The current treatment and predictors of outcome in elderly patients with non-ST-elevation myocardial infarction in an all comers population: the POPular Age registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M.E Gimbel ◽  
D.R.P.P Chan Pin Yin ◽  
R.S Hermanides ◽  
F Kauer ◽  
A.H Tavenier ◽  
...  

Abstract Background Elderly patients form a large and growing part of the patients presenting with non-ST-elevation myocardial infarction (NSTEMI). Choosing the optimal antithrombotic treatment in these elderly patients is more complicated because they frequently have characteristics indicating both a high ischaemic and high bleeding risk. Purpose We describe the treatment of elderly patients (>75 years) admitted with NSTEMI, present the outcomes (major adverse cardiovascular events (MACE) and bleeding) and aim to find predictors for adverse events. Methods The POPular AGE registry is an investigator initiated, prospective, observational, multicentre study of patients aged 75 years or older presenting with NSTEMI. Patients were recruited between August 1st, 2016 and May 7th, 2018 at 21 sites in the Netherlands. The primary composite endpoint of MACE included cardiovascular death, non-fatal myocardial infarction and non-fatal stroke at one-year follow-up. Results A total of 757 patients were enrolled. During hospital stay 76% underwent coronary angiography, 34% percutaneous coronary intervention and 12% coronary artery bypass grafting (CABG). At discharge 78.6% received aspirin (non-users mostly because of the combination of oral anticoagulant and clopidogrel), 49.7% were treated with clopidogrel, 34.2% with ticagrelor and 29.6% were prescribed oral anticoagulation. Eighty-three percent of patients received dual antiplatelet therapy (DAPT) or dual therapy consisting of oral anticoagulation and at least one antiplatelet agent for a duration of 12 months. At one year, the primary outcome of cardiovascular death, myocardial infarction or stroke occurred in 12.3% of patients and major bleeding (BARC 3 or 5) occurred in 4.8% of the patients. The risk of MACE and major bleeding was highest during the first month and stayed high over time for MACE while the risk for major bleeding levelled off. Independent predictors for MACE were age, renal function, medical history of CABG, stroke and diabetes. The only independent predictor for major bleeding was haemoglobin level on admission. Conclusion In this all-comers registry, most elderly patients (≥75 years) with NSTEMI are treated with DAPT and undergoing coronary angiography the same way as younger NSTEMI patients from the SWEDEHEART registry. Aspirin use was lower as was the use of the more potent P2Y12 inhibitors compared to the SWEDEHEART which is very likely due to the concomitant use of oral anticoagulation in 30% of patients. The fact that ischemic risk stays constant over 1 year of follow-up, while the bleeding risk levels off after one month may suggest the need of dual antiplatelet therapy until at least one year after NSTEMI. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): AstraZeneca

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Castineira Busto ◽  
S Raposeiras Roubin ◽  
E Abu Assi ◽  
F D'Ascenzo ◽  
S Manzano Fernandez ◽  
...  

Abstract Introduction Anemia is strongly associated with increased risk of morbidity and mortality in patients after acute coronary syndromes (ACS). The aim of our study was to determine, after matching the baseline characteristics, the bleeding-ischemic risk profile during treatment with Dual Antiplatelet Therapy (DAPT) of patients with severe anemia (hemoglobin <10 g/dL) after an ACS undergoing Percutaneous Coronary Intervention (PCI). Methods The data analyzed in this study were obtained from the fusion of 3 clinical registries of ACS patients: BleeMACS (2004–2013), CardioCHUVI/ARRITXACA (2010–2016) and RENAMI (2013–2016). All 3 registries include consecutive patients discharged after an ACS with DAPT and undergoing PCI. The merged data set contain 26,076 patients. A propensity-matched analysis was performed to match the baseline characteristics of patients according to presence or not of severe anemia (hemoglobin <10 g/dL). The impact of severe anemia in the ischemic and bleeding risk was assessed by a competitive risk analysis, using a Fine and Gray regression model, with death being the competitive event. For ischemic risk we have considered a new acute myocardial infarction, whereas for bleeding risk we have considered major bleeding defined as bleeding requiring hospital admission. Follow-up time was censored by DAPT suspension/withdrawal. Results From the 26,076 ACS patients, 630 had severe anemia (2.4%). During a mean follow-up of 12.2±4.8 months, 964 patients died (3.7%), 640 had myocardial infarction (2.5%) and 685 had major bleeding (2.6%). After propensity-score matching, we obtained two matched groups (with hemoglobin < and ≥10 g/dL) of 621 patients. In comparison with patients without severe anemia, patients with hemoglobin <10 g/dL had similar risk of myocardial infarction (sHR 1.37, 95% CI 0.82–2.31, p=0.231) with higher risk of major bleeding (sHR 1.89, 95% CI 1.18–2.72, p=0.006). After propensity score matching, the cumulative incidence of myocardial infarction was 6 and 5 per 100 patients/year in patients with and without severe anemia, respectively, during DAPT. And the cumulative incidence of major bleeding was 12 and 6 per 100 patients/year in patients with and without severe anemia, respectively. The difference between myocardial infarction rate and major bleeding rate was −6 in patients with severe anemia (more bleeding than ischemic event rates; p<0.05) and −1 in patients with hemoglobin ≥10 g/dL (similar bleeding and ischemic event rates; p>0.05), per 100 patient-years (Figure). Conclusions After an ACS underwent PCI, during DAPT, the ischemic-bleeding balance of patients with severe anemia (hemoglobin <10 g/dL) is not favorable. In those patients, a short-term DAPT (<6 months) should be recommended.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Dominguez Erquicia ◽  
S Raposeiras Roubin ◽  
E Abu-Assi ◽  
F D'Ascenzo ◽  
S Manzano Fernandez ◽  
...  

Abstract Introduction ESC guidelines recommend short-term dual antiplatelet therapy (DAPT) in patients with high bleeding risk. In this sense, patients with prior admissions by bleeding are considered of high-risk of bleeding. With our study, we aimed to show the ischemic-bleeding profile of patients with prior bleeding in comparison with those without prior bleeding during treatment with DAPT. Methods The data analyzed in this study were obtained from the fusion of 3 clinical registries of ACS patients: BleeMACS (2004–2013), CardioCHUVI/ARRITXACA (2010–2016) and RENAMI (2013–2016). All 3 registries include consecutive patients discharged after an ACS with DAPT and undergoing PCI. The merged data set contain 26,076 patients. A propensity-matched analysis was performed to match the baseline characteristics of patients with and without prior admission by bleeding. The impact of prior prior bleeding in the ischemic and bleeding risk was assessed by a competitive risk analysis, using a Fine and Gray regression model, with death being the competitive event. For ischemic risk we have considered a new acute myocardial infarction, whereas for bleeding risk we have considered major bleeding defined as bleeding requiring hospital admission. Follow-up time was censored by DAPT suspension/withdrawal. Results From the 26,076 ACS patients, 1,105 have PAD (4.2%). During a mean follow-up of 12.2±4.8 months, 964 patients died (3.7%), 640 had myocardial infarction (2.5%) and 685 had major bleeding (2.6%). After propensity-score matching, we obtained two matched groups of 1,101 patients. In comparison with patients without prior bleeding, those with prior bleeding had higher risk of major bleeding (sHR 2.03, 95% CI 1.33–3.11, p=0.001) with similar risk of myocardial infarction (sHR 0.98, 95% CI 0.61–1.59, p=0.945), in comparison with those without PAD. The cumulative incidence of myocardial infarction was 31 and 32 per 1,000 patients/year in patients with and without prior bleeding, respectively. The cumulative incidence of major bleeding was 63 and 29 per 1,000 patients/year in patients with and without prior bleeding, respectively. The difference between myocardial infarction rate and major bleeding rate was −32 and +3 per 1,000 patient-years in patients with and without prior bleeding (Figure). Conclusions Patients with ACS and prior history of bleeding have a significant increment of bleeding risk during treatment with DAPT. In these patients, short-term DAPT (6 months) should be recommended.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Fauchier ◽  
A Bisson ◽  
A Bodin ◽  
J Herbert ◽  
N Clementy ◽  
...  

Abstract Background Frailty and multimorbidity are common in patients with atrial fibrillation (AF). The quantifiable frailty phenotype has been validated as predictive of mortality and disability, and patients can be categorised as frail and non-frail using the Claims-based Frailty Index (CFI). The Charlson comorbidity index (CCI) is a tool to quantify multimorbidity and also a strong estimator of mortality. We evaluated whether frailty and multimorbidity are associated with the risk of major bleeding in patients with AF. Methods Based on the administrative hospital-discharge database, we collected information for all patients with AF between 2010 and 2019 in France. CCI and CFI were calculated for each patient, and their associated risks of bleeding compared to 4 bleeding risk scores (HAS-BLED, HEMORR2HAGES, ATRIA and ORBIT). The analysis focused on patients with events or with at least one year of follow-up. Predictive abilities of the scores were compared in the whole population, and then separately in the subgroup of elderly patients (&gt;75 yo). Results Among 1,372,567 patients with AF, 131,535 major bleeding events were recorded during a follow-up of 3.5±2.1 years (median 3.1, IQR 1.8–4.9) (yearly rate 2.7%). Bleeding occurred more commonly in patients with higher HAS-BLED, ATRIA, CCI and CFI scores. Those with high frailty and multimorbidity had markedly higher yearly incidences of bleeding events of 13.0% and 14.7%, respectively (vs low frailty and multimorbidity: 4.3%% and 4.1%, respectively; p&lt;0.001). The 4 bleeding risk scores significantly had lower c-statistics than CCI and CFI for predicting major bleeding (table). In elderly patients (n=853,833), the c-statistics were all lower than in the whole population and were lower for the 4 scores than for the CCI and CFI scores (0.463, 0.473, 0.443, 0.445, 0.622 and 0.620 for HAS-BLED, ATRIA, ORBIT, HEMORR2HAGES, CCI and CFI, respectively). Conclusion Multimorbidity and frailty, respectively assessed with CCI and CFI, demonstrated statistically better performances in predicting major bleeding than the 4 established bleeding risk scores in AF. Funding Acknowledgement Type of funding source: None


1994 ◽  
Vol 72 (05) ◽  
pp. 676-681 ◽  
Author(s):  
J van der Meer ◽  
H L Hillege ◽  
P H J M Dunselman ◽  
B J M Mulder ◽  
H R Michels ◽  
...  

SummaryTo assess the optimal level of oral anticoagulation to prevent occlusion of vein coronary bypass grafts, 318 patients from a graft patency trial were analysed retrospectively. Oral anticoagulant therapy was started one day before surgery and continued for one year, after which graft occlusion was assessed by angiography. The aimed level of anticoagulation was 2.8-1.8 International Normalized Ratio (INR). Clinical outcome was assessed by the incidence of myocardial infarction, thrombosis and major bleeding.The observed anticoagulation level was 2.8-4.8 INR for 54%, and 1.8-3.8 INR for 75% of time per patient. Occlusion rates in patients who spent <35, 35-70, and ≥70% of time within INR range 2.8-1.8 were 10.5%, 10.8% and 11.8%, respectively (differences not statistically significant). Patients who spent ≥70% of time within INR range 1.8-3.8 versus 2.8-4.8 showed comparable occlusion rates. The risk of graft occlusion was not related to quality of anticoagulation early (0-3 months) or late (3-12 months) after surgery. Myocardial infarction, thrombosis and major bleeding occurred in 1.3%, 2.0% and 2.9% of patients.To maintain vein graft patency in the first postoperative year by oral anticoagulation, a level within INR range 1.8-3.8 for ≥70% of time seems to be sufficient.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
O Hanon ◽  
J Vidal ◽  
E Chaussade ◽  
J P David ◽  
N Boulloche ◽  
...  

Abstract Background/Introduction Age is one of the strongest predictors/risk factors for ischemic stroke in subjects with atrial fibrillation (AF). Direct oral anticoagulants (DOACs) have been shown to be effective in the prevention of this condition; however, clinical evidence on bleeding risk with this therapeutic strategy in very old and frail geriatric patients is poor. Purpose To assess bleeding risk in French geriatric patients aged ≥80 years and diagnosed with AF newly treated with rivaroxaban. Methods Subjects, presenting to one of 33 geriatric centers, with non-valvular AF and recent initiation of a treatment with rivaroxaban were enrolled in the study and followed-up every 3 months for 12 months. Clinical and routine laboratory data and evaluation scores, such as HAS-BLED, HEMORR2HAGES, ATRIA, and CHA2DS2-VASc, as well as comprehensive geriatric evaluation were reported. Major bleeding, as defined in ROCKET AF study, was reported at each visit, and this primary outcome was adjudicated by an independent committee. Results of this cohort were compared with findings from a similar cohort treated with vitamin K antagonists (VKAs) from the same centers (n=924). Results A total of 1045 subjects were enrolled in the study of whom 995 (95%) had a one-year follow-up (analyzed population). The mean (standard deviation (SD)) age was 86.0 (4.3) years, with the majority of patients being female (61%), 23% aged 90 years or older, and 48% having an estimated glomerular filtration rate (eGFR) <50 mL/min. The main comorbidities were hypertension in 77% of subjects, malnutrition 49%, anemia 43%, dementia 39%, heart failure 36%, and falls 27%. The mean (SD) score for CHA2DS2-VASc was 4.8 (1.4), HAS-BLED 2.4 (0.9), Mini-Mental State Examination (MMSE) 21.5 (6.9), Activities of Daily Living (ADL) 4.4 (1.9), and Charlson Comorbidity Index 6.7 (2.0). The one-year rate of major bleeding events was 6.4% of which 0.8% were fatal and 1.1% intracranial hemorrhages (ICH), whereas the one-year rate of ischemic stroke was 1.4% and all-cause mortality 17.9%. Computed with VKA cohort findings and adjusted for age, gender, eGFR and Charlson score, this would result in a hazard ratio of 0.54 (95% confidence interval [CI], 0.38 to 0.78) for major bleeding, 0.36 (0.17 to 0.76) for ICH, 0.62 (0.29 to 1.33) for ischemic stroke, and 0.82 (0.65 to 1.02) for all-cause mortality, in favor of rivaroxaban. Conclusions This is the first large-scale prospective study in geriatric population in AF subjects treated with DOAC (rivaroxaban) Major bleeding risk appeared higher in very old than younger population, however major bleeding and ICH rates were significantly lower with rivaroxaban than with VKAs when used in the same geriatric population. This study indicates that Rivaroxaban can be used in very old and frail patients for the treatment of non-valvular AF. Acknowledgement/Funding Unrestricted grant from Bayer


BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e005781 ◽  
Author(s):  
Günter Christ ◽  
Jolanta M Siller-Matula ◽  
Marcel Francesconi ◽  
Cornelia Dechant ◽  
Katharina Grohs ◽  
...  

ObjectiveTo evaluate the clinical utility of individualising dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in an all-comers population, including ST-elevation myocardial infarction (STEMI) patients.SettingTertiary care single centre registry.Participants1008 consecutive PCI patients with stent implantation, without exclusion criteria.InterventionPeri-interventional individualisation of DAPT, guided by multiple electrode aggregometry (MEA), to overcome high on-treatment platelet reactivity (HPR) to ADP-induced (≥50 U) and arachidonic acid (AA)-induced aggregation (>35 U).Outcome measuresThe primary efficacy end point was definite stent thrombosis (ST) at 30 days. The primary safety end point was thrombolysis in myocardial infarction (TIMI) major and minor bleeding. Secondary end points were probable ST, myocardial infarction, cardiovascular death and the combined end point: major cardiac adverse event (MACE).Results53% of patients presented with acute coronary syndrome (9% STEMI, 44% non-ST-elevation). HPR to ADP after 600 mg clopidogrel loading occurred in 30% of patients (73±19 U vs 28±11 U; p<0.001) and was treated by prasugrel or ticagrelor (73%), or clopidogrel (27%) reloading (22±12 U; p<0.001). HPR to ADP after prasugrel loading occurred in 2% of patients (82±26 U vs 19±10 U; p<0.001) and was treated with ticagrelor (34±15 U; p=0.02). HPR to AA occurred in 9% of patients with a significant higher proportion in patients with HPR to ADP (22% vs 4%, p<0.001) and was treated with aspirin reloading. Definite ST occurred in 0.09% of patients (n=1); probable ST, myocardial infarction, cardiovascular death and MACE occurred in 0.19% (n=2), 0.09% (n=1) and 1.8% (n=18) of patients. TIMI major and minor bleeding did not differ between patients without HPR and individualised patients (2.6% for both).ConclusionsIndividualisation of DAPT with MEA minimises early thrombotic events in an all-comers PCI population to an unreported degree without increasing bleeding. A randomised multicentre trial utilising MEA seems warranted.Trial registration numberhttp://www.clinicaltrials.gov; NCT01515345.


JAMA ◽  
2014 ◽  
Vol 311 (3) ◽  
pp. 301 ◽  
Author(s):  
Jay H. Traverse ◽  
Timothy D. Henry ◽  
Carl J. Pepine ◽  
James T. Willerson ◽  
Stephen G. Ellis

Heart ◽  
2018 ◽  
Vol 104 (17) ◽  
pp. 1432-1438 ◽  
Author(s):  
Joëlle Elias ◽  
Ivo M van Dongen ◽  
Truls Råmunddal ◽  
Peep Laanmets ◽  
Erlend Eriksen ◽  
...  

BackgroundDuring primary percutaneous coronary intervention (PCI), a concurrent chronic total occlusion (CTO) is found in 10% of patients with ST-elevation myocardial infarction (STEMI). Long-term benefits of CTO-PCI have been suggested; however, randomised data are lacking. Our aim was to determine mid-term and long-term clinical outcome of CTO-PCI versus CTO-No PCI in patients with STEMI with a concurrent CTO.MethodsThe Evaluating Xience and left ventricular function in PCI on occlusiOns afteR STEMI (EXPLORE) was a multicentre randomised trial that included 302 patients with STEMI after successful primary PCI with a concurrent CTO. Patients were randomised to either CTO-PCI or CTO-No PCI. The primary end point of the current study was occurrence of major adverse cardiac events (MACE): cardiac death, coronary artery bypass grafting and MI. Other end points were 1-year left ventricular function (LVF); LV-ejection fraction and LV end-diastolic volume and angina status.ResultsThe median long-term follow-up was 3.9 (2.1–5.0) years. MACE was not significantly different between both arms (13.5% vs 12.3%, HR 1.03, 95% CI 0.54 to 1.98; P=0.93). Cardiac death was more frequent in the CTO-PCI arm (6.0% vs 1.0%, P=0.02) with no difference in all-cause mortality (12.9% vs 6.2%, HR 2.07, 95% CI 0.84 to 5.14; P=0.11). One-year LVF did not differ between both arms. However, there were more patients with freedom of angina in the CTO-PCI arm at 1 year (94% vs 87%, P=0.03).ConclusionsIn this randomised trial involving patients with STEMI with a concurrent CTO, CTO-PCI was not associated with a reduction in long-term MACE compared to CTO-No PCI. One-year LVF was comparable between both treatment arms. The finding that there were more patients with freedom of angina after CTO-PCI at 1-year follow-up needs further investigation.Clinical trial registrationEXPLORE trial number NTR1108 www.trialregister.nl.


Author(s):  
Axel Wester ◽  
Moman A. Mohammad ◽  
Göran Olivecrona ◽  
Jasminka Holmqvist ◽  
Troels Yndigegn ◽  
...  

Background The Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE‐DAPT) score has been shown to predict out‐of‐hospital major bleeding after myocardial infarction treated with percutaneous coronary intervention and dual antiplatelet therapy (DAPT). However, large validation studies have been scarce and the discriminative ability for patients with a preexisting bleeding risk factor (elderly, underweight, women, anemia, kidney dysfunction, or cancer) in a real‐world setting is unknown. Methods and Results Patients undergoing percutaneous coronary intervention for myocardial infarction between 2008 and 2017 were included from the SWEDEHEART (Swedish Web System for Enhancement of Evidence‐Based Care in Heart Disease Evaluated According to Recommended Therapies) registry (n=66 295). The predictive value of the PRECISE‐DAPT score for rehospitalization with major bleeding during dual antiplatelet therapy was evaluated using receiver operating characteristic analyses. A high PRECISE‐DAPT score (≥25; n=13 894) was associated with increased risk of major bleeding (3.9% versus 1.8%; hazard ratio [HR], 2.2; 95% CI, 2.0–2.5; P <0.001) compared with a non‐high score (<25; n=52 401). The score demonstrated a c‐statistic of 0.64 (95% CI, 0.63–0.66). The discriminative ability of the score to further stratify bleeding risk in patients with preexisting bleeding risk factors was poor, especially in patients who are elderly (c‐statistic=0.57; 95% CI, 0.55–0.60) or underweight (c‐statistic=0.56; 95% CI, 0.51–0.61), for whom a non‐high PRECISE‐DAPT score was associated with similar bleeding risk as a high PRECISE‐DAPT score in the general myocardial infarction population. Conclusions In this nationwide population‐based study, the PRECISE‐DAPT score performed moderately in the general myocardial infarction population and poorly in patients with preexisting bleeding risk factors, where its usefulness seems limited.


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