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  1. Article ; Online: Twenty year follow-up after successful percutaneous balloon mitral valvuloplasty in a large contemporary series of patients with mitral stenosis.

    Tomai, Fabrizio / Gaspardone, Achille / Versaci, Francesco / Ghini, Anna S / Altamura, Luca / De Luca, Leonardo / Gioffrè, Gaetano / Gioffrè, Pier Agostino

    International journal of cardiology

    2014  Volume 177, Issue 3, Page(s) 881–885

    Abstract: Background: Percutaneous balloon mitral valvuloplasty (PMV) is currently considered the standard of care for suitable patients with rheumatic mitral stenosis. We sought to assess very long-term outcome after PMV.: Methods: Between 1991 and 2010, 482 ... ...

    Abstract Background: Percutaneous balloon mitral valvuloplasty (PMV) is currently considered the standard of care for suitable patients with rheumatic mitral stenosis. We sought to assess very long-term outcome after PMV.
    Methods: Between 1991 and 2010, 482 consecutive patients underwent successful PMV in a single center. Procedural success was defined as post-procedural valve area ≥ 1.5 cm(2) and regurgitation moderate or less, without in-hospital major adverse cardiac and cerebro-vascular events. The primary endpoint was 20-year incidence of major adverse cardiac events (MACE), including cardiovascular death and need for mitral surgery or repeat PMV.
    Results: Long-term follow-up (mean 11.6 ± 4.9 years; range 0.5 to 20) was completed in 441 (91.5%) patients. The incidence of the primary endpoint was 41.9% (95% confidence interval [CI]: 37.3 to 46.7%). The rate of cardiovascular death, need for mitral surgery or repeat PMV was 9.1% (95% CI: 6.6 to 12.1), 27% (95% CI: 22.9 to 31.4), and 5.9% (95% CI: 3.9 to 8.5), respectively. Cumulative MACE-free survival at 20 years was 35.9 ± 4.7%. At multivariate analysis, male gender (hazard ratio [HR]: 1.99; 95% CI: 1.4-2.8, p < 0.001), echocardiographic score > 8 (HR: 2.19; 95% CI: 1.6-2.9, p < 0.001), atrial fibrillation (HR: 1.54; 95% CI: 1.2-2.1, p = 0.003) and valve area ≤ 1.75 cm(2) after PMV (HR: 3.1; 95% CI: 2.3-4.2, p < 0.001) were identified as independent predictors of the primary endpoint.
    Conclusions: Up to 20 years after successful PMV, a sizeable proportion of patients still exhibit a good clinical result.
    MeSH term(s) Adult ; Aged ; Balloon Valvuloplasty/mortality ; Balloon Valvuloplasty/trends ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Mitral Valve Stenosis/diagnostic imaging ; Mitral Valve Stenosis/mortality ; Mitral Valve Stenosis/therapy ; Prospective Studies ; Time Factors ; Treatment Outcome ; Ultrasonography
    Language English
    Publishing date 2014-12-20
    Publishing country Netherlands
    Document type Journal Article ; Observational Study
    ZDB-ID 779519-1
    ISSN 1874-1754 ; 0167-5273
    ISSN (online) 1874-1754
    ISSN 0167-5273
    DOI 10.1016/j.ijcard.2014.10.040
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  2. Article ; Online: Coronary plaque composition assessed by intravascular ultrasound virtual histology: association with long-term clinical outcomes after heart transplantation in young adult recipients.

    Tomai, Fabrizio / Adorisio, Rachele / De Luca, Leonardo / Pilati, Mara / Petrolini, Alessandro / Ghini, Anna S / Parisi, Francesco / Pongiglione, Giacomo / Gagliardi, Maria Giulia

    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

    2014  Volume 83, Issue 1, Page(s) 70–77

    Abstract: 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: ... ...

    Abstract 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 = 13; group B: >5 years, n = 27).
    Results: Group B showed an higher percentage of necrotic core and dense calcium (12 ± 2 vs. 5 ± 1%, P = 0.04; 8.2 vs. 2.1%, P = 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 = 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 = 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 = 0.007), time from HTx (HR 1.8; 95% CI 1.6-4.8; P = 0.02), and inflammatory plaque (HR 2.4; 95% CI 1.1-5.3; P = 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.
    MeSH term(s) Adolescent ; Age Factors ; Child ; Child, Preschool ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/etiology ; Coronary Artery Disease/mortality ; Coronary Vessels/diagnostic imaging ; Female ; Heart Transplantation/adverse effects ; Heart Transplantation/mortality ; Humans ; Italy ; Kaplan-Meier Estimate ; Male ; Multivariate Analysis ; Necrosis ; Plaque, Atherosclerotic ; Predictive Value of Tests ; Proportional Hazards Models ; Registries ; Retrospective Studies ; Risk Factors ; Time Factors ; Ultrasonography, Interventional ; Vascular Calcification/diagnostic imaging ; Vascular Calcification/etiology ; Young Adult
    Language English
    Publishing date 2014-01-01
    Publishing country United States
    Document type Journal Article ; Multicenter Study
    ZDB-ID 1459995-8
    ISSN 1522-726X ; 1522-1946
    ISSN (online) 1522-726X
    ISSN 1522-1946
    DOI 10.1002/ccd.25054
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  3. Article ; Online: Optical coherence tomography for characterization of cardiac allograft vasculopathy in late survivors of pediatric heart transplantation.

    Tomai, Fabrizio / De Luca, Leonardo / Petrolini, Alessandro / Di Vito, Luca / Ghini, Anna S / Corvo, Pierfrancesco / De Persio, Giovanni / Parisi, Francesco / Pongiglione, Giacomo / Giulia Gagliardi, Maria / Prati, Francesco

    The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation

    2015  Volume 35, Issue 1, Page(s) 74–79

    Abstract: Background: 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 ... ...

    Abstract Background: 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.
    Methods: 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.
    Results: 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.
    Conclusions: 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.
    MeSH term(s) Adult ; Allografts ; Coronary Angiography ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/etiology ; Coronary Artery Disease/pathology ; Coronary Vessels/diagnostic imaging ; Coronary Vessels/pathology ; Female ; Follow-Up Studies ; Heart Transplantation/adverse effects ; Heart Transplantation/mortality ; Humans ; Italy/epidemiology ; Male ; Postoperative Complications/diagnostic imaging ; Postoperative Complications/etiology ; Postoperative Complications/pathology ; Prospective Studies ; Survival Rate/trends ; Tomography, Optical Coherence/methods ; Tunica Intima/diagnostic imaging ; Tunica Intima/pathology ; Ultrasonography, Interventional ; Young Adult
    Language English
    Publishing date 2015-09-03
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1062522-7
    ISSN 1557-3117 ; 1053-2498
    ISSN (online) 1557-3117
    ISSN 1053-2498
    DOI 10.1016/j.healun.2015.08.011
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  4. Article ; Online: One-year outcome from an all-comers population of patients with ST-segment elevation myocardial infarction treated with biolimus-eluting stent with biodegradable polymer.

    Tomai, Fabrizio / De Luca, Leonardo / Altamura, Luca / Versaci, Francesco / Pennacchi, Mauro / Proietti, Igino / Ghini, Anna S / Corvo, Pierfrancesco / De Persio, Giovanni / Petrolini, Alessandro / Tommasino, Antonella / Sardella, Gennaro

    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

    2015  Volume 85, Issue 3, Page(s) 352–358

    Abstract: 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 ...

    Abstract 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 ischemia-driven TVR occurred in 2.3%, 1.3%, and 0.6% of patients, respectively. One-year MACE-free survival was 96.8% ± 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.
    MeSH term(s) Aged ; Cardiovascular Agents/administration & dosage ; Disease-Free Survival ; Drug-Eluting Stents ; Female ; Humans ; Italy ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Myocardial Infarction/diagnosis ; Myocardial Infarction/mortality ; Myocardial Infarction/therapy ; Percutaneous Coronary Intervention/adverse effects ; Percutaneous Coronary Intervention/instrumentation ; Percutaneous Coronary Intervention/mortality ; Prospective Studies ; Prosthesis Design ; Recurrence ; Registries ; Risk Factors ; Sirolimus/administration & dosage ; Sirolimus/analogs & derivatives ; Time Factors ; Treatment Outcome
    Chemical Substances Cardiovascular Agents ; umirolimus (U36PGF65JH) ; Sirolimus (W36ZG6FT64)
    Language English
    Publishing date 2015-02-15
    Publishing country United States
    Document type Journal Article ; Multicenter Study
    ZDB-ID 1459995-8
    ISSN 1522-726X ; 1522-1946
    ISSN (online) 1522-726X
    ISSN 1522-1946
    DOI 10.1002/ccd.25627
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  5. Article ; Online: Long-term outcome of provisional side-branch T-stenting for the treatment of unprotected distal left main coronary artery disease.

    De Luca, Leonardo / Altamura, Luca / Corvo, Pierfrancesco / De Persio, Giovanni / Ghini, Anna S / Petrolini, Alessandro / Aurigemma, Cristina / Tomai, Fabrizio

    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

    2011  Volume 77, Issue 6, Page(s) 765–772

    Abstract: Percutaneous coronary intervention (PCI) on distal left main (LM) remains an independent predictor of poor outcome. The strategy of implanting one stent on the main branch (MB), with provisional stenting on the side-branch (SB) only when required ( ... ...

    Abstract Percutaneous coronary intervention (PCI) on distal left main (LM) remains an independent predictor of poor outcome. The strategy of implanting one stent on the main branch (MB), with provisional stenting on the side-branch (SB) only when required (provisional T-stenting), has become the default approach to most bifurcation lesions. This prospective registry sought to investigate the long-term safety and efficacy of provisional SB T-stenting for the treatment of unprotected distal LM disease in patients undergoing PCI. From January 2006 to May 2009, 107 consecutive patients affected by unprotected distal LM disease underwent PCI at our center with the intent to use a provisional SB-stenting technique. We evaluated the rate of major adverse cardiac events (MACE) at long-term follow-up (up to 12-41 months). Procedural success was obtained in 98% of patients. A final kissing balloon inflation was performed in 95% and intravascular ultrasound in 83% of patients. Additional stenting on the SB after provisional stenting on MB was required in 29% of lesions. Long-term follow-up (3.5 years; 25-75th percentile and 1.1-4.5 years) was completed in 97% of patients. The cumulative incidence of MACE was 32.7%: all-cause death was 15.8%, nonfatal myocardial infarction 8.4%, and target vessel revascularization 21.5%. At multivariable analysis, age (hazard ratio, 2.08; 95% confidence interval: 2.01-3.32, P = 0.03), European System for Cardiac Operative Risk Evaluation (HR 1.20, 95% CI: 1.04-1.33, P = 0.02), and diabetes mellitus (HR 3.48, 95% CI: 1.12-6.87, P = 0.01) were identified as independent predictors of MACE. In patients with unprotected distal LM disease undergoing PCI, a provisional strategy of stenting the MB only is associated with good long-term clinical outcomes.
    MeSH term(s) Aged ; Angioplasty, Balloon, Coronary/adverse effects ; Angioplasty, Balloon, Coronary/instrumentation ; Angioplasty, Balloon, Coronary/mortality ; Coronary Angiography ; Coronary Artery Disease/diagnosis ; Coronary Artery Disease/mortality ; Coronary Artery Disease/therapy ; Drug Therapy, Combination ; Female ; Fibrinolytic Agents/therapeutic use ; Humans ; Italy ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Myocardial Infarction/etiology ; Patient Selection ; Proportional Hazards Models ; Prospective Studies ; Prosthesis Design ; Registries ; Risk Assessment ; Risk Factors ; Stents ; Thrombosis/etiology ; Time Factors ; Treatment Outcome ; Ultrasonography, Interventional
    Chemical Substances Fibrinolytic Agents
    Language English
    Publishing date 2011-05-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1459995-8
    ISSN 1522-726X ; 1522-1946
    ISSN (online) 1522-726X
    ISSN 1522-1946
    DOI 10.1002/ccd.22899
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  6. Article ; Online: Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease (RENAL-DES) Study.

    Tomai, Fabrizio / Ribichini, Flavio / De Luca, Leonardo / Petrolini, Alessandro / Ghini, Anna S / Weltert, Luca / Spaccarotella, Carmen / Proietti, Igino / Trani, Carlo / Nudi, Francesco / Pighi, Michele / Vassanelli, Corrado

    Circulation

    2014  Volume 129, Issue 10, Page(s) 1104–1112

    Abstract: 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 ... ...

    Abstract 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 filtration rate <60 mL/min). The primary end point of the study was the ischemia-driven target vessel revascularization as detected with myocardial scintigraphy at 12 months. In 215 patients, 512 coronary vessels were successfully treated with the randomly assigned DES (n=257) or BMS (n=255). At 1 year, the rate of ischemia-driven target vessel revascularization for DES and BMS groups was 2.7% (95% confidence interval, 1.1%-5.6%) and 11.4% (95% confidence interval, 7.8% to 16%), respectively, P<0.001. For the multivariate analysis, independent predictors of the ischemia-driven target vessel revascularization were BMS implantation (odds ratio, 4.95; 95% confidence interval, 2.1-11.6; P<0.001) and vessel size (odds ratio, 0.32; 95% confidence interval, 0.1-0.7; P=0.006).
    Conclusions: This is the first randomized trial showing a reduction of clinical restenosis with a new-generation DES in comparison with a BMS of equal design, in patients who have chronic kidney disease with multivessel coronary artery disease.
    Clinical trial registration url: http://clinicaltrials.gov. Unique identifier: NCT00818792.
    MeSH term(s) Aged ; Aged, 80 and over ; Comorbidity ; Coronary Angiography ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/epidemiology ; Coronary Artery Disease/therapy ; Drug-Eluting Stents ; Endpoint Determination ; Everolimus ; Female ; Glomerular Filtration Rate/physiology ; Humans ; Male ; Middle Aged ; Multivariate Analysis ; Percutaneous Coronary Intervention/instrumentation ; Percutaneous Coronary Intervention/methods ; Prospective Studies ; Renal Insufficiency, Chronic/epidemiology ; Renal Insufficiency, Chronic/physiopathology ; Risk Factors ; Sirolimus/analogs & derivatives ; Stents ; Treatment Outcome
    Chemical Substances Everolimus (9HW64Q8G6G) ; Sirolimus (W36ZG6FT64)
    Language English
    Publishing date 2014-03-11
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 80099-5
    ISSN 1524-4539 ; 0009-7322 ; 0069-4193 ; 0065-8499
    ISSN (online) 1524-4539
    ISSN 0009-7322 ; 0069-4193 ; 0065-8499
    DOI 10.1161/CIRCULATIONAHA.113.005186
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  7. Article ; Online: A prospective registry on carotid artery revascularisation selected by consensus of a cardiovascular team.

    Tomai, Fabrizio / De Luca, Leonardo / Weltert, Luca / Ghini, Anna S / Corvo, Pierfrancesco / De Persio, Giovanni / Altamura, Luca / Albano, Marzia / Borioni, Raoul / Garofalo, Mariano

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

    2014  Volume 9, Issue 11, Page(s) 1294–1300

    Abstract: Aims: This prospective registry was designed to evaluate the early and long-term incidence of clinical events in patients with carotid obstructive disease (COD), after carotid artery revascularisation selected by consensus of a cardiovascular team.: ... ...

    Abstract Aims: This prospective registry was designed to evaluate the early and long-term incidence of clinical events in patients with carotid obstructive disease (COD), after carotid artery revascularisation selected by consensus of a cardiovascular team.
    Methods and results: 403 consecutive patients with COD scheduled for carotid revascularisation were included: 130 were treated with carotid endarterectomy (CEA) and 273 with carotid artery stenting (CAS). Propensity score matching was performed to assemble a cohort of patients in whom all baseline covariates would be well balanced. The occurrence of major adverse cardiac and cerebrovascular events (MACCE), including any death, non-fatal myocardial infarction or stroke, was assessed at 30 days and at long-term follow-up. The incidence of MACCE at 30 days was 4.0% (95% confidence interval: 2.1 to 6.0), without any significant difference between the CAS and CEA groups in unmatched and matched populations. The cumulative freedom from MACCE at two-year follow-up was 80.5%±0.94%, with no statistically significant differences between the CAS and CEA groups, both in the total population and in the matched cohort.
    Conclusions: In this registry of patients undergoing carotid artery revascularisation selected by consensus of a cardiovascular team, the early and long-term incidence of clinical events is up to standard.
    MeSH term(s) Angioplasty/adverse effects ; Carotid Stenosis/therapy ; Creatine Kinase, MB Form/blood ; Endarterectomy, Carotid/adverse effects ; Humans ; Prospective Studies ; Registries ; Stents/adverse effects
    Chemical Substances Creatine Kinase, MB Form (EC 2.7.3.2)
    Language English
    Publishing date 2014-03-20
    Publishing country France
    Document type Journal Article
    ZDB-ID 2457174-X
    ISSN 1969-6213 ; 1774-024X
    ISSN (online) 1969-6213
    ISSN 1774-024X
    DOI 10.4244/EIJV9I11A219
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  8. Article ; Online: Long-term clinical follow-up of the multicentre, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: Cortisone plus BMS or DES veRsus BMS alone to EliminAte Restenosis (CEREA-DES).

    Ribichini, Flavio / Tomai, Fabrizio / Pesarini, Gabriele / Zivelonghi, Carlo / Rognoni, Andrea / De Luca, Giuseppe / Boccuzzi, Giacomo / Presbitero, Patrizia / Ferrero, Valeria / Ghini, Anna S / Marino, Paolo / Vassanelli, Corrado

    European heart journal

    2013  Volume 34, Issue 23, Page(s) 1740–1748

    Abstract: Aims: To analyse the clinical outcome at 4 years in patients with coronary artery disease treated with bare metal stents (BMS) vs. BMS and oral prednisone, or drug-eluting stents (DES), all assuming similar adjunctive medical treatment.: Methods and ... ...

    Abstract Aims: To analyse the clinical outcome at 4 years in patients with coronary artery disease treated with bare metal stents (BMS) vs. BMS and oral prednisone, or drug-eluting stents (DES), all assuming similar adjunctive medical treatment.
    Methods and results: Five Italian hospitals enrolled 375 non-diabetic, ischaemic patients without contraindications to dual anti-platelet treatment or corticosteroid therapy in a randomized controlled study. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischaemia needing repeated target vessel revascularization at 1 year, and this was significantly lower in the BMS group (80.8%) compared with the prednisone (88.0%) and DES group (88.8%, P = 0.04 and 0.006, respectively). The long-term analysis of the primary endpoint was a pre-specified aim of the trial, and was performed at 1447 days (median, IQ range = 1210-1641). Patients receiving BMS alone had significantly lower event-free survival (75.3%) compared with 84.1% in the prednisone group (HR: 0.447; 95% CI: 0.25-0.80, P = 0.007) and 80.6% in DES patients (HR: 0.519; 95% CI: 0.29-0.93, P = 0.03). Prednisone-treated patients did not develop new treatment-related clinical problems. Drug-eluting stents patients suffered more very late stent thrombosis as a cause of spontaneous myocardial infarction. The need for target vessel revascularization remained lower in the prednisone and DES groups (13.6 and 15.2%, respectively), compared with BMS (23.2%).
    Conclusions: The clinical benefits of prednisone compared with BMS only persisted almost unchanged at 4 years. Drug-eluting stents performed better than BMS at long-term, although the advantages observed at 1 year were in part attenuated because of the occurrence of very late stent thrombosis and late revascularizations. Clinical Trial NCT 00369356.
    MeSH term(s) Administration, Oral ; Anti-Inflammatory Agents/administration & dosage ; Coronary Restenosis/prevention & control ; Cortisone/administration & dosage ; Drug Therapy, Combination ; Drug-Eluting Stents ; Female ; Follow-Up Studies ; Humans ; Immunosuppressive Agents/administration & dosage ; Male ; Middle Aged ; Paclitaxel/administration & dosage ; Percutaneous Coronary Intervention ; Platelet Aggregation Inhibitors/administration & dosage ; Prednisone/administration & dosage ; Sirolimus/administration & dosage ; Treatment Outcome ; Tubulin Modulators/administration & dosage
    Chemical Substances Anti-Inflammatory Agents ; Immunosuppressive Agents ; Platelet Aggregation Inhibitors ; Tubulin Modulators ; Paclitaxel (P88XT4IS4D) ; Cortisone (V27W9254FZ) ; Prednisone (VB0R961HZT) ; Sirolimus (W36ZG6FT64)
    Language English
    Publishing date 2013-06
    Publishing country England
    Document type Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 603098-1
    ISSN 1522-9645 ; 0195-668X
    ISSN (online) 1522-9645
    ISSN 0195-668X
    DOI 10.1093/eurheartj/eht079
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  9. Article ; Online: Long-term results of immunosuppressive oral prednisone after coronary angioplasty in non-diabetic patients with elevated C-reactive protein levels.

    Ferrero, Valeria / Tomai, Fabrizio / Versaci, Francesco / Feola, Mauro / Proietti, Igino / Rognoni, Andrea / Ghini, Anna S / Gaspardone, Achille / Vacca, Giovanni / De Luca, Leonardo / Vassanelli, Corrado / Ribichini, Flavio

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

    2010  Volume 5, Issue 2, Page(s) 250–254

    Abstract: Aims: To present the long-term results of prednisone-treated patients enrolled in the IMPRESS studies. Such studies demonstrated the efficacy of a short course of immunosuppression with oral prednisone after percutaneous coronary intervention (PCI) with ...

    Abstract Aims: To present the long-term results of prednisone-treated patients enrolled in the IMPRESS studies. Such studies demonstrated the efficacy of a short course of immunosuppression with oral prednisone after percutaneous coronary intervention (PCI) with bare metal stent (BMS) implantation compared to BMS alone at one year.
    Methods and results: Eighty-four non-diabetic patients with elevated C-reactive protein after PCI treated with BMS and prednisone, were followed clinically for a minimum of five years. Event-free survival was defined as freedom from death, myocardial infarction, and need for target vessel revascularisation. Event-free survival rate at a mean of 6.5 +/- 1.4 years was significantly better in prednisone-treated patients of the IMPRESS and IMPRESS-2/MVD respectively compared to their original control arms: 87.8 versus 47.6%, relative risk: 7.9; 95%CI: 2.6-24.1, p<0.0001, log-rank=13.06, p=0.0003; and 93 versus 60.5%, relative risk: 8.7; 95%CI: 2.3-32.7, p=0.0004, log-rank=13,18, p=0.0003, respectively. The event-free survival was 54.1% in controls and 90.5% in the prednisone group; relative risk: 8.1; 95%CI: 3.5-18.7, p<0.0001, log-rank= 26.33, p<0.0001.
    Conclusions: The clinical benefits of oral treatment with prednisone after conventional PCI in non-diabetic patients with evidence of systemic inflammation after stenting are maintained at long-term follow-up, either in patients with single or multivessel coronary artery disease.
    MeSH term(s) Administration, Oral ; Adult ; Aged ; Aged, 80 and over ; Angioplasty, Balloon, Coronary/adverse effects ; Angioplasty, Balloon, Coronary/instrumentation ; Angioplasty, Balloon, Coronary/mortality ; Biomarkers/blood ; C-Reactive Protein/metabolism ; Chi-Square Distribution ; Coronary Artery Disease/drug therapy ; Coronary Artery Disease/immunology ; Coronary Artery Disease/mortality ; Coronary Artery Disease/therapy ; Disease-Free Survival ; Female ; Humans ; Immunosuppressive Agents/administration & dosage ; Inflammation Mediators/blood ; Kaplan-Meier Estimate ; Male ; Metals ; Middle Aged ; Myocardial Infarction/etiology ; Myocardial Infarction/prevention & control ; Prednisone/administration & dosage ; Prospective Studies ; Prosthesis Design ; Risk Assessment ; Risk Factors ; Single-Blind Method ; Stents ; Time Factors ; Treatment Outcome ; Up-Regulation
    Chemical Substances Biomarkers ; Immunosuppressive Agents ; Inflammation Mediators ; Metals ; C-Reactive Protein (9007-41-4) ; Prednisone (VB0R961HZT)
    Language English
    Publishing date 2010-03-31
    Publishing country France
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 2457174-X
    ISSN 1969-6213 ; 1774-024X
    ISSN (online) 1969-6213
    ISSN 1774-024X
    DOI 10.4244/eijv5i2a39
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  10. Article: Elevated C-reactive protein levels and coronary microvascular dysfunction in patients with coronary artery disease.

    Tomai, Fabrizio / Ribichini, Flavio / Ghini, Anna S / Ferrero, Valeria / Andò, Giuseppe / Vassanelli, Corrado / Romeo, Francesco / Crea, Filippo / Chiariello, Luigi

    European heart journal

    2005  Volume 26, Issue 20, Page(s) 2099–2105

    Abstract: Aims: It is still unknown whether elevated C-reactive protein levels are responsible for coronary microcirculatory dysfunction in patients with coronary artery disease (CAD). This study was aimed at evaluating the association between C-reactive protein ... ...

    Abstract Aims: It is still unknown whether elevated C-reactive protein levels are responsible for coronary microcirculatory dysfunction in patients with coronary artery disease (CAD). This study was aimed at evaluating the association between C-reactive protein levels and endothelium-dependent and endothelium-independent coronary blood flow (CBF) responses in non-culprit arteries of patients with CAD.
    Methods and results: We studied 28 patients (14 with normal and 14 with elevated C-reactive protein levels, >5 mg/L) with single-vessel disease and otherwise angiographically normal coronary arteries undergoing percutaneous transluminal coronary angioplasty (PTCA). CBF was measured in the non-PTCA vessel using an intracoronary Doppler guide wire and quantitative coronary angiography at baseline, after intracoronary infusion of substance P and of adenosine, and expressed as per cent change from baseline. The increases in CBF during infusion of substance P and of adenosine were lesser in patients with elevated than in those with normal C-reactive protein levels (34+/-22 vs. 61+/-34%, P=0.04 and 131+/-53 vs. 189+/-89%, P=0.03, respectively). Multivariable analysis identified elevated C-reactive protein level as the only independent predictor of reduced response to substance P (P=0.01) and adenosine (P=0.02).
    Conclusion: In patients with CAD, evidence of systemic inflammation is independently associated with endothelium-dependent and endothelium-independent coronary microvascular dysfunction, which, in turn, may be critical to precipitate myocardial ischaemia, in particular, in unstable patients.
    MeSH term(s) Adenosine/pharmacology ; Adult ; Aged ; Analysis of Variance ; Blood Flow Velocity/drug effects ; Blood Flow Velocity/physiology ; C-Reactive Protein/metabolism ; Case-Control Studies ; Coronary Angiography ; Coronary Artery Disease/blood ; Coronary Artery Disease/pathology ; Coronary Artery Disease/physiopathology ; Coronary Circulation/drug effects ; Coronary Circulation/physiology ; Coronary Stenosis/blood ; Coronary Stenosis/pathology ; Coronary Stenosis/physiopathology ; Endothelium, Vascular/physiopathology ; Female ; Hemodynamics/physiology ; Humans ; Male ; Microcirculation/physiology ; Microvascular Angina/blood ; Microvascular Angina/physiopathology ; Middle Aged ; Substance P/pharmacology ; Vasodilation/drug effects ; Vasodilator Agents/pharmacology
    Chemical Substances Vasodilator Agents ; Substance P (33507-63-0) ; C-Reactive Protein (9007-41-4) ; Adenosine (K72T3FS567)
    Language English
    Publishing date 2005-10
    Publishing country England
    Document type Journal Article
    ZDB-ID 603098-1
    ISSN 1522-9645 ; 0195-668X
    ISSN (online) 1522-9645
    ISSN 0195-668X
    DOI 10.1093/eurheartj/ehi356
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