Correction: van Veelen et al. First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study. J. Clin. Med. 2023, 12, 5807.

In the original publication [...].

First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study.

Patients with non-obstructive lipid-rich plaques (LRPs) on combined intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) are at high risk for future events. Local pre-emptive percutaneous treatment of LRPs with a paclitaxel-eluting drug-coated balloon (PE-DCB) may be a novel therapeutic strategy to prevent future adverse coronary events without leaving behind permanent coronary implants. In this pilot study, we aim to investigate the safety and feasibility of pre-emptive treatment with a PE-DCB of non-culprit non-obstructive LRPs by evaluating the change in maximum lipid core burden in a 4 mm segment (maxLCBImm4) after 9 months of follow up. Therefore, patients with non-ST-segment elevation acute coronary syndrome underwent 3-vessel IVUS-NIRS after treatment of the culprit lesion to identify additional non-obstructive non-culprit LRPs, which were subsequently treated with PE-DCB sized 1:1 to the lumen. We enrolled 45 patients of whom 20 patients (44%) with a non-culprit LRP were treated with PE-DCB. After 9 months, repeat coronary angiography with IVUS-NIRS will be performed. The primary endpoint at 9 months is the change in maxLCBImm4 in PE-DCB-treated LRPs. Secondary endpoints include clinical adverse events and IVUS-derived parameters such as plaque burden and luminal area. Clinical follow-up will continue until 1 year after enrollment. In conclusion, this first-in-human study will investigate the safety and feasibility of targeted pre-emptive PE-DCB treatment of LRPs to promote stabilization of vulnerable coronary plaque at risk for developing future adverse events.

Impact of the COVID-19 Outbreak on the Treatment of Myocardial Infarction Patients.

Purpose of review: The COVID-19 pandemic has led to an overburdened healthcare system. While an increased rate of ACS is expected due to the pro-thrombotic state of COVID patients, observed ACS incidence and admission rates were paradoxically decreased during the (first wave of the) pandemic. In this narrative review, we will discuss potential reasons for this decrease in ACS incidence. Furthermore, we will discuss ACS management during the COVID-19 pandemic, and we will discuss outcomes in ACS. Recent findings: A reluctance to seek medical contact (in order not to further overburden the health system or due to fear of being infected with COVID-19 while in hospital) and unavailability of medical services seem to be important factors. This may have led to an increased symptom onset to first medical contact time and an increased rate of out-of-hospital cardiac arrests. A trend towards less invasive management was observed (less invasive coronary angiography in NSTEMI patients and more "fibrinolysis-first" in STEMI patients), although a large variation was observed with some centers having a relative increase in early invasive management. Patients with ACS and concomitant COVID-19 infection have worse outcomes compared to ACS patients without COVID-19 infection. All of the above led to worse clinical outcomes in patients presenting with ACS during the COVID-19 pandemic. Interestingly, staffing and hospital bed shortages led to experimentation with very early discharge (24 h after primary PCI) in low-risk STEMI patients which had a very good prognosis and resulted in significant shorter hospital duration. Summary: During the COVID-19 pandemic, ACS incidence and admission rates were decreased, symptom onset to first medical contact time prolonged, and out-of-hospital rates increased. A trend towards less invasive management was observed. Patients presenting with ACS during the COVID-19 pandemic had a worse outcome. On the other hand, experimental very early discharge in low-risk patients may relieve the healthcare system. Such initiatives, and strategies to lower the reluctance of patients with ACS symptoms to seek medical help, are vital to improve prognosis in ACS patients in future pandemics.

Clinical Outcomes after Percutaneous Coronary Intervention for Cardiogenic Shock Secondary to Total Occlusive Unprotected Left Main Coronary Artery Lesion-Related Acute Myocardial Infarction.

BACKGROUND: Acute myocardial infarction (AMI) with occlusion of an unprotected left main coronary artery (ULMCA) is a rare condition with a high mortality. The literature on clinical outcomes after percutaneous coronary intervention (PCI) for cardiogenic shock secondary to ULMCA-related AMI is scarce. METHODS: In this retrospective analysis, all consecutive patients undergoing PCI for cardiogenic shock secondary to total occlusive ULMCA-related AMI were included between January 1998 and January 2017. The primary endpoint was 30-day mortality. The secondary endpoints were long-term mortality and 30-day and long-term major adverse cardiovascular and cerebrovascular events. The differences in clinical and procedural variables were assessed. A multivariable model was created to search for independent predictors of survival. RESULTS: Forty-nine patients were included, and the mean age was 62 ± 11 years. The majority of patients suffered cardiac arrest prior or during PCI (51%). Thirty-day mortality was 78%, of which 55% died within 24 h. The median follow-up of patients who survived 30 days (n = 11) was 9.9 years (interquartile range 4.7-13.6), and long-term mortality was 84%. Long-term all-cause mortality was independently associated with cardiac arrest prior or during PCI (hazard ratio [HR] 2.02, 95% confidence interval 1.02-4.01, p = 0.043). Patients who survived to the 30-day follow-up with severe left ventricular dysfunction had a significantly higher risk of mortality compared to patients with moderate to mild dysfunction (p = 0.007). CONCLUSIONS: Cardiogenic shock secondary to total occlusive ULMCA-related AMI carries a very high 30-day all-cause mortality. Thirty-day survivors with a severe left ventricular dysfunction have a poor long-term prognosis.

A Narrative Review of Ultrathin-strut Drug-eluting Stents: The Thinner the Better?

Second-generation drug-eluting stents (DES) are considered standard of care for revascularization of patients undergoing percutaneous coronary intervention. Besides the polymer and antiproliferative drug used, the metallic backbone of DES is an attractive target for further development. Ultrathin-strut DES (≤70 µm strut thickness) are more flexible, have an improved trackability and crossability compared to conventional second-generation DES. Importantly, ultrathin-strut DES reduce the risk of in-stent restenosis, thereby decreasing the risk of angiographic and clinical restenosis. In this narrative review, we will discuss the clinical outcomes of the commercially available ultrathin-strut DES.

Contemporary techniques in percutaneous coronary intervention for bifurcation lesions.

INTRODUCTION: Treatment of coronary bifurcation lesions with contemporary state-of-the-art percutaneous coronary intervention (PCI) is still associated with higher rate of adverse cardiovascular events compared to non-bifurcation lesions. Bench testing and virtual computer modeling have increased our understanding of bifurcation PCI guiding refinement in bifurcation techniques. New insights on bifurcation PCI have the potential to further improve clinical outcomes in patients presenting with bifurcation lesions. Areas covered: The present manuscript aims to review the methods for bifurcation lesion assessment and treatment strategy step by step supported on bench and clinical evidence. Expert commentary: Invasive pressure-wire evaluation is essential to determine the appropriateness of bifurcation PCI, particularly in intermediate coronary stenosis. Treatment strategy relies on four parameters: diameters of the three segments of the bifurcation; lesion length and plaque distribution; and bifurcation angle. The optimal technique for bifurcation PCI is still debated, an individualized approach with an initial provisional side branch stenting strategy seems to be suitable in the 75 to 95% of patients. For more complex bifurcations, two-stent techniques may be required with increasing evidence supporting the usefulness of the double kissing balloon crush (DK-crush) technique.

Biomechanical Impact of Wrong Positioning of a Dedicated Stent for Coronary Bifurcations: A Virtual Bench Testing Study.

The treatment of coronary bifurcations is challenging for interventional cardiologists. The Tryton stent (Tryton Medical, Inc., USA) is one of the few devices specifically designed for coronary bifurcations that underwent large clinical trials. Although the manufacturer provides specific recommendations to position the stent in the bifurcation side branch (SB) according to four radio-opaque markers under angiographic guidance, wrong device positioning may accidentally occur. In this study, the virtual bench testing approach was used to investigate the impact of wrong positioning of the Tryton stent in coronary bifurcations in terms of geometrical and biomechanical criteria. A finite element model of the left anterior descending/first diagonal coronary bifurcation was created with a 45° distal angle and realistic lumen diameters. A validated model of the Tryton stent mounted on stepped delivery balloon was used. All steps of the Tryton deployment sequence were simulated. Three Tryton positions, namely 'proximal', 'recommended', and 'distal' positions, obtained by progressively implanting the stent more distally in the SB, were compared. The 'recommended' case exhibited the lowest ostial area stenosis (44.8 vs. 74.3% ('proximal') and 51.5% ('distal')), the highest diameter at the SB ostium (2.81 vs. 2.70 mm ('proximal') and 2.54 mm ('distal')), low stent malapposition (9.9 vs. 16.3% ('proximal') and 8.5% ('distal')), and the lowest peak wall stress (0.37 vs. 2.20 MPa ('proximal') and 0.71 MPa ('distal')). In conclusion, the study shows that a 'recommended' Tryton stent positioning may be required for optimal clinical results.

Ex-vivo study in nephroureterectomy specimens defining the role of 3-D upper urinary tract visualization using optical coherence tomography and endoluminal ultrasound.

Minimal invasive endoscopic treatment for upper urinary tract urothelial carcinoma (UUT-UC) is advocated in patients with low-risk disease and limited tumor volume. Diagnostic ureterorenoscopy combined with biopsy is the diagnostic standard. This study aims to evaluate two alternative diagnostic techniques for UUT-UC: optical coherence tomography (OCT) and endoluminal ultrasound (ELUS). Following nephroureterectomy, OCT, ELUS, and computed tomography (CT) were performed of the complete nephroureterectomy specimen. Visualization software (AMIRA®) was used for reconstruction and coregistration of CT, OCT, and ELUS. Finally, CT was used to obtain exact probe localization. Coregistered OCT and ELUS datasets were compared with histology. Coregistration with three-dimensional CT makes exact data matching possible in this ex-vivo setting to compare histology with OCT and ELUS. In OCT images of normal-appearing renal pelvis and ureter, urothelium, lamina propria, and muscularis were visible. With ELUS, all anatomical layers of the ureter could be distinguished, besides the urothelial layer. ELUS identified suspect lesions, although exact staging and differentiation between noninvasive and invasive lesions were not possible. OCT provides high-resolution imaging of normal ureter and ureter lesions. ELUS, however, is of limited value as it cannot differentiate between noninvasive and invasive tumors.

Differences in rotational positioning and subsequent distal main branch rewiring of the Tryton stent: An optical coherence tomography and computational study.

OBJECTIVES: To evaluate the occurrence of rewiring through one of the panels of the Tryton stent (instead of the assumed re-wiring in-between the panels) and the influence on stent geometry and mechanics. BACKGROUND: Tryton is a side branch stent used in combination with a main branch device. It is placed without the need of rotational orientation. However, it is unknown whether main branch re-wiring accidentally may occur through a panel, instead of in-between the panels. METHODS: We used three-dimensional optical coherence tomography to evaluate the location of distal main branch re-wiring through Tryton. Furthermore, we used computer simulations to evaluate the influence on stent geometry and mechanics. RESULTS: Rewiring through a panel (instead of in-between two panels) occurred in 45% of the cases. By using virtual stent deployment, we found minimal differences in ostial side branch stenoses (44.8% in-between the panels and 39.0% through a panel). There were no differences in minimum stent areas of the distal main branch (6.38 mm2 vs. 6.39 mm2 ). In both scenarios, the re-wired Tryton cell was large enough for main branch stenting (expressed as the diameter of the largest possible circle that fits within the cells): 3.40 mm (in-between the panels) vs. 3.02 mm (through a panel). CONCLUSIONS: In 45% of the Tryton implantations, distal main branch rewiring (and subsequent main branch stenting) was performed through one Tryton panel, instead of the assumed rewiring in-between the panels. However, this did not result in unfavorable stent geometries or mechanics, as evaluated with computer simulations.

Visual estimation versus different quantitative coronary angiography methods to assess lesion severity in bifurcation lesions.

OBJECTIVES: To compare visual estimation with different quantitative coronary angiography (QCA) methods (single-vessel versus bifurcation software) to assess coronary bifurcation lesions. BACKGROUND: QCA has been developed to overcome the limitations of visual estimation. Conventional QCA however, developed in "straight vessels," has proved to be inaccurate in bifurcation lesions. Therefore, bifurcation QCA was developed. However, the impact of these different modalities on bifurcation lesion severity classification is yet unknown METHODS: From a randomized controlled trial investigating a novel bifurcation stent (Clinicaltrials.gov NCT01258972), patients with baseline assessment of lesion severity by means of visual estimation, single-vessel QCA, 2D bifurcation QCA and 3D bifurcation QCA were included. We included 113 bifurcations lesions in which all 5 modalities were assessed. The primary end-point was to evaluate how the different modalities affected the classification of bifurcation lesion severity and extent of disease. RESULTS: On visual estimation, 100% of lesions had side-branch diameter stenosis (%DS) >50%, whereas in 83% with single-vessel QCA, 27% with 2D bifurcation QCA and 26% with 3D bifurcation QCA a side-branch %DS >50% was found (P < 0.0001). With regard to the percentage of "true" bifurcation lesions, there was a significant difference between visual estimate (100%), single-vessel QCA (75%) and bifurcation QCA (17% with 2D bifurcation software and 13% with 3D bifurcation software, P < 0.0001). CONCLUSIONS: Our study showed that bifurcation lesion complexity was significantly affected when more advanced bifurcation QCA software were used. "True" bifurcation lesion rate was 100% on visual estimation, but as low as 13% when analyzed with dedicated bifurcation QCA software.

Does the novel delivery system for the STENTYS self-apposing coronary stent increase the risk of stent edge dissections? Optical coherence tomography post stent findings.

BACKGROUND: With optical coherence tomography (OCT), details of arterial injuries during percutaneous coronary intervention can be assessed accurately. There might be an increased risk of stent edge dissections with the novel delivery system for the STENTYS stent. We evaluated the prevalence of stent edge dissections using the novel Xposition delivery device as compared with the conventional delivery device. METHODS: A total of 38 patients who were treated with the self-apposing STENTYS stent and with OCT assessment at our center were retrospectively analysed. Twenty patients were treated using the Xposition- and 18 using the conventional delivery device. OCT was performed according to study protocol. Frames with poor quality were excluded. RESULTS: A total of 12(18%) dissections were detected, 7(20%) in the Xposition delivery device group, and 5(15%) in the conventional group (p = 1). Using the Xposition delivery device 4(33%) dissections were found proximally, using the conventional delivery device 3(25%) (p = ns). Mean longitudinal dissection length was 2.07 ± 1.80mm, 8(67%) appeared as flaps, 4(33%) as cavities. Morphometric parameters were comparable in both groups. CONCLUSIONS: Detailed OCT assessment of stent edge dissections was possible, which revealed no large differences using the Xposition delivery device as compared with conventional delivery device, however large studies are warranted.

In vitro validation of coronary CT angiography for the evaluation of complex lesions.

AIMS: The aim of this study was to assess in vitro the diagnostic accuracy of computed tomography angiography (CTA) for the evaluation of complex coronary lesions. METHODS AND RESULTS: Five Plexiglas phantoms with three bifurcation lesions each were designed to mimic the anatomic variations and fractal phenomena of the coronary tree. In addition, luminal stenoses were scaled up with increases of 10% from 40% to 80%, corresponding to luminal areas ranging from 3.0 mm2 to 0.22 mm2. Third-generation dual-source computed tomography was used. Automated quantitative CTA analysis was performed according to the bifurcation segment model. The primary objective was to determine the diagnostic accuracy of quantitative CTA in assessing bifurcation lesions with the phantoms as a reference. The accuracy of CTA for the assessment of minimal luminal diameter was -0.07 mm (limits of agreement -0.75 to 0.61), for reference vessel diameter 0.19 mm (limits of agreement -0.25 to 0.63) and diameter stenosis 8.2% (limits of agreement -13.2 to 29.5) with no difference regarding the location within the bifurcation (i.e., proximal and distal main vessel and side branch). In stenosis with minimal luminal diameter ≥1 mm, CTA overestimated the lesion severity (bias 0.19 mm, limits of agreement -0.09 to 0.47), whereas in lesions with severe stenosis and minimal luminal diameter ≤1 mm, CTA underestimated the lesion severity (bias -0.48 mm, limits of agreement -0.55 to -0.41). CTA was able to identify the contrast-filled lumen in all degrees of lesion severity. CONCLUSIONS: In vitro, CTA is accurate for the evaluation of bifurcation lesions. CTA was able to distinguish contrast-filled lumen even in severe obstructive lesions. These findings require further validation in the clinical setting.

Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions).

BACKGROUND: The long-term fate of Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, CA) struts jailing side branch ostia has not been clarified. We therefore evaluate serially (post-procedure and at 6 months, 1, 2, 3, and 5 years) the appearance and fate of jailed Absorb bioresorbable vascular scaffold struts. METHODS AND RESULTS: We performed 3-dimensional optical coherence tomographic analysis of the ABSORB Cohort B trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) up to 5 years using a novel, validated cut-plane analysis method. We included 29 patients with a total of 85 side branch ostia. From the 12 ostia which could be assessed in true serial fashion, 7 showed a pattern of initial decrease in the ostial area free from struts, followed by an increase in strut-free ostial area toward the end of the 5 years of follow-up. In a repeated-measures analysis with time as fixed variable and ostial area free from struts as dependent variable, we showed a numeric decrease in the estimated ostial area free from struts from 0.75 mm2 (baseline) to 0.68 mm2 (first follow-up visit at 6 months or 1 year) and 0.63 mm2 (second follow-up visit at 2 or 3 years). However, from the second visit to the 5-year follow-up visit, there was a statistically significant increase from 0.63 to 0.89 mm2 (P=0.001). Struts overlying an ostium divided the ostium into compartments, and the number of these compartments decreased over time. CONCLUSIONS: This study showed that in most cases, the side branch ostial area free from struts initially decreased. However, with full scaffold bioresorption, the ostial area free from scaffold increased between 2 to 3 years and 5 years in the vast majority of patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

State of the art: coronary angiography.

In the early days of coronary angiography, the precise quantification of luminal narrowing was challenging. The introduction of balloon angioplasty (percutaneous transluminal coronary angioplasty [PTCA]) by Andreas Grüntzig in 1977 was perhaps the greatest incentive to the development of quantitative coronary angiography (QCA). QCA has played a crucial role in evaluating interventional techniques and assessing the results of new technologies. With the advent of drug-eluting stents (DES), QCA metrics such as late lumen loss and diameter stenosis (restenosis) proved to be instrumental in assessing new technologies. Refinements in QCA with the advent of dedicated bifurcation analysis and three-dimensional (3D) QCA have broadened the application of QCA. Beyond angiographic metrics, new developments in the field of QCA have introduced the functional component in the assessment of coronary lesions. Angiography-derived fractional flow reserve (FFR) may be a good tool for diagnosing ischaemia-producing lesions in patients with non-complex coronary artery disease. Furthermore, the incremental functional information can be used to expand the traditional late lumen loss (LLL) and restenosis concepts.

One-Year Clinical Outcomes of Patients Presenting With ST-Segment Elevation Myocardial Infarction Caused by Bifurcation Culprit Lesions Treated With the Stentys Self-Apposing Coronary Stent: Results From the APPOSITION III Study.

OBJECTIVE: To investigate outcomes in patients with ST-segment elevation myocardial infarction (STEMI) after treatment with the Stentys self-apposing stent (Stentys SAS; Stentys S.A.) for bifurcation culprit lesions. BACKGROUND: The nitinol, self-expanding Stentys was initially developed as a dedicated bifurcation stent. The stent facilitates a provisional strategy by accommodating its diameter to both the proximal and distal reference diameters and offering an opportunity to "disconnect" the interconnectors, opening the stent toward the side branch. METHODS: The APPOSITION (a post-market registry to assess the Stentys self-expanding coronary stent in acute myocardial infarction) III study was a prospective, multicenter, international, observational study including STEMI patients undergoing primary percutaneous coronary intervention (PCI) with the Stentys SAS. Clinical endpoints were evaluated and stratified by bifurcation vs non-bifurcation culprit lesions. RESULTS: From 965 patients included, a total of 123 (13%) were documented as having a bifurcation lesion. Target-vessel revascularization (TVR) rates were higher in the bifurcation subgroup (16.4% vs 10.0%; P=.04). Although not statistically significant, other endpoints were numerically higher in the bifurcation subgroup: major adverse cardiac events (MACE; 12.7% vs 8.8%), myocardial infarction (MI; 3.4% vs 1.8%), and definite/probable stent thrombosis (ST; 5.8% vs 3.1%). However, when postdilation was performed, clinical endpoints were similar between bifurcation and non-bifurcation lesions: MACE (8.7% vs 8.4%), MI (1.2% vs 0.7%), and definite/probable ST (3.7% vs 2.4%). CONCLUSIONS: The use of the Stentys SAS was safe and feasible for the treatment of bifurcation lesions in the setting of primary PCI for STEMI treatment with acceptable 1-year cardiovascular event rates, which improved when postdilation was performed.

Safety and efficacy of the Tryton Side Branch Stent™ for the treatment of coronary bifurcation lesions: an update.

INTRODUCTION: Percutaneous coronary interventions (PCIs) involving coronary bifurcation lesions are associated with adverse outcomes compared with non-bifurcation lesions. The Tryton Side Branch Stent has been developed to improve clinical outcomes after bifurcation PCI. Areas covered: We will discuss observational data (clinical registries and intravascular imaging studies) and randomized data from the TRYTON trial (comparing Tryton [used in combination with a main branch drug-eluting stent (DES)] with side branch balloon angioplasty [in combination with a main branch DES; also referred to the provisional strategy]). Expert commentary: The published data showed that the use of Tryton was feasible (successful stent placement in ~95%) and safe (stent thrombosis rates ~0.5% at 9-12 months; no cardiac deaths in the TRYTON trial). Its use resulted in excellent acute angiographic results. However, the TRYTON trial also showed that due to neo-intimal tissue growth, luminal dimension at 9 months were similar between Tryton and the provisional strategy. Furthermore, the trial showed an increased risk of peri-procedural myocardial infarction when Tryton was used in small side branches. Based on all data available, the provisional strategy should still be considered as the default strategy in the majority of bifurcation cases, although the use of Tryton may be considered in complex bifurcation anatomies with extensive disease in large side branches, especially when the device will be further improved by a drug-coating.

Clinical outcomes with the STENTYS self-apposing coronary stent in patients presenting with ST-segment elevation myocardial infarction: two-year insights from the APPOSITION III (A Post-Market registry to assess the STENTYS self-exPanding COronary Stent In AcuTe MyocardIal InfarctiON) registry.

AIMS: The APPOSITION III registry evaluated the feasibility and performance of the STENTYS self-apposing stent in an ST-segment elevation myocardial infarction (STEMI) population. This novel self-apposing stent device lowers stent strut malapposition rates and therefore carries the potential to prevent stent undersizing during primary percutaneous coronary intervention (PCI) in STEMI patients. To date, no long-term data are available using this device in the setting of STEMI. We aimed to evaluate the long-term clinical outcomes of the APPOSITION III registry. METHODS AND RESULTS: This was an international, prospective, multicentre post-marketing registry. The study population consisted of 965 STEMI patients. The primary endpoint, major adverse cardiac events (MACE), was defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularisation (CD-TLR). At two years, MACE occurred in 11.2%, cardiac death occurred in 2.3%, TV-MI occurred in 2.3% and CD-TLR in 9.2% of patients. The two-year definite stent thrombosis (ST) rate was 3.3%. Incremental event rates between one- and two-year follow-up were 1.0% for TV-MI, 1.8% for CD-TLR, and 0.5% for definite ST. Post-dilation resulted in significantly reduced CD-TLR and ST rates at 30-day landmark analyses. Results were equivalent between the BMS and PES STENTYS subgroups. CONCLUSIONS: This registry revealed low rates of adverse events at two-year follow-up, with an incremental ST rate as low as 0.5% in the second year, demonstrating that the self-apposing technique is feasible in STEMI patients on long-term follow-up while using post-dilatation.

Segmental comparison between a dedicated bifurcation stent and balloon angioplasty using intravascular ultrasound and three-dimensional quantitative coronary angiography: A subgroup analysis of the Tryton IDE randomized trial.

OBJECTIVE: Randomized comparison between the Tryton Side Branch Stent (Tryton Medical, Durham, NC), used in combination with a main branch drug-eluting stent (DES), and side branch balloon angioplasty (SBBA, in combination with a main branch DES) using intravascular ultrasound (IVUS), and three-dimensional quantitative coronary angiography (3D-QCA). BACKGROUND: The Tryton stent has been developed to improve clinical outcomes after percutaneous coronary intervention (PCI) of bifurcation lesions. METHODS: We present the pre-specified IVUS (n = 159) and 3D-QCA (n = 190) sub-group analyses of the Tryton coronary bifurcation trial (randomizing Tryton vs. SBBA). RESULTS: There were no differences in the main branch with regard to minimal lumen area (MLA) (5.33 ± 1.37 in Tryton vs. 5.69 ± 1.72 mm2 in SBBA, P = 0.235) with low neo-intima area in both groups. In the side branch, there were also no statistical significant differences between both groups (3.04 ± 1.02 in Tryton vs. 3.46 ± 1.15 mm2 in SBBA, P = 0.072). On 3D-QCA, no differences in minimal lumen diameter (MLD) and percentage diameter stenosis (%DS) were observed in the proximal and distal main branches. In the side branch, there were also no differences found in %DS and MLD (MLD: 1.34 ± 0.043 mm [Tryton] vs. 1.45 ± 0.31 mm [SBBA], P = 0.090). CONCLUSIONS: There were no differences in 9-month luminal dimensions of the side branch between the Tryton Stent and Side Branch Balloon Angioplasty, as assessed with IVUS (MLA) and 3D QCA (MLD). Angiographic and ultrasound results of the main branch were not negatively influenced by the Tryton stent. © 2016 Wiley Periodicals, Inc.