title: First-in-human evaluation of a sirolimus-eluting coronary stent on an integrated delivery system: the DIRECT study.
abstract: OBJECTIVE
  The DIRECT study is a first-in-human evaluation of the safety and efficacy of the Svelte sirolimus-eluting coronary stent mounted on a fixed-wire, "all-in-one" integrated delivery system (IDS) in patients with de novo coronary artery lesions. The system permits easy delivery, deployment and post-dilatation of a cobalt-chromium stent eluting sirolimus from a fully bioabsorbable amino acid coating. The stent on its IDS has a very low profile, and is designed specifically to facilitate direct stenting.
  
  
  RESULTS
  Patients with symptomatic ischaemic heart disease and a single de novo native coronary lesion suitable for percutaneous coronary intervention were prospectively enrolled at four New Zealand sites. The lesion length had to be <23 mm and the vessel reference diameter 2.5-3.5 mm. The primary safety and efficacy endpoints were target vessel failure (TVF) and angiographic in-stent late lumen loss (LLL) at six months, respectively. Twenty-nine of 30 enrolled patients completed six-month follow-up. TVF occurred in two patients (7%). The in-stent LLL was 0.22 ± 0.27 mm. No patient had clinically-driven target lesion revascularisation. Intravascular ultrasound neointimal volume was 3.3 ± 4.4 mm3 and volume obstruction was 2.7 ± 4.5% at six months. Optical coherence tomography showed 98 ± 4% strut coverage at a depth of 0.12 ± 0.06 mm. No patient developed stent thrombosis.
  
  
  CONCLUSIONS
  Percutaneous coronary intervention using the Svelte sirolimus-eluting coronary stent mounted on an IDS appears safe and effective in de novo coronary artery lesions, with minimal in-stent proliferation and excellent stent strut coverage at six months.
authors.affiliation: Auckland City Hospital, Auckland, New Zealand.
authors.forename: Mark
authors.initials: M
authors.lastname: Webster
authors.forename: Scott
authors.initials: S
authors.lastname: Harding
authors.forename: Dougal
authors.initials: D
authors.lastname: McClean
authors.forename: Warwick
authors.initials: W
authors.lastname: Jaffe
authors.forename: John
authors.initials: J
authors.lastname: Ormiston
authors.forename: Andrew
authors.initials: A
authors.lastname: Aitken
authors.forename: Timothy
authors.initials: T
authors.lastname: Watson
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002858:Chromium Alloys; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D002858:Chromium Alloys; D020123:Sirolimus