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Randomised Trial of Three Rapamycin-Eluting Stents with Different Coating Strategies for the Reduction of Coronary Restenosis – Two-year Follow-Up Results
  1. Robert A Byrne (byrne{at}dhm.mhn.de)
  1. Deutsches Herzzentrum Munich, Germany
    1. Sebastian Kufner
    1. Deutsches Herzzentrum Munich, Germany
      1. Klaus Tiroch
      1. Medizinische Klinik, Klinikum Rechts der Isar, Germany
        1. Steffen Massberg
        1. Deutsches Herzzentrum Munich, Germany
          1. Karl-Ludwig Laugwitz
          1. Medizinische Klinik, Klinikum Rechts der Isar, Germany
            1. Anette Birkmeier
            1. Deutsches Herzzentrum Munich, Germany
              1. Stefanie Schulz
              1. Deutsches Herzzentrum Munich, Germany
                1. Julinda Mehilli
                1. Deutsches Herzzentrum Munich, Germany

                  Abstract

                  Background: Drug-eluting stent (DES) platforms devoid of durable polymer have potential to enhance long-term safety outcomes. The ISAR-TEST-3 study was a randomized trial comparing three rapamycin-eluting stents with different coating strategies. The present study examined 2-year outcomes of these patients and is the first large-scale study to report long-term outcomes with biodegradable polymer and polymer-free DES.

                  Methods: Patients with de novo coronary lesions in native vessels were randomly assigned to receive biodegradable polymer (BP; n=202), permanent polymer (PP; Cypher; n=202) and polymer-free (PF; n=201) stents. The 2-year endpoints of interest were target lesion revascularization (TLR), death/myocardial infarction (MI), stent thrombosis, and delayed angiographic late luminal loss (LLL) between 6-8 months and 2 years.

                  Results: There were no significant differences in TLR (8.4%, 10.4% and 13.4% for BP, PP and PF stents respectively; p=0.26), death/MI (5.9%, 6.4% and 6.5% with BP, PP and PF respectively; p=0.97) or stent thrombosis (definite/probable 0.5%, 1.0%, 1.0% with BP, PP and PF respectively; p=0.82). Paired angiographic follow-up at 6-8 months and 2 years was available for 302 patients (69.0% of eligible). Delayed LLL was significantly different across the treatment groups: 0.17±0.42 mm, 0.16±0.41 mm and -0.01±0.36 mm for BP, PP and PF stents respectively (p<0.001).

                  Conclusion: Clinical antirestenotic efficacy was maintained with all three platforms between 1 and 2 years, although angiographic surveillance showed ongoing delayed LLL with both BP and PP stent platforms. At 2 years there was no signal of a differential safety profile between the three stent platforms.

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