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1.
Eur Heart J Cardiovasc Pharmacother ; 6(1): 31-42, 2020 01 01.
Article En | MEDLINE | ID: mdl-31511896

AIMS: The aim of the present study was to establish the safety and efficacy profile of prasugrel and ticagrelor in real-life acute coronary syndrome (ACS) patients with renal dysfunction. METHODS AND RESULTS: All consecutive patients from RENAMI (REgistry of New Antiplatelets in patients with Myocardial Infarction) and BLEEMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registries were stratified according to estimated glomerular filtration rate (eGFR) lower or greater than 60 mL/min/1.73 m2. Death and myocardial infarction (MI) were the primary efficacy endpoints. Major bleedings (MBs), defined as Bleeding Academic Research Consortium bleeding types 3 to 5, constituted the safety endpoint. A total of 19 255 patients were enrolled. Mean age was 63 ± 12; 14 892 (77.3%) were males. A total of 2490 (12.9%) patients had chronic kidney disease (CKD), defined as eGFR <60 mL/min/1.73 m2. Mean follow-up was 13 ± 5 months. Mortality was significantly higher in CKD patients (9.4% vs. 2.6%, P < 0.0001), as well as the incidence of reinfarction (5.8% vs. 2.9%, P < 0.0001) and MB (5.7% vs. 3%, P < 0.0001). At Cox multivariable analysis, potent P2Y12 inhibitors significantly reduced the mortality rate [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.54-0.96; P = 0.006] and the risk of reinfarction (HR 0.53, 95% CI 0.30-0.95; P = 0.033) in CKD patients as compared to clopidogrel. The reduction of risk of reinfarction was confirmed in patients with preserved renal function. Potent P2Y12 inhibitors did not increase the risk of MB in CKD patients (HR 1.00, 95% CI 0.59-1.68; P = 0.985). CONCLUSION: In ACS patients with CKD, prasugrel and ticagrelor are associated with lower risk of death and recurrent MI without increasing the risk of MB.


Acute Coronary Syndrome/drug therapy , Glomerular Filtration Rate , Kidney/physiopathology , Myocardial Infarction/drug therapy , Platelet Aggregation Inhibitors/administration & dosage , Prasugrel Hydrochloride/administration & dosage , Purinergic P2Y Receptor Antagonists/administration & dosage , Renal Insufficiency, Chronic/physiopathology , Ticagrelor/administration & dosage , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/mortality , Aged , Aged, 80 and over , Female , Hemorrhage/chemically induced , Humans , Male , Middle Aged , Myocardial Infarction/diagnosis , Myocardial Infarction/mortality , Platelet Aggregation Inhibitors/adverse effects , Prasugrel Hydrochloride/adverse effects , Purinergic P2Y Receptor Antagonists/adverse effects , Recurrence , Registries , Renal Insufficiency, Chronic/diagnosis , Renal Insufficiency, Chronic/mortality , Retrospective Studies , Risk Assessment , Risk Factors , Ticagrelor/adverse effects , Time Factors , Treatment Outcome
2.
Am J Cardiovasc Drugs ; 20(3): 259-269, 2020 Jun.
Article En | MEDLINE | ID: mdl-31586336

INTRODUCTION: Real-life data comparing clopidogrel, prasugrel, and ticagrelor for unselected patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) are lacking, as are data for the temporal distribution of ischemic and bleeding risks. METHODS: A total of 19,825 patients were enrolled from the RENAMI and BleeMACS registries. Both were multicenter, retrospective, observational registries including the data and outcomes of consecutive patients with ACS who underwent primary PCI and were discharged with dual antiplatelet therapy (DAPT). We evaluated the long-term outcome stratified by the different antiplatelet agents. RESULTS: A total of 14,105 patients (71.2%) were treated with clopidogrel, 2364 patients (11.9%) with prasugrel and 3356 patients (16.9%) with ticagrelor. After propensity score matching, at 1 year, prasugrel reduced the incidence of net adverse clinical events (NACE; a composite endpoint of all-cause death, myocardial infarction [MI] and Bleeding Academic Research Consortium [BARC] 3-5 bleeding) (4.2% vs.7.6%, p = 0.002) and of major adverse cardiovascular events (MACE; a composite endpoint of death and MI) compared with clopidogrel (2.6% vs. 5.2%, p = 0.007). Ticagrelor decreased rates of MACE compared with clopidogrel (2.7% vs. 6.2%, p < 0.001), but not of NACE (6.6% vs. 8.7%, p = 0.07). Ticagrelor presented similar performance in terms of MACE compared with prasugrel (2.8% vs. 2.4%, p = 0.56), with a trend towards a reduction in MI (0.2% vs. 0.4%, p = 0.56), but with higher risk of BARC 3-5 bleedings (3.8% vs. 1.7%, p = 0.04). In the daily risk analysis, clopidogrel presented a binomial distribution with a peak of ischemic risk at 3 months, which decreased towards bleedings; prasugrel had a constant equivalence between opposite risks; and ticagrelor constantly reduced recurrent MIs despite higher risk of BARC 3-5 events. CONCLUSION: In real life, ticagrelor is more effective in reducing ischemic events during the first year after ACS, despite an increased risk of major bleedings, while prasugrel assures a better balance between ischemic and bleeding recurrent events.


Acute Coronary Syndrome/surgery , Clopidogrel , Hemorrhage , Myocardial Infarction , Percutaneous Coronary Intervention , Prasugrel Hydrochloride , Ticagrelor , Acute Coronary Syndrome/epidemiology , Clopidogrel/administration & dosage , Clopidogrel/adverse effects , Clopidogrel/pharmacokinetics , Europe/epidemiology , Female , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Male , Medication Therapy Management/statistics & numerical data , Middle Aged , Mortality , Myocardial Infarction/epidemiology , Myocardial Infarction/prevention & control , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/pharmacokinetics , Prasugrel Hydrochloride/administration & dosage , Prasugrel Hydrochloride/adverse effects , Prasugrel Hydrochloride/pharmacokinetics , Registries/statistics & numerical data , Risk Adjustment/methods , Therapeutic Equivalency , Ticagrelor/administration & dosage , Ticagrelor/adverse effects , Ticagrelor/pharmacokinetics
3.
Int J Cardiol ; 301: 200-206, 2020 02 15.
Article En | MEDLINE | ID: mdl-31785951

BACKGROUND: The PRECISE-DAPT and PARIS risk scores (RSs) were recently developed to help clinicians at individualizing the optimal dual antiplatelet therapy duration (DAPT) after percutaneous coronary intervention (PCI). Nevertheless, external validation of these RSs it has not yet been performed in ACS (acute coronary syndrome) patients treated with prasugrel or ticagrelor in a real- world scenario. METHODS: 4424 ACS patients who underwent PCI and survived to hospital discharge, from January 2012 to December 2016 at 12 European centers, were included. PRECISE-DAPT and PARIS bleeding RS, as well as PARIS ischemic RS, were computed, and their performance at predicting major bleeding (MB; BARC type 3 or 5) and ischemic events (MI and stent thrombosis) during follow up was compared. RESULTS: After a median follow-up of 14 (interquartile range 12-20.9) months, 83 (1.88%) patients developed MB and 133 (3.0%) suffered an ischemic episode. PRECISE-DAPT performed better than PARIS bleeding RS (c-statistic = 0.653 vs. 0.593; p = .01 for comparison) in predicting MB. The RSs performance for MB prediction remained consistent in STEMI patients (c-statistic = 0.632 vs 0.575) or in those treated with prasugrel (c-statistic = 0.623 vs 0.586). PARIS ischemic RS exhibited superior discrimination in predicting ischemic complications compared to PRECISE-DAPT (c-statistic = 0.604 vs 0.568 p = .05 for comparison). CONCLUSION: Our data provide support to the use of PRECISE-DAPT in MB risk stratification for patients receiving DAPT in form of aspirin and prasugrel or ticagrelor whereas the PARIS ischemic RS has potential to complement the risk prediction with respect to ischemic events.


Acute Coronary Syndrome/surgery , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Postoperative Complications/epidemiology , Prasugrel Hydrochloride/therapeutic use , Ticagrelor/therapeutic use , Aged , Aspirin/therapeutic use , Drug Therapy, Combination , Female , Humans , Male , Middle Aged , Reproducibility of Results , Retrospective Studies , Risk Assessment , Treatment Outcome
4.
Am J Cardiovasc Drugs ; 19(5): 487-495, 2019 Oct.
Article En | MEDLINE | ID: mdl-30924021

INTRODUCTION: The goal of this study was to determine the association between the use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) and follow-up heart failure (HF) according to left ventricular ejection fraction (LVEF) in patients with acute myocardial infarction (AMI). METHODS: This cohort study used a retrospective registry of 8169 consecutive patients discharged with a diagnosis of AMI from two university hospitals in Spain between 2010 and 2016. We used a multivariable competing risk analysis, survival-time inverse probability weighting (IPW) propensity score adjusting, and propensity score matching (PSM) to investigate the association between ACEI/ARB treatment and follow-up HF. RESULTS: During the follow-up (3.3 ± 2.2 years), 1296 patients were admitted for HF (5.2 per 100 person-years). ACEI/ARB use was not associated with fewer follow-up HF admissions in patients with LVEF > 40% (univariate analysis: sub-hazard ratio [sHR] 1.10; 95% confidence interval [CI] 0.95-1.27; p = 0.197; IPW adjusting analysis: sHR 1.11; 95% CI 0.95-1.29; p = 0.192; PSM analysis: sHR 1.12; 95% CI 0.92-1.36; p = 0.248). However, ACEI/ARB use was associated with a significant reduction in HF admission rates in patients with LVEF ≤ 40% (univariate analysis: HR 0.70; 95% CI 0.56-0.88; p = 0.003; IPW adjusting analysis: HR 0.64; 95% CI 0.50-0.83; p = 0.001; PSM analysis: HR 0.65; 95% CI 0.46-0.92; p = 0.014). CONCLUSION: Among hospitalized survivors of AMI, the use of ACEIs/ARBs was associated with a lower risk of follow-up HF in patients with LVEF ≤ 40% but not in those with LVEF > 40%. Further prospective studies are needed to confirm our results.


Angiotensin Receptor Antagonists/adverse effects , Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/adverse effects , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Heart Failure/chemically induced , Myocardial Infarction/drug therapy , Renin-Angiotensin System/drug effects , Ventricular Function, Left/drug effects , Aged , Female , Heart Failure/metabolism , Hospitalization , Humans , Male , Myocardial Infarction/metabolism , Propensity Score , Proportional Hazards Models , Registries , Retrospective Studies , Spain , Stroke Volume/drug effects , Time Factors
5.
Rev. esp. cardiol. (Ed. impr.) ; 71(10): 829-836, oct. 2018. tab, graf
Article Es | IBECS | ID: ibc-178825

Introducción y objetivos: El impacto de un infarto de miocardio (IM) sobre la mortalidad, comparado con la gravedad de la hemorragia ocurrida tras el alta por síndrome coronario agudo, no está bien caracterizado. Definir esta relación puede ayudar a que se logre un balance riesgo-beneficio terapéutico favorable. Métodos: Utilizando modelos de Cox con fragilidad compartida, se evaluó la relación de la mortalidad con el IM y la gravedad de la hemorragia -clasificada según el Bleeding Academic Research Consortium (BARC)- en 4.229 pacientes con síndrome coronario agudo tratados con coronariografía entre enero de 2012 y diciembre de 2015. Resultados: Tanto el IM como la hemorragia se asociaron con la mortalidad (respectivamente HR = 5,8; IC95%, 3,7-9,8, y HR = 5,1; IC95%, 3,6-7,7). El IM tuvo mayor impacto en la mortalidad que las hemorragias BARC 2 y 3a: (RRR = 3,8 y RRR = 1,9; p < 0,05), pero equivalente al de las BARC 3b (RRR = 0,9; p = 0,88). El riesgo de muerte tras el IM fue menor que tras una hemorragia BARC 3c (RRR = 0,25; p < 0,001). La mortalidad tras un IM fue mayor entre los pacientes en tratamiento antiagregante plaquetario doble (TAPD) (HR = 2,9; IC95%, 1,8-4,5) que entre aquellos sin TAPD (HR = 1,5; IC95%, 0,7-3,4). Sin embargo, tras una hemorragia la mortalidad fue menor entre los pacientes en TAPD (HR = 1,6; IC95%, 1,1-2,6) que sin TAPD (HR = 3,2; IC95%, 1,7-5,8). Conclusiones: El efecto en la mortalidad del IM o las hemorragias tras el alta por un síndrome coronario agudo depende de la gravedad de la hemorragia. Estar en TAPD en el momento del IM o la hemorragia es un modificador del ulterior riesgo de muerte


Introduction and objectives: The impact on mortality of myocardial infarction (MI) compared with the specific degree of bleeding severity occurring after discharge in acute coronary syndrome is poorly characterized. Defining this relationship may help to achieve a favorable therapeutic risk-benefit balance. Methods: Using Cox-based shared frailty models, we assessed the relationship between mortality and postdischarge MI and bleeding severity-graded according to Bleeding Academic Research Consortium (BARC)-in 4229 acute coronary syndrome patients undergoing in-hospital coronary arteriography between January 2012 and December 2015. Results: Both MI (HR, 5.8; 95%CI, 3.7-9.8) and bleeding (HR, 5.1; 95%CI, 3.6-7.7) were associated with mortality. Myocardial infarction had a stronger impact on mortality than BARC type 2 and 3a bleedings: (RRr, 3.8 and 1.9; P < .05), respectively, but was equivalent to BARC type 3b (RRr, 0.9; P = .88). Mortality risk after MI was significantly lower than after BARC type 3c bleeding (RRr, 0.25; P < .001). Mortality was higher after an MI in patients on dual antiplatelet therapy (DAPT) at the time of the event (HR, 2.9; 95%CI, 1.8-4.5) than in those off-DAPT (HR, 1.5; 95%CI, 0.7-3.4). In contrast, mortality was lower after a bleeding event in patients on-DAPT (HR, 1.6; 95%CI, 1.1-2.6) than in those off-DAPT (HR, 3.2; 95%CI, 1.7-5.8). Conclusions: The differential effect on mortality of a postdischarge MI vs bleeding largely depends on bleeding severity. The DAPT status at the time of MI or bleeding is a modifier of subsequent mortality risk


Humans , Male , Female , Middle Aged , Aged , Acute Coronary Syndrome/complications , Myocardial Infarction/complications , Hemorrhage/epidemiology , Fibrinolytic Agents/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/therapy , Myocardial Infarction/physiopathology , Myocardial Infarction/mortality , Retrospective Studies , Severity of Illness Index
6.
Rev Esp Cardiol (Engl Ed) ; 71(10): 829-836, 2018 Oct.
Article En, Es | MEDLINE | ID: mdl-29656987

INTRODUCTION AND OBJECTIVES: The impact on mortality of myocardial infarction (MI) compared with the specific degree of bleeding severity occurring after discharge in acute coronary syndrome is poorly characterized. Defining this relationship may help to achieve a favorable therapeutic risk-benefit balance. METHODS: Using Cox-based shared frailty models, we assessed the relationship between mortality and postdischarge MI and bleeding severity-graded according to Bleeding Academic Research Consortium (BARC)-in 4229 acute coronary syndrome patients undergoing in-hospital coronary arteriography between January 2012 and December 2015. RESULTS: Both MI (HR, 5.8; 95%CI, 3.7-9.8) and bleeding (HR, 5.1; 95%CI, 3.6-7.7) were associated with mortality. Myocardial infarction had a stronger impact on mortality than BARC type 2 and 3a bleedings: (RRr, 3.8 and 1.9; P < .05), respectively, but was equivalent to BARC type 3b (RRr, 0.9; P = .88). Mortality risk after MI was significantly lower than after BARC type 3c bleeding (RRr, 0.25; P < .001). Mortality was higher after an MI in patients on dual antiplatelet therapy (DAPT) at the time of the event (HR, 2.9; 95%CI, 1.8-4.5) than in those off-DAPT (HR, 1.5; 95%CI, 0.7-3.4). In contrast, mortality was lower after a bleeding event in patients on-DAPT (HR, 1.6; 95%CI, 1.1-2.6) than in those off-DAPT (HR, 3.2; 95%CI, 1.7-5.8). CONCLUSIONS: The differential effect on mortality of a postdischarge MI vs bleeding largely depends on bleeding severity. The DAPT status at the time of MI or bleeding is a modifier of subsequent mortality risk.


Acute Coronary Syndrome/complications , Drug-Eluting Stents , Hemorrhage/epidemiology , Myocardial Infarction/mortality , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors/adverse effects , Risk Assessment/methods , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/therapy , Aged , Coronary Angiography , Female , Follow-Up Studies , Hemorrhage/chemically induced , Hemorrhage/diagnosis , Humans , Male , Middle Aged , Myocardial Infarction/diagnosis , Myocardial Infarction/etiology , Platelet Aggregation Inhibitors/therapeutic use , Prognosis , Retrospective Studies , Severity of Illness Index , Spain/epidemiology , Survival Rate/trends , Time Factors
7.
Cardiorenal Med ; 7(3): 179-187, 2017 Jun.
Article En | MEDLINE | ID: mdl-28736558

BACKGROUND: Kidney dysfunction (KD) has been associated with increased risk for major bleeding (MB) in patients with acute coronary syndromes (ACS) and may be in part related to an underuse of evidence-based therapies. Our aim was to assess the predictive ability of the Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines (CRUSADE) risk score in patients with concomitant ACS and chronic kidney disease. METHODS: We conducted a retrospective analysis of a prospective registry including 1,587 ACS patients. In-hospital MB was prospectively recorded according to the CRUSADE and Bleeding Academic Research Consortium (BARC) criteria. KD was defined as an estimated glomerular filtration rate <60 mL/min/1.73 m2. RESULTS: The predictive ability of the CRUSADE risk score was assessed by discrimination and calibration analyses. A total of 465 (29%) subjects had KD. In multivariate logistic regression analyses, we found high CRUSADE risk score values to be associated with a higher rate of in-hospital MB; however, among patients with KD, it was not associated with BARC MB. Regardless of the MB definition, the predictive ability of the CRUSADE score in patients with KD was lower: area under the curve (AUC) 0.71 versus 0.79, p = 0.03 for CRUSADE MB and AUC 0.65 versus 0.75, p = 0.02 for BARC MB. Hosmer-Lemeshow analyses showed a good calibration in all renal function subgroups for both MB definitions (all p values >0.3). CONCLUSIONS: The CRUSADE risk score shows a lower accuracy for predicting in-hospital MB in KD patients compared to those without KD.

9.
Clin Cardiol ; 39(9): 507-15, 2016 Sep.
Article En | MEDLINE | ID: mdl-27249221

BACKGROUND: Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations estimate glomerular filtration rate (GFR) more accurately than the Modification of Diet in Renal Disease (MDRD) equation. HYPOTHESIS: New CKD-EPI equations improve risk stratification in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and provide complementary information to the Global Registry of Acute Coronary Events (GRACE) risk score. METHODS: We studied 350 subjects (mean age, 68 ± 12 years; 70% male) with NSTE-ACS. Estimated GFR was calculated using the MDRD and new CKD-EPI equations based on serum creatinine (SCr) and/or cystatin C (CysC) concentrations obtained within 48 hours of hospital admission. The primary endpoint was all-cause death during follow-up. RESULTS: Over the study period (median, 648 days [interquartile range, 236-1042 days]), 31 patients died (0.05% events per person-year). Decedents had poorer renal-function parameters (P < 0.001). Both CysC-based CKD-EPI equations had the highest areas under the receiver operating characteristic curve for the prediction of all-cause mortality. After multivariate adjustment, only CysC-based CKD-EPI equations were independent predictors of all-cause mortality (CKD-EPISCr - CysC , per mL/min/1.73 m(2) : hazard ratio: 0.975, 95% confidence interval: 0.956-0.994, P = 0.009; CKD-EPICysC , per mL/min/1.73 m(2) : hazard ratio: 0.976, 95% confidence interval: 0.959-0.993, P = 0.005). Reclassification analyses showed that only CysC-based CKD-EPI equations improved predictive accuracy of the GRACE risk score. CONCLUSIONS: In patients with NSTE-ACS, CysC-based CKD-EPI equations improved clinical risk stratification for mortality and added complementary prognostic information to the GRACE risk score.


Acute Coronary Syndrome/complications , Glomerular Filtration Rate , Kidney/physiopathology , Models, Biological , Non-ST Elevated Myocardial Infarction/complications , Renal Insufficiency, Chronic/diagnosis , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/mortality , Acute Coronary Syndrome/physiopathology , Aged , Aged, 80 and over , Area Under Curve , Biomarkers/blood , Creatinine/blood , Cystatin C/blood , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Non-ST Elevated Myocardial Infarction/diagnosis , Non-ST Elevated Myocardial Infarction/mortality , Non-ST Elevated Myocardial Infarction/physiopathology , Predictive Value of Tests , Prognosis , Proportional Hazards Models , ROC Curve , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/mortality , Renal Insufficiency, Chronic/physiopathology , Risk Assessment , Risk Factors , Time Factors
11.
J Geriatr Cardiol ; 13(1): 15-22, 2016 Jan.
Article En | MEDLINE | ID: mdl-26918008

OBJECTIVE: To assess the differences in incidence, clinical features, current treatment strategies and outcome in patients with type-2 vs. type-1 acute myocardial infarction (AMI). METHODS: We included 824 consecutive patients with a diagnosis of type-1 or type-2 AMI. During index hospitalization, clinical features and treatment strategies were collected in detail. At 1-year follow-up, mortality, stroke, non-fatal myocardial infarction and major bleeding were recorded. RESULTS: Type-1 AMI was present in 707 (86%) of the cases while 117 (14%) were classified as type-2. Patients with type-2 AMI were more frequently female and had higher co-morbidities such as diabetes, previous non-ST segment elevation acute coronary syndromes, impaired renal function, anaemia, atrial fibrillation and malignancy. However, preserved left ventricular ejection fraction and normal coronary arteries were more frequently seen, an invasive treatment was less common, and anti-platelet medications, statins and beta-blockers were less prescribed in patients with type-2 AMI. At 1-year follow-up, type-2 AMI was associated with a higher crude mortality risk (HR: 1.75, 95% CI: 1.14-2.68; P = 0.001), but this association did not remain significant after multivariable adjustment (P = 0.785). Furthermore, we did not find type-2 AMI to be associated with other clinical outcomes. CONCLUSIONS: In this real-life population, compared with type-1, type-2 AMI were predominantly women and had more co-morbidities. Invasive treatment strategies and cardioprotective medications were less used in type-2, while the 1-year clinical outcomes were similar.

12.
Am J Cardiol ; 117(7): 1047-54, 2016 Apr 01.
Article En | MEDLINE | ID: mdl-26857164

Risk assessment plays a major role in the management of acute coronary syndrome. The aim was to compare the performance of the Global Registry of Acute Coronary Events (GRACE) and the Can Rapid risk stratification of Unstable angina patients Suppress Adverse outcomes with Early implementation of the American College of Cardiology/American Heart Asociation guidelines (CRUSADE) risk scores to predict in-hospital mortality and major bleeding (MB) in 1,587 consecutive patients with acute coronary syndrome. In-hospital deaths and bleeding complications were prospectively collected. Bleeding complications were defined according to CRUSADE and Bleeding Academic Research Consortium (BARC) criteria. During the hospitalization, 71 patients (4.5%) died, 37 patients (2.3%) had BARC MB and 34 patients (2.1%) had CRUSADE MB. Receiver operating characteristic curves analyses showed GRACE risk score has better discrimination capacity than CRUSADE risk score for both, mortality (0.86 vs 0.79; p = 0.018) and BARC MB (0.80 vs 0.73; p = 0.028), but similar for CRUSADE MB (0.79 vs 0.79; p = 0.921). Both scores had low discrimination for predicting MB in the elderly (>75 years) and patients with atrial fibrillation, whereas CRUSADE risk score was especially poor for predicting MB in patients with <60 ml/min/1.73 m(2) or those treated with new antiplatelets. Reclassification analyses showed GRACE risk score was associated with a significant improvement in the predictive accuracy of CRUSADE risk score for predicting mortality (net reclassification improvement: 22.5%; p <0.001) and MB (net reclassification improvement: 17.6%; p = 0.033) but not for CRUSADE MB. In conclusion, GRACE risk score has a better predictive performance for predicting both in-hospital mortality and BARC MB. In light of these findings, we propose the GRACE score as a single score to predict these in-hospital complications.


Acute Coronary Syndrome/epidemiology , Angina, Unstable/complications , Angina, Unstable/therapy , Hemorrhage/epidemiology , Registries , Acute Coronary Syndrome/diagnosis , Aged , Aged, 80 and over , Angina, Unstable/diagnosis , Clinical Protocols , Female , Hemorrhage/diagnosis , Hospital Mortality , Humans , Male , Middle Aged , ROC Curve , Retrospective Studies , Risk Assessment
15.
Eur J Clin Invest ; 45(4): 385-93, 2015 Apr.
Article En | MEDLINE | ID: mdl-25661774

BACKGROUND: Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations estimate glomerular filtration rate more accurately than the Modification of Diet in Renal Disease (MDRD) Study equation. Our aim was to evaluate whether CKD-EPI equations based on serum creatinine and/or cystatin C (CysC) predict risk for major bleeding (MB) more accurately than the MDRD Study equation in patients with non-ST-segment elevation acute coronary syndromes (ACS). MATERIALS AND METHODS: Three hundred and fifty consecutive subjects with non-ST-segment elevation ACS (68 ± 12 years, 70% male) were studied. Glomerular filtration rate was estimated using the CKD-EPI and MDRD Study equations. The primary endpoint was the occurrence of MB during the follow-up, which was defined according to the Bleeding Academic Research Consortium Definition criteria as bleeding types 3-5. RESULTS: During the median follow-up of 589 days (interquartile range, 390-986), 27 patients had MB (0.04% events per person year). Patients with MB had worse kidney function parameters, regardless of the estimating equation used (P < 0.001). After multivariate Cox regression adjustment, both CysC-based CKD-EPI equations were independent predictors of MB (CKD-EPI(creatinine-cystatin) C per mL/min/1.73 m(2), HR = 0.973 (95%CI 0.955-0.991; P = 0.003) and CKD-EPI(cystatin) C per mL/min/1.73 m(2), HR = 0.976 (95%CI 0.976-0.992; P = 0.003), while the CKD-EPI(creatinine) and MDRD equations did not achieve statistical significance. Both CKD-EPI(creatine-cystatin) C and CKD-EPI(cystatin) C were associated with a significant improvement in MB risk reclassification. CONCLUSIONS: In this cohort of non-ST-segment elevation ACS patients with relatively preserved renal function, both CysC-based CKD-EPI equations improved ability to predict risk for MB and were superior to other equations for this application.


Acute Coronary Syndrome/metabolism , Algorithms , Creatinine/metabolism , Cystatin C/metabolism , Glomerular Filtration Rate , Hemorrhage/metabolism , Acute Coronary Syndrome/epidemiology , Aged , Aged, 80 and over , Cohort Studies , Decision Support Techniques , Female , Hemorrhage/epidemiology , Humans , Male , Middle Aged , Multivariate Analysis , Prognosis , Proportional Hazards Models , Prospective Studies , Risk Assessment , Spain
17.
Rev. esp. cardiol. (Ed. impr.) ; 67(10): 830-836, oct. 2014. ilus, tab
Article Es | IBECS | ID: ibc-128287

Introducción y objetivos El ancho de distribución eritrocitaria se ha relacionado con incremento del riesgo hemorrágico intrahospitalario en pacientes con síndrome coronario agudo sin elevación del ST. Sin embargo, se desconoce su utilidad para predecir complicaciones hemorrágicas tras el ingreso hospitalario. El objetivo fue evaluar el papel complementario del ancho de distribución eritrocitaria sobre la escala CRUSADE en la predicción del riesgo a largo plazo de hemorragias en estos pacientes. Métodos Se midió el ancho de distribución eritrocitaria al ingreso en 293 pacientes con síndrome coronario agudo sin elevación del ST; a todos se les dio seguimiento clínico y se registró la aparición de hemorragias mayores, definidas según los criterios del Bleeding Academic Research Consortium. Resultados Durante un seguimiento de 782 [intervalo intercuartílico, 510-1.112] días, 30 pacientes (10,2%) presentaron eventos hemorrágicos. El análisis por cuartiles reveló un incremento abrupto de hemorragias a partir del cuarto cuartil (> 14,9%; p = 0,001). Tras el análisis multivariable, el ancho de distribución eritrocitaria >14,9% se asoció con mayor riesgo de eventos (hazard ratio=2,67; intervalo de confianza del 95%, 1,17-6,10; p = 0,02). Los pacientes con valores ≤ 14,9% y CRUSADE ≤ 40 presentaron las menores tasas de hemorragias, mientras que los pacientes con valores >14,9% y CRUSADE >40 puntos (alto y muy alto riesgo) presentaron las mayores (log rank test, p < 0,001). Además, la adición del ancho de distribución eritrocitaria a la escala CRUSADE para predecir hemorragias mostró tasas de mejora integrada del 5,2% (p < 0,001) y de reclasificación del 10% (p = 0,001). CONCLUSIONES: Los valores elevados del ancho de distribución eritrocitaria se asocian a mayor riesgo hemorrágico y aportan información adicional a la escala CRUSADE


Introduction and objectives Red cell distribution width has been linked to an increased risk for in-hospital bleeding in patients with non-ST-segment elevation acute coronary syndrome. However, its usefulness for predicting bleeding complications beyond the hospitalization period remains unknown. Our aim was to evaluate the complementary value of red cell distribution width and the CRUSADE scale to predict long-term bleeding risk in these patients. Methods Red cell distribution width was measured at admission in 293 patients with non-ST-segment elevation acute coronary syndrome. All patients were clinically followed up and major bleeding events were recorded (defined according to Bleeding Academic Research Consortium Definition criteria). Results During a follow-up of 782 days [interquartile range, 510-1112 days], events occurred in 30 (10.2%) patients. Quartile analyses showed an abrupt increase in major bleedings at the fourth red cell distribution width quartile (> 14.9%; P = .001). After multivariate adjustment, red cell distribution width >14.9% was associated with higher risk of events (hazard ratio = 2.67; 95% confidence interval, 1.17-6.10; P=.02). Patients with values≤14.9% and a CRUSADE score≤40 had the lowest events rate, while patients with values >14.9% and a CRUSADE score >40 points (high and very high risk) had the highest rate of bleeding (log rank test, P<.001). Further, the addition of red cell distribution width to the CRUSADE score for the prediction of major bleeding had a significant integrated discrimination improvement of 5.2% (P<.001) and a net reclassification improvement of 10% (P=.001). Conclusions: In non–ST-segment elevation acute coronary syndrome patients, elevated red cell distribution width is predictive of increased major bleeding risk and provides additional information to the CRUSADE scale


Humans , Erythrocyte Volume , Acute Coronary Syndrome/physiopathology , Hemorrhage/epidemiology , Risk Factors , Hemorrhagic Disorders/epidemiology
19.
Rev Esp Cardiol (Engl Ed) ; 67(10): 830-6, 2014 Oct.
Article En | MEDLINE | ID: mdl-25262129

INTRODUCTION AND OBJECTIVES: Red cell distribution width has been linked to an increased risk for in-hospital bleeding in patients with non-ST-segment elevation acute coronary syndrome. However, its usefulness for predicting bleeding complications beyond the hospitalization period remains unknown. Our aim was to evaluate the complementary value of red cell distribution width and the CRUSADE scale to predict long-term bleeding risk in these patients. METHODS: Red cell distribution width was measured at admission in 293 patients with non-ST-segment elevation acute coronary syndrome. All patients were clinically followed up and major bleeding events were recorded (defined according to Bleeding Academic Research Consortium Definition criteria). RESULTS: During a follow-up of 782 days [interquartile range, 510-1112 days], events occurred in 30 (10.2%) patients. Quartile analyses showed an abrupt increase in major bleedings at the fourth red cell distribution width quartile (> 14.9%; P=.001). After multivariate adjustment, red cell distribution width >14.9% was associated with higher risk of events (hazard ratio=2.67; 95% confidence interval, 1.17-6.10; P=.02). Patients with values ≤ 14.9% and a CRUSADE score ≤ 40 had the lowest events rate, while patients with values >14.9% and a CRUSADE score >40 points (high and very high risk) had the highest rate of bleeding (log rank test, P<.001). Further, the addition of red cell distribution width to the CRUSADE score for the prediction of major bleeding had a significant integrated discrimination improvement of 5.2% (P<.001) and a net reclassification improvement of 10% (P=.001). CONCLUSIONS: In non-ST-segment elevation acute coronary syndrome patients, elevated red cell distribution width is predictive of increased major bleeding risk and provides additional information to the CRUSADE scale.


Acute Coronary Syndrome/complications , Erythrocyte Indices , Hemorrhage/etiology , Acute Coronary Syndrome/blood , Aged , Erythrocyte Indices/physiology , Female , Hemorrhage/blood , Humans , Male , Myocardial Infarction/blood , Myocardial Infarction/complications , Prospective Studies , Risk Factors
20.
Circ J ; 77(8): 2088-96, 2013.
Article En | MEDLINE | ID: mdl-23698027

BACKGROUND: Beta-trace protein (BTP) and cystatin C (CysC) are novel biomarkers of renal function. We assessed the ability of both to predict major bleeding (MB) in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS), compared to other renal function parameters and clinical risk scores. METHODS AND RESULTS: We included 273 patients. Blood samples were obtained within 24h of admission. The endpoint was MB. During a follow-up of 760 days (411-1,098 days), 25 patients (9.2%) had MB. Patients with MB had higher concentrations of BTP (0.98 mg/L; 0.71-1.16 mg/L vs. 0.72 mg/L, 0.60-0.91 mg/L, P=0.002), CysC (1.05 mg/L; 0.91-1.30 mg/L vs. 0.90 mg/L, 0.75-1.08 mg/L, P=0.003), higher CRUSADE score (39 ± 16 points vs. 29 ± 15 points, P=0.002) and lower estimated glomerular filtration rate (eGFR; 66 ± 27 vs. 80 ± 30 ml·min(-1)·1.73 m(-2), P=0.02) than patients without MB; there was no difference in creatinine level between the groups (P=0.14). After multivariable adjustment, both were predictors of MB, while eGFR and creatinine did not achieve statistical significance. Among subjects with eGFR >60 ml·min(-1)·1.73 m(-2), those with elevated concentrations of both biomarkers had a significantly higher risk for MB. Net reclassification indexes from the addition of BTP and CysC to CRUSADE risk score were 38% and 21% respectively, while the relative integrated discrimination indexes were 12.5% and 3.8%. CONCLUSIONS: Among NSTE-ACS patients, BTP and CysC were superior to conventional renal parameters for predicting MB, and improved clinical stratification for hemorrhagic risk.


Acute Coronary Syndrome/blood , Cystatin C/blood , Hemorrhage/blood , Intramolecular Oxidoreductases/blood , Lipocalins/blood , Acute Coronary Syndrome/complications , Acute Coronary Syndrome/physiopathology , Aged , Aged, 80 and over , Biomarkers/blood , Creatinine/blood , Female , Follow-Up Studies , Hemorrhage/etiology , Hemorrhage/physiopathology , Humans , Kidney Function Tests , Male , Middle Aged , Prospective Studies , Risk Factors
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