Clinical trial NCT01433627: Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX
Official title: Phase IIIb Study Minimizing Adverse Haemmhorragic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Coronary Syndromes
STEMI
NSTEMI
Keywords: acute coronary syndromes
myocardial infarction
access site
bivalirudin
bleedings
Lead sponsor: Italian Society of Invasive Cardiology
Sponsor class: OTHER
Collaborators: name: Eustrategy
First posted: 2011-09-14
Enrollment: 7200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This protocol describes a study to compare intended trans-radial versus trans-femoral intervention and bivalirudin monotherapy versus current European standard of care consisting of unfractionated heparin (UFH) plus provisional use of glycoprotein IIb/IIIa inhibition via the use of one of the three available agents on the market (e.g. abciximab, tirofiban or eptifibatide) in patients (≥18 years) with ACS, that are intended for an invasive management strategy. This study will be conducted in compliance with Good Clinical Practices (GCP) including the Declaration of Helsinki and all applicable regulatory requirements.

Detailed description: The use of combined antithrombotic therapies over the last two decades has decreased the risk of a heart attack after percutaneous coronary intervention substantially but has also been associated with a significant increase in bleeding risk. Therapies or strategies that maintain the benefits seen with currently available antithrombotic therapies but which have lower bleeding risk are therefore of great clinical importance. Indeed, major bleeding is currently the most common non-cardiac complication of therapy for patients with coronary artery disease who have undergone percutaneous coronary intervention (PCI).

Bleeding in patients with acute coronary syndrome (ACS) is associated with an increased risk of long term mortality and morbidity, and this relationship is currently thought to be causal. Therefore' reducing the frequency of bleeding events while maintaining efficacy is an important goal in the management of patients with ACS. The most common site of bleeding in invasively managed patients with ACS is at the femoral artery puncture site used for heart catheterization

The MATRIX study is a multi-centre, prospective, randomised, open-label, 2 by 2 factorial comparison of trans-radial vs. trans-femoral intervention and bivalirudin vs. unfractionated heparin and provisional use of glycoprotein IIb/IIIa inhibitor.

Objectives:

1. To demonstrate that trans-radial intervention as compared to femoral access site is associated to lower rate of the composite endpoint of death, MI or stroke within the first 30 days after randomization in acute coronary syndrome patients undergoing early invasive management.
2. To demonstrate that bivalirudin infusion as compared to standard of care therapy consisting of unfractionated heparin and provisional use of glycoprotein IIb/IIIa inhibitors are associated to lower rate of the composite endpoint of death, MI or stroke within the first 30 days after randomization in acute coronary syndrome patients undergoing early invasive management.

Patients randomly assigned to receive bivalirudin will be randomized to stop bivalirudin infusion at the end of PCI or to prolong bivalirudin at an infusion rate of 0.25 mg/kg/hour for at least 6 hours after completion of PCI. The primary hypothesis in this sub-randomization is that prolonged post-intervention bivalirudin infusion will be superior to no bivalirudin post-PCI infusion with respect to the net composite outcome consisting of any death, MI, stroke, urgent TVR, stent thrombosis and BARC-defined type 3 and 5 bleeding events within 30 days. Secondary objectives for the sub-randomization of prolonged bivalirudin versus no post-PCI infusion in the bivalirudin group will consist of each component of the primary composite endpoint through the entire follow-up duration

Eligibility criteria: Inclusion Criteria:

NSTEACS definition: Patients with all of the following criteria will be eligible:

1. history consistent with new, or worsening ischemia, occurring at rest or with minimal activity;
2. enrollment within 7 days of the most recent symptoms;
3. planned coronary angiography with possible indication to PCI;
4. at least 2 of the following criteria: 1. Aged 60 years or older, 2. Troponin T or I or creatine kinase MB above the upper limit of normal; 3. Electrocardiograph changes compatible with ischemia, ie, ST depression of 1 mm or greater in 2 contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts;

STEMI definition: i) chest pain for \>20 min with an electrocardiographic ST-segment elevation ≥1 mm in two or more contiguous electrocardiogram (ECG) leads, or with a new left bundle-branch block, or an infero-lateral myocardial infarction (MI) with ST segment depression of ≥1 mm in ≥2 of leads V1-3 with a positive terminal T wave and ii) admission either within 12 h of symptom onset or between 12 and 24 h after onset with evidence of continuing ischemia or previous lytic treatment.

Exclusion Criteria:

1. Patients who can not give informed consent or have a life expectancy of \<30 days
2. Allergy/intolerance to Bivalirudin or unfractionated heparin.
3. Stable or silent CAD as indication to coronary angiography
4. Treatment with LWMH within the past 6 hours
5. Treatment with any GPI in the previous 3 days
6. Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast or to any of the study medications including aspirin or clopidogrel.
7. Contraindications to angiography, including but not limited to severe peripheral vascular disease.
8. If it is known pregnant or nursing mothers. Women of child-bearing age will be asked if they are pregnant or think that they may be pregnant.
9. If it is known a creatinine clearance \<30 mL/min or dialysis dependent.
10. Previous enrollment in this study.
11. Treatment with other investigational drugs or devices within the 30 days preceding
12. Randomisation or planned use of other investigational drugs or devices in this trial.
13. Severe uncontrolled hypertension (defined as persistent systolic blood pressure higher than 220 mmHg despite medical treatment).
14. Subacute bacterial endocarditis
15. PCI in the previous 30 days

Primary outcomes:
measure: the composite of Death, non-fatal myocardial infarction or stroke
timeFrame: 30 days
measure: The composite of death, non-fatal myocardial infarction or stroke
timeFrame: 30 days
measure: Death, non-fatal myocardial infarction, stroke, stent thrombosis or BARC-defined type 3 or 5 bleedings
timeFrame: 30 days
Secondary outcomes:
measure: the composite endpoint of death, MI, stroke or BARC-defined type 3 and 5 major bleeding complications
timeFrame: 30 days
measure: Death, non-fatal MI, stroke or BARC-defined type 3 and 5 major bleeding
timeFrame: 30 days
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Ospedale Clinicizzato SS Annunziata di Chieti
state: Abruzzo
city: Pescara
country: Italy
facility: Ospedale Civile Santo Spirito
state: Abruzzo
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Pugliese Ciaccio - Catanzaro
state: Calabria
city: Napoli
country: Italy
facility: A.O. AORN Cardarelli
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera Monaldi
state: Campania
city: Napoli
country: Italy
facility: Policlinico Federico II
state: Campania
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
state: Emilia Romagna
city: Ferrara
country: Italy
facility: University Hospital of Ferrara
state: Emilia Romagna
city: Forlì
country: Italy
facility: Ospedale G. B. Morgagni
state: Emilia Romagna
city: Reggio Emilia
country: Italy
facility: Azienda S. Maria Nuova di Reggio Emilia
state: Emilia Romagna
city: Rimini
country: Italy
facility: Ospedale degli Infermi
state: Emilia Romagna
city: Trieste
country: Italy
facility: Azienda Ospedaliera Universitaria Ospedali Riuniti
state: Friuli Venezia Giulia
city: Udine
country: Italy
facility: Azienda Ospedaliera S. Maria della Misericordia di Udine
state: Friuli Venezia Giulia
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti
state: Lazio
city: Roma
country: Italy
facility: A.O. Sandro Pertini
state: Lazio
city: Roma
country: Italy
facility: Ospedale del Santo Spirito in Sassia
state: Lazio
city: Roma
country: Italy
facility: Ospedale San Camillo di Roma
state: Lazio
city: Roma
country: Italy
facility: Policlinico Casilino
state: Lazio
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria "San Martino"
state: Liguria
city: Genova
country: Italy
facility: Ospedale Villa Scassi
state: Liguria
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
state: Lombardia
city: Como
country: Italy
facility: Azienda Ospedaliera Sant'Anna di Como
state: Lombardia
city: Desio
country: Italy
facility: Azienda Ospedaliera di Desio e Vimercate - P.O. di Desio
state: Lombardia
city: Erba
country: Italy
facility: Ospedale Sacra Famiglia
state: Lombardia
city: Lodi
country: Italy
facility: Ospedale di Lodi
state: Lombardia
city: Milano
country: Italy
facility: A.O: Fatebenefratelli e oftalmico
state: Lombardia
city: Sesto San Giovanni
country: Italy
facility: IRCCS Multimedica
state: Lombardia
city: Treviglio
country: Italy
facility: A.O. Treviglio
state: Lombardia
city: Vimercate
country: Italy
facility: A. O. Ospedale Civile di Vimercate
state: Lombardia
city: Zingonia
country: Italy
facility: Policlinico San Marco
state: Lombardia
city: Ascoli Piceno
country: Italy
facility: A.O. G. Mazzoni
state: Marche
city: Pesaro
country: Italy
facility: Azienda Ospedaliera San Salvatore
state: Marche
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas IRCCS
state: MI
city: Cuneo
country: Italy
facility: Ospedale S. Croce e Carlo
state: Piemonte
city: Novara
country: Italy
facility: Azienda Ospedaliero-Universitaria "Maggiore della Carità"
state: Piemonte
city: Orbassano
country: Italy
facility: A. O. Universitaria San Luigi Gonzaga di Orbassano
state: Piemonte
city: Savigliano
country: Italy
facility: Ospedali Riuniti ASL 17
state: Piemonte
city: Torino
country: Italy
facility: A.O. Universitaria Molinette San Giovanni Battista
state: Piemonte
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco
state: Piemonte
city: Bari
country: Italy
facility: Ospedale Di Venere - ASL Bari
state: Puglia
city: Lecce
country: Italy
facility: Città di Lecce Ospedale (GVM)
state: Puglia
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
state: Puglia
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
state: Puglia
city: Taranto
country: Italy
facility: Casa di Cura Villa Verde
state: Puglia
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: RA
city: Carbonia
country: Italy
facility: Azienda USL Sirai
state: Sardegna
city: Nuoro
country: Italy
facility: Ospedale San Francesco
state: Sardegna
city: Catania
country: Italy
facility: A. O. Universitaria Policlinico V. Emanuele Ferrarotto
state: Sicilia
city: Palermo
country: Italy
facility: Villa Maria Eleonora Hospital
state: Sicilia
city: Siracusa
country: Italy
facility: Ospedale Umberto I di Siracusa
state: Sicilia
city: Taormina
country: Italy
facility: Ospedale S. Vincenzo
state: Sicilia
city: Sciacca
country: Italy
facility: A.O. Civili Riuniti - Giovanni Paolo II
state: Sicily
city: Arezzo
country: Italy
facility: P.O. Zona Aretina-Ospedale San Donato
state: Toscana
city: Grosseto
country: Italy
facility: Azienda USL - Grosseto
state: Toscana
city: Massa Carrara
country: Italy
facility: Ospedale del Cuore "G. Pasquinucci" Massa
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
state: Toscana
city: Rivoli
country: Italy
facility: Ospedale degli Infermi
state: TO
city: Trento
country: Italy
facility: Presidio Ospedaliero Santa Chiara
state: Trentino Alto Adige
city: Este
country: Italy
facility: Presidio Ospedaliero di Este
state: Veneto
city: Legnago
country: Italy
facility: Ospedale Mater Salutis di Legnago
state: Veneto
city: Mirano
country: Italy
facility: Ospedale Civile di Mirano
state: Veneto
city: Rome
country: Italy
facility: Università Campus Bio-Medico di Roma
Study officials:
affiliation: Erasmus MC, Thoraxcenter, The Netherlands
name: Marco Valgimigli, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dan K, Garcia-Garcia HM, Yacob O, Kuku KO, Diaz-Torres MA, Picchi A, Sardella G, Adamo M, Frigoli E, Limbruno U, Rigattieri S, Diletti R, Boccuzzi G, Zimarino M, Contarini M, Russo F, Calabro P, Ando G, Varbella F, Garducci S, Palmieri C, Briguori C, Karagiannis A, Dijkstra J, Valgimigli M. Ultra-Short Term Evaluation of Coronary Vessel Wall Changes in Reference Segments Adjacent to Culprit Lesions in ST-Segment Elevation Myocardial Infarction. J Invasive Cardiol. 2021 Dec;33(12):E923-E930. doi: 10.25270/jic/21.00035. Epub 2021 Nov 18.
citation: Landi A, Branca M, Ando G, Russo F, Frigoli E, Gargiulo G, Briguori C, Vranckx P, Leonardi S, Gragnano F, Calabro P, Campo G, Ambrosio G, Santucci A, Varbella F, Zaro T, Heg D, Windecker S, Juni P, Pedrazzini G, Valgimigli M; MATRIX Investigators. Acute kidney injury in patients with acute coronary syndrome undergoing invasive management treated with bivalirudin vs. unfractionated heparin: insights from the MATRIX trial. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1170-1179. doi: 10.1093/ehjacc/zuab080.
citation: Gragnano F, Branca M, Frigoli E, Leonardi S, Vranckx P, Di Maio D, Monda E, Fimiani L, Fioretti V, Chianese S, Esposito F, Franzese M, Scalise M, D'Angelo C, Scalise R, De Blasi G, Ando G, Esposito G, Calabro P, Windecker S, Pedrazzini G, Valgimigli M; MATRIX Trial Investigators. Access-Site Crossover in Patients With Acute Coronary Syndrome Undergoing Invasive Management. JACC Cardiovasc Interv. 2021 Feb 22;14(4):361-373. doi: 10.1016/j.jcin.2020.11.042.
citation: Leonardi S, Gragnano F, Carrara G, Gargiulo G, Frigoli E, Vranckx P, Di Maio D, Spedicato V, Monda E, Fimiani L, Fioretti V, Esposito F, Avvedimento M, Magliulo F, Leone A, Chianese S, Franzese M, Scalise M, Schiavo A, Mazzone P, Esposito G, Ando G, Calabro P, Windecker S, Valgimigli M. Prognostic Implications of Declining Hemoglobin Content in Patients Hospitalized With Acute Coronary Syndromes. J Am Coll Cardiol. 2021 Feb 2;77(4):375-388. doi: 10.1016/j.jacc.2020.11.046.
citation: Gargiulo G, Valgimigli M, Sunnaker M, Vranckx P, Frigoli E, Leonardi S, Spirito A, Gragnano F, Manavifar N, Galea R, De Caterina AR, Calabro P, Esposito G, Windecker S, Hunziker L. Choice of access site and type of anticoagulant in acute coronary syndromes with advanced Killip class or out-of-hospital cardiac arrest. Rev Esp Cardiol (Engl Ed). 2020 Nov;73(11):893-901. doi: 10.1016/j.rec.2020.01.005. Epub 2020 Mar 6. English, Spanish.
citation: Garcia-Garcia HM, Picchi A, Sardella G, Adamo M, Frigoli E, Limbruno U, Rigattieri S, Diletti R, Boccuzzi G, Zimarino M, Contarini M, Russo F, Calabro' P, Ando G, Varbella F, Garducci S, Palmieri C, Briguori C, Kuku KO, Rothenbuhler M, Karagiannis A, Valgimigli M. Comparison of intra-procedural vs. post-stenting prolonged bivalirudin infusion for residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing: the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) OCT study. Eur Heart J Cardiovasc Imaging. 2019 Dec 1;20(12):1418-1428. doi: 10.1093/ehjci/jez040.
citation: Gargiulo G, Carrara G, Frigoli E, Leonardi S, Vranckx P, Campo G, Varbella F, Calabro P, Zaro T, Bartolini D, Briguori C, Ando G, Ferrario M, Limbruno U, Colangelo S, Sganzerla P, Russo F, Nazzaro MS, Esposito G, Ferrante G, Santarelli A, Sardella G, Windecker S, Valgimigli M. Post-Procedural Bivalirudin Infusion at Full or Low Regimen in Patients With Acute Coronary Syndrome. J Am Coll Cardiol. 2019 Feb 26;73(7):758-774. doi: 10.1016/j.jacc.2018.12.023.
citation: Valgimigli M, Frigoli E, Leonardi S, Vranckx P, Rothenbuhler M, Tebaldi M, Varbella F, Calabro P, Garducci S, Rubartelli P, Briguori C, Ando G, Ferrario M, Limbruno U, Garbo R, Sganzerla P, Russo F, Nazzaro M, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Ferrante G, Santarelli A, Sardella G, de Cesare N, Tosi P, van 't Hof A, Omerovic E, Brugaletta S, Windecker S, Heg D, Juni P; MATRIX Investigators. 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. Lancet. 2018 Sep 8;392(10150):835-848. doi: 10.1016/S0140-6736(18)31714-8. Epub 2018 Aug 25.
citation: Gargiulo G, Carrara G, Frigoli E, Vranckx P, Leonardi S, Ciociano N, Campo G, Varbella F, Calabro P, Garducci S, Iannone A, Briguori C, Ando G, Crimi G, Limbruno U, Garbo R, Sganzerla P, Russo F, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Zavalloni D, Santarelli A, Sardella G, Tresoldi S, de Cesare N, Sciahbasi A, Zingarelli A, Tosi P, van 't Hof A, Omerovic E, Brugaletta S, Windecker S, Valgimigli M. Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes. J Am Coll Cardiol. 2018 Mar 20;71(11):1231-1242. doi: 10.1016/j.jacc.2018.01.033.
citation: Gargiulo G, Ariotti S, Vranckx P, Leonardi S, Frigoli E, Ciociano N, Tumscitz C, Tomassini F, Calabro P, Garducci S, Crimi G, Ando G, Ferrario M, Limbruno U, Cortese B, Sganzerla P, Lupi A, Russo F, Garbo R, Ausiello A, Zavalloni D, Sardella G, Esposito G, Santarelli A, Tresoldi S, Nazzaro MS, Zingarelli A, Petronio AS, Windecker S, da Costa BR, Valgimigli M. Impact of Sex on Comparative Outcomes of Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management: Data From the Randomized MATRIX-Access Trial. JACC Cardiovasc Interv. 2018 Jan 8;11(1):36-50. doi: 10.1016/j.jcin.2017.09.014.
citation: Ando G, Cortese B, Russo F, Rothenbuhler M, Frigoli E, Gargiulo G, Briguori C, Vranckx P, Leonardi S, Guiducci V, Belloni F, Ferrari F, de la Torre Hernandez JM, Curello S, Liistro F, Perkan A, De Servi S, Casu G, Dellavalle A, Fischetti D, Micari A, Loi B, Mangiacapra F, Russo N, Tarantino F, Saia F, Heg D, Windecker S, Juni P, Valgimigli M; MATRIX Investigators. Acute Kidney Injury After Radial or Femoral Access for Invasive Acute Coronary Syndrome Management: AKI-MATRIX. J Am Coll Cardiol. 2017 May 11:S0735-1097(17)36897-3. doi: 10.1016/j.jacc.2017.02.070. Online ahead of print.
citation: Leonardi S, Frigoli E, Rothenbuhler M, Navarese E, Calabro P, Bellotti P, Briguori C, Ferlini M, Cortese B, Lupi A, Lerna S, Zavallonito-Parenti D, Esposito G, Tresoldi S, Zingarelli A, Rigattieri S, Palmieri C, Liso A, Abate F, Zimarino M, Comeglio M, Gabrielli G, Chieffo A, Brugaletta S, Mauro C, Van Mieghem NM, Heg D, Juni P, Windecker S, Valgimigli M; MATRIX Investigators. Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX): randomised controlled trial. BMJ. 2016 Sep 27;354:i4935. doi: 10.1136/bmj.i4935.
citation: Valgimigli M, Frigoli E, Leonardi S, Rothenbuhler M, Gagnor A, Calabro P, Garducci S, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Garbo R, Sganzerla P, Russo F, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Presbitero P, Santarelli A, Sardella G, Varbella F, Tresoldi S, de Cesare N, Rigattieri S, Zingarelli A, Tosi P, van 't Hof A, Boccuzzi G, Omerovic E, Sabate M, Heg D, Juni P, Vranckx P; MATRIX Investigators. Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes. N Engl J Med. 2015 Sep 10;373(11):997-1009. doi: 10.1056/NEJMoa1507854. Epub 2015 Sep 1.
citation: Ando G, Cortese B, Frigoli E, Gagnor A, Garducci S, Briguori C, Rubartelli P, Calabro P, Valgimigli M; MATRIX investigators. Acute kidney injury after percutaneous coronary intervention: Rationale of the AKI-MATRIX (acute kidney injury-minimizing adverse hemorrhagic events by TRansradial access site and systemic implementation of angioX) sub-study. Catheter Cardiovasc Interv. 2015 Nov;86(5):950-7. doi: 10.1002/ccd.25932. Epub 2015 Apr 9.
citation: Valgimigli M, Gagnor A, Calabro P, Frigoli E, Leonardi S, Zaro T, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Cortese B, Sganzerla P, Lupi A, Galli M, Colangelo S, Ierna S, Ausiello A, Presbitero P, Sardella G, Varbella F, Esposito G, Santarelli A, Tresoldi S, Nazzaro M, Zingarelli A, de Cesare N, Rigattieri S, Tosi P, Palmieri C, Brugaletta S, Rao SV, Heg D, Rothenbuhler M, Vranckx P, Juni P; MATRIX Investigators. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015 Jun 20;385(9986):2465-76. doi: 10.1016/S0140-6736(15)60292-6. Epub 2015 Mar 16.
citation: Valgimigli M; MATRIX investigators. Design and rationale for the Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX program. Am Heart J. 2014 Dec;168(6):838-45.e6. doi: 10.1016/j.ahj.2014.08.013. Epub 2014 Sep 16.
citation: Sciahbasi A, Calabro P, Sarandrea A, Rigattieri S, Tomassini F, Sardella G, Zavalloni D, Cortese B, Limbruno U, Tebaldi M, Gagnor A, Rubartelli P, Zingarelli A, Valgimigli M. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX - RAdiation Dose study (RAD-MATRIX). Cardiovasc Revasc Med. 2014 Jun;15(4):209-13. doi: 10.1016/j.carrev.2014.03.010. Epub 2014 Mar 26.
citation: Valgimigli M, Calabro P, Cortese B, Frigoli E, Garducci S, Rubartelli P, Ando G, Santarelli A, Galli M, Garbo R, Repetto A, Ierna S, Briguori C, Limbruno U, Violini R, Gagnor A; MATRIX investigators. Scientific foundation and possible implications for practice of the Minimizing Adverse Haemorrhagic Events by Transradial Access Site andSystemic Implementation of AngioX (MATRIX) trial. J Cardiovasc Transl Res. 2014 Feb;7(1):101-11. doi: 10.1007/s12265-013-9537-1. Epub 2014 Jan 7.