The paclitaxel-eluting Coroflex Please stent pilot study (PECOPS I) : the one-year clinical follow-up.
BACKGROUND
The alleged superiority of drug-eluting stents over bare metal devices and those with passive coatings is diminished by a higher incidence of late target vessel thrombosis.


RESULTS
Therefore, the one-year clinical outcome of the paclitaxel-eluting Coroflex Please stent in patients with denovo coronary lesions was evaluated in the single-arm PECOPS I pilot study. The clinical data of 96/97 (99%) of the patients included per protocol and of 86/87 (98.9%) of those treated per protocol were available 13.1 +/- 1.8 months following stent deployment. In the inclusion and treatment per protocol groups the incidence of cardiac deaths was 1/96 (1%) and 1/86 (1.2%), of myocardial infarction 3/96 (3.1%) and 1/86 (1.2%), and of target lesion revascularization 9/96 (9.4%) and 8/86 (9.3%). In patients enrolled per protocol two early thromboses (2.1%) occurred one of which two days after premature discontinuation of clopidogrel. In patients treated per protocol one thrombosis was observed after 10 hours. The one-year event-free survival was 83/96 (86.5%) in patients enrolled per protocol and 75/86 (87.2%) in those treated per protocol.


CONCLUSIONS
The one-year clinical outcome of PECOPS I was within the range of other paclitaxel-eluting coronary stents. The relative small number of patients enrolled in PECOPS I precludes to infer any further conclusions.
Unverdorben
Martin
M
Clinical Research Institute, Center of Cardiovascular Diseases, Heinz-Meise-Strasse 100, 36199, Rotenburg an der Fulda, Germany.
Degenhardt
Ralf
R
Wiemer
Marcus
M
Horstkotte
Dieter
D
Schneider
Henrik
H
Nienaber
Christoph
C
Bocksch
Wolfgang
W
Gross
Michael
M
Boxberger
Michael
M
Vallbracht
Christian
C
D000368:Aged; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control; D003643:Death; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D009204:Myocardial Revascularization; D017239:Paclitaxel / Q000008:administration & dosage*; D010865:Pilot Projects; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D015996:Survival Rate; D013927:Thrombosis / Q000209:etiology*; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D050257:Tubulin Modulators / Q000008:administration & dosage*
D010975:Platelet Aggregation Inhibitors; D050257:Tubulin Modulators; D000077144:Clopidogrel; D013988:Ticlopidine; D017239:Paclitaxel
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