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.


CONCLUSIONS
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.
Unverdorben
Martin
M
Center for Cardiovascular Diseases, Clinical Research Institute, Rotenburg, Germany.
Degenhardt
Ralf
R
Sick
Peter
P
Kastrati
Adnan
A
Desmet
Walter
W
Colombo
Antonio
A
Garcia
Eulegio
E
Klein
Werner
W
Wagner
Eberhard
E
Köhler
Henning
H
Scholz
Manfred
M
Berthold
Heiner K
HK
Vallbracht
Christian
C
D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control*; D003331:Coronary Vessels / Q000473:pathology; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000628:therapy*; D009943:Organophosphorus Compounds; D011108:Polymers; D011446:Prospective Studies; D012307:Risk Factors; D015607:Stents / Q000592:standards*
D020099:Coated Materials, Biocompatible; D009943:Organophosphorus Compounds; D011108:Polymers; C108974:poly(phosphazene)