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Coronary Artery Disease: HELP
Articles by Sergio Leonardi
Based on 13 articles published since 2008
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Between 2008 and 2019, Sergio Leonardi wrote the following 13 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
1 Guideline A Multidisciplinary Approach on the Perioperative Antithrombotic Management of Patients With Coronary Stents Undergoing Surgery: Surgery After Stenting 2. 2018

Rossini, Roberta / Tarantini, Giuseppe / Musumeci, Giuseppe / Masiero, Giulia / Barbato, Emanuele / Calabrò, Paolo / Capodanno, Davide / Leonardi, Sergio / Lettino, Maddalena / Limbruno, Ugo / Menozzi, Alberto / Marchese, U O Alfredo / Saia, Francesco / Valgimigli, Marco / Ageno, Walter / Falanga, Anna / Corcione, Antonio / Locatelli, Alessandro / Montorsi, Marco / Piazza, Diego / Stella, Andrea / Bozzani, Antonio / Parolari, Alessandro / Carone, Roberto / Angiolillo, Dominick J / Anonymous911159 / Anonymous921159 / Anonymous931159 / Anonymous941159 / Anonymous951159 / Anonymous961159 / Anonymous971159 / Anonymous981159 / Anonymous991159 / Anonymous1001159 / Anonymous1011159 / Anonymous1021159 / Anonymous1031159 / Anonymous1041159 / Anonymous1051159 / Anonymous1061159 / Anonymous1071159 / Anonymous1081159 / Anonymous1091159 / Anonymous1101159 / Anonymous1111159 / Anonymous1121159 / Anonymous1131159. ·Dipartimento Emergenze e Aree Critiche, Ospedale Santa Croce e Carle, Cuneo, Italy. Electronic address: roberta.rossini2@gmail.com. · Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy. · Dipartimento Emergenze e Aree Critiche, Ospedale Santa Croce e Carle, Cuneo, Italy. · Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy. · Division of Cardiology, Department of Cardio-Thoracic Sciences, Università degli Studi della Campania "Luigi Vanvitelli," Naples, Italy. · Division of Cardiology, Cardio-Thoracic-Vascular Department, Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele, Catania, Italy; Department of General Surgery and Medical-Surgical Specialties, University of Catania, Catania, Italy. · Coronary Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · Cardiovascular Department, Humanitas Research Hospital, Rozzano, Italy. · U.O.C. Cardiologia, Azienda USL Toscana Sudest, Grosseto, Italy. · Unità Operativa di Cardiologia, Azienda Ospedaliero-Universitaria di Parma, Italy. · U.O.C. Cardiologia Interventistica, Anthea Hospital, GVM Care & Research, Bari, Italy. · Cardiology Unit, Cardio-Thoraco-Vascular Department, University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy. · Swiss Cardiovascular Centre Bern, Bern University Hospital, Bern, Switzerland. · Degenza Breve Internistica e Centro Trombosi ed Emostasi, Dipartimento di Medicina e Chirurgia, Università dell'Insubria, Varese, Italy. · Department of Immunohematology and Transfusion Medicine, Thrombosis and Hemostasis Center, ASST Papa Giovanni XXIII, Bergamo, Italy. · Department of Anaesthesia and Critical Care, AORN Dei Colli, Naples, Italy. · Dipartimento di Chirurgia Generale, Humanitas Research Hospital and University, Milano, Italy. · Policlinico Vittorio Emanuele di Catania, Catania, Italy. · Chirurgia Vascolare, Università di Bologna, Ospedale Sant'Orsola-Malpighi, Bologna, Italy. · UOC Chirurgia Vascolare, Dipartimento di Scienze Chirurgiche, Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy. · Dipartimento di Scienze Biomediche per la Salute, Policlinico San Donato IRCCS, University of Milano, Milan, Italy. · Azienda Ospedaliera Universitaria Città della salute e della scienza, Torino, Italy. · Division of Cardiology, University of Florida, College of Medicine-Jacksonville, Jacksonville, Florida. ·JACC Cardiovasc Interv · Pubmed #29519377.

ABSTRACT: Perioperative management of antithrombotic therapy in patients treated with coronary stents undergoing surgery remains poorly defined. Importantly, surgery represents a common reason for premature treatment discontinuation, which is associated with an increased risk in mortality and major adverse cardiac events. However, maintaining antithrombotic therapy to minimize the incidence of perioperative ischemic complications may increase the risk of bleeding complications. Although guidelines provide some recommendations with respect to the perioperative management of antithrombotic therapy, these have been largely developed according to the thrombotic risk of the patient and a definition of the hemorrhagic risk specific to each surgical procedure, key to defining the trade-off between ischemia and bleeding, is not provided. These observations underscore the need for a multidisciplinary collaboration among cardiologists, anesthesiologists, hematologists and surgeons to reach this goal. The present document is an update on practical recommendations for standardizing management of antithrombotic therapy management in patients treated with coronary stents (Surgery After Stenting 2) in various types of surgery according to the predicted individual risk of thrombotic complications against the anticipated risk of surgical bleeding complications. Cardiologists defined the thrombotic risk using a "combined ischemic risk" approach, while surgeons classified surgeries according to their inherent hemorrhagic risk. Finally, a multidisciplinary agreement on the most appropriate antithrombotic treatment regimen in the perioperative phase was reached for each surgical procedure.

2 Editorial Peri-procedural myocardial infarction and troponism: a quick journey through the land of confusion. 2012

Valgimigli, Marco / Leonardi, Sergio. · ·Heart · Pubmed #22965794.

ABSTRACT: -- No abstract --

3 Review Cangrelor: review of the drug and the CHAMPION programme (including PHOENIX). 2014

Marino, Marcello / Rizzotti, Diego / Leonardi, Sergio. ·University of Pavia, Pavia, Italy. ·Curr Cardiol Rep · Pubmed #24879371.

ABSTRACT: Platelet inhibition is the main goal of ancillary pharmacologic therapy during percutaneous coronary interventions (PCI). Thienopyridines and ticagrelor are oral drugs developed for this purpose. Cangrelor is an intravenous, non-thienopyridine antagonist of the P2Y12 receptor with a rapid, potent, predictable, and quickly reversible effect. Cangrelor has been studied in a broad population intended to receive PCI in the CHAMPION program, where it was compared with different clopidogrel regimens. The first two trials, CHAMPION PCI and PLATFORM, failed their primary objective, likely for challenges in the adjudication of PCI-related myocardial infarction. In a third trial that implemented the universal definition of MI, CHAMPION PHOENIX, a reduction of thrombotic events, including stent thrombosis, was observed. In the BRIDGE trial cangrelor has been studied in patients who had to prematurely interrupt antiplatelet therapy for surgery. Cangrelor appears a promising agent in patients who require PCI or when a rapid reversal is needed.

4 Clinical Trial Rationale and design of the randomized, double-blind trial testing INtraveNous and Oral administration of elinogrel, a selective and reversible P2Y(12)-receptor inhibitor, versus clopidogrel to eVAluate Tolerability and Efficacy in nonurgent Percutaneous Coronary Interventions patients (INNOVATE-PCI). 2010

Leonardi, Sergio / Rao, Sunil V / Harrington, Robert A / Bhatt, Deepak L / Gibson, C Michael / Roe, Matthew T / Kochman, Janusz / Huber, Kurt / Zeymer, Uwe / Madan, Mina / Gretler, Daniel D / McClure, Matthew W / Paynter, Gayle E / Thompson, Vivian / Welsh, Robert C. ·Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. sergio.leonardi@duke.edu ·Am Heart J · Pubmed #20598974.

ABSTRACT: Despite current dual-antiplatelet therapy with aspirin and clopidogrel, adverse clinical events continue to occur during and after percutaneous coronary intervention (PCI). The failure of clopidogrel to provide optimal protection may be related to delayed onset of action, interpatient variability in its effect, and an insufficient level of platelet inhibition. Furthermore, the irreversible binding of clopidogrel to the P2Y(12) receptor for the life span of the platelet is associated with increased bleeding risk especially during urgent or emergency surgery. Novel antiplatelet agents are required to improve management of patients undergoing PCI. Elinogrel is a potent, direct-acting (ie, non-prodrug), selective, competitive, and reversible P2Y(12) inhibitor available in both intravenous and oral formulations. The INNOVATE-PCI study is a phase 2 randomized, double-blind, clopidogrel-controlled trial to evaluate the safety, tolerability, and preliminary efficacy of this novel antiplatelet agent in patients undergoing nonurgent PCI.

5 Article Dual versus triple therapy in patients on oral anticoagulants and undergoing coronary stent implantation: A systematic review and meta-analysis. 2018

Fortuni, Federico / Ferlini, Marco / Leonardi, Sergio / Angelini, Filippo / Crimi, Gabriele / Somaschini, Alberto / Cornara, Stefano / Potenza, Antonella / De Servi, Stefano / Oltrona Visconti, Luigi / De Ferrari, Gaetano Maria. ·Coronary Care Unit and Laboratory of Clinical and Experimental Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Department of Molecular Medicine, University of Pavia, Pavia, Italy. · Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. Electronic address: marco.ferlini@gmail.com. · Coronary Care Unit and Laboratory of Clinical and Experimental Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · Division of Cardiology, University of Torino, Città della Salute e della Scienza Hospital, Italy. · Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · IRCCS Multimedica, Sesto San Giovanni, Milan, Italy. ·Int J Cardiol · Pubmed #30115419.

ABSTRACT: BACKGROUND AND AIMS: There is contrasting evidence regarding the optimal antithrombotic regimen after percutaneous coronary stent implantation in patients on oral anticoagulants. A systematic review and meta-analysis was performed to explore the comparative efficacy and safety of dual (an antiplatelet plus an oral anticoagulant) versus triple therapy (dual antiplatelet therapy plus an oral anticoagulant). METHODS: We searched the literature for randomized controlled trials (RCTs) or observational studies (OSs) addressing this issue. The efficacy outcomes were all-cause mortality, cardiovascular mortality, myocardial infarction and stent thrombosis. The safety outcomes were major bleeding events and all bleeding events. The analyses were stratified by type of anticoagulant and of antiplatelet used in dual therapy. RESULTS: Four RCTs and ten OSs met our inclusion criteria including a total of 10,126 patients. 5671 patients received triple therapy whereas 4455 received dual therapy. Median follow up was 12 months. There was no difference between dual therapy and triple therapy regarding efficacy outcomes. Dual therapy significantly reduced the risk of major bleeding (RR 0.66; CI 95% 0.52-0.83; P = 0.0005) and of all bleeding events (RR 0.67, CI 95% 0.55-0.80; P < 0.0001). The effect was consistent regardless of the type of antiplatelet and anticoagulant used in dual therapy. CONCLUSION: Dual antithrombotic therapy after coronary stenting in anticoagulated patients significantly reduces bleeding events compared with triple therapy. Dual therapy might be considered in this setting especially when bleeding risk outweighs ischemic risk, although our study was not sufficiently powered to detect a difference in ischemic endpoints.

6 Article Short- and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention: insights from four validated bleeding scales in the CHAMPION trials. 2018

Vaduganathan, Muthiah / Harrington, Robert A / Stone, Gregg W / Steg, Gabriel / Gibson, C Michael / Hamm, Christian W / Price, Matthew J / Lopes, Renato D / Leonardi, Sergio / Deliargyris, Efthymios N / Prats, Jayne / Mahaffey, Kenneth W / White, Harvey D / Bhatt, Deepak L. ·Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA. ·EuroIntervention · Pubmed #28988157.

ABSTRACT: AIMS: The aim of this study was to determine the prognostic significance of periprocedural bleeding based on various definitions on 30-day and one-year all-cause mortality in patients undergoing routine or urgent percutaneous coronary intervention (PCI). METHODS AND RESULTS: In this exploratory analysis of 25,107 patients enrolled in the three phase-3 CHAMPION trials, we assessed the prognostic impact of four bleeding scales (GUSTO, TIMI, ACUITY, and BARC) at 48 hrs. Follow-up all-cause mortality data were available at 30 days in all three trials, and at one year in CHAMPION PCI and CHAMPION PLATFORM. Bleeding rates within 48 hrs of PCI were variably identified by each clinical definition (range: <0.5% to >3.5%). Severe/major bleeding, measured by all bleeding scales, and blood transfusion requirement were independently associated with increased mortality at 30 days and one year after PCI (p<0.001 for all associations). Mild/minor bleeding was not independently predictive of one-year mortality (p>0.07 for all associations). Each bleeding definition demonstrated only modest ability to discriminate 30-day and one-year mortality (adjusted C-statistics range: 0.49 to 0.67). CONCLUSIONS: Commonly employed clinical definitions variably identify rates of bleeding after PCI. Severe or major, but not mild or minor, bleeding is independently associated with increased 30-day and one-year mortality. These data may aid in selection of appropriate bleeding metrics in future clinical trials.

7 Article APpropriAteness of percutaneous Coronary interventions in patients with ischaemic HEart disease in Italy: the APACHE pilot study. 2017

Leonardi, Sergio / Marino, Marcello / Crimi, Gabriele / Maiorana, Florinda / Rizzotti, Diego / Lettieri, Corrado / Bettari, Luca / Zuccari, Marco / Sganzerla, Paolo / Tresoldi, Simone / Adamo, Marianna / Ghiringhelli, Sergio / Sponzilli, Carlo / Pasquetto, Giampaolo / Pavei, Andrea / Pedon, Luigi / Bassan, Luciano / Bollati, Mario / Camisasca, Paola / Trabattoni, Daniela / Brancati, Marta / Poli, Arnaldo / Panciroli, Claudio / Lettino, Maddalena / Tarelli, Giuseppe / Tarantini, Giuseppe / De Luca, Leonardo / Varbella, Ferdinando / Musumeci, Giuseppe / De Servi, Stefano. ·Coronary Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · Cardiology, Ospedale Maggiore di Crema, Crema, Italy. · Cardiology, ASST Mantova-Ospedale Carlo Poma, Mantova, Italy. · Cardiology, ASST Cremona-Ospedale di Cremona, Cremona, Italy. · Cardiology, Ospedale Fornaroli di Magenta, Magenta, Italy. · Cardiology, ASST Bergamo Ovest-Ospedale di Treviglio, Treviglio, Italy. · Cardiology, Azienda Ospedaliera di Desio e Vimercate, Vimercate, Italy. · Cardiology, Spedali Civili di Brescia, Brescia, Italy. · Cardiology, Ospedale di Circolo Fondazione Macchi, Varese, Italy. · Cardiology, Ospedale San Paolo, Milano, Italy. · Cardiology, Ospedali Riuniti Padova Sud Madre Teresa di Calcutta, Monselice, Italy. · Cardiology, Presidio Ospedaliero di Conegliano, Conegliano, Italy. · Cardiology, Presidio Ospedaliero di Cittadella, Cittadella, Italy. · Cardiology, ULSS 4 Alto Vicentino, Thiene, Italy. · Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Italy. · Cardiology, Ospedale San Gerardo, Monza, Italy. · Cardiology, Centro Cardiologico Monzino, Milano, Italy. · Cardiology, Fondazione Poliambulanza, Milano, Italy. · Cardiology, ASST Ovest Milanese, Legnano, Italy. · Cardiology, ASST di Lodi, Lodi, Italy. · Cardiology, Humanitas Research Hospital, Rozzano, Italy. · Cardiology, Ospedale di Padova, Padova, Italy. · Cardiology, Ospedale San Giovanni Evangelista, Tivoli, Italy. · Cardiology, Ospedale degli Infermi, Rivoli, Italy. · Cardiology, ASST-Papa Giovanni XXIII-Bergamo, Bergamo, Italy. · Cardiology, IRCCS MultiMedica, Milano, Italy. ·BMJ Open · Pubmed #28877948.

ABSTRACT: OBJECTIVES: To first explore in Italy appropriateness of indication, adherence to guideline recommendations and mode of selection for coronary revascularisation. DESIGN: Retrospective, pilot study. SETTING: 22 percutaneous coronary intervention (PCI)-performing hospitals (20 patients per site), 13 (59%) with on-site cardiac surgery. PARTICIPANTS: 440 patients who received PCI for stable coronary artery disease (CAD) or non-ST elevation acute coronary syndrome were independently selected in a 4:1 ratio with half diabetics. PRIMARY AND SECONDARY OUTCOME MEASURES: Proportion of patients who received appropriate PCI using validated appropriate use scores (ie, AUS≥7). Also, in patients with stable CAD, we examined adherence to the following European Society of Cardiology recommendations: (A) per cent of patients with complex coronary anatomy treated after heart team discussion; (B) per cent of fractional flow reserve-guided PCI for borderline stenoses in patients without documented ischaemia; (C) per cent of patients receiving guideline-directed medical therapy at the time of PCI as well as use of provocative test of ischaemia according to pretest probability (PTP) of CAD. RESULTS: Of the 401 mappable PCIs (91%), 38.7% (95% CI 33.9 to 43.6) were classified as appropriate, 47.6% (95% CI 42.7 to 52.6) as uncertain and 13.7% (95% CI 10.5% to 17.5%) as inappropriate. Median PTP in patients with stable CAD without known coronary anatomy was 69% (78% intermediate PTP, 22% high PTP). Ischaemia testing use was similar (p=0.71) in patients with intermediate (n=140, 63%) and with high PTP (n=40, 66%). In patients with stable CAD (n=352) guideline adherence to the three recommendations explored was: (A) 11%; (B) 25%; (C) 23%. AUS was higher in patients evaluated by the heart team as compared with patients who were not (7 (6.8) vs 5 (4.7); p=0.001). CONCLUSIONS: Use of heart team approaches and adherence to guideline recommendations on coronary revascularisation in a real-world setting is limited. This pilot study documents the feasibility of measuring appropriateness and guideline adherence in clinical practice and identifies substantial opportunities for quality improvement. TRIAL REGISTRATION NUMBER: NCT02748603.

8 Article Aspirin Desensitization in Patients With Coronary Artery Disease: Results of the Multicenter ADAPTED Registry (Aspirin Desensitization in Patients With Coronary Artery Disease). 2017

Rossini, Roberta / Iorio, Annamaria / Pozzi, Roberto / Bianco, Matteo / Musumeci, Giuseppe / Leonardi, Sergio / Lettieri, Corrado / Bossi, Irene / Colombo, Paola / Rigattieri, Stefano / Dossena, Cinzia / Anzuini, Angelo / Capodanno, Davide / Senni, Michele / Angiolillo, Dominick J. ·From the Dipartimento Cardiovascolare, ASST Papa Giovanni XXIII, Bergamo, Italy (R.R., A.I., G.M., M.S.) · Division of Cardiology, A.O.U San Luigi Gonzaga, Orbassano, Torino, Italy (R.P., M.B.) · IRCCS Fondazione Policlinico S. Matteo, Pavia, Italy (S.L.) · Divisione di Cardiologia, Ospedale Carlo Poma, Mantova, Italy (C.L.) · Cardiologia 1 Emodinamica, Dipartimento Cardiovascolare, ASST Niguarda Grande Ospedale Metropolitano, Milano, Italy (I.B., P.C.) · U.O. Emodinamica, Ospedale Sandro Pertini, Roma, Italy (S.R.) · Università degli Studi di Pavia, Italy (C.D.) · Unità operativa di Cardiologia, Humanitas Mater Domini, Castellanza (Varese), Italy (A.A.) · Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Italy (D.C.) · and Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.). ·Circ Cardiovasc Interv · Pubmed #28193678.

ABSTRACT: BACKGROUND: There are limited data on aspirin (ASA) desensitization for patients with coronary artery disease. The aim of the present study was to assess the safety and efficacy of a standard rapid desensitization protocol in patients with ASA sensitivity undergoing coronary angiography. METHODS AND RESULTS: This is a prospective, multicenter, observational study including 7 Italian centers including patients with a history of ASA sensitivity undergoing coronary angiography with intent to undergo percutaneous coronary intervention. A total of 330 patients with history of ASA sensitivity with known/suspected stable coronary artery disease or presenting with an acute coronary syndrome, including ST-segment-elevation myocardial infarction were enrolled. Adverse effects to aspirin included urticaria (n=177, 53.6%), angioedema (n=69, 20.9%), asthma (n=65, 19.7%), and anaphylactic reaction (n=19, 5.8%). Among patients with urticaria/angioedema, 13 patients (3.9%) had a history of idiopathic chronic urticaria. All patients underwent a rapid ASA (5.5 hours) desensitization procedure. The desensitization procedure was performed before cardiac catheterization in all patients, except for those (n=78, 23.6%) presenting with ST-segment-elevation myocardial infarction who underwent the desensitization after primary percutaneous coronary intervention. Percutaneous coronary intervention was performed in 235 patients (71%) of the overall study population. The desensitization procedure was successful in 315 patients (95.4%) and in all patients with a history of anaphylactic reaction. Among the 15 patients (4.6%) who did not successfully respond to the desensitization protocol, adverse reactions were minor and responded to treatment with corticosteroids and antihistamines. Among patients with successful in-hospital ASA desensitization, 253 patients (80.3%) continued ASA for at least 12 months. Discontinuation of ASA in the 62 patients (19.7%) who had responded to the desensitization protocol was because of medical decision and not because of hypersensitivity reactions. CONCLUSIONS: A standard rapid desensitization protocol is safe and effective across a broad spectrum of patients, irrespective of the type of aspirin sensitivity manifestation, with indications to undergo coronary angiography with intent to perform percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02848339.

9 Article Comparison of Outcomes of Staged Complete Revascularization Versus Culprit Lesion-Only Revascularization for ST-Elevation Myocardial Infarction and Multivessel Coronary Artery Disease. 2017

Marino, Marcello / Crimi, Gabriele / Leonardi, Sergio / Ferlini, Marco / Repetto, Alessandra / Camporotondo, Rita / Demarchi, Andrea / De Pascali, Ilaria / Falcinella, Francesca / Oltrona Visconti, Luigi / De Servi, Stefano / Ferrario, Maurizio / De Ferrari, Gaetano Maria / Gnecchi, Massimiliano. ·Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Department of Molecular Medicine, University of Pavia, Pavia, Italy. · Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Coronary Care Unit and Laboratory for Clinical and Experimental Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · Coronary Care Unit and Laboratory for Clinical and Experimental Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · Department of Molecular Medicine, University of Pavia, Pavia, Italy; Coronary Care Unit and Laboratory for Clinical and Experimental Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · Department of Molecular Medicine, University of Pavia, Pavia, Italy; Coronary Care Unit and Laboratory for Clinical and Experimental Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. Electronic address: g.deferrari@smatteo.pv.it. · Department of Molecular Medicine, University of Pavia, Pavia, Italy; Coronary Care Unit and Laboratory for Clinical and Experimental Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Department of Medicine, University of Cape Town, Cape Town, South Africa. ·Am J Cardiol · Pubmed #28007297.

ABSTRACT: The management of noninfarct-related arteries in patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary disease (MVD) is still debated. We evaluated the prognostic impact of staged complete revascularization with percutaneous coronary intervention (PCI) in STEMI patients with MVD admitted to our hospital from 2005 to 2013. Patients undergoing staged complete revascularization (n = 300) were compared with 1:1 propensity score-matched patients with culprit lesion-only treatment (n = 300). We considered a composite primary end point of all-cause death, myocardial infarction, and urgent PCI. Secondary end points included components of the primary, cardiovascular death, any PCI excluding staged PCI. We also performed an analysis including only patients surviving at least 5 days. The median follow-up was 553 days. The primary end point occurred in 10.3% of patients in the staged complete revascularization group and in 16.3% of patients in the culprit lesion-only group (hazard ratio 0.61, 95% CI 0.38 to 0.95, p = 0.031). Although this difference was no longer significant when considering only the survivors at day 5, all-cause and cardiovascular mortalities were still reduced in the staged complete revascularization group. Complete revascularization was associated with a better outcome (hazard ratio 0.35, 95% CI 0.17 to 0.63, p = 0.005) if performed within 30 days of STEMI. In conclusion, compared with culprit lesion-only revascularization, in STEMI patients with MVD undergoing primary PCI, an approach of staged complete revascularization was associated with a better outcome.

10 Article Left main or proximal left anterior descending coronary artery disease location identifies high-risk patients deriving potentially greater benefit from prolonged dual antiplatelet therapy duration. 2016

Costa, Francesco / Adamo, Marianna / Ariotti, Sara / Ferrante, Giuseppe / Navarese, Eliano Pio / Leonardi, Sergio / Garcia-Garcia, Hector / Vranckx, Pascal / Valgimigli, Marco. ·Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #26342472.

ABSTRACT: AIMS: It is currently unclear if the location of coronary artery disease affects decision making with regard to dual antiplatelet therapy (DAPT). We investigated if the presence of at least 30% luminal narrowing in the left main (LM) and/or proximal left anterior descending (pLAD) coronary arteries on angiography is an outcome modifier with respect to DAPT duration. METHODS AND RESULTS: In the Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) study, 953 (54.3%) patients with and 801 (45.7%) without LM/pLAD lumen narrowing at the qualifying coronary intervention were randomised to six or 24 months of DAPT. Twenty-four month as compared to six-month DAPT reduced the occurrence of definite, probable or possible stent thrombosis by 50% in patients with (2.8% vs. 5.6%; HR 0.45, 95% CI: 0.23-0.89; p=0.02) but not in those without LM/pLAD lumen narrowing, with a highly significant interaction testing (PINT= 0.002). This result remained consistent irrespective of whether stenting was (PINT: 0.01) or was not (PINT: 0.02) performed in the LM/pLAD. CONCLUSIONS: Left main and/or proximal LAD lumen narrowing may be a treatment modifier with respect to the duration of DAPT. Patients fulfilling these angiographic characteristics seem to benefit from a prolonged dual antiplatelet treatment. Trial registration: ClinicalTrials.gov Identifier: NCT00611286

11 Article Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation: a pre-specified analysis from the PRODIGY (Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial. 2015

Costa, Francesco / Vranckx, Pascal / Leonardi, Sergio / Moscarella, Elisabetta / Ando, Giuseppe / Calabro, Paolo / Oreto, Giuseppe / Zijlstra, Felix / Valgimigli, Marco. ·Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, The Netherlands Department of Clinical and Experimental Medicine, Policlinico 'G. Martino', University of Messina, Italy. · Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium. · Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy. · Division of Cardiology, Department of Cardiothoracic Sciences, Second University of Naples, Naples, Italy. · Department of Clinical and Experimental Medicine, Policlinico 'G. Martino', University of Messina, Italy. · Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, The Netherlands. · Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, The Netherlands m.valgimigli@erasmusmc.nl vlgmrc@unife.it. ·Eur Heart J · Pubmed #25718355.

ABSTRACT: AIMS: We investigated if acute coronary syndrome (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual-antiplatelet therapy (DAPT) in patients undergoing coronary stenting. METHODS AND RESULTS: In the Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) trial, a total of 1465 (74.3%) patients presented ACS whereas 505 (25.7%) had SCAD and were randomized to 6- or 24-month DAPT. At 24 months, the composite of death, myocardial infarction (MI), or cerebrovascular accident (CVA) did not differ between the long- and short-term DAPT arms in both ACS (11.1 vs. 11.7%; P = 0.67) and SCAD (7.5 vs. 4.8%; P = 0.21) patients, respectively. Long-term DAPT was associated with a 75% increase of Bleeding Academic Research Consortium (BARC)-class 2, 3, or 5 bleeding in ACS [7.1 vs. 4.1%; hazard ratio (HR) 1.75, 95% confidence interval (CI) 1.11-2.74, P = 0.015; number needed to treat for harm (NNTH): 33.3] and a five-fold increase in SCAD (8.2 vs. 1.6%; HR 5.37, 95% CI 1.84-15.74, P = 0.002; NNTH: 15.1) patients, with a borderline quantitative interaction (PINT = 0.056). As a result, net adverse cardiovascular events (death, MI, CVA, BARC class 2, 3, or 5 bleeding) were more than doubled in SCAD patients receiving 24-month DAPT, whereas they did not differ in ACS patients (PINT = 0.024). CONCLUSIONS: This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD-but not ACS-patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24-month compared with 6-month therapy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00611286. http://clinicaltrials.gov/ct2/show/NCT00611286?term=prodigy&rank=2.

12 Article Incidence, prognostic impact, and optimal definition of contrast-induced acute kidney injury in consecutive patients with stable or unstable coronary artery disease undergoing percutaneous coronary intervention. insights from the all-comer PRODIGY trial. 2015

Crimi, Gabriele / Leonardi, Sergio / Costa, Francesco / Ariotti, Sara / Tebaldi, Matteo / Biscaglia, Simone / Valgimigli, Marco. ·Cardiology Department, Foundation IRCCS Policlinico San Matteo, Pavia, Italy. · Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands. · Cardiology Department, University of Ferrara, Ferrara, Italy. ·Catheter Cardiovasc Interv · Pubmed #25703119.

ABSTRACT: BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) is associated with poor outcome. Whether this association differs in stable coronary artery disease (CAD) as compared to acute coronary syndrome (ACS) patients is unknown. Definitions and Methods: PRODIGY trial patients were defined as stable CAD or ACS according to the initial presentation. CI-AKI was defined as an increase (Δ) of serum creatinine (SCr) ≥25% above baseline. Two endpoints were considered: all-cause death and the composite of death, stroke, or myocardial infarction (MI). The interaction between CI-AKI, clinical setting, and the impact of increasing ΔSCr% cut-offs were also explored. RESULTS: Two thousand three patients were enrolled in the PRODIGY trial, 85 patients were excluded for missing SCr data, leading to a population of 1,918 patients. CI-AKI incidence was 6.7% in stable CAD and 12.2% in ACS patients. CI-AKI was associated with all-cause mortality [adjusted hazard ratio (aHR) of 2.05, 95% confidence interval (CI) 1.38-3.05, P < 0.001] and the composite of death, stroke, or MI [aHR of 1.49, 95% CI 1.13-1.97, P < 0.001]. The risk of CI-AKI for the composite endpoint was higher in stable CAD, P for interaction: 0.048. A ΔSCr of 35% was associated with the highest aHR for all-cause mortality: 2.34 [95% CI, 1.46-3.76, P < 0.001] and the composite of death, stroke, or MI: 1.70 [95% CI, 1.20-2.40, P > 0.001]. CONCLUSIONS: In a large, contemporary, all-comers percutaneous coronary intervention population, CI-AKI was associated with an increased risk of all-cause death and the composite of death, stroke, or MI. While CI-AKI is more common in ACS than in stable CAD patients, its adjusted prognostic impact on the composite endpoint appears to be more pronounced in patients with stable CAD.

13 Article Rationale and design of the Cangrelor versus standard therapy to acHieve optimal Management of Platelet InhibitiON PHOENIX trial. 2012

Leonardi, Sergio / Mahaffey, Kenneth W / White, Harvey D / Gibson, C Michael / Stone, Gregg W / Steg, Gabriel W / Hamm, Christian W / Price, Matthew J / Todd, Meredith / Dietrich, Markus / Gallup, Dianne / Liu, Tiepu / Skerjanec, Simona / Harrington, Robert A / Bhatt, Deepak L. ·Duke Clinical Research Institute, Durham, NC, USA. ·Am Heart J · Pubmed #22607853.

ABSTRACT: BACKGROUND: Despite robust efficacy in the reduction of ischemic events in patients who require percutaneous coronary intervention (PCI), current P2Y(12) inhibitors have limitations. In particular, they require hours to be effective, and they can only be administered orally. Cangrelor is an intravenous, potent, and reversible P2Y(12) inhibitor with fast onset and offset of action. We designed CHAMPION PHOENIX to evaluate the efficacy and safety of cangrelor in patients with atherosclerosis undergoing PCI. TRIAL DESIGN: The CHAMPION PHOENIX is a randomized, double-blind, double-dummy, superiority trial comparing cangrelor with clopidogrel standard of care in approximately 10,900 patients who have not previously received a P2Y(12) inhibitor and who require PCI, including patients with stable angina and with acute coronary syndromes (with or without ST-segment elevation). The primary objective of the study is to demonstrate that cangrelor will reduce the incidence of the composite of death, myocardial infarction (MI), ischemia-driven revascularization, or stent thrombosis in the 48 hours after randomization compared with clopidogrel without excessive periprocedural bleeding. The key secondary objective is to demonstrate that cangrelor will reduce the incidence of stent thrombosis. Myocardial infarction will be defined according to the universal MI definition, adapting the definition of PCI-related (type 4a) MI. Bleeding will be assessed according to the thrombolysis in myocardial infarction, GUSTO, and Bleeding Academic Research Consortium (BARC) scales. CONCLUSION: The CHAMPION PHOENIX may establish the role of cangrelor in the care of patients who require PCI across the spectrum of stable and unstable coronary diseases in the setting of current treatment strategies.