Drug-eluting Stents Research Articles

Biodegradable Stents in the Treatment of Arterial Stenosis

Arterial diseases (ADs) are a significant health problem, with high mortality and morbidity rates. Endovascular interventions, such as balloon angioplasty (BA), bare-metal stents (BMSs), drug-eluting stents (DESs) and drug-coated balloons (DCBs), have made significant progress in their treatments. However, the issue has not been fully resolved, with restenosis remaining a major concern. In this context, bioresorbable vascular stents (BVSs) have emerged as a promising area of investigation. This manuscript includes articles that assess the use of BVSs. Studies have identified ongoing challenges, such as negative vascular remodeling and elastic recoil post-angioplasty, stent-related injury, and in-stent restenosis following BMS placement. While DESs have mitigated these issues to a considerable extent, their durable structures are unable to prevent late stent thrombosis and delay arterial recovery. BVSs, with their lower support strength and tendency towards thicker scaffolds, increase the risk of scaffold thrombosis. Despite inconsistent study results, the superiority of BVSs over DESs has not been demonstrated in randomized trials, and DES devices continue to be the preferred choice for most cases of arterial disease. Esprit BTK (Abbott Vascular) received approval from the US FDA for below-knee lesions in 2024, offering hope for the use of BVSs in other vascular conditions. Enhancing the design and thickness of BVS scaffolds may open up new possibilities. Large-scale and longer-term comparative studies are still required. This article aims to provide an overview of the use of biodegradable stents in the endovascular treatment of vascular stenosis.

Effect of high-quality nursing interventions on the quality of life and cardiac index in acute coronary syndrome patients treated with drug-eluting stents: a randomized trial study

BackgroundNursing care is important and necessary for Acute Coronary Syndrome patients who have undergone angiography and stenting, to minimize complications. The purpose of this study was to assess the effects of High-Quality Nursing Interventions on the quality of life and cardiac index of Acute Coronary Syndrome patients, treated with drug-eluting stents.MethodsIn this randomized trial, 70 patients of the cardiac intensive care units in one of Jahrom university of medical sciences hospitals (Iran) were selected from July 2023 to October 2023 by the available method, and randomly allocated (stochastic assignment) to two intervention (High-Quality Nursing Interventions) and control groups (routine nursing care). Quality of life and Cardiac Index were measured by cardiac index calculation formula and the McNew Cardiac Quality Questionnaire, respectively. Data were analysed using SPSS version 19 software, Mann‒Whitney, chi‒square and Wilcoxon tests, with a significance level at a p < .05.ResultsA statistically significant difference demonstrated between the mean of the quality of life and cardiac index in the intervention group(p < .05).ConclusionsHigh-Quality Nursing Interventions improved quality of life and cardiac index of Acute Coronary Syndrome patients, treated with drug-eluting stents. Therefore, it is recommended to use this nursing approach in special cardiac care units.Trial registrationIRCT79432(2024.10.08), “Retrospectively registered”.

Contrastive learning with transformer for adverse endpoint prediction in patients on DAPT post-coronary stent implantation

BackgroundEffective management of dual antiplatelet therapy (DAPT) following drug-eluting stent (DES) implantation is crucial for preventing adverse events. Traditional prognostic tools, such as rule-based methods or Cox regression, despite their widespread use and ease, tend to yield moderate predictive accuracy within predetermined timeframes. This study introduces a new contrastive learning-based approach to enhance prediction efficacy over multiple time intervals.MethodsWe utilized retrospective, real-world data from the OneFlorida + Clinical Research Consortium. Our study focused on two primary endpoints: ischemic and bleeding events, with prediction windows of 1, 2, 3, 6, and 12 months post-DES implantation. Our approach first utilized an auto-encoder to compress patient features into a more manageable, condensed representation. Following this, we integrated a Transformer architecture with multi-head attention mechanisms to focus on and amplify the most salient features, optimizing the representation for better predictive accuracy. Then, we applied contrastive learning to enable the model to further refine its predictive capabilities by maximizing intra-class similarities and distinguishing inter-class differences. Meanwhile, the model was holistically optimized using multiple loss functions, to ensure the predicted results closely align with the ground-truth values from various perspectives. We benchmarked model performance against three cutting-edge deep learning-based survival models, i.e., DeepSurv, DeepHit, and SurvTrace.ResultsThe final cohort comprised 19,713 adult patients who underwent DES implantation with more than 1 month of records after coronary stenting. Our approach demonstrated superior predictive performance for both ischemic and bleeding events across prediction windows of 1, 2, 3, 6, and 12 months, with time-dependent concordance (Ctd) index values ranging from 0.88 to 0.80 and 0.82 to 0.77, respectively. It consistently outperformed the baseline models, including DeepSurv, DeepHit, and SurvTrace, with statistically significant improvement in the Ctd-index values for most evaluated scenarios.ConclusionThe robust performance of our contrastive learning-based model underscores its potential to enhance DAPT management significantly. By delivering precise predictive insights at multiple time points, our method meets the current need for adaptive, personalized therapeutic strategies in cardiology, thereby offering substantial value in improving patient outcomes.

The eff ect of standard lipid-lowering therapy and the type of stent on the course of the atherosclerotic process in the coronary arteries in patients with hereditary hypercholesterolemia and acute coronary syndrome

Objective. Тo study the impact of standard hypolipidemic therapy and stent type on the progression of atherosclerosis in coronary arteries in patients with familial hypercholesterolemia and acute coronary syndrome. Material and methods. Analyzed treatment results of 100 patients with familial hypercholesterolemia and acute coronary syndrome, divided into two equal groups. Group 1 received bare-metal stents, while Group 2 received drug-eluting stents. All patients were prescribed standard hypolipidemic therapy to reduce restenosis risk and normalize lipid profiles. Immediate postoperative outcomes included coronary flow restoration and adverse event rates, with long-term assessments focused on lipid profile dynamics and restenosis rates. Results. Coronary flow was restored in 98%, with adverse events occurring in 8% equally across both groups. Hypolipidemic therapy normalized lipid profiles in one-third of patients after 1 month, half after 3 months, and two-thirds after 6 months. Restenosis rates at 6 months were 45.2% in Group 1 and 21.2% in Group 2, escalating to 84.6% and 48% at 12 months. Repeat stent implantation occurred in 14% of Group 1 and 8% of Group 2. Conclusion. Standard hypolipidemic therapy is insufficient for rapid lipid normalization, while drug-eluting stents significantly reduce restenosis risk.

Comparative Outcomes of Supera Interwoven Nitinol Versus Eluvia Fluoropolymer-Based Drug-Eluting Stents for the Treatment of Severely Calcified Femoropopliteal Artery Lesions: Results of the ELDORADO Study.

Supera interwoven nitinol stents (IWNS) and Eluvia fluoropolymer-based drug-eluting stents (DES) were designed to improve the patency of the femoropopliteal (FP) artery; however, which type of stent yields superior outcomes in calcified FP lesions remains unclear. To compare the safety and efficacy of Supera IWNS and Eluvia DES in severely calcified FP lesions. This study retrospectively analyzed 257 consecutive patients who underwent endovascular therapy using either IWNS (n = 123) or DES (n = 134) for FP lesions with peripheral arterial calcium scoring system (PACSS) grade 3 or 4 severe calcification between April 2018 and December 2021 at eight cardiovascular centers in Japan. Propensity score (PS) matching extracted 138 matched patients with no remarkable intergroup difference in patient and lesion characteristics. The 1-year primary patency rates in the matched population were not significantly different between the IWNS and DES groups (85.4% vs. 89.8%, p = 0.320). A significant interaction between the stents used and the number of below-the-knee (BTK) runoff vessels was observed (interaction p = 0.048). The hazard ratio for restenosis was 2.68 (95% confidence interval, 0.51-14.2) in the group with no BTK runoff, favoring DES. In PS-matched patients with severely calcified FP lesions, 1-year primary patency was not significantly different between treatments using Supera IWNS and Eluvia DES.

Development of a Highly Hydrophobic Micro/Nanostructured Nanocomposite Coating of PLA-PEG-Cloisite 20A Nanoclay with Excellent Hemocompatibility and Rapid Endothelialization Properties for Cardiovascular Applications.

Despite the unique properties of clay nanocomposites for cardiovascular applications, there are few data on the hemocompatibility of these nanomaterials. This study represents the first comprehensive investigation of the hemo/biocompatibility of clay nanocomposites in vitro. Nanocomposite coatings of polylactic acid (PLA)-polyethylene glycol (3 wt %)-Cloisite20A nanoclay (3 wt %) were produced using electrospraying technique as potential drug-eluting stent (DES) coatings. Pristine PLA coating served as a control. The coatings ' different structural and biological properties were assessed, including surface morphology, topography, hydrophobicity, mechanics, and the interaction of nanocomposites with blood components, endothelial cells (EC), and bacteria. Findings indicated that all of the coatings were highly hydrophobic with microbead/nanofiber morphology and had antifouling properties. The absorption profiles of plasma proteins were similar for all groups, and nanocomposites did not trigger the coagulation cascade and complement activation. The nanocomposites did not increase hemolysis or platelet and leukocyte adhesion and activation. Interestingly, the nanocomposites exhibited the lowest levels of interleukin-6 production. Cellular experiments showed that the nanocomposites did not reduce ECs survival compared to the control group, and a continuous layer of ECs covered the nanocomposite surfaces after 4 days. These results demonstrate the exceptional hemo/biocompatibility of as-prepared clay nanocomposites as promising biomaterials for implants such as DESs.

Chronic total occlusion- Percutaneous coronary intervention (CTO-PCI) experience in a single, multi-operator Tunisian center : A Five-Year Report.

In recent years, advancements in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have been notable, improving procedural techniques, imaging, and management of complications. We sought to assess the performance and the practice of a high-volume Tunisian PCI center in treating patients with a CTO. We retrospectively evaluated data from consecutive CTO patients who underwent percutaneous revascularization from October 2019 to January 2024 at the cardiology department of Habib Thameur Teaching Hospital, Tunisia. Operators' experience and CTO-PCI volume were also documented. The cohort consisted of 58 patients, predominantly male (86.2%), with an average age of 59.8±9.6 years. The right coronary artery was the most common CTO site (56.9%). The antegrade approach was adopted in 96.5% of the cases, with the antegrade wiring (AW) being the preferred technique (81%). Key procedural characteristics included the use of multiple access sites and dual coronary injection in 44.8% of the cases, multiple guidewires in 50%, additional support modality in 68.9% and drug-eluting stents in all instances. The procedural success rate was 75.9%, with an in-hospital adverse outcome rate of 13.8% and a major adverse cardiac event (MACE) rate of 3.4%. A significant impact of operator experience and volume on success rates (85.3% vs 62.5%, p=0.04) and adverse outcomes (25% vs 5.8%, p=0.03) was observed, with trained operators and higher-volume practitioners achieving better results. In a single-center setting with a conservative CTO cohort, acceptable PCI success rates were achieved. We highlighted the positive impact of CTO training programs and PCI procedures volume on the overall outcomes.

Novel Use of Drug-eluting Stent in Otologic Surgery to Prevent Restenosis

Objectives: The primary objective of this case series is to assess the effectiveness of the off-label use of the PROPEL drug-eluting stent, traditionally FDA-approved for sinus surgery, in preventing restenosis following canalplasty in patients with chronic otologic conditions or congenital anomalies. The stent provides both mechanical support to maintain canal patency and localized steroid delivery to reduce inflammation and scarring. Methods: Four patients with various otologic conditions underwent canalplasty, followed by the placement of drug-eluting stents into the external auditory canal. The stents were inserted to address postoperative stenosis. Clinical outcomes, including ear canal patency, hearing improvement, and the rate of restenosis, were evaluated through regular follow-ups. Results: All patients showed improved ear canal patency, with minimal restenosis observed during follow-up. Hearing improvement was reported in 3 out of 4 patients. The pediatric case exhibited mild medial canal stenosis despite stent placement, but overall improvement was noted. No adverse effects were associated with the stent usage. Conclusions: The off-label use of a drug-eluting stent in canalplasty appears to reduce restenosis rates and maintain canal patency in adults effectively. Further research is warranted to standardize protocols and expand its indications for otologic surgery, particularly in pediatric cases where outcomes may vary.

The Effects of Nicotine on Re-endothelialization, Inflammation, and Neoatherosclerosis After Drug-Eluting Stent Implantation in a Porcine Model.

Cigarette smoking is a major risk factor for atherosclerosis. Nicotine, a crucial constituent of tobacco, contributes to atherosclerosis development and progression. However, evidence of the association between nicotine and neointima formation is limited. We aimed to evaluate whether nicotine enhances neointimal hyperplasia in the native epicardial coronary arteries of pigs after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). After coronary angiography (CAG) and quantitative coronary angiography (QCA), we implanted 20 DES into 20 pigs allocated to 2 groups: no-nicotine (n=10) and nicotine (n=10) groups. Post-PCI CAG and QCA were performed immediately. Follow-up CAG, QCA, optical coherence tomography (OCT), and histopathological analyses were performed 2 months post-PCI. Despite intergroup similarities in the baseline QCA findings, OCT analysis showed that the nicotine group had a smaller mean stent and lumen areas, a larger mean neointimal area, greater percent area stenosis, and higher peri-strut fibrin and inflammation scores than the no-nicotine group. In immunofluorescence analysis, the nicotine group displayed higher expression of CD68 and α-smooth muscle actin but lower CD31 expression than the no-nicotine group. Nicotine inhibited re-endothelialization and promoted inflammation and NIH after PCI with DES in a porcine model.

A Strategy for the In-Silico Assessment of Drug Eluting Stents: A Comparative Study for the Evaluation of Retinoic Acid as a Novel Drug Candidate for Drug Eluting Stents.

In this work, a methodology for the in-silico evaluation of drug eluting stents (DES) is presented. A stent model developed by Rontis S.A. has been employed. For modeling purposes two different stent parts have been considered: the metal core and the coating. For the arterial models, we used animal specific imaging data and realistic geometries were reconstructed which were used as input to the drug-delivery model. More specifically, optical coherence tomography (OCT) imaging data from two coney iliac arterial segments were 3D reconstructed, and the preprocessed 3D stent was deployed in-silico. The deformed geometries of the in-silico deployed stents and the dilated arterial segments were used as input to the drug elution model. The same reconstructed arteries were used in three different cases: (i) Case A. The coatings contain retinoic acid at an initial concentration 49.2% w/w. (ii) Case B. The coatings contain retinoic acid at an initial concentration 1% w/w. (iii) Case C. The coatings contain sirolimus at an initial concentration 0.85% w/w. In each case, two different coatings were examined: (a) polylactic acid and (b) polylactic-co-glycolic acid. The results proved that retinoic acid is a very promising drug candidate for DES due to its binding time to the smooth muscle cells of the arterial wall that exceeds the corresponding time of sirolimus, while being non-toxic to the smooth muscle cells.

Recurrent drug eluting stent, in-stent restenosis (DES-ISR): Epidemiology, pathophysiology & treatment.

Coronary artery in-stent restenosis (ISR) is driven by neointimal hyperplasia and neo-atherosclerosis in previously placed stents. Drug eluting stents (DES) have been adopted as first line therapy for the initial episode of ISR. However, recurrent ISR has limited durable salvage options. In this article we review the pathophysiology, incidence, and management options of recurrent DES- ISR.

Systematically study the comprehensive performance of poly (L-lactic acid) drug-coated stent in vitro and in vivo during full degradation cycle

Systematically study the comprehensive performance of poly (L-lactic acid) drug-coated stent in vitro and in vivo during full degradation cycle

Sex Differences in Procedural Characteristics and Clinical Outcomes Among Patients Undergoing Bifurcation PCI.

The risk profiles, procedural characteristics, and clinical outcomes for women undergoing bifurcation percutaneous coronary intervention (PCI) are not well defined compared to those in men. COronary BIfurcation Stenting III (COBIS III) is a multicenter, real-world registry of 2,648 patients with bifurcation lesions treated with second-generation drug-eluting stents. We compared the angiographic and procedural characteristics and clinical outcomes based on sex. The primary outcome was 5-year target lesion failure (TLF), a composite of cardiac death, myocardial infarction, and target lesion revascularization. Women (n=635, 24%) were older, had hypertension and diabetes more often, and had smaller main vessel and side branch reference diameters than men. The pre- and post-PCI angiographic percentage diameter stenoses of the main vessel and side branch were comparable between women and men. There were no differences in procedural characteristics between the sexes. Women and men had a similar risk of TLF (6.3% vs. 7.1%, p=0.63) as well as its individual components and sex was not an independent predictor of TLF. This finding was consistent in the left main and 2 stenting subgroups. In patients undergoing bifurcation PCI, sex was not an independent predictor of adverse outcome.

Impact of coronary artery tortuosity on outcomes following stenting with newer-generation drug-eluting stents. An analysis of the randomized BIOFLOW trials

Impact of coronary artery tortuosity on outcomes following stenting with newer-generation drug-eluting stents. An analysis of the randomized BIOFLOW trials

Incidence and Management of In-Stent Restenosis in Patients with Drug-Eluting Stents

Introduction: The most prevalent complication of cardiac intervention is restenosis. After the BMS period, drug-eluting stents (DES) are the most suitable choice for stenosis treatment, particularly for patients with a high risk of bleeding. The rate of restenosis was much lower with current DES technology. The introduction of drug-eluting balloons (DEBs) is a potential breakthrough for coronary revascularisation treatments, particularly in-stent restenosis. Objective: This retrospective study was carried out to find the incidence and management of in-stent restenosis in patients with drug-eluting strains. Methods: After the hospital ethics committee's permission, patients' medical data was evaluated. Clinical and personal data were acquired from medical records. Risk variables for atherosclerosis were collected, along with baseline labs and echocardiography, to assess the ejection fraction of each patient. Classified interventional cardiologists analysed angiographic pictures to confirm the existence of ISR. Details about prior angioplasty and the kind of stent were noted. All patients with considerable drug-eluting in-stent restenosis (DES-ISR) and eligible for therapy with DEB were included in the analysis. Results: Two hundred ninety-eight patients received at least one DES throughout the research period. ISR was identified in 50 individuals (16.77%). Thus, 50 patients who fulfilled the inclusion criteria were included in the study. 2% of the study population presented with STEMI, 22% with NSTEMI, 24% with UA, and 52% presented with non-ACS. Among all the patients that had ISR, diabetes and hypertension were the most common comorbidities found in the study population. Following coronary angiography, it was discovered that the frequency of ISR was 11(22%) in patients with Xlimus sirolimus stent, 10(20%) with Xience (everolimus-eluting stent), 13(26%) with Ultimate (sirolimus-eluting stent), and 16(32%) with Biomatrix stent. Twenty-eight patients with DES ISR who met the inclusion criteria received revascularisation with DEB. After a median of 18 months of follow-up, eight patients remained symptomatic, with 4 developing MACE, one resulting in cardiac death, and 3 requiring revascularisation. Thus, the overall MACE rate was 21%. There were two fatalities from non-cardiac causes. Conclusions: In all new-generation DES, ISR often manifests as angina. There was no statistically significant difference in terms of ISR between second- and third-generation DES.DEB technology, particularly for DES, holds potential for ISR. Our experience highlights the need for more data, including randomised studies in various patient groups.

Impact of Smoking on Long-Term Revascularization Success and Complications in Multivessel Percutaneous Coronary Intervention: A Retrospective Cohort Study

Background: Smoking is a major modifiable risk factor in coronary artery disease (CAD) and is associated with adverse outcomes following percutaneous coronary intervention (PCI). PCI, widely utilized for revascularization in multivessel CAD, aims to restore coronary blood flow and reduce ischemic complications. However, smokers face increased risks of restenosis and major adverse cardiac events (MACE) after PCI, highlighting a need for further investigation into these associations. Objective: This study aimed to assess the impact of smoking on revascularization success and complications in patients undergoing multivessel PCI. Methods: A retrospective cohort study was conducted at a tertiary cardiovascular center, evaluating clinical data from patients who underwent PCI from January 1, 2023, to December 31, 2023. Patients aged 18 and older with confirmed multivessel CAD were included. Participants were divided into smokers (N=779) and non-smokers (N=779) based on documented smoking status. All patients underwent PCI with either drug-eluting stents (DES) or drug-eluting balloons (DEB), followed by standard dual antiplatelet therapy. The primary outcome was revascularization success, defined as achieving TIMI grade ≥2. Secondary outcomes included incidences of MACE and restenosis. Statistical analyses were performed using SPSS v27, with t-tests and chi-square tests used for continuous and categorical variables, respectively. Logistic regression adjusted for confounders. Results: Revascularization success was significantly lower in smokers (69.8%) compared to non-smokers (81.6%) (p &lt; 0.001). Smokers also exhibited higher rates of MACE (15.5%) and restenosis (12.6%) versus 8.4% and 7.3% in non-smokers, respectively (p &lt; 0.001 for both outcomes). Conclusion: Smoking negatively affects revascularization success and increases MACE and restenosis risks in multivessel PCI patients. These findings underscore the importance of tailored therapeutic strategies and smoking cessation efforts to improve PCI outcomes in this high-risk group.

Effectiveness of in-stent restenosis treatment using drug-eluting stents, paclitaxel-coated balloons, and sirolimus-coated balloons in managing complications after PCI in atherosclerosis patients

Introduction: Coronary artery disease (CAD) is one of the leading causes of death worldwide. One of the primary causes of CAD is atherosclerosis. One of the management strategies for atherosclerosis is Percutaneous Coronary Intervention (PCI) using drug-eluting stents (DES). This procedure involves the insertion of a catheter to place a stent that opens narrowed blood vessels due to plaque accumulation. However, this procedure may be repeated due to complications such as in-stent restenosis (ISR), which is the re-narrowing of the arterial lumen after stent placement, caused by intimal hyperplasia. Two endovascular interventions that can be options for treating ISR are re-implantation of a DES or the use of drug-coated balloons (DCB). DCB presents an alternative to re-stenting. There are two DCB treatment options: Paclitaxel Coated Balloon (PCB) and Sirolimus Coated Balloon (SCB), whose effectiveness will be compared. Methods: This literature review is written as a result of various interrelated literature studies, supported by analytical discussions. Literature search sources used six databases namely PubMed, Web of Science, Scopus, CINAHL, Proquest, and Cochrane with published years 2014-2024. The types of studies included are full text articles, systematic review, meta-analysis, randomized controlled trials, and case-control study. Summary: Both DCBs showed nearly identical angiographic courses with very low lumen narrowing in this high-risk group in the treatment of DES restenosis after 6 months. This is the first indication that SCB is as effective as the best-in-class PCB.

The impact of drug eluting stents on the co-release of interleukin-6 in patients with stable angina

Background: Drug-eluting stents represent an important revolution in the treatment of coronary artery disease. However, the mechanical trauma of stent deployment can trigger vascular injury and inflammatory cytokine cascades, potentially precipitating in-stent restenosis. The release of cytokines is not firmly established in patients with stable angina. Aims: To evaluate the acute effect of drug-eluting stents on the acute inflammatory response in patients with stable angina by quantifying interleukin-6 levels. Methods and materials: A single-centre exploratory study was conducted on 13 patients with stable angina undergoing elective angioplasty. Arterial blood samples were collected before angioplasty and directly after angioplasty. Additionally, venous blood samples were collected 24 hours post-angioplasty. Concentrations of interleukin-6 were analysed to assess changes in the acute inflammatory response. Results: IL-6 concentration significantly increased immediately after stent placement (5.95 ± 0.49 pg/ml, p = &lt;0.05) and 24 hours post-stent placement (8.96 ± 1.16 pg/ml, p= &lt;0.01). Gender-based analysis indicated significant increases in IL-6 levels in males post-stent placement (5.94 ± 0.08 pg/ml, p= &lt; 0.05) and 24 hours post-stent placement (7.27 ± 0.56 pg/ml, p= &lt; 0.01). Statin medication significantly reduced IL-6 expression in patients at baseline (3.27 ± 0.71 pg/ml versus 5.44 ± 0.18 pg/ml, p= &lt; 0.05), but this distinction diminished rapidly after stent insertion, resulting in comparable IL-6 levels at 24 hours post-stent insertion in both groups. Conclusion: Interleukin-6 levels markedly increased immediately after coronary stenting, suggesting its role as an early initiator of the inflammatory response to coronary stenting. While limited by sample size, it lays the groundwork for larger, more comprehensive research to optimize drug-eluting stents outcomes and inflammatory management.

Impact of Bifurcation Lesions on Outcomes After FFR-Guided PCI or CABG.

In the era of first-generation drug-eluting stents and angiography-guided percutaneous coronary intervention (PCI), the presence of a bifurcation lesion was associated with adverse outcomes after PCI. In contrast, the presence of a bifurcation lesion had no impact on outcomes following coronary artery bypass grafting (CABG). Therefore, the presence of a coronary bifurcation lesion requires special attention when choosing between CABG and PCI. The aim of this study is to assess whether the presence of a bifurcation lesion still influences clinical outcomes after contemporary PCI using second-generation drug-eluting stent and fractional flow reserve (FFR) guidance versus CABG. The randomized FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) compared FFR-guided PCI using current drug-eluting stents with CABG in patients with 3-vessel coronary artery disease. The prespecified key end point at 3-year follow-up was the composite of death, myocardial infarction, or stroke. In this substudy, the impact of bifurcation lesions on outcomes after FFR-guided PCI and CABG was investigated. The FAME 3 trial enrolled 1500 patients and 653 (45.2%) patients had at least 1 true bifurcation lesion. There was no difference in the composite of death, myocardial infarction, or stroke at the 3-year follow-up between patients with or without at least 1 true bifurcation lesion (11.6% versus 10.0%; hazard ratio, 1.17 [95% CI, 0.86-1.61]; P=0.32), regardless of revascularization strategy. The composite end point was not statistically different between FFR-guided PCI and CABG in patients with at least 1 true bifurcation lesion (hazard ratio, 1.27 [95% CI, 0.80-2.00]) or without a true bifurcation lesion (hazard ratio, 1.36 [95% CI, 0.87-2.12]), with no significant interaction (Pinteraction=0.81). In patients with 3-vessel coronary artery disease, the presence of a true bifurcation lesion was not associated with a different treatment effect after FFR-guided PCI with contemporary drug-eluting stent versus CABG.

Platelets, Biomarkers of Coagulation and Fibrinolysis, and Early Coronary Stent Thrombosis.

Background/Objectives: Acute stent thrombosis (ST) is a rare yet severe complication following percutaneous coronary intervention (PCI). Herein, we investigated the possible association between routinely available coagulation and fibrinolysis markers with early ST. Methods: Within a single-center registry, we investigated the association between the preprocedural platelet count, plasma levels of fibrinogen and D-Dimer, and the incidence of early ST in the first 30 days after PCI. Results: Out of 10,714 consecutive patients who underwent PCI using drug-eluting stents (DESs), the preprocedural platelet count, fibrinogen, and D-Dimer measurements were available in 6337, 6155, and 956 patients, respectively. Fifty-eight patients (0.92%) experienced an early ST within 30 days after PCI. Compared with those without ST, patients with early ST showed significantly elevated preprocedural platelet counts (p < 0.05) and fibrinogen levels (p < 0.05). D-Dimer levels were not associated with early ST. Patients in the fifth quintile of platelet count had a significantly increased risk for early ST (HR 2.43; 95% CI 1.43-4.14; p = 0.001) compared with patients in the lower four quintiles. In addition, patients in the fifth quintile of fibrinogen also had a significantly increased risk for early ST (HR 1.86; 95% CI 1.07-3.26; p < 0.05) compared with patients in the lower four quintiles. These associations were independent of clinical risk factors, the number of stents, the presence of acute coronary syndromes, and white blood cell count. Conclusions: Preprocedural platelet counts and fibrinogen plasma levels can identify patients at elevated risk of early ST after implantation of DESs in addition to procedure-level and device-related risk factors.