title: Early invasive strategy in high-risk acute coronary syndrome without ST-segment elevation. The Sisca randomized trial.
abstract: BACKGROUND
  The optimal therapeutic strategy for patients with high-risk acute coronary syndrome without ST-segment elevation (NSTE-ACS) remains unclear.
  
  
  OBJECTIVE
  Our aim was to compare the effectiveness of an early invasive strategy and a delayed invasive strategy in the management of high-risk NSTE-ACS patients.
  
  
  METHODS
  This randomized clinical trial in a primarily pre-hospital setting enrolled patients with chest pain, electrocardiographic criteria for an NSTE-ACS, and at least one criterion of severity (ESC criterion or TIMI score >5). Patients were randomized to either an early invasive strategy (tirofiban infusion and coronary angiography within 6h) or delayed invasive strategy (as per guidelines and physician discretion; coronary angiography within 6h was not advised). The primary endpoint was the cumulative incidence of deaths, myocardial infarctions, or urgent revascularizations at 30days of follow-up. Secondary endpoints were failure of delayed management, length of hospital stay and long-term mortality.
  
  
  RESULTS
  Between January 2007 and February 2010, 170 patients were enrolled. The cumulative incidence of adverse outcomes was significantly lower for early invasive than delayed management (2% [95% CI 0-9] vs. 24% [95% CI 16-35], p<10(-4)). Delayed management failed in 24% of cases. The length of hospital stay was significantly shorter in patients undergoing angioplasty or treated with tirofiban within 6h (p=0.0003). Long-term mortality was 16% in both arms after a median follow-up of 4.1years.
  
  
  CONCLUSIONS
  An early invasive strategy reduced major adverse cardiac events in patients with high-risk NSTE-ACS. Early angiography or tirofiban (GP IIb/IIIa inhibitor) infusion proved necessary in a quarter of patients assigned to delayed management.
authors.affiliation: Service des Urgences et Service d'Aide Médicale Urgente, Centre Hospitalier Universitaire Avicenne, Assistance Publique-Hôpitaux de Paris, 125 rue de Stalingrad, 93009 Bobigny Cedex, France; Université Paris 13, Sorbonne Paris Cité, EA 3509 Bobigny, France. Electronic address: paul-georges.reuter@avc.aphp.fr.
authors.forename: Paul-Georges
authors.initials: PG
authors.lastname: Reuter
authors.affiliation: Service des Urgences et Service d'Aide Médicale Urgente, Centre Hospitalier de Châteauroux, 216 Avenue de Verdun, 36000 Châteauroux, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Rouchy
authors.affiliation: Département de Cardiologie, Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, 10 Rue du Général Leclerc, 93370 Montfermeil, France.
authors.forename: Simon
authors.initials: S
authors.lastname: Cattan
authors.affiliation: Département de Cardiologie, Clinique la Roseraie, 120 Avenue de la République, 93300 Aubervilliers, France.
authors.forename: Hakim
authors.initials: H
authors.lastname: Benamer
authors.affiliation: Département de Cardiologie, Centre Cardiologique du Nord, 36 Rue des Moulins Gémeaux, 93200 Saint-Denis, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Jullien
authors.affiliation: Service Mobile d'Urgence et de Réanimation, Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, 10 Rue du Général Leclerc, 93370 Montfermeil, France.
authors.forename: Ariel
authors.initials: A
authors.lastname: Beruben
authors.affiliation: Département de Cardiologie, Centre Hospitalier Intercommunal Robert Ballanger, Boulevard Robert Ballanger, 93600 Aulnay-sous-Bois, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Montely
authors.affiliation: Service d'Aide Médicale Urgente du Nord Pôle de l'Urgence, Centre Hospitalier Régional Universitaire de Lille, 5 avenue Oscar-Lambret, 59037 Lille Cedex, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Assez
authors.affiliation: Service Mobile d'Urgence et de Réanimation, Centre Hospitalier Intercommunal Robert Ballanger, Boulevard Robert Ballanger, 93600 Aulnay-sous-Bois, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Raphael
authors.affiliation: Service Mobile d'Urgence et de Réanimation, Centre hospitalier de Saint-Denis, 2 Rue du Docteur Delafontaine, 93200 Saint-Denis, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Hennequin
authors.affiliation: Département de Cardiologie, Centre Hospitalier Intercommunal André Grégoire, 56 Boulevard de la Boissière, 93100 Montreuil, France.
authors.forename: Albert
authors.initials: A
authors.lastname: Boccara
authors.affiliation: Service des Urgences, Centre Hospitalier Universitaire Jean Verdier, Assistance Publique-Hôpitaux de Paris, Avenue du 14 Juillet, 93140 Bondy, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Javaud
authors.affiliation: Service des Urgences et Service d'Aide Médicale Urgente, Centre Hospitalier de Châteauroux, 216 Avenue de Verdun, 36000 Châteauroux, France.
authors.forename: Louis
authors.initials: L
authors.lastname: Soulat
authors.affiliation: Service des Urgences et Service d'Aide Médicale Urgente, Centre Hospitalier Universitaire Avicenne, Assistance Publique-Hôpitaux de Paris, 125 rue de Stalingrad, 93009 Bobigny Cedex, France; Université Paris 13, Sorbonne Paris Cité, EA 3509 Bobigny, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Adnet
authors.affiliation: Service des Urgences et Service d'Aide Médicale Urgente, Centre Hospitalier Universitaire Avicenne, Assistance Publique-Hôpitaux de Paris, 125 rue de Stalingrad, 93009 Bobigny Cedex, France; Université Paris 13, Sorbonne Paris Cité, EA 3509 Bobigny, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Lapostolle
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D000368:Aged; D017023:Coronary Angiography / Q000379:methods*; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D005602:France / Q000453:epidemiology; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D000077466:Tirofiban; D014443:Tyrosine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D014443:Tyrosine; D000077466:Tirofiban
keywords: Acute coronary syndrome; High risk patients; Long-term outcome; Prehospital; Tirofiban