title: Comparative Case-Control analysis of a dedicated self-expanding Biolimus A9-eluting Bifurcation stent versus provisional or mandatory side branch intervention strategies in the treatment of coronary bifurcation lesions.
abstract: BACKGROUND
  In a number of coronary bifurcation lesions, both the main vessel and the side branch (SB) need stent coverage.
  
  
  OBJECTIVE
  To analyze the procedural performance and the impact on radiation times (RT) and contrast medium consumption (CMC) of the Axxess™ stent system (Biosensors, Switzerland) treating de novo bifurcation lesions (DBL).
  
  
  METHODS
  One hundred and ten consecutive prospectively enrolled cases (Axxess Group) and 110 age, sex, and lesion location matched controls undergoing mandatory (Group A, n = 56) or provisional (Group B, n = 54) SB intervention were analyzed.
  
  
  RESULTS
  Although more pre-dilatation was performed in the Axxess Group (92.7% vs. 46.4% [Group A] vs. 24.1% [Group B]), and more stents were used (2.4 vs. 1.2 vs. 1.05), RT and CMC were significantly lower in the Axxess Group [7.9 min/129 ml vs. 14.2 min/209 ml vs. 7.8 min/152 ml; P < 0.001]. Final Thrombolysis In Myocardial Infarction three flow in both branches was significantly more frequent in the Axxess Group (98.2% vs. 94.6% vs. 88.9%; P = 0.02), and post-interventional troponin T elevations were the lowest in the Axxess Group. Eighty one percent of the Axxess-stents could be implanted without technical difficulties. Difficult implantations procedures were mainly related to coronary anatomy. There was no safety concerns (cardiac death, stent-thrombosis) compared to controls. Cumulative 6-months MACE rates were 11% versus 23% versus 25%. TLR rates at 6-months were 5%, 18%, and 15%, respectively.
  
  
  CONCLUSIONS
  Axxess bifurcation stent system procedures were associated with significantly less RT and CMC compared to conventional DBL therapy strategies. Difficult coronary anatomy may hinder successful implantation and a learning curve has to be considered. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, Zentralklinik, Bad Berka, Germany.
authors.forename: Marc-Alexander
authors.initials: MA
authors.lastname: Ohlow
authors.affiliation: Department of Cardiology, Knappschaftskrankenhaus, Dortmund, Germany.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Farah
authors.affiliation: Department of Cardiology, Zentralklinik, Bad Berka, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Richter
authors.affiliation: Department of Cardiology, Zentralklinik, Bad Berka, Germany.
authors.forename: Mohamad
authors.initials: M
authors.lastname: El-Garhy
authors.affiliation: Medizinische Klinik, I, Hetzelstift, Neustadt, Weinstrasse, Germany.
authors.forename: Hubertus
authors.initials: H
authors.lastname: von Korn
authors.affiliation: Department of Cardiology, Zentralklinik, Bad Berka, Germany.
authors.forename: Bernward
authors.initials: B
authors.lastname: Lauer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016022:Case-Control Studies; D003287:Contrast Media / Q000008:administration & dosage; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D011829:Radiation Dosage; D000069079:Radiation Exposure; D015641:Radiography, Interventional; D012042:Registries; D012307:Risk Factors; D000072657:ST Elevation Myocardial Infarction / Q000209:etiology; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D003287:Contrast Media; C518022:umirolimus; D020123:Sirolimus
keywords: Axxess; contrast medium consumption; dedicated bifurcation stent; outcome; radiation time; side branch