Search

Objectives: Based on previous studies with clopidogrel, the time between acute myocardial infarction (AMI) symptoms onset and primary percutaneous coronary intervention (PCI) was proven as important prognostic factor. Our aim was to assess the relationship between symptoms onset to needle time (SNT) and procedural results and the occurrence of ischemic endpoints in primary angioplasty patients treated with potent P2Y12 inhibitors., Methods: A total of 1,131 out of 1,230 patients randomized to the Prague-18 study (prasugrel vs. ticagrelor in primary PCI) were divided into a high and a low-risk group. The effect of defined SNT on patients' ischemic endpoints and prognosis by their risk status at admission was tested., Results: The median SNT was 3.2 hours. Longer SNTs resulted in a more frequent incidence of TIMI flow <3 post PCI (p=0.015). There were significant differences in the occurrence of the combined ischemic endpoint among the compared SNT groups at 30 days (p=0.032), and 1 year (p=0.011), with the highest incidence in the ≤1 h SNT group of patients. "Latecomers" (SNT>4 hs) in the high-risk group experienced more reinfarction within 1 year [OR (95% CI) 3.23 (1.09-9.62) p=0.035]; no difference was found in the low-risk group., Conclusions: In the era of intense antithrombotic medication, stratification of MI patients undergoing primary angioplasty, based on initial ischemic risk assessment affected prognosis more than symptom onset to needle time. Longer time delay was significantly related to increased incidence of ischemic events and all-cause mortality only in patients with high ischemic risk., Competing Interests: Declaration of Competing Interest Dr Motovska reports receiving speaking and advisory board fees from AstraZeneca and Eli Lilly. Dr Varvarovsky reports receiving honoraria form AstraZeneca and Eli Lilly. Dr Rokyta reports receiving lecture fees from AstraZeneca. Dr Widimsky reports receiving honoraria from AstraZeneca, Eli Lilly, and Daiichi Sankyo. The other authors report no conflicts., (Copyright © 2021. Published by Elsevier Ltd.)

Background: Early outcomes of patients in the PRAGUE-18 (Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction) study did not find any significant differences between 2 potent P2Y 12 inhibitors., Objectives: The 1-year follow-up of the PRAGUE-18 study focused on: 1) a comparison of efficacy and safety between prasugrel and ticagrelor; and 2) the risk of major ischemic events related to an economically motivated post-discharge switch to clopidogrel., Methods: A total of 1,230 patients with acute myocardial infarction (MI) treated with primary percutaneous coronary intervention were randomized to prasugrel or ticagrelor with an intended treatment duration of 12 months. The combined endpoint was cardiovascular death, MI, or stroke at 1 year. Because patients had to cover the costs of study medication after hospital discharge, some patients decided to switch to clopidogrel., Results: The endpoint occurred in 6.6% of prasugrel patients and in 5.7% of ticagrelor patients (hazard ratio: 1.167; 95% confidence interval: 0.742 to 1.835; p = 0.503). No significant differences were found in: cardiovascular death (3.3% vs. 3.0%; p = 0.769), MI (3.0% vs. 2.5%; p = 0.611), stroke (1.1% vs. 0.7%; p = 0.423), all-cause death (4.7% vs. 4.2%; p = 0.654), definite stent thrombosis (1.1% vs. 1.5%; p = 0.535), all bleeding (10.9% vs. 11.1%; p = 0.999), and TIMI (Thrombolysis In Myocardial Infarction) major bleeding (0.9% vs. 0.7%; p = 0.754). The percentage of patients who switched to clopidogrel for economic reasons was 34.1% (n = 216) for prasugrel and 44.4% (n = 265) for ticagrelor (p = 0.003). Patients who were economically motivated to switch to clopidogrel had (compared with patients who continued the study medications) a lower risk of major cardiovascular events; however, they also had lower ischemic risk., Conclusions: Prasugrel and ticagrelor are similarly effective during the first year after MI. Economically motivated early post-discharge switches to clopidogrel were not associated with an increased risk of ischemic events. (Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction [PRAGUE-18]; NCT02808767)., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: No randomized head-to-head comparison of the efficacy and safety of ticagrelor and prasugrel has been published in the 7 years since the higher efficacy of these newer P2Y 12 inhibitors were first demonstrated relative to clopidogrel., Methods: This academic study was designed to compare the efficacy and safety of prasugrel and ticagrelor in acute myocardial infarction treated with primary or immediate percutaneous coronary intervention. A total of 1230 patients were randomly assigned across 14 sites to either prasugrel or ticagrelor, which was initiated before percutaneous coronary intervention. Nearly 4% were in cardiogenic shock, and 5.2% were on mechanical ventilation. The primary end point was defined as death, reinfarction, urgent target vessel revascularization, stroke, or serious bleeding requiring transfusion or prolonging hospitalization at 7 days (to reflect primarily the in-hospital phase). This analysis presents data from the first 30 days (key secondary end point). The total follow-up will be 1 year for all patients and will be completed in 2017., Results: The study was prematurely terminated for futility. The occurrence of the primary end point did not differ between groups receiving prasugrel and ticagrelor (4.0% and 4.1%, respectively; odds ratio, 0.98; 95% confidence interval, 0.55-1.73; P=0.939). No significant difference was found in any of the components of the primary end point. The occurrence of key secondary end point within 30 days, composed of cardiovascular death, nonfatal myocardial infarction, or stroke, did not show any significant difference between prasugrel and ticagrelor (2.7% and 2.5%, respectively; odds ratio, 1.06; 95% confidence interval, 0.53-2.15; P=0.864)., Conclusions: This head-to-head comparison of prasugrel and ticagrelor does not support the hypothesis that one is more effective or safer than the other in preventing ischemic and bleeding events in the acute phase of myocardial infarction treated with a primary percutaneous coronary intervention strategy. The observed rates of major outcomes were similar but with broad confidence intervals around the estimates. These interesting observations need to be confirmed in a larger trial., Clinical Trial Registration: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT02808767., (© 2016 American Heart Association, Inc.)

Background: The aim of this randomized study was to investigate the effect of seven-day high-dose atorvastatin therapy on the incidence of peri-procedural myocardial infarction (PMI) in patients receiving long-term statin therapy., Methods: The patients with stable angina receiving statin therapy and referred for percutaneous coronary intervention (PCI) were randomized (ratio 1:1) to a 7-day pre-treatment with atorvastatin of 80 mg daily and subsequent PCI (Atorvastatin group), or immediate PCI (Control group). The incidence of PMI was based on serum concentration of creatine kinase myocardial band (CK-MB) mass and troponin I (TnI), which were measured prior to and between 16 and 24h post PCI. The values were considered as positive if they were elevated ≥ 3 times the upper limit normal., Results: We randomized 202 patients (male 67%, 65.5 ± 9.2 years; 100 vs. 102 pts.). There were no significant differences in the baseline characteristics among the randomized groups. The incidence of PMI, based on post-interventional release of TnI and/or CK-MB mass was 15% in the Atorvastatin group vs. 14% in the Control group (p=0.80). One patient (3%) in Atorvastatin group suffered from MI between randomization and PCI., Conclusions: These results suggest that 7-day pre-PCI therapy with high-dose atorvastatin did not reduce the occurrence of PMI in patients receiving chronic statin therapy., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

The prognostic significance of periprocedural myocardial infarction (MI) remains controversial. The study aims to investigate the incidence of periprocedural MI in the era of high sensitivity diagnostic markers and intense antithrombotics, and its impact on early outcomes of patients with acute MI treated with primary angioplasty (pPCI). Data from the PRAGUE-18 (prasugrel versus ticagrelor in pPCI) study were analyzed. The primary net-clinical endpoint (EP) included death, spontaneous MI, stroke, severe bleeding, and revascularization at day 7. The key secondary efficacy EP included cardiovascular death, spontaneous MI, and stroke within 30 days. The incidence of peri-pPCI MI was 2.3% (N = 28) in 1230 study patients. The net-clinical EP occurred in 10.7% of patients with, and in 3.6% of patients without, peri-pPCI MI (HR 2.92; 95% CI 0.91–9.38; P = 0.059). The key efficacy EP was 10.7% and 3.2%, respectively (HR 3.44; 95% CI 1.06–11.13; P = 0.028). Patients with periprocedural MI were at a higher risk of spontaneous MI (HR 6.19; 95% CI 1.41–27.24; P = 0.006) and stent thrombosis (HR 10.77; 95% CI 2.29–50.70; P = 0.003) within 30 days. Age, hyperlipidemia, multi-vessel disease, post-procedural TIMI <3, pPCI on circumflex coronary artery, and periprocedural GP IIb/IIIa inhibitor were independent predictors of peri-pPCI MI. In the era of intense antithrombotic therapy, the occurrence of peri-pPCI MI is despite highly sensitive diagnostic markers a rare complication, and is associated with an increased risk of early reinfarction and stent thrombosis. • Incidence of peri-PCI MI depends on the definition used, and its prognostic significance remains controversial. • Our data showed, that in the era of intense antithrombotic therapy, the occurrence of peri-pPCI MI is despite highly sensitive diagnostic markers a rare complication. • Presented study found, that peri-pPCI MI significantly affects the occurrence of ischaemic complications within the first months after the index procedure. [ABSTRACT FROM AUTHOR]

Introduction: Prasugrel and ticagrelor have shown similar primary net-clinical endpoint (cardiovascular death, spontaneous MI, stroke, severe bleeding or revascularization at day 7) and similar clinical effectivity in the PRAGUE-18 study at one year. Hypothesis: Impact of gender on the clinical outcome up to 12 months. Methods: A total of 1,230 patients with acute MI (931 males; 75.7%) treated with primary PCI were randomized to prasugrel or ticagrelor with an intended treatment duration of 12 months. Key secondary efficacy endpoint (EP) was cardiovascular death, spontaneous MI, stroke within 30 days and at one year. Results: Females were older (64.9 vs 60.9 years; p<0.001), more often hypertensive (63.2% vs 47.4%; p<0.001) and diabetics (27.8% vs 17.9%; p<0.001) and there were less smokers (58.9% vs 66.8%; p=0.015). Females suffered significantly longer time interval from symptom onset to the admission to PCI center (3.3hrs vs 2.5hrs; p=0.001). In females, the primary net-clinical EP at 7 days was not different from males (4.4% vs 3.9%; p=0.645) but at 30 days, the rate of MI and combined key efficacy EP occurred significantly more often(5.4% vs 2.7%; p=0.030 [HR 5.234; 95% CI, 1.902-14.401] and 3.3% vs 0.6%; p=0.001 [HR 2.007 95% CI, 1.072-3.759], respectively). At 12 months, there was no significant difference between the groups, though a strong trend to higher rate of MI and bleeding was found (HR 1.968, 95% CI 0.985-3.929; p=0.055 and HR 1.399 95% CI 0.970-2.020; p=0.073, respectively). End of potent P2Y12 treatment within one year was observed more often in females than males, though not statistically significant (58.5% vs 52.0%; p=0.053). No significant difference was found in the economically driven switch to clopidogrel (43.1% vs 37.8%; p=0.103). Conclusions: In the PRAGUE-18 study, the female patients were at higher baseline clinical risk, had significantly higher rate of MI and cardiovascular death/MI/stroke at 30 days and tended to have a higher rate of repeated MI and bleeding complications at 12 months. Longer pre-hospital ischemic time in females requires special attention. [ABSTRACT FROM AUTHOR]