Clinical trial NCT00595647: Study to Test the Efficacy and Safety of Drug Eluting vs. Bare-Metal Stents for Saphenous Vein Graft Interventions
Official title: BAsel Stent Kosten Effektivitäts Trial - SAphenous Venous Graft Angioplasty Using Glycoprotein IIb/IIIa Receptor Inhibitors and Drug-Eluting Stents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Leipzig
First posted: 2008-01-16
Enrollment: 162
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: 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.

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

Primary outcomes:
measure: MACE (composite of cardiac death, i.e., all deaths not clearly non-cardiac, non-fatal myocardial infarction, and TVR
timeFrame: 12 months
Secondary outcomes:
measure: Non-fatal MI and cardiac death; MACE; QoL; individual components of the primary endpoint; non-cardiac death; major bleeding; minor bleeding
timeFrame: 30 days and 6, 12, 36, and 60 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Leipzig
country: Germany
facility: University of Leipzig/Heart Center
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Zurich
country: Switzerland
facility: Triemli Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Matthias Pfisterer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Raban Jeger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leipzig/Heart Center, Germany
name: Sven Möbius-Winkler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.