6110OCT guidance during primary PCI may increase long-term risk of device oriented events: subanalysis of ROBUST study

Abstract

Abstract Background Optical coherence tomography (OCT) guidance in primary percutaneous coronary intervention (pPCI) is expected to be safe in short and mid-term follow-up. Long term merits or risks of OCT guidance are unknown. Purpose To assess the possible merits of OCT guidance in pPCI in long-term follow-up. Methods 201 patients with ST-elevation myocardial infarction (STEMI) were enrolled in this study. Patients were randomized either to pPCI alone (angio-guided group, n=96) or to pPCI with OCT guidance (OCT-guided group, n=105) and also either to biolimus A9 or to everolimus-eluting stent implantation. The OCT study was performed after PCI with C7-XRTM intravascular imaging system employing a non-occlusive technique. Incidence of Device-oriented Composite Endpoints (DoCE) was compared in both study groups. DoCE were defined as composite of definite or possible cardiovascular death, myocardial infarction and target vessel revascularization. The search for DoCE was performed by means of medical check-ups, repeated telephone contacts, analysis of medical records and search in national population registry. Results Mean follow-up was 6.5 (6.5–7.1 years). Of these patients, 2 (1.0%) patients died of cardiovascular reason, 4 patients (2%) suffered myocardial infarction and 7 (3.5%) patients underwent target lesion revascularization. In OCT guided group, number of stents per patient was higher (1.4 vs. 1.2, p=0.03). Risk of DoCE was significantly higher in OCT-guided group (7.6% vs. 2.1%, p=0.023). Event-free survival in study groups Conclusion Our data suggest increased risk of adverse events related to OCT guided tailoring of stent implantation performed after pPCI. These findings should be confirmed by further randomised trials with higher statistical power. Acknowledgement/Funding The work was supported by a long-term organization development plan 1011 (FMHS)