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1. Acute Kidney Injury After Radial or Femoral Access for Invasive Acute Coronary Syndrome Management

Author

Giuseppe Andò, Bernardo Cortese, Filippo Russo, Martina Rothenbühler, Enrico Frigoli, Giuseppe Gargiulo, Carlo Briguori, Pascal Vranckx, Sergio Leonardi, Vincenzo Guiducci, Flavia Belloni, Fabio Ferrari, Jose Maria de la Torre Hernandez, Salvatore Curello, Francesco Liistro, Andrea Perkan, Stefano De Servi, Gavino Casu, Antonio Dellavalle, Dionigi Fischetti, Antonio Micari, Bruno Loi, Fabio Mangiacapra, Nunzio Russo, Fabio Tarantino, Francesco Saia, Dik Heg, Stephan Windecker, Peter Jüni, Marco Valgimigli, Maria Salomone, Pierpaolo Occhilupo, Veronica Lodolini, Monia Monti, Maria Grazia Mazzone, Erika Delos, Maria Teresa Caruso, Maggie Testa, Nestor Ciociano, Maurizio Lazzero, Davide Gazzotti, Lorenzo Cagliari, Leila Shahmohammadi, Martina Caiazza, Vittorio Virga, Elena Guerra, Eva Michalska, Sara Castellini, Vincenzo Serino, Gabriella Visconti, Gianluca Pendenza, Monica Portolan, Marco Anzini, Elisa Silvetti, Tiziana Coco, Francesco Costa, Sara Ariotti, Linda Valli, Marianna Adamo, Marcello Marino, Pierluigi Tricoci, Andrea Gagnor, Paolo Calabrò, Paolo Rubartelli, Stefano Garducci, Andrea Santarelli, Mario Galli, Roberto Garbo, Ezio Bramucci, Salvatore Ierna, Ugo Limbruno, Roberto Violini, Patrizia Presbitero, Nicoletta de Cesare, Paolo Sganzerla, Arturo Ausiello, Paolo Tosi, Gennaro Sardella, Manel Sabate’, Salvatore Brugaletta, Giovanni Saccone, Pietro Vandoni, Antonio Zingarelli, Armando Liso, Stefano Rigattieri, Emilio Di Lorenzo, Carlo Vigna, Cataldo Palmieri, Camillo Falcone, Raffaele De Caterina, Marcello Caputo, Giovanni Esposito, Alessandro Lupi, Pietro Mazzarotto, Fernando Varbella, Tiziana Zaro, Marco Nazzaro, Sunil V. Rao, Arnoud W.J. van‘t Hof, Elmir Omerovic, Gianluca Campo, Lucia Uguccioni, Corrado Tamburino, Dennis Zavalloni-Parenti, Roberto Ceravolo, Giampaolo Pasquetto, Stefano Mameli, Maria Letizia Stochino, Alberto Cremonesi, Fabio abate, Andrea Picchi, Salvatore Colangelo, Giacomo Boccuzzi, Ferdinando Varbella, Stefano Tresoldi, Marco Contarini, Rosario Evola, Manuela Creaco, Antonio Colombo, Alaide Chieffo, Alessandro Sciahbasi, Edoardo Pucci, Enrico Romagnoli, Claudio Moretti, Luciano Moretti, Marco Zimmarino, Maurizio Ferrario, Maurizio Turturo, Roberto Bonmassari, Carlo Penzo, Ciro Mauro, Anna Sonia Petronio, Gabriele Gabrielli, Francesco Amico, Marco Comeglio, Claudio Fresco, Nicolas Van Mieghem, Roberto Diletti, Evelyn Regar, Manel Sabaté, Joan Antoni Gómez Hospital, José Francisco Díaz Fernández, and Vicente Mainar

Subjects
medicine.medical_specialty, Acute coronary syndrome, estimated glomerular filtration rate, medicine.medical_treatment, Renal function, ST-segment elevation, 030204 cardiovascular system & hematology, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, bleeding, coronary intervention, creatinine, 0302 clinical medicine, Internal medicine, medicine, 030212 general & internal medicine, Dialysis, Creatinine, business.industry, Acute kidney injury, Odds ratio, medicine.disease, Confidence interval, Surgery, chemistry, Cardiology and Cardiovascular Medicine, business, Kidney disease
Abstract

Background It remains unclear whether radial access (RA), compared with femoral access (FA), mitigates the risk of acute kidney injury (AKI). Objectives The authors assessed the incidence of AKI in patients with acute coronary syndrome (ACS) enrolled in the MATRIX-Access (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial. Methods Among 8,404 patients, 194 (2.3%) were excluded due to missing creatinine values, no or an incomplete coronary angiogram, or previous dialysis. The primary AKI-MATRIX endpoint was AKI, defined as an absolute (>0.5 mg/dl) or a relative (>25%) increase in serum creatinine (sCr). Results AKI occurred in 634 patients (15.4%) with RA and 712 patients (17.4%) with FA (odds ratio [OR]: 0.87; 95% confidence interval [CI]: 0.77 to 0.98; p = 0.0181). A >25% sCr increase was noted in 633 patients (15.4%) with RA and 710 patients (17.3%) with FA (OR: 0.87; 95% CI: 0.77 to 0.98; p = 0.0195), whereas a >0.5 mg/dl absolute sCr increase occurred in 175 patients (4.3%) with RA versus 223 patients (5.4%) with FA (OR: 0.77; 95% CI: 0.63 to 0.95; p = 0.0131). By implementing the Kidney Disease Improving Global Outcomes criteria, AKI was 3-fold less prevalent and trended lower with RA (OR: 0.85; 95% CI: 0.70 to 1.03; p = 0.090), with stage 3 AKI occurring in 28 patients (0.68%) with RA versus 46 patients (1.12%) with FA (p = 0.0367). Post-intervention dialysis was needed in 6 patients (0.15%) with RA and 14 patients (0.34%) with FA (p = 0.0814). Stratified analyses suggested greater benefit with RA than FA in patients at greater risk for AKI. Conclusions In ACS patients who underwent invasive management, RA was associated with a reduced risk of AKI compared with FA. (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627 )

Published
2017
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2. Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial

Author

Marco Valgimigli, Enrico Frigoli, Sergio Leonardi, Pascal Vranckx, Martina Rothenbühler, Matteo Tebaldi, Ferdinando Varbella, Paolo Calabrò, Stefano Garducci, Paolo Rubartelli, Carlo Briguori, Giuseppe Andó, Maurizio Ferrario, Ugo Limbruno, Roberto Garbo, Paolo Sganzerla, Filippo Russo, Marco Nazzaro, Alessandro Lupi, Bernardo Cortese, Arturo Ausiello, Salvatore Ierna, Giovanni Esposito, Giuseppe Ferrante, Andrea Santarelli, Gennaro Sardella, Nicoletta de Cesare, Paolo Tosi, Arnoud van 't Hof, Elmir Omerovic, Salvatore Brugaletta, Stephan Windecker, Dik Heg, Peter Jüni, Gianluca Campo, Lucia Uguccioni, Corrado Tamburino, Patrizia Presbitero, Dennis Zavalloni-Parenti, Fabio Ferrari, Roberto Ceravolo, Fabio Tarantino, Giampaolo Pasquetto, Gavino Casu, Stefano Mameli, Maria Letizia Stochino, Pietro Mazzarotto, Alberto Cremonesi, Francesco Saia, Giovanni Saccone, Fabio Abate, Andrea Picchi, Roberto Violini, Salvatore Colangelo, Giacomo Boccuzzi, Vincenzo Guiducci, Carlo Vigna, Antonio Zingarelli, Andrea Gagnor, Tiziana Zaro, Simone Tresoldi, Pietro Vandoni, Marco Contarini, Armando Liso, Antonio Dellavalle, Salvatore Curello, Fabio Mangiacapra, Rosario Evola, Cataldo Palmieri, Camillo Falcone, Francesco Liistro, Manuela Creaco, Antonio Colombo, Alaide Chieffo, Andrea Perkan, Stefano De Servi, Dionigi Fischetti, Stefano Rigattieri, Alessandro Sciahbasi, Edoardo Pucci, Enrico Romagnoli, Claudio Moretti, Luciano Moretti, Raffaele De Caterina, Marcello Caputo, Marco Zimmarino, Ezio Bramucci, Emilio Di Lorenzo, Maurizio Turturo, Roberto Bonmassari, Carlo Penzo, Bruno Loi, Ciro Mauro, Anna Sonia Petronio, Gabriele Gabrielli, Antonio Micari, Flavia Belloni, Francesco Amico, Marco Comeglio, Claudio Fresco, Isala Klinieken, Nicolas Van Mieghem, Roberto Diletti, Evelyn Regar, Manel Sabaté, Joan Antoni Gómez Hospital, José Francisco Díaz Fernández, Vicente Mainar, Jose Maria de la Torre Hernandez, Valgimigli, Marco, Frigoli, Enrico, Leonardi, Sergio, Vranckx, Pascal, Rothenbühler, Martina, Tebaldi, Matteo, Varbella, Ferdinando, Calabrò, Paolo, Garducci, Stefano, Rubartelli, Paolo, Briguori, Carlo, Andó, Giuseppe, Ferrario, Maurizio, Limbruno, Ugo, Garbo, Roberto, Sganzerla, Paolo, Russo, Filippo, Nazzaro, Marco, Lupi, Alessandro, Cortese, Bernardo, Ausiello, Arturo, Ierna, Salvatore, Esposito, Giovanni, Ferrante, Giuseppe, Santarelli, Andrea, Sardella, Gennaro, de Cesare, Nicoletta, Tosi, Paolo, van 't Hof, Arnoud, Omerovic, Elmir, Brugaletta, Salvatore, Windecker, Stephan, Heg, Dik, Jüni, Peter, Cardiologie, RS: CARIM - R2.01 - Clinical atrial fibrillation, MUMC+: MA Med Staf Spec Cardiologie (9), Campo, Gianluca, Uguccioni, Lucia, Tamburino, Corrado, Presbitero, Patrizia, Zavalloni-Parenti, Denni, Ferrari, Fabio, Ceravolo, Roberto, Tarantino, Fabio, Pasquetto, Giampaolo, Casu, Gavino, Mameli, Stefano, Stochino, Maria Letizia, Mazzarotto, Pietro, Cremonesi, Alberto, Saia, Francesco, Saccone, Giovanni, Abate, Fabio, Picchi, Andrea, Violini, Roberto, Colangelo, Salvatore, Boccuzzi, Giacomo, Guiducci, Vincenzo, Vigna, Carlo, Zingarelli, Antonio, Gagnor, Andrea, Zaro, Tiziana, Tresoldi, Simone, Vandoni, Pietro, Contarini, Marco, Liso, Armando, Dellavalle, Antonio, Curello, Salvatore, Mangiacapra, Fabio, Evola, Rosario, Palmieri, Cataldo, Falcone, Camillo, Liistro, Francesco, Creaco, Manuela, Colombo, Antonio, Chieffo, Alaide, Perkan, Andrea, De Servi, Stefano, Fischetti, Dionigi, Rigattieri, Stefano, Sciahbasi, Alessandro, Pucci, Edoardo, Romagnoli, Enrico, Moretti, Claudio, Moretti, Luciano, De Caterina, Raffaele, Caputo, Marcello, Zimmarino, Marco, Bramucci, Ezio, Di Lorenzo, Emilio, Turturo, Maurizio, Bonmassari, Roberto, Penzo, Carlo, Loi, Bruno, Mauro, Ciro, Petronio, Anna Sonia, Gabrielli, Gabriele, Micari, Antonio, Belloni, Flavia, Amico, Francesco, Comeglio, Marco, Fresco, Claudio, Klinieken, Isala, Van Mieghem, Nicola, Diletti, Roberto, Regar, Evelyn, Sabaté, Manel, Gómez Hospital, Joan Antoni, Díaz Fernández, José Francisco, Mainar, Vicente, and de la Torre Hernandez, Jose Maria

Subjects
Male, Prasugrel, medicine.medical_treatment, MONOTHERAPY, Myocardial Infarction, 030204 cardiovascular system & hematology, Coronary Angiography, ANGIOGRAPHY, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Bivalirudin, ARTERY-DISEASE, 030212 general & internal medicine, Myocardial infarction, 610 Medicine & health, Medicine (all), SITE, 2017 ESC, PCI, General Medicine, Hirudins, Middle Aged, Clopidogrel, Recombinant Proteins, Prosthesis Failure, Stroke, Femoral Artery, Acute Coronary Syndrome, Aged, Anticoagulants, Antithrombins, Female, Hemorrhage, Heparin, Humans, Mortality, Peptide Fragments, Percutaneous Coronary Intervention, Perioperative Care, Platelet Glycoprotein GPIIb-IIIa Complex, Stents, Radial Artery, Cardiology, Ticagrelor, INTERVENTION, medicine.drug, Acute coronary syndrome, medicine.medical_specialty, ACUTE MYOCARDIAL-INFARCTION, 03 medical and health sciences, Internal medicine, medicine, METAANALYSIS, business.industry, Percutaneous coronary intervention, medicine.disease, business
Abstract

Summary Background The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) programme was designed to assess the comparative safety and effectiveness of radial versus femoral access and of bivalirudin versus unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors in patients with the whole spectrum of acute coronary syndrome undergoing invasive management. Here we describe the prespecified final 1-year outcomes of the entire programme. Methods MATRIX was a programme of three nested, randomised, multicentre, open-label, superiority trials in patients with acute coronary syndrome in 78 hospitals in Italy, the Netherlands, Spain, and Sweden. Patients with ST-elevation myocardial infarction were simultaneously randomly assigned (1:1) before coronary angiography to radial or femoral access and to bivalirudin, with or without post-percutaneous coronary intervention infusion or unfractionated heparin (one-step inclusion). Patients with non-ST-elevation acute coronary syndrome were randomly assigned (1:1) before coronary angiography to radial or femoral access and, only if deemed eligible to percutaneous coronary intervention after angiography (two-step inclusion), entered the antithrombin type and treatment duration programmes. Randomisation sequences were computer generated, blocked, and stratified by intended new or current use of P2Y12 inhibitor (clopidogrel vs ticagrelor or prasugrel), and acute coronary syndrome type (ST-elevation myocardial infarction, troponin-positive, or troponin-negative non-ST-elevation acute coronary syndrome). Bivalirudin was given as a bolus of 0·75 mg/kg, followed immediately by an infusion of 1·75 mg/kg per h until completion of percutaneous coronary intervention. Heparin was given at 70–100 units per kg in patients not receiving glycoprotein IIb/IIIa inhibitors, and at 50–70 units per kg in patients receiving glycoprotein IIb/IIIa inhibitors. Clinical follow-up was done at 30 days and 1 year. Co-primary outcomes for MATRIX access and MATRIX antithrombin type were major adverse cardiovascular events, defined as the composite of all-cause mortality, myocardial infarction, or stroke up to 30 days; and net adverse clinical events, defined as the composite of non-coronary artery bypass graft-related major bleeding, or major adverse cardiovascular events up to 30 days. The primary outcome for MATRIX treatment duration was the composite of urgent target vessel revascularisation, definite stent thrombosis, or net adverse clinical events up to 30 days. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01433627. Findings Between Oct 11, 2011, and Nov 7, 2014, we randomly assigned 8404 patients to receive radial (4197 patients) or femoral (4207 patients) access. Of these 8404 patients, 7213 were included in the MATRIX antithrombin type study and were randomly assigned to bivalirudin (3610 patients) or heparin (3603 patients). Patients assigned to bivalirudin were included in the MATRIX treatment duration study, and were randomly assigned to post-procedure infusion (1799 patients) or no post-procedure infusion (1811 patients). At 1 year, major adverse cardiovascular events did not differ between patients assigned to radial access compared with those assigned to femoral access (14·2% vs 15·7%; rate ratio 0·89, 95% CI 0·80–1·00; p=0·0526), but net adverse clinical events were fewer with radial than with femoral access (15·2% vs 17·2%; 0·87, 0·78–0·97; p=0·0128). Compared with heparin, bivalirudin was not associated with fewer major adverse cardiovascular (15·8% vs 16·8%; 0·94, 0·83–1·05; p=0·28) or net adverse clinical events (17·0% vs 18·4%; 0·91, 0·81–1·02; p=0·10). The composite of urgent target vessel revascularisation, stent thrombosis, or net adverse clinical events did not differ with or without post-procedure bivalirudin infusion (17·4% vs 17·4%; 0·99, 0·84–1·16; p=0·90). Interpretation In patients with acute coronary syndrome, radial access was associated with lower rates of net adverse clinical events compared with femoral access, but not major adverse cardiovascular events at 1 year. Bivalirudin with or without post-procedure infusion was not associated with lower rates of major adverse cardiovascular events or net adverse clinical events. Radial access should become the default approach in acute coronary syndrome patients undergoing invasive management. Funding Italian Society of Invasive Cardiology, The Medicines Company, Terumo, amd Canada Research Chairs Programme.

Published
2018

3. Zofenopril and Ramipril in Combination with Acetyl Salicylic Acid in Postmyocardial Infarction Patients with Left Ventricular Systolic Dysfunction: A Retrospective Analysis of the SMILE-4 Randomized, Double-Blind Study in Diabetic Patients

Author

BORGHI, CLAUDIO, AMBROSIONI, ETTORE, Omboni, Stefano, Novo, Salvatore, Vinereanu, Dragos, Ambrosio, Giuseppe, Dimitrios, Alexopolulus, Ioannis, Nanas, Marco, Agrusta, Antonio, Barsotti, Serena, Bergerone, Luigi, Caliendo, Pio, Caso, Antonio, Castello, Domenico, Cianflone, Tommaso, Cipolla, Gaetano, De Ferrari, Giuseppe, De Nittis, Livio, Dei Cas, Paolo, Di Pasquale, Rosario, Evola, Luciano, Fattore, Raffaele, Ferrante, Antonio, Fiscella, Achille, Gaspardone, Giuseppe, Ielasi, Niccoló, Marchionni, Giancarlo, Marenzi, Filippo, Marte, Federico, Miccoli, Patrizia, Noussan, Mario, Orlandi, Giancarlo, Piovaccari, Maurizio, Porcu, Patrizia, Presbitero, Antonio, Raviele, Emiliano, Renaldini, Jorge, Salerno Uriarte, Giovanni, Storti, Corrado, Tamburino, Pierfranco, Terrosu, Roberto, Testa, Rita, Trinchero, Bernardino, Tuccillo, Ludovico, Vasquez, Quinto, Villani Giovanni, Garcia, Alvés Mario, Aurora, Andrade, Silva, Cardoso, Ilidio, Moreira Joseà, Catalina, Arsenescu Georgescu, Mircea, Cinteza, Maria, Dorobantu, Dominic, Ionescu, Ioan, Manitiu, Florin, Ortan, Calin, Pop, Mariana, Radoi, Yuriy, Alexandrovich Vasyuk, Victor, Avenirovitch Kostenko, Yuriy, Borisovich Karpov, Vira, Iosifovna Tseluiko, Abram, Lvovich Syrkin, Boris, Mikhailovich Goloschekin, Evgeniy, Mikhaylovich Nifontov, Sergey, Nikolaevich Tereschenko, Natalia, Nikolaevna Burova, Konstantin, Nikolayevich Zrazhevsky, Grigory, Pavlovich Arutuynov, Valentin, Sergeevich Moiseev, Leonid, Victorovich Rudenko, Alexander, Yurievich Vishnevsky, Diaz, D. L. Y. De La Yera, Fernández, Romero, Cevat, Kirma, Kayikcioglu, Meral, Abdurrahman, Oğuzhan, Dilek, Ural Komsuoglu, Olena, Ankindinovna Koval, Alexan, Nikolaevich Parkhomenko, Igor, Petrovich Vakalyuk, Mykola, Tihonovich Vatutin, Valerii, Vladimirovich Batushkin, Borghi, Claudio, Omboni, Stefano, Novo, Salvatore, Vinereanu, Drago, Ambrosio, Giuseppe, Ambrosioni, Ettore, Dimitrios, Alexopolulu, Ioannis, Nana, Marco, Agrusta, Antonio, Barsotti, Serena, Bergerone, Luigi, Caliendo, Pio, Caso, Antonio, Castello, Domenico, Cianflone, Tommaso, Cipolla, Gaetano, De Ferrari, Giuseppe, De Nitti, Livio, Dei Ca, Paolo, Di Pasquale, Rosario, Evola, Luciano, Fattore, Raffaele, Ferrante, Antonio, Fiscella, Achille, Gaspardone, Giuseppe, Ielasi, Niccoló, Marchionni, Giancarlo, Marenzi, Filippo, Marte, Federico, Miccoli, Patrizia, Noussan, Mario, Orlandi, Giancarlo, Piovaccari, Maurizio, Porcu, Patrizia, Presbitero, Antonio, Raviele, Emiliano, Renaldini, Jorge, Salerno Uriarte, Giovanni, Storti, Corrado, Tamburino, Pierfranco, Terrosu, Roberto, Testa, Rita, Trinchero, Bernardino, Tuccillo, Ludovico, Vasquez, Quinto, Villani Giovanni, Garcia, Alvés Mario, Aurora, Andrade, Silva, Cardoso, Ilidio, Moreira Joseà, Catalina, Arsenescu Georgescu, Mircea, Cinteza, Maria, Dorobantu, Dominic, Ionescu, Ioan, Manitiu, Florin, Ortan, Calin, Pop, Mariana, Radoi, Yuriy, Alexandrovich Vasyuk, Victor, Avenirovitch Kostenko, Yuriy, Borisovich Karpov, Vira, Iosifovna Tseluiko, Abram, Lvovich Syrkin, Boris, Mikhailovich Goloschekin, Evgeniy, Mikhaylovich Nifontov, Sergey, Nikolaevich Tereschenko, Natalia, Nikolaevna Burova, Konstantin, Nikolayevich Zrazhevsky, Grigory, Pavlovich Arutuynov, Valentin, Sergeevich Moiseev, Leonid, Victorovich Rudenko, Alexander, Yurievich Vishnevsky, Diaz, D.L.Y.De La Yera, Fernández, Romero, Cevat, Kirma, Kayikcioglu, Meral, Abdurrahman, Oğuzhan, Dilek, Ural Komsuoglu, Olena, Ankindinovna Koval, Alexan, Nikolaevich Parkhomenko, Igor, Petrovich Vakalyuk, Mykola, Tihonovich Vatutin, Valerii, Vladimirovich Batushkin, on behalf of the SMILE-4 Working, Party, and Cianflone, Domenico

Subjects
Male, Captopril, Diabetic Cardiomyopathies, Myocardial Infarction, Infarction, Angiotensin-Converting Enzyme Inhibitors, 030204 cardiovascular system & hematology, chemistry.chemical_compound, Ventricular Dysfunction, Left, 0302 clinical medicine, Diabetes mellitus, Ramipril, Retrospective Studie, Cardiovascular Disease, Medicine, Pharmacology (medical), 030212 general & internal medicine, Myocardial infarction, Diabetic Cardiomyopathie, Randomized Controlled Trials as Topic, Aspirin, Left ventricular dysfunction, General Medicine, Acetyl salicylic acid, Acute myocardial infarction, Angiotensin-converting enzyme inhibitors, Zofenopril, Cardiology and Cardiovascular Medicine, Pharmacology, Middle Aged, Cardiovascular Diseases, Cardiology, Platelet aggregation inhibitor, Drug Therapy, Combination, Female, medicine.drug, Human, medicine.medical_specialty, Diabetes mellitu, Systole, 03 medical and health sciences, Internal medicine, Humans, Aged, Retrospective Studies, business.industry, Platelet Aggregation Inhibitor, Angiotensin-Converting Enzyme Inhibitor, medicine.disease, chemistry, Angiotensin-converting enzyme inhibitor, business, Mace, Platelet Aggregation Inhibitors
Abstract

Summary Objective In the SMILE-4 study, zofenopril + acetyl salicylic acid (ASA) was more effective than ramipril + ASA on 1-year prevention of major cardiovascular events (MACE) in patients with acute myocardial infarction complicated by left ventricular dysfunction. In this retrospective analysis, we evaluated drug efficacy in subgroups of patients, according to a history of diabetes mellitus. Methods The primary study endpoint was 1-year combined occurrence of death or hospitalization for cardiovascular causes. Diabetes was defined according to medical history (previous known diagnosis). Results A total of 562 of 693 (81.0%) patients were classified as nondiabetics and 131 (18.9%) as diabetics. The adjusted rate of MACE was lower under zofenopril than under ramipril in both nondiabetics [27.9% vs. 34.9% ramipril; odds ratio, OR and 95% confidence interval: 0.55 (0.35, 0.86)] and diabetics [30.9% vs. 41.3%; 0.56 (0.18, 1.73)], although the difference was statistically significant only for the nondiabetic group (P = 0.013). Zofenopril was superior to ramipril as regards to the primary study endpoint in the subgroup of 157 patients with uncontrolled blood glucose (≥126 mg/dL), regardless of a previous diagnosis of diabetes [0.31 (0.10, 0.90), P = 0.030]. Zofenopril significantly reduced the risk of hospitalization for cardiovascular causes in both nondiabetics [0.64 (0.43, 0.96), P = 0.030] and diabetics [0.38 (0.15, 0.95), P = 0.038], whereas it was not better than ramipril in terms of prevention of cardiovascular deaths. Conclusions This retrospective analysis of the SMILE-4 study confirmed the good efficacy of zofenopril plus ASA in the prevention of long-term MACE also in the subgroup of patients with diabetes mellitus.

Published
2016

4. The Drop That Spilled the Cup: Acute Myocardial Infarction in a Young Woman with Underlying Thrombophilic Polymorphisms and Oral Contraceptive Use

Author

Anella Antonietta Patané, Gianfranco Capilli, Rosario Evola, Silvia Paola Russo, Enrico Franzì, and Nunzio Russo

Subjects
lcsh:Diseases of the circulatory (Cardiovascular) system, medicine.medical_specialty, Acute coronary syndrome, education.field_of_study, biology, business.industry, Population, Case Report, Disease, medicine.disease, Bioinformatics, Contraceptive use, lcsh:RC666-701, Family planning, Internal medicine, Methylenetetrahydrofolate reductase, medicine, biology.protein, Cardiology, Myocardial infarction, Cardiology and Cardiovascular Medicine, business, education, Plasminogen activator
Abstract

We present the case of a 28-year-old woman who was admitted to our cardiology unit for acute coronary syndrome. Her history was notable for cardiovascular disease familiarity, active smoking, and oral contraceptive use. On further analysis, she was noted to have thrombophilic polymorphisms involving the plasminogen activator inhibitor (PAI), angiotensin-converting enzyme (ACE), and methylenetetrahydrofolate reductase (MTHFR) genes. We discuss the implications that these cofactors may have had in the genesis of the disease.

Published
2014
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5. Minimally Invasive Implantation of the Myopore Sutureless Myocardial Pacing Lead

Author

Rosario Evola, Giuseppe Mario Calvagna, Maria Paola Maiorana, Fabrizio Ceresa, Santina Patanè, Fabrizio Sansone, Francesco Patanè, and Giuseppe Busà

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Ventricular lead, medicine.medical_treatment, Heart Ventricles, Cardiac resynchronization therapy, Risk Assessment, Prosthesis Implantation, Text mining, Risk Factors, Internal medicine, medicine, Humans, Minimally Invasive Surgical Procedures, Lead (electronics), Aged, Heart Failure, business.industry, Cardiac Pacing, Artificial, General Medicine, Middle Aged, medicine.disease, Electrodes, Implanted, Treatment Outcome, Thoracotomy, Heart failure, Cardiology, Female, Surgery, business, Cardiology and Cardiovascular Medicine, Follow-Up Studies
Abstract

Cardiac resynchronization therapy improves symptoms and survival of patients with congestive heart failure. Usually, the transvenous placement of the left ventricular lead is feasible, but in case of anatomic abnormalities of the coronary sinus, an unintended left phrenic nerve stimulation, a dislodgement of the percutaneous electrode, or a loss of capture of the electrode, surgical treatment should be considered. From January 2010 to September 2011, 15 patients underwent surgical implantation of the left ventricular lead after failure of transvenous placement. The MyoPore sutureless myocardial pacing lead (MSMPL) was implanted through a left minithoracotomy (~5 cm) under selective right lung ventilation. Time of surgery was 38.5 ± 3.0 minutes, and no surgical complications or early deaths are reported so far. After 10.7 ± 8.3 months of follow-up, no cases of late mortality, dislodgement, or loss of capture of the electrode are described. The use of the MSMPL is not novel, although the association with a minimally invasive approach may represent an alternative for a high-risk population. The screw-in of the lead ensures low impedance and threshold of stimulation (1.1 ± 0.6 V at 0.5 milliseconds) both in early and medium terms. In conclusion, in case of failure of the transvenous approach, the MSMPL may be easily implanted through a left minithoracotomy, and the results are noteworthy.

Published
2012
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6. Acute myocardial infarction in a young patient with myocardial bridge and elevated levels of free triiodothyronine

Author

Salvatore Patanè, Francesco Patanè, Giuseppe Cinnirella, Filippo Marte, Sebastiano Chiofalo, Gianluca Di Bella, and Rosario Evola

Subjects
Myocardial bridge, medicine.medical_specialty, Triiodothyronine, medicine.diagnostic_test, business.industry, Electrocardiography in myocardial infarction, medicine.disease, Pathophysiology, Internal medicine, Free triiodothyronine, Cardiology, Medicine, Myocardial infarction, Young adult, Cardiology and Cardiovascular Medicine, business, Electrocardiography
Abstract

Revelation of a myocardial bridge has been described at coronary angiography. The pathophysiology of myocardial bridging is incompletely understood. It is sometimes associated with overt pathology, as well as it can just be an incidental finding without any significance. It has been also reported an acute myocardial infarction with normal coronary arteries associated with iatrogenic hyperthyroidism. We present a case of acute myocardial infarction in a 28-year-old Italian man with normal coronary arteries, iatrogenic elevated levels of free triiodothyronine and myocardial bridge.

Published
2009
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7. Zofenopril and ramipril and acetylsalicylic acid in postmyocardial infarction patients with left ventricular systolic dysfunction: a retrospective analysis in hypertensive patients of the SMILE-4 study

Author

Borghi, Claudio, Ambrosioni, Ettore, Omboni, Stefano, Cicero, Arrigo F. G., Bacchelli, Stefano, Esposti, Daniela D., Vinereanu, Dragos, Ambrosio, Giuseppe, Zava, Dario, SMILE-4 Working Party: Dimitrios Alexopolulus, Mario Garcia Alvés, Aurora Andrade, Marco Agrusta, Antonio Barsotti, Serena Bergerone, Luigi Caliendo, Pio Caso, Antonio Castello, Domenico Cianflone, Tommaso Cipolla, Gaetano De Ferrari, Giuseppe De Nittis, Livio Dei Cas, Paolo Di Pasquale, Rosario Evola, Luciano Fattore, Raffaele Ferrante, Antonio Fiscella, Achille Gaspardone, Giuseppe Ielasi, Niccol ‘o Marchionni, Giancarlo Marenzi, Filippo Marte, Federico Miccoli, Patrizia Noussan, Ioannis Nanas, Salvatore Novo, Mario Orlandi, Giancarlo Piovaccari, Maurizio Porcu, Patrizia Presbitero, Antonio Raviele, Emiliano Renaldini, Jorge Uriarte Salerno, Giovanni Storti, Corrado Tamburino, Pierfranco Terrosu, Roberto Testa, Rita Trinchero, Bernardino Tuccillo, Ludovico Vasquez, Giovanni Quinto Villani, Claudio, Borghi, Ettore, Ambrosioni, Stefano, Omboni, Arrigo F. G., Cicero, Stefano, Bacchelli, Daniela D., Esposti, Dragos, Vinereanu, Giuseppe, Ambrosio, Dario, Zava, Working Party: Dimitrios Alexopolulus, SMILE-4, Garcia Alvés, Mario, Andrade, Aurora, Agrusta, Marco, Barsotti, Antonio, Bergerone, Serena, Caliendo, Luigi, Caso, Pio, Castello, Antonio, Cianflone, Domenico, Cipolla, Tommaso, De Ferrari, Gaetano, De Nittis, Giuseppe, Dei Cas, Livio, Di Pasquale, Paolo, Evola, Rosario, Fattore, Luciano, Ferrante, Raffaele, Fiscella, Antonio, Gaspardone, Achille, Ielasi, Giuseppe, ‘o Marchionni, Niccol, Marenzi, Giancarlo, Marte, Filippo, Miccoli, Federico, Noussan, Patrizia, Nanas, Ioanni, Novo, Salvatore, Orlandi, Mario, Piovaccari, Giancarlo, Porcu, Maurizio, Presbitero, Patrizia, Raviele, Antonio, Renaldini, Emiliano, Uriarte Salerno, Jorge, Storti, Giovanni, Tamburino, Corrado, Terrosu, Pierfranco, Testa, Roberto, Trinchero, Rita, Tuccillo, Bernardino, Vasquez, Ludovico, Quinto Villani, Giovanni, Claudio Borghi, Ettore Ambrosioni, Stefano Omboni, Arrigo F.G. Cicero, Stefano Bacchelli, Daniela D. Esposti, Dragos Vinereanu, Giuseppe Ambrosio, Dario Zava, and on behalf of the SMILE-4 Working Party

Subjects
Male, Captopril, Physiology, Myocardial Infarction, Infarction, Blood Pressure, law.invention, chemistry.chemical_compound, Ventricular Dysfunction, Left, Randomized controlled trial, Ramipril, Retrospective Studie, law, Retrospective analysis, zofenopril, Myocardial infarction, Randomized Controlled Trials as Topic, left ventricular dysfunction, Middle Aged, humanities, Zofenopril, Europe, Antihypertensive Agent, angiotensin-converting enzyme inhibitor, Hypertension, Cardiology, Female, Cardiology and Cardiovascular Medicine, Human, medicine.drug, arterial hypertension, medicine.medical_specialty, acute myocardial infarction, Internal medicine, Internal Medicine, medicine, Humans, cardiovascular diseases, Risk factor, Antihypertensive Agents, Aged, Retrospective Studies, Aspirin, business.industry, Platelet Aggregation Inhibitor, Retrospective cohort study, acetylsalicylic acid, medicine.disease, chemistry, business, Platelet Aggregation Inhibitors
Abstract

BACKGROUND: Antecedent hypertension represents a risk factor for adverse outcomes in survivors of acute myocardial infarction (AMI). Prognosis of such patients might be greatly improved by drugs enhancing blood pressure control. In the present retrospective analysis of the randomized, double-blind, parallel-group, SMILE-4 study we compared the efficacy of zofenopril 60 mg and acetylsalicylic acid (ASA) 100 mg versus ramipril 10 mg and ASA in patients with AMI complicated by left ventricular dysfunction, classified according to a history of hypertension. METHODS: The primary study end-point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. Hypertension was defined according to medical history and current blood pressure values at entry and could be determined in 682 of 716 patients of the intention-to-treat analysis. RESULTS: One hundred and fifty-seven patients (23%) were normotensives and 525 (77%) hypertensives. In the normotensive population the primary end-point occurred in 19 of 76 zofenopril-treated patients (25%) and in 23 of 81 ramipril-treated patients (28%) [odds ratio (95% confidence interval): 0.84 (0.41-1.71), P = 0.631]. In the hypertensive population, major cardiovascular outcomes were reported in 84 of 273 zofenopril-treated patients (31%) and in 99 of 252 ramipril-treated patients (39%), with a 31% significantly (P = 0.041) lower risk with zofenopril [0.69 (0.48-0.99)]. The superiority of zofenopril versus ramipril was particularly evident in patients with isolated systolic hypertension [n = 131, 0.48 (0.23-0.99), P = 0.045]. CONCLUSION: This retrospective analysis of the SMILE-4 study confirmed the good efficacy of zofenopril and ASA in the prevention of long-term cardiovascular outcomes also in the subgroup of patients with hypertension.

Published
2013

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