Clinical Trial: Safety and Efficacy Study Comparing 3 New Types of Coronary Stents

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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-PRO

Brief Summary:

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.

The primary objective is to demonstrate non-inferiority of the Nobori DES stent compared to the Xience Prime DES stent on safety and e cacy in patients requiring stents >=3.0mm in diameter on the background of contemporary dual antiplatelet therapy (DAPT) with prasugrel and aspirin

Set-up:

Multicenter open-label 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 transient ischemic attack (TIA).

Randomization:

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


Detailed Summary:

Background and Study Design

The study is a multicentre, prospective, randomized, open-label trial comparing safety and efficacy of the Nobori® drug-eluting stent (DES), the Xience Prime® DES, and the ProKinetic® bare-metal stent (BMS) in patients at low risk of restenosis, i.e. receiving stents >=3.0mm diameter only, on the background of contemporary antiplatelet therapy.

2289 patients were recruited at 8 centres in 5 countries and randomized 2:1 to DES or BMS, and 1:1 to either DES subgroup. Randomization was stratified according to centre.

Analysis Datasets

The full analysis set (FAS) will include all randomized patients of whom written informed consent was obtained. Patients needing an urgent PCI were asked for oral consent prior to the percutaneous coronary intervention (PCI) and for written informed consent afterwards. This means that some randomized patients gave oral but not written informed consent. Patients who gave oral informed consent and died before written informed consent could be obtained will be included in the FAS. All other patients without signed informed consent will be excluded regardless of oral informed consent. In accordance with the intention-to-treat principle all patients will be analysed according to the allocated treatment group.

The per-protocol set (PPS) will include only those patients from the FAS who did not have one of the following major protocol violations:

  • inclusion criteria not met
  • exclusion criteria met
  • procedures performed that were not approved by Institutional Revie
    Sponsor: University Hospital, Basel, Switzerland

    Current Primary Outcome: MACE (composite endpoint including cardiac death, myocardial infarction (MI) and target-vessel revascularization (TVR) [ Time Frame: 2 years ]

    Original Primary Outcome:

    Current Secondary Outcome:

    • Cardiac death [ Time Frame: 2 years ]
    • Myocardial infarction (MI) [ Time Frame: 2 years ]
      • Any MI
      • Non-fatal MI
    • Target vessel revascularization (TVR) [ Time Frame: 2 years ]
      • Any TVR
      • Non-MI related TVR
    • Composite safety endpoint of cardiac death and non-fatal MI [ Time Frame: 2 years ]
    • Stent thrombosis according to ARC definitions [ Time Frame: 2 years ]
      • Definite
      • Definite or probable
      • Definite, probable or possible
    • Major bleeding including fatal bleeding, i.e., BARC >=3 [ Time Frame: 2 years ]
    • All cause death [ Time Frame: 2 years ]
    • Net clinical benefit = Primary endpoint plus major bleeding [ Time Frame: 2 years ]


    Original Secondary Outcome:

    Information By: University Hospital, Basel, Switzerland

    Dates:
    Date Received: July 19, 2010
    Date Started: April 2010
    Date Completion:
    Last Updated: June 4, 2014
    Last Verified: June 2014