title: Adjunctive devices in primary or rescue PCI: a meta-analysis of randomized trials.
abstract: OBJECTIVE
  To overview and summarize the results emerging from the studies on adjunctive devices (AD) with theoretical anti-embolic properties in patients with ST-elevation acute myocardial infarction (STEMI) undergoing percutaneous coronary interventions (PCI).
  
  
  BACKGROUND
  A series of small-to-medium size randomized studies have compared different AD with standard PCI (SP) in the setting of STEMI. The reported results are conflicting.
  
  
  METHODS
  Eighteen prospective randomized studies on 3180 STEMI patients comparing AD with SP were identified and entered the meta-analysis. Pre-specified angiographic, electrocardiographic (absence of ST-segment resolution, STR) and early (up to 30 days) clinical end-points were assessed.
  
  
  RESULTS
  AD were associated with lower rates of angiographically evident distal embolization: OR (95% CI): 0.54 (0.37-0.81). Analyses of angiographic and electrocardiographic reperfusion showed striking heterogeneity among studies and an overall trend toward better results with AD: OR (95% CI) 0.76 (95% CI 0.51-1.12) for TIMI<3, 0.53 (0.37-0.76) for myocardial blush grade (MBG)<3, 0.60 (0.45-0.78) for absence of STR. Subgroup analysis according to the type of AD for the end-point of no STR showed concordant absence of benefit in studies testing distal protection devices, positive results being confined to the studies using thrombectomy devices (OR 0.46, 95% CI 0.32-0.66). However, the possibility of a "small study" bias within thrombectomy studies cannot be discharged (significant heterogeneity and positive Egger's test). Early major adverse cardiac events were not different between AD and SP.
  
  
  CONCLUSIONS
  AD use may be associated with reduced rate of angiographic distal embolization, and improved MBG 3 and STR rates. However, efficacy might vary with the type of device employed. Moreover, early clinical outcome is not modified suggesting that further, larger, studies are needed to assess the clinical impact of AD.
  
  
  CONCLUSIONS
  We conducted a meta-analysis of 18 prospective randomized trials comparing adjunctive devices (AD) with standard PCI in the setting of STEMI. The use of AD was associated with lower rates of (angiographically evident) distal embolization. Analyses of angiographic and electrocardiographic reperfusion showed striking heterogeneity and an overall trend toward better results with AD. Subgroup analysis suggested that different types of device may have different effects. Early major adverse cardiac events were similar between AD and SP.
authors: Institute of Cardiology, Catholic University of the Sacred Heart, Via Prati Fiscali 158, 00141 Rome, Italy. f.burzotta@rm.unicatt.it
authors: Francesco
authors: F
authors: Burzotta
authors: Luca
authors: L
authors: Testa
authors: Floriana
authors: F
authors: Giannico
authors: Giuseppe G L
authors: GG
authors: Biondi-Zoccai
authors: Carlo
authors: C
authors: Trani
authors: Enrico
authors: E
authors: Romagnoli
authors: Mario
authors: M
authors: Mazzari
authors: Rocco
authors: R
authors: Mongiardo
authors: Massimo
authors: M
authors: Siviglia
authors: Giampaolo
authors: G
authors: Niccoli
authors: Maria
authors: M
authors: De Vita
authors: Italo
authors: I
authors: Porto
authors: Giovanni
authors: G
authors: Schiavoni
authors: Filippo
authors: F
authors: Crea
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000379:methods; D006328:Cardiac Catheterization; D017023:Coronary Angiography; D003326:Coronary Circulation / Q000502:physiology; D003328:Coronary Thrombosis / Q000517:prevention & control*; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D015201:Meta-Analysis as Topic; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D019736:Prostheses and Implants; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012720:Severity of Illness Index; D015607:Stents; D016019:Survival Analysis; D016896:Treatment Outcome; D014654:Vascular Patency