The ProLimus trial: a prospective, non-randomised, multicentre trial to evaluate the safety and clinical performance of the pimecrolimus eluting stent system (ProGenic).

Abstract

AIMS:

The aim of this multicentre, non-randomised trial was to evaluate the safety and efficacy at 180+/-14 days of a pimecrolimus eluting coronary stent based on a cobalt-chromium platform and a poly-L-lactic acid (PLLA) bioresorbable polymer.

METHODS AND RESULTS:

Sixty-one patients, with single de novo coronary lesions <14 mm in length and a reference vessel diameter of 3.0 to 3.5 mm, were enrolled in five centres (Germany and Belgium). Angiography and IVUS were performed at baseline, post-procedure and 180+/-14 days later. The primary endpoint was a composite of major adverse cardiac events (MACE) at 180+/-14 days and expected to be below 20%. Patients had single vessel disease in 59%, 2-vessel disease in 28% and 3-vessel disease in 13% of cases. MACE rate at 180+/-14 days was 18.0%. Binary in-stent restenosis was 32.7% due to in-stent late lumen loss of 1.11+/-0.65 mm by QCA. Stent thrombosis rate at 30+/-7 and 180+/-14 days was 1.6% and 3.3%, respectively. Overall TLR rate at 30+/-7, 180+/-14 days and 12+/-1 months was 1.6%, 27.9% and 32.8% respectively.

CONCLUSIONS:

The primary endpoint was met at 180+/-14 days. However, the anti-restenotic effect of the pimecrolimus eluting stent did not reach levels similar to clinically established DES.

• Authors: Stefan Verheye, Giovanna Sarno, Ralf Müller, Ralf Birkemeyer, Christiaan Vrints, Werner Jung, Pierfrancesco Agostoni, Glenn van Langenhove, Steven Haine, Tine Willems, Michael Haude, Eberhard Grube, William Wijns
• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 5 Issue 2 Pg. 233-8 (Jun 2009) ISSN: 1969-6213 [Electronic] France
• PMID: 19527981 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Cardiovascular Agents
• Chromium Alloys
• Polyesters
• Polymers
• Lactic Acid
• poly(lactide)
• pimecrolimus
• Tacrolimus

Topics

• Aged
• Angioplasty, Balloon, Coronary (adverse effects, instrumentation, mortality)
• Belgium
• Cardiovascular Agents (administration & dosage)
• Chromium Alloys
• Coronary Angiography
• Coronary Restenosis (etiology, prevention & control)
• Coronary Stenosis (diagnosis, mortality, therapy)
• Drug-Eluting Stents
• Female
• Germany
• Humans
• Lactic Acid
• Male
• Middle Aged
• Myocardial Infarction (etiology)
• Polyesters
• Polymers
• Prospective Studies
• Prosthesis Design
• Severity of Illness Index
• Tacrolimus (administration & dosage, analogs & derivatives)
• Thrombosis (etiology)
• Time Factors
• Treatment Outcome
• Ultrasonography, Interventional