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

NCT ID: NCT00595647

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2014-03-31

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.

Conditions

Coronary Artery Disease

Study Design

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

Study Groups

1

Percutaneous coronary intervention

Group Type: ACTIVE_COMPARATOR

Drug eluting stent

Intervention Type: DEVICE

Implantation of stent

2

Percutaneous coronary intervention

Group Type: PLACEBO_COMPARATOR

Bare metal stent

Intervention Type: DEVICE

Implantation of stent

Interventions

Drug eluting stent

Implantation of stent

Intervention Type: DEVICE

Bare metal stent

Implantation of stent

Intervention Type: DEVICE

Other Intervention Names

TAXUS Liberté; Liberté

Eligibility Criteria

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

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

Sponsors

University of Leipzig

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Raban Jeger

PD Dr. med. / MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias Pfisterer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Raban Jeger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Sven Möbius-Winkler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig/Heart Center, Germany

Locations

Rigshospitalet

Copenhagen, , Denmark

Gentofte Hospital

Hellerup, , Denmark

University of Leipzig/Heart Center

Leipzig, , Germany

University Hospital Basel

Basel, , Switzerland

Triemli Hospital

Zurich, , Switzerland

Countries

Denmark; Germany; Switzerland

References

Fahrni G, Farah A, Engstrom T, Galatius S, Eberli F, Rickenbacher P, Conen D, Mueller C, Pfister O, Twerenbold R, Coslovsky M, Cattaneo M, Kaiser C, Mangner N, Schuler G, Pfisterer M, Mobius-Winkler S, Jeger RV; BASKET-SAVAGE-Investigators*. Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts: Randomized Controlled Trial. J Am Heart Assoc. 2020 Oct 20;9(20):e017434. doi: 10.1161/JAHA.120.017434. Epub 2020 Oct 9.

Reference Type: DERIVED

PMID: 33032485 (View on PubMed)

Other Identifiers

SNF 3200B0_120029

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EKBB 278/07

Identifier Type: OTHER

Identifier Source: secondary_id

BASKET-SAVAGE EKBB# 278/07

Identifier Type: -

Identifier Source: org_study_id