Randomized comparison of Zotarolimus-Eluting Endeavor Sprint versus bare-metal stent implantation in uncertain drug-eluting stent candidates: rationale, design, and characterization of the patient population for the Zotarolimus-eluting Endeavor Sprint stent in uncertain DES candidates study.

BACKGROUND: The use of drug-eluting stent (DES) instead of bare-metal stent (BMS) in patients at high stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns. HYPOTHESIS: The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by stent type and, as such, can be as short as 30 days after intervention in both stent groups. STUDY DESIGN: The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization. SUMMARY: The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria.

Role of real-time myocardial contrast echocardiography in the assessment of viability after acute myocardial infarction and angioplasty.

OBJECTIVE: To assess the role of myocardial contrast echocardiography (MCE) in early identification of myocardial viability in patients with residual segmental dysfunction after myocardial infarction and primary angioplasty (PA), in comparison with dobutamine stress echocardiography (DSE), using late functional recovery as gold standard. DESIGN: Prospective study for comparison of the two methods. SETTING: Hospital. PATIENTS: 17 patients (11 male, 53 +/- 11 years old) were consecutively included, with a first myocardial infarction and PA, with residual segmental akinesis or dyskinesis and good echocardiographic window. METHODS: All patients underwent: a) baseline echocardiographic study, MCE, and DSE obtained at 4.0 +/- 1.2 days after PA; b) late echocardiographic study performed at 4.4 +/- 0.8 months after PA. MCE was performed with Optison, administered as a slow infusion via a peripheral vein and a modality of real-time perfusion imaging with power pulse inversion and flash and subsequent data acquisition of triggered end-systolic images. Segmental contractility and perfusion were assessed using a 16-segment model. Perfusion assessment was qualitative (three perfusion patterns) and quantitative (ratio of maximal intensity between dysfunctional segments and contralateral normal segments). The viability criterion for MCE was defined as homogenous enhancement in 50% of wall thickness in each segment. The standard criterion for myocardial viability was defined as late functional recovery. 6. RESULTS: Viability was present in 56 (63.6%, Group 1) of dysfunctional segments and was absent in the remaining 32 (36.4%, Group 2). The sensitivity of DSE for viability was 80.0%, while specificity was 86.5%. The positive and negative predictive values were, respectively, 91.8% and 69.6%. MCE yielded a sensitivity of 96.5% and specificity of 78.1%, while positive and negative predictive values were respectively 86.2% and 94.1%. With the two methods together, the positive predictive value was 90.3% and negative was 80.0%. The intensity ratio was higher for viable segments (Group 1) in comparison with non-viable ones (Group 2; p<0.005). 7. CONCLUSIONS: This study showed a potentially valuable role for MCE in assessing viability in patients with myocardial infarction and PA. In comparison with DSE, MCE yielded a higher negative predictive value as well as a high positive predictive value. The use of both methods together is promising as a useful tool for early assessment of viability after primary angioplasty.

Evaluation of aortic stenosis severity: role of contrast echocardiography in comparison with conventional echocardiography and cardiac catheterization.

OBJECTIVES: To evaluate the role of contrast Doppler echocardiography in the assessment of aortic stenosis severity, in comparison with the conventional method and using the catheterization study as the gold standard. STUDY DESIGN: Prospective comparative study. SETTING: Echocardiography Laboratory of Cardiology Department. POPULATION: We included 36 consecutive patients, 20 male, aged 67 +/- 11 years, referred for catheterization study to evaluate aortic stenosis severity. METHODS: All patients underwent conventional and contrast Doppler echocardiography and catheterization study. For contrast Doppler, we used Levovist (300 mg/ml infusion). We analyzed the following echocardiographic parameters: a) left ventricle dimensions, wall thickness and function; b) aortic valve morphology; c) post-stenotic aortic valve flow--peak velocity, velocity-time integral, peak gradient, mean gradient; d) left ventricle outflow tract flow--peak velocity, velocity-time integral; e) aortic valve functional area; f) acquisition time and Doppler signal intensity for post-stenotic aortic valve flow. Catheterization parameters analyzed: a) peak aortic valve gradient; b) mean aortic valve gradient. RESULTS: Contrast Doppler yielded higher peak gradients than conventional Doppler (85.6 +/- 30.2 vs 72.6 +/- 26.1 mmHg, p < 0.001), as well as higher mean gradients (51.4 +/- 19.0 vs 44.2 +/- 15.9 mmHg, p < 0.001). Peak gradients obtained with contrast Doppler correlated with those obtained invasively (r = 0.88, p < 0.001), although the values were higher (85.6 +/- 30.2 vs 73.6 +/- 32.0 mmHg, p < 0.001). There was no difference between mean contrast Doppler gradients and mean catheterization gradients, which showed a high correlation (r = 0.89, p < 0.001). There was no difference between peak and mean gradients obtained by conventional Doppler and invasively, which yielded correlations of 0.73 and 0.75, respectively (p < 0.001). The sensitivity of contrast Doppler for detection of severe aortic stenosis was 100% for peak gradient and 84% for mean gradient, while for conventional Doppler it was 68% and 58%. The specificity of contrast Doppler was 65% for peak gradient and 88% for mean gradient, while for conventional Doppler it was, respectively, 58% and 88%. Acquisition time for aortic flow visualization was lower (p < 0.001) and flow intensity higher for contrast Doppler, in comparison with conventional Doppler. CONCLUSIONS: In this study, contrast Doppler yielded high correlations with invasive data and higher sensitivity and specificity for detection of severe aortic stenosis than conventional Doppler. It is a useful method for evaluation of aortic stenosis severity.