Alessandro Petrolini - Academia.edu (original) (raw)

Papers by Alessandro Petrolini

Research paper thumbnail of Acute Pseudoaneurysm Following Carotid Artery Stenting

JACC: Cardiovascular Interventions, 2017

Research paper thumbnail of Abstract 21544: Long-Term Outcome of Provisional Side-Branch T-Stenting for the Treatment of Unprotected Distal Left Main Coronary Artery Diseas

Circulation, Nov 23, 2010

Research paper thumbnail of Optical coherence tomography for characterization of cardiac allograft vasculopathy in late survivors of pediatric heart transplantation

The Journal of Heart and Lung Transplantation, 2016

Optical coherence tomography (OCT) has been shown to reliably detect cardiac allograft vasculopat... more Optical coherence tomography (OCT) has been shown to reliably detect cardiac allograft vasculopathy (CAV). In recent studies performed in adult heart transplant (HTx) recipients, OCT revealed the presence of vulnerable plaques and complicated coronary artery lesions, thus challenging the current concept that CAV disease is a diffuse concentric and fibrosing vasculopathy. The aim of our study was to characterize CAV by OCT in a young population of HTx recipients. We prospectively enrolled 21 young HTx recipients (mean age 27 years, range 22 to 38 years) to undergo OCT of the left anterior descending coronary artery (LAD) in addition to annual CAV screening by coronary angiography and virtual histology intravascular ultrasound (VH-IVUS). Quantitative OCT analysis was performed at the site of maximal intimal thickness (MIT) for each LAD segment. Patients were 27 years old with a mean time from cardiac transplantation of 14.7 ± 6.8 years. All patients exhibited intimal hyperplasia with an abnormal (>1) intima-to-media ratio. The median (interquartile range) MIT values by OCT were 0.37 (0.22 to 0.54) mm, 0.46 (0.29 to 0.54) mm and 0.34 (0.25 to 0.49) mm in the distal, middle and proximal LAD segments, respectively. Qualitative OCT analysis rarely showed features of vulnerable plaque or complicated lesions. Consistently, at VH-IVUS, the prevalent component at the site of MIT per vessel assessed by OCT was fibrous tissue. Unlike recent evidence in adult HTx recipients, OCT findings of vulnerable plaque and complicated coronary lesions were found to be rare among late survivors of pediatric HTx.

Research paper thumbnail of Clinical relevance of apoptosis in early and late post-infarction left ventricular remodeling

Italian heart journal : official journal of the Italian Federation of Cardiology, 2002

Apoptosis may represent an important pathophysiological mechanism causing progressive myocardiocy... more Apoptosis may represent an important pathophysiological mechanism causing progressive myocardiocyte loss and left ventricular dilation, even late after acute myocardial infarction (AMI). This review discusses the role of myocardial apoptosis on the basis of findings from experimental studies in animals and from observational studies in humans with the purpose of assessing the clinical relevance, determinants and mechanisms of myocardial apoptosis and the potential therapeutic implications. A more profound understanding of the impact of myocardiocyte loss on prognosis and of the mechanisms involved may lead to an improved understanding of cardiac remodeling and possibly to an improved patient care. In fact, among the potential modulators of myocardial apoptosis, angiotensin-converting enzyme inhibitors and beta-adrenergic receptor blockers have already been shown to improve the prognosis and symptoms in patients with post-infarction heart failure, and a reduction in myocardial apopto...

Research paper thumbnail of Benefits on coronary restenosis from elective paclitaxel-eluting stent implantation in patients aged 75 years and older

Journal of Cardiovascular Medicine, 2007

Elderly patients are increasingly referred for revascularisation yet have been underrepresented i... more Elderly patients are increasingly referred for revascularisation yet have been underrepresented in some large clinical trials. Although the advent of drug-eluting stents has dramatically reduced clinical events related to restenosis, older age remains one of the most important correlates of adverse outcome, even after an elective percutaneous coronary intervention (PCI). We sought to evaluate the impact of paclitaxel-eluting stents on coronary restenosis in elderly patients undergoing elective PCI. Patients undergoing successful elective PCI with stenting of de novo coronary artery lesions were identified and screened for participation in this study. All patients included in our analysis were divided into two cohort groups: patients aged <75 years (younger cohort) and patients aged >or=75 years (elderly cohort). We evaluated the six-month incidence of target lesion revascularisation (TLR) and major adverse cardiac events, which included TLR, death and myocardial infarction. A total of 171 (58 aged >or=75 years) consecutive patients were enrolled in the study. At six months, TLR rate was similar in both groups [1.77 vs. 1.72%, odds ratio (OR) 0.97, 95% confidence interval (CI) 0.08-10.9, P = 0.98, in the younger and elderly group, respectively]. Even the rate of major adverse cardiac events was comparable between the two groups (7.96 vs. 8.62%, OR 1.09, 95% CI 0.34-3.41, P = 0.88, in the younger and elderly group, respectively). Also the angiographic restenosis rates were comparable between patients <75 or >or=75 years (4.42 vs. 3.46%, P = 0.76). After elective paclitaxel-eluting stent implantation, there is no difference in coronary restenosis in younger and elderly patients, suggesting an age-independent efficacy.

Research paper thumbnail of One-year outcome from an all-comers population of patients with ST-segment elevation myocardial infarction treated with biolimus-eluting stent with biodegradable polymer

Catheterization and Cardiovascular Interventions, 2014

Objectives: To evaluate the performance of biolimus-eluting stent (BES) in patients with ST-eleva... more Objectives: To evaluate the performance of biolimus-eluting stent (BES) in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) in a real world clinical scenario. Background: Randomized studies suggest that the BES with biodegradable polymer is more effective and safe than early generation coronary stents in patients with STEMI. Methods: We included all consecutive STEMI patients undergoing PCI in this prospective, multicenter registry. The primary endpoint of the study was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction and ischemia-driven target vessel revascularization at 1-year follow-up. Results: Between June and December 2012 we enrolled 311 STEMI patients. The primary endpoint occurred in 3.2% (95% confidence interval: 1.6-5.8) of patients: cardiac death, re-infarction, and ischemiadriven TVR occurred in 2.3%, 1.3%, and 0.6% of patients, respectively. One-year MACE-free survival was 96.8% 6 1.0%. Conclusions: In a real-world cohort of STEMI patients undergoing PCI, the use of BES is associated with good 1-year clinical outcome. These results confirm and expand previous findings showing the efficacy and safety of BES in the setting of randomized trials. V

Research paper thumbnail of Rationale and design of the Randomized comparison of XiEnce V and Multilink VisioN coronary stents in the sAme muLtivessel patient with chronic kiDnEy disease (RENAL-DES) study

Journal of Cardiovascular Medicine, 2010

Background Percutaneous coronary intervention with bare metal stents (BMS) in patients with chron... more Background Percutaneous coronary intervention with bare metal stents (BMS) in patients with chronic kidney disease (CKD) has shown suboptimal results. Drug-eluting stents (DESs) might reduce the incidence of restenosis and therefore of target lesion revascularization in these patients. Of note, in patients with CKD, multiple concomitant individual variables may be responsible for neointimal hyperplasia after coronary stenting, thus making the comparison of BMS and DES in different patient groups difficult. Study design The RENAL-DES is a prospective, randomized, multicenter, not-sponsored study to directly compare the efficacy in the prevention of clinical restenosis, of everolimus-eluting stent (Xience V) and BMS with identical design (Multilink Vision), both implanted in the same patient with multivessel coronary artery disease and CKD in order to obviate the multiple and unpredictable baseline differences. The primary endpoint of the study is 9month ischemia-driven target vessel revascularization. Sample size The expected primary endpoint rates are 20% for BMS and 10% for DES. According to these estimates, with a significant level of 0.05, a sample size of 194 patients provides an 80% statistical power. Assuming a 10% dropout rate, the goal is to enroll 213 patients (426 treated vessels) from five Italian centers. As 20% of the patients will likely require stent implantation in three vessels, approximately 500 treated vessels will be analyzed. Conclusion This intraindividual, randomized study will provide, for the first time, data on the efficacy, in the prevention of clinical restenosis, of DES compared to BMS in patients with multivessel coronary artery disease and CKD (ClinicalTrials.gov Identifier: NCT 00818792).

Research paper thumbnail of High-risk clinical features predict enhanced post-infarction myocardial apoptosis and the need to achieve infarct-related artery patency

Journal of the American College of Cardiology, 2003

Research paper thumbnail of Hypoxia inducible factor-1 expression mediates myocardial response to ischemia late after acute myocardial infarction

International Journal of Cardiology, 2005

Research paper thumbnail of Reduced post-infarction myocardial apoptosis in women: a clue to their different clinical course?

Research paper thumbnail of Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study

European Heart Journal, 2014

Aims We evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbab... more Aims We evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds (BVS) for the treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI). Methods and results The present investigation is a prospective, single-arm, single-centre study, reporting data after the BVS implantation in STEMI patients. Quantitative coronary angiography and optical coherence tomography (OCT) data were evaluated. Clinical outcomes are reported at the 30-day follow-up. The intent-to-treat population comprises a total of 49 patients. The procedural success was 97.9%. Pre-procedure TIMI-flow was 0 in 50.0% of the patients; after the BVS implantation, a TIMIflow III was achieved in 91.7% of patients and the post-procedure percentage diameter stenosis was 14.7 + 8.2%. No patients had angiographically visible residual thrombus at the end of the procedure. Optical coherence tomography analysis performed in 31 patients showed that the post-procedure mean lumen area was 8.02 + 1.92 mm 2 , minimum lumen area 5.95 + 1.61 mm 2 , mean incomplete scaffold apposition area 0.118 + 0.162 mm 2 , mean intraluminal defect area 0.013 + 0.017 mm 2 , and mean percentage malapposed struts per patient 2.80 + 3.90%. Scaffolds with .5% malapposed struts were 7. At the 30-day follow-up, target-lesion failure rate was 0%. Non-target-vessel revascularization and targetvessel myocardial infarction (MI) were reported. A non-target-vessel non-Q-wave MI occurred. No cases of cardiac death or scaffold thrombosis were observed. Conclusion In the present series, the BVS implantation in patients presenting with acute MI appeared feasible, with high rate of final TIMI-flow III and good scaffold apposition. Larger studies are currently needed to confirm these preliminary data.

Research paper thumbnail of Infarct-related artery occlusion, tissue markers of ischaemia, and increased apoptosis in the peri-infarct viable myocardium

European Heart Journal, 2005

Unfavourable cardiac remodelling often complicates acute myocardial infarction (AMI) as a result ... more Unfavourable cardiac remodelling often complicates acute myocardial infarction (AMI) as a result of increased cardiomyocyte apoptosis. It is currently unclear whether ongoing or recurrent ischaemia is an independent determinant for increased apoptosis in peri-infarct viable myocardium. Methods and results In order to assess the link between infarct-related artery (IRA) occlusion, ischaemia, and apoptosis, 30 subjects dying 7-120 days after AMI (16 with IRA occlusion and 14 with patent IRA) and five control subjects were selected at autopsy. Cardiomyocytes were defined as apoptotic if co-expressing TUNEL and activated caspase-3. Expression of both hypoxia-inducible factor-1 and cyclo-oxygenase-2 was assessed in the peri-infarct myocardium and considered as tissue markers of ischaemia. Evidence of ischaemia was significantly more frequent in cases with IRA occlusion (53%) than in cases with patent IRA (15%) or control hearts (0%, P ¼ 0.026). The finding of IRA occlusion and markers of ischaemia identified cases with higher apoptotic rates (ARs) in the peri-infarct viable myocardium [12.2% (8.2-14.0), P , 0.001 vs. others], whereas IRA occlusion without ischaemia was associated with lower AR, not significantly different from patent IRA [3.0% (1.0-7.9) vs. 2.2% (1.0-5.8), respectively, P ¼ 0.42] Conclusion Ischaemia in the peri-infarct viable myocardium is present in over 50% of subjects dying late after AMI with IRA occlusion, and it is associated with increased apoptosis. Relief of ischaemia after AMI may prove of benefit in preventing apoptosis and its consequences.

Research paper thumbnail of Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease (RENAL-DES) Study

Circulation, 2013

Background— Percutaneous coronary interventions in patients with chronic kidney disease have show... more Background— Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results. Drug-eluting stents (DES) might reduce the rate of target vessel revascularization in comparison with bare-metal stents (BMS) in patients with chronic kidney disease. However, given the multiple concomitant individual variables present in such patients, the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess. Methods and Results— Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient with Chronic Kidney Disease (RENAL-DES) was a prospective, randomized, multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and BMS with an identical design (Multi-Link Vision), both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease (estimated glomerular filtr...

Research paper thumbnail of Coronary plaque composition assessed by intravascular ultrasound virtual histology: Association with long-term clinical outcomes after heart transplantation in young adult recipients

Catheterization and Cardiovascular Interventions, 2014

Objectives: To assess coronary plaque composition by virtual histology intravascular ultrasound (... more Objectives: To assess coronary plaque composition by virtual histology intravascular ultrasound (VH-IVUS) analysis in young adult recipients and to correlate these findings with time from heart transplant (HTx) and long-term outcomes. Background: Rapid progression of coronary allograft vasculopathy after heart transplantation is a powerful predictor of mortality and clinical events at long-term. Methods: Forty consecutive young adult recipients transplanted during childhood undergoing VH-IVUS during coronary surveillance have been prospectively included in this study. According to the time interval from HTx to VH-IVUS assessment, our cohort was divided into two groups (group A: 5 years, n 5 13; group B: >5 years, n 5 27). Results: Group B showed an higher percentage of necrotic core and dense calcium (12 6 2 vs. 5 6 1%, P 5 0.04; 8.2 vs. 2.1%, P 5 0.03; respectively). An "inflammatory plaque" (necrotic core and dense calcium 30%) was detected in 34.8% of patients in group B and in none among group A patients (P 5 0.03). Patients in group B had a number of adverse clinical events significantly higher than group A patients (53.8 vs. 14.3%; HR 4.45; 95% CI 1.62-12.16; P 5 0.029) at long-term follow-up (4.2 years). The multivariate regression analysis showed that age (HR 1.5; 95% CI 1.1-2.0; P 5 0.007), time from HTx (HR 1.8; 95% CI 1.6-4.8; P 5 0.02), and inflammatory plaque (HR 2.4; 95% CI 1.1-5.3; P 5 0.03) were independent predictors of adverse clinical events. Conclusions: This study supports the hypothesis that time-dependent differences in plaque composition, as assessed by VH-IVUS, occur after HTx in young adult recipients, probably determining an increased risk of long-term clinical events. V

Research paper thumbnail of Long-term outcome of provisional side-branch T-stenting for the treatment of unprotected distal left main coronary artery disease

Catheterization and Cardiovascular Interventions, 2011

Research paper thumbnail of The effect of thrombectomy on myocardial blush in primary angioplasty: The randomized evaluation of thrombus aspiration by two thrombectomy devices in acute myocardial infarction (RETAMI) trial

Catheterization and Cardiovascular Interventions, 2007

In patients with ST-segment elevation myocardial infarction (STEMI), primary percutaneous coronar... more In patients with ST-segment elevation myocardial infarction (STEMI), primary percutaneous coronary intervention (PCI) may cause thrombus dislodgment leading to microvascular function impairment, which is a negative independent predictor of myocardial function recovery. Compared with conventional stenting, pretreatment with aspiration thrombectomy during primary PCI significantly improves coronary epicardial flow and myocardial tissue perfusion parameters. We sought to evaluate the angiographic findings of two different manual aspiration thrombectomy devices (Diver-Invatec (DI) and Export-Medtronic (EM)) in STEMI patients undergoing primary angioplasty. We randomized 103 STEMI patients referred to our hospital to undergo primary PCI (<12 hr from symptoms onset) to DI (n = 52) and EM (n = 51) devices. The primary angiographic composite end-points were the rates of post-thrombectomy thrombus score (TS) < or =2, TIMI flow grade > or =2, and post-stenting myocardial blush grade (MBG) > or =2 in the two groups. Baseline, clinical, and angiographic preprocedural findings did not differ between the two groups. After aspiration thrombectomy, a TS < or = 2 was more frequently present in EM group (92.3 vs. 69.3%, P = 0.0052). Also the rate of post-thrombectomy TIMI…

Research paper thumbnail of One-year clinical results of the Italian diffuse/multivessel disease ABSORB prospective registry (IT-DISAPPEARS)

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 16, 2017

The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating... more The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating early and long-term clinical outcomes of the Absorb BVS in patients with long coronary lesions and/or multivessel coronary artery disease. The aim of this article is to present the one-year clinical results of this study. Between November 2014 and January 2016, we enrolled 1,002 patients undergoing BVS implantation (long lesion [≥ 24 mm] of a single vessel in 80.4%, at least two BVS in two or three coronary vessels in 8.6% and both criteria in 11%). Clinical presentation was an acute coronary syndrome in 59.8% of patients, including ST-elevation myocardial infarction in 21.8%. The primary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI, and ischaemia-driven TLR at one year. We implanted 2,040 BVS according to a pre-specified technique. One-year follow-up was available in 956 patients (95.4%). The rate of DOCE was 9.9% (95 patients). Cardiac ...

Research paper thumbnail of Impact of abciximab on coronary restenosis in diabetic patients undergoing elective paclitaxel-eluting stent implantation. A prospective, randomized, placebo-controlled study

Acute Cardiac Care, 2008

Recent studies suggested that abciximab reduces the risk of restenosis in diabetic patients recei... more Recent studies suggested that abciximab reduces the risk of restenosis in diabetic patients receiving coronary bare metal stent. We sought to evaluate whether abciximab may reduce in-segment late luminal loss (LLL), in patients with diabetes mellitus undergoing elective drug-eluting stents (PES) implantation. We conducted a prospective, randomized, double-blind study on diabetic patients after a paclitaxel-eluting stent (PES) implantation on de novo coronary artery lesions. 132 consecutive patients with diabetes (mean age 63.1+/-7.4 years, 82 males) were randomized to abciximab (n=66) or placebo (n=66). Among the 124 (93.9%) patients who underwent a 6-months angiographic follow-up, the mean difference in in-segment LLL between patients who received abciximab and placebo was 0.02 mm (P=0.8). In addition, the rates of angiographic in-segment restenosis were comparable between the two groups (14.3 versus 9.8%, P=0.5). Cumulative rates of clinical events did not differ (death: 1.5 versus 1.5, P=0.9 and MI: 1.5 versus 3%, P=0.8) between abciximab and placebo group, respectively. Similarly, the incidence of target lesion revascularization was 9.1% and 6.1% (P=0.7) at six months, in the two groups. Abciximab does not seem to have any impact on the extent of in-segment LLL in diabetic patients undergoing an elective PES implantation.

Research paper thumbnail of Everolimus-Eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy: the CART (Cardiac Allograft Reparative Therapy) Prospective Multicenter Pilot Study

Journal of cardiovascular translational research, Jan 18, 2015

Cardiac allograft vasculopathy (CAV) is a form of accelerated atherosclerosis, which represents t... more Cardiac allograft vasculopathy (CAV) is a form of accelerated atherosclerosis, which represents the leading cause of late morbidity and mortality after heart transplantation. The recent bioresorbable vascular scaffold (BVS) technology represents a potential novel therapeutic tool, in the context of CAV, by allowing transient scaffolding and concomitant vessel healing. Eligible subjects will be treated by using the Absorb Everolimus-Eluting BVS (Abbott Vascular, Santa Clara, CA, USA), and evaluated at pre-determined time points, up to 3 years since the index procedure. Both clinical and imaging data will be collected in dedicated case report forms (CRF). All imaging data will be analyzed in an independent core laboratory. The primary aim of the study is to evaluate the angiographic performance at 1 year of second-generation Absorb BVS, in heart transplant recipients affected by CAV.

Research paper thumbnail of Acute Pseudoaneurysm Following Carotid Artery Stenting

JACC: Cardiovascular Interventions, 2017

Research paper thumbnail of Abstract 21544: Long-Term Outcome of Provisional Side-Branch T-Stenting for the Treatment of Unprotected Distal Left Main Coronary Artery Diseas

Circulation, Nov 23, 2010

Research paper thumbnail of Optical coherence tomography for characterization of cardiac allograft vasculopathy in late survivors of pediatric heart transplantation

The Journal of Heart and Lung Transplantation, 2016

Optical coherence tomography (OCT) has been shown to reliably detect cardiac allograft vasculopat... more Optical coherence tomography (OCT) has been shown to reliably detect cardiac allograft vasculopathy (CAV). In recent studies performed in adult heart transplant (HTx) recipients, OCT revealed the presence of vulnerable plaques and complicated coronary artery lesions, thus challenging the current concept that CAV disease is a diffuse concentric and fibrosing vasculopathy. The aim of our study was to characterize CAV by OCT in a young population of HTx recipients. We prospectively enrolled 21 young HTx recipients (mean age 27 years, range 22 to 38 years) to undergo OCT of the left anterior descending coronary artery (LAD) in addition to annual CAV screening by coronary angiography and virtual histology intravascular ultrasound (VH-IVUS). Quantitative OCT analysis was performed at the site of maximal intimal thickness (MIT) for each LAD segment. Patients were 27 years old with a mean time from cardiac transplantation of 14.7 ± 6.8 years. All patients exhibited intimal hyperplasia with an abnormal (>1) intima-to-media ratio. The median (interquartile range) MIT values by OCT were 0.37 (0.22 to 0.54) mm, 0.46 (0.29 to 0.54) mm and 0.34 (0.25 to 0.49) mm in the distal, middle and proximal LAD segments, respectively. Qualitative OCT analysis rarely showed features of vulnerable plaque or complicated lesions. Consistently, at VH-IVUS, the prevalent component at the site of MIT per vessel assessed by OCT was fibrous tissue. Unlike recent evidence in adult HTx recipients, OCT findings of vulnerable plaque and complicated coronary lesions were found to be rare among late survivors of pediatric HTx.

Research paper thumbnail of Clinical relevance of apoptosis in early and late post-infarction left ventricular remodeling

Italian heart journal : official journal of the Italian Federation of Cardiology, 2002

Apoptosis may represent an important pathophysiological mechanism causing progressive myocardiocy... more Apoptosis may represent an important pathophysiological mechanism causing progressive myocardiocyte loss and left ventricular dilation, even late after acute myocardial infarction (AMI). This review discusses the role of myocardial apoptosis on the basis of findings from experimental studies in animals and from observational studies in humans with the purpose of assessing the clinical relevance, determinants and mechanisms of myocardial apoptosis and the potential therapeutic implications. A more profound understanding of the impact of myocardiocyte loss on prognosis and of the mechanisms involved may lead to an improved understanding of cardiac remodeling and possibly to an improved patient care. In fact, among the potential modulators of myocardial apoptosis, angiotensin-converting enzyme inhibitors and beta-adrenergic receptor blockers have already been shown to improve the prognosis and symptoms in patients with post-infarction heart failure, and a reduction in myocardial apopto...

Research paper thumbnail of Benefits on coronary restenosis from elective paclitaxel-eluting stent implantation in patients aged 75 years and older

Journal of Cardiovascular Medicine, 2007

Elderly patients are increasingly referred for revascularisation yet have been underrepresented i... more Elderly patients are increasingly referred for revascularisation yet have been underrepresented in some large clinical trials. Although the advent of drug-eluting stents has dramatically reduced clinical events related to restenosis, older age remains one of the most important correlates of adverse outcome, even after an elective percutaneous coronary intervention (PCI). We sought to evaluate the impact of paclitaxel-eluting stents on coronary restenosis in elderly patients undergoing elective PCI. Patients undergoing successful elective PCI with stenting of de novo coronary artery lesions were identified and screened for participation in this study. All patients included in our analysis were divided into two cohort groups: patients aged <75 years (younger cohort) and patients aged >or=75 years (elderly cohort). We evaluated the six-month incidence of target lesion revascularisation (TLR) and major adverse cardiac events, which included TLR, death and myocardial infarction. A total of 171 (58 aged >or=75 years) consecutive patients were enrolled in the study. At six months, TLR rate was similar in both groups [1.77 vs. 1.72%, odds ratio (OR) 0.97, 95% confidence interval (CI) 0.08-10.9, P = 0.98, in the younger and elderly group, respectively]. Even the rate of major adverse cardiac events was comparable between the two groups (7.96 vs. 8.62%, OR 1.09, 95% CI 0.34-3.41, P = 0.88, in the younger and elderly group, respectively). Also the angiographic restenosis rates were comparable between patients <75 or >or=75 years (4.42 vs. 3.46%, P = 0.76). After elective paclitaxel-eluting stent implantation, there is no difference in coronary restenosis in younger and elderly patients, suggesting an age-independent efficacy.

Research paper thumbnail of One-year outcome from an all-comers population of patients with ST-segment elevation myocardial infarction treated with biolimus-eluting stent with biodegradable polymer

Catheterization and Cardiovascular Interventions, 2014

Objectives: To evaluate the performance of biolimus-eluting stent (BES) in patients with ST-eleva... more Objectives: To evaluate the performance of biolimus-eluting stent (BES) in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) in a real world clinical scenario. Background: Randomized studies suggest that the BES with biodegradable polymer is more effective and safe than early generation coronary stents in patients with STEMI. Methods: We included all consecutive STEMI patients undergoing PCI in this prospective, multicenter registry. The primary endpoint of the study was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction and ischemia-driven target vessel revascularization at 1-year follow-up. Results: Between June and December 2012 we enrolled 311 STEMI patients. The primary endpoint occurred in 3.2% (95% confidence interval: 1.6-5.8) of patients: cardiac death, re-infarction, and ischemiadriven TVR occurred in 2.3%, 1.3%, and 0.6% of patients, respectively. One-year MACE-free survival was 96.8% 6 1.0%. Conclusions: In a real-world cohort of STEMI patients undergoing PCI, the use of BES is associated with good 1-year clinical outcome. These results confirm and expand previous findings showing the efficacy and safety of BES in the setting of randomized trials. V

Research paper thumbnail of Rationale and design of the Randomized comparison of XiEnce V and Multilink VisioN coronary stents in the sAme muLtivessel patient with chronic kiDnEy disease (RENAL-DES) study

Journal of Cardiovascular Medicine, 2010

Background Percutaneous coronary intervention with bare metal stents (BMS) in patients with chron... more Background Percutaneous coronary intervention with bare metal stents (BMS) in patients with chronic kidney disease (CKD) has shown suboptimal results. Drug-eluting stents (DESs) might reduce the incidence of restenosis and therefore of target lesion revascularization in these patients. Of note, in patients with CKD, multiple concomitant individual variables may be responsible for neointimal hyperplasia after coronary stenting, thus making the comparison of BMS and DES in different patient groups difficult. Study design The RENAL-DES is a prospective, randomized, multicenter, not-sponsored study to directly compare the efficacy in the prevention of clinical restenosis, of everolimus-eluting stent (Xience V) and BMS with identical design (Multilink Vision), both implanted in the same patient with multivessel coronary artery disease and CKD in order to obviate the multiple and unpredictable baseline differences. The primary endpoint of the study is 9month ischemia-driven target vessel revascularization. Sample size The expected primary endpoint rates are 20% for BMS and 10% for DES. According to these estimates, with a significant level of 0.05, a sample size of 194 patients provides an 80% statistical power. Assuming a 10% dropout rate, the goal is to enroll 213 patients (426 treated vessels) from five Italian centers. As 20% of the patients will likely require stent implantation in three vessels, approximately 500 treated vessels will be analyzed. Conclusion This intraindividual, randomized study will provide, for the first time, data on the efficacy, in the prevention of clinical restenosis, of DES compared to BMS in patients with multivessel coronary artery disease and CKD (ClinicalTrials.gov Identifier: NCT 00818792).

Research paper thumbnail of High-risk clinical features predict enhanced post-infarction myocardial apoptosis and the need to achieve infarct-related artery patency

Journal of the American College of Cardiology, 2003

Research paper thumbnail of Hypoxia inducible factor-1 expression mediates myocardial response to ischemia late after acute myocardial infarction

International Journal of Cardiology, 2005

Research paper thumbnail of Reduced post-infarction myocardial apoptosis in women: a clue to their different clinical course?

Research paper thumbnail of Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study

European Heart Journal, 2014

Aims We evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbab... more Aims We evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds (BVS) for the treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI). Methods and results The present investigation is a prospective, single-arm, single-centre study, reporting data after the BVS implantation in STEMI patients. Quantitative coronary angiography and optical coherence tomography (OCT) data were evaluated. Clinical outcomes are reported at the 30-day follow-up. The intent-to-treat population comprises a total of 49 patients. The procedural success was 97.9%. Pre-procedure TIMI-flow was 0 in 50.0% of the patients; after the BVS implantation, a TIMIflow III was achieved in 91.7% of patients and the post-procedure percentage diameter stenosis was 14.7 + 8.2%. No patients had angiographically visible residual thrombus at the end of the procedure. Optical coherence tomography analysis performed in 31 patients showed that the post-procedure mean lumen area was 8.02 + 1.92 mm 2 , minimum lumen area 5.95 + 1.61 mm 2 , mean incomplete scaffold apposition area 0.118 + 0.162 mm 2 , mean intraluminal defect area 0.013 + 0.017 mm 2 , and mean percentage malapposed struts per patient 2.80 + 3.90%. Scaffolds with .5% malapposed struts were 7. At the 30-day follow-up, target-lesion failure rate was 0%. Non-target-vessel revascularization and targetvessel myocardial infarction (MI) were reported. A non-target-vessel non-Q-wave MI occurred. No cases of cardiac death or scaffold thrombosis were observed. Conclusion In the present series, the BVS implantation in patients presenting with acute MI appeared feasible, with high rate of final TIMI-flow III and good scaffold apposition. Larger studies are currently needed to confirm these preliminary data.

Research paper thumbnail of Infarct-related artery occlusion, tissue markers of ischaemia, and increased apoptosis in the peri-infarct viable myocardium

European Heart Journal, 2005

Unfavourable cardiac remodelling often complicates acute myocardial infarction (AMI) as a result ... more Unfavourable cardiac remodelling often complicates acute myocardial infarction (AMI) as a result of increased cardiomyocyte apoptosis. It is currently unclear whether ongoing or recurrent ischaemia is an independent determinant for increased apoptosis in peri-infarct viable myocardium. Methods and results In order to assess the link between infarct-related artery (IRA) occlusion, ischaemia, and apoptosis, 30 subjects dying 7-120 days after AMI (16 with IRA occlusion and 14 with patent IRA) and five control subjects were selected at autopsy. Cardiomyocytes were defined as apoptotic if co-expressing TUNEL and activated caspase-3. Expression of both hypoxia-inducible factor-1 and cyclo-oxygenase-2 was assessed in the peri-infarct myocardium and considered as tissue markers of ischaemia. Evidence of ischaemia was significantly more frequent in cases with IRA occlusion (53%) than in cases with patent IRA (15%) or control hearts (0%, P ¼ 0.026). The finding of IRA occlusion and markers of ischaemia identified cases with higher apoptotic rates (ARs) in the peri-infarct viable myocardium [12.2% (8.2-14.0), P , 0.001 vs. others], whereas IRA occlusion without ischaemia was associated with lower AR, not significantly different from patent IRA [3.0% (1.0-7.9) vs. 2.2% (1.0-5.8), respectively, P ¼ 0.42] Conclusion Ischaemia in the peri-infarct viable myocardium is present in over 50% of subjects dying late after AMI with IRA occlusion, and it is associated with increased apoptosis. Relief of ischaemia after AMI may prove of benefit in preventing apoptosis and its consequences.

Research paper thumbnail of Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease (RENAL-DES) Study

Circulation, 2013

Background— Percutaneous coronary interventions in patients with chronic kidney disease have show... more Background— Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results. Drug-eluting stents (DES) might reduce the rate of target vessel revascularization in comparison with bare-metal stents (BMS) in patients with chronic kidney disease. However, given the multiple concomitant individual variables present in such patients, the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess. Methods and Results— Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient with Chronic Kidney Disease (RENAL-DES) was a prospective, randomized, multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and BMS with an identical design (Multi-Link Vision), both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease (estimated glomerular filtr...

Research paper thumbnail of Coronary plaque composition assessed by intravascular ultrasound virtual histology: Association with long-term clinical outcomes after heart transplantation in young adult recipients

Catheterization and Cardiovascular Interventions, 2014

Objectives: To assess coronary plaque composition by virtual histology intravascular ultrasound (... more Objectives: To assess coronary plaque composition by virtual histology intravascular ultrasound (VH-IVUS) analysis in young adult recipients and to correlate these findings with time from heart transplant (HTx) and long-term outcomes. Background: Rapid progression of coronary allograft vasculopathy after heart transplantation is a powerful predictor of mortality and clinical events at long-term. Methods: Forty consecutive young adult recipients transplanted during childhood undergoing VH-IVUS during coronary surveillance have been prospectively included in this study. According to the time interval from HTx to VH-IVUS assessment, our cohort was divided into two groups (group A: 5 years, n 5 13; group B: >5 years, n 5 27). Results: Group B showed an higher percentage of necrotic core and dense calcium (12 6 2 vs. 5 6 1%, P 5 0.04; 8.2 vs. 2.1%, P 5 0.03; respectively). An "inflammatory plaque" (necrotic core and dense calcium 30%) was detected in 34.8% of patients in group B and in none among group A patients (P 5 0.03). Patients in group B had a number of adverse clinical events significantly higher than group A patients (53.8 vs. 14.3%; HR 4.45; 95% CI 1.62-12.16; P 5 0.029) at long-term follow-up (4.2 years). The multivariate regression analysis showed that age (HR 1.5; 95% CI 1.1-2.0; P 5 0.007), time from HTx (HR 1.8; 95% CI 1.6-4.8; P 5 0.02), and inflammatory plaque (HR 2.4; 95% CI 1.1-5.3; P 5 0.03) were independent predictors of adverse clinical events. Conclusions: This study supports the hypothesis that time-dependent differences in plaque composition, as assessed by VH-IVUS, occur after HTx in young adult recipients, probably determining an increased risk of long-term clinical events. V

Research paper thumbnail of Long-term outcome of provisional side-branch T-stenting for the treatment of unprotected distal left main coronary artery disease

Catheterization and Cardiovascular Interventions, 2011

Research paper thumbnail of The effect of thrombectomy on myocardial blush in primary angioplasty: The randomized evaluation of thrombus aspiration by two thrombectomy devices in acute myocardial infarction (RETAMI) trial

Catheterization and Cardiovascular Interventions, 2007

In patients with ST-segment elevation myocardial infarction (STEMI), primary percutaneous coronar... more In patients with ST-segment elevation myocardial infarction (STEMI), primary percutaneous coronary intervention (PCI) may cause thrombus dislodgment leading to microvascular function impairment, which is a negative independent predictor of myocardial function recovery. Compared with conventional stenting, pretreatment with aspiration thrombectomy during primary PCI significantly improves coronary epicardial flow and myocardial tissue perfusion parameters. We sought to evaluate the angiographic findings of two different manual aspiration thrombectomy devices (Diver-Invatec (DI) and Export-Medtronic (EM)) in STEMI patients undergoing primary angioplasty. We randomized 103 STEMI patients referred to our hospital to undergo primary PCI (<12 hr from symptoms onset) to DI (n = 52) and EM (n = 51) devices. The primary angiographic composite end-points were the rates of post-thrombectomy thrombus score (TS) < or =2, TIMI flow grade > or =2, and post-stenting myocardial blush grade (MBG) > or =2 in the two groups. Baseline, clinical, and angiographic preprocedural findings did not differ between the two groups. After aspiration thrombectomy, a TS < or = 2 was more frequently present in EM group (92.3 vs. 69.3%, P = 0.0052). Also the rate of post-thrombectomy TIMI…

Research paper thumbnail of One-year clinical results of the Italian diffuse/multivessel disease ABSORB prospective registry (IT-DISAPPEARS)

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 16, 2017

The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating... more The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating early and long-term clinical outcomes of the Absorb BVS in patients with long coronary lesions and/or multivessel coronary artery disease. The aim of this article is to present the one-year clinical results of this study. Between November 2014 and January 2016, we enrolled 1,002 patients undergoing BVS implantation (long lesion [≥ 24 mm] of a single vessel in 80.4%, at least two BVS in two or three coronary vessels in 8.6% and both criteria in 11%). Clinical presentation was an acute coronary syndrome in 59.8% of patients, including ST-elevation myocardial infarction in 21.8%. The primary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI, and ischaemia-driven TLR at one year. We implanted 2,040 BVS according to a pre-specified technique. One-year follow-up was available in 956 patients (95.4%). The rate of DOCE was 9.9% (95 patients). Cardiac ...

Research paper thumbnail of Impact of abciximab on coronary restenosis in diabetic patients undergoing elective paclitaxel-eluting stent implantation. A prospective, randomized, placebo-controlled study

Acute Cardiac Care, 2008

Recent studies suggested that abciximab reduces the risk of restenosis in diabetic patients recei... more Recent studies suggested that abciximab reduces the risk of restenosis in diabetic patients receiving coronary bare metal stent. We sought to evaluate whether abciximab may reduce in-segment late luminal loss (LLL), in patients with diabetes mellitus undergoing elective drug-eluting stents (PES) implantation. We conducted a prospective, randomized, double-blind study on diabetic patients after a paclitaxel-eluting stent (PES) implantation on de novo coronary artery lesions. 132 consecutive patients with diabetes (mean age 63.1+/-7.4 years, 82 males) were randomized to abciximab (n=66) or placebo (n=66). Among the 124 (93.9%) patients who underwent a 6-months angiographic follow-up, the mean difference in in-segment LLL between patients who received abciximab and placebo was 0.02 mm (P=0.8). In addition, the rates of angiographic in-segment restenosis were comparable between the two groups (14.3 versus 9.8%, P=0.5). Cumulative rates of clinical events did not differ (death: 1.5 versus 1.5, P=0.9 and MI: 1.5 versus 3%, P=0.8) between abciximab and placebo group, respectively. Similarly, the incidence of target lesion revascularization was 9.1% and 6.1% (P=0.7) at six months, in the two groups. Abciximab does not seem to have any impact on the extent of in-segment LLL in diabetic patients undergoing an elective PES implantation.

Research paper thumbnail of Everolimus-Eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy: the CART (Cardiac Allograft Reparative Therapy) Prospective Multicenter Pilot Study

Journal of cardiovascular translational research, Jan 18, 2015

Cardiac allograft vasculopathy (CAV) is a form of accelerated atherosclerosis, which represents t... more Cardiac allograft vasculopathy (CAV) is a form of accelerated atherosclerosis, which represents the leading cause of late morbidity and mortality after heart transplantation. The recent bioresorbable vascular scaffold (BVS) technology represents a potential novel therapeutic tool, in the context of CAV, by allowing transient scaffolding and concomitant vessel healing. Eligible subjects will be treated by using the Absorb Everolimus-Eluting BVS (Abbott Vascular, Santa Clara, CA, USA), and evaluated at pre-determined time points, up to 3 years since the index procedure. Both clinical and imaging data will be collected in dedicated case report forms (CRF). All imaging data will be analyzed in an independent core laboratory. The primary aim of the study is to evaluate the angiographic performance at 1 year of second-generation Absorb BVS, in heart transplant recipients affected by CAV.