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).

[Management strategies and choice of antithrombotic treatment in patients admitted with acute coronary syndrome--executive summary for clinical practice. Consensus Document of the Regional Chapters of the Italian National Association of Hospital Cardiologists (ANMCO) and of the Italian Society of Emergency Medicine (SIMEU)]. / Strategie Assistenziali e Scelta della Terapia Antitrombotica nei Pazienti Ricoverati con Diagnosi di Sindrome Coronarica Acuta--Sintesi Operativa per la Pratica Clinica. Documento congiunto delle Sezioni Regionali del Lazio dell'Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO) e della Società Italiana di Medicina di Emergenza-Urgenza (SIMEU).

This document has been developed by the Lazio regional chapters of two scientific associations, the Italian National Association of Hospital Cardiologists (ANMCO) and the Italian Society of Emergency Medicine (SIMEU), whose members are actively involved in the everyday management of Acute Coronary Syndromes (ACS). The document is aimed at providing a specific, practical, evidence-based guideline for the effective management of antithrombotic treatment (antiplatelet and anticoagulant) in the complex and ever changing scenario of ACS. The document employs a synthetic approach which considers two main issues: the actual operative context of treatment delivery and the general management strategy.

Primary percutaneous coronary intervention in nonagenarians: six-month outcomes from a single-center registry.

Little is known about the efficacy and medium-term outcomes of primary percutaneous coronary intervention (PCI) in very old patients. We evaluated in-hospital and 6-month outcomes in a retrospective cohort of nonagenarian patients presenting at our hospital with ST-segment elevation myocardial infarction (STEMI) and treated by primary PCI from January 2003 to May 2012. During this period, primary PCI was performed in 1598 consecutive patients; twenty-seven patients (age, 92.5 ± 2.5 years) were enrolled in the study. Four patients (15%) were in advanced Killip class at presentation. STEMI location was anterior in 44%. Patients received aspirin, 300 mg clopidogrel loading dose, and heparin. Abciximab was given to 41% of patients. Coronary angiography showed multivessel disease in 52% of patients. Pain-to-balloon and door-to-balloon times were 375.0 ± 410.2 minutes and 107.3 ± 47.6 minutes, respectively. Intra-aortic balloon pump was implanted in 1 patient. An average of 1.3 ± 0.7 stents (95% bare-metal stents) were implanted per patient. Procedural success rate, defined as Thrombolysis in Myocardial Infarction (TIMI) flow grade ≥ 2 and residual stenosis <20%, was 89%. Hospital mortality was 18.5%. TIMI major bleeding and acute renal failure, defined as an absolute increase of 0.5 mg/dL serum creatinine, occurred in 7% and 22% of patients, respectively. Overall 6-month survival rate was 67%. Our data suggest that primary PCI can be performed in nonagenarian patients with high success rate and with an acceptable bleeding risk, even when aggressive antithrombotic drugs, such as glycoprotein IIb/IIIa inhibitors, are given.

The clinical spectrum of longitudinal deformation of coronary stents: from a mere angiographic finding to a severe complication.

BACKGROUND: Longitudinal deformation of coronary stents has been recently described and seems to be more frequent with certain contemporary stent platforms. Indeed, in order to increase flexibility and deliverability, stent manufacturers have reduced strut thickness and the number of connectors within cells; this could negatively affect other mechanical properties of the device, such as the resistance to longitudinal stress. Moreover, longitudinal deformation has been associated to adverse events, such as stent thrombosis. METHODS: We report 3 cases of longitudinal stent deformation observed at our institution. RESULTS: The first case was a consequence of postdilatation of the stent with a non-compliant balloon, whereas the other 2 cases involved the treatment of bifurcation lesions. One case was complicated by acute, intraprocedural stent thrombosis; such a dreadful complication, to the best of our knowledge, has not been previously reported. CONCLUSIONS: Although longitudinal stent deformation is an infrequent finding, usually not associated with adverse events, at least in the short term, it can sometimes turn into a catastrophic, life-threatening complication. The growing number of reports about this issue in recent years should prompt the operators to carefully select coronary stents, especially when dealing with certain lesion subsets, such as ostial lesions, bifurcations, and long lesions.

Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study.

OBJECTIVES: The purpose of this study was to assess whether transradial access for ST-segment elevation acute coronary syndrome undergoing early invasive treatment is associated with better outcome compared with conventional transfemoral access. BACKGROUND: In patients with acute coronary syndrome, bleeding is a significant predictor of worse outcome. Access site complications represent a significant source of bleeding for those patients undergoing revascularization, especially when femoral access is used. METHODS: The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) was a multicenter, randomized, parallel-group study. Between January 2009 and July 2011, 1,001 acute ST-segment elevation acute coronary syndrome patients undergoing primary/rescue percutaneous coronary intervention were randomized to the radial (500) or femoral (501) approach at 4 high-volume centers. The primary endpoint was the 30-day rate of net adverse clinical events (NACEs), defined as a composite of cardiac death, stroke, myocardial infarction, target lesion revascularization, and bleeding). Individual components of NACEs and length of hospital stay were secondary endpoints. RESULTS: The primary endpoint of 30-day NACEs occurred in 68 patients (13.6%) in the radial arm and 105 patients (21.0%) in the femoral arm (p = 0.003). In particular, compared with femoral, radial access was associated with significantly lower rates of cardiac mortality (5.2% vs. 9.2%, p = 0.020), bleeding (7.8% vs. 12.2%, p = 0.026), and shorter hospital stay (5 days first to third quartile range, 4 to 7 days] vs. 6 [range, 5 to 8 days]; p = 0.03). CONCLUSIONS: Radial access in patients with ST-segment elevation acute coronary syndrome is associated with significant clinical benefits, in terms of both lower morbidity and cardiac mortality. Thus, it should become the recommended approach in these patients, provided adequate operator and center expertise is present. (Radial Versus Femoral Investigation in ST Elevation Acute Coronary Syndrome [RIFLE-STEACS]; NCT01420614).

Impact of vascular approach (transradial vs. transfemoral) on the efficacy of thrombus aspiration in acute myocardial infarction patients.

BACKGROUND: Manual thrombus aspiration improves the efficacy of percutaneous coronary interventions (PCIs) in ST-elevation acute myocardial infarction (STEMI). The transradial approach (TRA) is an emerging vascular approach for PCI but is associated with specific technical requirements. As data on the combination of thrombus aspiration and TRA are scarce, we sought to assess the feasibility of TRA manual thrombus aspiration in STEMI patients. METHODS: All consecutive patients treated with manual thrombectomy for acute STEMI in three Italian hospitals were considered. Patients were divided according to the vascular approach into two groups: TRA and transfemoral (TFA). Two primary end points were defined: thrombectomy feasibility (ability to cross the occlusion with the device) and thrombectomy efficacy (absolute thrombus score reduction after device crossing). RESULTS: From January 2008 to December 2009, 303 patients were included: 151 patients (63±13 years) were treated through TFA, and 152 patients (61±12 years, P=.25) were treated through TRA. There were no significant differences in thrombectomy feasibility (75% in the TRA compared to 74.8% in the TFA group, P=.97) or in thrombectomy efficacy (2.6±.8 for TRA and 2.9±2 for TFA, P=.15). In both groups, there was a significant reduction in thrombus score after manual thrombus aspiration. Angiographically evident distal embolization after device crossing was low and observed in seven cases (5%) either for TFA and TRA (P=.99). CONCLUSIONS: The present study suggests that, in the setting of acute STEMI, manual thrombus aspiration through TRA is feasible, and its efficacy is comparable to the TFA.

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.

Our technique for transradial coronary angiography and interventions.

The transradial approach for coronary angiography was introduced twenty years ago. Since then, considerable advancements have been made in this technique that proved to be effective in many interventional procedures and in several, even high-risk patient subsets (acute coronary syndromes, elderly, fully anticoagulated and obese patients). The main advantage of transradial approach over transfemoral approach is represented by the striking reduction in the rate of access-related vascular complications and bleedings. In recent years, bleeding prevention has become an issue of paramount importance, since recent large trials and registries clearly showed that bleedings are associated with major adverse events at follow up. Nevertheless, the prevalence of transradial approach for coronary procedures worldwide is still quite low and nowadays, in the United States, the favourite strategy for bleeding prevention is mostly based on the adoption of new antithrombotic drugs (such as bivalirudin and fondaparinux) rather than on the selection of an alternative, safer vascular access route. In this review we deal with several clinical and technical issues about transradial approach, including: 1) patient selection; 2) cath lab set-up, access technique and dedicated hardware; 3) reaching the coronary ostia: how to deal with anomalous anatomy; 4) selection and manipulation of catheters; 5) haemostasis and post-procedural issues.

Coronary-to-bronchial artery fistula in a patient with multivessel coronary disease treated by percutaneous coronary intervention.

We describe the case of a 78-year-old patient, admitted to our hospital with an acute coronary syndrome. Coronary angiography showed multivessel coronary artery disease and an anomalous coronary vessel branching from the right coronary artery. After successful percutaneous revascularization and discharge, the anomalous vessel was diagnosed by contrast enhanced 64-multidetector computed tomography as a coronary-to-bronchial fistula. Since the patient was asymptomatic, conservative treatment was selected.

Thrombus aspiration during primary angioplasty for cardiogenic shock.

We sought to assess the clinical efficacy of thrombus aspiration during primary percutaneous coronary interventions (PCI) in patients presenting with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS). We retrospectively selected 44 patients with CS out of a population of 842 STEMI patients treated with primary PCI at our Hospital between March 2003 and October 2007. Twenty-six patients died during hospital stay (59.1%, Group 1), whereas the remaining 18 were discharged (40.9%, Group 2). Post-procedural ST-segment resolution was greater (68.0%+/-35.6 vs. 43.0%+/-35.0; p=0.06) and in-hospital mortality was significantly lower (21.4% vs 76.6%; p<0.01) in patients treated by TA as compared to patients undergoing standard PCI. At multivariate logistic regression analysis, TA was the only variable independently associated with survival.

MicroRNAs and ischemic heart disease: towards a better comprehension of pathogenesis, new diagnostic tools and new therapeutic targets.

MicroRNAs are key, recently discovered, regulators of gene expression. They are involved in many physiological cellular pathways so it is not surprising that an altered microRNA expression pattern can be involved in the pathogenesis of many disease states. The possibility to manipulate microRNAs to obtain a therapeutical effect is very attractive since they represent specific targets in a particular cellular pathway and because it is quite easy to synthesize short oligonucleotides with the ability to interfere with microRNA mechanism of action. The main problem for microRNA-based therapy is represented by delivery. In the last two years many studies have underlined the involvement of microRNAs in many aspects of ischemic heart disease, the leading cause of morbidity and mortality in the Western World. MiR-29 is involved in fibrotic reaction after myocardial infarction while miR-21 may exert a fundamental role in post-angioplasty restenosis. MiR-208 is involved in the shift toward a fetal gene expression pattern in contractile proteins in heart failure. MiR-1 influences susceptibility to cardiac arrhythmias after myocardial infarction. This review will focus on microRNAs involvement in multiple aspects of ischemic heart disease and on their promising novel therapeutic applications including some recent patents.

The use of functional tests and planned coronary angiography after percutaneous coronary revascularization in clinical practice. Results from the AFTER multicenter study.

BACKGROUND: The follow-up strategies after percutaneous coronary intervention (PCI) have relevant clinical and economic implications. The purpose of this prospective observational multicenter study was to evaluate the effect of clinical, procedural and organizational variables on the execution of functional testing (FT) and planned coronary angiography (CA) after PCI, and to assess the impact of American College of Cardiology (ACC)/American Heart Association (AHA) guidelines on clinical practice. METHODS: Four hundred twenty consecutive patients undergoing PCI were categorized as class I, IIB and III indications for follow-up FT according to ACC/AHA guidelines recommendations. Furthermore, all patients were grouped according to the presence or absence of FT and/or planned CA over 12 months after PCI. Multivariable analysis was used to assess the potential predictors of test execution. RESULTS: During the 12-month follow-up at least one test was performed in 72% of patients with class I indication, 63% of patients with class IIB indication and 75% of patients with class III indication (p=ns). A total of 283 patients (67%) underwent testing. The use of tests was associated with younger age (R.R. 0.94, C.I. 0.91+/-0.97, p<0.001), a lower number of diseased vessels (R.R. 0.60, C.I. 0.43+/-0.84, p=0.003), follow-up by the center performing PCI (R.R. 2.64, C.I. 1.43+/-4.86, p=0.002), and the specific center at which PCI was performed. Most asymptomatic patients completed their testing prematurely with respect to the risk period for restenosis. CONCLUSIONS: The use of FT and planned CA after PCI is unrelated to patient's symptom status, and depends on patient's age and logistics. ACC/AHA guidelines have no influence in clinical practice, and test timing is not tailored to the risk period for restenosis.

Drug-eluting stents in a patient with favism: is the aspirin administration safe?

We describe the case of a 64-year-old patient with glucose-6-phosphate dehydrogenase deficiency who was referred to our hospital because of an acute inferior myocardial infarction.Given the possible risk of acute haemolytic anaemia, aspirin was not given in the acute phase, and the patient was successfully treated by balloon angioplasty of the right coronary artery.After functional and genetic testing showing the presence of the Mediterranean mutation, known to be a class II variant, the patient received oral daily aspirin (100 mg) under strict monitoring in order to promptly detect any sign of haemolysis. After 4 days, a complex percutaneous coronary intervention with an implantation of two drug-eluting stents was successfully performed on the left coronary artery. After 3 months, the patient is free from adverse events.Glucose-6-phosphate dehydrogenase deficiency is commonly considered a contraindication to aspirin intake; however, this case shows that aspirin at low, antiplatelet dosage is well tolerated and should not be denied to patients with ischaemic heart disease and complex coronary anatomy.

Management of multivessel coronary disease after ST elevation myocardial infarction treated by primary angioplasty.

BACKGROUND: Optimal treatment strategy of patients with ST elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD) undergoing primary angioplasty is still unclear. Percutaneous coronary intervention (PCI) of non-culprit vessels simultaneously or soon after primary angioplasty is feasible and safe, but available data failed to consistently show a benefit in long-term clinical outcomes. METHODS: We retrospectively compared in-hospital and long-term outcomes for patients with STEMI and multivessel CAD treated by primary angioplasty with (Group 1, n=64) or without (Group 2, n=46) early, staged PCI of other angiographically significant coronary lesions. In-hospital major adverse cardiovascular events (MACE) were defined as a composite of death, periprocedural myocardial infarction after staged, elective PCI, stroke, stent thrombosis, major bleeding, and vascular complications. MACE at follow-up were defined as a composite of death, stroke, stent thrombosis, any coronary revascularization, and re-hospitalization for acute coronary syndrome. RESULTS: Group 1 patients underwent staged PCI 5.9 +/- 3.5 days after primary angioplasty. The mean length of follow-up was 13 months (392 +/- 236 days). The incidence of in-hospital MACE was 20.3% in Group 1 and 10.8% in Group 2 (P=0.186); the incidence of out of hospital MACE was 9.3% in Group 1 and 23.9% in Group 2 (P=0.037). In Group 1 in-hospital MACE were driven by periprocedural myocardial infarction after the elective procedure, which occurred in 15.6% of patients. CONCLUSIONS: Our data show that multivessel, staged PCI in STEMI patients is associated with a low incidence of adverse events at follow-up but with a higher incidence of in-hospital MACE, mainly driven by periprocedural myocardial infarction during the elective procedure.

[An atypical case of tako-tsubo syndrome presenting with symptomatic bradycardia]. / Sindrome di tako-tsubo: descrizione di un caso atipico con bradicardia sintomatica all'esordio.

The tako-tsubo syndrome (transient left ventricular apical ballooning with normal coronary arteries), initially described in Japanese patients, is now being increasingly observed worldwide and should be considered in the differential diagnosis of acute coronary syndromes. Angina-like chest pain, electrocardiographic changes and an increase in myocardial markers are often present, as well as history of acute stressful events preceding symptom onset. We report the case of an Asiatic woman in whom typical, reversible abnormalities in left ventricular motion were associated with symptomatic junctional bradycardia. Nevertheless, the patient was completely free from angina and excluded acute pain or emotions in the previous weeks. Coronary angiography showed absence of significant disease and left ventricular function was found to be unremarkable 1 month after the acute event. Although infrequent, atypical presentations of tako-tsubo syndrome have occasionally been reported and, in our opinion, they could provide interesting insights into the ill-defined pathophysiology of the disease.

Very late thrombosis of a drug-eluting stent deployed during primary angioplasty for ST-elevation myocardial infarction.

Drug-eluting stents, despite being very effective in reducing restenosis after percutaneous coronary interventions, are associated with a low but definite risk of late thrombotic occlusion with adverse clinical events. To date, the incidence and overall risk of late thrombosis of drug-eluting stents after primary percutaneous coronary interventions for ST-elevation myocardial infarction are not well defined because of the relative paucity of evidence-based data. We report the case of an angiographically confirmed paclitaxel-eluting stent thrombosis, occurring 20 months after successful primary percutaneous coronary intervention in a 41-year-old woman. To the best of our knowledge, this is the most delayed case of paclitaxel-eluting stent thrombosis described so far.

Transradial unprotected left main coronary artery stenting in an octogenarian with severe angina and Leriche syndrome.

Coronary artery disease in octogenarians is often diffuse and difficult to manage due to concomitant peripheral vascular disease. The authors describe a case in which an unprotected left main coronary artery was successfully treated by transradial stenting in a patient with severe angina and Leriche syndrome.