardiovascular (CV) outcomes in high-risk patients with either peripheral artery disease (PAD) or stable coronary artery disease (CAD) compared with aspirin alone, at the price of increased bleeding. A previous analysis of the REACH Registry reported an eligibility rate of 52.9% within a population with stable vascular disease. However, most of cardiologists actually treat patients with stable CAD, rather than PAD. Data regarding eligibility to COMPASS in CAD patients from real life practice are scarce. Purpose We aimed to describe the proportion of patients eligible to COMPASS within the CLARIFY Registry. Additionally, we aimed to describe their management and outcomes, comparing patients excluded from the trial (COMPASS Excluded), patients eligible for the trial (COMPASS Eligible), and patients who did not meet the “enrichment criteria” for enrolment (COMPASS Not Included). Methods We used the CLARIFY Registry, an international observational registry of more than 30.000 patients with stable CAD. In accordance with COMPASS exclusion criteria, patients with a REACH bleeding risk score >10, heart failure (HF), severe renal insufficiency, need for dual antiplatelet therapy (DAPT), or anticoagulant (AC) therapy were excluded. Then, COMPASS inclusion criteria were applied: CAD patients had to be 65 years or more, or, if younger, have documented atherosclerosis (PAD or revascularization involving at least two vascular beds) or at least two enrichment criteria (current smoker, diabetes mellitus, GFR <60 mL/min, or non lacunar ischemic stroke).The ischemic outcome was a composite of CV death, MI, or stroke and bleeding outcome was a composite of bleeding leading to either admission or transfusion, or haemorrhagic stroke. Results Among 15.185 patients with comprehensive data allowing precise assessment of eligibility, 43.1% (n=6.540) had at least one exclusion criteria (COMPASS-Excluded), 23.1% (n=3.503) did not have enrichment criteria (COMPASS-Not Included) and 33.9% (n=5.142) were eligible. The vast majority of excluded patients were excluded due to high bleeding risk (62.7% needing DAPT, and 52.7% for high REACH bleeding risk score). The rates (100 patients/year) of ischemic and bleeding outcome were 2.3 [2.1–2.5] and 0.5 [0.4–0.6] respectively for COMPASS-Eligible, 3.0 [2.8–3.2] and 0.6 [0.5–0.7] for COMPASS-Excluded and 1.2 [1.0–1.4] and 0.2 [0.2–0.3] for COMPASS-Not Included. Ischemic and bleeding events Conclusion In a large contemporary registry of stable CAD patients, approximately one of three patients was potentially eligible for adjunction of low-dose rivaroxaban to aspirin. This group is at particularly high risk of ischemic outcome. Patients with exclusion criteria for COMPASS had the worse ischemic and bleeding outcomes and represent a group in need of improved therapy. Acknowledgement/Funding None


2020 ◽  
Vol 9 (2) ◽  
pp. 493-503 ◽  
Author(s):  
Naveen Seecheran ◽  
Brent Boodhai ◽  
Aarti Maharaj ◽  
Arvinash Ramdeen ◽  
Niranjan Debideen ◽  
...  

2020 ◽  
Vol 13 (8) ◽  
Author(s):  
Kasra Moazzami ◽  
Matthew T. Wittbrodt ◽  
Mhmtjamil Alkhalaf ◽  
Bruno B. Lima ◽  
Jonathon A. Nye ◽  
...  

Background: The inferior frontal lobe is an important area of the brain involved in the stress response, and higher activation with acute mental stress may indicate a more severe stress reaction. However, it is unclear if activation of this region with stress correlates with angina in individuals with coronary artery disease. Methods: Individuals with stable coronary artery disease underwent acute mental stress testing using a series of standardized speech/arithmetic stressors in conjunction with high resolution positron emission tomography imaging of the brain. Blood flow to the inferior frontal lobe was evaluated as a ratio compared with whole brain flow for each scan. Angina was assessed with the Seattle Angina Questionnaire’s angina frequency subscale at baseline and 2 years follow-up. Results: We analyzed 148 individuals with coronary artery disease (mean age [SD] 62 [8] years; 69% male, and 35.8% Black). For every doubling in the inferior frontal lobe activation, angina frequency was increased by 13.7 units at baseline ( , 13.7 [95% CI, 6.3–21.7]; P =0.008) and 11.6 units during follow-up ( , 11.6 [95% CI, 4.1–19.2]; P =0.01) in a model adjusted for baseline demographics. Mental stress-induced ischemia and activation of other brain pain processing regions (thalamus, insula, and amygdala) accounted for 40.0% and 13.1% of the total effect of inferior frontal lobe activation on angina severity, respectively. Conclusions: Inferior frontal lobe activation with mental stress is independently associated with angina at baseline and during follow-up. Mental stress-induced ischemia and other pain processing brain regions may play a contributory role.


Sign in / Sign up

Export Citation Format

Share Document