Resolute integrity zes

After consenting for the trial, patients underwent diagnostic angiography. If angiographically found to be suitable, patients were randomised in a sequential 1:1 fashion either Resolute Integrity ZES (Medtronic) DES implantation or Promus Element EES (Boston Scientific) implantation. Randomisation was performed using dedicated randomisation software prior to the start of the trial and sealed within externally numbered opaque envelopes to conceal the treatment designation. When a consented patient fit all-inclusion criteria, the appropriate numbered envelope would be open during the case within the appropriate catheter lab.

The study design of the BIO‐RESORT trial, including details regarding sample size, was previously reported.⁷ In brief, this investigator‐initiated, patient‐ and assessor‐blinded, noninferiority (3.5% noninferiority margin, 2.5% one‐sided α level), randomized clinical trial was executed in 4 cardiac centers in the Netherlands (ClinicalTrials.gov NCT01674803). A total of 3514 all‐comer patients requiring PCI with DES were randomly assigned in a 1:1:1 fashion to treatment with either Orsiro SES (Biotronik), Synergy EES (Boston Scientific), or Resolute Integrity ZES (Medtronic). Randomization was performed via web‐based allocation and was stratified for diabetes.⁷ There were few exclusion criteria, which included known intolerance to dual antiplatelet therapy, known pregnancy, and life expectancy of <1 year. There was no limit for reference vessel size, lesion length, and number of lesions or vessels to be treated. Patients presenting with any coronary syndrome could participate, and any type of lesion (eg, de novo, restenotic, or coronary bypass lesion) was permitted. The trial was approved by the medical ethics committee Twente and the institutional review boards of all participating centers. In addition, the trial complied with the Declaration of Helsinki. All patients provided written informed consent.