Most cited article - PubMed ID 29079414
OCT guidance during stent implantation in primary PCI: A randomized multicenter study with nine months of optical coherence tomography follow-up
BACKGROUND: The aim of the study was to compare healing (assessed by optical coherence tomography [OCT]) of biolimus A9 (BES) and everolimus drug-eluting stents (EES) at 9-month follow-up in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (pPCI). Nine-month clinical and angiographic data were also compared in both groups as well as clinical data at 5 years of follow-up. METHODS: A total of 201 patients with STEMI were enrolled in the study and randomized either to pPCI with BES or EES implantation. All patients were scheduled for 9 months of angiographic and OCT follow-up. RESULTS: The rate of major adverse cardiovascular events (MACE) was comparable at 9 months in both groups (5% in BES vs. 6% in the EES group; p = 0.87). Angiographic data were also comparable between both groups. The main finding at 9-month OCT analysis was the greatly reduced extent of mean neointimal area at the cost of a higher proportion of uncovered struts in the BES group (1.3 mm² vs. 0.9 mm²; p = 0.0001 and 15.9% vs. 7.0%; p = 0.0001, respectively). At 5 years of clinical follow-up the rate of MACE was comparable between both groups (16.8% vs. 14.0%, p = 0.74). CONCLUSIONS: The study demonstrates a very low rate of MACE and good 9-month stent strut coverage of second-generation BES and EES in patients with STEMI. BES showed greatly reduced extent of mean neointimal hyperplasia area at the cost of a higher proportion of uncovered struts when compared to EES. The rate of MACE was low and comparable in both groups at 5 years.
Intravascular optical coherence tomography (IVOCT) is used to assess stent tissue coverage and malapposition in stent evaluation trials. We developed the OCT Image Visualization and Analysis Toolkit for Stent (OCTivat-Stent), for highly automated analysis of IVOCT pullbacks. Algorithms automatically detected the guidewire, lumen boundary, and stent struts; determined the presence of tissue coverage for each strut; and estimated the stent contour for comparison of stent and lumen area. Strut-level tissue thickness, tissue coverage area, and malapposition area were automatically quantified. The software was used to analyze 292 stent pullbacks. The concordance-correlation-coefficients of automatically measured stent and lumen areas and independent manual measurements were 0.97 and 0.99, respectively. Eleven percent of struts were missed by the software and some artifacts were miscalled as struts giving 1% false-positive strut detection. Eighty-two percent of uncovered struts and 99% of covered struts were labeled correctly, as compared to manual analysis. Using the highly automated software, analysis was harmonized, leading to a reduction of inter-observer variability by 30%. With software assistance, analysis time for a full stent analysis was reduced to less than 30 minutes. Application of this software to stent evaluation trials should enable faster, more reliable analysis with improved statistical power for comparing designs.
- MeSH
- Endovascular Procedures instrumentation methods MeSH
- Humans MeSH
- Tomography, Optical Coherence instrumentation methods MeSH
- Sensitivity and Specificity MeSH
- Software standards MeSH
- Stents adverse effects standards MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Evaluation Study MeSH
- Research Support, N.I.H., Extramural MeSH
