The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial.
The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up.



Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent.



The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 - minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected.



Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p < 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; p = 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037).



BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281).
ThoraxCenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Academic Medical Center, Amsterdam, the Netherlands; Northern Region Heart Center, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Pannipa
P
Suwannasom
Academic Medical Center, Amsterdam, the Netherlands.
Yohei
Y
Sotomi
ThoraxCenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
Yuki
Y
Ishibashi
ThoraxCenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
Rafael
R
Cavalcante
Montefiore Medical Center, Albert Einstein College of Medicine, New York, New York.
Felipe N
FN
Albuquerque
Hospital Universitario Clínico San Carlos, Madrid, Spain.
Carlos
C
Macaya
Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.
John A
JA
Ormiston
King's College Hospital, London, England.
Jonathan
J
Hill
Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria.
Irene M
IM
Lang
Freeman Hospital, Newcastle upon Tyne, England.
Mohaned
M
Egred
Department of Cardiology, Pasteur Hospital, Toulouse, France.
Jean
J
Fajadet
1st Department of Cardiology, Medical University of Poznan, Poland.
Maciej
M
Lesiak
Academic Medical Center, Amsterdam, the Netherlands.
Jan G
JG
Tijssen
Academic Medical Center, Amsterdam, the Netherlands.
Joanna J
JJ
Wykrzykowska
Academic Medical Center, Amsterdam, the Netherlands.
Robbert J
RJ
de Winter
Institut Jacques Cartier, Massy, France.
Bernard
B
Chevalier
International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, England. Electronic address: patrick.w.j.c.serruys@pwserruys.com.
Patrick W
PW
Serruys
ThoraxCenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
Yoshinobu
Y
Onuma
D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D008670:Metals; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D016037:Single-Blind Method; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D002317:Cardiovascular Agents; D008670:Metals; D000068338:Everolimus
asymmetry; bioresorbable vascular scaffolds; eccentricity; expansion