A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease: the EXECUTIVE trial (EXecutive RCT: evaluating XIENCE V in a multi vessel disease).

OBJECTIVES: This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD). BACKGROUND: Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery. METHODS: Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months. RESULTS: The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (-0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30). CONCLUSIONS: The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011).

Clinical and angiographic outcomes in elderly patients treated with endothelial progenitor cell capture coronary stents: results from a prospective single-center registry.

OBJECTIVE: To evaluate the outcomes in elderly patients treated with endothelial progenitor cell (EPC) capture stent, designed to promote rapid stent endothelialization, and dual-antiplatelet therapy for only 1 month. BACKGROUND: Although some registries showed that drug-eluting stents have better clinical outcomes and can reduce reinterventions in comparison to bare-metal stents in elderly patients, the subsequent prolonged dual-antiplatelet therapy needed after drug-eluting stent implantation can likely be interrupted because of intolerance or comorbidities in this subset of patients, with high risk of stent thrombosis. METHODS: One hundred consecutive patients ≥ 75 years with de novo lesions in native coronary arteries underwent EPC capture stent implantation. The study endpoints were major adverse cardiac events (MACE), binary restenosis and late lumen loss. RESULTS: Mean age was 79 ± 3 years (78% male), 28% had diabetes, and 81% had non-ST-elevation acute coronary syndrome. A total of 134 lesions were treated, 69% were type B2/C, and 143 EPC capture stents were implanted (1.4 stents per patient). At 1-year follow up, clinical outcomes were: all-cause death, 8%; myocardial infarction, 2%; clinically-justified target lesion revascularization (TLR), 22%; MACE, 28%; and definite stent thrombosis, 2% (2 cases in the same patient). Angiographic 6-month follow up showed a binary restenosis rate of 35% and a late lumen loss of 0.94 ± 0.86 mm. CONCLUSION: This study suggests that EPC capture stent is safe and feasible in patients ≥ 75 years of age, but clinically justified TLR and binary restenosis were frequently observed.

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.

Thin strut chrome-cobalt stent implantation for treatment of de-novo lesions in small coronary vessels: results of the RISICO Italian Registry (Registro Italiano Mini VISION nei piccolo Vasi) utilizing the Mini VISION coronary stent platform.

OBJECTIVES: The Registro Italiano Mini VISION nei piccoli Vasi registry is a prospective, multicenter, observational study, aimed at assessing immediate and long-term angiographic and clinical outcomes of a small-vessel cobalt-chrome super alloy-dedicated stent (Multi-Link RX VISION) in de-novo and long lesions. BACKGROUND: Small artery size is an important determinant of poor outcomes in percutaneous coronary interventions. METHODS: Patients with ischemic heart disease were included. The primary end point was procedural success. Secondary end points included clinical restenosis (need for target lesion revascularization ), incidence of major adverse cardiac events at 6 months, and cost-effectiveness analysis. RESULTS: Between September 2004 and October 2005, 143 patients (mean age 67 +/- 11 years; 22% diabetes) were enrolled; 6-month follow-up was completed in May 2006. Average lesion length, mean stent length and diameter were 16.8 +/- 7.1, 17.01 +/- 3.9 and 2.41 +/- 0.14 mm, respectively. Procedural success was 96%. At 6-month follow-up, the hierarchical major adverse cardiac event rate was 11.6%, 2.9% deaths, 2.9% myocardial infarction and 5.8% target lesion revascularization. Cost-effectiveness analysis will be reported in a further publication. CONCLUSION: Small-vessel disease treatment with Mini VISION stents permits an elevated procedural success rate with low incidence of clinical restenosis and major adverse cardiac events at mid-term follow-up. Such results require confirmation by means of a randomized controlled study against drug-eluting stents.

Multivessel spontaneous coronary artery dissection in a postpartum woman treated with multiple drug-eluting stents.

Multivessel spontaneous coronary artery dissection is a very rare cause of myocardial ischemia. Its optimal treatment is not yet well defined and is usually tailored to clinical features. We report a case of a postpartum woman with multivessel spontaneous coronary artery dissection and acute myocardial infarction, in whom the drug-eluting stenting of the only alleged 'culprit' vessel did not prevent the propagation of dissection from another vessel. Although the recommendations drawn from a single case report are not conclusive, we believe that when there is a multivessel spontaneous coronary artery dissection in a setting of acute myocardial infarction, all dissected coronary segments should be treated using stents.

Apical thrombus in a patient with takotsubo cardiomyopathy.

We report a case of apical thrombus formation among a group of 15 patients with takotsubo cardiomyopathy who were referred for a suspected acute coronary syndrome over a 2.5-year period. To the best of our knowledge, no data are available regarding the treatment of this syndrome. According to current literature and our reported experience, the use of anticoagulant therapy administered until complete resolution of wall motion abnormalities appears to be appropriate to treat apical thrombus formation and any possible subsequent embolism.

Two-year clinical follow up of coronary drug-eluting stent in patients at high risk for coronary restenosis.

OBJECTIVE: To evaluate the long-term follow up of patients at high risk for coronary restenosis. BACKGROUND: Drug-eluting stents (DES) have been proven to reduce restenosis and reintervention compared with bare-metal stents (BMS). Although the safety of DES is not different from that of BMS in the short-to-medium term, concern has arisen about the potential for late stent thrombosis related to delayed endothelialization of the stent struts. METHODS: Among 495 patients who underwent percutaneous coronary intervention between June 2004 and March 2005, we retrospectively identified a subset of 150 patients (30%) at high risk for coronary restenosis on the basis of angiographic characteristics who were treated with DES. We assessed the incidence of major adverse cardiac events (MACE) during a 2-year follow-up period. The risk of MACE was estimated by computing the hazard ratio and the 95% confidence interval using the Cox regression method. RESULTS: At baseline, 31% of the patients had diabetes mellitus, 43% had previous myocardial infarction (MI), and 12% had ST-elevation acute MI as the cause of admission. The most frequent selection criteria observed were the presence of a long lesion (73% of patients) and the execution of multivessel angioplasty (43% of patients). Overall, 284 lesions were treated (1.9 lesions/patient) and 318 stents were implanted (2 stents/patient). Two-year cumulative incidence of the combined endpoint of death or MI, target vessel revascularization (TVR), MACE and target lesion revascularization were 7.3%, 10%, 16% and 7.3%, respectively. Significant predictors of MACE at 2 years were total occlusion, number of lesions treated and age. Significant predictors of TVR at 2 years were bypass graft treatment, total occlusion, number of stents implanted and number of lesions treated. Stent thrombosis occurred in 3 patients (2%). CONCLUSION: In these real-world patients at high risk for coronary restenosis, the use of DES was associated with a low incidence of cardiac events.

Sicilian DES Registry: prospective in-hospital and 9-month clinical and angiographic follow-up in selected high restenosis risk patients.

OBJECTIVE: This is a multicentre, open label, prospective non-randomized registry, with 9-month angiographic follow-up, conducted to evaluate the safety and effectiveness of drug-eluting stents (DES) when used in high restenosis risk patients from the real world. METHODS: From June 2004 to February 2005, a total of 1622 consecutive patients were enrolled to the Sicilian DES Registry, according to specific inclusion criteria. Both paclitaxel-eluting and sirolimus-eluting stents were used. The analysis was performed on 1472 patients because 150 patients were excluded from the study. The primary endpoint was to evaluate the rate of major adverse cardiac events (MACE) within 9 months after DES implantation. Major adverse cardiac events were defined as cardiac death, non-Q-wave or Q-wave myocardial infarction (MI) and target vessel revascularization (TVR). The secondary endpoints were procedural success, angiographic binary restenosis and stent thrombosis within 9 months post-procedure. RESULTS: Patients were more frequently male; 472 (32.1%) were diabetics, of whom 130 (27.5%) were treated with insulin. Mean ejection fraction of the left ventricle was 51.5 +/- 8.7%. Multivessel disease was found and treated in 627 patients (42.6%). A total of 2439 lesions were treated with DES. Final angiographic success was achieved in 2422 (99.3%) lesions. Procedural success was achieved in 1422 (96.6%) patients. The 9-month cumulative incidence of MACE was 7.3% with 0.8% of cardiac deaths, 0.8% non-fatal MI, 7.9% TVR. Binary restenosis was observed in 101 patients (8.3%). Stent thrombosis was documented in 11 patients (0.8%). CONCLUSIONS: Drug-eluting stents appear to be safe and associated with a low incidence of MACE at 9-month follow-up, even in patients selected for their complexity.

Primary coronary angioplasty in a patient with anomalous origin of the right coronary artery from the left sinus of Valsalva.

We report a rare case of primary coronary angioplasty in a patient with acute myocardial infarction due to thrombotic occlusion of an anomalous right coronary artery arising from the left sinus of Valsalva. The non-invasive method of ischaemia localisation, such as ST-segment elevation on the electrocardiogram, was useful in identifying the infarct-related artery. A major factor was the selection of the guiding catheter to access the anomalous right coronary artery and also to obtain good angiographic visualisation and adequate support for percutaneous coronary intervention.

Intraventricular obstruction in a patient with tako-tsubo cardiomyopathy.

We describe a case of a 70-year-old woman who developed chest pain and shortness of breath not related to a stress. The patient, with history of hypertension, presented T-wave inversion and prolonged QTc interval at admission electrocardiogram, peak troponin I level was normal, and no signs of myocarditis were found. Angiography demonstrated the "apical ballooning" without any obstructive coronary artery disease; on pullback of the pigtail catheter from the left ventricular apex to the basal tract, a 35 mm Hg gradient was observed. The echocardiographic evaluation showed asymmetric septal wall thickening of 19 mm, systolic anterior motion of the anterior mitral leaflet, juxtaposition of the septum to the mitral chordal apparatus, no significant left ventricular outflow tract gradient, moderate-to-severe mitral regurgitation and a pulmonary systolic pressure of 40 mm Hg. Rest (201)tallium myocardial perfusion scintigraphy SPECT showed a perfusion defect in the left ventricular apex. At 1-month echocardiographic and scintigraphic follow-up, left ventricular wall motion and myocardial perfusion returned completely normal. Nine months after the acute event the patient remained asymptomatic. We hypothesize that septal ventricular hypertrophy and intraventricular obstruction could be related to the development of some of the cases of tako-tsubo cardiomyopathy.

A case of transient left mid ventricular ballooning.

We describe a case of an 85-year-old woman who presented with chest pain after a crisis of bronchial asthma. On admission, the electrocardiogram showed ST-segment elevation in leads II, III, and aVF. Peak troponin I level was 3.0 ng/dl (normal value <0.4 ng/dl). Angiography demonstrated ballooning of the mid portion of the left ventricle without involvement of the apex. No obstructive epicardial coronary artery disease was present. After 8 days, left ventricular wall motion improved and returned completely to normal at 1-month echocardiographic follow-up.

Transient impairment of myocardial perfusion in a patient with apical ballooning syndrome.

We describe a case of a 76-year-old woman who presented with chest pain after a violent argument. On admission the electrocardiogram showed 1-mm ST segment elevation in II, III, aVF, V3-V6 leads; the subsequent electrocardiogram showed T-wave inversion in the same leads. Peak troponin I level was 7.3 ng/dl (normal <0.4 ng/dl). Emergency angiography demonstrated the so-called "apical ballooning", in the absence of any obstructive coronary artery disease. A myocardial contrast echocardiogram performed 5 days later showed a large perfusion defect in the akinetic apical region of the left ventricle; at 1-month follow-up myocardial perfusion and left ventricular wall motion became completely normal. In patients with apical ballooning syndrome a catecholamine-mediated endothelial injury might be responsible of a microvascular coronary dysfunction which causes myocardial ischemia and subsequent myocardial stunning.

Clinical features of transient left ventricular apical ballooning.

This report describes the clinical characteristics of 8 consecutive patients with transient left ventricular apical ballooning identified among 389 patients (2%) admitted to a tertiary referral hospital with suspected acute coronary syndromes over a 1-year period. Among these patients, 2 cases appeared to be caused by acute myocarditis and 1 case by head trauma with intracranial bleeding. In the remaining 5 cases, no apparent cause was found. All patients but 1 were postmenopausal women (mean age 60 +/- 13.5 years). Preceding strong emotional or physical stress was present in 6 patients. The presenting symptom in 7 patients was chest pain. Four patients had significant ST-segment elevation, and the remaining 4 had T-wave inversions on their admission electrocardiograms. Mean peak troponin I was moderately elevated (3.7 +/- 4.5 ng/dl). The mean echocardiographic left ventricular ejection fraction was 40 +/- 10% on admission and increased significantly to 63 +/- 4% at 1-month follow-up (p <0.0001). All patients but 1 had abnormal corrected Thrombolysis In Myocardial Infarction frame counts (>27 frames) in >or=1 major epicardial coronary artery. All patients were alive and without major adverse cardiac events at 6-month follow-up. In conclusion, transient left ventricular apical ballooning should be considered in the differential diagnosis of patients presenting with suspected acute coronary syndromes, because it may account for approximately 2% of hospital admissions.

Which strategy should be used for acute ST-elevation myocardial infarction in patients aged more than 75 years?

The optimal management of acute myocardial infarction in elderly people (>or= 75 years) is controversial because elderly patients have been excluded or are under-represented in most acute myocardial infarction trials. Randomized studies show that, also in the elderly, thrombolytic therapy is effective in reducing mortality after acute myocardial infarction but the benefit in terms of mortality, recurrent infarction and stroke is smaller compared to primary percutaneous coronary intervention. Among the available mechanical therapeutic strategies, stenting is found to be superior to balloon angioplasty, whereas the role of drug-eluting stents in this setting still remains to be evaluated. The standard use of intravenous unfractionated heparin is still recommended because of the increased risk of intracranial haemorrhage by a combination of low molecular weight heparin or IIb/IIIa inhibitors and thrombolytic agents. Dedicated randomized clinical trials are needed to establish the best reperfusion therapy for this expanding population, especially in patients admitted to hospitals without percutaneous coronary intervention facilities and in patients developing cardiogenic shock.

[Potential impact of drug-eluting stents in Sicily: results from a multicenter survey and cost-benefit analysis of drug-eluting stents versus bare metal stents]. / Impatto potenziale dello stent medicato nella pratica clinica siciliana: risultati di una "survey" multicentrica e di un'analisi costo-beneficio rispetto allo stent metallico.

BACKGROUND: The recent introduction of drug-eluting stents (DES) has shown, in randomized controlled trials, to reduce the incidence of restenosis as compared to bare metal stents (BMS). Since their cost is considerably higher than that of BMS, the study assessed the economic impact of the adoption of this new therapy in the Sicilian clinical practice. METHODS: An economic evaluation was carried out by means of a linear decision model developed in Excel that simulated and compared costs and clinical pathway, within 1 year of the intervention, of hypothetical groups of patients with de novo lesions undergoing angioplasty with DES or BMS. Clinical data were obtained from the available literature and adapted to the Sicilian reality, using data from an original survey conducted in 7 local cath labs. The survey collected information on the anatomical case-mix of the population treated, the average number of stents used in the various procedures and the methods of treatment for in-stent restenosis. RESULTS: Compared to BMS, DES allows to avoid, on average, 11.8 revascularizations out of 100 patients over a period of 1 year, but requires to bear an incremental net cost of Euro 931 for the annual treatment of each patient. The cost-benefit ratio is more favorable for those categories of patients/lesions in which the risk of in-stent restenosis is higher and, at the same time, the number of stents implanted per procedure is lower (single-vessel diabetics and small vessels). CONCLUSIONS: The results of the study show how, within the scope of a policy that has tended more and more to rationalize the use of available health resources, the use of the expensive DES is not justified from an economic point of view in groups of patients and types of lesions in which a BMS is also associated with a lower likelihood of revascularization. Therefore, the study provides a starting point for consideration by hospital centers, suggesting the use of a mixture of DES for the treatment of lesions/patients at the highest risk of restenosis and BMS for the treatment of lesions/patients at lower risk of re-intervention.