Laboratory of Interventional Cardiology

Napoli, Italy

Laboratory of Interventional Cardiology

Napoli, Italy
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Rubboli A.,Laboratory of Interventional Cardiology | Agewall S.,University of Oslo | Huber K.,Wilhelminenhospital | Lip G.Y.H.,University of Birmingham
International Journal of Cardiology | Year: 2015

The antithrombotic management of patients on oral anticoagulation (OAC), with either warfarin or non-vitamin K-antagonist oral anticoagulants (NOACs), undergoing percutaneous coronary intervention with stent (PCI-S) has been recently addressed in a joint European consensus document. In accordance, triple therapy (TT) of OAC, aspirin and clopidogrel should generally be given as the initial therapy. More uncertainty exists over whether warfarin or a NOAC should be added in patients already on dual antiplatelet therapy of aspirin and clopidogrel (DAPT) after recent PCI-S. Upon review of available data, it appears that the risk of major bleeding of TT as compared to DAPT is similar with either warfarin or a NOAC. In particular, TT consistently appears associated to an approximately 2.5 fold increase in the risk of major bleeding. Because of the higher convenience, NOACs might be considered the preferred OAC to be added to DAPT. Given the reported different safety profiles of the various NOACs on the incidence of major, and gastrointestinal, bleeding, the NOACs, and the dose, showing the greatest safety in this regard should be selected. In accordance, dabigatran 110 mg and apixaban 2.5 mg twice daily appear as the most valuable options in patients who are not and who are respectively, at increased risk of bleeding. As an alternative, apixaban 5 mg twice daily might be considered in patients at risk of bleeding not increased, whereas rivaroxaban 15 mg once daily may be considered in the presence of increased risk of bleeding (essentially when related to moderate renal impairment). © 2015 Elsevier Ireland Ltd.


Rubboli A.,Laboratory of Interventional Cardiology | Faxon D.P.,Brigham and Women's Hospital | Juhani Airaksinen K.E.,University of Turku | Schlitt A.,Martin Luther University of Halle Wittenberg | And 3 more authors.
Thrombosis and Haemostasis | Year: 2014

Even 10 years after the first appearance in the literature of articles reporting on the management of patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S), this issue is still controversial. Nonetheless, some guidance for the everyday management of this patient subset, accounting for about 5–8% of all patients referred for PCI-S, has been developed. In general, a period of triple therapy (TT) of OAC, with either vitamin K–antagonists (VKA) or non-vitamin K–antagonist oral anticoagulants (NOAC), aspirin, and Clopidogrel is warranted, followed by the combination of OAC, and a single antiplatelet agent for up to 12 months, and then OAC alone. The duration of the initial period of TT is dependent on the individual risk of thromboembolism, and bleeding, as well as the clinical context in which PCI-S is performed (elective vs acute coronary syndrome), and the type of stent implanted (bare-metal vs drug-eluting). In this article, we aim to provide a comprehensive, ata-glance, overview of the management strategies, which are currently suggested for the peri-procedural, medium-term, and long-term periods following PCI-S in OAC patients. While acknowledging that most of the evidence has been obtained from patients on OAC because of atrial fibrillation, and with warfarin being the most frequently used VKA, we refer in this overview to the whole population of OAC patients undergoing PCI-S. We refer to the whole population of patients on OAC undergoing PCI-S also when OAC is carried out with NOAC rather than VKA, pointing out, when appropriate, the particular management issues. © Schattauer 2014


Rubboli A.,Laboratory of Interventional Cardiology | Oldgren J.,Uppsala University | Marin F.,Hospital Universitario Virgen Of La Arrixaca | Lip G.,University of Birmingham
Internal and Emergency Medicine | Year: 2013

Effective secondary prevention after acute coronary syndrome (ACS) is largely dependent on dual antiplatelet therapy (DAPT). Despite DAPT, however, patients remain at substantial risk of major adverse cardiovascular events (i.e., cardiovascular death, myocardial infarction, stroke), and, therefore, combination therapy of oral anticoagulant and antiplatelets has been previously proposed. Because of the increase in bleeding and the cumbersome management of vitamin K antagonists, such combination therapy has never gained much popularity. The recent development of new, non vitamin K antagonists, direct oral anticoagulants (NOACs), including dabigatran, apixaban, rivaroxaban, and darexaban, which have more favorable pharmacokinetics and pharmacodynamics, as well as higher safety, has renewed the interest on combination therapy. Whereas phase II trials with dabigatran, apixaban, rivaroxaban, and darexaban have consistently shown an increased bleeding risk with combination therapy, a potential increased efficacy has emerged for apixaban and rivaroxaban, thereby prompting phase III studies. Both APPRAISE-2 and ATLAS ACS 2-TIMI 51 trials confirm a dose-dependent increase in major bleeding events, including intracranial, with apixaban and rivaroxaban when combined with DAPT. Low-dose (2.5 mg twice daily) rivaroxaban on the other hand, is associated with a significantly higher efficacy on the occurrence of combined cardiovascular death, myocardial infarction, stroke, and of stent thrombosis. Owing to the persistent uncertainty regarding the net clinical benefit of combined therapy of NOAC, namely low-dose (2.5 mg twice daily) rivaroxaban and DAPT of aspirin and clopidogrel, further studies are warranted to identify the ACS patient who will benefit most from such treatment, also in comparison to the current therapeutic standard represented by DAPT of aspirin and ticagrelor (or prasugrel). © 2013 SIMI.


Briguori C.,Laboratory of Interventional Cardiology | Visconti G.,Laboratory of Interventional Cardiology | Ricciardelli B.,Laboratory of Interventional Cardiology | Condorelli G.,University of Naples Federico II
EuroIntervention | Year: 2011

Aims: The combined prophylactic strategy of sodium bicarbonate plus N-acetylsyteine (NAC) seems to be effective in preventing contrast induced acute kidney injury (CI-AKI) in patients at low-to-medium risk. However, in patients at high and very high risk the rate of CI-AKI is still high. In this subset of patients the anticipated advantages of the RenalGuard™ System should be investigated. The RenalGuard™ System (PLC Medical Systems, Inc., Franklin, MA, USA) is a real-time measurement and real time matched fluid replacement device designed to accommodate the RenalGuard therapy, which is based on the theory that creating and maintaining a high urine output is beneficial by allowing a quick elimination of contrast media, and, therefore, reducing its toxic effects. Methods and results: The REMEDIAL II trial is a randomised, multicentre, investigator-sponsored trial addressing the hypothesis that the RenalGuard System is superior to the prophylaxis with sodium bicarbonate infusion plus NAC in preventing CI-AKI in high and very high risk patients. Consecutive patients with chronic kidney disease (CKD) and at high to very high risk for CI-AKI, referred to our institutions for coronary and/or peripheral procedures, will be randomly assigned to 1) prophylactic administration of sodium bicarbonate plus NAC (control group) and 2) RenalGuard System treatment (RenalGuard group). All enrolled patients must have an estimated glomerular filtration rate ≤30 ml/min/1.73 m2 and/or a contrast nephropathy risk score ≥11. In all cases iodixanol (an iso-osmolar, non-ionic contrast agent) will be administered. The primary endpoint is an increase of ≥0.3 mg/dL in the serum creatinine concentration 48 hours after the procedure. Conclusions: The REMEDIAL II trial will give important answers on how to prevent CI-AKI in high and very high risk patients undergoing contrast media exposure. © Europa Edition 2011. All rights reserved.


Briguori C.,Laboratory of Interventional Cardiology | Airoldi F.,Laboratory of Interventional Cardiology IRCCS Multimedica | Visconti G.,Laboratory of Interventional Cardiology | Focaccio A.,Laboratory of Interventional Cardiology | And 5 more authors.
Circulation: Cardiovascular Interventions | Year: 2011

Background-To expand the paucity of data on the efficacy of various drug-eluting stents in diabetic patients. Methods and Results-Type 2 diabetic patients treated in our institution from October 2005 to January 2007 presenting with of de novo lesions in native coronary arteries were randomly assigned to sirolimus-eluting stents (Cypher group; n=76); paclitaxel-eluting stents (Taxus group; n=75); and everolimus-eluting stents (Endeavor group; n=75). Poor metabolic control (HbA1c >7% and low-density lipoprotein cholesterol >100 mg/dL) and microvascular complications (retinopathy and/or nephropathy) were assessed. The primary end point was the 3-year composite of major adverse cardiac events (MACE), including death of any cause, myocardial infarction, and clinically driven target vessel revascularization. MACE-free survival was 86.8% in the Cypher group, 82.5% in the Taxus group, and 64.4% in the Endeavor group (P=0.006 by log-rank test). The post hoc comparisons showed no significant difference between Cypher versus Taxus groups (adjusted P=1.0) but a higher MACE rate in the Endeavor group versus both the Cypher group (adjusted P=0.012) and the Taxus group (adjusted P=0.075). Independent predictors of 3-year MACE at Cox analysis were treatment by Endeavor versus Cypher stent (2.35 [95% confidence interval, 1.07 to 5.41]; P=0.030), multivessel disease (hazard ratio, 1.78 [95% confidence interval, 1.06 to 2.66]; P=0.031), diabetic retinopathy (hazard ratio, 1.60; [95% confidence interval, 1.03 to 2.76]; P=0.038), and poor metabolic control (hazard ratio, 1.60; [95% confidence interval, 1.02 to 2.52]; P=0.048). Conclusions-The present pilot study suggests that in diabetic patients, the Endeavor stent is associated with a higher 3-year MACE rate when compared with Cypher and Taxus stents. Copyright © 2011 American Heart Association. All rights reserved.


Briguori C.,Laboratory of Interventional Cardiology | Visconti G.,Laboratory of Interventional Cardiology | Focaccio A.,Laboratory of Interventional Cardiology | Airoldi F.,Laboratory of Interventional Cardiology IRCCS Multimedica | And 5 more authors.
Circulation | Year: 2011

Background-: The RenalGuard System, which creates high urine output and fluid balancing, may be beneficial in preventing contrast-induced acute kidney injury. Methods and Results-: The Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II) trial is a randomized, multicenter, investigator-driven trial addressing the prevention of contrast-induced acute kidney injury in high-risk patients. Patients with an estimated glomerular filtration rate ≤30 mL • min • 1.73 m and/or a risk score ≥11 were randomly assigned to sodium bicarbonate solution and N-acetylcysteine (control group) or hydration with saline and N-acetylcysteine controlled by the RenalGuard System and furosemide (RenalGuard group). The primary end point was an increase of ≥0.3 mg/dL in the serum creatinine concentration at 48 hours after the procedure. The secondary end points included serum cystatin C kinetics and rate of in-hospital dialysis. Contrast-induced acute kidney injury occurred in 16 of 146 patients in the RenalGuard group (11%) and in 30 of 146 patients in the control group (20.5%; odds ratio, 0.47; 95% confidence interval, 0.24 to 0.92). There were 142 patients (48.5%) with an estimated glomerular filtration rate ≤30 mL • min • 1.73 and 149 patients (51.5%) with only a risk score ≥11. Subgroup analysis according to inclusion criteria showed a similarly lower risk of adverse events (estimated glomerular filtration rate ≤30 mL • min • 1.73 m: odds ratio, 0.44; risk score ≥11: odds ratio, 0.45; P for interaction=0.97). Changes in cystatin C at 24 hours (0.02±0.32 versus-0.08±0.26; P=0.002) and 48 hours (0.12±0.42 versus 0.03±0.31; P=0.001) and the rate of in-hospital dialysis (4.1% versus 0.7%; P=0.056) were higher in the control group. Conclusion-: RenalGuard therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury in high-risk patients. © 2011 American Heart Association. All rights reserved.


Briguori C.,Laboratory of Interventional Cardiology | Briguori C.,Vita-Salute San Raffaele University | Visconti G.,Laboratory of Interventional Cardiology | Rivera N.V.,Instituto Ricovero e Cura A Carattere Scientifico Multimedica | And 8 more authors.
Circulation | Year: 2010

BACKGROUND-: Cystatin C (CyC) is more sensitive than serum creatinine (sCr) to rapidly detect acute changes in renal function. METHODS AND RESULTS-: We measured CyC together with sCr in 410 consecutive patients with chronic kidney disease undergoing either coronary and/or peripheral angiography and/or angioplasty. sCr was assessed at baseline and 24 and 48 hours after contrast media exposure. CyC was assessed at baseline and at 24 hours. Major adverse events (including death of any cause and dialysis) at 12 months were assessed. At 48 hours after contrast media exposure, contrast-induced acute kidney injury (defined as a sCr increase >0.3 mg/dL) occurred in 34 patients (8.2%). A CyC increase concentration >10% at 24 hours after contrast media exposure was detected in 87 patients (21.2%). This was the best CyC cutoff for the early identification of patients at risk for contrast-induced acute kidney injury (negative predictive value=100%; positive predictive value=39.1%). According to the defined cutoffs (that is, increase in CyC >0% and sCr >0.3 mg/dL), major adverse events occurred in 16 of 297 patients (5.4%) without any cutoffs satisfied (group 1), in 9 of 49 patients (18.4%) with only a CyC increase >10% (group 2), and in 9 of 31 patients (29%) with both cutoffs satisfied (group 3). By logistic regression analysis, the independent predictors of major adverse events at 1 year were group 2 (odds ratio=2.52; 95% confidence interval, 1.17 to 5.41; P=0.02), group 3 (odds ratio=4.45; 95% confidence interval, 1.72 to 11.54; P=0.002), and baseline glomerular filtration rate (odds ratio=0.91; 95% confidence interval, 0.88 to 0.95; P<0.001). CONCLUSIONS-: In patients with chronic kidney disease, CyC seems to be a reliable marker for the early diagnosis and prognosis of contrast-induced acute kidney injury. © 2010 American Heart Association, Inc.


Briguori C.,Laboratory of Interventional Cardiology | Quintavalle C.,CNR Institute of Neuroscience | De Micco F.,IRCCS Multimedica | Condorelli G.,Fondazione SDN
Archives of Toxicology | Year: 2011

Contrast-induced acute kidney injury (CI-AKI) accounts for approximately 10% of all causes of hospital-acquired renal failure, causes a prolonged in-hospital stay, and represents a powerful predictor of poor early and late outcome. N-acetylcysteine (NAC) is a thiol compound classically known as a mucolytic agent, which is a potent antioxidant that scavenges a wide variety of oxygen-derived-free-radicals and may be capable of preventing acute kidney injury. In the present study, we will review (1) the pathophysiology of the CI-AKI and (2) the experimental and clinical data on the effects of NAC in preventing CI-AKI. © 2010 Springer-Verlag.


Visconti G.,Laboratory of Interventional Cardiology | Marino L.,Clinica Mediterranea | Briguori C.,Laboratory of Interventional Cardiology
Catheterization and Cardiovascular Interventions | Year: 2014

Management of patient with concomitant severe coronary and carotid artery disease is challenging. The combined or staged surgical revascularization is burdened by a high risk of morbidity and mortality. Carotid artery stenting (CAS) has been recently introduced as an alternative revascularization approach. We describe a case of simultaneous hybrid revascularization by CAS followed by immediate coronary artery bypass graft in a patient with a severe coronary artery disease and bilateral carotid artery stenosis. Copyright © 2013 Wiley Periodicals, Inc.


Rubboli A.,Laboratory of Interventional Cardiology
Current Medical Research and Opinion | Year: 2015

Once daily dosing schedule is associated with increased adherence to and persistence with cardiovascular therapies. Such feature has been claimed responsible for the significantly lower (both temporary and permanent) discontinuation of oral anticoagulation with rivaroxaban (which is given once daily) compared to dabigatran (which is given twice daily) in a large, real-world dataset of patients with atrial fibrillation (AF) in the United States. While a cause-effect relationship between dosing schedule and adherence and persistence could not be established, the above finding supports nonetheless the preferential selection of the non vitamin-K-antagonists oral anticoagulant (NOAC) with the easiest and most convenient regimen. Given however, the differences in efficacy and safety observed with the various NOACs compared to warfarin in the phase III clinical trials in non-valvular AF, careful individualization of treatment should be pursued, being dosing schedule only one of the variables to be taken into account. Maximal effort instead, should be put in implementing measures to enhance patient's adherence to and persistence with treatment. © 2015 Taylor & Francis.

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