Patients with restenosis after implantation of a drug-eluting stent: Paclitaxel-eluting balloons, Paclitaxel-eluting stents, and balloon angioplasty


The best way to manage restenosis in patients who have previously received a drug-eluting stent is unknown. Researchers have investigated the efficacy of Paclitaxel-eluting balloons ( PEB ), Paclitaxel-eluting stents ( PES ), and balloon angioplasty in these patients.

In this randomised, open-label trial, 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, were enrolled.
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.

Researchers 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% vs 37•4%; difference 0.6%; pnon-inferiority=0.007; non-inferiority margin of 7% ).
Findings were consistent in per-protocol analysis ( p non-inferiority=0.011 ).

PEB and PES were superior to balloon angioplasty alone ( 54.1%; p superiority less than 0.0001 for both comparisons ).

Frequency of death, myocardial infarction, or target lesion thrombosis did not differ between groups.

By obviating the need for additional stent implantation, Paclitaxel-eluting balloons could be a useful treatment for patients with restenosis after implantation of a drug-eluting stent. ( Xagena )

Byrne RA et al, The Lancet 2013; 381: 461-467

XagenaMedicine_2013



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