Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): A randomised, open-label trial

Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, Schulz S, Fusaro M, Ott I, Ibrahim T, Hausleiter J, Valina C, Pache J, Laugwitz KL, Massberg S, Kastrati A (2013)

Publication Type: Journal article

Publication year: 2013

Journal

Lancet Elsevier: Lancet

Book Volume: 381

Pages Range: 461-467

Journal Issue: 9865

DOI: 10.1016/S0140-6736(12)61964-3

Abstract

Background: The best way to manage restenosis in patients who have previously received a drug-eluting stent is unknown. We investigated the efficacy of paclitaxel-eluting balloons (PEB), paclitaxel-eluting stents (PES), and balloon angioplasty in these patients. Methods: In this randomised, open-label trial, we enrolled patients older than 18 years with restenosis of at least 50% after implantation of any limus-eluting stent at three centres in Germany between Aug 3, 2009, and Oct 27, 2011. Patients were randomly assigned (1:1:1; stratified according to centre) to receive PEB, PES, or balloon angioplasty alone by means of sealed, opaque envelopes containing a computer-generated sequence. Patients and investigators were not masked to treatment allocation, but events and angiograms were assessed by individuals who were masked. The primary endpoint was diameter stenosis at follow-up angiography at 6-8 months. Primary analysis was done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00987324. Findings: We enrolled 402 patients, of whom 137 (34%) were assigned to PEB, 131 (33%) to PES, and 134 (33%) to balloon angioplasty. Follow-up angiography at 6-8 months was available for 338 (84%) patients. PEB was non-inferior to PES in terms of diameter stenosis (38·0% [SD 21·5] vs 37·4% [21·8]; difference 0·6%, one-sided 95% CI 4·9%; p non-inferiority=0·007; non-inferiority margin of 7%). Findings were consistent in per-protocol analysis (pnon-inferiority= 0·011). PEB and PES were superior to balloon angioplasty alone (54·1% [25·0]; psuperiority<0·0001 for both comparisons). Frequency of death, myocardial infarction, or target lesion thrombosis did not differ between groups. Interpretation: By obviating the need for additional stent implantation, PEB could be a useful treatment for patients with restenosis after implantation of a drug-eluting stent. Funding: Deutsches Herzzentrum. © 2013 Elsevier Ltd.

Involved external institutions

Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH DE Germany (DE) Klinikum der Universität München DE Germany (DE) Deutsches Herzzentrum München DE Germany (DE) Schön Kliniken DE Germany (DE) Klinikum rechts der Isar DE Germany (DE) HELIOS Kliniken DE Germany (DE)

How to cite

APA:

Byrne, R.A., Neumann, F.J., Mehilli, J., Pinieck, S., Wolff, B., Tiroch, K.,... Kastrati, A. (2013). Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): A randomised, open-label trial. Lancet, 381(9865), 461-467. https://doi.org/10.1016/S0140-6736(12)61964-3

MLA:

Byrne, Robert A., et al. "Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): A randomised, open-label trial." Lancet 381.9865 (2013): 461-467.

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