Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: Results of the randomized BIOFLOW-II trial

Stephan Windecker, Michael Haude, Franz Josef Neumann, Karl Stangl, Bernhard Witzenbichler, Ton Slagboom, Manel Sabaté, Javier Goicolea, Paul Barragan, Stéphane Cook, Christophe Piot, Gert Richardt, B. Merkely, Henrik Schneider, Johannes Bilger, Paul Erne, Ron Waksman, Serge Zaugg, Peter Jüni, Thierry Lefèvre

Research output: Contribution to journalArticle

104 Citations (Scopus)

Abstract

Background-Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months. Methods and Results-A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10±0.32 versus 0.11±0.29 mm; difference=0.00063 mm; 95% confidence interval, -0.06 to 0.07; Pnoninferiority2 versus X-EES, 0.43±0.56 mm2; P=0.04). Conclusions-Compared with durable polymer X-EES, novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up.

Original languageEnglish
Article numbere001441
JournalCirculation: Cardiovascular Interventions
Volume8
Issue number2
DOIs
Publication statusPublished - Feb 1 2015

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Sirolimus
Stents
Polymers
Drug-Eluting Stents
Everolimus
Multicenter Studies
Blood Vessels
Thrombosis
Confidence Intervals

Keywords

  • Percutaneous coronary intervention
  • Risk factors

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent : Results of the randomized BIOFLOW-II trial. / Windecker, Stephan; Haude, Michael; Neumann, Franz Josef; Stangl, Karl; Witzenbichler, Bernhard; Slagboom, Ton; Sabaté, Manel; Goicolea, Javier; Barragan, Paul; Cook, Stéphane; Piot, Christophe; Richardt, Gert; Merkely, B.; Schneider, Henrik; Bilger, Johannes; Erne, Paul; Waksman, Ron; Zaugg, Serge; Jüni, Peter; Lefèvre, Thierry.

In: Circulation: Cardiovascular Interventions, Vol. 8, No. 2, e001441, 01.02.2015.

Research output: Contribution to journalArticle

Windecker, S, Haude, M, Neumann, FJ, Stangl, K, Witzenbichler, B, Slagboom, T, Sabaté, M, Goicolea, J, Barragan, P, Cook, S, Piot, C, Richardt, G, Merkely, B, Schneider, H, Bilger, J, Erne, P, Waksman, R, Zaugg, S, Jüni, P & Lefèvre, T 2015, 'Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: Results of the randomized BIOFLOW-II trial', Circulation: Cardiovascular Interventions, vol. 8, no. 2, e001441. https://doi.org/10.1161/CIRCINTERVENTIONS.114.001441
Windecker, Stephan ; Haude, Michael ; Neumann, Franz Josef ; Stangl, Karl ; Witzenbichler, Bernhard ; Slagboom, Ton ; Sabaté, Manel ; Goicolea, Javier ; Barragan, Paul ; Cook, Stéphane ; Piot, Christophe ; Richardt, Gert ; Merkely, B. ; Schneider, Henrik ; Bilger, Johannes ; Erne, Paul ; Waksman, Ron ; Zaugg, Serge ; Jüni, Peter ; Lefèvre, Thierry. / Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent : Results of the randomized BIOFLOW-II trial. In: Circulation: Cardiovascular Interventions. 2015 ; Vol. 8, No. 2.
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abstract = "Background-Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months. Methods and Results-A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10±0.32 versus 0.11±0.29 mm; difference=0.00063 mm; 95{\%} confidence interval, -0.06 to 0.07; Pnoninferiority2 versus X-EES, 0.43±0.56 mm2; P=0.04). Conclusions-Compared with durable polymer X-EES, novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up.",
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AU - Neumann, Franz Josef

AU - Stangl, Karl

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AU - Slagboom, Ton

AU - Sabaté, Manel

AU - Goicolea, Javier

AU - Barragan, Paul

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AU - Piot, Christophe

AU - Richardt, Gert

AU - Merkely, B.

AU - Schneider, Henrik

AU - Bilger, Johannes

AU - Erne, Paul

AU - Waksman, Ron

AU - Zaugg, Serge

AU - Jüni, Peter

AU - Lefèvre, Thierry

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