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

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• 作者：Dr Robert A Byrne ; PhD^a ; ^{byrne@dhm.mhn.de} ; Prof Franz-Josef Neumann ; MD^c ; Prof Julinda Mehilli ; MD^d ; Susanne Pinieck^a ; Britta Wolff^a ; Klaus Tiroch ; MD^e ; Stefanie Schulz ; MD^a ; Massimiliano Fusaro ; MD^a ; Prof Ilka Ott ; MD^a ; Tareq Ibrahim ; MD^b ; Prof Jö ; rg Hausleiter ; MD^d ; Christian Valina ; MD^c ; Jü ; rgen Pache ; MD^f ; Prof Karl-Ludwig Laugwitz ; MD^b ; Prof Steffen Massberg ; MD^d ; Prof Adnan Kastrati ; MD^a ; for the ISAR-DESIRE 3 investigators
• 刊名：The Lancet
• 出版年：2013
• 出版时间：9-15 February, 2013
• 年：2013
• 卷：381
• 期：9865
• 页码：461-467
• 全文大小：223 K

文摘

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Summary

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 , number .

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 (p_{non-inferiority}=0¡¤011). PEB and PES were superior to balloon angioplasty alone (54¡¤1 % [25¡¤0]; p_superiority<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.