title: Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of the MiStent absorbable polymer sirolimus-eluting stent (APSES) with a zotarolimus-eluting stent (ZES).
  
  
  RESULTS
  The trial was a 2:1 randomisation at 26 sites of 184 patients implanted with an APSES (n=123) versus a ZES (n=61). Following stent implantation, all patients underwent quantitative coronary angiography at baseline and at nine months of follow-up, while a select subgroup also underwent optical coherence tomography (OCT). The primary efficacy hypothesis was superiority of in-stent late lumen loss (LLL) of APSES compared to ZES. At nine months, the primary endpoint was met, with a mean in-stent LLL of 0.27±0.46 mm in 103 APSES patients versus 0.58±0.41 mm in 52 ZES patients (p<0.001). The proportion of uncovered stent struts by OCT at nine months was very low in both groups. The mean neointimal thickness of covered struts (p=0.002) and percent net volume obstruction (p≤0.003) were significantly lower in the APSES than in the ZES group. Major adverse cardiac event and stent thrombosis rates were low and comparable between groups.
  
  
  CONCLUSIONS
  The DESSOLVE II trial demonstrated superiority in the primary efficacy endpoint of nine-month mean LLL for APSES compared to ZES. Strut coverage by OCT was high with both stents and the clinical safety endpoints including stent thrombosis were equally low in both groups. ClinicalTrials.gov Identifier: NCT01294748.
authors.affiliation: Cardiovascular Center Aalst, OLV Hospital, Aalst, Belgium.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Mathias
authors.initials: M
authors.lastname: Vrolix
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.forename: Danny
authors.initials: D
authors.lastname: Schoors
authors.forename: Ton
authors.initials: T
authors.lastname: Slagboom
authors.forename: Marcel
authors.initials: M
authors.lastname: Gosselink
authors.forename: Edouard
authors.initials: E
authors.lastname: Benit
authors.forename: Dennis
authors.initials: D
authors.lastname: Donohoe
authors.forename: Charlene
authors.initials: C
authors.lastname: Knape
authors.forename: Guilherme F
authors.initials: GF
authors.lastname: Attizzani
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: John
authors.initials: J
authors.lastname: Ormiston
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000473:pathology*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima / Q000000981:diagnostic imaging / Q000473:pathology*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011108:Polymers; D016037:Single-Blind Method; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D011108:Polymers; C489443:zotarolimus; D020123:Sirolimus