Arterial healing following primary PCI using the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) versus the durable polymer everolimus-eluting metallic stent (XIENCE) in patients with acute ST-elevation myocardial infarction: rationale and design of the randomised TROFI II study.
OBJECTIVE
The Absorb bioresorbable vascular scaffold (Absorb BVS) provides similar clinical outcomes compared with a durable polymer-based everolimus-eluting metallic stent (EES) in stable coronary artery disease patients. ST-elevation myocardial infarction (STEMI) lesions have been associated with delayed arterial healing and impaired stent-related outcomes. The purpose of the present study is to compare directly the arterial healing response, angiographic efficacy and clinical outcomes between the Absorb BVS and metallic EES.


RESULTS
A total of 191 patients with acute STEMI were randomly allocated to treatment with the Absorb BVS or a metallic EES 1:1. The primary endpoint is the neointimal healing (NIH) score, which is calculated based on a score taking into consideration the presence of uncovered and malapposed stent struts, intraluminal filling defects and excessive neointimal proliferation, as detected by optical frequency domain imaging (OFDI) six months after the index procedure. The study will provide 90% power to show non-inferiority of the Absorb BVS compared with the EES.


CONCLUSIONS
This will be the first randomised study investigating the arterial healing response following implantation of the Absorb BVS compared with the EES. The healing response assessed by a novel NIH score in conjunction with results on angiographic efficacy parameters and device-oriented events will elucidate disease-specific applications of bioresorbable scaffolds.
Bern University Hospital, Bern, Switzerland.
Lorenz
L
Räber
Yoshinobu
Y
Onuma
Salvatore
S
Brugaletta
Hector M
HM
Garcia-Garcia
Bianca
B
Backx
Andres
A
Iñiguez
Lisette
L
Okkels Jensen
Àngel
À
Cequier-Fillat
Thomas
T
Pilgrim
Evald Høi
EH
Christiansen
Sjoerd H
SH
Hofma
Maarten
M
Suttorp
Patrick W
PW
Serruys
Manel
M
Sabaté
Stephan
S
Windecker
D020341:Absorbable Implants / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000628:therapy; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011108:Polymers; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
D002317:Cardiovascular Agents; D007166:Immunosuppressive Agents; D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus