Fate of post-procedural malapposition of everolimus-eluting polymeric bioresorbable scaffold and everolimus-eluting cobalt chromium metallic stent in human coronary arteries: sequential assessment with optical coherence tomography in ABSORB Japan trial.
The natural course of post-procedural incomplete strut apposition (ISA) after the implantation of bioresorbable scaffolds (BVS) remains unknown. The purpose of the present study was to evaluate the fate of post-procedural ISA after everolimus-eluting Absorb BVS in comparison with the second-generation everolimus-eluting cobalt chromium stent (CoCr-EES).



Fate of post-procedural ISA was evaluated by serial optical coherence tomography (OCT) in the ABSORB Japan randomized trial [OCT-1 subgroup: 110 paired lesions of post-procedure and 2-year follow-up (BVS 73 lesions vs. CoCr-EES 37 lesions)] with respect to ISA distance. Post-procedure ISA struts were categorized into either 'resolved' or 'persistent' by matched OCT imaging at 2-year follow-up. Post-procedure %malapposed strut and ISA area were smaller in BVS than in CoCr-EES (%malapposed strut: 4.8 ± 6.9% vs. 9.9 ± 9.8%, P = 0.002; ISA area 0.10 ± 0.18 mm2 vs. 0.23 ± 0.26 mm2, P = 0.003). At 2-year follow-up, the difference diminished, and majority of the ISA struts spontaneously resolved in both arms (%malapposed strut: 0.10 ± 0.46% vs. 0.24 ± 0.65%, P = 0.183). Receiver operating characteristic curve analysis (BVS 661 struts vs. CoCr-EES 807 struts) demonstrated that the best cut-off value of endoluminal ISA distance post-procedure for predicting persistent-ISA at 2-year follow-up was 396 µm for BVS (sensitivity 0.875; specificity 0.851) and 359 µm for CoCr-EES (sensitivity 0.778; specificity 0.881).



BVS as compared with CoCr-EES allows larger ISA distance at post-procedure, although we should make every effort to minimize post-procedure ISA. The reported cut-off value of OCT-estimated ISA distance at post-stenting for predicting persistent-ISA would be helpful to optimize PCI with BVS and CoCr-EES.
Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Yohei
Y
Sotomi
ThoraxCenter, Erasmus Medical Center, Rotterdam, The Netherlands.|Cardialysis, Rotterdam, The Netherlands.
Yoshinobu
Y
Onuma
LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands.
Jouke
J
Dijkstra
ThoraxCenter, Erasmus Medical Center, Rotterdam, The Netherlands.
Yosuke
Y
Miyazaki
Teikyo University Hospital, Tokyo, Japan.
Ken
K
Kozuma
Division of Cardiology, Cardiac Intensive Care Unit, Mitsui Memorial Hospital, Tokyo, Japan.
Kengo
K
Tanabe
Beth Israel Deaconess Medical Center, Boston, MA, USA.
Jeffrey J
JJ
Popma
Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Robbert J
RJ
de Winter
NHLI, Imperial College London, London, United Kingdom.
Patrick W
PW
Serruys
Department of Cardiovascular Medicine, Kyoto University Hospital, Kyoto, Japan.
Takeshi
T
Kimura
D020341:Absorbable Implants; D000368:Aged; D002857:Chromium; D003035:Cobalt; D017023:Coronary Angiography / Q000379:methods; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D016014:Linear Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D016011:Normal Distribution; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000379:methods; D011183:Postoperative Complications / Q000000981:diagnostic imaging; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012372:ROC Curve; D018570:Risk Assessment; D016037:Single-Blind Method; D041623:Tomography, Optical Coherence / Q000379:methods*
D008670:Metals; D002857:Chromium; D003035:Cobalt; D000068338:Everolimus
bioresorbable scaffold ; metallic stent ; optical coherence tomography ; randomized controlled trial; strut malapposition 