title: Six-month clinical and angiographic results of the STENTYS® self-apposing stent in bifurcation lesions.
abstract: OBJECTIVE
  We report the clinical and angiographic results of the OPEN I study, a multicentre prospective single-arm study evaluating both the drug-eluting and bare metal STENTYS® stents in the treatment of coronary bifurcation lesions.
  
  
  RESULTS
  The STENTYS® stent is a provisional, self-expanding, nitinol stent with small interconnections that can be disconnected by balloon angioplasty in between the stent struts to provide access to the side branch (SB) and full ostium coverage. In nine European centres, 60 stents (33 BMS, 27 DES) were implanted in 63 patients (procedural success of 95.2%). Angiographic QCA and IVUS were used to measure acute gain and late loss. The Medina classification showed 35 patients (58%) had disease affecting the SB (true bifurcations) and 19 patients (32%) had disease in all three arms. The average bifurcation angulation pre-stenting was 60°±21°. Post-stenting, disconnection was performed on 90% of the stents implanted. In 18 cases, disconnection was followed by SB stenting with all SB stents successfully implanted. Post-stenting, the bifurcation angle was 51°. The primary clinical endpoint, cumulative MACE at six months, was low for DES (3.7%) but higher for BMS (27.3%) with the latter driven exclusively by clinically-driven TLR rates (3.7% vs. 24.2%). No cardiac deaths were recorded at six months and one patient had a non-Q wave infarct. The secondary angiographic endpoint of late luminal loss (LLL) was measured for both DES (paclitaxel) and BMS stents in the proximal main branch (MB), MB, distal MB as well as the SB. The values for DES were 0.39 mm, 0.42 mm, 0.40 mm and 0.16 mm, respectively. The values for BMS were 0.86 mm, 0.87 mm, 0.85 mm and 0.54 mm, respectively. Observed results using matched IVUS analysis at six months revealed an increase in mean stent area (mm²) for DES from 7.52±1.86 at baseline to 12.32±2.90 at six month follow-up (p <0.001); and for BMS from 7.95±1.40 to 11.56±2.22 (p <0.001), with no decrease in minimum lumen area (MLA) for DES (5.10 to 4.91) and a minimal decrease for BMS (5.74 to 5.15).
  
  
  CONCLUSIONS
  This first-in-man (FIM) study on the STENTYS® stent showed excellent procedural success and a relatively low MACE with competitively low LLL in both MB and SB at six months for the DES version and LLL comparable to other BMS for the BMS version. The disconnectable struts offered excellent "cross over" to T- stenting when necessary and the increased gains in stent area over time.
authors.affiliation: ZNA Middelheim, Antwerp, Belgium. stefan.verheye@gmail.com
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.forename: Steve
authors.initials: S
authors.lastname: Ramcharitar
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Joachim J
authors.initials: JJ
authors.lastname: Schofer
authors.forename: Bernhard
authors.initials: B
authors.lastname: Witzenbichler
authors.forename: Jan
authors.initials: J
authors.lastname: Kovac
authors.forename: Karl E
authors.initials: KE
authors.lastname: Hauptmann
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
authors.forename: Marcus
authors.initials: M
authors.lastname: Wiemer
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.forename: René
authors.initials: R
authors.lastname: Spaargaren
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Héctor M
authors.initials: HM
authors.lastname: García-García
authors.forename: Robert-Jan
authors.initials: RJ
authors.lastname: van Geuns
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging* / Q000209:etiology / Q000401:mortality; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D015607:Stents; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D008670:Metals