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


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.
Verheye
Stefan
S
Middelheim Hospital Antwerp, Belgium.
Sarno
Giovanna
G
Müller
Ralf
R
Birkemeyer
Ralf
R
Vrints
Christiaan
C
Jung
Werner
W
Agostoni
Pierfrancesco
P
van Langenhove
Glenn
G
Haine
Steven
S
Willems
Tine
T
Haude
Michael
M
Grube
Eberhard
E
Wijns
William
W
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001530:Belgium; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002858:Chromium Alloys; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D019344:Lactic Acid; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011091:Polyesters; D011108:Polymers; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D002317:Cardiovascular Agents; D002858:Chromium Alloys; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide); C117268:pimecrolimus; D016559:Tacrolimus