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Assessment of residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing bivalirudin versus unfractionated heparin infusion: The MATRIX (minimizing adverse hemorrhagic events by transradial access site and angioX) OCT study.

Abstract

BACKGROUND

Residual stent strut thrombosis after primary percutaneous coronary intervention (PCI), negatively affects myocardial perfusion, may increase stent thrombosis risk, and it is associated with neointima hyperplasia at follow-up.

OBJECTIVES

To study the effectiveness of any bivalirudin infusion versus unfractionated heparin (UFH) infusion in reducing residual stent strut thrombosis in patients with ST-elevation myocardial infarction (STEMI).

METHODS

Multi-vessel STEMI patients undergoing primary PCI and requiring staged intervention were selected among those randomly allocated to two different bivalirudin infusion regimens in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Those receiving heparin only were enrolled into a registry arm. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of primary PCI and 3-5 days thereafter during a staged intervention. The primary endpoint was the change in minimum flow area (ΔMinFA) defined as (stent area + incomplete stent apposition [ISA] area) - (intraluminal defect + tissue prolapsed area) between the index and staged PCI.

RESULTS

123 patients in bivalirudin arm and 28 patients in the UFH arm were included. Mean stent area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The ΔMinFA in the bivalirudin group was 0.25 versus 0.05 mm2 in the UFH group, which resulted in a between-group significant difference of 0.36 [95% CI: (0.05, 0.71); p = .02]. This was mostly related to a decrease in tissue protrusion in the bivalirudin group (p = .03). There was a trend towards more patients in the bivalirudin group who achieved a 5% difference in the percentage of OCT frames with the area >5% (p = .057).

CONCLUSIONS

The administration of bivalirudin after primary PCI significantly reduces residual stent strut thrombosis when compared to UFH. This observation should be considered hypothesis-generating since the heparin-treated patients were not randomly allocated.

Authors+Show Affiliations

MedStar Washington Hospital Center, Washington, District of Columbia.Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Cardio-Thoracic Department, Civil Hospitals, Brescia, Italy.Rutgers New Jersey Medical School, Newark, New Jersey.MedStar Washington Hospital Center, Washington, District of Columbia.Cardiovascular and Neurologic Department, Misericordia Hospital, Grosseto, Italy.Department of Cardiology, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.Clinical Trials Unit, University of Bern, Bern, Switzerland.Cardiovascular and Neurologic Department, Misericordia Hospital, Grosseto, Italy.Division of Cardiology, Sant'Andrea Hospital, Rome, Italy.Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.Department of Cardiology, San Giovanni Bosco Hospital, Turin, Italy.Institute of Cardiology "G. d'Annunzio" University, Chieti, Italy.Interventional Cardiology Unit Umberto I Hospital, Syracuse, Italy.Interventional Cardiology Unit, Cardio-thoracic-Vascular Department, San Raffaele Scientific Institute, Milan, Italy.Division of Cardiology, Department of Cardiothoracic and Respiratory Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.Cardiology Unit, Ospedali Riuniti di Rivoli, Turin, Italy.Unita' Operativa Complessa di Cardiologia ASST di Vimercate (MB), Vimercate, Italy.Fondazione Toscana G. Monasterio - Ospedale del Cuore G. Pasquinucci, Pisa/Massa, Massa, Italy.Department of Cardiology, Interventional Cardiology, Mediterranea Cardiocentro, Naples, Italy.Clinical Trials Unit, University of Bern, Bern, Switzerland.Swiss Cardiovascular Center Bern, University of Bern, Bern, Switzerland.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31883294

Citation

Garcia-Garcia, Hector M., et al. "Assessment of Residual Thrombus Burden in Patients With ST-segment Elevation Myocardial Infarction Undergoing Bivalirudin Versus Unfractionated Heparin Infusion: the MATRIX (minimizing Adverse Hemorrhagic Events By Transradial Access Site and angioX) OCT Study." Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions, 2019.
Garcia-Garcia HM, Adamo M, Soud M, et al. Assessment of residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing bivalirudin versus unfractionated heparin infusion: The MATRIX (minimizing adverse hemorrhagic events by transradial access site and angioX) OCT study. Catheter Cardiovasc Interv. 2019.
Garcia-Garcia, H. M., Adamo, M., Soud, M., Yacob, O., Picchi, A., Sardella, G., ... Valgimigli, M. (2019). Assessment of residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing bivalirudin versus unfractionated heparin infusion: The MATRIX (minimizing adverse hemorrhagic events by transradial access site and angioX) OCT study. Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions, doi:10.1002/ccd.28661.
Garcia-Garcia HM, et al. Assessment of Residual Thrombus Burden in Patients With ST-segment Elevation Myocardial Infarction Undergoing Bivalirudin Versus Unfractionated Heparin Infusion: the MATRIX (minimizing Adverse Hemorrhagic Events By Transradial Access Site and angioX) OCT Study. Catheter Cardiovasc Interv. 2019 Dec 28; PubMed PMID: 31883294.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Assessment of residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing bivalirudin versus unfractionated heparin infusion: The MATRIX (minimizing adverse hemorrhagic events by transradial access site and angioX) OCT study. AU - Garcia-Garcia,Hector M, AU - Adamo,Marianna, AU - Soud,Mohamad, AU - Yacob,Omar, AU - Picchi,Andrea, AU - Sardella,Gennaro, AU - Frigoli,Enrico, AU - Limbruno,Ugo, AU - Rigattieri,Stefano, AU - Diletti,Roberto, AU - Boccuzzi,Giacomo, AU - Zimarino,Marco, AU - Contarini,Marco, AU - Russo,Filippo, AU - Calabrò,Paolo, AU - Andò,Giuseppe, AU - Varbella,Ferdinando, AU - Garducci,Stefano, AU - Palmieri,Cataldo, AU - Briguori,Carlo, AU - Karagiannis,Alexios, AU - Valgimigli,Marco, Y1 - 2019/12/28/ PY - 2019/07/10/received PY - 2019/12/08/accepted PY - 2019/12/29/pubmed PY - 2019/12/29/medline PY - 2019/12/29/entrez KW - ST-segment elevation myocardial infarction KW - bivalirudin KW - heparin KW - optical coherence tomography JF - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions JO - Catheter Cardiovasc Interv N2 - BACKGROUND: Residual stent strut thrombosis after primary percutaneous coronary intervention (PCI), negatively affects myocardial perfusion, may increase stent thrombosis risk, and it is associated with neointima hyperplasia at follow-up. OBJECTIVES: To study the effectiveness of any bivalirudin infusion versus unfractionated heparin (UFH) infusion in reducing residual stent strut thrombosis in patients with ST-elevation myocardial infarction (STEMI). METHODS: Multi-vessel STEMI patients undergoing primary PCI and requiring staged intervention were selected among those randomly allocated to two different bivalirudin infusion regimens in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Those receiving heparin only were enrolled into a registry arm. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of primary PCI and 3-5 days thereafter during a staged intervention. The primary endpoint was the change in minimum flow area (ΔMinFA) defined as (stent area + incomplete stent apposition [ISA] area) - (intraluminal defect + tissue prolapsed area) between the index and staged PCI. RESULTS: 123 patients in bivalirudin arm and 28 patients in the UFH arm were included. Mean stent area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The ΔMinFA in the bivalirudin group was 0.25 versus 0.05 mm2 in the UFH group, which resulted in a between-group significant difference of 0.36 [95% CI: (0.05, 0.71); p = .02]. This was mostly related to a decrease in tissue protrusion in the bivalirudin group (p = .03). There was a trend towards more patients in the bivalirudin group who achieved a 5% difference in the percentage of OCT frames with the area >5% (p = .057). CONCLUSIONS: The administration of bivalirudin after primary PCI significantly reduces residual stent strut thrombosis when compared to UFH. This observation should be considered hypothesis-generating since the heparin-treated patients were not randomly allocated. SN - 1522-726X UR - https://www.unboundmedicine.com/medline/citation/31883294/Assessment_of_residual_thrombus_burden_in_patients_with_ST-segment_elevation_myocardial_infarction_undergoing_bivalirudin_versus_unfractionated_heparin_infusion:_The_MATRIX_(minimizing_adverse_hemorrhagic_events_by_transradial_access_site_and_angioX)_OCT_study L2 - https://doi.org/10.1002/ccd.28661 DB - PRIME DP - Unbound Medicine ER -