Objectives
To assess the efficacy and safety of ticagrelor versus prasugrel in patients with acute coronary syndrome (ACS) presenting during off- and on-hours.
Background
The efficacy and safety of ...ticagrelor versus prasugrel in patients with ACS according to time of hospital presentation remain unknown.
Methods
This post hoc analysis of the ISAR-REACT 5 trial included 1565 patients with ACS presenting off-hours and 2453 patients presenting on-hours, randomized to ticagrelor or prasugrel. The primary endpoint was a composite of death, myocardial infarction, or stroke; the safety endpoint was Bleeding Academic Research Consortium (BARC) type 3–5 bleeding, both at 12 months.
Results
The primary endpoint occurred in 80 patients (10.4%) in the ticagrelor group and 57 patients (7.3%) in the prasugrel group in patients presenting off-hours (hazard ratio HR = 1.45; 95% confidence interval CI 1.03–2.03;
P
= 0.033), and 104 patients (8.5%) in the ticagrelor group and 80 patients (6.7%) in the prasugrel group in patients presenting on-hours (HR = 1.29 0.97–1.73;
P
= 0.085), without significant treatment arm-by-presentation time interaction (P
int
= 0.62). BARC type 3 to 5 bleeding occurred in 35 patients (5.1%) in the ticagrelor group and 37 patients (5.3%) in the prasugrel group (
P
= 0.84) in patients presenting off-hours, and 60 patients (5.9%) in the ticagrelor group and 43 patients (4.6%) in the prasugrel group in patients presenting on-hours (
P
= 0.17).
Conclusions
In patients with ACS planned to undergo an invasive treatment strategy, time of presentation (off-hours vs. on-hours) does not interact significantly with the relative efficacy and safety of ticagrelor vs. prasugrel.
Clinical trial registration.
NCT01944800.
Graphical abstract
There is limited clinical data comparing different P2Y12-receptor inhibitors in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock. The aim of the ISAR-SHOCK registry ...was to compare the clinical outcome of patients treated with clopidogrel vs prasugrel in this setting. Patients (n=145) with AMI complicated by cardiogenic shock and undergoing primary PCI in two centres (Deutsches Herzzentrum München and Klinikum rechts der Isar, Technical University Munich) between January 2009 and May 2012 were included in this registry. The use of prasugrel for patients within this registry reflected co-morbidities and platelet function testing results during the acute AMI phase. Early outcome at 30-days was reported with regard to all-cause mortality, myocardial infarction (MI), stent thrombosis (ST) and bleeding events. With regard to antiplatelet treatment in the 145 cardiogenic shock patients, 50 patients were initially treated or immediately switched to prasugrel while 95 patients were treated with clopidogrel. All-cause mortality was lower in prasugrel- vs clopidogrel-treated patients (30 % vs 50.5%, HR: 0.51, 95% CI 0.29-0.92, p=0.025). No significant differences in prasugrel- vs clopidogrel-treated patients were observed for the occurrence of MI (p=0.233), ST (p=0.306) or TIMI major bleedings (p=0.571). Results of the ISAR-SHOCK registry suggest that the use of prasugrel in AMI patients complicated by cardiogenic shock might be associated with a lower mortality risk as compared to clopidogrel therapy without increasing the risk of bleeding. These findings, however, need confirmation from specifically designed randomised studies in this high-risk cohort of patients.
The incidence of new cerebral lesions at diffusion-weighted magnetic resonance imaging (DW-MRI) represents a surrogate endpoint for embolization, though the clinical impact is controversial.
Background Current recommendation on the use of bivalirudin in patients undergoing percutaneous coronary intervention (PCI) are mostly based on trials comparing bivalirudin versus heparin plus ...planned glycoprotein IIb/IIIa inhibitor (GPI).
The presence of coronary artery ectasia (CAE) is influenced by genetic factors and related to the presence of aneurysms in other vascular beds. Bicuspid aortic valve (BAV) disease is frequently ...accompanied by ascending aortic aneurysm. Because the aortic valve and the proximal parts of the coronary arteries share a common embryonic origin, we hypothesized that CAE is associated with BAV disease.
One hundred seventy-seven patients with suspected aortic valve disease (n=94 BAV, n=83 tricuspid aortic valve) underwent both cardiac magnetic resonance imaging and coronary angiography. To confirm the association of CAE with BAV, the frequency of CAE was evaluated in an in-house BAV registry (n=600, n=231 with available coronary angiogram) and compared with the frequency of CAE in the German Myocardial Infarction (MI) Family Study, in which the heritability of CAE was formerly established (n=899). Furthermore, the frequency of CAE was investigated in an observational registry of real-life patients undergoing coronary angiography for clinically indicated reasons (n=3.097) and in a subgroup of the KORA MI study (Cooperative Health Research in the Region of Augsburg), which is a population-based MI registry (n=403).Compared with tricuspid aortic valve disease, CAE occurred more than twice as frequently in cardiac magnetic resonance-confirmed BAV disease (17% versus 44%; P<0.0001) and CAE was observed similarly often in subjects with BAV with (37%) and without (54%, P=0.11) ascending aortic pathology. The common appearance of CAE in patients with BAV could be independently confirmed in the BAV registry (frequency 37%), whereas CAE was found less frequently in family history of positive MI patients (21%), sporadic MI without familial disposition (10%), and rarely in unrelated real-life catheterization patients (6%).
To our knowledge, our data show for the first time that ectatic coronary artery disease is a common appearance of BAV disease with and without ascending aortic ectasia.
Erythropoietin (EPO) has been suggested to promote cardiac repair after MI. However, the randomized, double-blind, placebo controlled REVIVAL-3 trial showed that short term high dose EPO in timely ...reperfused myocardium does not improve left ventricular ejection fraction after 6 months. Moreover, the study raised safety concerns due to a trend towards a higher incidence of adverse clinical events as well as a increase in neointima formation after treatment with EPO. The present study therefore aimed to assess the 5-year clinical outcomes.
After successful reperfusion 138 patients with STEMI were randomly assigned to receive epoetin beta (3.33×10
U, n = 68) or placebo (n = 70) immediately, 24 and 48 h after percutaneous coronary intervention. The primary outcome of the present study- the combined incidence of MACE 5 years after randomization - occurred in 25% of the patients assigned to epoetin beta and 17% of the patients assigned to placebo (RR 1.5; 95% CI 0.8-3.5; p = 0.26). Target lesion revascularization was required in 15 patients (22.1%) treated with epoetin-ß and 9 patients (12.9%) treated with placebo (p = 0.15). Analysis of patients in the upper and lower quartile of baseline hemoglobin as an indirect estimate of endogenous erythropoietin levels revealed no significant impact of endogenous erythropoietin on efficiency of exogen administered epoetin-ß in terms of death and MACE.
These long-term follow-up data show that epoetin beta does not improve clinical outcomes of patients with acute myocardial infarction.
URL www.clinicaltrials.gov ; Unique identifier NCT00390832; trial registration date October 19th 2006.
...PPI rate is largely influenced by parameters, such as prosthesis oversizing and implantation depth. ...we analyzed its influence on PPI and on the composite endpoint "PPI and new-onset CA" ...(PPI/new-onset CA).
Angioplasty with paclitaxel-coated balloons (PCB) is recommended for treatment of patients with coronary in-stent restenosis (ISR) according to European clinical practice guidelines. Most clinical ...trials have investigated iopromide-based PCB and there is a paucity of data comparing efficacy against butyryl-tri-hexyl citrate (BTHC)-based PCB. Our aim was to compare the performance of two widely-used PCB in the treatment of coronary ISR.
We analysed patients treated with BTHC- or iopromide-PCB for treatment of drug-eluting stent ISR in the setting of 2 consecutive trials with identical inclusion and exclusion criteria. The primary endpoint was diameter stenosis at 6-8month angiographic surveillance. The secondary endpoint of interest was the composite of death, myocardial infarction (MI) or target-lesion revascularisation (TLR) at 1year. Multivariate analysis was performed to adjust for differences in baseline characteristics between groups.
In total, 264 patients were treated with BTHC-PCB (n=127) or iopromide-PCB (n=137). Baseline patient characteristics were similar for both groups. Post-procedure stenosis was slightly larger with BTHC-PCB (22.3 SD 8.2% vs. 18.4 SD 9.9%, P=0.001). At 6-8month angiography, diameter stenosis was 40.4 SD 21.9% vs. 37.4 SD 21.4% in the BTHC-PCB and iopromide-PCB groups, respectively (P=0.16, P
=0.32). At 1year, death, MI or TLR occurred in 29 (23.2%) vs. 32 (23.4%) patients in the BTHC-PCB and iopromide-PCB groups, respectively (HR 1.03 95% CI 0.62-1.70, P=0.91, P
=0.96).
In patients undergoing intervention for ISR, angioplasty with BTHC-PCB showed similar angiographic and clinical results at 1year compared with iopromide-PCB.
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