title: High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial.
abstract: OBJECTIVE
  This study sought to determine the effect of rotational atherectomy (RA) on drug-eluting stent (DES) effectiveness.
  
  
  BACKGROUND
  DES are frequently used in complex lesions, including calcified stenoses, which may challenge DES delivery, expansion, and effectiveness. RA can adequately modify calcified plaques and facilitate stent delivery and expansion. Its impact on DES effectiveness is widely unknown.
  
  
  METHODS
  The ROTAXUS (Rotational Atherectomy Prior to TAXUS Stent Treatment for Complex Native Coronary Artery Disease) study randomly assigned 240 patients with complex calcified native coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120, standard therapy group). Stenting was performed using a polymer-based slow-release paclitaxel-eluting stent. The primary endpoint was in-stent late lumen loss at 9 months. Secondary endpoints included angiographic and strategy success, binary restenosis, definite stent thrombosis, and major adverse cardiac events at 9 months.
  
  
  RESULTS
  Despite similar baseline characteristics, significantly more patients in the standard therapy group were crossed over (12.5% vs. 4.2%, p = 0.02), resulting in higher strategy success in the rotablation group (92.5% vs. 83.3%, p = 0.03). At 9 months, in-stent late lumen loss was higher in the rotablation group (0.44 ± 0.58 vs. 0.31 ± 0.52, p = 0.04), despite an initially higher acute lumen gain (1.56 ± 0.43 vs. 1.44 ± 0.49 mm, p = 0.01). In-stent binary restenosis (11.4% vs. 10.6%, p = 0.71), target lesion revascularization (11.7% vs. 12.5%, p = 0.84), definite stent thrombosis (0.8% vs. 0%, p = 1.0), and major adverse cardiac events (24.2% vs. 28.3%, p = 0.46) were similar in both groups.
  
  
  CONCLUSIONS
  Routine lesion preparation using RA did not reduce late lumen loss of DES at 9 months. Balloon dilation with only provisional rotablation remains the default strategy for complex calcified lesions before DES implantation.
authors.affiliation: Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg, Germany. mohamed.abdel-wahab@segebergerkliniken.de
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Wahab
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.forename: Heinz
authors.initials: H
authors.lastname: Joachim Büttner
authors.forename: Ralph
authors.initials: R
authors.lastname: Toelg
authors.forename: Volker
authors.initials: V
authors.lastname: Geist
authors.forename: Thomas
authors.initials: T
authors.lastname: Meinertz
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.forename: Lamin
authors.initials: L
authors.lastname: King
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Khattab
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D017225:Atherectomy, Coronary / Q000009:adverse effects / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D003328:Coronary Thrombosis / Q000209:etiology; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome; D061205:Vascular Calcification / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel