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Navarese E.P.,University of Piemonte Orientale | De Servi S.,Civic Hospital | Buffon A.,Catholic University of the Sacred Heart | Suryapranata H.,De Weezenlanden Hospital | De Luca G.,University of Piemonte Orientale
Journal of Thrombosis and Thrombolysis | Year: 2011

Primary Percutaneous Intervention (PCI) is the treatment of choice for acute ST-elevation myocardial infarction (STEMI). Nearly half of STEMI patients have multivessel (MV) disease that has been associated with worse survival. However, current guidelines recommend to treat only the culprit artery (COR) during the acute procedure. Thus, the aim of the current study was to perform a meta-analysis of trials comparing MV PCI vs. COR for STEMI patients with MV disease. Medline/CENTRAL and Web were searched for comparative studies (both randomized and non randomized trials) about MV PCI vs. COR for STEMI patients reporting mortality, re-PCI and re-MI data. Primary endpoint was 30-day mortality. The meta-analysis included 10 studies (2 randomized and 8 registries; N = 31224). As compared with COR, MV PCI significantly reduced long term rate of re-PCI (OR [95% CI] = 0.47 [0.28-0.78], P = 0.003) without increasing 30-day mortality (OR [95% CI] = 1.30 [0.79-2.12], P = 0.31) and long term re-MI (OR [95% CI] = 0.94 [0.43-2.06], P = 0.88). This meta-analysis showed safety and efficacy of MV PCI approach as compared with COR, with a significant reduction in rate of revascularizations, but no advantages in death and re-MI. © 2010 Springer Science+Business Media, LLC. Source

Navarese E.P.,Nicolaus Copernicus University | Kubica J.,Nicolaus Copernicus University | Castriota F.,GVM Care and Research | Gibson C.M.,Beth Israel Deaconess Medical Center | And 7 more authors.
EuroIntervention | Year: 2011

Aims: Drug-eluting stents (DES) are a major advance in interventional cardiology; however concerns have been raised regarding their long-term safety due to the permanent nature of the polymer. New generation stents with biodegradable polymers (BDS) have recently been developed. The aim of this study was to perform a meta-analysis of randomised controlled trials (RCTs) comparing the safety and efficacy profile of BDS vs. durable polymer DES. Methods and results: The MEDLINE/CENTRAL and Google Scholar databases were searched for RCTs comparing safety and efficacy of BDS vs. DES. Safety endpoints were mortality, myocardial infarction (MI), and stent thrombosis (ST). Efficacy endpoints were target vessel revascularisation (TVR), target lesion revascularisation (TLR) and six-month in-stent late loss (ISLL). The meta-analysis included eight RCTs (n=7,481). At a median follow-up of nine months, as compared to DES, BDS use did not increase mortality (OR [95% CI] = 0.91 [0.69-1.22], p=0.53) or MI (OR [95% CI] = 1.14 [0.90-1.44], p=0.29). Rate of late/very late ST was significantly reduced in BDS patients (OR [95% CI] = 0.60 [0.39-0.91], p=0.02), as was six-month ISLL (mean difference [95% CI] = -0.07 [-0.12; -0.02] mm, p=0.004) in comparison with DES patients. Rates of TVR and TLR were comparable between BDS and DES. Conclusions: BDS are at least as safe as standard DES with regard to survival and MI, and more effective in reducing late ST, as well as six-month ISLL. Further large RCTs with long-term follow-up are warranted to definitively confirm the potential benefits of BDS. © Europa Edition 2011. All rights reserved. Source

Lupi A.,Cardiologia Ospedaliera | Navarese E.P.,Catholic University of the Sacred Heart | Navarese E.P.,Interventional Cardiology Unit | Lazzero M.,Cardiologia Ospedaliera | And 5 more authors.
Circulation Journal | Year: 2011

Background: Evidence supporting the use of drug-eluting stents (DES) in saphenous vein graft (SVG) disease is uncertain. Previous studies have suggested that DES might reduce the re-intervention rate in SVG disease, with conflicting data on mortality. Thus, a meta-analysis was performed to compare outcomes of DES vs. bare metal stent (BMS) in SVG disease. Methods and Results: Medline and Web databases were searched for studies comparing DES and BMS for SVG disease, reporting rates of overall mortality, target vessel revascularization (TVR) and myocardial infarction (MI) with a follow-up of ≥6 months. The meta-analysis included 23 studies (7,090 patients). Compared with BMS, DES-treated patients had lower rates of TVR (odds ratio (OR), 0.53; confidence interval (CI), 0.39-0.72; P<0.0001) and overall mortality (OR, 0.63; CI, 0.40-0.99; P=0.05), but similar rates of MI (OR, 0.92; CI, 0.64-1.33; P=0.7). Subgroup analysis highlighted differences between non-randomized studies, in which DES improved mortality rates, and randomized trials, in which benefit from DES was not evident. Meta-regression analysis showed that DES were more effective in the presence of older grafts and type 2 diabetes. Conclusions: The present meta-analysis showed that, in SVG disease, DES significantly reduced TVR, but did not provide clear benefits on mortality and MI, with an opposite direction of results in mortality observed from randomized and observational data (clinicaltrials.gov identifier: NCT01036048). Source

Navarese E.P.,Nicolaus Copernicus University | De Luca G.,University of Piemonte Orientale | Castriota F.,Interventional Cardio Angiology Unit | Kozinski M.,Nicolaus Copernicus University | And 8 more authors.
Journal of Thrombosis and Haemostasis | Year: 2011

Background: The aim of the current study was to perform two separate meta-analyses of available studies comparing low-molecular-weight heparins (LMWHs) vs. unfractionated heparin (UFH) in ST-elevation myocardial infarction (STEMI) patients treated (i) with primary percutaneous coronary intervention (pPCI) or (ii) with PCI after thrombolysis. Methods: All-cause mortality was the pre-specified primary endpoint and major bleeding complications were recorded as the secondary endpoints. Relative risk (RR) with a 95% confidence interval (CI) and absolute risk reduction (ARR) were chosen as the effect measure. Results: Ten studies comprising 16286 patients were included. The median follow-up was 2months for the primary endpoint. Among LMWHs, enoxaparin was the compound most frequently used. In the pPCI group, LMWHs were associated with a reduction in mortality [RR (95% CI)=0.51 (0.41-0.64), P<0.001, ARR=3%] and major bleeding [RR (95% CI)=0.68 (0.49-0.94), P=0.02, ARR=2.0%] as compared with UFH. Conversely, no clear evidence of benefits with LWMHs was observed in the PCI group after thrombolysis. Meta-regression showed that patients with a higher baseline risk had greater benefits from LMWHs (r=0.72, P=0.02). Conclusions: LMWHs were associated with greater efficacy and safety than UFH in STEMI patients treated with pPCI, with a significant relationship between risk profile and clinical benefits. Based on this meta-analysis, LMWHs may be considered as a preferred anticoagulant among STEMI patients undergoing pPCI. © 2011 International Society on Thrombosis and Haemostasis. Source

Carnelli D.,Polytechnic of Milan | Pennati G.,Polytechnic of Milan | Villa T.,Polytechnic of Milan | Baglioni L.,Polytechnic of Milan | And 2 more authors.
Artificial Organs | Year: 2011

Mechanical properties of carotid stents are important for the selection of the implantable device. The efficacy of cell design is usually investigated on the basis of clinical follow-ups; however, for the specific carotid application the relative importance of the cell design on the stenting outcome is debated. Ideally, a carotid stent should have at the same time low bending stiffness (i.e., high flexibility) to correctly conform to the vessel curvatures in the stenotic region and high stiffness to sustain the vessel wall in the radial direction. In this study, experimental tests on six carotid open-cell design self-expandable stents were carried out to assess bending and radial stiffness. A four-point bending test was adopted to measure the bending stiffness. Radial stiffness was obtained by measuring the stent resistance to local compression in a V-shaped support. Geometrical features, such as the link positioning and their length, were examined as a possible determinant of the mechanical properties of the tested stents. The tested stents showed very different geometrical features and mechanical properties despite similar material and a common open-cell structure consisting in rings connected by roughly straight links. In particular, different strategies are evident regarding the link position. Three distinct behaviors were observed: stents with both low radial and bending stiffness, moderate bending and high radial stiffness, and high bending and moderate radial stiffness. In general, a large link length allows the stent to be more flexible under bending condition, whereas the mutual links positioning plays a key role in the radial stiffness of these devices. Furthermore, for a fixed strut layout, a correlation was found between the strut cross area, as well as metal-to-artery ratio and the resultant radial and bending stiffness. © 2010, the Authors. Artificial Organs © 2010, International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc. Source

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