title: Direct implantation of rapamycin-eluting stents with bioresorbable drug carrier technology utilising the Svelte coronary stent-on-a-wire: the DIRECT II study.
abstract: OBJECTIVE
  Our aim was to demonstrate the safety and efficacy of the Svelte sirolimus-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) with bioresorbable drug coating compared to the Resolute Integrity zotarolimus-eluting stent with durable polymer in patients with de novo coronary artery lesions.
  
  
  RESULTS
  Direct stenting, particularly in conjunction with transradial intervention (TRI), has been associated with reduced bleeding complications, procedure time, radiation exposure and contrast administration compared to conventional stenting with wiring and predilatation. The low-profile Svelte IDS is designed to facilitate TRI and direct stenting, reducing the number of procedural steps, time and cost associated with coronary stenting. DIRECT II was a prospective, multicentre trial which enrolled 159 patients to establish non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1 randomisation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Target vessel failure (TVF), as well as secondary clinical endpoints, will be assessed annually up to five years. At six months, in-stent LLL was 0.09±0.31 mm in the Svelte IDS group compared to 0.13±0.27 mm in the Resolute Integrity group (p<0.001 for non-inferiority). TVF at one year was similar across the Svelte IDS and Resolute Integrity groups (6.5% vs. 9.8%, respectively).
  
  
  CONCLUSIONS
  DIRECT II demonstrated the non-inferiority of the Svelte IDS to Resolute Integrity with respect to in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.
authors: Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium.
authors: Stefan
authors: S
authors: Verheye
authors: Ahmed A
authors: AA
authors: Khattab
authors: Didier
authors: D
authors: Carrie
authors: Pieter
authors: P
authors: Stella
authors: Ton
authors: T
authors: Slagboom
authors: Jozef
authors: J
authors: Bartunek
authors: Yoshinobu
authors: Y
authors: Onuma
authors: Patrick W
authors: PW
authors: Serruys
mesh_terms: D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000628:therapy*; D004337:Drug Carriers / Q000627:therapeutic use*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004337:Drug Carriers; D020123:Sirolimus