Prediction of Post-Discharge Bleeding in Elderly Patients with Acute Coronary Syndromes: Insights from the BleeMACS Registry

Background A poor ability of recommended risk scores for predicting in-hospital bleeding has been reported in elderly patients with acute coronary syndromes (ACS). No study assessed the prediction of post-discharge bleeding in the elderly. The new BleeMACS score (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome), was designed to predict post-discharge bleeding in ACS patients. We aimed to assess the predictive ability of the BleeMACS score in elderly patients. Methods We assessed the incidence and characteristics of severe bleeding after discharge in ACS patients aged ≥ 75 years. Bleeding was defined as any intracranial bleeding or bleeding leading to hospitalization and/or red blood transfusion, occurring within the first year after discharge. We assessed the predictive ability of the BleeMACS score according to age by Fine-Gray proportional hazards regression analysis, calculating receiver-operating characteristic (ROC) curves and the area under the ROC curves (AUC). Results The BleeMACS registry included 15,401 patients of whom 3,376/15,401 (21.9%) were aged ≥ 75 years. Elderly patients were more commonly treated with clopidogrel and less often treated with ticagrelor or prasugrel. Of 3,376 elderly patients, 190 (5.6%) experienced post-discharge bleeding. The incidence of bleeding was moderately higher in elderly patients (hazard ratio [HR], 2.31, 95% confidence interval [CI], 1.92-2.77). The predictive ability of the BleeMACS score was moderately lower in elderly patients (AUC, 0.652 vs. 0.691, p = 0.001). Conclusion Elderly patients with ACS had a significantly higher incidence of post-discharge bleeding. Despite a lower predictive ability in older patients, the BleeMACS score exhibited an acceptable performance in these patients

Association of Beta-Blockers with Survival on Patients Presenting with ACS Treated with PCI: A Propensity Score Analysis from the BleeMACS Registry

Purpose: The aim was to evaluate prognostic value of beta-blocker (BB) administration in acute coronary syndromes (ACS) patients in the percutaneous coronary intervention (PCI) era. Methods and Results: The BleeMACS project is a multicenter, observational, retrospective registry enrolling patients with ACS worldwide in 15 hospitals. Patients discharged with BB therapy were compared to those discharged without a BB before and after propensity score with matching. The primary endpoint was all-cause mortality at 1 year. Secondary endpoints included in-hospital reinfarction, in-hospital heart failure, 1-year myocardial infarction, 1-year bleeding and 1-year composite of death and recurrent myocardial infarction. After matching, 2935 patients for each group were enrolled. The primary endpoint of 1-year death was significantly lower in the group on BB therapy (4.5 vs 7%, p < 0.05), while only a trend was noted for recurrent acute myocardial infarction (4.5 vs 4.9%, p = 0.54). These results were consistent for patients older than 80 years of age, for ST-elevation myocardial infarction (STEMI) patients, and for those discharged with complete versus incomplete revascularization, but not for non-STEMI/unstable angina patients. Conclusions: BB therapy was related to 1-year lower risk of all-cause mortality, independently from completeness of revascularization, admission diagnosis, age and ejection fraction. Randomized controlled trials for patients treated with PCI for ACS should be performed

Comparative external validation of the PRECISE-DAPT and PARIS risk scores in 4424 acute coronary syndrome patients treated with prasugrel or ticagrelor

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

Average daily ischemic versus bleeding risk in patients with ACS undergoing PCI: Insights from the BleeMACS and RENAMI registries

Background: The risk of recurrent ischemia and bleeding after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) may vary during the first year of follow-up according to clinical presentation, and medical and interventional strategies. Methods: BleeMACS and RENAMI are 2 multicenter registries enrolling patients with ACS treated with PCI and clopidogrel, prasugrel, or ticagrelor. The average daily ischemic and bleeding risks (ADIR and ADBR) in the first year after PCI were the primary end points. The difference between ADBR and ADIR was calculated to estimate the potential excess of bleeding/ischemic events in a given period or specific subgroup. Results: A total of 19,826 patients were included. Overall, in the first year after PCI, the ADBR was 0.008085%, whereas ADIR was 0.008017% (P =.886). In the first 2 weeks ADIR was higher than ADBR (P =.013), especially in patients with ST-segment elevation myocardial infarction or incomplete revascularization. ADIR continued to be, albeit non-significantly, greater than ADBR up to the third month, whereas ADBR became higher, although not significantly, afterward. Patients with incomplete revascularization had an excess in ischemic risk (P =.003), whereas non–ST-segment elevation ACS patients and those on ticagrelor had an excess of bleeding (P =.012 and P =.022, respectively). Conclusions: In unselected ACS patients, ADIR and ADBR occurred at similar rates within 1 year after PCI. ADIR was greater than ADBR in the first 2 weeks, especially in ST-segment elevation myocardial infarction patients and those with incomplete revascularization. In the first year, ADIR was higher than ADBR in patients with incomplete revascularization, whereas ADBR was higher in non–ST-segment elevation ACS patients and in those discharged on ticagrelor

Ticagrelor versus prasugrel in acute coronary syndrome: sex-specific analysis from the RENAMI Registry

BACKGROUND: The use of potent P2Y12 inhibitors (ticagrelor & prasugrel) in acute coronary syndrome (ACS) patients undergoing percutaneous coronary interventions (PCI) is a class I recommendation. We performed a sex-specific analysis comparing the difference in efficacy and safety outcomes between ticagrelor and prasugrel in a real-world ACS population. METHODS: Data from the multicenter REgistry of New Antiplatelets in patients with Myocardial Infarction (RENAMI) for 4424 ACS patients who underwent PCI and were treated with ticagrelor or prasugrel between 2012 to 2016 were analyzed. Mean follow-up was 17±9 months. RESULTS: After propensity score matching, there was no significant difference in the occurrence of primary endpoint of net adverse cardiac events between ticagrelor and prasugrel in men (HR: 0.94; 95% CI: 0.69-1.29; P=0.71), or women (HR: 1.17; 95% CI: 0.63-2.20; P=0.62; P interaction [sex] = 0.40). Similarly, no differences were found in the occurrence of any of the secondary endpoints (MACE, all cause death, re-infarction, stent thrombosis, BARC major bleeding and BARC any bleeding) between the two P2Y12 groups between men and women. CONCLUSIONS: In this real-world ACS population, no relative difference in efficacy or safety outcomes were found between ticagrelor and prasugrel between sexes

Mechanisms of nonfatal acute myocardial infarction late after stent implantation: the relative impact of disease progression, stent restenosis, and stent thrombosis

Background: The impact of stent restenosis, stent thrombosis, or progression of disease at another site as responsible mechanisms of acute myocardial infarction (AMI) after stent implantation is not clear.Methods: By searching our catheterization laboratory database for a 4-year period, 91 cases of nonfatal AMI at least 1month after stent implantation (32.6% drug-eluting stents) were identified. By detailed comparison of post-AMI with the initial percutaneous coronary intervention angiogram, the mechanism of AMI was analyzed.Results: Acute myocardial infarction was attributed to disease progression at another site in 42(46.2%), stent restenosis in 35(38.4%) and stent thrombosis in 10(11%) cases. The AMI mechanism could be either stent related or disease progression (non-identifiable culprit lesion) in 4 cases (4.4%). The median time from percutaneous coronary intervention to AMI was 27, 19 and 9 months for disease progression at another site, restenosis, and stent thrombosis group, respectively (P = .03). ST-elevation myocardial infarction occurred in 38.1% of the disease progression, in 20% of the restenosis, and in 60% of the stent thrombosis cases (P = .046).Conclusions: In a “real world” population, late after stent implantation, a patient has an almost equal probability to have suffered a nonfatal AMI from either stent restenosis/thrombosis or disease progression at another site. Continuous research efforts are necessary to equally address both stent therapy and disease progression.Επιστημονικό υπόβαθρο: Η συμμετοχή της επαναστένωσης ή της θρόμβωσης της στεφανιαίας ενδοπροθέσεως (stent), καθώς και της προόδου της στεφανιαίας νόσου σε άλλο σημείο του αγγειακού δικτύου, ως υπεύθυνων μηχανισμών του οξέος εμφράγματος του μυοκαρδίου (ΟΕΜ) μετά την τοποθέτηση stent, δεν είναι αποσαφηνισμένη Μέθοδοι: Μετά από ανασκόπηση της βάσης δεδομένων καταχώρησης ασθενών του αιμοδυναμικού εργαστηρίου για χρονικό διάστημα 4 ετών, συγκεντρώθηκαν 91 περιστατικά μη θανατηφόρου ΟΕΜ, το οποίο επήλθε τουλάχιστον 1 μήνα μετά την εμφύτευση stent (το 32,6% εκ των οποίων ήταν επικαλυμένα με φαρμακευτική ουσία stent-DES). Μετά από λεπτομερή εξέταση σε παράθεση των στεφανιογραφιών αναφοράς –κατά τη διεξαγωγή της πρώτης αγγειοπλαστικής– και των μετεμφραγματικών στεφανιογραφιών, ταυτοποιήθηκε η αγγειογραφική προέλευση του εμφράγματος του μυοκαρδίου. Αποτελέσματα: Το ΟΕΜ αποδόθηκε σε πρόοδο της νόσου σε άλλο σημείο του στεφανιαίου δικτύου σε 42(42.6%), επαναστένωση του stent σε 35(38.4%) και θρόμβωση του stent σε 10(11%) περιπτώσεις. Σε 4(4.4%) περιπτώσεις ο υπεύθυνος μηχανισμός πρόκλησης ΟΕΜ δεν κατέστη δυνατόν να ταυτοποιηθεί. Το διάμεσο χρονικό διάστημα που μεσολάβησε από την αγγειοπλαστική μέχρι το ΟΕΜ ήταν 27, 19 και 9 μήνες σε περίπτωση εξέλιξης της νόσου σε άλλο σημείο, επαναστένωσης και θρόμβωσης του stent αντίστοιχα (P= .03). Οξύ έμφραγμα του μυοκαρδίου με ανάσπαση του ST διαστήματος (ST elevation myocardial infarction –STEMI) παρατηρήθηκε στο 38,1% των περιπτώσεων εξέλιξης της νόσου, στο 20% των περιπτώσεων επαναστένωσης και στο 60% των περιπτώσεων θρόμβωσης του stent (P= .046). Συμπεράσματα: Σε έναν πληθυσμό ασθενών που υποβάλλεται σε αγγειοπλαστική των στεφανιαίων αρτηριών στα πλαίσια της καθημερινής κλινικής πράξης, υπάρχει παρόμοια πιθανότητα για μεταγενέστερο μη-θανατηφόρο ΟΕΜ όψιμα μετά την εμφύτευση του stent λόγω επαναστένωσης/θρόμβωσης του stent και λόγω προόδου της νόσου εκτός της αρχικής βλάβης-στόχου. Περεταίρω μελέτη χρειάζεται όχι μόνο για τις μελλοντικές κλινικές εκδηλώσεις που σχετίζονται με την εμφύτευση stent, αλλά και για τη διερεύνηση του ρόλου της προοδευτικής εξέλιξης της στεφανιαίας νόσου σε άλλα σημεία των στεφανιαίων αγγείων