A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease. Study design and rationale of the EXECUTIVE trial.

BACKGROUND: Myocardial revascularization with drug-eluting stents (DESs) is emerging as an alternative to conventional coronary artery bypass surgery in patients with multivessel coronary artery disease (MV-CAD). First-generation DESs have yielded equivalent safety results at mid-term compared with surgery, but inferior efficacy in preventing the recurrence of ischemic symptoms. The outcome of percutaneous coronary intervention with a second-generation everolimus DES as compared with a paclitaxel DES in patients with MV-CAD has not been established. AIM OF THE STUDY: The aim of the study is the assessment of the efficacy and performance of the XIENCE V everolimus-eluting stent in the treatment of de-novo coronary artery lesions in patients with MV-CAD. STUDY DESIGN: The study is composed of two parts: a prospective, double arm, randomized multicenter trial to assess the angiographic efficacy of the XIENCE V everolimus-eluting coronary stent system (EECSS) compared with the Taxus Liberté Paclitaxel Eluting Coronary Stent System (Taxus Liberté Stent) and a prospective, open-label, single arm, controlled registry to analyze the clinical efficacy and safety of XIENCE V EECSS at mid-term and long-term follow-up in patients treated for MV-CAD. ENDPOINTS: For the EXECUTIVE randomized trial, the primary endpoint is in-stent late lumen loss at 9 months. For the EXECUTIVE registry, the primary endpoint is a composite of all death, myocardial infarction (Q-wave and non-Q-wave), and ischemia-driven target vessel revascularization at 12 months. The study will be conducted at 30 study centers in Italy and 600 patients will be enrolled in total: 200 patients will be enrolled (1: 1) in the randomized trial and 400 patients will enter the registry. SAMPLE SIZE: It was calculated that, assuming a mean in-stent late lumen loss of 0.20 +/- 0.41 mm in the XIENCE V EECSS arm and 0.30 +/- 0.53 mm in the Taxus Liberté stent arm, and a noninferiority margin delta of 0.12 (according to the SPIRIT III results), the analysis of 81 lesions per arm would provide over 90% power. Therefore, 200 patients will be enrolled to account for dropouts. CONCLUSION: The present study is expected to provide as yet unavailable information about the performance of second-generation stents in the specific setting of patients with MV-CAD.

[Anomalous origin of the circumflex artery from the right aortic sinus: assessment with conventional coronary angiography and multislice computed tomography]. / Origine anomala dell'arteria circonflessa dal seno di Valsalva destro: valutazione mediante tomografia computerizzata multistrato ed angiografia coronarica convenzionale.

Anomalous origin of the circumflex coronary artery from the right sinus of Valsalva is the most common coronary anomaly. This anomaly is thought to be of little clinical significance without the presence of severe narrowing of the vessel. A 43-year-old woman was referred to our institution for evaluation of atypical chest pain and equivocal results of the exercise stress test. We decided to perform multislice computed tomography coronary angiography before any other invasive studies. The scan was performed with a 16-row scanner (Aquilion 16 CFX, Toshiba Medical Systems, Tokyo, Japan) after intravenous administration of non-ionic contrast material. Scans revealed that the circumflex coronary artery originated from the right sinus of Valsalva; the initial course was retro-aortic until it reached its target in the atrioventricular groove; peripheral distribution of the circumflex coronary artery was then normal. The anomalous vessel presented a significant stenosis in its proximal tract. Coronary angiography confirmed that the origin of the circumflex coronary artery was from the right aortic sinus and the significant stenosis of the proximal portion of this vessel. This case confirms the full capability and accuracy of multislice computed tomography with the aid of post-processing techniques in the identification and evaluation of the ectopic origin of the left circumflex coronary artery from the right sinus of Valsalva, displaying accurately the origin, size, course, and relationship of the anomalous vessel with respect to surrounding structures.

Ultrasonographic assessment of basal coronary flow as a screening tool to exclude significant left anterior descending coronary artery stenosis.

OBJECTIVE: Coronary blood flow exhibits a biphasic pattern at rest with a higher diastolic and a smaller systolic component. In the present investigation, we evaluated whether a decreased diastolic to systolic velocity ratio of basal coronary flow may be useful in the identification of subjects with significant left anterior descending coronary artery (LAD) stenosis. METHODS: One hundred and twenty-nine consecutive patients (62 with unstable angina, 25 with acute myocardial infarction and 42 with chronic coronary artery disease) were included in the study. Blood flow velocities were recorded in the mid-distal portion of the LAD using an ATL 5000 CV HDI ultrasound system. All patients underwent coronary angiography and were divided into two groups according to the absence (group 1) or the presence (group 2) of significant LAD stenosis (lumen narrowing > or = 70%). In 60 of the 129 patients, coronary flow reserve was evaluated non-invasively. RESULTS: Adequate Doppler recordings in the LAD were obtained by transthoracic echocardiography in 113 patients. There were no differences between groups with regard to sex, cardiovascular risk factors, left ventricular mass and volumes, ejection fraction, whereas the diastolic to systolic velocity ratio of basal coronary flow was significantly lower in group 2 patients (1.41 +/- 4.7 vs. 2.08 +/- 0.64, P < 0.00001). The receiver operating characteristic curve showed that a diastolic to systolic velocity ratio < 1.6 had a sensitivity of 77%, a specificity of 91%, a positive predictive value of 77%, a negative predictive value of 97%, and a diagnostic accuracy of 84% for the presence of significant LAD stenosis. In 55/60 patients, results of basal coronary flow and coronary flow reserve were concordant. On multivariate logistic regression analysis, the diastolic to systolic velocity ratio was a strong independent predictor of LAD stenosis > or = 70% (odds ratio 4.90, 95% confidence interval 1.65-7.30). CONCLUSIONS: The present findings suggest that assessment of basal coronary flow in the LAD may be useful to rule out the presence of significant stenosis.

Incremental diagnostic value of ultrasonographic assessment of coronary flow reserve with high-dose dipyridamole in patients with acute coronary syndrome.

BACKGROUND: Coronary flow reserve (CFR) assessment by transthoracic Doppler echocardiography has been found to be useful in subjects with suspected coronary artery disease. An important clinical question is whether such technique can be successfully applied in patients admitted to the coronary care unit with an acute coronary syndrome to detect a significant left anterior descending (LAD) disease. METHODS: One hundred fifty-nine patients with acute coronary syndrome (93 patients with unstable angina, 66 with acute inferior or lateral myocardial infarction) were included in the present analysis. Patients underwent a high-dose dipyridamole stress (0.84 mg/kg) with combined assessment of CFR in the LAD and regional wall motion. Blood flow velocities were recorded in the mid-distal portion of the LAD using a digital ultrasonographic system and CFR was calculated as the ratio of hyperemia-induced peak diastolic velocity to resting peak diastolic flow velocity. All patients underwent coronary angiography and a significant LAD stenosis was classified for lumen narrowing > or = 70%. RESULTS: Adequate Doppler recordings in the LAD were obtained in 92% of patients. A contrast agent was used in the 39% of examinations. No major adverse reaction occurred in any patient. A receiving operating characteristic curve showed that a CFR value < 1.9 had a sensitivity of 85%, a specificity of 87%, a positive predictive value of 71%, a negative predictive value of 94% and a diagnostic accuracy of 86% for identifying a significant LAD stenosis. The area under the receiving operating characteristic curve computed for CFR was significantly higher than for wall motion score index (p < 0.001). In a stepwise forward, multiple logistic regression analysis, both CFR (OR = 4.8, 95% C.I. 3.7-5.3; p < 0.00001) and the wall motion score index for the LAD territory (OR = 4.2, 95% C.I. 2.6-6.8; p < 0.0001) were independent determinants of LAD stenosis > or = 70%. CONCLUSION: Early assessment of CFR by transthoracic Doppler echocardiography is feasible and safe and provides additional information to identify subjects with acute coronary syndrome and significant LAD stenosis.

Three-dimensional echocardiographic and magnetic resonance assessment of the effect of telmisartan compared with carvedilol on left ventricular mass a multicenter, randomized, longitudinal study.

BACKGROUND: The hypothesis that left ventricular hypertrophy regression in hypertension relates to blood pressure (BP) control and to non-antihypertensive activity of some drugs was tested by comparing the effects of telmisartan and carvedilol on 24-h mean ambulatory BP and left ventricular mass (LVM) regression, measured using three-dimensional echocardiography (3-DECHO) and magnetic resonance imaging (MRI). METHODS: A total of 82 patients with mild-to-moderate hypertension and an optimal echocardiographic acoustic window were randomized to receive once-daily telmisartan 80 mg or carvedilol 25 mg for 44 weeks. RESULTS: Ten patients withdrew from the study because office diastolic BP remained >90 mm Hg. The 24-h mean ambulatory systolic/diastolic BP reductions were similar in both treatment groups (telmisartan, from 159.6 +/- 10.2/97.8 +/- 5.4 to 128.6 +/- 6.5/78.2 +/- 5.8 mm Hg; carvedilol, from 157.8 +/- 11.1/95.7 +/- 11.9 to 128.2 +/- 5.6/78.7 +/- 5.2 mm Hg). However, night-time and last 6-h mean BP reductions were nonsignificantly greater with telmisartan. Using 3-DE, telmisartan (P< .001) and carvedilol (P< .001) progressively reduced LVM index by 21.97 +/- 5.84 (15.7%) and 12.31 +/- 3.14 (9.1%) g/m2, respectively, at week 44. Similar magnitudes of reductions were observed using MRI (15.5% and 9.6%, respectively). Reductions in LVM index achieved with telmisartan were statistically superior to carvedilol (P< or = .001). CONCLUSIONS: The superior LVM regression with telmisartan versus carvedilol suggests telmisartan has a mechanism that may be beyond that of lowering BP in hypertensive patients.