Abstract Background Atrial fibrillation (AF), with a prevalence of 1–2%, is the most common cardiac arrhythmia. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5–6%. The ...source of a cardioembolic event is a thrombus, which is usually formed in the left atrial appendage (LAA). Prevention of cardioembolic events involves treatment with anticoagulant drugs: either vitamin K antagonists, or, recently, novel anticoagulants (NOAC). The other (non-pharmacologic) option for the prevention of a cardioembolic event involves interventional occlusion of the LAA. Objective To determine whether percutaneous LAA occlusion is non-inferior to treatment with NOAC in AF patients indicated for long-term systemic anti-coagulation. Study design The trial will be a prospective, multicenter, randomized non-inferiority trial comparing two treatment strategies in moderate to high risk AF patients (i.e. patients with history of significant bleeding, or history of cardiovascular event(s), or a with CHA2 DS2 VASc≥ 3 and HAS-BLED score≥ 2). Patients will be randomized into a percutaneous LAA occlusion (group A) or a NOAC treatment (group B) in a 1:1 ratio, the randomization was done using web-based randomization software. A total of 396 study participants (198 patients in each group) will be enrolled in the study. The primary endpoint will be the occurrence of any of the following events within 24 months following randomization: stroke or TIA (any type), systemic cardioembolic event, clinically significant bleeding, cardiovascular death, or a significant peri-procedural or device-related complications. Conclusion The PRAGUE-17 trial will determine if LAA occlusion is non-inferior to treatment with NOAC in moderate to high-risk AF patients.
Abstract Background Little is known about the valve degeneration process after transcutaneous aortic valve implantations (TAVI) that can have an important impact on patients’ long-term prognosis. Aim ...To evaluate degenerative changes of TAVI using computed tomography (CT) compared to findings in patients that underwent surgical aortic valve replacement (SAVR). Subsequently, to compare the level of immune and inflammatory markers in both groups and test their possible role in the valve degeneration process. Methods and results 49 patients after TAVI and 29 patients in the control group after SAVR underwent 2 years of follow-up and 8 patients from the TAVI group and 7 patients after SAVR underwent five years of follow-up. CT was performed in all patients and calcifications on prosthesis cusps in both groups were measured using Agatson calcium score. TAVI patients were older compared to patients who underwent SAVR 82 (62;86) vs. 74 (64;84) years, p < 0.001, and had more comorbidities – higher EuroScore I 21.0 (5.0;46.0) vs. 6.15 (2.54;11.17), p < 0.001. TAVI patients had more often concomitant coronary artery disease (69.4% vs. 13.8%, p < 0.001) and previous history of cardiac surgery (32.7% vs. 0.0%, p < 0.001). Slight calcifications (mean Agatson score 50.76) on prosthetic cusps were found in 2 patients 4–5 years after TAVI and in 1 patient 2 years after SAVR ( p = NS). Even though significant differences were found in values of tumor necrosis factor-α and E-selectin before, 1 year, and 2 years after implantation, no significant changes in values of inflammatory markers were observed during follow-up period in both groups of patients. Detailed analysis revealed no significant difference between values of inflammatory markers of patients with and without calcifications present on CT. Conclusion Minimal degenerative changes on TAVI prosthesis were observed in mid- and long-term follow-up. Systemic immune response did not differ between patients after TAVI and SAVR.
Severe Left Ventricular Dyssynchrony Is Associated With Poor Prognosis in Patients With Moderate Systolic Heart Failure Undergoing Coronary Artery Bypass Grafting Martin Penicka, Jozef Bartunek, Otto ...Lang, Karel Medilek, Petr Tousek, Marc Vanderheyden, Bernard De Bruyne, Michaela Maruskova, Petr Widimsky The objective of the present study was to assess the relationship between the presence of left ventricular dyssynchrony and clinical outcome in patients with moderate systolic heart failure undergoing coronary artery bypass graft (CABG) surgery. The presence of pre-CABG dyssynchrony ≥119 ms had the highest predictive accuracy for in-hospital mortality (sensitivity 84%, specificity 71%). During the median follow-up period of 359 days, post-CABG dyssynchrony ≥72 ms was the strongest independent predictor for death or hospitalization for heart failure (hazard ratio 5.02; 95% confidence interval 2.57 to 10.02; p < 0.001). Patients without post-CABG dyssynchrony had excellent prognosis compared with patients with severe post-CABG dyssynchrony (event rate 10% vs. 55%; p < 0.001).
Early and Late Benefits of Prasugrel in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: A TRITON–TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by ...Optimizing Platelet InhibitioN with Prasugrel–Thrombolysis In Myocardial Infarction) Analysis Elliott M. Antman, Stephen D. Wiviott, Sabina A. Murphy, Juri Voitk, Yonathan Hasin, Petr Widimsky, Harish Chandna, William Macias, Carolyn H. McCabe, Eugene Braunwald Significant reductions in myocardial infarction, stent thrombosis, and urgent target vessel revascularization were observed with the use of prasugrel both during the first 3 days and from 3 days to the end of TRITON–TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel–Thrombolysis In Myocardial Infarction). The excess major bleeding found with the use of prasugrel occurred predominantly during the maintenance phase. Approaches to reduce the relative excess of bleeding with prasugrel should focus on the maintenance dose (e.g., reduction in maintenance dose in previously reported high-risk subgroups such as the elderly and those patients with low body weight).
Abstract Study Objective The aim of this study was to explore the prognostic role of serum uric acid (UA) measurement in the hospital and long-term mortality assessment in subjects with acute heart ...failure (AHF) from the Acute HEart FAilure Database registry (AHEAD). The AHEAD registry comprised 4153 patients with AHF syndromes hospitalized at the AHEAD participating centers. Patients and Methods The study included 1255 patients who were admitted to the AHEAD participating centers with acute decompensated chronic heart failure, de novo heart failure, or cardiogenic shock between September 2006 and October 2009 and who had information about serum UA concentration available at the time of hospital admission. The hospital and long-term mortality was followed using the centralized database of the Ministry of Health, Czech Republic. The mean age of the cohort was 73.4 years, the female population represented 43%, the median hospital stay was 8 days, and the mean hospital mortality was 7.6%. Results The median UA concentration of the patients with AHF was 432 μ mol/L (7.26 mg/dL), the median estimated glomerular filtration rate (eGFR) was 49.0 mL/min, and N-terminal pro–brain natriuretic peptide level was 5510 pg/mL. Among other laboratory variables, UA concentration greater than 515 μ mol/L (8.67 mg/dL) was associated with increased hospital mortality ( P < .001), as well as eGFR less than 30 mL/min ( P < .001), Na 135 mmol/L or less, and positive troponin. Uric acid concentration greater than 500 μ mol/L (8.41 mg/dL) was associated with increased long-term mortality ( P < .001), followed by eGFR less than 30 mL/min ( P < .001), Na 135 mmol/L or less, and hemoglobin level lower than 130 g/L ( P < .001). The 1-year survival rate of patients discharged from hospital (n = 1159) was 75.6%, and the 2-year rate was 66.8%. Survival of patients treated with allopurinol for hyperuricemia was significantly lower compared with untreated subjects (70.1 vs 77.2 for 1-year survival and 60.3 vs 68.5 for 2-year survival). Conclusion In patients with AHF, increased UA levels and documented allopurinol therapy for hyperuricemia were associated with increased hospital and long-term mortality. Allopurinol therapy is not a cause but the identifier of the subjects at risk.
Abstract Objectives The purpose of this study was to compare the 1-year outcome between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic stent (EES) in ST-segment elevation ...myocardial infarction (STEMI) patients. Background The Absorb BVS (Abbott Vascular, Santa Clara, California) is a polymeric scaffold approved for treatment of stable coronary lesions. Limited and not randomized data are available on its use in ST-segment elevation myocardial infarction (STEMI) patients. Methods This study included 290 consecutive STEMI patients treated by BVS, compared with either 290 STEMI patients treated with EES or 290 STEMI patients treated with bare-metal stents (BMS) from the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction) trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization, at 1-year follow-up. Device thrombosis, according to the Academic Research Consortium criteria, was also evaluated. Results The cumulative incidence of DOCE did not differ between the BVS and EES or BMS groups either at 30 days (3.1% vs. 2.4%, hazard ratio HR: 1.31 95% confidence interval (CI): 0.48 to 3.52, p = 0.593; vs. 2.8%, HR: 1.15 95% CI: 0.44 to 2.30, p = 0.776, respectively) or at 1 year (4.1% vs. 4.1%, HR: 0.99 95% CI: 0.23 to 4.32, p = 0.994; vs. 5.9%, HR: 0.50 95% CI: 0.13 to 1.88, p = 0.306, respectively). Definite/probable BVS thrombosis rate was numerically higher either at 30 days (2.1% vs. 0.3%, p = 0.059; vs. 1.0%, p = 0.324, respectively) or at 1 year (2.4% vs. 1.4%, p = 0.948; vs. 1.7%, p = 0.825, respectively), as compared with EES or BMS. Conclusions At 1-year follow-up, STEMI patients treated with BVS showed similar rates of DOCE compared with STEMI patients treated with EES or BMS, although rate of scaffolds thrombosis, mostly clustered in the early phase, was not negligible. Larger studies with longer follow-up are needed to confirm our findings.
Abstract Background Acute heart failure (AHF) is associated with a poor prognosis. Objectives The objectives of this study are to describe mechanisms of AHF and to identify the predictors for ...all-cause mortality by patients admitted for hospitalization by emergency departments (EDs) as well as to compare European and American data. Methods We designed a prospective registry of consecutively admitted patients for AHF to a high-volume university hospital ED during a 1-year period (n = 202; age, 75 ± 11 years; 51% men; ejection fraction, 38% ± 15%). Results The major causes of AHF were coronary artery disease, often with concomitant mitral regurgitation, hypertension, or atrial fibrillation (>90% of cases). At admission, 24.9% of patients had preserved ejection fractions (>50%); and only 7.7% fulfilled the definition of diastolic AHF. The 30-day and long-term mortality (median follow-up, 793 days) were 20.3% and 31.0%, respectively. A low systolic blood pressure ( P = .006), reduced ejection fraction ( P = .044), and low serum hemoglobin level ( P < .01) emerged as the strongest predictors of all-cause mortality. In patients with AHF without acute myocardial infarction (MI) (63.9%), prescription, at discharge, of statins ( P < .05) was independently associated with all-cause mortality. Conclusions The patient's blood pressure, ejection fraction, and hemoglobin values, at admission, were identified as the strongest predictors of all-cause mortality. In AHF not triggered by acute MI, long-term use of statins may be associated with reduced survival. The prevalence of diastolic AHF is low. The American AHF population had similar baseline characteristics; needed fewer intensive care unit admissions; had a better 30 days of prognosis, lower incidence of MI, and de novo AHF diagnoses. In a similar subgroup, we observed similar incidences of inotropic support and mechanical ventilation. Our results could not be generalized to all patients with AHF admitted to US EDs.
Objectives The study sought to evaluate the relationship between procedural volume and outcomes with radial and femoral approach. Background RIVAL (RadIal Vs. femorAL) was a randomized trial of ...radial versus femoral access for coronary angiography/intervention (N = 7,021), which overall did not show a difference in primary outcome of death, myocardial infarction, stroke, or non–coronary artery bypass graft major bleeding. Methods In pre-specified subgroup analyses, the hazard ratios for the primary outcome were compared among centers divided by tertiles and among individual operators. A multivariable Cox proportional hazards model was used to determine the independent effect of center and operator volumes after adjusting for other variables. Results In high-volume radial centers, the primary outcome was reduced with radial versus femoral access (hazard ratio HR: 0.49; 95% confidence interval CI: 0.28 to 0.87) but not in intermediate- (HR: 1.23; 95% CI: 0.88 to 1.72) or low-volume centers (HR: 0.83; 95% CI: 0.52 to 1.31; interaction p = 0.021). High-volume centers enrolled a higher proportion of ST-segment elevation myocardial infarction (STEMI). After adjustment for STEMI, the benefit of radial access persisted at high-volume radial centers. There was no difference in the primary outcome between radial and femoral access by operator volume: high-volume operators (HR: 0.79; 95% CI: 0.48 to 1.28), intermediate (HR: 0.87; 95% CI: 0.60 to 1.27), and low (HR: 1.10; 95% CI: 0.74 to 1.65; interaction p = 0.536). However, in a multivariable model, overall center volume and radial center volume were independently associated with the primary outcome but not femoral center volume (overall percutaneous coronary intervention volume HR: 0.92, 95% CI: 0.88 to 0.96; radial volume HR: 0.88, 95% CI: 0.80 to 0.97; and femoral volume HR: 1.00, 95% CI: 0.94 to 1.07; p = 0.98). Conclusions Procedural volume and expertise are important, particularly for radial percutaneous coronary intervention. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention PCI Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy RIVAL; NCT01014273 )
Summary Background Treatment with prasugrel and aspirin improves outcomes compared with clopidogrel and aspirin for patients with acute coronary syndrome who have had angiography and percutaneous ...coronary intervention; however, no clear benefit has been shown for patients managed first with drugs only. We assessed outcomes from the TRILOGY ACS trial based on whether or not patients had coronary angiography before treatment was chosen. Methods TRILOGY ACS ( ClinicalTrials.gov number NCT00699998 ) was a randomised controlled trial, done at more than 800 sites worldwide. Patients with non-ST-elevation acute coronary syndrome who were selected for management without revascularisation were randomly assigned to clopidogrel or prasugrel. The primary endpoint was cardiovascular death, myocardial infarction, or stroke at 30 months. In the present analysis we assessed differences in the primary endpoint by angiography status and whether the effects of treatment on the primary endpoint differed between patients who had angiography before enrolment and those who had not. Findings 7243 patients younger than 75 years were included in the TRILOGY ACS primary analysis. 3085 (43%) had angiography at baseline, 4158 (57%) had not. Fewer patients who had angiography reached the primary endpoint at 30 months compared with those who did not have angiography, according to Kaplan-Meier analysis (281/3085 12·8% vs 480/4158 16·5%, adjusted hazard ratio HR 0·63, 95% CI 0·53–0·75; p<0·0001). The proportion of patients who reached the primary endpoint was lower in the prasugrel group than in the clopidogrel group for those who had angiography (122/1524 10·7% vs 159/1561 14·9%, HR 0·77, 95% CI 0·61–0·98; p=0·032) but did not differ between groups in patients who did not have angiography (242/2096 16·3% vs 238/2062 16·7%, HR 1·01, 0·84–1·20; p=0·94; pinteraction =0·08). Overall, TIMI major bleeding and GUSTO severe bleeding were rare. Bleeding outcomes tended to be higher with prasugrel but did not differ significantly between treatment groups in either angiography cohort. Interpretation Among patients who had angiography who took prasugrel there were fewer cardiovascular deaths, myocardial infarctions, or strokes than in those who took clopidogrel. This result needs to be corroborated, but it is consistent with previous trials of more versus less intensive antiplatelet treatment. When angiography is done for acute coronary syndrome and anatomic coronary disease confirmed, the benefits and risks of intensive antiplatelet treatment exist whether the patient is treated with drugs or percutaneous coronary intervention. Funding Daiichi Sankyo, Eli Lilly.
Background Radial access for percutaneous coronary intervention is associated with lower rates of access site complications and bleeding. However, elderly patients have more complex vascular anatomy ...and radial access may be more challenging in this population. There remains uncertainty regarding the role of radial access in elderly patients undergoing cardiac catheterization. Methods and Results The RIVAL trial randomized patients with acute coronary syndromes undergoing cardiac catheterization to radial versus femoral access. In this analysis, the rates of access site complications and access site cross-over were compared across different age groups. Among the 7,021 patients, 1035 (15%) were ≥75 years of age. Across all age categories, radial access was consistently associated with higher rates of access site cross over and lower rates of major access site complications, with no significant interaction between age and access site. Radial access was associated with lower rates of major vascular access site complications in patients ≥75 years of age (3.6% vs 6.6%; P = .03) and in patients <75 years of age (1.0% vs 3.2%; P < .001; P value for interaction = .2). The rates of access site crossover were higher with radial access among patients ≥75 (12.5% vs 2.6%; P < .001) and <75 (6.7% vs 1.9%; P < .001; P value for interaction = .9). There were no significant differences in the primary composite outcome (death, myocardial infarction, stroke or non coronary artery bypass graft major bleeding) or its individual components in either age group. In patients ≥75 years of age undergoing primary percutaneous coronary intervention, there was no significant difference in procedure time (120 vs 115 minutes; P = .3). Conclusions Consistent with the overall RIVAL trial population, elderly patients undergoing cardiac catheterization have lower rates of major bleeding or access site complications and higher rates of access site crossover with radial access compared to femoral access.
PDF
