Author + information
- Received July 17, 2017
- Revision received September 12, 2017
- Accepted September 14, 2017
- Published online January 1, 2018.
- Giuseppe Gargiulo, MDa,b,
- Sara Ariotti, MDa,
- Pascal Vranckx, MD, PhDc,d,
- Sergio Leonardi, MDe,
- Enrico Frigoli, MDa,
- Nestor Ciociano, PharmDf,
- Carlo Tumscitz, MDg,
- Francesco Tomassini, MDh,
- Paolo Calabrò, MDi,
- Stefano Garducci, MDj,
- Gabriele Crimi, MDe,k,
- Giuseppe Andò, MD, PhDl,
- Maurizio Ferrario, MDe,
- Ugo Limbruno, MDm,
- Bernardo Cortese, MDn,o,
- Paolo Sganzerla, MDp,
- Alessandro Lupi, MDq,
- Filippo Russo, MDr,
- Roberto Garbo, MDs,
- Arturo Ausiello, MDt,
- Dennis Zavalloni, MDu,
- Gennaro Sardella, MDv,
- Giovanni Esposito, MD, PhDb,
- Andrea Santarelli, MDw,
- Simone Tresoldi, MDx,
- Marco Stefano Nazzaro, MD, PhDy,
- Antonio Zingarelli, MDz,
- Anna Sonia Petronio, MDaa,
- Stephan Windecker, MDa,
- Bruno R. da Costa, PhDa,bb and
- Marco Valgimigli, MD, PhDa,∗ ()
- aDepartment of Cardiology, Bern University Hospital, Bern, Switzerland
- bDepartment of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy
- cDepartment of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium
- dFaculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium
- eUOC Cardiologia, Dipartimento CardioToracoVascolare, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
- fEUSTRATEGY Association, Forlì, Italy
- gCardiology Unit, Azienda Ospedaliero Universitaria di Ferrara, Cona, Italy
- hCardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy
- iDivision of Cardiology, Department of Cardiothoracic Sciences, University of Campania “Luigi Vanvitelli,” Naples, Italy
- jStruttura complessa di Cardiologia ASST di Vimercate, Desio, Italy
- kDepartment of Cardiology, ASL3 Ospedale Villa Scassi, Genoa, Italy
- lAzienda Ospedaliera Universitaria Policlinico “Gaetano Martino,” University of Messina, Messina, Italy
- mUO Cardiologia, Azienda USL Toscana Sudest, Grosseto, Italy
- nASST Fatebenefratelli-Sacco, Milan, Italy
- oFondazione Toscana Gabriele Monasterio, Pisa, Italy
- pASST Bergamo Ovest, Ospedale di Treviglio, Bergamo, Italy
- qCardiology Unit, University Hospital “Maggiore della Carità,” Novara, Italy
- rCardiovascular Interventional Unit, Cardiology Department, S.Anna Hospital, Como, Italy
- sInterventional Cardiology Unit, Ospedale San Giovanni Bosco, Turin, Italy
- tCasa di Cura Villa Verde, Taranto, Italy
- uHumanitas Research Hospital, IRCCS, Rozzano, Italy
- vDepartment of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, “Sapienza” University of Rome, Rome, Italy
- wCardiovascular Department, Infermi Hospital, Rimini, Italy
- xCardiology Unit, A.O. Ospedale di Desio, Desio, Italy
- yInterventional Cardiology Unit, San Camillo-Forlanini, Rome, Italy
- zInterventional Cardiology Unit, IRCCS AOU San Martino, Genoa, Italy
- aaCatheterisation Laboratory, Cardiothoracic and Vascular Department, University of Pisa, Pisa, Italy
- bbInstitute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
- ↵∗Address for correspondence:
Dr. Marco Valgimigli, Bern University Hospital, Freiburgstrasse 4, CH-3010, Bern, Switzerland.
Objectives This study sought to assess whether transradial access (TRA) compared with transfemoral access (TFA) is associated with consistent outcomes in male and female patients with acute coronary syndrome undergoing invasive management.
Background There are limited and contrasting data about sex disparities for the safety and efficacy of TRA versus TFA for coronary intervention.
Methods In the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) program, 8,404 patients were randomized to TRA or TFA. The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACCE or major bleeding.
Results Among 8,404 patients, 2,232 (26.6%) were women and 6,172 (73.4%) were men. MACCE and NACE were not significantly different between men and women after adjustment, but women had higher risk of access site bleeding (male vs. female rate ratio [RR]: 0.64; p = 0.0016), severe bleeding (RR: 0.17; p = 0.0012), and transfusion (RR: 0.56; p = 0.0089). When comparing radial versus femoral, there was no significant interaction for MACCE and NACE stratified by sex (pint = 0.15 and 0.18, respectively), although for both coprimary endpoints the benefit with TRA was relatively greater in women (RR: 0.73; p = 0.019; and RR: 0.73; p = 0.012, respectively). Similarly, there was no significant interaction between male and female patients for the individual endpoints of all-cause death (pint = 0.79), myocardial infarction (pint = 0.25), stroke (pint = 0.18), and Bleeding Academic Research Consortium type 3 or 5 (pint = 0.45).
Conclusions Women showed a higher risk of severe bleeding and access site complications, and radial access was an effective method to reduce these complications as well as composite ischemic and ischemic or bleeding endpoints.
The trial was sponsored by the Società Italiana di Cardiologia Inasiva (a nonprofit organization), which received grant support from The Medicines Company and Terumo. This substudy did not receive any direct or indirect funding. Dr. Gargiulo has received research grant support from the Cardiopath PhD program and from the Società Italiana di Cardiologia supported by MSD Italia-Merck Sharp and Dohme Corporation. Dr. Vranckx has received personal fees from Daiichi-Sankyo and Bayer Healthcare. Dr. Leonardi has received personal fees from The Medicines Company, AstraZeneca, Chiesi, outside the submitted work; and grant support from AstraZeneca outside the submitted work. Dr. Andò has received nonfinancial support from Terumo and Volcano-Phillips; and personal fees from Abbott, Bayer Healthcare Pharmaceuticals, AstraZeneca, and Daiichi-Sankyo. Dr. Cortese has received research grants from AB Medica, Abbott, St. Jude Medical, and Stentys; and personal fees from Abbott, AstraZeneca, Daiichi-Sankyo and Eli-Lilly, Stentys, all outside the submitted work. Dr. Petronio is consultant for Medtronic, Boston Scientific, and Abbott. Dr Windecker has received research grants to the institution from Bracco, Boston Scientific, and Terumo. Dr. Valgimigli has received research grant support from The Medicines Company, Terumo, and AstraZeneca; and personal fees from Terumo, St. Jude Vascular, and Abbott Vascular. Dr. Sonia has served as a consultant for Medtronic, Boston Scientific, and Abbott. Dr. Windecker has received institutional research grants from Abbott, Boston Scientific, Biotronik, Medtronic, Edwards Lifesciences, and St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 17, 2017.
- Revision received September 12, 2017.
- Accepted September 14, 2017.
- 2018 American College of Cardiology Foundation