title: A randomized comparison of manual versus mechanical thrombus removal in primary percutaneous coronary intervention in the treatment of ST-segment elevation myocardial infarction (TREAT-MI).
abstract: OBJECTIVE
  The objective of this study was to compare the efficacy and long-term clinical outcome of manual thrombus aspiration with the Export catheter (Medtronic, Minneapolis, MN) versus mechanical thrombus cutting/aspiration with the X-sizer system (eV3, White Bear Lake, MN) in primary percutaneous coronary intervention (PPCI).
  
  
  BACKGROUND
  In PPCI for acute ST-segment elevation myocardial infarction (STEMI), markers of myocardial reperfusion are improved with adjunctive thrombectomy. Previous studies of different devices showed a variability in performance, suitability, and short-term clinical outcome. In current literature, no direct comparison is available.
  
  
  METHODS
  We prospectively randomized 201 patients admitted for PPCI for STEMI to either the Export catheter or the X-sizer prior to stent deployment. Technical success in advancing to and across the lesion, improvement of flow, reduction of thrombus, and the effect on ST-segment resolution were examined. The primary endpoint of the follow-up study was the combined endpoint of cardiac death, recurrent myocardial infarction (MI), or target-vessel revascularization (TVR) at 3 years.
  
  
  RESULTS
  Although the Export catheter was more successfully deployed, other procedural parameters were similar with a trend toward better ST-segment resolution (56.6% vs. 44%; P = 0.06) as compared to the X-sizer system. The occurrence of the primary clinical endpoint at 3 years was 22.2% and 18.6%, respectively (HR 1.20; 95% CI 0.65-2.22; P = 0.35).
  
  
  CONCLUSIONS
  Despite shorter procedural times, better lesion crossing, and fewer complications, both surrogate endpoints as well as 3-year clinical follow-up were similar with the use of the Export catheter as compared to the X-sizer system.
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands. m.a.vink@olvg.nl
authors.forename: Maarten A
authors.initials: MA
authors.lastname: Vink
authors.forename: Mark S
authors.initials: MS
authors.lastname: Patterson
authors.forename: Jeroen
authors.initials: J
authors.lastname: van Etten
authors.forename: Alexander J J
authors.initials: AJ
authors.lastname: Ijsselmuiden
authors.forename: Maurits T
authors.initials: MT
authors.lastname: Dirksen
authors.forename: Giovanni
authors.initials: G
authors.lastname: Amoroso
authors.forename: Ton
authors.initials: T
authors.lastname: Slagboom
authors.forename: GertJan
authors.initials: G
authors.lastname: Laarman
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Kiemeneij
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D057785:Catheters; D016009:Chi-Square Distribution; D003328:Coronary Thrombosis / Q000150:complications / Q000401:mortality / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D009426:Netherlands; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D013396:Suction; D017131:Thrombectomy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome