Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents (DESIRE-2)

• Need of target lesion revascularization. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Combined incidence of death or myocardial infarction. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Incidence of stent thrombosis. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Incidence of binary restenosis at follow-up angiography [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]

• Need of target lesion revascularization. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Combined incidence of death or myocardial infarction. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Incidence of stent thrombosis. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

For lesions which develop restenosis after a drug-eluting stent, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug.

Treatment of in-stent restenosis after implantation of a DES has poorly been studied. Although there are no data, it may be assumed that certain lesions might be resistant to a given drug and in need of a different DES. Thus, for lesions which develop restenosis after a DES, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug. This prospective, randomized trial will compare the anti-restenotic efficacy of PES or SES in patients with restenosis after initial implantation of a SES

• Device: Sirolimus eluting stent
  Sirolimus-eluting stent will be implanted
  Other Name: Cypher
• Device: Paclitaxel-eluting stent
  Paclitaxel-eluting stent will be implanted
  Other Name: Taxus

• Experimental: Same drug
  sirolimus-eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent
  Intervention: Device: Sirolimus eluting stent
• Active Comparator: Different drug
  paclitaxel eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent
  Intervention: Device: Paclitaxel-eluting stent

• Mehilli J, Byrne RA, Tiroch K, Pinieck S, Schulz S, Kufner S, Massberg S, Laugwitz KL, Schömig A, Kastrati A; ISAR-DESIRE 2 Investigators. Randomized trial of paclitaxel- versus sirolimus-eluting stents for treatment of coronary restenosis in sirolimus-eluting stents: the ISAR-DESIRE 2 (Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis 2) study. J Am Coll Cardiol. 2010 Jun 15;55(24):2710-6. Epub 2010 Mar 11.
• Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schühlen H, Schmitt C, Dirschinger J, Schömig A; ISAR-DESIRE Study Investigators. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA. 2005 Jan 12;293(2):165-71.

Inclusion Criteria:

• Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of > 50% re- stenosis after prior implantation of Sirolimus eluting stents in native coronary vessels
• Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
• In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

• Cardiogenic shock
• Acute myocardial infarction within the first 48 hours from symptom onset.
• Target lesion located in the left main trunk or bypass graft.
• Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
• Allergy to antiplatelet therapy, sirolimus, paclitaxel, stainless steel.
• Pregnancy (present, suspected or planned) or positive pregnancy test.
• Previous enrollment in this trial.
• Patient's inability to fully comply with the study protocol.