Showing papers by "Gennaro Sardella published in 2017"
TL;DR: Compared to femoral access, radial access is associated with greater operator and patient radiation exposure when performed by expert operators in current practice and Radial operators and institutions should be sensitized towards radiation risks and adopt adjunctive radioprotective measures.
58 citations
TL;DR: Radial as compared with femoral access provided consistent benefit across the whole spectrum of patients with ACS, without evidence that type of presenting syndrome affected the results of the random access allocation.
Abstract: Aims
To assess whether radial compared with femoral access is associated with consistent outcomes in patients with ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation acute coronary syndrome (NSTE-ACS).
Methods and results
In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) programme patients were randomized to radial or femoral access, stratified by STEMI (2001 radial, 2009 femoral) and NSTE-ACS (2196 radial, 2198 femoral). The 30-day co-primary outcomes were major adverse cardiovascular events (MACE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACE or major bleeding In the overall study population, radial access reduced the NACE but not MACE endpoint at the prespecified 0.025 alpha. MACE occurred in 121 (6.1%) STEMI patients with radial access vs. 126 (6.3%) patients with femoral access [rate ratio (RR) = 0.96, 95% CI = 0.75-1.24; P = 0.76] and in 248 (11.3%) NSTE-ACS patients with radial access vs. 303 (13.9%) with femoral access (RR = 0.80, 95% CI = 0.67-0.96; P = 0.016) (Pint = 0.25). NACE occurred in 142 (7.2%) STEMI patients with radial access and in 165 (8.3%) patients with femoral access (RR = 0.86, 95% CI = 0.68-1.08; P = 0.18) and in 268 (12.2%) NSTE-ACS patients with radial access compared with 321 (14.7%) with femoral access (RR = 0.82, 95% CI = 0.69-0.97; P = 0.023) (Pint = 0.76). All-cause mortality and access site-actionable bleeding favoured radial access irrespective of ACS type (Pint = 0.11 and Pint = 0.36, respectively).
Conclusion
Radial as compared with femoral access provided consistent benefit across the whole spectrum of patients with ACS, without evidence that type of presenting syndrome affected the results of the random access allocation.
51 citations
TL;DR: An OCT‐guided approach reduced the number of stents used, number of patients treated with more than one stent, while there was no statistically significant difference in clinical endpoints while most of them were numerically lower, including stent thrombosis rates.
Abstract: AIM To determine the potential clinical impact of OCT (Optical Coherence Tomography) during primary percutaneous coronary intervention in patients presenting with ACS (Acute Coronary Syndrome). METHODS AND RESULTS FORMIDABLE is a multicentre retrospective registry enrolling all patients presenting with ACS and treated with an OCT-guided approach, while the USZ registry enrolled patients treated with a standard angiography guided approach. Multivariate adjustment was performed via a propensity score matching. The number stents useds was the primary outcome, while the incidence of MACE (a composite of death, myocardial infarction, target vessel revascularization, and stent thrombosis) was the secondary endpoint. A total of 285 patients OCT-guided and 1,547 angiography guided patients were enrolled, resulting in 270 for each cohort after propensity score with matching. Two stents were used in 12% versus 34%; 3 stents in 8% versus 38% of the patients (P < 0.001). After a follow up of 700 days (450-890), there was no difference in myocardial infarction (6% vs. 6%, P = 0.86), while MACE (11% vs. 16%, P = 0.06), target vessel revascularization (2% vs. 4%, P = 0.15) and stent thrombosis rates (0% vs. 2.7%, P = 0.26) were numerically lower for the OCT-guided cohort but none of these endpoints did reach statistical significance. CONCLUSIONS An OCT-guided approach reduced the number of stents used, number of patients treated with more than one stent, while there was no statistically significant difference in clinical endpoints while most of them were numerically lower, including stent thrombosis rates. © 2016 Wiley Periodicals, Inc.
24 citations
TL;DR: According to the RISPEVA results, the Italian uptake of TAVI is steady, with evident trends toward less invasive approaches and fitter patients.
Abstract: AIMS Clinical trials have shown that transcatheter aortic valve implantation for aortic stenosis compares favorably to surgical replacement in high-risk patients and is superior to medical therapy in those at prohibitive risk. There is uncertainty however on patterns and trends in transcatheter aortic valve implantation, especially focusing on Italy. METHODS The RISPEVA study is a prospective Italian registry including 21 institutions. Patients have been enrolled since late 2012, and data collection includes several baseline, procedural, in-hospital, and follow-up details. For the present analysis on patterns and trends, we focused on patients enrolled between 2012 and 2015, and as primary variable on the prevalence of high versus prohibitive surgical risk, limiting our scope to procedural outcomes. RESULTS A total of 1157 patients were included. The temporal breakdown was 376 (33%) patients enrolled in 2013, 408 (35%) in 2014, and 373 (32%) in 2015. Several patient features differed over time, including risk score, peripheral artery disease, end-stage pulmonary disease, and prior valvuloplasty (all P < 0.05). Several procedural features differed significantly over time, including sheath size, use of general anesthesia, Prostar closure device, predilation, antiembolic device, new TAVI device, and multiple prostheses (all P < 0.05). No significant temporal differences were found for major clinical outcomes, whereas the occurrence of moderate or severe postprocedural regurgitation and pacemaker dependency decreased over the years (both P < 0.05). CONCLUSION According to the RISPEVA results, the Italian uptake of TAVI is steady, with evident trends toward less invasive approaches and fitter patients.
23 citations
TL;DR: A low CD4+ cell count is associated with long cQT independently from HAART in HIV-positive patients and may be useful to correctly stratify arrhythmic risk in these patients.
Abstract: AIMS HIV and highly active antiretroviral therapy (HAART) may affect cardiac conduction, and a higher incidence of sudden death has been recognized in HIV-positive patients. Nevertheless, predictors of prolonged corrected QT interval (cQT) have been poorly described. The aim of the study was to investigate the prevalence and predictors of long cQT in a cohort of HIV-positive patients. METHODS Consecutive HIV-positive patients followed in a primary prevention clinic at two Italian institutions were retrospectively enrolled. A 12-lead ECG was recorded in all patients; main clinical features were collected. Prevalence of long cQT (defined as cQT >470 ms in women and >450 ms in men) was the primary end-point. Secondary end-points were the identification of predictors of cQT prolongation, and the association between HAART and HIV-related features with long cQT. RESULTS Three hundred and fifty-one HIV-positive patients were included, 26 (7.4%) with long cQT. Mean age was higher among those with long cQT (51.6 vs. 57.6 years; P = 0.007). A higher prevalence of long cQT was reported for patients with a CD4+ cell count below 200 cells/μl at the moment of ECG (60 vs. 24.2%; P = 0.002) and with a nadir of CD4+ cell count below 200 cells/μl (91.3 vs. 58.6%; P = 0.001). At multivariate analysis, only the nadir of CD4+ cell count below 200 cells/μl consistently related to the presence of long cQT (odds ratio 5.8, 95% confidence interval 1.3-26.4). CONCLUSION A low CD4+ cell count is associated with long cQT independently from HAART in HIV-positive patients and may be useful to correctly stratify arrhythmic risk in these patients.
19 citations
TL;DR: It is shown that RA followed by stent implantation in patients with heavily calcified ULM narrowing is feasible and associated with good in-hospital results, and procedural aspects (relatively low intravascular ultrasound guidance) may affect the worse subacute mid-term prognosis in the more complex ULM group.
Abstract: Heavily calcified unprotected left main (ULM) disease continues to be a challenging situation and represent a high-risk subset for interventional cardiologist. To date, there are limited data investigating the results after rotational atherectomy (RA) in this setting. The aim of this study was to investigate the in-hospital and 1-year outcomes after RA of heavily calcified ULM lesions. A retrospective cohort analysis was performed on all calcified patients with ULM (n = 86) enrolled in the multicenter international ROTATE registry (overall patients, n = 962). End points of the study were the in-hospital and 1-year incidence of major adverse cardiovascular events (MACE): a composite of death, myocardial infarction, and target-vessel revascularization in the ULM versus non-ULM group. Patients in the ULM group were older (p = 0.01) and more frequently with diabetes (p = 0.001) compared with the non-ULM group, whereas intravascular ultrasound guidance was higher, even if not systematic, in the ULM group (p
18 citations
TL;DR: This matched-cohort study suggests that PF-AES has better safety and efficacy profile than BD-BES in patients with DM.
18 citations
TL;DR: The present report suggests the feasibility of BVS implantation in complex CTO lesions, given adequate lesion preparation and post-dilatation, with good acute angiographic results and midterm clinical outcomes.
Abstract: AIMS: Bioresorbable vascular scaffolds (BVS) represent a novel therapeutic option for the treatment of coronary artery diseases. The objective of this study was to evaluate the feasibility of BVS implantation in complex chronic total occlusions (CTO). METHODS AND RESULTS: The present report is a multicentre registry evaluating results after BVS deployment in challenging CTO lesions, defined as J-CTO score >/=2 (difficult or very difficult). A total of 105 patients were included in the present analysis. The mean J-CTO score was 2.61 (difficult 52.4%, very difficult 47.6%). Device success and procedural success rates were 98.1% and 97.1%, respectively. The retrograde approach was used in 25.7% of cases. After wire crossing, predilatation was performed in all cases with a mean predilatation balloon diameter of 2.73+/-0.43 mm. The mean scaffold length was 59.75+/-25.85 mm, with post-dilatation performed in 89.5% of the cases and a mean post-dilatation balloon diameter of 3.35+/-0.44 mm. Post-PCI minimal lumen diameter was 2.50+/-0.51 mm and percentage diameter stenosis 14.53+/-10.31%. At six-month follow-up, a total of three events were reported: one periprocedural myocardial infarction, one late scaffold thrombosis and one additional target lesion revascularisation. CONCLUSIONS: The present report suggests the feasibility of BVS implantation in complex CTO lesions, given adequate lesion preparation and post-dilatation, with good acute angiographic results and midterm clinical outcomes.
17 citations
TL;DR: The RESET 2D trial was a prospective, randomized, pharmacodynamic study evaluating platelet inhibition by loading dose (LD) of ticagrelor or prasugrel in P2Y12-naive patients with diabetes mellitus presenting with STEMI.
Abstract: Prasugrel or ticagrelor is recommended in patients with ST-segment–elevation myocardial infarction (STEMI). Patients with diabetes mellitus are characterized by enhanced platelet reactivity (PR) and a reduced response to oral antiplatelet agents.1
The RESET 2D trial (Prasugrel vs Ticagrelor in ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus) was a prospective, randomized, pharmacodynamic study evaluating platelet inhibition by loading dose (LD) of ticagrelor or prasugrel in P2Y12-naive patients with diabetes mellitus presenting with STEMI. The local ethics committee approved the study (ClinicalTrials.gov NCT01531114).
All consecutive patients with STEMI with diabetes mellitus undergoing primary percutaneous coronary intervention who were P2Y12 naive were considered for PR assessment. Major exclusion criteria were bleeding diathesis, periprocedural glycoprotein IIb/IIIa receptor inhibitor use, morphine administration, previous ischemic/hemorrhagic stroke, and any contraindication to antiplatelet therapy. Eligible patients were randomized 1:1 to receive ticagrelor 180-mg LD or prasugrel 60-mg LD at the time of percutaneous coronary intervention. All patients received oral aspirin 325 mg and intravenous unfractionated heparin (70 U/kg). Platelet function testing was performed with VerifyNow (Accumetrics, San Diego, CA) at baseline and …
11 citations
TL;DR: An OCT based approach in ACS patients offers a reduction in TLR when compared to a PCI-FFR driven, and these findings should be confirmed in randomized controlled trial.
9 citations
TL;DR: To compare the safety and efficacy of the Axxess™ biolimus‐eluting stent with the second‐generation drug‐eluted stent (DES) in the treatment of bifurcation lesions.
Abstract: OBJECTIVES To compare the safety and efficacy of the Axxess™ biolimus-eluting stent with the second-generation drug-eluting stent (DES) in the treatment of bifurcation lesions. BACKGROUND The Axxess™ is a dedicated bifurcation stent, designed to cover the lesion at the carina level. METHODS Between April 2012 and August 2014, 165 patients with de novo bifurcation lesions were treated with the Axxess™ stent (Axxess group). A propensity-score matched group of 165 patients treated with DES in the same period was selected (Control group). The primary objectives were (1) the procedural complication rate, including side branch (SB) occlusion and trouble in SB access after main vessel stenting; and (2) the device, the angiographic, and the procedural success rate. RESULTS Procedural complications occurred in 1 patient (0.6%) in the Axxess group and in 20 patients (12%) in the Control group (OR = 0.03; 95% confidence interval 0.005-0.27; P < 0.001). Device success was obtained in 164 (99.5%) patients in the Axxess group and in all in the Control group (P = 1.00). Angiographic success was obtained in all patients. Inaccurate Axxess™ stent position occurred in 21 (13%) patients, and was more often associated with moderate-to-severe calcifications and distal lesion site. Procedural success was obtained in 91.5% patients in the Axxess group and in 90% patients in the Control group (P = 0.72). CONCLUSIONS The present registry suggests that the Axxess™ stent (1) may represent a valid alternative approach for the treatment of bifurcation lesions and (2) should be avoided in moderate-to-severe calcifications and/or in distal lesions. © 2016 Wiley Periodicals, Inc.
TL;DR: The Cre8™ (Alvimedica) drug-eluting stent (DES) as discussed by the authors has unique features that may improve clinical outcomes in patients with diabetes, such as abluminal reservoir technology, a proprietary polymer-free drug-release system consisting of reservoirs on the stent's outer surface that control and direct drug release exclusively towards the vessel wall, and Amphilimus™ formulation, which enables enhanced drug tissue permeation, utilising fatty acid transport pathways.
Abstract: Patients with diabetes have poor outcomes compared to the general patient population when undergoing percutaneous coronary intervention The Cre8™ (Alvimedica) drug-eluting stent (DES) has unique features that may improve clinical outcomes in patients with diabetes These include abluminal reservoir technology, a proprietary polymer-free drug-release system consisting of reservoirs on the stent's outer surface that control and direct drug release exclusively towards the vessel wall, and the Amphilimus™ formulation, which enables enhanced drug tissue permeation, utilising fatty acid transport pathways This is particularly advantageous in diabetic patients, since increased uptake of fatty acid occurs in diabetic cells Furthermore, mTOR inhibitors (-limus drugs), which are utilised in DESs, are relatively ineffective in diabetic cells Clinical efficacy and safety of the Cre8™ in patients with diabetes has been demonstrated in a number of clinical trials and real-world studies, and further studies are on-going
TL;DR: The number of PCIs performed in Italy has steadily grown over the last decade, and was driven by a striking increase in the number of PPCIs for patients with acute myocardial infarction, which was higher in northern Italy than in central or southern Italy.
Abstract: AimsTo study the trends in the use of percutaneous coronary interventions (PCIs) in Italy between 2005 and 2014.MethodsPublicly available data were obtained from the Italian Society of Invasive Cardiology (GISE), which organizes an annual audit of public and private cardiac catheterization laborator
TL;DR: New-generation S-EES with a bioresorbable polymer coating appear to be safe and effective irrespective of patient complexity as compared to X-E ESPs with a durable polymer coating.
Abstract: Aims The aim of this study was to evaluate the safety and efficacy profile of new-generation, SYNERGY everolimus-eluting stents (S-EES) as compared to XIENCE everolimus-eluting stents (X-EES) with a durable polymer coating in "complex patients". Methods and results We included 2,001 consecutive patients treated with S-EES (n=400) or X-EES (n=1,601) at two Italian centres between May 2013 and May 2015. We used propensity score matching to obtain two cohorts of patients with similar baseline risk profiles. Patients were stratified according to baseline complexity based on the EVOLVE II trial exclusion criteria. The primary outcome was major adverse cardiac events (MACE), defined as the composite of all-cause death, myocardial infarction (MI), and target lesion revascularisation (TLR), at one year. Among 391 matched pairs of patients treated with S-EES or X-EES, we identified 253 (63%) as complex. At one-year follow-up, among "complex" patients, MACE rates did not differ between the S-EES and X-EES groups (9.9% vs. 9.5%, p=0.830, HR 1.04, CI: 0.72-1.48). Similarly, death, MI, and TLR, stratified for complexity, were comparable between S-EES and X-EES treated patients at one year. Of note, no definite ST was observed in either the S-EES or the X-EES cohort. Conclusions New-generation S-EES with a bioresorbable polymer coating appear to be safe and effective irrespective of patient complexity as compared to X-EES.
TL;DR: This work sought to compare outcomes by valve [balloon expandable or non‐BE] and anticoagulant [bivalirudin vs. unfractionated heparin (UFH)] type from the BRAVO‐3 trial.
Abstract: Background: Selection of valve and procedural anticoagulant type may impact bleeding and vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We sought to compare outcomes by valve [balloon expandable (BE) or non-BE] and anticoagulant [bivalirudin vs. unfractionated heparin (UFH)] type from the BRAVO-3 trial.
Methods: BRAVO-3 was a randomized multicenter trial included 500 BE-TAVR and 282 non-BE TAVR patients, randomized to bivalirudin vs. UFH. Selection of valve type was at the discretion of the operator and randomization was stratified according to device type. Total follow up was to 30 days. We examined the incidence of Bleeding Academic Research Consortium (BARC) type ≥3b bleeding, major vascular complications and all ischemic outcomes at 30-days. Outcomes were adjusted using logistic regression analysis.
Results: Of the trial cohort treated, 63.9% were treated with BE valves (n=251 bivalirudin vs. n=249 UFH) and 36.1% with non-BE valves (n=140 bivalirudin vs. n=142 UFH). Patients treated with non-BE valves were older, with higher euroSCORE I. At 30 days, there were non-significant differences between the two valve types with a trend for higher adjusted risk of all-cause mortality (HR 2.07, 95% CI 0.91-4.70, p = 0.084) and major vascular complications (HR 1.78, 95% CI 0.97-3.26, p = 0.062) with non-BE compared to BE valves. A significant interaction was observed between valve and anticoagulant type, with lower risk of major vascular complications with bivalirudin compared to UFH in non-BE TAVR (p-interaction = 0.039).
Conclusions: Majority of patients in the BRAVO 3 trial received BE valves. At 30-days, there were non-significant differences with a tendency for greater death and major vascular complications with non-BE vs. BE valves. A significant interaction was observed between valve type and procedural anticoagulant for lower risk of major vascular complications with bivalirudin versus UFH in non-BE TAVR. This article is protected by copyright. All rights reserved.
TL;DR: RSD is associated to a significant reduction of plasma ET-1 levels, representing an useful tool into reduction of BP in RHT patients, and showed a possible physio-pathological role ofET-1.
Abstract: Introduction: Resistant arterial hypertension (RHT) is defined as poor controlled blood pressure (BP) despite optimal doses of three or more antihypertensive agents, including a diuretic. In the de...