1. X-Sizer for Thrombectomy in Acute Myocardial Infarction Improves ST-Segment Resolution: Results of the X-Sizer in AMI for Negligible Embolization and Optimal ST Resolution (X AMINE ST) Trial
- Author
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Lefèvre, Thierry, Garcia, Eulegio, Reimers, Bernhard, Lang, Iréne, di Mario, Carlo, Colombo, Antonio, Neumann, Franz-Joseph, Chavarri, Mariano Valdés, Brunel, Philippe, Grube, Eberhart, Thomas, Martin, Glatt, Bernard, and Ludwig, Joseph
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THROMBOLYTIC therapy , *ENDOCRINE diseases , *BLOOD circulation , *MULTIVARIATE analysis - Abstract
Objectives: We sought to compare, in a prospective randomized multicenter study, the effect of adjunctive thrombectomy using X-Sizer (eV3, White Bear Lake, Minnesota) before percutaneous coronary intervention (PCI) versus conventional PCI in patients with acute myocardial infarction (AMI) for <12 h and Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1. The primary end point was the magnitude of ST-segment resolution after PCI. Background: Despite a high rate of TIMI flow grade 3 achieved by PCI in patients with AMI, myocardial reperfusion remains relatively low. Distal embolization of thrombotic materials may play a major role in this setting. Methods: We conducted a prospective, randomized, multicenter study in patients with AMI <12 h and initial TIMI flow grade 0 to 1 who were treated with primary PCI. The magnitude of ST-segment resolution 1 h after PCI was the primary end point. Results: A total of 201 patients were included. Treatment groups were comparable by age (61 ± 13 years), diabetes (22%), previous MI (8%), anterior MI (52%), onset-to-angiogram (258 ± 173 min), and glycoprotein IIb/IIIa inhibitor use (59%). The magnitude of ST-segment resolution was greater in the X-Sizer group compared with the conventional group (7.5 vs. 4.9 mm, respectively; p = 0.033) as ST-segment resolution >50% (68% vs. 53%; p = 0.037). The occurrence of distal embolization was reduced (2% vs. 10%; p = 0.033) and TIMI flow grade 3 was obtained in 96% vs. 89%, respectively (p = 0.105). Myocardial blush grade 3 was similar (30% vs. 31%; p = NS). Six-month clinical outcome was comparable (death, 6% vs. 4% and major adverse cardiac and cerebral events, 13% vs. 13%, respectively). By multivariate analysis, independent predictors of ST-segment resolution >50% were: younger age, non-anterior MI, use of the X-Sizer, and a short time interval from symptom onset. Conclusions: Reducing thrombus burden with X-Sizer before stenting leads to better myocardial reperfusion, as illustrated by a reduced risk of distal embolization and better ST-segment resolution. [Copyright &y& Elsevier]
- Published
- 2005
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