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Interventional cardiology
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
  1. Ahmed A Khattab1,
  2. Christian W Hamm2,
  3. Jochen Senges3,
  4. Ralph Toelg1,
  5. Volker Geist1,
  6. Tassilo Bonzel4,
  7. Malte Kelm5,
  8. Benny Levenson6,
  9. Franz-Josef Neumann7,
  10. Christoph A Nienaber8,
  11. Thomas Pfannebecker9,
  12. Georg Sabin10,
  13. Steffen Schneider3,
  14. Ulrich Tebbe11,
  15. Gert Richardt1
  1. 1
    Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Bad Segeberg, Germany
  2. 2
    Kerckhoff Klinik, Kardiologie, Bad Nauheim, Germany
  3. 3
    Herzzentrum, Kardiologie, Ludwigshafen, Germany
  4. 4
    Klinikum Fulda, Kardiologie, Fulda, Germany
  5. 5
    Universitätsklinikum, Kardiologie, Aachen, Germany
  6. 6
    Kardiologische Praxis, Berlin, Germany
  7. 7
    Herzzentrum, Bad Krozingen, Germany
  8. 8
    Universitätsklinikum, Kardiologie, Rostock, Germany
  9. 9
    Medical Affairs Cordis Germany, Langenfeld, Germany
  10. 10
    Elisabeth Krankenhaus, Kardiologie, Essen, Germany
  11. 11
    Klinikum Lippe-Detmold, Kardiologie, Detmold, Germany
  1. Dr A A Khattab, Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Akademisches Lehrkrankenhaus der Universität Kiel, Am Kurpark 1, 23795 Bad Segeberg, Germany; ahmed.khattab{at}segebergerkliniken.de

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.

Setting and patients: 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).

Conclusion: 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.

  • left main coronary artery
  • drug-eluting stents
  • sirolimus
  • angioplasty

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Footnotes

  • The design of the German Cypher Stent Registry as well as the collection, analysis and interpretation of the data were all independent of Cordis Corporation, a Johnson & Johnson company, who supported the study by an unrestricted grant.

  • Conflict of interest: None. Mr Pfannebecker is an employee of Cordis, Germany.

  • Abbreviations:
    BMS
    bare metal stents
    CABG
    coronary artery bypass graft
    DES
    drug-eluting stents
    HR
    hazard ratio
    LMCA
    left main coronary artery
    MI
    myocardial infarction
    PCI
    percutaneous coronary intervention
    SES
    sirolimus-eluting stent
    STEMI
    ST-elevation myocardial infarction
    TLR
    target lesion revascularisation
    TVR
    target vessel revascularisation

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