title: Rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: Two-year clinical outcome of the randomized ROTAXUS trial.
abstract: BACKGROUND
  In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported.
  
  
  RESULTS
  ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups.
  
  
  CONCLUSIONS
  Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA.
authors.affiliation: Department of Cardiology and Angiology, Segeberger Kliniken - Heart Centre, Bad Segeberg, Germany.
authors.forename: Suzanne
authors.initials: S
authors.lastname: de Waha
authors.affiliation: Department of Cardiology and Angiology, Segeberger Kliniken - Heart Centre, Bad Segeberg, Germany.
authors.forename: Abdelhakim
authors.initials: A
authors.lastname: Allali
authors.affiliation: Department of Cardiology, University Heart Centre Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Heinz-Joachim
authors.initials: HJ
authors.lastname: Büttner
authors.affiliation: Department of Cardiology and Angiology, Segeberger Kliniken - Heart Centre, Bad Segeberg, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Toelg
authors.affiliation: Department of Cardiology and Angiology, Segeberger Kliniken - Heart Centre, Bad Segeberg, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Geist
authors.affiliation: Department of Cardiology, University Heart Centre Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.affiliation: Department of Cardiology, University of Bern, Bern, Switzerland.
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Khattab
authors.affiliation: Department of Cardiology and Angiology, Segeberger Kliniken - Heart Centre, Bad Segeberg, Germany.
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.affiliation: Department of Cardiology and Angiology, Segeberger Kliniken - Heart Centre, Bad Segeberg, Germany.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Wahab
mesh_terms: D000368:Aged; D017225:Atherectomy, Coronary / Q000009:adverse effects / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D017239:Paclitaxel / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D061205:Vascular Calcification / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel
keywords: clinical outcome; complex calcified lesions; paclitaxel-eluting stent; rotational atherectomy