Bernardo Cortese, MD, FESC Intv’ Cardiology, A.O. Fatebenefratelli MI CNR-Fondazione Monasterio-Regione Toscana bernardocortese.com.

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Presentation transcript:

Bernardo Cortese, MD, FESC Intv’ Cardiology, A.O. Fatebenefratelli MI CNR-Fondazione Monasterio-Regione Toscana bernardocortese.com Radial versus femoral access in patients with acute coronary syndromes with or without ST-segment elevation A Pre-specified Analysis from the Randomized MATRIX trial

Study Organization and Sites Clinical Event Committee P. Vranckx, Chair S. Leonardi Co-Chair P. Tricoci Italian society of interventional cardiology Grant suppliers: The Medicines Company and Terumo Principal Investigator: Marco Valgimigli, MD, PhD 78 Sites, 4 EU countries recruited 8404 patients Statistical Committee P.Jüni, MD, Chair M. Rothenbühler Dik Heg Data Mng Executive Committee Marco Valgimigli, Andrea Gagnor; Paolo Calabrò, Paolo Rubartelli, Stefano Garducci, Giuseppe Andò, Andrea Santarelli, Mario Galli; Roberto Garbo; Ezio Bramucci; Salvatore Ierna, Carlo Briguori, Bernardo Cortese; Ugo Limbruno, Roberto Violini; Patrizia Presbitero; Nicoletta de Cesare; Paolo Sganzerla; Arturo Ausiello; Paolo Tosi; Gennaro Sardella; Manel Sabate’; Salvatore Brugaletta. E. Frigoli, Eustrategy Project Leader

1:1 1:1 NSTEACS or STEMI with invasive management Aspirin+P2Y12 blocker Randomization stratified for type of ACS NSTEACS or STEMI with invasive management Aspirin+P2Y12 blocker Randomization stratified for type of ACS Trans-Femoral Access Heparin ±GPI Bivalirudin Mono-Tx Stop Infusion Prolong≥ 6 hs infusion 1:1 Trans-Radial Access MATRIX Access ClinicalTrials.gov NCT Am Heart J Dec;168(6): e6.

8.8% 10.3% 15% significant reduction at nominal 5% alpha which is however NOT significant at the pre-specificed alpha of 2.5% Results of the main study: MACE Femoral Radial Valgimigli, Lancet 2015

Rate Ratio 0.83; 95% CI, 0.73 to 0.96; p= % 9.8% NNTB: 53 Femoral Radial Valgimigli, Lancet 2015 Results of the main study: NACE

Matrix Access Objectives  This study assessed whether radial compared with femoral access is associated with consistent outcomes in patients with ST-segment elevation myocardial infarction (STEMI) and non-ST- segment elevation (NSTE-ACS). This substudy had two pre-specified primary superiority endpoints at 30 days: MACE: composite of death, MI and stroke NACE: composite of death, MI, stroke and major bleeding (BARC 3 or 5)

Primary outcome STEMI UA/NSTEMI STEMI UA/NSTEMI MACE NACE p=0.76 p=0.18 p= p= p for interaction=0.25 p for interaction=0.76

Secondary outcomes STEMI UA/NSTEMI STEMI UA/NSTEMI mortality MI p= p=0.93 p=0.49 p=0.13 p for interaction=0.11 p for interaction=0.42

BARC 3 or 5 STEMI: 1.9 RAD vs 3 FEM, p=0.022 UA/NSTEMI: 1.3 RAD vs 1.7 FEM, p=0.26 Secondary outcomes p for interaction=0.54

CONCLUSIONS The results of this pre-specified sub-analysis of the MATRIX-Access study suggest that the overall trial results remain entirely consistent in patients with NSTE-ACS and STEMI. Unselected ACS patients, irrespective of the type of ACS, undergoing invasive mng should receive a TR approach.