Author + information
- Received December 21, 2009
- Revision received February 8, 2010
- Accepted February 9, 2010
- Published online June 15, 2010.
- Julinda Mehilli, MD*,
- Robert A. Byrne, MB*,
- Klaus Tiroch, MD*,
- Susanne Pinieck*,
- Stefanie Schulz, MD*,
- Sebastian Kufner, MD*,
- Steffen Massberg, MD*,
- Karl-Ludwig Laugwitz, MD†,
- Albert Schömig, MD†,
- Adnan Kastrati, MD*,* (, )
- ISAR-DESIRE 2 Investigators
- ↵*Reprint requests and correspondence:
Dr. Adnan Kastrati, Deutsches Herzzentrum, Lazarettstrasse 36, Munich 80636, Germany
Objectives For patients with sirolimus-eluting stent (SES) restenosis requiring reintervention, we compared a strategy of repeat SES (Cypher, Cordis, Miami Lakes, Florida) implantation with paclitaxel-eluting stent (PES) (Taxus, Boston Scientific, Natick, Massachusetts) implantation.
Background Despite their high anti-restenotic efficacy, the widespread utilization of SES therapy has led to a significant absolute number of patients presenting with SES treatment failure. The optimal treatment strategy for such patients remains unclear.
Methods The ISAR-DESIRE 2 (Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis 2) study was a randomized, open-label, active-controlled trial conducted among 450 patients with clinically significant in-SES restenosis at 2 centers in Munich, Germany. After pre-treatment with 600 mg clopidogrel, all patients were randomly assigned to either SES or PES implantation. The primary end point was late lumen loss, based on in-stent analysis, at 6- to 8-month follow-up angiography. Secondary end points were binary angiographic restenosis (diameter stenosis >50%) at 6- to 8-month follow-up, target lesion revascularization, the composite of death or myocardial infarction, and definite stent thrombosis at 12 months.
Results Regarding anti-restenotic efficacy, there were no differences between SES and PES in late loss (0.40 ± 0.65 mm vs. 0.38 ± 0.59 mm; p = 0.85), binary restenosis (19.6% vs. 20.6%; p = 0.69), or target lesion revascularization (16.6% vs. 14.6%; p = 0.52). In terms of safety outcomes, the rates of death/myocardial infarction (6.1% vs. 5.8%; p = 0.86) and stent thrombosis (0.4% vs. 0.4%; p > 0.99) were also similar.
Conclusions In cases of SES restenosis, treatment with either repeat SES or switch to PES was associated with a comparable degree of efficacy and safety. Drug resistance at an individual patient level may play a contributory role to the somewhat higher than expected late loss observed with the SES in the current study. (Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for In-Stent Restenosis 2 [ISAR-DESIRE 2]; NCT00598715)
Dr. Mehilli has received lecture fees from Cordis. Dr. Byrne was supported by a Research Fellowship in Atherothrombosis from the European Society of Cardiology. Dr. Kastrati has received lecture fees from Cordis and Medtronic.
The study design, analysis, and funding were performed by Deutsches Herzzentrum, Munich, and was industry independent.
An abstract of this work was presented as a Late Breaking Clinical Trial at Transcatheter Cardiovascular Therapeutics 2009 in San Francisco, California.
- Received December 21, 2009.
- Revision received February 8, 2010.
- Accepted February 9, 2010.
- American College of Cardiology Foundation