Identification of anatomic risk factors for acute coronary events by optical coherence tomography in patients with myocardial infarction and residual nonflow limiting lesions: rationale and design of the PECTUS-obs study.

INTRODUCTION: In patients with myocardial infarction, the decision to treat a nonculprit lesion is generally based on its physiological significance. However, deferral of revascularisation based on nonischaemic fractional flow reserve (FFR) values in these patients results in less favourable outcomes compared with patients with stable coronary artery disease, potentially caused by vulnerable nonculprit lesions. Intravascular optical coherence tomography (OCT) imaging allows for in vivo morphological assessment of plaque 'vulnerability' and might aid in the detection of FFR-negative lesions at high risk for recurrent events. METHODS AND ANALYSIS: The PECTUS-obs study is an international multicentre prospective observational study that aims to relate OCT-derived vulnerable plaque characteristics of nonflow limiting, nonculprit lesions to clinical outcome in patients with myocardial infarction. A total of 438 patients presenting with myocardial infarction (ST-elevation myocardial infarction and non-ST-elevation myocardial infarction) will undergo OCT-imaging of any FFR-negative nonculprit lesion for detection of plaque vulnerability. The primary study endpoint is a composite of major adverse cardiovascular events (all-cause mortality, nonfatal myocardial infarction or unplanned revascularisation) at 2-year follow-up. Secondary endpoints will be the same composite at 1-year and 5-year follow-up, target vessel failure, target vessel revascularisation, target lesion failure and target lesion revascularisation. ETHICS AND DISSEMINATION: This study has been approved by the Medical Ethics Committee of the region Arnhem-Nijmegen. The results of this study will be disseminated in a main paper and additional papers with subgroup analyses. TRIAL REGISTRATION NUMBER: NCT03857971.

Primary PCI during off-hours is not related to increased mortality.

AIM: Previous studies have shown contradictory outcomes in ST-segment elevation myocardial infarction (STEMI) patients who underwent primary percutaneous coronary intervention (pPCI) during off-hours versus regular 'office' hours. We aimed to evaluate the relationship between pPCI timing (off-hours versus regular hours) and mortality in patients with STEMI undergoing pPCI. METHODS: The study population comprised 4352 consecutive STEMI patients treated with pPCI in a high-volume centre with a 24/7 programme during 2000-2009. Descriptive statistics and multivariable survival analyses were applied to evaluate the relationship between treatment during off-hours (Monday-Friday, 6.00 pm-8.00 am and weekends) versus regular hours and the incidence of all-cause mortality at 30-day and 4-year follow-up. RESULTS: A total of 2760 patients (63.4%) were treated during off-hours and 1592 patients (36.6%) during regular hours. With the exception of smoking, diabetes mellitus, use of glycoprotein IIb/IIIa antagonists and calcium antagonists, no major differences in baseline characteristics were observed between the groups. Mortality at 30-day follow-up was similar in patients treated during off-hours and those treated during regular hours (7.7% vs 7.7%; hazard ratio adjusted for potential confounders 1.03; 95% CI 0.82-1.28). Four-year mortality was similar (17.3% vs 17.3%; adjusted hazard ratio 0.95; 95% CI 0.81-1.11). CONCLUSION: In STEMI patients who present during off-hours in a high-volume centre with 24/7 service, pPCI provides similar survival as patients who were treated during regular hours.