Clinical Comparison With Short-Term Follow-Up of Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Stent in Primary Percutaneous Coronary Interventions.

Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p = 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p = 0.4); death (BVS 0.8%, EES 2.0%, p = 0.4), MI (BVS 4.1%, EES 2.0%, p = 0.2), TLR (BVS 4.1%, EES 4.5%, p = 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p = 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.

[The heart of Italians. A population survey on the perception and evaluation of the National Health Service by citizens with heart disease and without heart disease (with special reference to cardiology)]. / Il cuore degli italiani. Indagine demoscopica sulla percezione e valutazione del Servizio Sanitario Nazionale da parte dei cittadini italiani cardiopatici e non cardiopatici (con specifico riferimento alla Cardiologia).

BACKGROUND: The purpose of this study was to collect information to understand how citizens perceive the National Health System (NHS), and what is the degree of confidence they have in the NHS. METHODS: We carried out an opinion poll with the Demos & Pi group on the perception of the NHS by Italian citizens, with particular reference to the activities related to cardiology, by interviewing 2311 people with a set of 33 questions, about the perception of their health status, lifestyles, the propensity to use public or private services, consideration of the level of the NHS, and the trust in the medical profession. The subjects included were also preliminarily stratified according to the presence or absence of heart disease. RESULTS: Overall, Italian citizens express a high level of satisfaction for the NHS (on average, 65% of approval rating), including the whole professional staff, hoping that the NHS will be kept appropriately funded. The result is even better in the subset of interviewed citizens, who suffered from cardiovascular disease. People also consider the NHS an essential requirement to ensure equity in access to medical treatment and to keep costs competitive, even compared to private healthcare. The NHS major weakness remains the waiting lists, which are considered too long for diagnostic procedures and ordinary interventions. CONCLUSIONS: There is a widespread positive feeling among Italian citizens concerning the role and functioning of the NHS. Such opinion, shared by the whole country, should be taken into account when the time will come to define strategies for health policy of the Italian society in the near future.

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).

Comparison by meta-analysis of eptifibatide and tirofiban to abciximab in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention.

Adjunctive therapy with abciximab during primary percutaneous coronary intervention (PPCI) in patients with ST-elevation myocardial infarction (STEMI) determines a better short-term outcome compared to placebo. Tirofiban and eptifibatide represent a valid option with lower cost, but these have been less studied. The aim of the present study was to combine all randomized trials and registries to demonstrate the noninferiority of tirofiban and eptifibatide compared to abciximab in patients with STEMI treated with PPCI. We identified 6 randomized trials and 4 registries. Overall, 4,653 received small molecules and 2,696 abciximab, and the rate of combined death and nonfatal reinfarction did not differ (4.6% vs 4.5%, odds ratio 0.99, 95% confidence interval [CI] 0.78 to 1.27, p = 0.95) up to 30 days of follow-up, with an absolute difference of 0.1% (95% CI -1.06 to 0.8). Because the noninferiority limit was set at +1.5%, and because the upper point estimate (0.8%) of the 95% CI did not cross the prespecified limit, the noninferiority of the small molecules was documented. In-hospital major bleeding was also similar (8.8% vs 6.1%, odds ratio 0.92, 95% CI 0.75 to 1.13, p = 0.43). Sensitivity analysis comparing randomized trials to registries and tirofiban or eptifibatide to abciximab did not show any significant differences. In conclusion, our results documented noninferiority of "small molecules" compared to abciximab and, therefore, support their alternative use as adjunctive therapy during PPCI for patients with STEMI.

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.

Naphthalen-1-yl-(4-pentyloxynaphthalen-1-yl)methanone: a potent, orally bioavailable human CB1/CB2 dual agonist with antihyperalgesic properties and restricted central nervous system penetration.

Selective activation of peripheral cannabinoid CB1 receptors has the potential to become a valuable therapy for chronic pain conditions as long as central nervous system effects are attenuated. A new class of cannabinoid ligands was rationally designed from known aminoalkylindole agonists and showed good binding and functional activities at human CB1 and CB2 receptors. This has led to the discovery of a novel CB1/CB2 dual agonist, naphthalen-1-yl-(4-pentyloxynaphthalen-1-yl)methanone (13), which displays good oral bioavailability, potent antihyperalgesic activity in animal models, and limited brain penetration.

[Coronary angioplasty in subgroups at risk: patients treated with bypass]. / L'angioplastica coronarica in sottogruppi a rischio: gli operati di bypass.

Percutaneous coronary intervention represents an established method to obtain revascularization in patients suffering from obstructive coronary artery disease. Despite the predictability of procedural results and the favorable clinical outcome shown in large series, there are still areas in which the clinical benefits of intervention are less impressive and a lot remains to be done to improve both procedural and clinical outcomes. Among these areas, one may well include the subgroup of patients with previous bypass surgery, who have been consistently shown to be affected by a high rate of periprocedural complications as well as late recurrence. The risk profile of these patients is examined under two main perspectives: the burden of more severe baseline clinical conditions (age, ventricular function, severity of coronary disease) and the negative impact of graft atherosclerosis. The basic assumption of this article is that a variable combination of these characteristics identifies subsets with increasing risk of complications and/or recurrence. For this reason, results of percutaneous revascularization in these patients may still represent a technical as well as a clinical challenge. In particular, the long debated relationship between composition of atherosclerotic plaque in saphenous vein graft, distal embolization, periprocedural myocardial damage and early and late adverse events represents a negative sequence that currently available pharmacologic and interventional resources cannot consistently antagonize. Added to this, are the unresolved issues of diffuse degeneration and chronic total occlusion of saphenous vein grafts, in which no therapeutic approach, alone or in combination, has substantially modified the poor outcome of these lesions. The use of glycoprotein IIb/IIIa receptor antagonists is also discussed, in the light of available data derived from large clinical trials, casting doubts on the efficacy of these otherwise essential pharmacologic agents. Lastly, the setting of acute myocardial infarction represents the clinical scenario in which the adverse effects of the combination of clinical and angiographic characteristics are clearly appreciated. Both coronary intervention and cardiac surgery represent fields of rapidly growing knowledge and technology. It is likely that in the near future we will witness major changes in the clinical management of these patients, thanks to the increasing utilization of arterial conduits, the widespread use of local drug delivery, the availability of new percutaneous devices, and the development of integrated pharmacologic and mechanical revascularization strategies.