Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial.

IMPORTANCE: The role of vascular closure devices (VCD) for the achievement of hemostasis in patients undergoing transfemoral coronary angiography remains controversial. OBJECTIVE: To compare outcomes with the use of 2 hemostasis strategies after diagnostic coronary angiography performed via transfemoral access-a VCD-based strategy with 2 types of devices, an intravascular device and an extravascular device, vs standard manual compression. The primary hypothesis to be tested was that femoral hemostasis achieved through VCD is noninferior to manual compression in terms of vascular access-site complications. A secondary objective was the comparison of the 2 types of VCD. DESIGN, SETTING, AND PARTICIPANTS: Randomized, large-scale, multicenter, open-label clinical trial. We enrolled 4524 patients undergoing coronary angiography with a 6 French sheath via the common femoral artery from April 2011 through May 2014 in 4 centers in Germany. Last 30-day follow-up was performed in July 2014. INTERVENTIONS: After angiography of the access site, patients were randomized to hemostasis with an intravascular VCD, extravascular VCD, or manual compression in a 1:1:1 ratio. MAIN OUTCOMES AND MEASURES: Primary end point: the composite of access site-related vascular complications at 30 days after randomization with a 2% noninferiority margin. Secondary end points: time to hemostasis, repeat manual compression, and VCD failure. An α-level of .025 was chosen for primary and secondary comparisons. RESULTS: Of the 4524 enrolled patients, 3015 were randomly assigned to a VCD group (1509 received intravascular VCD and 1506 received extravascular VCD) and 1509 patients were randomly assigned to the manual compression group. Before hospital discharge, duplex sonography of the access site was performed in 4231 (94%) patients. The primary end point was observed in 208 patients (6.9%) assigned to receive a VCD and 119 patients (7.9%) assigned to manual compression (difference, -1.0% [1-sided 97.5% CI, 0.7%]; P for noninferiority<.001). Time to hemostasis was significantly shorter in patients with VCD (1 minute [interquartile range {IQR}, 0.5-2.0]), vs manual compression (10 minutes [IQR, 10-15]; P < .001). Time to hemostasis was significantly shorter among patients with intravascular VCD (0.5 minute [IQR, 0.2-1.0]), vs extravascular VCD (2.0 minutes [IQR, 1.0-2.0]; P <.001) and closure device failure was also significantly lower among those with intravascular vs extravascular VCD (80 patients [5.3%], vs 184 patients [12.2%]; P < .001). CONCLUSIONS AND RELEVANCE: In patients undergoing transfemoral coronary angiography, VCDs were noninferior to manual compression in terms of vascular access-site complications and reduced time to hemostasis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01389375.

Myocardial perfusion grade, myocardial salvage indices and long-term mortality in patients with acute myocardial infarction and full restoration of epicardial blood flow after primary percutaneous coronary intervention.

INTRODUCTION AND OBJECTIVES: The relationship between microcirculatory myocardial perfusion grade (MPG), myocardial salvage and long-term mortality after acute ST-segment elevation myocardial infarction (STEMI) and full restoration of epicardial blood flow by primary percutaneous coronary intervention (PCI) remains poorly understood. METHODS: This study included 1213 patients with STEMI and Thrombolysis in Myocardial Infarction (TIMI) grade-3 flow after primary PCI. The MPG was determined and paired scintigraphic studies (before and 7-14 days after the intervention) were performed. The primary outcome was 5-year mortality. RESULTS: The MPG was 0-1 in 217 patients, 2 in 195, and 3 in 801. In patients with an MPG of 0-1, 2 and 3, respectively, the median infarct size was 13% (interquartile range [IQR] 5.6-28%), 12% (IQR 4-27%) and 7% (IQR 1-19%) of the left ventricle, respectively (P< .001), the myocardial salvage index (i.e. the proportion of the initial area at risk that recovered) was 0.44 (IQR 0.22-0.73), 0.46 (IQR 0.25-0.75) and 0.58 (IQR 0.31-0.85), respectively (P< .001), and the Kaplan-Meier estimated 5-year mortality was 16.6% (i.e. 28 deaths), 15.3% (i.e. 25 deaths) and 7.8% (i.e. 48 deaths), respectively. The odds ratio (OR) for death for an MPG of 0-1 vs. 3 was 2.32 (95% confidence interval [CI] 1.42-3.8; P< .001) and for an MPG of 2 vs. 3, 2.3 (95% CI 1.38-3.85; P=.001). The Cox proportional hazards model identified MPG as independently associated with mortality at 5 years: the hazard ratio for an MPG of 3 vs. 0-2 was 0.65 (95% CI 0.41-0.97; P=.037). CONCLUSIONS: In patients with STEMI and TIMI grade-3 flow after primary PCI, suboptimal microcirculatory myocardial perfusion (i.e. MPG < or =2) was associated with poorer myocardial salvage, a larger infarct, and higher 5-year mortality than observed in patients whose tissue perfusion was reestablished (i.e. MPG=3).

Grado de perfusión miocárdica, índices de rescate miocárdico y mortalidad a largo plazo en pacientes con infarto agudo de miocardio y restablecimiento completo del flujo sanguíneo epicárdico tras intervención coronaria percutánea primaria / Myocardial perfusion grade, myocardial salvage indices and long-term mortality in patients with acute myocardial infarction and full restoration of epicardial blood flow after primary percutaneous coronary intervention

Introducción y objetivos. La relación entre el grado de perfusión miocárdica (GPM), el rescate miocárdico y la mortalidad a largo plazo tras el infarto agudo de miocardio con elevación del segmento ST (IAMEST) y restablecimiento pleno del flujo sanguíneo epicárdico con una intervención coronaria percutánea (ICP) primaria continúa sin conocerse bien. Métodos. Participaron en el estudio 1.213 pacientes con IAMEST y un flujo de grado Thrombolysis in Myocardial Infarction (TIMI) 3 tras la ICP primaria. Se realizaron determinaciones del GPM y dos exploraciones gammagráficas (antes y 7-14 días después de la intervención). La variable de valoración principal fue la mortalidad a 5 años. Resultados. Se observó un GPM de 0-1, 2 o 3 en un total de 217, 195 y 801 pacientes, respectivamente. En los grupos con un GPM 0-1, 2 y 3, los tamaños del infarto (mediana [cuartiles 25-75]) fueron del 13% [5,6%- 28%], el 12% [4%-27%] y el 7% [1%-19%] del ventrículo izquierdo, respectivamente (p < 0,001); los índices de rescate (proporción del área inicial en riesgo que se rescata) fueron 0,44 [0,22-0,73], 0,46 [0,25-0,75] y 0,58 [0,31-0,85], respectivamente (p < 0,001); las estimaciones de Kaplan-Meier de la mortalidad a 5 años fueron del 16,6% (28 muertes), el 15,3% (25 muertes) y el 7,8% (48 muertes); con una odds ratio (OR) = 2,32 (intervalo de confianza [IC] del 95%, 1,42-3,8) (p < 0,001) para GPM 0-1 frente a GPM 3, y OR = 2,3 (IC del 95%, 1,38-3,85) (p = 0,001) para GPM 2 frente a GPM 3. El modelo de riesgos proporcionales de Cox identificó el GPM como factor independiente correlacionado con la mortalidad a 5 años (razón de riesgos = 0,65 [0,41-0,97]; p = 0,037 para el GPM 3 frente a GPM 0-2). Conclusiones. En los pacientes con IAMEST y un flujo de grado TIMI 3 tras una ICP primaria, la reperfusión miocárdica subóptima (GPM <= 2) se asoció a una reducción del rescate miocárdico, un mayor tamaño del infarto y un aumento de la mortalidad a 5 años en comparación con los pacientes con restablecimiento de la perfusión tisular (GPM = 3) (AU)

Introduction and objectives. The relationship between microcirculatory myocardial perfusion grade (MPG), myocardial salvage and long-term mortality after acute ST-segment elevation myocardial infarction (STEMI) and full restoration of epicardial blood flow by primary percutaneous coronary intervention (PCI) remains poorly understood. Methods. This study included 1213 patients with STEMI and Thrombolysis in Myocardial Infarction (TIMI) grade-3 flow after primary PCI. The MPG was determined and paired scintigraphic studies (before and 7–14 days after the intervention) were performed. The primary outcome was 5-year mortality. Results. The MPG was 0-1 in 217 patients, 2 in 195, and 3 in 801. In patients with an MPG of 0-1, 2 and 3, respectively, the median infarct size was 13% (interquartile range [IQR] 5.6-28%), 12% (IQR 4-27%) and 7% (IQR 1-19%) of the left ventricle, respectively (P<.001), the myocardial salvage index (i.e. the proportion of the initial area at risk that recovered) was 0.44 (IQR 0.22-0.73), 0.46 (IQR 0.25-0.75) and 0.58 (IQR 0.31-0.85), respectively (P<.001), and the Kaplan-Meier estimated 5-year mortality was 16.6% (i.e. 28 deaths), 15.3% (i.e. 25 deaths) and 7.8% (i.e. 48 deaths), respectively. The odds ratio (OR) for death for an MPG of 0-1 vs. 3 was 2.32 (95% confidence interval [CI] 1.42-3.8; P<.001) and for an MPG of 2 vs. 3, 2.3 (95% CI 1.38-3.85; P=.001). The Cox proportional hazards model identified MPG as independently associated with mortality at 5 years: the hazard ratio for an MPG of 3 vs. 0-2 was 0.65 (95% CI 0.41-0.97; P=.037). Conclusions. In patients with STEMI and TIMI grade-3 flow after primary PCI, suboptimal microcirculatory myocardial perfusion (i.e. MPG <=2) was associated with poorer myocardial salvage, a larger infarct, and higher 5-year mortality than observed in patients whose tissue perfusion was reestablished (i.e. MPG=3) (AU)

Stent thrombosis after drug-eluting stent implantation: incidence, timing, and relation to discontinuation of clopidogrel therapy over a 4-year period.

AIMS: To assess the incidence, timing, and relation of drug-eluting stent (DES) thrombosis to discontinuation of clopidogrel therapy. METHODS AND RESULTS: This prospective observational cohort study included 6816 consecutive patients that underwent successful DES implantation. Primary endpoint was definite stent thrombosis (ST). During 4 years of follow-up, definite ST was observed in 73 patients, corresponding to a cumulative incidence of 1.2%. Cumulative incidence of ST at 30 days was 0.5 and 0.8% at 1 year, respectively. Discontinuation of clopidogrel therapy was significantly associated with ST only in the first 6 months after the procedure (P < 0.001). During that period, the median time interval from clopidogrel discontinuation to ST was 9 days [interquartile range (IQR) 5.5-22.5] while thereafter it was 104.3 days (IQR 7.4-294.8). CONCLUSION: The 4 year incidence of ST after DES implantation is low. A relevant number of ST occur early after discontinuation of clopidogrel therapy. The dependence of ST on discontinuation of clopidogrel therapy seems to be mostly confined to the first 6 months after DES implantation. However, specifically designed randomized studies are required to establish the optimal length of clopidogrel therapy after DES implantation.