Imad Sheiban

Casa di Cura Villa Garda

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Author Order

Document Type

Co-Authors

Giuseppe Biondi‐Zoccai

Sapienza University of Rome

120

Claudio Moretti

CTO Hospital

Pierluigi Omedè

Azienda Ospedaliera Citta' della Salute e della Scienza di Torino

Fabrizio D’Ascenzo

Azienda Ospedaliera Citta' della Salute e della Scienza di Torino

Filippo Sciuto

University of Turin

Antonio Colombo

EMO GVM Centro Cuore Columbus

Giuseppe Sangiorgi

University of Rome Tor Vergata

Corrado Tamburino

University of Catania

Fiorenzo Gaïta

University of Turin

Alaide Chieffo

San Raffaele University of Rome

Cooperative Institutions

University of Turin

172

Istituti di Ricovero e Cura a Carattere Scientifico

146

Azienda Ospedaliera Citta' della Salute e della Scienza di Torino

Azienda Ospedaliero Universitaria San Giovanni Battista

Ospedale Maggiore

Vita-Salute San Raffaele University

Sapienza University of Rome

University of Milan

San Raffaele University of Rome

Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele

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Sirolimus-eluting stents for the treatment of bare-metal in-stent restenosis: long-term clinical follow up.

PubMed (2007)

Imad Sheiban Amedeo Chiribiri Serena Beninati Claudio Moretti Pierluigi Omedè

Studies focusing on short- and mid-term follow up support the beneficial role of sirolimus-eluting stents (SES) in the treatment of in-stent restenosis (ISR), yet no long-term safety and/or efficacy data are available.Patients with ISR following bare-metal stenting (BMS) and treated with SES were prospectively studied. Baseline, procedural, and in-hospital data were appraised. The primary endpoint was the rate of major cardiovascular events (MACE) at long-term follow up (>9 months). Secondary endpoints were the individual contributors to MACE.A total of 180 SES were implanted to treat 138 consecutive patients. Procedural success was achieved in all patients without in-hospital death, acute stent thrombosis, stroke, or urgent coronary artery bypass. During follow up, MACE occurred in 5.8% of patients at 6 months, 14.3% at 12 months, and 25% at 24 months. Specifically, all-cause mortality was 1.7% at 6 months, 3.5% at 12 months, and 4.8% at 24 months, for a total of 5 deaths. Target vessel revascularization occurred at 6, 12, and 24 months in 4.2%, 11.2%, and 15.9% of patients, respectively, while target lesion revascularization (TLR) alone accounted for 3.4% at 6 months, 9.6% at 12 months, and 11% at 24 months. Three case of myocardial infarction occurred during follow up (2.2%), without any surgical revascularization or stent thrombosis.Treatment of ISR with SES appears safe and effective, even if a 10% annual rate of MACE can be expected, with a sizable portion of these due to apparently nontarget lesion events.

Mace

Bare-metal stent

Clinical endpoint

Sirolimus

Source

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Citations (3)

Making sense of the recent meta-analytical confusion concerning the safety of drug-eluting stents

EuroIntervention (2007)

Giuseppe Biondi‐Zoccai Pierfrancesco Agostoni Claudio Moretti Emanuele Meliga Imad Sheiban

The safety of drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention has been questioned in several independent meta-analyses (i.e., systematic reviews of primary research studies employing statistical methods to provide pooled estimates) published or presented at the end of 2006. Other reviews and meta-analyses have followed in the beginning of 2007, albeit with unclear or conflicting results. This article provides a succinct perspective and critical appraisal of recently published meta-analyses focusing on DES safety, summarising key features and findings of each work, and recommending avenues for further research and practice.

Confusion

Critical appraisal

10.4244/eijv3i3a68

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Citations (18)

Treatment effects of systematic two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: rationale and design of a prospective, randomised and multicentre DEFINITION II trial

BMJ Open (2018)

Jun‐Jie Zhang Xiao-Fei Gao Yaling Han Jing Kan Ling Tao

Introduction Provisional stenting (PS) for simple coronary bifurcation lesions is the mainstay of treatment. A systematic two-stent approach is widely used for complex bifurcation lesions (CBLs). However, a randomised comparison of PS and two-stent techniques for CBLs has never been studied. Accordingly, the present study is designed to elucidate the benefits of two-stent treatment over PS in patients with CBLs. Methods and analysis This DEFINITION II study is a prospective, multinational, randomised, endpoint-driven trial to compare the benefits of the two-stent technique with PS for CBLs. A total of 660 patients with CBLs will be randomised in a 1:1 fashion to receive either PS or the two-stent technique. The primary endpoint is the rate of 12-month target lesion failure defined as the composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularisation. The major secondary endpoints include all causes of death, MI, target vessel revascularisation, in-stent restenosis, stroke and each individual component of the primary endpoints. The safety endpoint is the occurrence of definite or probable stent thrombosis. Ethics and dissemination The study protocol and informed consent have been approved by the Institutional Review Board of Nanjing First Hospital, and accepted by each participating centre. Written informed consent was obtained from all enrolled patients. Findings of the study will be published in a peer-reviewed journal and disseminated at conferences. Trial registration number NCT02284750 ; Pre-results.

Clinical endpoint

Target lesion

10.1136/bmjopen-2017-020019

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Citations (8)

Management of multivessel coronary disease after ST-elevation myocardial infarction treated by primary coronary angioplasty

American Heart Journal (2010)

Giuseppe Biondi‐Zoccai Marzia Lotrionte Imad Sheiban

Culprit

10.1016/j.ahj.2010.10.013

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Citations (17)

Are drug-eluting stents superior to bare-metal stents in patients with unprotected non-bifurcational left main disease? Insights from a multicentre registry

European Heart Journal (2009)

Corrado Tamburino M. Salvo Davide Capodanno A Marzocchi Imad Sheiban

To compare long-term clinical outcome following drug-eluting stents (DES) or bare-metal stents (BMS) implantation on lesions located at the ostium or the shaft of the left main in a large real-world population. The advent of DES decreased the risk of unprotected left main coronary artery (ULMCA) restenosis when compared with BMS, but it is unclear if this advantage continues when non-bifurcational lesions are considered. The GISE-SICI registry is a retrospective, observational multicentre registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centres enrolled 1453 consecutive patients who underwent percutaneous coronary intervention on ULMCA between January 2002 and December 2006. From the registry, a total of 479 consecutive patients with ostial and shaft lesions who underwent DES (n = 334) or BMS (n = 145) implantation were analysed with extensive multivariable and propensity score adjustments. At 3-year follow-up, risk-adjusted survival rates were higher in patients treated with DES than in those treated with BMS. The adjusted hazard ratio (HR) for the risk of mortality after DES implantation relative to BMS implantation was 0.37 (95% CI: 0.15–0.96, P = 0.04). The adjusted HR for the risk of cardiac mortality was 0.31 (95% CI: 0.09–1.04, P = 0.06). The adjusted 3-year rates of target lesion revascularization (TLR) were not significantly lower in the DES group than in the BMS group (P = 0.60). In a large population of patients with lesions located at the ostium or the shaft of the left main in a real-world setting, DES were associated with favourable clinical outcomes when compared with BMS, although there was no evidence of a significant reduction in TLR with DES vs. BMS.

Ostium

Target lesion

10.1093/eurheartj/ehp052

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Citations (54)

Systematic review and meta‐analysis of currently available clinical evidence on migraine and patent foramen ovale percutaneous closure: Much ado about nothing?

Catheterization and Cardiovascular Interventions (2009)

Gianfranco Butera Giuseppe Biondi‐Zoccai Mário Carminati Luigi Caputi Susanna Usai

To investigate the role of transcatheter closure of patent foramen ovale on the occurrence of migraine.In recent years, a potential relationship between, migraine, stroke, and patent foramen ovale (PFO) has emerged.BioMedCentral, Google Scholar, and PubMed from January 2000 to December 2008 were systematically searched for pertinent clinical studies. Secondary sources were also used. Secondary prevention studies of transcatheter closure for patent foramen ovale were required to include at least more than 10 patients followed for more than 6 months. The primary end-point was the rate of cured or significantly improved migraine after percutaneous PFO closure.After excluding 637 citations, we finally included a total of 11 studies for a total of 1,306 patients. Forty percent of the subjects included suffered from migraine, while most had a previous history of transient ischemic attack/stroke and were investigated retrospectively. Quantitative synthesis showed that complete cure of migraine in 46% (95% C.I.25-67%), while resolution or significant improvement of migraine occurred in 83% (95% C.I. 78-88%) of cases.Notwithstanding the limitations inherent in the primary studies, this systematic review suggests that a significant group of subjects with migraine, in particular if treated after a neurological event, may benefit from percutaneous closure of their patent foramen ovale. However, many questions remain unsolved.

Stroke

Closure (psychology)

10.1002/ccd.22232

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Citations (51)

Remote ischaemic preconditioning in coronary artery bypass surgery: a meta-analysis

Heart (2012)

Fabrizio D’Ascenzo Erika Cavallero Claudio Moretti Pierluigi Omedè Filippo Sciuto

Aim

Randomised trials exploring remote ischaemic preconditioning (RIPC) in patients undergoing coronary artery bypass graft (CABG) surgery have yielded conflicting data regarding potential cardiovascular and renal protection, and are individually flawed by small sample size.

Methods

Three investigators independently searched the MEDLINE, EMBASE and Cochrane databases to identify randomised trials testing RIPC in patients undergoing CABG.

Results

Nine studies with 704 patients were included. Standardised mean difference of troponin I and T release showed a significant decrease (−0.36 (95% CI −0.62 to −0.09)). This difference held true after excluding the trials with cross-clamp fibrillation, the study with off-pump CABG and studies using a flurane as anaesthetic agent (−0.41 (95% CI −0.69 to −0.12), −0.38 (95% CI −0.70 to −0.07) and −0.37 (95% CI −0.63 to −0.12), respectively). A similar trend was also obtained for patients with multivessel disease (−0.41 (95% CI −0.73 to −0.08)). The trials evaluating postoperative creatinine reported a non-significant reduction (0.02 (95% CI −0.09 to 0.13)). Moreover, the length of in-hospital stay was not influenced by the kind of treatment (weighted mean difference 0.27 (95% CI −0.24 to 0.79)).

Conclusion

RIPC reduced the release of troponin in patients undergoing CABG. Larger randomised trials are needed to clarify the presence of a causal relationship between RIPC-induced troponin release and clinical adverse events.

Ischemic Preconditioning

10.1136/heartjnl-2011-301551

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Citations (86)

The future of new aortic valve replacement approaches

Future Cardiology (2010)

Mario Bollati Emanuele Tizzani Claudio Moretti Filippo Sciuto Pierluigi Omedè

Aortic valve disease is a growing cause of mortality and morbidity, especially in developed countries. Whereas medical therapy is associated with an ominous prognosis, since the 1970s, surgical valve replacement has represented a standard therapy for fit patients. Indeed, this approach is safe and feasible in younger patients without comorbidities. However, in unfit patients, surgery may be associated with a very high risk. The advent of transcatheter valve replacement techniques, by means of percutaneous or transapical approaches, has been recently introduced into mainstream clinical practice and is likely to radically change the treatment of aortic valve disease. At present, further data are needed to thoroughly appraise the long-term risk-benefit balance of transcatheter valve replacement techniques. For this reason, it can only be considered for high surgical risk patients, but early results are so promising that in the future, transcatheter aortic valve implantation could became the first therapeutic choice, even for low-risk patients.

Valve replacement

Medical Therapy

10.2217/fca.10.14

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Citations (5)

Incidence of Adverse Events at 3 Months Versus at 12 Months After Dual Antiplatelet Therapy Cessation in Patients Treated With Thin Stents With Unprotected Left Main or Coronary Bifurcations

The American Journal of Cardiology (2019)

Fabrizio D’Ascenzo Umberto Barbero Mohamed Abdirashid Daniela Trabattoni Giacomo Boccuzzi

10.1016/j.amjcard.2019.10.058

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Citations (11)

Use and Misuse of Multivariable Approaches in Interventional Cardiology Studies on Drug‐Eluting Stents: A Systematic Review

Journal of Interventional Cardiology (2012)

Fabrizio D’Ascenzo Erika Cavallero Giuseppe Biondi‐Zoccai Claudio Moretti Pierluigi Omedè

Aims: Randomized clinical trials (RCTs) are the most reliable evidence, even if they require important resource and logistic efforts. Large, cost‐free and real‐world datasets may be easily accessed yielding to observational studies, but such analyses often lead to problematic results in the absence of careful methods, especially from a statistic point of view. We aimed to appraise the performance of current multivariable approaches in the estimation of causal treatment and effects in studies focusing on drug‐eluting stents (DES). Methods and Results: Pertinent studies published in the literature were searched, selected, abstracted, and appraised for quality and validity features. Six studies with a logistic regression were included, all of them reporting more than 10 events for covariates and different length of follow‐up, with an overall low risk of bias. Most of the 15 studies with a Cox proportional hazard analysis had a different follow‐up, with less than 10 events for covariates, yielding an overall low or moderate risk of bias. Sixteen studies with propensity score were included: the most frequent method for variable selection was logistic regression, with underlying differences in follow‐up and less than 10 events for covariate in most of them. Most frequently, calibration appraisal was not reported in the studies, on the contrary of discrimination appraisal, which was more frequently performed. In seventeen studies with propensity and matching, the latter was most commonly performed with a nearest neighbor‐matching algorithm yet without appraisal in most of the studies of calibration or discrimination. Balance was evaluated in 46% of the studies, being obtained for all variables in 48% of them. Conclusions: Better exploitation and methodological appraisal of multivariable analysis is needed to improve the clinical and research impact and reliability of nonrandomized studies. (J Interven Cardiol 2012;25:611–621)

Critical appraisal

Statistic

10.1111/j.1540-8183.2012.00753.x

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Citations (54)