Loic Belle1, Pascal Motreff2, Lionel Mangin2, Grégoire Rangé2, Xavier Marcaggi2, Antoine Marie2, Nadine Ferrier2, Olivier Dubreuil2, Gilles Zemour2, Géraud Souteyrand2, Christophe Caussin2, Nicolas Amabile2, Karl Isaaz2, Raphael Dauphin2, René Koning2, Christophe Robin2, Benjamin Faurie2, Laurent Bonello2, Stanislas Champin2, Cédric Delhaye2, François Cuilleret2, Nathan Mewton2, Céline Genty2, Magalie Viallon2, Jean Luc Bosson2, Pierre Croisille2. 1. From the Departments of Cardiology and Radiology, Centre Hospitalier Annecy-Genevois, Annecy, France (L. Belle, L.M., A.M.); Department of Cardiology, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France (P.M., G.S.); Department of Cardiology, Les Hôpitaux de Chartres, Eure-et-Loir, France (G.R.); Department of Cardiology, Centre Hospitalier de Vichy, Vichy, France (X.M., N.F.); Department of Cardiology, Centre Hospitalier St Luc St Joseph, Lyon, France (O.D.); Department of Cardiology, Centre Hospitalier de Cannes, Cannes, France (G.Z.); Department of Cardiology, Institut Mutualiste Monsouris, Paris, France (C.C., N.A.); Department of Cardiology, Hopital Nord, University hospital of Saint-Étienne, Saint-Étienne, France (K.I.); Department of Cardiology, Centre Hospitalier Universitaire de La Croix Rousse, Lyon, France (R.D.); Department of Cardiology, Clinique Saint Hilaire, Rouen, France (R.K.); Department of Cardiology, Clinique Convert, Bourg en Bresse, France (C.R.); Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France (B.F.); Department of Cardiology, Centre Hospitalier Universaitaire Marseille Nord, France (L. Bonello); Department of Cardiology, Hôpital de Valence, Valence, France (S.C.); Department of Cardiology, Hôpital Cardiologique, Lille university hospital, Lille, France (C.D.); Department of Cardiology, Hospital of Macon, Macon, France (F.C.); Department of Cardiology, Clinical Investigation Center, INSERM 1407, Hôpital Cardiovasculaire Louis Pradel, Lyon, France (N.M.); Clinical Investigation Centre, University Hospital of Grenoble, Grenoble, France (C.G., J.L.B.); and Department of Radiology, Hôpital Nord, University Hospital of Saint-Étienne, Saint-Étienne, France (M.V., P.C.). loic.belle@wanadoo.fr. 2. From the Departments of Cardiology and Radiology, Centre Hospitalier Annecy-Genevois, Annecy, France (L. Belle, L.M., A.M.); Department of Cardiology, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France (P.M., G.S.); Department of Cardiology, Les Hôpitaux de Chartres, Eure-et-Loir, France (G.R.); Department of Cardiology, Centre Hospitalier de Vichy, Vichy, France (X.M., N.F.); Department of Cardiology, Centre Hospitalier St Luc St Joseph, Lyon, France (O.D.); Department of Cardiology, Centre Hospitalier de Cannes, Cannes, France (G.Z.); Department of Cardiology, Institut Mutualiste Monsouris, Paris, France (C.C., N.A.); Department of Cardiology, Hopital Nord, University hospital of Saint-Étienne, Saint-Étienne, France (K.I.); Department of Cardiology, Centre Hospitalier Universitaire de La Croix Rousse, Lyon, France (R.D.); Department of Cardiology, Clinique Saint Hilaire, Rouen, France (R.K.); Department of Cardiology, Clinique Convert, Bourg en Bresse, France (C.R.); Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France (B.F.); Department of Cardiology, Centre Hospitalier Universaitaire Marseille Nord, France (L. Bonello); Department of Cardiology, Hôpital de Valence, Valence, France (S.C.); Department of Cardiology, Hôpital Cardiologique, Lille university hospital, Lille, France (C.D.); Department of Cardiology, Hospital of Macon, Macon, France (F.C.); Department of Cardiology, Clinical Investigation Center, INSERM 1407, Hôpital Cardiovasculaire Louis Pradel, Lyon, France (N.M.); Clinical Investigation Centre, University Hospital of Grenoble, Grenoble, France (C.G., J.L.B.); and Department of Radiology, Hôpital Nord, University Hospital of Saint-Étienne, Saint-Étienne, France (M.V., P.C.).
Abstract
BACKGROUND:Delayed stent implantation after restoration of normal epicardial flow by a minimalist immediate mechanical intervention aims to decrease the rate of distal embolization and impaired myocardial reperfusion after percutaneous coronary intervention. We sought to confirm whether a delayed stenting (DS) approach (24-48 hours) improves myocardial reperfusion, versus immediate stenting, in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. METHODS AND RESULTS: In the prospective, randomized, open-label minimalist immediate mechanical intervention (MIMI) trial, patients (n=140) with ST-segment-elevation myocardial infarction ≤12 hours were randomized to immediate stenting (n=73) or DS (n=67) after Thrombolysis In Myocardial Infarction 3 flow restoration by thrombus aspiration. Patients in the DS group underwent a second coronary arteriography for stent implantation a median of 36 hours (interquartile range 29-46) after randomization. The primary end point was microvascular obstruction (% left ventricular mass) on cardiac magnetic resonance imaging performed 5 days (interquartile range 4-6) after the first procedure. There was a nonsignificant trend toward lower microvascular obstruction in the immediate stenting group compared with DS group (1.88% versus 3.96%; P=0.051), which became significant after adjustment for the area at risk (P=0.049). Median infarct weight, left ventricular ejection fraction, and infarct size did not differ between groups. No difference in 6-month outcomes was apparent for the rate of major cardiovascular and cerebral events. CONCLUSIONS: The present findings do not support a strategy of DS versus immediate stenting in patients with ST-segment-elevation infarction undergoing primary percutaneous coronary intervention and even suggested a deleterious effect of DS on microvascular obstruction size. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360242.
RCT Entities:
BACKGROUND: Delayed stent implantation after restoration of normal epicardial flow by a minimalist immediate mechanical intervention aims to decrease the rate of distal embolization and impaired myocardial reperfusion after percutaneous coronary intervention. We sought to confirm whether a delayed stenting (DS) approach (24-48 hours) improves myocardial reperfusion, versus immediate stenting, in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. METHODS AND RESULTS: In the prospective, randomized, open-label minimalist immediate mechanical intervention (MIMI) trial, patients (n=140) with ST-segment-elevation myocardial infarction ≤12 hours were randomized to immediate stenting (n=73) or DS (n=67) after Thrombolysis In Myocardial Infarction 3 flow restoration by thrombus aspiration. Patients in the DS group underwent a second coronary arteriography for stent implantation a median of 36 hours (interquartile range 29-46) after randomization. The primary end point was microvascular obstruction (% left ventricular mass) on cardiac magnetic resonance imaging performed 5 days (interquartile range 4-6) after the first procedure. There was a nonsignificant trend toward lower microvascular obstruction in the immediate stenting group compared with DS group (1.88% versus 3.96%; P=0.051), which became significant after adjustment for the area at risk (P=0.049). Median infarct weight, left ventricular ejection fraction, and infarct size did not differ between groups. No difference in 6-month outcomes was apparent for the rate of major cardiovascular and cerebral events. CONCLUSIONS: The present findings do not support a strategy of DS versus immediate stenting in patients with ST-segment-elevation infarction undergoing primary percutaneous coronary intervention and even suggested a deleterious effect of DS on microvascular obstruction size. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360242.
Authors: Xenofon M Sakellariou; Georgios I Katsanos; Andreas P Efstathopoulos; Dimitrios G Sfairopoulos; Konstantinos V Stamatis; Spyridon D Pappas; Theofilos M Kolettis; Dimitrios N Nikas Journal: J Cardiovasc Dev Dis Date: 2021-05-21