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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

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

Thierry Lefèvre, MD^_*,_*, Eulegio Garcia, MD, Bernhard Reimers, MD, Iréne Lang, MD, Carlo di Mario, MD^||, Antonio Colombo, MD^¶, Franz-Joseph Neumann, MD^#, Mariano Valdés Chavarri, MD^_**, Philippe Brunel, MD, Eberhart Grube, MD, Martin Thomas, MD, Bernard Glatt, MD^||||, Joseph Ludwig, MD^¶¶ on behalf of the X AMINE ST Investigators

^_* Institut Cardiovasculaire Paris Sud, Massy, France
Hospital Gregorio Marañon, Madrid, Spain
Ospedale Civile, Mirano, Italy
AKH, Vienna, Austria
^|| Ospedale San Raffaele, Milano, Italy
^¶ Centro Cuore Columbus, Milano, Italy
^# Herzzentrum, Bad Krozingen, Germany
^_** Hospital Universitario ‘Virgen de la Arrixaca’, Murcia, Spain
Clinique Saint Henri, Nantes, France
Heart Center Hospital, Siegburg, Germany
King’s College Hospital, London, United Kingdom
^|||| Centre Cardiologique du Nord, Saint-Denis, France
^¶¶ Klinikum der Uni, Erlangen, Germany.

Manuscript received November 18, 2004; revised manuscript received March 8, 2005, accepted April 14, 2005.

^_* Reprint requests and correspondence: Dr. Thierry Lefèvre, Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, 91300 Massy, France. (Email: t.lefevre{at}icps.com.fr).

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.

Abbreviations and Acronyms   AMI = acute myocardial infarction   CI = confidence interval   cTFC = corrected TIMI frame count   ECG = electrocardiogram/electrocardiographic   GP = glycoprotein   IRA = infarct-related artery   MACCE = major adverse cardiac and cerebral events   OR = odds ratio   PCI = percutaneous coronary intervention   TIMI = Thrombolysis In Myocardial Infarction

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