Safety and efficacy of everolimus-eluting stents versus paclitaxel-eluting stents in a diabetic population.

OBJECTIVES: This study aimed to analyze the use of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an unrestricted diabetic population and to compare the performance of these two drug-eluting stents. BACKGROUND: EES have demonstrated superiority in efficacy when compared to PES in a general population. However, it is controversial whether this superiority holds true in a diabetic population. METHODS: From March 2004 to May 2010, 968 patients with consecutive diabetes who underwent percutaneous coronary intervention and implantation of an EES (n = 388) or PES (n = 580) at our institution. In-hospital, 1-month, 6-month, and 1-year clinical outcomes were analyzed and compared. Correlates of major adverse cardiac events (MACE) were identified. RESULTS: Baseline clinical characteristics were similar between stent types except for more family history of coronary artery disease in the PES group and more insulin-dependent diabetes and unstable angina at initial diagnosis in the EES group. The PES group had higher number of lesions treated, longer stents used, and a higher proportion of intravascular ultrasound and glycoprotein IIb/IIIa inhibitor use. The EES group had more type C and distal lesions. There was higher target lesion revascularization (TLR)-MACE in the PES group (3.3% vs. 1.0%, P = 0.03) as well as a higher rate of stent thrombosis (ST) (8 patients vs. 0 in the EES group, P = 0.03). ST continued to be higher in the PES group at 6 and 12 months and mortality was higher at 12 months in the PES group (9.4% vs. 5.2%, P = 0.02). After adjustment, no significant differences were found between stent types on Cox regression analysis for hazard ratios at 1-year follow-up of TLR-MACE. CONCLUSIONS: In a diabetic population undergoing PCI, the use of an EES compared to PES was associated with lower rates of stent thrombosis; but after adjustment the composite TLR-MACE at 1 year was similar between both stents.

Usefulness of real-time three-dimensional transoesophageal echocardiography in the assessment of chronic aortic dissection.

AIMS: To assess the usefulness of three-dimensional transoesophageal echocardiography (3D-TOE) vs. two-dimensional (2D)-TOE in the evaluation of morphological and dynamic findings of aortic dissection, and compare the results with those obtained by multi-slice computed tomography (CT). METHODS AND RESULTS: Twenty-six patients (21 men and 5 women, median age: 67 years, range: 28-74 years) diagnosed of chronic aortic dissection with patent false lumen were studied. A comprehensive 2D-TOE and a real-time 3D-TOE study targeted at assessing dissection variables were performed and compared with CT within 3 months. Both 3D-TOE and 2D-TOE visualized the intimal flap extension and presence of flow in aortic dissection lumina in the same aortic segments. Three-dimensional TOE correctly identified true lumen in all cases, being superior to 2D-TOE in three cases with a spiroidal course of the dissection in descending aorta. Maximum entry tear diameter measured by 3D-TOE showed a better correlation with CT than 2D-TOE (0.96 and 0.87, P< 0.001, respectively). Compared with CT, 2D-TOE underestimated maximum entry tear diameter (-1.75 ± 3.28 mm, P< 0.01) but 3D-TOE did not (-0.20 ± 1.92 mm, P: n.s.). However, entry tear area measured by 3D-TOE and CT showed the best correlation (r: 0.97) and agreement (0.05 ± 0.20 cm(2), P: n.s.). CONCLUSION: Three-dimensional TOE provides additional information to 2D-TOE in aortic dissection assessment, particularly in entry tear size quantification. Agreement between entry tear area defined by 3D-TOE and CT was excellent. Three-dimensional TOE permits better morphological and dynamic understanding of aortic dissection when the flap is spiroidal.

Multimodality Assessment of Ascending Aortic Diameters: Comparison of Different Measurement Methods.

BACKGROUND: Transthoracic echocardiography (TTE), multidetector computed tomography (MDCT), and magnetic resonance imaging (MRI) have been widely used to monitor aortic diameters, with no consensus as to the best measurement approach. Thus, the aim of this study was to establish the best measurement methods by two-dimensional (2D) TTE, MDCT, and MRI to achieve comparable aortic diameters. METHODS: One hundred forty patients with severe aortic valvular disease or aortic dilatation were prospectively evaluated using 2D TTE and MDCT (n = 70) or MRI (n = 70). The aorta was measured at three different levels: sinuses of Valsalva, sinotubular junction, and ascending aorta. Three different measurements were made by 2D TTE-inner edge to inner edge, leading edge to leading edge (L-L), and outer edge to outer edge-and then compared with the inner edge-to-inner edge and outer edge-to-outer edge measurements of cusp-to-cusp and cusp-to-commissure diameters by MDCT or MRI. Inter- and intraobserver variability was analyzed. RESULTS: Aortic diameters by 2D TTE, MDCT, and MRI showed excellent inter- and intraobserver variability using all conventions. Significant underestimation was observed of all aortic diameters assessed by 2D TTE using the inner edge-to-inner edge convention compared with those obtained by MDCT or MRI (P < .0001). However, excellent accuracy was observed by 2D TTE when the L-L convention was used and compared with the internal diameter by MDCT and MRI (mean differences, 0.6 ± 2.6 mm [P = .158] for MDCT and 0.4 ± 3.5 mm [P = .852] for MRI). Cusp-to-cusp diameters were slightly larger than cusp-to-commissure diameters. The diameter by 2D TTE using the L-L convention correlated best with the noncoronary cusp-to-right coronary cusp diameter determined by both MDCT and MRI. CONCLUSIONS: Aortic root and ascending aortic diameters measured by 2D TTE using the L-L convention showed accurate and reproducible values compared with internal diameters assessed by MDCT or MRI. This approach permits a multimodality follow-up of patients with aortic diseases and avoids disparities in measurements obtained by different conventions.

Safety and efficacy of prasugrel use in patients undergoing percutaneous coronary intervention and anticoagulated with bivalirudin.

The randomized TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis In Myocardial Infarction (TRITON-TIMI) 38 trial compared prasugrel and clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). Patients treated with prasugrel had fewer ischemic events but more procedure-related bleeding. In the present study, we aimed to determine the effect of bivalirudin on bleeding in patients treated with prasugrel. A total of 692 patients with consecutive acute coronary syndrome underwent PCI with stent implantation and were anticoagulated with bivalirudin. The patients were divided into 2 groups according to the antiplatelet regimen (clopidogrel or prasugrel) chosen during or just after PCI. The bleeding complications during hospitalization were tabulated. Ischemic events were analyzed during hospitalization and at 30 days. Prasugrel was used in 96 patients (13.9%) and clopidogrel in 596 (86.1%). The clinical and procedural characteristics were similar, although the clopidogrel patients more often reported systemic hypertension (p = 0.01), previous PCI (p <0.001), and chronic renal insufficiency (p = 0.05). During hospitalization, the bleeding and ischemic complication rates were similar and low in both groups (major in-hospital complications 4.2% for clopidogrel vs 2.1% for prasugrel, p = 0.6; Thrombolysis In Myocardial Infarction major bleeding 2.5% vs 2.1%, p = 1.00; Thrombolysis In Myocardial Infarction minor bleeding 4.2% vs 5.2%, p = 0.6). At 30 days, no differences were found in ischemic events between both groups (target vessel revascularization/major adverse cardiac events 5.4% vs 2.1%, p = 0.2). In conclusion, prasugrel, when given after bivalirudin as the intraprocedural antithrombin agent for patients with acute coronary syndrome undergoing PCI, is as safe and effective as clopidogrel.

Frequency of conduction disturbances after Edwards SAPIEN percutaneous valve implantation.

Disturbances in atrioventricular conduction and the additional need for a permanent pacemaker are recognized complications after transcatheter aortic valve replacement (TAVR). We analyzed the incidence of postprocedural conduction disorders and the need for permanent pacemaker implantation in patients undergoing TAVR with the Edwards SAPIEN valve. In 125 consecutive patients with symptomatic, severe aortic stenosis undergoing TAVR, a standard 12-lead electrocardiogram was obtained before and serially after the procedure. The cohort was divided into 2 groups with regard to the post-TAVR appearance of conduction disturbances, defined as left bundle branch block, right bundle branch block, fascicular hemiblock, atrioventricular block, and the need for a permanent pacemaker. The patients with and without conduction disturbances were compared. After TAVR, 19 patients (15.2%) met the study definition of a "new conduction defect" and 5 patients (4%) required a permanent pacemaker because of an advanced atrioventricular block. New left bundle branch block appeared in 5 patients (4%) and left anterior hemiblock in 9 (7.2%). No new right bundle branch block or left posterior hemiblock was observed. Although most baseline, echocardiographic, and procedural characteristics were equally distributed, the patients with new conduction disturbances more often had diabetes mellitus and peripheral vascular disease. Also, they more often were taking an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker, and the procedure was performed more often with apical access (12 [63.2%] vs 7 with femoral access [36.8%], p = 0.002). In conclusion, although the incidence of conduction disturbances was high after TAVR using the Edwards SAPIEN valve, with a significant increase in the rate of left bundle branch block and left anterior hemiblock, the need for permanent pacemaker implantation after TAVR with this valve remained low.

Frequency of cardiac conduction disturbances after balloon aortic valvuloplasty.

Disturbances in atrioventricular conduction are well-recognized complications of transcatheter aortic valve replacement. Percutaneous balloon aortic valvuloplasty (BAV) is a requisite step in transcatheter aortic valve replacement; however, the contribution of the BAV to atrioventricular conduction disturbances has not been elucidated. The present analysis was undertaken to ascertain the incidence and type of electrocardiographic changes associated with BAV and to consider the role of BAV in the conduction abnormalities after transcatheter aortic valve replacement. In 271 consecutive patients with symptomatic, severe aortic stenosis undergoing BAV, a standard 12-lead electrocardiogram was obtained before and serially after the procedure. Each was examined by experienced electrocardiographers. The cohort was divided into 2 groups with regard to the post-BAV appearance of conduction disturbances. The clinical and procedural characteristics of patients with these disturbances were compared to those in whom no conduction disturbance appeared. After BAV, 23 patients (8.5%) met the study definition of "new conduction defect": 4 patients (1.5%) required permanent pacemaker implantation for advanced atrioventricular block. New left bundle branch block appeared in 9 (3.3%) and left anterior hemiblock in 7 (2.6%). New right bundle branch block appeared in 2 and left posterior hemiblock in 1. No significant difference was found in the clinical or procedural characteristics. The ratio of the balloon size to the left ventricular outflow tract diameter was 1.21 ± 1.6 in those with new conduction defects and 1.15 ± 0.12 (p = 0.032) in those without. In conclusion, BAV is associated with a low incidence of cardiac conduction disturbances and a requirement for permanent ventricular pacing. The size of the valvuloplasty balloon should be carefully selected to avoid oversizing, which can lead to the development of postprocedure conduction disturbances.