COMPASS criteria applied to a contemporary cohort of unselected patients with stable coronary artery diseases: insights from the START registry

Author(s):  
Leonardo De Luca ◽  
Dario Formigli ◽  
Jennifer Meessen ◽  
Massimo Uguccioni ◽  
Nicola Cosentino ◽  
...  

Abstract Aims Recently, the cardiovascular outcomes for people using anticoagulation strategies (COMPASS) trial demonstrated that dual therapy reduced cardiovascular outcomes compared with aspirin alone in patients with stable atherosclerotic disease. Methods and results We sought to assess the proportion of patients eligible for the COMPASS trial and to compare the epidemiology and outcome of these patients with those without COMPASS inclusion or with any exclusion criteria in a contemporary, nationwide cohort of patients with stable coronary artery disease. Among the 4068 patients with detailed information allowing evaluation of eligibility, 1416 (34.8%) did not fulfil the inclusion criteria (COMPASS-Not-Included), 841 (20.7%) had exclusion criteria (COMPASS-Excluded), and the remaining 1811 (44.5%) were classified as COMPASS-Like. At 1 year, the incidence of major adverse cardiovascular event (MACE), a composite of cardiovascular death, myocardial infarction, and stroke, was 0.9% in the COMPASS-Not-Included and 2.0% in the COMPASS-Like (P = 0.01), and 5.0% in the COMPASS-Excluded group (P < 0.0001 for all comparisons). Among the COMPASS-Like population, patients with multiple COMPASS enrichment criteria presented a significant increase in the risk of MACE (from 1.0% to 3.3% in those with 1 and ≥3 criteria, respectively; P = 0.012), and a modest absolute increase in major bleeding risk (from 0.2% to 0.4%, respectively; P = 0.46). Conclusion In a contemporary real-world cohort registry of stable coronary artery disease, most patients resulted as eligible for the COMPASS. These patients presented a considerable annual risk of MACE that consistently increases in the presence of multiple risk factors.

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


2018 ◽  
Vol 277 ◽  
pp. 108-112 ◽  
Author(s):  
Hideki Wada ◽  
Tomotaka Dohi ◽  
Katsumi Miyauchi ◽  
Jun Shitara ◽  
Hirohisa Endo ◽  
...  

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&lt;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


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