Análisis combinado de dos ensayos aleatorizados de comparación de stents con recubrimiento de titanio-óxido nítrico con stents liberadores de fármacos en el IAMCEST / Pooled Analysis of Two Randomized Trials Comparing Titanium-nitride-oxide-coated Stent Versus Drug-eluting Stent in STEMI

Introducción y objetivos Análisis combinado basado en los datos de pacientes de los ensayos TITAX-AMI y BASE-ACS para evaluar los resultados clínicos obtenidos con stents bioactivos con recubrimiento de titanio-óxido nítrico comparados con los stents liberadores de fármacos en pacientes con infarto agudo de miocardio con elevación del segmento ST tras un seguimiento de 2 años. Métodos El ensayo TITAX-AMI comparó los stents bioactivos con los liberadores de paclitaxel en 425 pacientes con infarto agudo de miocardio. El ensayo BASE-ACS comparó stents bioactivos con stents liberadores de everolimus en 827 pacientes con síndrome coronario agudo. El objetivo principal para el análisis combinado fueron los eventos adversos cardiacos mayores: muerte cardiaca, infarto de miocardio recurrente o revascularización de la lesión diana por causa isquémica tras un seguimiento de 2 años. Resultados El análisis combinado incluyó a 501 pacientes; se trató a 245 con stents bioactivos y se implantó stent liberador de fármacos a 256. En el análisis conjunto, el grupo de stentsbioactivos presentó un cociente de riesgos de eventos adversos cardiacos mayores de 0,85 (intervalo de confianza del 95%, 0,53-1,35; p = 0,49) comparado con el grupo de stentsliberadores de fármacos. De igual modo, el grupo conjunto de stents bioactivos mostró un cociente de riesgos de muerte cardiaca de 0,71 (intervalo de confianza del 95%, 0,26-1,95; p = 0,51); de infarto de miocardio recurrente, 0,44 (intervalo de confianza del 95%, 0,20-0,97; p = 0,04), y de revascularización de la lesión diana por causa isquémica, 1,39 (intervalo de confianza del 95%, 0,74-2,59; p = 0,30), en comparación con el grupo conjunto tratado con stents liberadores de fármacos. Estos resultados se confirmaron por un análisis de puntuación de propensión ajustado respecto a la serie de datos conjunta. Conclusiones: En pacientes con infarto agudo de miocardio con elevación del segmento ST, los stents bioactivos, comparados con los stents liberadores de fármacos, se asociaron a menores tasas de infarto de miocardio recurrente tras un seguimiento de 2 años; no obstante, las tasas de muerte cardiaca y de revascularización de la lesión diana por causa isquémica fueron similares

Introduction and objectives We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. Methods The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. Results The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P = .49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P = .51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P = .04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P = .30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. Conclusions In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar

Pooled analysis of two randomized trials comparing titanium-nitride-oxide-coated stent versus drug-eluting stent in STEMI.

INTRODUCTION AND OBJECTIVES: We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. METHODS: The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. RESULTS: The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P=.49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P=.51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P=.04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P=.30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. CONCLUSIONS: In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar.

Idiopathic dilated cardiomyopathy and chronic atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) is common in idiopathic dilated cardiomyopathy (IDC). We explored the clinical characteristics of IDC patients with chronic AF compared with those with sinus rhythm (SR). METHODS: A group of patients with IDC underwent extensive non-invasive and invasive evaluation during a hospitalization period. The patients were further divided into two groups with AF (n = 19) and SR (n = 68). RESULTS: Left atrial diameter was greater (P<0·001), left ventricular end-diastolic diameter smaller (P<0·05), left ventricular end-diastolic and end-systolic volumes smaller (P<0·01 for all), mean pulmonary artery pressure and pulmonary capillary wedge pressure higher (P<0·05 for both), cardiac output and maximal oxygen consumption lower (P<0·01 and P<0·05, respectively), and the levels of N-terminal pro-brain natriuretic peptide and interleukin-6 higher (P<0·05 for both) in AF group compared with SR group. Left ventricular ejection fraction and left ventricular end-diastolic pressure were similar in both groups. CONCLUSIONS: In spite of otherwise more unfavourable prognostic factor profile, left ventricular size was observed to be smaller in chronic AF compared with SR in well-characterized patients with IDC. The confirmation and possible explainers of this paradoxical phenomenon need further studies in larger patient cohorts.

Intermittent levosimendan treatment in patients with severe congestive heart failure.

OBJECTIVE: Levosimendan (LS) is a novel inodilator for the treatment of severe congestive heart failure (CHF). In this study, we investigated the potential long-term effects of intermittent LS treatment on the pathophysiology of heart failure. METHODS: Thirteen patients with modest to severe CHF received three 24-h intravenous infusions of LS at 3-week intervals. Exercise capacity was determined by bicycle ergospirometry, well-being assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ) and laboratory parameters of interest measured before and after each treatment. RESULTS: One patient experienced non-sustained periods of ventricular tachycardia (VT) during the first infusion and had to discontinue the study. Otherwise the LS infusions were well tolerated. Exercise capacity (VO2max) did not improve significantly during the study although symptoms decreased (P < 0.0001). Levels of plasma NT-proANP, NT-proBNP and NT-proXNP decreased 30-50% during each infusion (P < 0.001 for all), but the changes disappeared within 3 weeks. Although norepinephrine (NE) appeared to increase during the first treatment (P = 0.019), no long-term changes were observed. CONCLUSION: Intermittent LS treatments decreased effectively and repetitively plasma vasoactive peptide levels, but no carryover effects were observed. Patients' symptoms decreased for the whole study period although there was no objective improvement of their exercise capacity. The prognostic significance of these effects needs to be further studied.

Five-year clinical outcome of titanium-nitride-oxide-coated bioactive stents versus paclitaxel-eluting stents in patients with acute myocardial infarction: long-term follow-up from the TITAX AMI trial.

BACKGROUND: The TITAX-AMI randomized controlled trial demonstrated a better clinical outcome with titanium-nitride-oxide-coated bioactive stents (BAS) as compared with paclitaxel-eluting stents (PES) at 2-year follow-up, in patients with acute myocardial infarction (MI) undergoing early percutaneous coronary intervention (PCI). We sought to present the 5-year clinical outcome of the TITAX-AMI trial. METHODS: A total of 425 patients with acute MI were randomly assigned to receive either BAS (214), or PES (211). The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, recurrent MI or ischemia-driven target lesion revascularization (TLR). Clinical follow-up was performed to 5 years. RESULTS: The 5-year cumulative incidence of MACE was significantly lower in patients assigned to BAS as compared with those assigned to PES (16.4% versus 25.1%, respectively, p=0.03). Similarly, the 5-year rates of cardiac death and recurrent MI were significantly lower in patients assigned to BAS (1.9% versus 5.7%, and 8.4% versus 18.0%, p=0.04 and p=0.004, respectively). Yet, the rates of ischemia-driven TLR were similar between the two study groups (11.2% versus 10.9%, respectively, p=0.92). The rate of definite stent thrombosis (ST) was again significantly lower in patients assigned to BAS (0.9% versus 7.1%, respectively, p=0.001). CONCLUSIONS: In the current prospective randomized TITAX-AMI trial, among patients presenting with acute MI who underwent early PCI, BAS achieved a better clinical outcome as compared with PES at 5-year follow-up, as reflected by lower cumulative rates of overall MACE, cardiac death, recurrent MI, and definite ST; yet, with statistically similar rates of ischemia-driven TLR.

Gender-based analysis of the 3-year outcome of bioactive stents versus paclitaxel-eluting stents in patients with acute myocardial infarction: an insight from the TITAX-AMI trial.

BACKGROUND: The TITAX-AMI trial demonstrated a better clinical outcome of titanium-nitride-oxide-coated bioactive stents (BAS) as compared with paclitaxel-eluting stents (PES) in patients with acute myocardial infarction (MI) undergoing early percutaneous coronary intervention (PCI). We explored the gender-based 3-year outcome of BAS as compared with PES in a subgroup analysis of the TITAX-AMI trial. METHODS: A total of 214 patients (52 women) with acute MI were randomly assigned to BAS, and 211 patients (54 women) to PES. The primary endpoint was major adverse cardiac events (MACE) including cardiac death, recurrent MI, and target lesion revascularization (TLR). Secondary endpoints were all-cause death, a composite of cardiac death or recurrent MI, and stent thrombosis (ST). RESULTS: Women were older and had smaller reference vessel diameter (P<.001 for both) as compared with men. At 3-year follow-up, both MACE and TLR showed a trend to be higher in women as compared with men (24.5% versus 16.3% [P=.059] and 15.1% versus 8.8% [P=.065], respectively). The rate of all-cause death was significantly higher in women as compared with men (13.2% versus 6.0%, respectively; P=.02). Among female patients, MACE, cardiac death, recurrent MI, TLR, and ST were all statistically similar between the two stent groups (P>.05 for all). CONCLUSIONS: In the current post hoc gender-based analysis of the TITAX-AMI trial, the 3-year outcome of patients undergoing PCI for acute MI was slightly worse in female patients as compared with their male counterparts, as reflected by a trend toward a higher primary composite endpoint of MACE and TLR.