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)

Catheter Cardiovasc Interv. 2011 Jul 1;78(1):14-9. doi: 10.1002/ccd.22932.


Objectives: 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).

Conclusion: 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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary* / adverse effects
  • Angioplasty, Balloon, Coronary* / instrumentation
  • Angioplasty, Balloon, Coronary* / mortality
  • Catheters
  • Chi-Square Distribution
  • Coronary Thrombosis / complications
  • Coronary Thrombosis / mortality
  • Coronary Thrombosis / therapy*
  • Equipment Design
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy*
  • Netherlands
  • Prospective Studies
  • Prosthesis Design
  • Recurrence
  • Risk Assessment
  • Risk Factors
  • Stents
  • Suction
  • Thrombectomy / adverse effects
  • Thrombectomy / instrumentation
  • Thrombectomy / methods*
  • Thrombectomy / mortality
  • Time Factors
  • Treatment Outcome