Sirolimus-eluting vs Zotarolimus-eluting Stents for Chronic Total Coronary Occlusions

NCT ID: NCT00428454

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2015-06-30

Brief Summary

Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. In the PRISON II study we demonstrated that sirolimus-eluting stents were superior to bare metal stents in CTO. In this prospective randomized trial, sirolimus-stent implantation will be compared with zotarolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. A total of 300 patients will be clinically followed up for 1, 6, 12 months, 2, 3, 4, 5 year with angiographic follow-up at 8 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is in-segment late luminal loss at 8 month angiographic follow-up.

Detailed Description

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) was traditionally limited by high restenosis rates. Coronary stenting using bare metal stents significantly decreases restenosis in CTO compared to balloon angioplasty alone, but restenosis rates still reach 32-55%. In 200 patients with CTO, randomized in the PRISON I study we demonstrated a restenosis rate of 22% after bare metal stent (BMS) implantation as compared with 33% after conventional balloon angioplasty. During the past few years, sirolimus (rapamycin), a cytostatic macrocyclic lactone with anti-inflammatory and antiproliferative properties, delivered from a polymer-encapsulated stent was shown to almost eliminate the risk of restenosis in selected groups of patients. The drug zotarolimus (ABT-578), a sirolimus analogue, is designed to inhibit the cellular process that leads to restenosis. In the PRISON II study we have randomized 200 patients with CTO to either BMS implantation or sirolimus-eluting stent implantation and we demonstrated a reduction of in-stent binary restenosis from 36% to 7% and in-segment binary restenosis rates from 41% to 11% in favour of the sirolimus eluting stent. However, no data are available on direct comparison of the clinical efficacy, safety, and angiographic outcome of particular drug-eluting stents in patients with CTO and there may be differences between various drug-eluting stents. The PRISON III study is designed to address this issue and provide information about two different drug-eluting stents. It is a prospective randomized, single blinded trial comparing the relative safety, clinical efficacy and angiographic outcomes of sirolimus and zotarolimus-eluting stents in patients undergoing successful recanalization of CTO.

Conditions

Coronary Artery Disease; Coronary Disease; Coronary Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Zotarolimus eluting stent

Zotarolimus eluting stent

Group Type: EXPERIMENTAL

sirolimus-eluting stent, zotarolimus-eluting stent

Intervention Type: DEVICE

PCI in chronically occluded coronary artery

Sirolimus eluting stent

Sirolimus eluting stent

Group Type: ACTIVE_COMPARATOR

sirolimus-eluting stent, zotarolimus-eluting stent

Intervention Type: DEVICE

PCI in chronically occluded coronary artery

Interventions

sirolimus-eluting stent, zotarolimus-eluting stent

PCI in chronically occluded coronary artery

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• the estimated duration of the occlusion is at least 2 weeks.
• signs of ischemia related to the occluded coronary artery.
• successful recanalization of the occluded artery is achieved.
• reference diameter is > 2.5 mm.
• written informed consent obtained.

Exclusion Criteria

• primary or rescue PCI for acute myocardial infarction
• the lesion could not be crossed.
• lesions with complex anatomy making successful stent deployment unlikely.
• the guide wire is not in the true lumen distal to the occlusion.
• Sirolimus or zotarolimus allergy
• venous or arterial bypass grafts
• pregnant or nursing women.
• participation in an other trial.
• factors making long-term follow-up difficult or unlikely.
• life expectancy <1 year.
• contraindications for ASA or Clopidogrel or heparin.
• use of coumadins that could not be stopped before the procedure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: collaborator

R&D Cardiologie

OTHER

Sponsor Role: lead

Responsible Party

Dr. M.J. Suttorp

MD, PhD, FESC, FACC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maarten J. Suttorp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

AZ Middelheim

Antwerp, Antwerpen, Belgium

AMC

Amsterdam, Amsterdam, Netherlands

Catharina Ziekenhuis

Eindhoven, Eindhoven, Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

St Antonius Hospital

Nieuwegein, , Netherlands

Countries

Belgium; Netherlands

References

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Reference Type: BACKGROUND

PMID: 15131557 (View on PubMed)

Suttorp MJ, Mast EG, Plokker HW, Kelder JC, Ernst SM, Bal ET. Primary coronary stenting after successful balloon angioplasty of chronic total occlusions: a single-center experience. Am Heart J. 1998 Feb;135(2 Pt 1):318-22. doi: 10.1016/s0002-8703(98)70099-7.

Reference Type: BACKGROUND

PMID: 9489982 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 8917256 (View on PubMed)

Suttorp MJ, Laarman GJ, Rahel BM, Kelder JC, Bosschaert MA, Kiemeneij F, Ten Berg JM, Bal ET, Rensing BJ, Eefting FD, Mast EG. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation. 2006 Aug 29;114(9):921-8. doi: 10.1161/CIRCULATIONAHA.106.613588. Epub 2006 Aug 14.

Reference Type: BACKGROUND

PMID: 16908768 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 17174180 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: DERIVED

PMID: 17719285 (View on PubMed)

Other Identifiers

RDC-2006-02

Identifier Type: -

Identifier Source: org_study_id