Coronary Artery Disease, Coronary Disease, Coronary Stenosis
Conditions
Keywords
drug-eluting stent, chronic total occlusion, sirolimus-eluting stent, zotarolimus-eluting stent, QCA
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.
Interventions
DEVICEsirolimus-eluting stent, zotarolimus-eluting stent
PCI in chronically occluded coronary artery
Sponsors
Cordis US Corp.
R&D Cardiologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment late luminal loss at 8 months as assessed by an independent angiographic core lab. | 8 month |
Secondary
| Measure | Time frame |
|---|---|
| In-stent and in-segment binary restenosis rate | 8 month |
| In-stent and in-segment MLD | 8 month |
| Percentage diameter stenosis | 8 month |
| In-stent late luminal loss | 8 month |
| Stent thrombosis (acute, <1day; subacute, 1 to 30 days; and late, >30 days) | 30 days |
| Target vessel failure up to 5 year of clinical follow-up. | 5 years |
| A composite of major adverse cardiac events (MACE: death, myocardial infarction and clinically driven target lesion revascularization) | 8 month |
Countries
Belgium, Netherlands
Outcome results
None listed