title: RAPSTROM™ first-in-man study long-term results of a biodegradable polymer sustained-release sirolimus-eluting stent in de novo coronary stenoses.
abstract: BACKGROUND
  Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. We report the first real-life human experience with the rapamycin-eluting biodegradable polymer-coated Rapstrom stent.
  
  
  METHODS
  All consecutive patients with single de novo native coronary stenosis (<30 mm and between 2.5 and 4.0 mm) were enrolled. Major adverse cardiac events (MACE) at 1 year (cardiac death, myocardial infarction [Q and non-Q], or ischemia-driven target lesion revascularization) were the primary end-point.
  
  
  RESULTS
  A total of 123 patients were enrolled. The stent was implanted without complications in all patients, and no MACE were recorded at 30 days. At 12-month follow-up 9 patients (7.3%) experienced a MACE and 4 (3.2%) required a target lesion revascularization, while 1 (1%) stent thrombosis was recorded. A planned angiographic follow-up (FU) was performed in 73 patients (59%) at 9.4 ± 2.6 months following the index procedure. In-stent late loss was 0.16 ± 0.09 mm, and in-segment late loss was 0.18 ± 0.8 mm.
  
  
  CONCLUSIONS
  The Rapstrom biodegradable polymer rapamycin-eluting stent appeared safe and efficacious in this first real-life human experience, due to a low late lumen loss. Larger randomized studies are required to confirm these preliminary results.
authors.affiliation: Meditrina Hospital, Trivandrum, India.
authors.forename: Prathap
authors.initials: P
authors.lastname: Kumar
authors.forename: Ramakrishna
authors.initials: R
authors.lastname: Pillai
authors.forename: Madhu
authors.initials: M
authors.lastname: Sreedharan
authors.forename: Deepak
authors.initials: D
authors.lastname: Davidson
authors.forename: C N
authors.initials: CN
authors.lastname: Manjunath
authors.forename: Louie
authors.initials: L
authors.lastname: Fischer
authors.forename: K P
authors.initials: KP
authors.lastname: Balakrishnan
authors.forename: Fabrizio
authors.initials: F
authors.lastname: D'Ascenzo
authors.forename: Imad
authors.initials: I
authors.lastname: Sheiban
mesh_terms: D020341:Absorbable Implants; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000628:therapy*; D003692:Delayed-Action Preparations; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D013927:Thrombosis / Q000209:etiology
chemical_list: D003692:Delayed-Action Preparations; D020123:Sirolimus