title: Coronary artery bifurcation narrowing treated by Axxess stent implantation: The CARINAX registry.
abstract: OBJECTIVE
  To compare the safety and efficacy of the Axxess™ biolimus-eluting stent with the second-generation drug-eluting stent (DES) in the treatment of bifurcation lesions.
  
  
  BACKGROUND
  The Axxess™ is a dedicated bifurcation stent, designed to cover the lesion at the carina level.
  
  
  METHODS
  Between April 2012 and August 2014, 165 patients with de novo bifurcation lesions were treated with the Axxess™ stent (Axxess group). A propensity-score matched group of 165 patients treated with DES in the same period was selected (Control group). The primary objectives were (1) the procedural complication rate, including side branch (SB) occlusion and trouble in SB access after main vessel stenting; and (2) the device, the angiographic, and the procedural success rate.
  
  
  RESULTS
  Procedural complications occurred in 1 patient (0.6%) in the Axxess group and in 20 patients (12%) in the Control group (OR = 0.03; 95% confidence interval 0.005-0.27; P < 0.001). Device success was obtained in 164 (99.5%) patients in the Axxess group and in all in the Control group (P = 1.00). Angiographic success was obtained in all patients. Inaccurate Axxess™ stent position occurred in 21 (13%) patients, and was more often associated with moderate-to-severe calcifications and distal lesion site. Procedural success was obtained in 91.5% patients in the Axxess group and in 90% patients in the Control group (P = 0.72).
  
  
  CONCLUSIONS
  The present registry suggests that the Axxess™ stent (1) may represent a valid alternative approach for the treatment of bifurcation lesions and (2) should be avoided in moderate-to-severe calcifications and/or in distal lesions. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
authors.affiliation: Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.
authors.forename: Michael
authors.initials: M
authors.lastname: Donahue
authors.affiliation: Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Visconti
authors.affiliation: Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.
authors.forename: Amelia
authors.initials: A
authors.lastname: Focaccio
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza" University of Rome.
authors.forename: Mauro
authors.initials: M
authors.lastname: Pennacchi
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza" University of Rome.
authors.forename: Luigi
authors.initials: L
authors.lastname: Lucisano
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza" University of Rome.
authors.forename: Rocco
authors.initials: R
authors.lastname: Stio
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza" University of Rome.
authors.forename: Massimo
authors.initials: M
authors.lastname: Mancone
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza" University of Rome.
authors.forename: Simone
authors.initials: S
authors.lastname: Calcagno
authors.affiliation: Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.
authors.forename: Vito
authors.initials: V
authors.lastname: Di Palma
authors.affiliation: Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Labalestra
authors.affiliation: Department Mental Health and Preventive Medicine, Second University of Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Signoriello
authors.affiliation: Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza" University of Rome.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Sardella
mesh_terms: D000368:Aged; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000175:diagnosis / Q000601:surgery*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D057216:Propensity Score; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D018084:Ultrasonography, Interventional
chemical_list: D007166:Immunosuppressive Agents; C518022:umirolimus; D020123:Sirolimus
keywords: coronary bifurcation lesions; coronary self-expanding drug-eluting stent; percutaneous coronary intervention