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 46/103 (44.6%) type B2] were enrolled for elective single stent deployment into de-novo coronary lesions (stenoses: ≥ 70%, < 100%; reference diameter ≥ 2.75 mm, ≤ 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, 3/100 (3.0%) patients underwent premature target lesion revascularizations, 4/100 (4%) had non-target lesion-related deaths, and 1/100 (1%) suffered myocardial infarction. Among the 77/100 (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 12/77 (15.6%), with reintervention required in 11/77 (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.