Giuseppe Gargiulo1, Marco Valgimigli2, Mikael Sunnåker3, Pascal Vranckx4, Enrico Frigoli5, Sergio Leonardi6, Alessandro Spirito5, Felice Gragnano7, Negar Manavifar5, Roberto Galea5, Alberto R De Caterina8, Paolo Calabrò9, Giovanni Esposito10, Stephan Windecker5, Lukas Hunziker5. 1. Department of Cardiology, Bern University Hospital, Bern, Switzerland; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. 2. Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch. 3. Clinical Trials Unit (CTU) Bern, University of Bern, Bern, Switzerland. 4. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium & Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium. 5. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 6. Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 7. Department of Cardiology, Bern University Hospital, Bern, Switzerland; Division of Cardiology, Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy. 8. Ospedale del Cuore - Massa, Fondazione Toscana "G. Monasterio", Pisa, Italy. 9. Division of Cardiology, Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy. 10. Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
Abstract
INTRODUCTION AND OBJECTIVES: Patients who are vulnerable to hemodynamic or electrical disorders (VP) are often excluded from clinical trials and data on the optimal access-site or antithrombotic treatment are limited. We assessed outcomes of transradial vs transfemoral access and bivalirudin vs unfractionated heparin (UFH) in VP with acute coronary syndrome undergoing invasive management. METHODS: The MATRIX trial randomized 8404 patients to radial or femoral access and 7213 patients to bivalirudin or UFH. Among them, 934 (11.1%) were deemed VP due to advanced Killip class (n = 808), cardiac arrest (n = 168), or both (n = 42). The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACE: death, myocardial infarction, or stroke) and net adverse clinical events (NACE: MACE or major bleeding). RESULTS: MACE and NACE were similarly reduced with radial vs femoral access in VP and non-VP. Transradial access was also associated with consistent relative benefits in all-cause and cardiovascular mortality or Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding with greater absolute benefits in VP. The effects of bivalirudin vs UFH on MACE and NACE were consistent in VP and non-VP. Bivalirudin was associated with lower all-cause and cardiovascular mortality in VP but not in non-VP, with borderline interaction testing. Bivalirudin reduced bleeding in both VP and non-VP with a larger absolute benefit in VP. CONCLUSIONS: In acute coronary syndrome patients undergoing invasive management, the effects of randomized treatments were consistent in VP and non-VP, but absolute risk reduction with radial access and bivalirudin were greater in VP, with a 5- to 10-fold lower number needed to treat for benefits. Trial registry number: NCT01433627.
INTRODUCTION AND OBJECTIVES: Patients who are vulnerable to hemodynamic or electrical disorders (VP) are often excluded from clinical trials and data on the optimal access-site or antithrombotic treatment are limited. We assessed outcomes of transradial vs transfemoral access and bivalirudin vs unfractionated heparin (UFH) in VP with acute coronary syndrome undergoing invasive management. METHODS: The MATRIX trial randomized 8404 patients to radial or femoral access and 7213 patients to bivalirudin or UFH. Among them, 934 (11.1%) were deemed VP due to advanced Killip class (n = 808), cardiac arrest (n = 168), or both (n = 42). The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACE: death, myocardial infarction, or stroke) and net adverse clinical events (NACE: MACE or major bleeding). RESULTS: MACE and NACE were similarly reduced with radial vs femoral access in VP and non-VP. Transradial access was also associated with consistent relative benefits in all-cause and cardiovascular mortality or Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding with greater absolute benefits in VP. The effects of bivalirudin vs UFH on MACE and NACE were consistent in VP and non-VP. Bivalirudin was associated with lower all-cause and cardiovascular mortality in VP but not in non-VP, with borderline interaction testing. Bivalirudin reduced bleeding in both VP and non-VP with a larger absolute benefit in VP. CONCLUSIONS: In acute coronary syndrome patients undergoing invasive management, the effects of randomized treatments were consistent in VP and non-VP, but absolute risk reduction with radial access and bivalirudin were greater in VP, with a 5- to 10-fold lower number needed to treat for benefits. Trial registry number: NCT01433627.
Authors: Amir Faour; Nicholas Collins; Trent Williams; Arshad Khan; Craig P Juergens; Sidney Lo; Darren L Walters; Derek P Chew; John K French Journal: PLoS One Date: 2021-10-26 Impact factor: 3.240