Abstract
Purpose: The aim of this study was to provide 2-year clinical outcomes for patients with Medina 1,1,1 bifurcation lesions treated with a culotte technique, comparing Synergy and Xience drug eluting stent (DES) platforms. A sub-group analysis of 9-month Optical Coherence Tomography (OCT) was performed to assess stent healing.
Methods: A total of 170 patients with non-left main stem Medina 1,1,1 lesions, were randomized to treatment with Synergy or Xience DES. The primary outcome was a composite of death, myocardial infarction, stroke, target vessel failure, stent thrombosis and angiographic restenosis. Qualitative and quantitative analyses of 30 bifurca- tions were carried out on OCT images taken at 9-month follow-up.
Results: After 2 years, the primary outcome had occurred in 17.7% of patients in the Synergy group and 18.8% of patients in the Xience group. The non-inferiority test was met (p = 0.0055). MACCE occurred in 7.3% of all pa- tients by 2 years.
OCT analysis found smaller stent and lumen areas in
Methods: A total of 170 patients with non-left main stem Medina 1,1,1 lesions, were randomized to treatment with Synergy or Xience DES. The primary outcome was a composite of death, myocardial infarction, stroke, target vessel failure, stent thrombosis and angiographic restenosis. Qualitative and quantitative analyses of 30 bifurca- tions were carried out on OCT images taken at 9-month follow-up.
Results: After 2 years, the primary outcome had occurred in 17.7% of patients in the Synergy group and 18.8% of patients in the Xience group. The non-inferiority test was met (p = 0.0055). MACCE occurred in 7.3% of all pa- tients by 2 years.
OCT analysis found smaller stent and lumen areas in
| Original language | English |
|---|---|
| Pages (from-to) | 71-79 |
| Number of pages | 9 |
| Journal | Cardiovascular Revascularization Medicine |
| Volume | 43 |
| Early online date | 20 Apr 2022 |
| DOIs | |
| Publication status | Published - 1 Oct 2022 |
Bibliographical note
Funding Information:The CELTIC study was an investigator-led, prospective, randomized, multi-centre trial undertaken in 9 centres in Ireland and the United Kingdom. The trial was administered and overseen by a clinical research organisation (European Cardiovascular Research Center [CERC]) and the data were overseen, assessed, and adjudicated by a clinical events committee, angiographic core laboratory (CERC core laboratory using CASS QCA V7.3 software by Pie Medical Imaging BV, Maastricht, the Netherlands) and data and safety monitoring board. The study protocol was approved by the relevant authorities in each country/centre and there was compliance with the Declaration of Helsinki. All patients provided written, informed consent prior to trial participation. The research was funded by an unrestricted educational grant from Boston Scientific and was registered on clinicaltrials.gov ( NCT02232815 ). Procedural technique and inclusion and exclusion criteria have been described previously [4] and can be found i