Clinical trial NCT00428454: Sirolimus-eluting vs Zotarolimus-eluting Stents for Chronic Total Coronary Occlusions
Official title: A Randomized Comparison of Sirolimus-eluting Stent Implantation With Zotarolimus-eluting Stent Implantation for the Treatment of Chronic Total Coronary Occlusions. The PRISON III Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Coronary Disease
Coronary Stenosis
Keywords: drug-eluting stent
chronic total occlusion
sirolimus-eluting stent
zotarolimus-eluting stent
QCA
Lead sponsor: R&D Cardiologie
Sponsor class: OTHER
Collaborators: name: Cordis Corporation
First posted: 2007-01-30
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: In-segment late luminal loss at 8 months as assessed by an independent angiographic core lab.
timeFrame: 8 month
Secondary outcomes:
measure: In-stent late luminal loss
timeFrame: 8 month
measure: In-stent and in-segment binary restenosis rate
timeFrame: 8 month
measure: In-stent and in-segment MLD
timeFrame: 8 month
measure: Percentage diameter stenosis
timeFrame: 8 month
measure: A composite of major adverse cardiac events (MACE: death, myocardial infarction and clinically driven target lesion revascularization)
timeFrame: 8 month
measure: Stent thrombosis (acute, <1day; subacute, 1 to 30 days; and late, >30 days)
timeFrame: 30 days
measure: Target vessel failure up to 5 year of clinical follow-up.
timeFrame: 5 years
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: AZ Middelheim
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Amsterdam
country: Netherlands
facility: AMC
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
Study officials:
affiliation: St. Antonius Hospital
name: Maarten J. Suttorp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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