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Sirolimus-Eluting Stent Treatment for Unprotected versus Protected Left Main Coronary Artery Disease in the Widespread Clinical Routine: 6-Month and 3-Year Clinical Follow-up Results From The Prospective Multi-Centre German Cypher Registry
  1. Ahmed A. Khattab (ahmed.khattab{at}segebergerkliniken.de)
  1. Segeberger Kliniken GmbH, Germany
    1. Christian W. Hamm
    1. Kerckhoff Klinik, Germany
      1. Jochen Senges
      1. Klinikum Ludwigshafen, Germany
        1. Ralph Toelg
        1. Segeberger Kliniken, Germany
          1. Volker Geist
          1. Segeberger Kliniken, Germany
            1. Tassilo Bonzel
            1. Klinikum Fulda, Germany
              1. Malte Kelm
              1. Universitätsklinikum Aachen, Germany
                1. Benny Levenson
                1. Kardiologische Praxis Berlin, Germany
                  1. Franz-Joseph Neumann
                  1. Herzzentrum Bad Krozingen, Germany
                    1. Christoph A. Nienaber
                    1. Universitätsklinikum Rostock, Germany
                      1. Thomas Pfannebecker
                      1. Cordis Germany, Germany
                        1. Georg Sabin
                        1. Elisabeth Krankenhaus Essen, Germany
                          1. Steffen Schneider
                          1. Klinikum Ludwigshafen, Germany
                            1. Ulrich Tebbe
                            1. Klinikum Lippe-Detmold, Germany
                              1. Gert Richardt
                              1. Segeberger Kliniken, Germany

                                Abstract

                                Objective and design: PCI of left main coronary artery (LMCA) disease in the bare stent era was limited by high restenosis rates which eventually manifested by sudden death in unprotected cases. Clinical and angiographic restenosis has been substantially reduced by drug-eluting stents reviving therefore this indication for PCI inspite of absence of direct comparative studies with CABG surgery. We assessed the acute, mid- and long-term outcomes of sirolimus-eluting stent treated patients for unprotected LMCA stenoses and compared 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 and target vessel revascularization at six months follow-up. Survival free of myocardial infarction at long-term was considered as safety endpoint.

                                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 myocardial infarction and TVR at 6 months was 14.1% in the unprotected LMCA group and 13.1% in the protected group (HR = 0.81 [95% CI 0.37 - 1.74] p= 0.8). At long-term death/myocardial infarction were reported among 20.2% (95% CI 13.5% - 29.6%) of the protected group versus 11.8% (95% CI 6.3% - 21.4%) of the unprotected group (p= 0.2).

                                Conclusion: Sirolimus-eluting stent treatment of unprotected and protected LMCA stenoses is technically feasible in the widespread routine clinical use. Acceptable long-term clinical results can be achieved, with no particular safety concerns regarding unprotected LMCA disease treatment.

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