Evaluation of the Coroflex™ theca-stent for reduction of restenosis (ECORI)

Martin Unverdorben, Ralf Degenhardt, Peter Sick, Adnan Kastrati, Walter Desmet, Antonio Colombo, Eulegio Garcia, Werner Klein, Eberhard Wagner, Henning Köhler, Manfred Scholz, Heiner K. Berthold, Christian Vallbracht

Research output: Contribution to journalArticle

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 46/103 (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.

Original languageEnglish
Pages (from-to)199-202
Number of pages4
JournalJournal of Invasive Cardiology
Volume17
Issue number4
Publication statusPublished - Apr 2005

Keywords

  • Coating
  • Polyphosphazene
  • Restenosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Unverdorben, M., Degenhardt, R., Sick, P., Kastrati, A., Desmet, W., Colombo, A., Garcia, E., Klein, W., Wagner, E., Köhler, H., Scholz, M., Berthold, H. K., & Vallbracht, C. (2005). Evaluation of the Coroflex™ theca-stent for reduction of restenosis (ECORI). Journal of Invasive Cardiology, 17(4), 199-202.