Safety and Efficacy Study Comparing 3 New Types of Coronary Stents

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01166685
First received: July 19, 2010
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

Background:

- Retrospective analyses of long-term BASKET findings identified patients with large drug-eluting stents (DES) (>2.5mm Stents) as patients at risk for late cardiac death/nonfatal myocardial infarction. In view of new DES with absorbable polymers and new bare metal stents BMS) with thin struts and biocompatible polymers, BP-II will be launched to test their comparative clinical safety up to 12 years if treated with an aspirin/prasugrel combination, since prasugrel halved stent thrombosis rates compared to clopidogrel in a large ACS trial.

Aims / Hypotheses

  • to test whether the DES Nobori® is non-inferior to the currently leading Xince PRIME® with regard to cardiac death, non-fatal MI and TVR non-related to myocardial infarction up to 24 months in patients at low risk of restenosis, i.e. receiving stents of >2,5mm diameter only, on the background of contemporary antiplatelet therapy,
  • to test whether modern DES are superior to a newest-generation BMS (ProKinetic®),
  • To document the safety - or possible harm - of DAPT with prasugrel and aspirin in patients with stable CAD regarding bleeding events.

Set-up:

- Multicenter prospective randomized trial.

Patient inclusion:

- Unselected series of patients in need of large (>3mm) stents only in native vessels irrespective of clinical indication.

Patient exclusion:

- In-stent restenosis, Left-main disease, cardiogenic shock, planned surgery <12months, increased bleeding risk, no compliance expected, History of stroke or TIA.

Randomization:

- By centre using sealed envelopes 1:1:1: Nobori- Versus Xience- versus Prokinetik-stent.


Condition Intervention Phase
Coronary Artery Disease
Drug-Eluting Stents
Coronary Thrombosis
Device: coronary stent placement
Device: Coronary stent placement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Late Clinical Events After Drug-eluting Versus Bare-metal Stents in Patients at Risk: BAsel Stent Kosten Effektivitäts Trial - PROspective Validation Examination Part II (BASKET-PROVE II)

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Freedom of major cardiac events (combination of cardiac death,non-fatal MI and target vessel revascularization) [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stent thrombosis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Major non-CABG-related bleeding [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2400
Study Start Date: April 2010
Estimated Study Completion Date: May 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Xience-stent Device: coronary stent placement
Everolimus-eluting stent
Experimental: Prokinetic stent Device: Coronary stent placement
Bare metal stent
Experimental: Nobori stent Device: coronary stent placement
drug-eluting stent with bioabsorbable polymer

Detailed Description:

Statistics:

Based on the results o fBP, the original primary "safety" endpoint, i.e., the composite of cardiac death and MI, was changed to the more "global" endpoint of major adverse cardiac events (MACE), i.e., cardiac death, MI, and TVR. Using this new endpoint, it will be tested whether Nobori® DES is non-inferior to Xience Prime® DES regarding MACE in a first step, while it will be tested whether both DES are superior to BMS in a second step. Based on the findings from BP, the trial sample size was reassessed. In BP, the MACE rates at 24 months were 7.6% for Xience Prime® DES, 7.7% for both DES (Xience Prime® and Cypher®), and 12.9% for Vision® BMS. For the non-inferiority test, a sample size of 2x 800 patients will have at least 80% power expecting a MACE rate of 7.6% for both DES and declaring non-inferiority if the upper limit of the 95% confidence interval of the absolute risk difference is not larger than 3.8%.18 For the superiority test, there will be at least 95% power to detect a difference assuming a MACE rate of 7.7 % for DES and 12.9 % for BMS. All analyses will be done according to the intention-to-treat principle. Time-dependent occurrence of events will be investigated with Cox proportional hazard models and Kaplan-Meier curves. In addition, time-independent analyses for the occurrence of events within pre-specified follow-up periods will be performed using logistic regression.

Endpoints:

  • 1° end-point = freedom of combination of MACE (cardiac death, non--fatal MI and non-MI-related TVR) after 24 months.
  • 2° end-points = non-MI related TVR; MACE = 1° end-point events + non-MI related TVR ;1° end-point events up to 18 months (for comparison with BASKET and BASKET-LATE); stent thrombosis according to the ARC-definitions; components of the 1° end-points; non-cardiac death (total death); major non-CABG bleeding (need for surgery, blood transfusions, cerebral haemorrhages) during dual antiplatelet therapy (up to twelve months); "net clinical benefit" = 1° end-point + bleeding; long-term follow-up after 36 and 60 months; subgroups with diabetes, acute coronary syndrome, ST-elevation MI, need for GP IIb/IIIa inhibitors, lesions >25 mm.
  • Additional safety/bleeding analysis: a) Bleeding events in BPII: Stable vs. ACS patients; b) Bleeding events in stable and ACS-patients: BP II vs. BP End-points will be adjudicated by an independent Critical Events Committee(CEC) blinded to the stent type used.

Clinical Relevance:

The results of BPII will provide evidence for the performance of the newest-generation stents on the market in daily practice and insights about the efficacy and safety of current stent designs in an all-comer population. Moreover, BPII will assess the performance of DAPT with aspirin and prasugrel compared with aspirin plus clopidogrel in terms of ischemic and bleeding endpoints. - Thus, these findings should have major impact on the current use of coronary stents, medical antiplatelet therapy regimes and our understanding of possible reasons for late stent thrombosis.

Abbreviations:

BP-I = BASKET-PROVE I BP-II = BASKET-PROVE II X = XienceV: 2nd generation DES with lower "limus"-drug dose. N = Nobori: DES with bioabsorbable polymer and a novel "limus"-drug (biolimus) P = PROKinetik Energy: BMS with thin struts and a biocompatible polymer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • written informed concent
  • need for large (≥3.0 mm stents only) native vessel stenting

Exclusion Criteria:

  • in-Stent Restenosis or in-Stent Thrombosis
  • bypass graft disease to be stented
  • main stem disease to be stented
  • cardiogenic shock by clinical assessment (signs of organ hypoperfusion)
  • planned surgery within the next 12 months
  • oral anticoagulation needed (artificial heart valves,atrial fibrillation) or chronic haemorrhagic diathesis
  • active bleeding disorders
  • index-PCI = planned PCI of additional lesion
  • no FU expected/possible
  • History of stroke or TIA (contraindication for prasugrel)
  • known severe hypersensitivity reaction to ASS and/or Prasugrel
  • no compliance expected / no informed consent given
  • enrolled in another study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166685

Locations
Austria
Universitätsklinikum
Innsbruck, Austria, 6020
Denmark
Gentofte Hospital
Hellerup, Denmark, 2900
Germany
Elisabethen Krankenhaus
Essen, NRW, Germany, 45138
Switzerland
Kantonsspital
Aarau, AG, Switzerland, 5000
University Hospital
Basel, BS, Switzerland, 4055
Kantonsspital
St. Gallen, SG, Switzerland
Cardiocentro
Lugano, TI, Switzerland, 6903
Stadtspital Triemli
Zürich, ZH, Switzerland, 8063
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Chair: Christoph A Kaiser, Prof. MD University Hospital Basel Cardiology
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01166685     History of Changes
Obsolete Identifiers: NCT01097187
Other Study ID Numbers: BPII
Study First Received: July 19, 2010
Last Updated: January 24, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Thrombosis
Thrombosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis

ClinicalTrials.gov processed this record on April 17, 2014