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

ABSTRACT

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.