title: Sirolimus-eluting stent treatment for unprotected versus protected left main coronary artery disease in widespread clinical routine: 6-month and 3-year clinical follow-up results from the prospective multicentre German Cypher Registry.
abstract: BACKGROUND
  Percutaneous coronary intervention (PCI) of left main coronary artery (LMCA) disease in the bare stent era was limited by high restenosis rates which eventually resulted in sudden death in unprotected cases. Clinical and angiographic restenosis has been substantially reduced by drug-eluting stents, reviving therefore this indication for PCI despite the absence of direct comparative studies with coronary artery bypass graft surgery.
  
  
  OBJECTIVE
  To assess the acute, mid- and long-term outcomes of patients treated with sirolimus-eluting stents for unprotected LMCA stenoses and to compare them with those treated for protected LMCA disease in the same time period from the German Cypher Registry.
  
  
  METHODS
  The German Cypher Registry included 6755 patients. Eighty-two patients treated for unprotected LMCA disease were compared with 118 patients treated for protected LMCA stenoses. All patients were treated by sirolimus-eluting stents. The primary end point was death, myocardial infarction (MI) and target vessel revascularisation at 6 months' follow-up. Survival free of MI at the long term was considered as the safety end point.
  
  
  RESULTS
  One-third of the patients in both groups were treated for the distal left main bifurcation. Angiographic success was 98.5% for both groups. The cumulative combined incidence of all-cause death, non-fatal MI and target vessel revascularisation at 6 months was 14.1% in the unprotected LMCA group and 13.1% in the protected group (hazard ratio = 0.81 (95% CI 0.37 to 1.74), p = 0.8). At long-term, death/MI were reported among 20.2% (95% CI 13.5% to 29.6%) of the protected group versus 11.8% (95% CI 6.3% to 21.4%) of the unprotected group (p = 0.2).
  
  
  CONCLUSIONS
  Sirolimus-eluting stent treatment of unprotected and protected LMCA stenoses is technically feasible in widespread routine clinical use. Acceptable long-term clinical results can be achieved, with no particular safety concerns about treatment of unprotected LMCA disease.
authors: Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Akademisches Lehrkrankenhaus der Universität Kiel, Bad Segeberg, Germany. ahmed.khattab@segebergerkliniken.de
authors: Ahmed A
authors: AA
authors: Khattab
authors: Christian W
authors: CW
authors: Hamm
authors: Jochen
authors: J
authors: Senges
authors: Ralph
authors: R
authors: Toelg
authors: Volker
authors: V
authors: Geist
authors: Tassilo
authors: T
authors: Bonzel
authors: Malte
authors: M
authors: Kelm
authors: Benny
authors: B
authors: Levenson
authors: Franz-Josef
authors: FJ
authors: Neumann
authors: Christoph A
authors: CA
authors: Nienaber
authors: Thomas
authors: T
authors: Pfannebecker
authors: Georg
authors: G
authors: Sabin
authors: Steffen
authors: S
authors: Schneider
authors: Ulrich
authors: U
authors: Tebbe
authors: Gert
authors: G
authors: Richardt
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D023921:Coronary Stenosis / Q000401:mortality / Q000628:therapy*; D018572:Disease-Free Survival; D004343:Drug Implants; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage*
chemical_list: D004343:Drug Implants; D050257:Tubulin Modulators; D020123:Sirolimus