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Published on: May 14, 2018
The paclitaxel-eluting Coroflex Please stent study (PECOPS I): the 3-year clinical follow-up
Martin Unverdorben1, Ralf Degenhardt, Marcus Wiemer
1Clinical Research Institute, Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany.
Insights
Long-term follow-up of the paclitaxel-eluting Coroflex Please stent shows a low incidence of major adverse cardiac events and stent thrombosis. This drug-eluting stent demonstrates safe and effective performance in native coronary arteries over three years.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Drug-eluting stents require long-term human follow-up due to potential late target vessel thrombosis.
- Assessing the long-term safety and efficacy of paclitaxel-eluting stents is crucial for clinical practice.
Purpose of the Study:
- To evaluate the three-year clinical outcomes of the paclitaxel-eluting Coroflex Please stent in patients with de-novo coronary lesions.
- To assess the incidence of major adverse cardiac events (MACE) and stent thrombosis.
Main Methods:
- A single-arm pilot study (PECOPS I) evaluated 123 patients with de-novo coronary lesions.
- Clinical data were collected up to 3.05 years post-stent deployment.
- Intention-to-treat analysis was used to determine event rates.
Main Results:
- The three-year incidence of cardiac death was 7.3%, myocardial infarction was 3.3%, and target lesion revascularization was 11.4%.
- Stent thrombosis occurred in 1.6% of patients within the first six months.
- The overall three-year MACE rate was 17.9%.
Conclusions:
- The paclitaxel-eluting Coroflex Please stent is a safe device for use in native coronary arteries.
- The stent demonstrated good long-term performance with a low occurrence of late major adverse events and late thromboses.
Background:
The evaluation of drug-eluting devices in humans should include longterm follow-up owing to risk of late target vessel thrombosis with the possible fatal sequel.
Methods And Results:
Therefore, the three-year clinical outcome of the paclitaxel-eluting Corofiex Please stent in patients with de-novo coronary lesions was evaluated in the single-arm PECOPS I pilot study. The clinical data of 123/125 (98.4%) of all patients included were available 3.05 +/- 0.12 years following stent deployment. In the intention-to-treat analysis the incidence of cardiac death was 9/123 (7.3%), of myocardial infarction 4/123 (3.3%), and of in-segment target lesion revascularization 14/123 (11.4%). Target lesion revascularizations tended (p = 0.30) to occur less frequently (9/96 (16.6%)) in those patients in whom the stent length was longer than the lesion (4.80 +/- 2.71 mm) compared to 5/27 (18.5%) in those patients in whom the stent was shorter than the lesion (-3.0 +/- 2.43 mm). Stent thromboses occurred in 2/123 (1.6%) patients during the first 6 months, one of which two days after premature discontinuation of clopidogrel. The total 3-year MACE rate was 22/123 (17.9%).
Conclusion:
The present study describes the paclitaxel-eluting Corotlex Please stent as a safe device with good long term performance when deployed in native coronary arteries. The occurrence of late major adverse events and late thromboses in particular seem to be very low.
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