Collagenase to facilitate guidewire crossing in chronic total occlusion PCI-The Total Occlusion Study in Coronary Arteries-5 (TOSCA-5) trial.

Autor: Graham JJ; Terrence Donnelly Heart Center, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada., Bagai A; Terrence Donnelly Heart Center, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada., Wijeysundera H; Schulich Heart Program, Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada., Weisz G; Department of Cardiology, Shaare Zedek Medical Center, Hebrew University-Hadassah Medical School, Jerusalem, Israel., Rinfret S; Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada., Dick A; University of Ottawa Heart Institute, University of Ottawa, Ottawa, Ontario, Canada., Jolly SS; McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada., Schaempert E; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada., Mansour S; Division of Cardiology, Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Québec, Canada., Dzavik V; Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada., Henriques JPS; Department of Cardiology, Heart Center, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands., Elbarouni B; St. Boniface General Hospital Winnipeg, Winnipeg, Manitoba, Canada., Vo MN; St. Boniface General Hospital Winnipeg, Winnipeg, Manitoba, Canada., Teefy P; Department of Medicine, Cardiology Division, London Health Sciences Centre, University Hospital, London, Ontario, Canada., Goodhart D; Libin Cardiovascular Institute of Alberta, Calgary, Alberta, Canada., Mancini GBJ; Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada., Strauss BH; Matrizyme Pharma Corporation, Toronto, Ontario, Canada., Buller CE; Terrence Donnelly Heart Center, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Jazyk: angličtina
Zdroj: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2022 Mar; Vol. 99 (4), pp. 1065-1073. Date of Electronic Publication: 2022 Jan 25.
DOI: 10.1002/ccd.30101
Abstrakt: Background: Chronic total occlusions (CTO) are common and are associated with lower percutaneous coronary intervention (PCI) success rates, often due to failure of antegrade guidewire crossing. Local, intralesional delivery of collagenase (MZ-004) may facilitate guidewire crossing in CTO.
Aims: To evaluate the effect of MZ-004 in facilitating antegrade wire crossing in CTO angioplasty.
Methods: A total of 76 patients undergoing CTO PCI were enrolled at 13 international sites: 38 in the randomized training stage (collagenase [MZ-004] 900 or 1200 μg) and 38 in the placebo-controlled stage (MZ-004 900 or 1200 μg or placebo). Patients received the MZ-004 or identical volume saline (placebo group) in a double-blind design, injected via microcatheter directly into the proximal cap of the CTO. The following day patients underwent CTO PCI using antegrade wire techniques only.
Results: Patients were generally similar except for a trend for higher Japanese chronic total occlusion (J-CTO) score in the MZ-004 group (MZ-004 J-CTO score 1.9 vs. 1.4, p = 0.07). There was a numerical increase in the rates of guidewire crossing in the MZ-004 groups compared to placebo (74% vs. 63%, p = 0.52). Guidewire crossing with a soft-tip guidewire (≤1.5 g tip load) was significantly higher in the MZ-004 groups (0% in placebo, 17% in 900 μg, and 29% in 1200 μg MZ-004 group, p = 0.03). Rates of the major adverse cardiovascular event were similar between groups.
Conclusion: Local delivery of MZ-004 into coronary CTOs appears safe and may facilitate CTO crossing, particularly with softer tipped guidewires. These data support the development of a pivotal trial to further evaluate this agent.
(© 2022 Wiley Periodicals LLC.)
Databáze: MEDLINE
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