Study to Test the Efficacy and Safety of Drug Eluting vs. Bare-Metal Stents for Saphenous Vein Graft Interventions

Phase 4

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: Bare metal stent; Device: Drug eluting stent

• Registration Number: NCT00595647
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Prospective multicenter controlled randomized trial to compare the safety and efficacy of drug eluting vs. bare metal stents in percutaneous coronary interventions of saphenous vein grafts. Hypothesis: Survival and outcome will be significantly better in patients receiving DES than in patients receiving BMS regarding both short-term and long-term outcome.

Detailed Description

Research Question: What is the effect of the paclitaxel eluting TAXUS® Liberté® stent compared with the bare-metal Liberté® stent (both Boston Scientific Corporation, Natick, MA) in saphenous vein graft (SVG) percutaneous coronary interventions (PCI) when used in conjunction with a glycoprotein IIb/IIIa inhibitor, e.g., abciximab (ReoPro®, Eli Lilly \& Co., Indianapolis, IN), and a distal filter system? Design: Prospective, multicenter, controlled randomized trial. Subjects: Inclusion criteria: Patients undergoing SVG PCI with a target vessel reference diameter ≤ 5.5 mm (visual estimate); documented silent ischemia, stable angina pectoris Canadian Cardiovascular Society (CCS) class I to IV, or acute coronary syndrome. Exclusion criteria: Previous stent implantation anywhere in the target SVG; concomitant native vessel PCI; SVG age \<6 months; arterial grafts; oral anticoagulation; platelet count \<100x109/L or \>700x109/L; any major non-cardiac condition with a life expectancy \<12 months; known allergies against the components tested; white blood cell count \<3000 cell/mm3; enrolled in other study; no consent; patients unlikely to comply to the study treatment and the follow-up visits. Recruitment: Consecutive sample of all patients who qualify Variables: Predictor: Randomization will be single-blinded 1:1 to the TAXUS® Liberté® vs. the Liberté® stent (both Boston Scientific Corporation, Natick, MA). In all patients, a distal filter system will be used during PCI. The use of a glycoprotein IIb/IIIa inhibitor, e.g., abciximab (ReoPro®, Eli Lilly \& Co., Indianapolis, IN), will be strongly recommended (bolus prior to PCI and 12 h infusion post PCI). Outcome: Primary: MACE after 12 months. MACE will be defined as the composite of cardiac death (all deaths not clearly non-cardiac), non-fatal myocardial infarction, and TVR. Secondary: Non-fatal myocardial infarction and cardiac death at 30 days and 6, 12, 36, and 60 months; MACE at 30 days and 6, 36, and 60 months; quality of life; individual components of the primary endpoint; non-cardiac death; major bleeding, defined as need for surgery, need for blood transfusions, and cerebral hemorrhage during antiplatelet therapy; minor bleeding, defined as a drop in hematocrit of \>2 mg/dL.

Study Timeline

• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Study Start: 2008-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-19
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Patients undergoing SVG PCI with a target vessel reference diameter ≤ 5.5 mm (visual estimate)
• Documented silent ischemia, stable angina pectoris Canadian Cardiovascular Society (CCS) class I to IV, or acute coronary syndrome

Exclusion Criteria

• Previous stent implantation anywhere in the target SVG
• Concomitant native vessel PCI
• SVG age <6 months
• Arterial grafts
• Oral anticoagulation
• Platelet count <100x109/L or >700x109/L, white blood cell count <3000 cells/mm3
• Any major non-cardiac condition with a life expectancy <12 months
• Planned elective surgery in the next 12 months
• Known allergies against the components tested
• Enrolled in other study
• No consent
• Patients unlikely to comply to the study treatment and the follow-up visits
• Age <18 years
• Known pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Bare metal stent	Percutaneous coronary intervention
1	Drug eluting stent	Percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
MACE (composite of cardiac death, i.e., all deaths not clearly non-cardiac, non-fatal myocardial infarction, and TVR	12 months

Secondary Outcome Measures

Name	Time	Method
Non-fatal MI and cardiac death; MACE; QoL; individual components of the primary endpoint; non-cardiac death; major bleeding; minor bleeding	30 days and 6, 12, 36, and 60 months

Trial Locations

Locations (5)

University of Leipzig/Heart Center; 🇩🇪 Leipzig, Germany

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Gentofte Hospital; 🇩🇰 Hellerup, Denmark

Triemli Hospital; 🇨🇭 Zurich, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland