title: Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions: The PRISON IV Trial.
abstract: The aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs).
  
  
  
  The introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs.
  
  
  
  In this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints.
  
  
  
  Overall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: -0.01 to 0.25 mm; pnoninferiority= 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 ± 0.59 mm vs. 0.07 ± 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [p = 0.08] and 9.2% vs. 6.0% [p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups.
  
  
  
  This randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.
authors.affiliation: Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands. Electronic address: k.teeuwen@gmail.com.
authors.forename: Koen
authors.initials: K
authors.lastname: Teeuwen
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.
authors.forename: René J
authors.initials: RJ
authors.lastname: van der Schaaf
authors.affiliation: Department of Cardiology, University Hospital Leuven, Belgium.
authors.forename: Tom
authors.initials: T
authors.lastname: Adriaenssens
authors.affiliation: Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
authors.forename: Jacques J
authors.initials: JJ
authors.lastname: Koolen
authors.affiliation: Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.
authors.forename: Pieter C
authors.initials: PC
authors.lastname: Smits
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: José P S
authors.initials: JP
authors.lastname: Henriques
authors.affiliation: Department of Cardiology, Middelheim Hospital, Antwerp, Belgium.
authors.forename: Paul H M J
authors.initials: PH
authors.lastname: Vermeersch
authors.affiliation: Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.
authors.forename: R Melvyn
authors.initials: RM
authors.lastname: Tjon Joe Gin
authors.affiliation: Department of Cardiology, Amphia Hospital, Breda, the Netherlands.
authors.forename: Bastiaan E
authors.initials: BE
authors.lastname: Schölzel
authors.affiliation: Department of Research and Statistics, St. Antonius Hospital, Nieuwegein, the Netherlands.
authors.forename: Johannes C
authors.initials: JC
authors.lastname: Kelder
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
authors.forename: Jan G P
authors.initials: JG
authors.lastname: Tijssen
authors.affiliation: Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
authors.affiliation: Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
authors.forename: Maarten J
authors.initials: MJ
authors.lastname: Suttorp
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D001530:Belgium; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002908:Chronic Disease; D017023:Coronary Angiography; D054059:Coronary Occlusion / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000209:etiology; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging* / Q000209:etiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011108:Polymers / Q000737:chemistry*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus
keywords: biodegradable polymer; chronic total occlusion; drug-eluting stent(s); percutaneous coronary intervention