Trombosis del stent 10 años después de la intervención coronaria percutánea con stents nuevos frente a stents de la primera generación. Observaciones del metanálisis DECADE / Ten-year patterns of stent thrombosis after percutaneous coronary intervention with new- versus early-generation drug-eluting stents: insights from the DECADE cooperation

Introducción y objetivos El metanálisis DECADE es un análisis de datos de pacientes individuales de ensayos de stents liberadores de fármacos (SLF) con un seguimiento de 10 años. El objetivo del estudio es analizar el riesgo de trombosis definitiva del stent (TS) hasta 10 años después de la intervención coronaria percutánea (ICP) en pacientes tratados con DES de primera y de nueva generación. Métodos Se agruparon los datos de pacientes individuales de cinco ensayos de SLF con un seguimiento de 10 años. El objetivo primario fue la TS hasta 10 años después de la ICP. Los pacientes se dividieron en 2 grupos según la generación de stent implantada (primera y nueva). El análisis de los datos de los participantes individuales se realizó mediante el enfoque de una etapa. Resultados Se incluyeron 9.700 pacientes, 6.866 en el grupo de SLF nuevos y 2.834 en el grupo de SLF de primera generación. A los 10 años, la TS se produjo en 69 de los 6.866 pacientes tratados con SLF de nueva generación y en 91 de los 2.834 pacientes tratados con la SLF de primera generación (1,0% frente a 3,5%, razón de tasas 0,32; IC95%, 0,23-0,45). La tasa de TS fue menor en el grupo de SLF de nueva generación en comparación con el grupo de SLF de primera, de 1-5 años (razón de tasas 0,14; IC95%, 0,08-0,26) y de 5-10 años (razón de tasas 0,23; IC95%, 0,08-0,61) después de la ICP. Conclusiones La incidencia de TS hasta 10 años después de la ICP con los SLF de nueva generación es del 1%. Los SLF de nueva generación se asocian a una menor incidencia de TS a 10 años comparados con los SLF de primera generación, especialmente después de 1 año de la ICP (AU)

Introduction and objectives The DECADE cooperation is a pooled analysis of individual patient data from drug-eluting stent (DES) trials with a 10-year follow-up. This analysis reports the risk of definite stent thrombosis (ST) through to 10 years after percutaneous coronary intervention (PCI) in patients treated with early- and new-generation DES. Methods Individual patient data from 5 DES trials with a 10-year follow-up were pooled. The primary endpoint was definite ST up to 10 years after PCI. Patients were divided into 2 groups as per the generation of DES implanted (early and new DES). Individual participant data were analyzed using a 1-stage approach. Results We included 9700 patients, 6866 in the new DES group and 2834 in the early DES group. Through to 10 years, definite ST occurred in 69 of 6866 patients treated with new DES and in 91 of 2834 patients treated with early DES (1.0% vs 3.5%, adjusted hazard ratio, 0.32; 95%CI, 0.23-0.45). The rate of definite ST was lower in the new DES group than in the early DES group from 1 to 5 years (rate ratio, 0.14; 95%CI, 0.08-0.26) and from 5 to 10 years (rate ratio, 0.23; 95%CI, 0.08-0.61) after PCI. Conclusions The incidence of definite ST through to 10 years after PCI with new-generation DES was 1%. New-generation DES are associated with a lower 10-year incidence of definite ST than early-generation DES, particularly beyond 1 year after PC (AU)

Brecha de género en los cuidados médicos en las redes de atención al infarto agudo de miocardio con elevación del segmento ST: hallazgos de la red catalana Codi Infart / Gender gap in medical care in ST segment elevation myocardial infarction networks: Findings from the Catalan network Codi Infart

OBJETIVO: Evaluar el impacto del género sobre el pronóstico y el manejo en una red regional de atención al infarto agudo de miocardio con elevación del segmento ST. DISEÑO: Estudio observacional sobre una base de pacientes consecutivos recogida prospectivamente. Ámbito: Red catalana de atención al infarto agudo de miocardio con elevación del segmento ST. PACIENTES: Pacientes atendidos entre enero de 2010 y diciembre de 2011. INTERVENCIONES: Angioplastia primaria, fibrinólisis o manejo conservador. Variables de interés: Se compararon, según el género, intervalos de tiempo, proporción y tipo de reperfusión, mortalidad global y complicaciones intrahospitalarias y mortalidad global a 30 días y un año. RESULTADOS: De 5.831 pacientes atendidos, 4.380 tenían diagnóstico de infarto agudo de miocardio con elevación del segmento ST, siendo 961 (21,9%) de ellos mujeres. Estas tenían mayor edad (69,8±13,4 frente a 60,6±12,8 años, p < 0,001), mayor prevalencia de diabetes (27,1 frente a 18,1%, p < 0,001), Killip>I (24,9 frente a 17,3%, p < 0,001) y ausencia de reperfusión (8,8 frente a 5,2%, p < 0,001) que los hombres. Además, las mujeres presentaban mayores retrasos en la atención (primer contacto médico-balón: 132 frente a 122min, p < 0,001; inicio de síntomas-balón: 236 frente a 210min, p < 0,001), más complicaciones intrahospitalarias (20,6 frente a 17,4%, p = 0,031) y mortalidad intrahospitalaria, a 30 días y un año (4,8 frente a 2,6%, p = 0,001; 9,1 frente a 4,5%, p < 0,001; 14,0 frente a 8,3%, p < 0,001). Sin embargo, tras el análisis multivariado no hubo diferencias en mortalidad a 30 días y un año. CONCLUSIONES: A pesar del peor perfil de riesgo y el peor tratamiento recibido, las mujeres presentaron similares resultados a 30 días y un año que sus homólogos masculinos atendidos por una red de atención al infarto

OBJECTIVE: To assess the impact of gender upon the prognosis and medical care in a regional acute ST-elevation myocardial infarction management network. DESIGN: An observational study was made of consecutive patients entered in a prospective database. Scope: The Catalan acute ST-elevation myocardial infarction management network. PATIENTS: Patients treated between January 2010 and December 2011. INTERVENTIONS: Primary angioplasty, thrombolysis or conservative management. Variables of interest: Time intervals, proportion and type of reperfusion, overall mortality, and in-hospital complication and overall mortality at 30 days and one year were compared in relation to gender. RESULTS: Of the 5,831 patients attended by the myocardial infarction network, 4,380 had a diagnosis of acute ST-elevation myocardial infarction, and 961 (21.9%) were women. Women were older (69.8±13.4 vs. 60.6±12.8 years; P<.001), had a higher prevalence of diabetes (27.1 vs. 18.1%, P<.001), Killip class>I (24.9 vs. 17.3%; P<.001) and no reperfusion (8.8 vs. 5.2%; P<.001) versus men. In addition, women had greater delays in medical care (first medical contact-to-balloon: 132 vs. 122min; P<.001, and symptoms onset-to-balloon: 236 vs. 210min; P<.001). Women presented higher percentages of overall in-hospital complications (20.6 vs. 17.4%; P=.031), in-hospital mortality (4.8 vs. 2.6%; P=.001), 30-day mortality (9.1 vs. 4.5%; P<.001) and one-year mortality (14.0 vs. 8.3%; P<.001) versus men. Nevertheless, after multivariate adjustment, no gender differences in 30-day and one-year mortality were observed. CONCLUSIONS: Despite a higher risk profile and poorer medical management, women present similar 30-day and one-year outcomes as their male counterparts in the context of the myocardial infarction management network

Gender gap in medical care in ST segment elevation myocardial infarction networks: Findings from the Catalan network Codi Infart. / Brecha de género en los cuidados médicos en las redes de atención al infarto agudo de miocardio con elevación del segmento ST: hallazgos de la red catalana Codi Infart.

OBJECTIVE: To assess the impact of gender upon the prognosis and medical care in a regional acute ST-elevation myocardial infarction management network. DESIGN: An observational study was made of consecutive patients entered in a prospective database. SCOPE: The Catalan acute ST-elevation myocardial infarction management network. PATIENTS: Patients treated between January 2010 and December 2011. INTERVENTIONS: Primary angioplasty, thrombolysis or conservative management. VARIABLES OF INTEREST: Time intervals, proportion and type of reperfusion, overall mortality, and in-hospital complication and overall mortality at 30 days and one year were compared in relation to gender. RESULTS: Of the 5,831 patients attended by the myocardial infarction network, 4,380 had a diagnosis of acute ST-elevation myocardial infarction, and 961 (21.9%) were women. Women were older (69.8±13.4 vs. 60.6±12.8 years; P<.001), had a higher prevalence of diabetes (27.1 vs. 18.1%, P<.001), Killip class>I (24.9 vs. 17.3%; P<.001) and no reperfusion (8.8 vs. 5.2%; P<.001) versus men. In addition, women had greater delays in medical care (first medical contact-to-balloon: 132 vs. 122min; P<.001, and symptoms onset-to-balloon: 236 vs. 210min; P<.001). Women presented higher percentages of overall in-hospital complications (20.6 vs. 17.4%; P=.031), in-hospital mortality (4.8 vs. 2.6%; P=.001), 30-day mortality (9.1 vs. 4.5%; P<.001) and one-year mortality (14.0 vs. 8.3%; P<.001) versus men. Nevertheless, after multivariate adjustment, no gender differences in 30-day and one-year mortality were observed. CONCLUSIONS: Despite a higher risk profile and poorer medical management, women present similar 30-day and one-year outcomes as their male counterparts in the context of the myocardial infarction management network.

The use of the acute Pd/Pa drop after intracoronary nitroglycerin infusion to rule out significant FFR: CANICA (Can intracoronary nitroglycerin predict fractional flow reserve without adenosine?) multicenter study.

OBJECTIVE: Functional assessment of coronary artery stenosis is performed by measuring the fractional flow reserve (FFR) under hyperemic conditions (Adenosine). However, the use of adenosine portends limitations. OBJECTIVE: We sought to investigate the relationship and correlation between FFR and the Pd/Pa value obtained just after the intracoronary infusion (acute drop) of nitroglycerin (Pd/Pa-NTG) and if this parameter enhances diagnostic accuracy for FFR prediction compared to the resting baseline Pd/Pa. METHODS: We conducted a multicenter study including prospectively patients presenting intermediate coronary artery stenosis (30-70%) evaluated with pressure wire. Resting baseline Pd/Pa, Pd/Pa-NTG and FFR were measured. RESULTS: 283 patients (335 lesions) were included. Resting baseline Pd/Pa value was 0.72 to 1.0 (0.93 ± 0.04), Pd/Pa-NTG was 0.60 to 1.0 (0.87 ± 0.07) and FFR 0.55 to 1.0 (0.83 ± 0.08). The ROC curves for resting baseline Pd/Pa and for Pd/Pa-NTG, using a FFR ≤ 0.80 showed an AUC of 0.88 (95% CI: 0.84-0.92, P < 0.001) and 0.94 (95% CI: 0.92-0.96, P < 0.001) respectively. The optimal cutoff values of resting baseline Pd/Pa and Pd/Pa-NTG for an FFR > 0.80, were >0.96 and >0.88, respectively. These values were present in a 29.8% (n = 100) and a 47.1% (n = 158), of the total lesions. Scatter plots showed a better correlation and agreement points with Pd/Pa-NTG than resting baseline Pd/Pa. The cutoff value of Pd/Pa-NTG > 0.88 showed an excellent NPV (96.2% for FFR > 0.8 and 100% for FFR > 0.75) and sensitivity (95% for FFR > 0.8 and 100% for FFR > 0.75) which were consistently high across all the subgroups analysis. CONCLUSION: The cutoff value of acute Pd/Pa-NTG > 0.88 has a high NPV meaning adenosine-FFR can be avoided in almost half of lesions.

Rationale and study design of the RESERVOIR trial: a randomized trial comparing reservoir-based polymer-free amphilimus-eluting stents versus everolimus-eluting stents with durable polymer in patients with diabetes mellitus.

BACKGROUND: Patients with diabetes mellitus (DM) remain at high risk for stent restenosis and adverse cardiovascular events in the drug-eluting stent era. The amphilimus-eluting stent (AES) is a third generation reservoir-based polymer-free drug-eluting stent that has shown promising preliminary results in patients with DM. It has been suggested that the formulation of the drug with fatty acids could not only modulate the drug release in a timely manner but also achieve convenient levels of drug concentration in diabetic cardiac cells. The aim of this trial is to assess the efficacy of the AES in patients with DM compared with the cobalt chromium everolimus-eluting stent with non-erodible polymer (EES). STUDY DESIGN: This is an investigator-initiated, multicenter, randomized clinical trial, performed in patients with DM. A total of 112 diabetic patients receiving glucose-lowering agents and requiring percutaneous revascularization of a de novo lesion will be randomized in a 1:1 fashion to receive AES or EES. The primary endpoint is the neointimal volume obstruction at 9 months, evaluated by optical coherence tomography. Secondary endpoints will include strut coverage, angiographic in-stent late loss and clinical endpoints such as target vessel revascularization or probable/definite stent thrombosis. This study completed the inclusion in October 2013. CONCLUSIONS: The RESERVOIR trial is an investigator-initiated trial that will evaluate whether the polymer-free AES is not inferior to the EES inhibiting the neointimal hyperplasia in patients with DM. These results are also expected to improve our knowledge of the neointimal healing process in this population (Clinicaltrials.gov number NCT01710748).

Bioresorbable scaffolds: focus on vascular response and long-term safety.

Bioresorbable vascular scaffolds (BVS) are considered the fourth revolution in Interventional Cardiology, thus promising to address some of the pending issues with current-generation drug eluting stents (DES). Notably, most of the potential advantages of BVS over other current devices are due to a peculiar vascular response, called "vascular restoration therapy". The emerging data from real-world expanded use registries suggest that BVS use is feasible in a wide variety of patients (from low- to high- risk), and lesions (from simplex to complex). However, few safety concerns with currently available BVS have arised from initial experiences all over the word. Data from ongoing large-scale randomized controlled trials will be able to demonstrate whether BVS improve patient early and long-term outcomes compared to best-in-class DES.

RAndomized Comparison of raDIal vs. femorAL Access for Routine Catheterization of Heart Transplant Patients (RADIAL-heart transplant study).

Although a transradial approach (TRA) is considered feasible in many clinical situations, no data are available in patients undergoing orthotopic heart transplantation (OHT). Our goal was to randomly compare TRA versus a transfemoral approach (TFA) in this clinical setting. This single-center, prospective, randomized trial was conducted from January to November 2006, and all OHT patients scheduled for a control coronary angiography were randomized to receive TRA or TFA. The primary endpoint was the amount of contrast used during the procedure. The participating interventional cardiologists were intermediate-volume radial operators, and this was their initial experience of TRA in OHT patients. The analysis was performed according to the intention-to-treat principle. Overall, 49 patients (mean age, 55 ± 13 years; 74% male) were included in the trial: 26 patients were assigned to TRA, and 23 were assigned to TFA. A higher amount of contrast (147 mL [range, 113-175 mL] vs 105 mL [range, 86-127 mL]; P = .009), a longer fluoroscopy time (9.2 minutes [range, 6-12 minutes] vs 3.5 minutes [range, 3-5 minutes]; P < .001), a trend toward increased number of catheters used for left ostium cannulation, and a higher crossover rate (19% vs 0%; P = .03) were associated with TRA compared with TFA. Furthermore, patients treated with TRA exhibit a shorter hospital stay (6 [range 4-8]) compared with the other group (26 [range 24-28]) (P < .001). There were no significant differences between the 2 groups regarding total procedural time, and no vascular complications were reported in either group. For these operators with their first experience of TRA in OHT patients, TFA seemed to be more efficient.

Restauración ventricular percutánea con Parachute® / Percutaneous ventricular restoration with Parachute®

No disponible

Prediction of functional capacity by low-dose dobutamine stress echocardiography in chronic heart failure.

AIM: The aim of this study was to determine if low-dose dobutamine stress echocardiography (LD-DSE) is associated with functional capacity in unselected elderly patients with chronic heart failure. METHODS: This was a prospective trial. Thirty five consecutive patients were included, with age >65 years and left ventricular dysfunction (12 ischemic), by blindly assessed LD-DSE and cardiopulmonary exercise testing (CPT). Contractile reserve was defined as a change (D) in wall motion score index (WMSI) = or <0.2 at peak dose dobutamine. At CPT treadmill exercise time, peak VO2, %Vo2 and VE/VCO2 slope were determined. Preserved functional capacity was defined as percent of maximal predicted O2 consumption (%VO2) >80%. Baseline NT-proBNP plasma levels were assessed. RESULTS: CPT variables were not related to clinical and baseline echocardiography characteristics but were related to DWMSI (exercise time, P=0.004; peak VO2, P=0.008; %VO2, P<0.001; VE/Vco2, P<0.001). Contractile reserve was present in 16 of 17 patients with preserved functional capacity (sensitivity=94%) and in 2 of 13 patients without (specificity=85%). Baseline NT-proBNP levels were lower in patients with contractile reserve (476+/-365 pg/mL) than in those without (1 345+/-1 219 pg/mL) (P=0.019), but were mildly related to CPT variables (P=0.049 and 0.027 with exercise time and %VO2, respectively). CONCLUSION: Contractile reserve elicited at LD-DSE is associated with functional capacity in unselected elderly patients with chronic heart failure.

Sirolimus, Tacrolimus and Zotarolimus eluting stents to treat bifurcated lesions: a 7-month clinical outcome comparison.

AIM: Drug eluting stents (DES) have been shown to reduce restenosis compared with bare metal stents in bifurcated lesions. The aim of this study was to evaluate the long-term clinical outcomes of patients with bifurcated lesions treated by 3 different DES. METHODS: Consecutive patients with symptomatic coronary artery disease on one bifurcated lesion with SB>2.25 mm (on visual estimation) undergoing at the Department of Cardiology of the Catholic University of Rome, Italy were screened. Patients treated with Sirolimus-eluting stent (Cypher Select; SES Group), Tacrolimus-eluting stent (Taxus-Libertè; TA Group) and Zotarolimus-eluting stent (Endeavor Driver; ZOT Group) were enrolled in the study. Clinical and angiographic characteristics of all patients were prospectively recorded. Major adverse clinical events (MACE), including death, acute myocardial infarction (MI) or target lesion revascularization (TVR) by either percutaneous coronary intervention (PCI) or coronary surgery were recorded during the follow-up. Incidence of definite or probable stent thrombosis was calculated according to the ARC criteria. RESULTS: Two hundred and forty-one consecutive patients were enrolled (89 Group CY, 98 Group TA and 54 Group EN). Length of follow-up was 235+/-60 days. Baseline clinical and angiographic characteristic were similar across the groups. The adopted technique for stent implantation was provisional stenting (73.4%), T-stenting technique (7%), crush (7%) and V-stenting (2.6%). The rate of patients finally treated with two stents was similar among groups. The cumulative rate of MACE (9% SES, 12% TA, 11% ZOT: P=0.7) and of TVR (2% SES, 9% TA, 7% ZOT) was similar among groups. No definite stent thrombosis was observed during follow-up, while 1 probable stent thrombosis was observed in TA group. CONCLUSION: The clinical outcome of bifurcated lesions using DES and mainly a technique of single stent implantation is good. In the present observational study, clinical adverse events did not differ in patients with bifurcated lesions treated by Cypher, Taxus or Endeavor stent implantation.