Procedural resources utilization and clinical outcomes with bioresorbable everolimus-eluting scaffolds and Pt-Cr everolimus-eluting stent with resorbable abluminal polymer in clinical practice. A randomized trial.
OBJECTIVE
We sought to compare the procedural implications of using bioresorbable everolimus-eluting scaffolds (BVS) and Pt-Cr everolimus-eluting stent with abluminal bioabsorbable polymer (Synergy).


BACKGROUND
There are important differences in the respective platforms, which could impact on procedural performance, complications and outcomes.


METHODS
A prospective, randomized single center study including consecutive patients in stable clinical condition and with lesions amenable to be treated with BVS according to predefined criteria. Patients were randomized to either treatment with BVS or Synergy. All procedural data were collected and 12 months clinical follow up conducted. Primary objectives were fluoroscopy time, median dose-area product, contras agent volumen, and peri-procedural troponin release.


RESULTS
A total of 200 patients were included, 100 in BVS group and 100 in Synergy group. No significant differences were observed in baseline clinical and angiographic characteristics. Predilatation (97.6 vs. 25.4%; P < 0.001), postdilatation (64.8 vs. 38.4%: P < 0.01), and use of 2 wires (20.8 vs. 10%; P = 0.02) were more frequent with BVS. The BVS group showed a significant increase in fluoroscopy time (18%), dose-area product (20%), and contrast volume (10%). Post-procedural increase of creatinine was similar and amount of TnI release was significantly higher with BVS but incidence of peri-procedural infarction was comparable. Clinical outcomes at 12 months were similar with definite thrombosis being 1% with BVS and 0% with Synergy.


CONCLUSIONS
The use of BVS in comparison with the Synergy stent in a similar lesional setting is associated with a higher use of resources in the procedure, more radiation, and higher TnI release. © 2016 Wiley Periodicals, Inc.
Hospital Universitario Marques de Valdecilla, Department of Cardiology, Interventional Cardiology Unit, Santander, Spain.
Jose M
JM
de la Torre Hernandez
Hospital Universitario Marques de Valdecilla, Department of Cardiology, Interventional Cardiology Unit, Santander, Spain.
Tamara
T
Garcia Camarero
Hospital Universitario Marques de Valdecilla, Department of Cardiology, Interventional Cardiology Unit, Santander, Spain.
Dae-Hyun
DH
Lee
Hospital Universitario Marques de Valdecilla, Department of Cardiology, Interventional Cardiology Unit, Santander, Spain.
Fermin
F
Sainz Laso
Hospital Universitario Marques de Valdecilla, Department of Cardiology, Interventional Cardiology Unit, Santander, Spain.
Gabriela
G
Veiga Fernandez
Hospital Universitario Marques de Valdecilla, Department of Cardiology, Interventional Cardiology Unit, Santander, Spain.
Tania
T
Pino
Hospital Universitario Marques de Valdecilla, Department of Cardiology, Interventional Cardiology Unit, Santander, Spain.
Silvia
S
Rubio
Hospital Universitario Marques de Valdecilla, Department of Cardiology, Interventional Cardiology Unit, Santander, Spain.
Pablo
P
Legarra
Hospital Universitario Marques de Valdecilla, Department of Cardiology, Interventional Cardiology Unit, Santander, Spain.
Jorge R
JR
Valdivia
Hospital Universitario Marques de Valdecilla, Department of Cardiology, Interventional Cardiology Unit, Santander, Spain.
Javier
J
Zueco Gil
D020341:Absorbable Implants; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D003287:Contrast Media / Q000008:administration & dosage; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011108:Polymers / Q000737:chemistry*; D011446:Prospective Studies; D011474:Prosthesis Design; D011829:Radiation Dosage; D000069079:Radiation Exposure; D015641:Radiography, Interventional; D012307:Risk Factors; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D003287:Contrast Media; D011108:Polymers; D000068338:Everolimus
bioabsorbable stent; drug-eluting stent; percutaneous coronary intervention