TY - JOUR
T1 - Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3)
T2 - A randomised, open-label trial
AU - Byrne, Robert A.
AU - Neumann, Franz Josef
AU - Mehilli, Julinda
AU - Pinieck, Susanne
AU - Wolff, Britta
AU - Tiroch, Klaus
AU - Schulz, Stefanie
AU - Fusaro, Massimiliano
AU - Ott, Ilka
AU - Ibrahim, Tareq
AU - Hausleiter, Jörg
AU - Valina, Christian
AU - Pache, Jürgen
AU - Laugwitz, Karl Ludwig
AU - Massberg, Steffen
AU - Kastrati, Adnan
N1 - Funding Information:
The trial was sponsored by the Deutsches Herzzentrum, which is where most authors work. Data collection and monitoring were done by the ISAResearch Centre, which is affiliated with the Deutsches Herzzentrum. No extramural funding was used for this trial. RAB and AK had full access to all the data in the study and had final responsibility for the decision to submit for publication.
PY - 2013/2
Y1 - 2013/2
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84873706439&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(12)61964-3
DO - 10.1016/S0140-6736(12)61964-3
M3 - Article
C2 - 23206837
AN - SCOPUS:84873706439
SN - 0140-6736
VL - 381
SP - 461
EP - 467
JO - The Lancet
JF - The Lancet
IS - 9865
ER -