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.

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.

Evaluation of the Coroflex Theca-Stent for reduction of restenosis (ECORI).

BACKGROUND: Various stent coatings have been shown to significantly reduce restenosis rates in comparison to non-coated devices. Therefore, the short- and mid-term performance of the new polyphosphazene-coated Coroflex Theca-Stent was investigated. METHODS: 103 patients [63.9 +/- 11 yrs, 5/103 (4.9%) lesion type A, 52/103 (50.5%) type B1, and 46 of 103 (44.6%) type B2] were enrolled for elective single stent deployment into de-novo coronary lesions (stenoses: greater than or equal to 70%, < 100%; reference diameter greater than or equal to 2.75 mm, less than or equal to 4 mm; lesion length: < 16 mm). RESULTS: Deployment and procedural success were 100%, in 57/103 (55.3%) patients without pre-dilatation. 3/103 (2.9%) patients were lost to follow-up. During the 7.1 +/- 2.3 months clinical follow-up, 3 of 100 (3.0%) patients underwent premature target lesion revascularizations, 4 /100 (4%) had non-target lesion-related deaths, and 1 of 100 (1%) suffered myocardial infarction. Among the 77 of 100 (77.0%) patients who underwent angiographic follow-up, the initial stenosis declined from 87.3 +/- 5.7% to 14.2 +/- 8.3% after stenting, and increased to 32.8 +/- 22.7% after 6.4 +/- 1.3 months. The late loss and late loss index were 0.6 +/- 0.7 mm and 0.2 +/- 0.4, respectively; the recurrence rate was 12 of 77 (15.6%), with reintervention required in 11 of 77 (14.3%) of these patients. CONCLUSION: The Coroflex Theca-Stent provides excellent procedural results and a low restenosis rate. Further development of this polymer as the final coating and as the basis for drug-eluting stents seems justified.