Patients with acute myocardial infarction (AMI) who have concomitant peripheral artery disease (PAD) represent a subgroup at high risk of subsequent ischaemic events. This post hoc analysis of PRAGUE-18, a multicenter, randomised trial comparing prasugrel versus ticagrelor in primary PCI, analysed the effect of symptomatic PAD and intensity of antithrombotic therapy on the prognosis of AMI patients treated with primary percutaneous coronary intervention (PCI). During 12-month follow-up, de-escalation from intensive antiplatelet therapy to clopidogrel was allowed with the permission of the treating physician for economic reasons. Symptomatic PAD was present in 2.9% of the study population (n = 1230). The presence of PAD did not significantly affect short-term outcome. At one year, the risk of death was higher in patients with concomitant PAD, 49 (4.1%) vs. 6(16.7%), HR 4.211 (1.803–9.830); p = 0,001. All-cause mortality significantly increased only in subgroup of patients who de-escalated to clopidogrel [6.37 (2.16–18.84), p = 0.001] as opposed to those who did not [3.02 (0.72–12.61), p = 0.13]. These findings suggest that long-term intensive antithrombotic therapy may be particularly important for post-AMI patients with concomitant symptomatic PAD and warrant further investigation.
Abstract Aims In patients with recently diagnosed non‐ischaemic LV systolic dysfunction, left ventricular reverse remodelling (LVRR) and favourable prognosis has been documented in studies with short‐term follow‐up. The aim of our study was to assess the long‐term clinical course and stability of LVRR in these patients. Methods and results We prospectively studied 133 patients (37 women; 55 [interquartile range 46, 61] years) with recently diagnosed unexplained LV systolic dysfunction, with heart failure symptoms lasting <6 months and LV ejection fraction <40% persisting after at least 1 week of therapy. All patients underwent endomyocardial biopsy (EMB) at the time of diagnosis and serial echocardiographic and clinical follow‐up over 5 years. LVRR was defined as the combined presence of (1) LVEF ≥ 50% or increase in LVEF ≥ 10% points and (2) decrease in LV end‐diastolic diameter index (LVEDDi) ≥ 10% or (3) LVEDDi ≤ 33 mm/m2. LVRR was observed in 46% patients at 1 year, in 60% at 2 years and 50% at 5 years. Additionally, 2% of patients underwent heart transplantation and 12% experienced heart failure hospitalization. During 5‐year follow‐up, 23 (17%) of the study cohort died. In multivariate analysis, independent predictors of mortality were baseline right atrial size (OR 1.097, CI 1.007–1.196), logBNP level (OR 2.02, CI 1.14–3.56), and PR interval (OR 1.02, CI 1.006–1.035) (P < 0.05 for all). The number of macrophages on EMB was associated with overall survival in univariate analysis only. LVRR at 1 year of follow‐up was associated with a lower rate of mortality and heart failure hospitalization (P = 0.025). In multivariate analysis, independent predictors of LVRR were left ventricular end‐diastolic volume index (OR 0.97, CI 0.946–0.988), LVEF (OR 0.89, CI 0.83–0.96), and diastolic blood pressure (OR 1.04, CI 1.01–1.08) (P < 0.05 for all). Conclusions LVRR occurs in over half of patients with recent onset unexplained LV systolic dysfunction during first 2 years of optimally guided heart failure therapy and then remains relatively stable during 5‐year follow‐up. Normalization of adverse LV remodelling corresponds to a low rate of mortality and heart failure hospitalizations during long‐term follow‐up.
Fyziologický ústav a II.interní klinika kardiologie a angiologie, 1
Drug-eluting stents (DES) are the recommended stents for primary percutaneous coronary intervention (PCI). This study aimed to determine why interventional cardiologists used non-DES and how it influenced patient prognoses. The efficacy and safety outcomes of the different stents were also compared in patients treated with either prasugrel or ticagrelor. Of the PRAGUE-18 study patients, 749 (67.4%) were treated with DES, 296 (26.6%) with bare-metal stents (BMS), and 66 (5.9%) with bioabsorbable vascular scaffold/stents (BVS) between 2013 and 2016. Cardiogenic shock at presentation, left main coronary artery disease, especially as the culprit lesion, and right coronary artery stenosis were the reasons for selecting a BMS. The incidence of the primary composite net-clinical endpoint (EP) (death, nonfatal myocardial infarction, stroke, serious bleeding, or revascularization) at seven days was 2.5% vs. 6.3% and 3.0% in the DES, vs. with BMS and BVS, respectively (HR 2.7; 95% CI 1.419–5.15, p = 0.002 for BMS vs. DES and 1.25 (0.29–5.39) p = 0.76 for BVS vs. DES). Patients with BMS were at higher risk of death at 30 days (HR 2.20; 95% CI 1.01–4.76; for BMS vs. DES, p = 0.045) and at one year (HR 2.1; 95% CI 1.19–3.69; p = 0.01); they also had a higher composite of cardiac death, reinfarction, and stroke (HR 1.66; 95% CI 1.0–2.74; p = 0.047) at one year. BMS were associated with a significantly higher rate of primary EP whether treated with prasugrel or ticagrelor. In conclusion, patients with the highest initial risk profile were preferably treated with BMS over BVS. BMS were associated with a significantly higher rate of cardiovascular events whether treated with prasugrel or ticagrelor.
Purpose : Based on previous studies with clopidogrel, the time between onset of symptoms and primary PCI was proven as an important prognostic factor. Our aim was to assess the effect of symptoms onset to needle time (SNT) on procedural results and on 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 angioplasty) 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 reMI within 1 year [OR (95% CI) 3.23 (1.09–9.62) p = 0.035]; no difference was found in the low-risk group. Conclusion : In the era of intense antithrombotic medication, stratification of STEMI patients undergoing primary angioplasty, based on initial ischemic risk assessment affected prognosis more than symptom onset to needle time. Longer time delay significantly increased the incidence of ischemic events and all-cause mortality only in patients with high ischemic risk.
Purpose: To investigate the prognostic significance of diabetes mellitus (DM) in patients with high risk acute myocardial infarction (AMI) treated with primary percutaneous coronary intervention (pPCI) in the era of potent antithrombotics. Methods: Data from 1230 ST-segment elevation myocardial infarction (STEMI) patients enrolled in the PRAGUE-18 (prasugrel vs. ticagrelor in pPCI) study were analyzed. Ischemic and bleeding event rates were calculated for patients with and without diabetes. The independent impact of diabetes on outcomes was evaluated after adjustment for outcome predictors. Results: The prevalence of DM was 20% (N = 250). Diabetics were older and more often female. They were more likely to have hypertension, hyperlipoproteinemia, multivessel coronary disease and left main disease, and be obese. The primary net-clinical endpoint (EP) containing death, spontaneous nonfatal MI, stroke, severe bleeding, and revascularization at day 7 occurred in 6.1% of patients with, and in 3.5% of patients without DM (HR 1.8; 95% CI 0.978–3.315; P = 0.055). At one year, the key secondary endpoint defined as cardiovascular death, spontaneous MI, or stroke occurred in 8.8% with, and 5.5% without DM (HR 1.621; 95% CI 0.987–2.661; P = 0.054). In those with DM the risk of total one-year mortality (6.8% vs. 3.9% (HR 1.773; 95% CI 1.001–3.141; P = 0.047)) and the risk of nonfatal reinfarction (4.8% vs. 2.2% (HR 2.177; 95% CI 1.077–4.398; P = 0.026)) were significantly higher compared to in those without DM. There was no risk of major bleeding associated with DM (HR 0.861; 95% CI 0.554–1.339; P = 0.506). In the multivariate analysis, diabetes was independently associated with the one-year risk of reinfarction (HR 2.176; 95% Confidence Interval, 1.055–4.489; p = 0.035). Conclusion: Despite best practices STEMI treatment, diabetes is still associated with significantly worse prognoses, which highlights the importance of further improvements in the management of this high-risk population.
Background: The prognostic significance of periprocedural myocardial infarction (MI) remains controversial. Methods and results: 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. Conclusions: 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. (C) 2020 Elsevier B.V. All rights reserved.
Background: The prognostic significance of periprocedural myocardial infarction (MI) remains controversial. Purpose: The study aims to evaluate the incidence of periprocedural MI in the era of high...
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 cli...
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) (c) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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 P2Y12 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.
BACKGROUNDThere is no study focusing on changes in coronary atherosclerosis during dual lipid-lowering therapy with statin and ezetimibe.METHODS AND RESULTSEighty-nine patients with stable angina randomized in a 1:1 ratio to Group A (aggressive therapy: atorvastatin 80mg, ezetimibe 10mg) and Group S (standard therapy) were analyzed. Treatment period was 12 months. Coronary arteries were examined by intravascular ultrasound and virtual histology. We found a decrease in the percent atheroma volume (PAV) (-0.4%) in Group A compared with an increase (+1.4%) in Group S (P=0.014) and this was accompanied by an increased frequency of combined atherosclerosis regression (increased lumen volume+decreased PAV) in group A (40.5%) compared with group S (14.9%) (P=0.007). The target low-density lipoprotein cholesterol level <2mmol/L, presence of at least 4 of 5 atherosclerotic risk factors, and decreased level of vascular cellular adhesive molecule were independent predictors of plaque regression. There were no significant differences in plaque composition between the 2 groups over the study duration. However, during analysis of the 2 groups together, fibrous and fibro-fatty tissues decreased and dense calcification and necrotic core increased during follow-up.CONCLUSIONSDual lipid-lowering therapy starts atherosclerosis regression, but does not lead to significant changes in plaque composition. The continuous shift in plaque from fibro and fibro-fatty to necrotic with calcification was present in both groups.
In a primary prevention study of coronary artery disease (CAD), 164 men with risk factors (RFs) at the start of the study (1975-79) were examined from 1996 to 2002 with body surface mapping (BSM). Results were divided into two groups based upon prognosis, which allowed for statistical analysis. Seventy-one men (43.3%) had a benign prognosis (normal BSM + syndrome X), while 93 men (56.7%) had a severe prognosis (CAD moderate and advanced BSM). In univariate analysis, smoking had a statistically significant effect on CAD BSM pattern (p = 0.002), while hypertension (SBP) and total cholesterol had no significant influence on BSM. In multivariate analysis, the odds of smokers developing a CAD BSM pattern were 2.6 times higher compared with nonsmokers (p = 0.007). BSM results were partly related to SBP (p = 0.074) and men with a SBP > 140 mm Hg were 1.9 times more likely to develop a CAD BSM pattern than men having a normal SBP. No statistical significance was found for total cholesterol, and the reason for this result is discussed in comparison with the data from the long-term study. BSM results are compared with those obtained in two of our small angina pectoris studies (AP), where an ECG test was used.
Dilated cardiomyopathy (DCM) represents the third most common cause of heart failure and the most frequent cause of heart transplantation. Infectious, mostly viral, and autoimmune mechanisms, together with genetic abnormalities, have been reported as three major causes of DCM. We hypothesized that Lyme disease (LD), caused by spirochete Borrelia burgdorferi (Bb), might be an important cause of new-onset unexplained DCM in patients living in a highly endemic area for LD such as the Czech Republic. We performed endomyocardial biopsy (EMB) in 39 consecutive patients presenting with symptomatic unexplained left ventricular (LV) systolic dysfunction lasting no more than 12 months. In eight subjects (21%), Bb was detected in the EMB sample by polymerase chain reaction or by electron microscopy. None of these patients exhibited any form of atrioventricular block or other extracardiac manifestation of Bb infection. Serological testing identified IgG antibodies against Bb in only two cases and IgM antibodies in none. All affected patients were treated with intravenous ceftriaxone for 3 weeks. At 6 months follow-up, LV morphology and function as well as functional status of these patients significantly improved. In conclusion, Bb infection may represent an important cause of new-onset unexplained DCM in patients living in endemic regions such as the Czech Republic. Because the antibiotic treatment appears to be markedly effective and serological examination does not provide a tool for diagnosing the disease, EMB focused on the detection of Bb should be performed in all patients from endemic areas with new-onset unexplained DCM not responding to conventional therapy.
Inflammatory dilated cardiomyopathy (DCMi) represents an acquired form of dilated cardiomyopathy. Viral infection is the most common cause of DCMi. In contrast with other cardiotropic viruses, herpes simplex virus (HSV) is a very rare finding in endomyocardial biopsies of patients with dilated cardiomyopathy. We report a case of HSV-induced cardiomyopathy successfully treated with acyclovir.
Zvětseni prsů silikonovými implantaty může zhorsit proveditelnost koronarni angiografie a připadne koronarni intervence. Při rozhodnuti o jejich implantaci by tato skutecnost měla být brana v potaz u žen s vyssim rizikem aterosklerozy.
Mezinarodni randomizovana studie CHAMPION-PLATFORM testuje použiti noveho intravenozniho inhibitoru destickových ADP receptorů – cangreloru v situaci ad-hoc PCI. Ackoli výskyt primarniho sledovaneho ukazatele (kombinace smrti, IM a opakovane revaskularizace) nebyl podanim cangreloru významně ovlivněn, 30denni mortalita a výskyt trombozy stentu byly v aktivně lecene skupině významně nižsi. Potvrdi-li rocni sledovani pacientů v teto studii přiznivý vliv cangreloru na prognozu nemocných, ma tento preparat dobrý potencial stat se standardni protidestickovou lecbou během koronarnich intervenci.