Efficacy and safety of a double-coated paclitaxel-eluting coronary stent: the EUCATAX trial.
OBJECTIVE
The aim of this study was the comparison of a new double-coated paclitaxel-eluting coronary stent with bare-metal stent (BMS) in patients undergoing percutaneous coronary intervention.


BACKGROUND
Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications.


METHODS
Multicenter randomized trial comparing a paclitaxel-eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis.


RESULTS
At 1 year of follow-up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P=0.02), and MACE rate was 10% in PES and 19% in BMS arm (P=0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms.


CONCLUSIONS
The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow-up should be necessary to assess true advantages of this technology compared with the previous one.
Rodriguez
Alfredo E
AE
Sanatorio Otamendi, Cardiac Unit, Capital federal, Buenos Aires, Argentina. rodriguezalfredo.e@gmail.com
Vigo
Cesar F
CF
Delacasa
Alejandro
A
Mieres
Juan
J
Fernandez-Pereira
Carlos
C
Bernardi
Victor
V
Bettinoti
Marcelo
M
Rodriguez-Granillo
Alfredo M
AM
Rodriguez-Granillo
Gaston
G
Santaera
Omar
O
Curotto
Valeria
V
Rubilar
Bibiana
B
Tronge
Jorge
J
Palacios
Igor F
IF
Antoniucci
David
D
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001118:Argentina; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D019276:Glycocalyx; D006801:Humans; D053208:Kaplan-Meier Estimate; D019344:Lactic Acid; D016015:Logistic Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D011100:Polyglycolic Acid; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D015607:Stents; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; D017239:Paclitaxel