Impact of arterial access site on outcomes after primary percutaneous coronary intervention: prespecified subgroup analysis from the EUROMAX trial.

BACKGROUND: In European Ambulance Acute Coronary Syndrome Angiography (EUROMAX), bivalirudin improved 30-day clinical outcomes with reduced major bleeding compared with heparins plus optional glycoprotein IIb/IIIa inhibitors. We assessed whether choice of access site (radial or femoral) had an impact on 30-day outcomes and whether it interacted with the benefit of bivalirudin. METHODS AND RESULTS: In EUROMAX, choice of arterial access was left to operator discretion. Overall, 47% of patients underwent radial and 53% femoral access. Baseline risk was higher in the femoral access group. Unadjusted proportions for the primary outcome (death or noncoronary artery bypass graft protocol major bleeding at 30 days) were lower with radial access, however, without differences in major or major plus minor bleeding proportions. After multivariable adjustment, ischemic outcomes were no longer different between access site groups, except for a lower risk of stroke in radial patients. Bivalirudin was associated with lower proportions of the primary outcome in both the radial (odds ratio, 0.58; 95% CI, 0.33-1.03; P=0.058) and the femoral groups (odds ratio, 0.59; 95% CI, 0.37-0.93; P=0.022; interaction P=0.97). Bleeding was significantly lower in the bivalirudin group both in the radial- and femoral-treated patients but no significant difference was observed in ischemic outcomes. In multivariable analysis, bivalirudin emerged as the only independent predictor of reduced major bleeding (odds ratio, 0.45; 95% CI, 0.27-0.74; P=0.002). CONCLUSIONS: In this prespecified analysis from EUROMAX, radial access was preferred in lower risk patients and did not improve clinical outcomes. Bivalirudin was associated with less bleeding irrespective of access site. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01087723.

Impact of age-adjusted insulin-like growth factor 1 on major cardiovascular events after acute myocardial infarction: results from the fast-MI registry.

BACKGROUND: The GH/IGF-1 axis is being targeted for therapeutic development in diseases such as short stature, cancer, and metabolic disorders. The impact of IGF-1 in cardiovascular disease remains controversial. We therefore studied whether IGF-1 at admission for acute myocardial infarction (AMI) predicted death, recurrent AMI, and stroke over a 2-year follow-up. METHODS: Using data from the French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction registry, we measured IGF-1 among all the 1005 patients with AMI who participated in the serum data bank. Because IGF-1 decreases with age, a standardized IGF-1 score was calculated as previously described [IGF-1 score = (log [IGF-1 (micrograms per liter)] + 0.00625 × age - 2.555)/0.104]. Impact of IGF-1 score (continuous and quartiles) on outcomes were compared using Cox proportional hazards regression models. RESULTS: During follow-up, 190 patients died or had a recurrent AMI or stroke. Patients in the lowest quartile of IGF-1 were older and more frequently female and diabetic compared with patients in the other quartiles. After adjustment for known cardiovascular factors, an increase of five units of IGF-1 score was associated with a 30% decrease of the risk of events during follow-up (adjusted hazard ratio 0.70; 95% confidence interval 0.54-0.92; P = .0093). Similarly, the lowest quartile of IGF-1 was associated with an increased risk of events (adjusted hazard ratio 1.52, 95% confidence interval 1.11-2.08; compared with others quartiles, P = .010). CONCLUSIONS: Low IGF-1 score is associated with an increased risk of all-cause death, recurrent myocardial infarction, and stroke in AMI patients. Whether patients treated by IGF-1 axis inhibitors have a specific clinical course after AMI would be worth studying.

Acute stent thrombosis after primary percutaneous coronary intervention: insights from the EUROMAX trial (European Ambulance Acute Coronary Syndrome Angiography).

OBJECTIVES: This study sought to determine clinical, procedural, and treatment factors associated with acute stent thrombosis (AST) in the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial. BACKGROUND: Bivalirudin started during transport for primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction significantly reduced major bleeding compared with heparin with or without glycoprotein IIb/IIIa inhibitors (GPI), but it was associated with an increase in AST. METHODS: We compared patients with (n = 12) or without AST (n = 2,184) regarding baseline, clinical, and procedural characteristics and antithrombotic treatment strategies (choice of P2Y12 inhibitor, post-primary PCI bivalirudin infusion dose [0.25 mg/kg/h, or BIV-LOW] vs. [1.75 mg/kg/h, or BIV-PCI] vs. heparin ± GPI). Logistic regression was performed to identify independent correlates of AST. RESULTS: The overall AST rate was 0.6% and was higher with bivalirudin than with heparin ± GPI (1.1% vs. 0.2%; p = 0.007). Median time to AST was 2.3 h (interquartile range: 1.9 to 2.8 h). Patients with AST had less hypertension (2 of 14 [14.0%] vs. 961 of 2,182 [44.0%]; p = 0.03), and more frequently received GPI (11 of 14 [78.6%] vs. 880 of 2,183 [40.3%]; p = 0.004). Multivariate analysis using Firth penalized maximum likelihood estimation found hypertension (odds ratio [OR]: 0.24, 95% confidence interval [CI]: 0.07 to 0.92; p = 0.037) and BIV-LOW (OR: 5.8, 95% CI: 1.5 to 22.2; p = 0.010) predictive of AST. Choice of P2Y12 inhibitor had no impact on AST. Compared with heparin ± GPI, AST rates were higher for BIV-LOW (11 of 670 [1.6%] vs. 2 of 947 [0.2%]; p = 0.008), but not different for BIV-PCI (1 of 244 [0.4%]; p = 0.588). CONCLUSIONS: In this post-hoc analysis from EUROMAX, AST occurred very early and was not mitigated by the novel P2Y12 inhibitors. Prolonging the bivalirudin infusion at the PCI dose (but not at a lower dose) appeared to mitigate the risk of AST.

Clinical and economic outcomes of infective endocarditis.

BACKGROUND: In France, the estimated annual incidence of infective endocarditis (IE) is 33.8 cases per million residents. Valvular surgery is frequently undergone. We report an epidemiological and economic study of IE for 2007-2009 in a French region, using the hospital discharge database (HDD). METHODS: The population studied concerned all the patients living in Centre region, France, hospitalized for IE. We extracted hospital stay data for IE from the regional HDD, with a definition based on IE-related diagnosis codes. The predictive positive value (PPV) and sensitivity (Se) of the definition were 87.4% and 90%, respectively, according to the Duke criteria (definite IE frequency 74.4%). Hospitalization costs were estimated, taking into account the fixed hospital charges of the diagnosis-related group (DRG) and supplementary charges due to intensive care unit (ICU) stay. RESULTS: The analysis included 578 patients. The annual average incidence was 45.4 cases per million residents. Valvular surgery was performed in 19.4% of cases. The hospital mortality was 17.6%. Multivariate analysis identified as risk factors for mortality an age ≥ 70 years (odds ratio (OR) = 3.03, 95% confidence interval (CI) = 1.78-5.18), staphylococcal IE (OR = 3.3, 95% CI = 1.9-5.7), chronic renal insufficiency (OR = 2.04, 95% CI = 1.00-4.15), ischemic stroke (OR = 2.55, 95% CI = 1.19-5.47), and hemorrhagic stroke (OR = 5.7, 95% CI = 1.9-17.3). The average cost per episode was $20 103 (€15 281). CONCLUSIONS: We report a higher incidence of IE than described by the French national study of 2008. Valvular surgery was considerably less frequent than in the published data, whereas mortality was similar. IE generates substantial costs.

Improved outcome of cardiogenic shock at the acute stage of myocardial infarction: a report from the USIK 1995, USIC 2000, and FAST-MI French nationwide registries.

AIM: The historical evolution of incidence and outcome of cardiogenic shock (CS) in acute myocardial infarction (AMI) patients is debated. This study compared outcomes in AMI patients from 1995 to 2005, according to the presence of CS. METHOD AND RESULTS: Three nationwide French registries were conducted 5 years apart, using a similar methodology in consecutive patients admitted over a 1-month period. All 7531 AMI patients presenting ≤48 h of symptom onset were included. The evolution of mortality was compared in the 486 patients with CS vs. those without CS. The incidence of CS tended to decrease over time (6.9% in 1995; 5.7% in 2005, P = 0.07). Thirty-day mortality was considerably higher in CS patients (60.9 vs. 5.2%). Over the 10-year period, mortality decreased for both patients with (70-51%, P = 0.003) and without CS (9-4%, P < 0.001). In CS patients, the use of percutaneous coronary intervention (PCI) increased from 20 to 50% (P < 0.001). Time period was an independent predictor of early mortality in CS patients (OR for death, 2005 vs. 1995 = 0.45; 95% CI: 0.27-0.75, P = 0.005), along with age, diabetes, and smoking status. When added to the multivariate model, PCI was associated with decreased mortality (OR = 0.38; 95% CI: 0.24-0.58, P < 0.001). In propensity-score-matched cohorts, CS patients with PCI had a significantly higher survival. CONCLUSIONS: Cardiogenic shock remains a clinical concern, although early mortality has decreased. Improved survival is concomitant with a broader use of PCI and recommended medications at the acute stage. Beyond the acute stage, however, 1-year survival has remained unchanged.

Insuficiencia cardiaca en el infarto agudo de miocardio: comparación de pacientes con o sin criterios de insuficiencia cardiaca del registro FAST-MI / Heart failure in acute myocardial infarction: a comparison between patients with or without heart failure criteria from the FAST-MI registry

Introducción y objetivos. El papel las lipoproteínas de alta densidad en la estratificación de riesgo en pacientes con dolor torácico no está bien definido. El objetivo de este estudio es conocer la contribución relativa del perfil lipídico al riesgo de padecer síndrome coronario agudo de los pacientes ingresados por dolor torácico en una planta de cardiología. Métodos. Incluimos todos los ingresos consecutivos no programados en planta de cardiología durante 15 meses y realizamos seguimiento al año. Resultados. Se incluyó a 959 pacientes, 457 (47,7%) diagnosticados de dolor torácico no isquémico, 355 (37%) de síndrome coronario agudo sin elevación del ST y 147 (15,3%) de síndrome coronario agudo con elevación del ST. El 54,6% de los pacientes presentaron cifras de lipoproteínas de alta densidad < 40mg/dl y la prevalencia fue más elevada entre los pacientes con síndrome coronario agudo (el 69,4 frente al 30,6%; p<0,01). Se observó mayor presencia de síndrome coronario agudo a menores cifras medias de lipoproteínas de alta densidad. Edad, tabaquismo activo, diabetes mellitus, glucemia basal > 100mg/dl y concentraciones de lipoproteínas de alta densidad < 40mg/dl se asociaron independientemente a la presencia de síndrome coronario agudo, el factor con mayor asociación (odds ratio=4,11; intervalo de confianza del 95%, 2,87-5,96). El análisis de supervivencia determinó que los pacientes con síndrome coronario agudo, frente a dolor torácico no isquémico, asociaron un riesgo significativamente superior de mortalidad por cualquier causa, así como por causa cardiovascular. Conclusiones. Las concentraciones bajas de colesterol unido a las lipoproteínas de alta densidad (≤ 40mg/dl) se asociaron de manera independiente a diagnóstico de síndrome coronario agudo en pacientes ingresados por dolor torácico, con una relación inversa significativa entre los valores más bajos de lipoproteínas de alta densidad y el diagnóstico de síndrome coronario agudo (AU)

Introduction and objectives. To compare acute myocardial infarction patients with or without congestive heart failure in the French FAST-MI registry. Methods. The French FAST-MI registry included 374 centers and 3059 patients over a 1-month period at the end of 2005, with 1-year follow-up. Among this population, patients with at least one congestive heart failure criterion constituted group 1 (n=1149; 37.5%) and were compared to patients without congestive heart failure (group 2, n=1910; 62.5%). The congestive heart failure patients were further divided according to presence of both beta-blockers and antagonists of the renin-angiotensin-aldosterone system at hospital discharge (n=511) or not (n=498), in order to assess the real-world clinical importance of recommended medications. Results. Overall in-hospital and 1-year mortality rates were 3.4% and 13.2%, respectively. In hospital survivors, presence of congestive heart failure was associated with increased mortality (adjusted hazard ratio=1.55; 95% confidence interval, 1.10-2.17; P=.01). Survival was higher in patients without congestive heart failure, compared with congestive heart failure patients receiving or not recommended medications (P<.001). Congestive heart failure patients receiving neither renin-angiotensin-aldosterone system blockers nor beta-blockers (adjusted hazard ratio=1.66; 95% confidence interval, 1.08-2.55; P=.02) had a significantly higher risk of death than patients receiving both classes of medications (adjusted hazard ratio=1.16; 95% confidence interval, 0.82-1.64; not statistically significant). Patients receiving only one of the recommended classes had an intermediate risk (adjusted hazard ratio=1.47; 95% confidence interval, 1.04-2.07; P=.03). Conclusions. Patients admitted for acute myocardial infarction with congestive heart failure criteria are still at very high risk of mortality. When receiving major recommended medications, they presented with significantly reduced mortality rates. Additional efforts should therefore be made to encourage the prescription of recommended medications in acute myocardial infarction patients with congestive heart failure (AU)

French Ministry of Health prospective multicentre study using bio-active stents coated with titanium nitride oxide: the EVIDENCE registry.

BACKGROUND: Coronary stents have evolved over time, from bare-metal stents to drug-eluting stents, and now to bioactive stents. AIMS: We sought to explore the immediate outcome of the titanium-nitride-oxide-coated bioactive stent, Titan2(®), in real-world practice, and the incidence of major cardiac events at follow-up. METHODS: Consecutive patients admitted for percutaneous intervention for at least one significant (≥50%) lesion in a native coronary artery were treated with Titan2(®) stent implantation. The primary endpoint was total major adverse cardiac events at 12-month follow-up. Secondary endpoints included target lesion revascularization at 12-month follow-up and the duration of dual antiplatelet therapy. RESULTS: Among 356 patients (mean age 67.4 ± 12.1 years), 77.2% were male and 39.3% were treated for myocardial infarction (MI). A total of 546 Titan2(®) stents were implanted in 420 lesions. Angiographic and clinical procedural success was achieved in all cases. No cases of in-hospital major adverse cardiac events or acute stent thrombosis were reported. Of 335 patients (94.1%) with 12-month clinical follow-up, four (1.2%) died, MI occurred in five (1.5%), target lesion revascularization was performed in 17 (5.1%) and major adverse cardiac events occurred in 24 (7.2%). One patient (0.3%) suffered late stent thrombosis during follow-up, but no cases of acute or subacute stent thrombosis occurred. Dual antiplatelet therapy continued beyond 6 months in 64.5% of patients. CONCLUSIONS: In real-world practice, Titan2(®) stent implantation achieves an excellent immediate outcome, with a low incidence of major adverse cardiac events at 12-month follow-up.

Heart failure in acute myocardial infarction: a comparison between patients with or without heart failure criteria from the FAST-MI registry.

INTRODUCTION AND OBJECTIVES: To compare acute myocardial infarction patients with or without congestive heart failure in the French FAST-MI registry. METHODS: The French FAST-MI registry included 374 centers and 3059 patients over a 1-month period at the end of 2005, with 1-year follow-up. Among this population, patients with at least one congestive heart failure criterion constituted group 1 (n=1149; 37.5%) and were compared to patients without congestive heart failure (group 2, n=1910; 62.5%). The congestive heart failure patients were further divided according to presence of both beta-blockers and antagonists of the renin-angiotensin-aldosterone system at hospital discharge (n=511) or not (n=498), in order to assess the real-world clinical importance of recommended medications. RESULTS: Overall in-hospital and 1-year mortality rates were 3.4% and 13.2%, respectively. In hospital survivors, presence of congestive heart failure was associated with increased mortality (adjusted hazard ratio: 1.55; 95% confidence interval, 1.10-2.17; P=.01). Survival was higher in patients without congestive heart failure, compared with congestive heart failure patients receiving or not recommended medications (P<.001). Congestive heart failure patients receiving neither renin-angiotensin-aldosterone system blockers nor beta-blockers (adjusted hazard ratio: 1.66; 95% confidence interval, 1.08-2.55; P=.02) had a significantly higher risk of death than patients receiving both classes of medications (adjusted hazard ratio: 1.16; 95% confidence interval, 0.82-1.64; not statistically significant). Patients receiving only one of the recommended classes had an intermediate risk (adjusted hazard ratio: 1.47; 95% confidence interval, 1.04-2.07; P=.03). CONCLUSIONS: Patients admitted for acute myocardial infarction with congestive heart failure criteria are still at very high risk of mortality. When receiving major recommended medications, they presented with significantly reduced mortality rates. Additional efforts should therefore be made to encourage the prescription of recommended medications in acute myocardial infarction patients with congestive heart failure.

Impact of type of preadmission sulfonylureas on mortality and cardiovascular outcomes in diabetic patients with acute myocardial infarction.

BACKGROUND: The impact of antidiabetic medications on clinical outcomes in patients developing acute myocardial infarction (MI) is controversial. We sought to determine whether in-hospital outcomes in patients who were on sulfonylureas (SUs) when they developed their MIs differed from that of diabetic patients not receiving SUs and whether clinical outcomes were related to the pancreatic cells specificity of SUs. METHODS AND RESULTS: We analyzed the outcomes of the 1310 diabetic patients included in the nationwide French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction in 2005. Medications used before the acute episode were recorded. In-hospital complications were analyzed according to prior antidiabetic treatment. Mortality was lower in patients previously treated with SUs (3.9%) vs. those on other oral medications (6.4%), insulin (9.4%), or no medication (8.4%) (P = 0.014). Among SU-treated patients, in-hospital mortality was lower in patients receiving pancreatic cells-specific SUs (gliclazide or glimepiride) (2.7%), compared with glibenclamide (7.5%) (P = 0.019). Arrhythmias and ischemic complications were also less frequent in patients receiving gliclazide/glimepiride. The lower risk in patients receiving gliclazide/glimepiride vs. glibenclamide persisted after multivariate adjustment (odds ratio 0.15; 95% confidence interval 0.04-0.56) and in propensity score-matched cohorts. CONCLUSION: In this nationwide registry of patients hospitalized for acute MI, no hazard was associated with the use of SUs before the acute episode. In addition, patients previously receiving gliclazide/glimepiride had improved in-hospital outcomes, compared with those on glibenclamide.