Stent Implantation Research Articles

The effect of single pigtail bile duct stents without lateral wings bile duct drainage after removal of common bile duct stones in endoscopic retrograde cholangiopancreatography

Objective: To analyze the effect of single pigtail bile duct stents without lateral wings bile duct drainage after removal of common bile duct stones in endoscopic retrograde cholangiopancreatography (ERCP). Methods: Patients who underwent ERCP and implantation of a single pigtail bile duct stent for choledocholithiasis in Cholelithic Center of East Hospital Affiliated to Tongji University from January 2019 to September 2023 were retrospectively selected and divided into lateral wingless group (without the lateral wing) and lateral wing group(with the lateral wing) according to whether the lateral wings of the single pigtail bile plastic stents were preserved. The patients were followed up for 1 to 3 months. The stent detachment rate at 2 days, 1 week and 1 month, as well as the incidence of postoperative complications at 1 week and 1 month after ERCP were compared between the two groups. Results: A total of 402 patients were included, including 177 males and 225 females, aged 32-83 (58±12) years. There were 215 cases in the lateral wingless group and 187 cases in the lateral wing group. The stent detachment rate in the lateral wingless group was higher than that in the lateral wing group at 2 days after ERCP [12.6% (27/215) vs 5.9% (11/187), P=0.022]. The stent detachment rate in the lateral wingless was higher than that in the lateral wing group at 1 week after ERCP [87.0% (187/215) vs 25.1% (47/187), P<0.001]. The stent detachment rate in the lateral wing group was higher than that in the lateral wing group at 1 month after ERCP [97.2% (206/215) vs 67.3% (126/187), P<0.001]. The incidence of postoperative complications at 1 week after ERCP revealed no statistical significance between the two groups[(10.7% (23/215) vs 8.6% (16/187), P>0.05]. The incidence of postoperative complications at 1 month after ERCP in the lateral wingless group was lower than that in the lateral wing group [0.9% (2/215) vs 9.6% (18/187), P=0.001]. Conclusion: After the removal of choledocholithiasis with ERCP, bile is drained by a single pigtail bile duct stent with lateral removal, which has a high rate of natural shedding and a low incidence of complications.

Past and Recent Progress on Metallic Digestive Tract Stents.

The implantation of digestive tract stents at various lesion sites can effectively improve digestive tract patency, opening up an excellent treatment method for diseases that are currently incurable or resistant to conventional surgery. Digestive tract stents have been extensively studied and widely used worldwide due to their unique advantages of simple implantation, low trauma, satisfactory effect, and low complication rate. Among the various types of stents, metallic stents have been developed to improve surgical efficacy due to their excellent mechanical properties and are constantly being improved. This review provides an overview of the design and development of conventional nonbiodegradable metallic digestive tract stents such as nitinol (NiTi alloy), stainless steel, and cobalt-based alloy stents. Furthermore, biodegradable metallic stents for the digestive tract, such as magnesium-based, iron-based, and zinc-based stents, are described. This paper also evaluates the advantages and disadvantages of existing metallic digestive stents as well as future research directions and challenges in the development of metallic digestive tract stents.

Efficacy of XEN gel stent implantation combined with mitomycin C injection in the treatment of open-angle glaucoma: a meta-analysis.

To assess the efficacy of XEN gel stent implantation combined with mitomycin C (MMC) injection in controlling intraocular pressure (IOP) and the dosage of postoperative medication for open-angle glaucoma (OAG) patients. The PubMed, Embase, Cochrane Library, and Science Direct databases were searched from inception to August 2022 without any language restriction. All studies that compared IOP and the dose of medication before and after XEN gel stent implantation and MMC injection for OAG patients were included. Data extraction and methodological quality evaluation were performed. A total of 26 studies (2329 eyes) were involved in meta-analysis. It was revealed that IOP at 1month after XEN implantation was significantly lower than preoperative IOP [group 1, IOP between 19.2 and 21.2mmHg: mean difference (MD) = 7.60, 95% confidence interval (CI) [6.55, 8.66], I2 = 0%, P < 0.01; group 2, IOP between 21.6 and 22.8mmHg: MD = 5.83, 95% CI [4.94, 6.71], I2 = 0%; group 3, IOP between 23.5 and 24.3mmHg: MD = 9.22, 95% CI [8.33, 10.10], I2 = 0%; group 4, IOP between 24.4 and 26.2mmHg: MD = 11.64, 95% CI [10.49, 12.80], I2 = 0%)]. Moreover, IOP at 3months after XEN implantation was also significantly lower than preoperative IOP (MD = 8.31, 95% CI [2.54, 8.46], Z = 13.92, P < 0.00001). IOP at 6months after XEN implantation was significantly lower than preoperative IOP, and no heterogeneity was found between two groups (group 1, IOP between 17.8 and 21.8mmHg: MD = 5.71, 95% CI: [5.05, 6.36], I2 = 0%, P < 0.01); group 2, IOP between 22.1 and 23.9mmHg: MD = 7.92, 95% CI [7.15, 8.70], I2 = 0%, P < 0.01). Low heterogeneity was noted in one group (group 3, IOP between 24.3 and 26.2mmHg: MD = 9.32, 95% CI [8.66, 9.97], I2 = 30%). It was found that IOP at 12months after XEN implantation was significantly lower than preoperative IOP (MD = 8.11, 95% CI [7.09, 9.12], Z = 15.68, P < 0.00001). There was high heterogeneity among the different baseline IOP groups at 24-month post-surgery (CHi2 = 41.74, df = 1, I2 = 97.6%, P < 0.01), while no heterogeneity was identified in two groups (group 1, IOP between 19.2 and 22.1mmHg: MD = 6.30, 95% CI [5.76, 6.85], I2 = 0%, P < 0.01); group 2, IOP between 22.8 and 23.8mmHg: MD = 9.11, 95% CI [8.45, 9.77], I2 = 0%). Subgroup analysis indicated that the dosage of medication was significantly reduced at 6months after XEN implantation (group 1, the amount of medication was 2.3-2.96: MD = 1.90, 95% CI [1.78, 2.02], I2 = 0%, P < 0.01); group 2, the amount of medication was 3.2-3.3: MD = 2.59, 95% CI [2.43, 2.75], I2 = 0%). Furthermore, the dosage of medication at 12months (MD = 1.96, 95% CI [1.72, 2.21], Z = 15.80, P < 0.01) and 24months (group 1, the amount of medication was 1.89-2.7: MD = 6.30, 95% CI [5.76, 6.85], I2 = 0%, P < 0.01); group 2, the amount of medication was 2.72-3.07: MD = 9.11, 95% CI [8.45, 9.77], I2 = 0%) after XEN implantation was significantly lower compared with the preoperative level. XEN implantation combined with MMC injection significantly decreased IOP in OAG patients at 1, 6, 9, 12, and 24months after treatment. In addition, XEN implantation combined with MMC injection decreased the amount of medication used at 6, 12, and 24months after treatment in OAG patients.

Characteristics and outcomes of patients with stent implantation for coronary artery lesions caused by Kawasaki disease - insights from second-generation stent implantation.

Adult Kawasaki patients may require intervention for occlusive coronary artery disease. Some adverse effects of first-generation drug-eluting stent implantation with sirolimus have been reported in this population. A total of nine lesions in eight (seven males, one female) patients who underwent stent implantations in this population between 2000 and 2021 were reviewed. The age at stent implantation ranged from 31 to 47 years, with a median of 37 years. There were six lesions treated by primary percutaneous transluminal coronary interventions, and three by elective procedures. A coronary aneurysm was found in two lesions, and coronary artery calcification was found in all culprit lesions. The numbers of everolimus-eluting stents, sirolimus-eluting stents and bare metal stents were six, two, and one, respectively. As anti- thrombotic therapy, aspirin, clopidogrel, and prasugrel were given to four, three, and one, respectively. Warfarin was given to five patients. The follow-up ranged from 2 to 12 years, with a median of 4 years. Follow-up angiograms were performed for eight lesions, at 2 to 38 months, with a median of 11 months. The patency of the target vessel was confirmed in all eight vessels. Slight malapposition, and peri-stent contrast staining were found in two lesions each. Acute coronary syndrome due to coronary artery lesions caused by Kawasaki disease occurred, even in lesions without any apparent coronary artery aneurysms. In our study, we show safe and efficacious placement of second-generation stent without adverse effects during the short-term follow-up, but long-term follow-up is needed to determine the efficacy and complication.

Peripheral arterial disease: a single center experience

Aims: Angiography and interventional treatment modalities in peripheral arterial disease have recently been widely used because they are easier to perform and more comfortable than surgical treatment. Revascularization is the most effective treatment method in cases such as critical leg ischemia in this disease where pharmacological agents are also widely used. In this study, we aimed to investigate interventional treatment methods in peripheral arterial disease in our center. Methods: Patients who underwent peripheral angiography or endovascular intervention in the Cardiology Clinic of Kırıkkale University Medical Faculty Hospital between March 2020 and June 2024 were retrospectively reviewed. Results: A total of 55 patients, including 10 women and 45 men, were included in the study. The mean age of the patients included in the study was 64 years. Of the angiographic procedures, 46 were performed in the lower extremity, 6 in the upper extremity and 3 in the renal arteries. Endovascular treatment were performed in 26 of them. Of the endovascular treatment, 11 were balloon angioplasty and 15 were stent implantation. In 5 patients, peripheral bypass was decided. Conclusion: Interventional treatment of peripheral arterial disease is increasingly and successfully performed in our center.

Assessment of Cutting-Balloon Angioplasty with Novel Bioabsorbable Polymer-Coated Everolimus-Eluting Stent in Treating Calcified Coronary Lesions Guided by Intravascular Ultrasound (CUPID Trial): study design and protocol

BackgroundVarious devices and techniques have been used for plaque modification in the treatment of severe coronary artery calcification. This prospective, multicenter, randomized, open-label study aims to evaluate the safety and efficacy of cutting balloon angioplasty using a novel bioabsorbable polymer-coated everolimus-eluting coronary stent for treating various degrees of calcified coronary lesions.MethodsWe outline the trial design aimed at assessing whether the cutting balloon (Wolverine™) is non-inferior to the non-compliant balloon in treating patients with calcified lesions, encompassing both de novo and in-stent restenosis (ISR) lesions. We aim to enroll 250 patients who have undergone bioabsorbable polymer-coated everolimus-eluting coronary stent (Synergy™) implantation. The primary endpoint is the minimal stent cross-sectional area at the calcium site as determined by intravascular ultrasonography. The secondary endpoints include major adverse cardiac events and target lesion revascularization at 12 months, alongside procedural convenience and operator-centric parameters, such as the number of balloons used, procedure time, and total contrast medium volume used.DiscussionIn this study, we will evaluate the efficacy and safety of Wolverine™ and non-compliant balloon in patients with calcified coronary lesions and provide a rationale for which type of balloons will optimally modify calcium lesions. In addition, we will attempt to expand the indications of the cutting balloon for treating mild-to-severe calcified coronary lesions. As the scope of insurance coverage for cutting balloons remains limited in some countries, this study may provide evidence for extending insurance coverage to the treatment of de novo calcified and ISR lesions.Trial registrationClinicalTrials.gov NCT06177808. Registered on January 1, 2024.

Association between stent implantation results and target vessel failure after IVUS-Guided PCI: A FLAVOUR substudy

Abstract Background Despite substantial advancements in coronary stent systems and implantation techniques, target vessel failure (TVF) remains a clinical issue to be addressed. Purpose We used deep learning algorithms for automatic stent analysis of intravascular ultrasound (IVUS) data to identify stent implantation characteristics associated with TVF. Methods In patients from the IVUS-guided group of the FLAVOUR trial who had undergone successful stenting, validated deep learning algorithms were applied to IVUS images to delineate plaque and stent strut for the quantification of stent expansion, apposition, and residual plaque burden. Stent overexpansion was defined as stent area exceeding 120% of the hypothetical healthy lumen area. Murray law-based quantitative flow ratio (μQFR) was also assessed from angiographic images. The primary endpoint was TVF at 2 years, defined as a composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. Results A total of 459 vessels in 441 patients were included, with TVF events occurred in 15 vessels (3.3%) during the 2-year follow-up. Stent analysis was performed in 687,379 stent struts from 70,369 IVUS image frames of the interrogated vessels with the assistance of specific deep learning algorithms. On vessel-level multivariate analysis adjusting for procedural covariates, stent overexpansion length &amp;gt;5 mm (hazard ratio, 4.57; 95% confidence interval [CI], 1.31 to 15.92; P=0.017), residual plaque burden at proximal stent edge &amp;gt;50% (hazard ratio, 3.34; 95% CI, 1.19 to 9.33; P=0.022), and post-PCI μQFR &amp;lt;0.90 (hazard ratio, 5.09; 95% CI, 1.62 to 15.97; P=0.005) were more likely to be present in vessels with TVF events than in those without. Conclusions Besides the established indexes of post-procedural residual plaque burden and low μQFR, deep learning-powered IVUS stent overexpansion was significantly associated with increased risk of TVF.Suboptimal stenting results and TVF

The evolution of endothelial dysfunction according to the length of the implanted stent on the background of nebivolol therapy

Abstract Introduction The development of atherosclerosis is the driving cause for arterial interventions using coronary stents. Long-stent implantation can increase the vascular injury thereby contributing to the progression of endothelial dysfunction (ED) by the degradation and reduction bioavailability of the nitric oxide (NO) - thus increasing the risk of major cardiovascular events. Purpose Evaluation the evolution of endothelial dysfunction biomarker depending on the length of the stent implanted on the background of nebivolol therapy. Methods The study included 100 patients with stable angina pectoris II–III functional class (age 59.72±0.59 years) undergoing PCI with stent implantation who started the treatment with nebivolol 5mg per day tangent to the conventional treatment and were exposed to PCI with stent implantation, depending on the stent’s length they were divided in three groups: I group - 14 patients with implanted stent’s length ≤15 mm, II group - 57 subjects with implanted stent’s length =15-30 mm and the III group -29 cases where the implanted stent’s length was ≥30 mm. In all the groups was appreciated in blood the endothelial dysfunction’s marker - NO. This marker was assessed preprocedural, postprocedural (after 24 hours) and at intervals of one month, 3,6,12 months after coronary angioplasty, the NO level being compared between these groups and the reference pattern consisting of 20 healthy people. Results The circulating level of nitric oxide determined in I group -61,28±6,92 μM/L and in the II group -56.6±3.03 μM/L and the III group52.39±3.35 was compromised at the preprocedural stage versus the reference pattern - 78.67±2.72 μM/L. During the post- PCI period (first 24 hours), the biomarker level’s was reduced in I group -52.35±1.66 μM/ L, II group -53.74±2.77 μM/L and III group - 52.98±2.91 μM/L. After one month after the intervention on the backroung of the treatment with nebivolol, was recorded a gaing of the NO value in I group - 64.97±5.35 μM/L, II group -63.15±3.99 μM /L and the III group-59.38±4.46 μM/L. The NO serum concentration during the period 3 and 6 months continued to increase in all groups vs the reference pattern. At the 12-month period, the NO level remained high in all the studied groups versus the baseline: I group 99.2±1.1 μM / L (p&amp;gt;0.05), II group-97.96±2.2 μM/L (p&amp;lt;0.001) and the III group -97.65±1.9 μM/L (p&amp;lt;0.001). Conclusion The stent’s length = 15-30 mm and ≥30 mm reveals the presence of an expanded atherosclerotic process, the substrate of which is constituted by the endothelial dysfunction, this being confirmed by the low preprocedural level of NO. The stent implantation procedure induced the accentuation of endothelial dysfunction, and the 12-month nebivolol treatment favored the increase of NO serum concentraon in all groups by 24.9% vs the reference pattern and by 73.3% vs baseline.

A study of intracoronary thrombolytic agents in high thrombotic burden lesions during primary PCI

Abstract Objectives High thrombus burden during Primary PCI begets worst possible outcomes, studies on adjunctive intracoronary thrombolytic agents show heterogeneous1,2 results &amp; have limited long term follow-up. Although early studies support mechanical thrombectomy devices, larger randomized trial show that they are not able to reduce the MACE3, 4. There is no randomised clinical data for sustained mechanical thrombectomy devices till now. Purpose of the study The main purpose of this study is to analyse long term outcomes of low bleeding risk group patients undergoing Primary PCI with high thrombus burden, receiving intracoronary thrombolytic agents as an adjunctive therapy. Methods In this prospective observational single centre study, we analysed one year follow-up data of 108 consecutive primary PCI patients with high thrombus burden (G4, G5) and low bleeding risk, who were stratified into two groups basing on whether they receive intracoronary thrombolytic agent as an adjunctive agent before stent implantation. The primary outcome was NACE (Net Adverse Clinical Events, which include MACE, Death, ST/MI, major bleeding events), secondary outcomes include the individual components of the primary outcomes when analysed separately. Results The primary outcome events occurred in 21 patients (26%) in Primary stent group(PS, n=80), whereas it occurred in 2 patients(6%) in primary intra coronary thrombolysis group(PIT, n=28). Log-Rank (Mantel Cox) NACE curves show that PS group has high events when compared to PIT group(26% Vs 7%, p value – 0.042, Hazard ratio - 2.56; 95% CI - 0.76 – 8.57), there is no statistically significant difference in all other key secondary outcome event curves. Conclusion In patients presenting with STEMI, undergoing primary PCI, with high thrombus burden &amp; low bleeding risk group, those receiving intracoronary thrombolytic agent as the adjunctive therapy before stent implantation, are able to reduce the NACE event rates during the one year of follow-up.Fig1:Log Rank (Mantel Cox) NACE curve

Design and implementation of digital home blood pressure monitoring based on Bluetooth and WeChat App in the FAIR-Pilot study

Abstract Background Home blood pressure monitoring (HBPM) could be an alternative way to office blood pressure and ambulatory blood pressure monitoring for hypertensive patient management. However, the measurement protocol of HBPM still requires standardization, which may be improved by digital technology. Purpose To investigate the use of digital HBPM management in hypertensive patients and its application in clinical practice. Methods Fractional Flow Reserve to Determine the Appropriateness of Percutaneous Renal Artery Intervention in Atherosclerosis Renal Hypertension Patients (FAIR)-pilot study is a multicenter pilot randomized controlled trial exploring the application of fractional flow reserve (FFR) to guide the renal artery stenting in patients with renovascular hypertension. After randomization and FFR measurement, participants were divided into stenting with FFR≥ 0.8 (Stent group), no stent implantation with FFR≥ 0.8 (No stent group), and stenting with FFR＜ 0.8 (Controlled group). Participants of the FAIR-pilot study enrolled from February 1st, 2023 to February 25th, 2024 were included. A validated Bluetooth blood pressure monitor was given to every participant at the time of enrollment. Participants were taught to undertake standardized HBP and were advised to take morning and night HBPs every day. HBPM data were automatically uploaded to a WeChat App developed by FAIR investigators and could be reviewed by both participants and investigators. Twice-daily blood pressure reports were automatically generated and sent to investigators for participant compliance monitoring and reminding (Figure 1). HBPM data and blood pressure variability were analyzed. Results A total of 93 participants with 58 males (62.4%) and a mean age of 59.97 ± 16.18 years, including 26,802 HBP readings were analyzed. The average numbers of daily HBP measurement were similar between three groups and were all less than twice a day. Systolic HBP decreased from 143.11 ± 14.91 to 133.01 ± 13.01mmHg after the procedure in the Controlled group, which was more than the other two groups (140.51 ± 13.38 to 138.53 ± 17.30 mmHg and 136.20 ± 15.67 to 130.84 ± 11.04 mmHg). During the follow-up after the procedure, the HBP variability (BPV) of overall participants was 13.78 ± 4.87 and 5.46 ± 3.14 for systolic and diastolic BP, respectively. The systolic BPV of No stent group was higher than the other two groups (No stent vs. Stent vs. Controlled: 33.00 ± 9.49 vs. 8.34 ± 2.86 vs. 9.12 ± 2.71, P=0.125), however without statistical significance. Similar was found for morning and night systolic BPVs. (Table 1). Conclusion Digital HBPM management via novel information technology is feasible in the hypertension field and could be a helpful tool in clinical practice.

The risk factors for in-stent restenosis following drug-eluting stent implantation in end-stage renal disease patients receiving renal replacement therapy

Abstract Background Chronic renal disease is a recognized risk factor for in-stent restenosis (ISR) following percutaneous coronary intervention (PCI) with a drug-eluting stent (DES). However, the specific risk of ISR among individuals with end-stage renal disease (ESRD) remains unclear or insufficiently studied. Purpose It is imperative to identify the risk factors associated with ISR among patients with ESRD and coronary artery disease following the implantation of DES. This identification is crucial for generating evidence-based strategies aimed at preventing ISR. Methods ESRD patients undergoing renal replacement therapy with concomitant coronary artery disease who underwent PCI with their initial DES implantation at our hospital between January 2013 and December 2022 were included in the study cohort. Clinical data, laboratory test results, and PCI specifics were compared between patients with and without ISR. Univariate and multivariate analyses utilizing Cox proportional hazard regression were employed to identify independent risk factors for DES-ISR. Results Among the 321 patients with ESRD who underwent PCI with DES implantation, totaling 874.5 patient-years of follow-up, 53 cases of ISR occurred during this period, yielding an incidence rate of 6.1 per 100 patient-years. Several baseline characteristics, angiographic findings, and procedural details were found to elevate the risk of ISR significantly. These included underlying diabetes mellitus, peripheral artery disease (PAD), high serum parathyroid hormone levels, LDL-C levels, acute coronary syndrome as the clinical presentation, the presence of triple vessel disease, duration of dual antiplatelet therapy less than 1 year, target lesion involving the left main (LM) or left anterior descending (LAD) artery, target vessel size less than 3 mm, ostial lesion, bifurcation lesion, number of stents implanted equal to or more than 3, and stent size less than 3 mm. In the multivariate Cox proportional hazard model, bifurcation lesion (HR 14.70, 95% CI 4.66-46.38), PCI of LM or LAD (HR 5.29, 95% CI 1.14-24.60), target vessel size less than 3 mm (HR 4.10, 95% CI 1.77-9.50), PAD (HR 3.92, 95% CI 1.52-10.08), and ostial lesion (HR 2.92, 95% CI 1.16-7.38) were identified as independent risk factors for ISR (all p-values &amp;lt; 0.05). Conclusions Among ESRD patients with coronary artery disease, bifurcation lesion, PCI involving the LM or LAD, target vessel size less than 3 mm, PAD, and ostial lesion are identified as independent risk factors for ISR. These findings hold significance in enhancing risk stratification and decision-making concerning treatment planning for this population.Univariate analysis risk factors for ISR

The usefulness of IVUS and OCT in patients treated with rotational atherectomy

Abstract Background Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have been shown to improve clinical outcomes of percutaneous coronary interventions (PCIs) in selected subsets of patients. Purpose To investigate whether the use of OCT or IVUS during PCI with rotational atherectomy (RA-PCI) will increase odds for successful revascularization defined as thrombolysis in myocardial infarction (TIMI) 3 flow. Methods Data were obtained from the national registry of PCIs (ORPKI) maintained by the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The dataset includes PCIs spanning from January 2014 to December 2021 Results A total of 6,522 RA-PCIs were analyzed, out of which 708 (10.9%) were guided by IVUS and 86 (1.3%) by OCT. The postprocedural TIMI 3 flow was achieved significantly more often in RA-PCIs guided by intravascular imaging (98.7% vs 96.6%, p&amp;lt;0.0001). Multivariable analysis revealed that using of IVUS and OCT was independently associated with an increased chance of achieving postprocedural TIMI 3 flow by 67% (odds ratio (OR), 1.67; 95% confidence interval (CI): 1.40–1.99; p&amp;lt;0.0001) and 66% (OR, 1.66; 95% CI: 1.09–2.54; p=0.02), respectively. Other factors associated with successful revascularization were as follows: previous PCI (OR, 1.72; p&amp;lt;0.0001) and coronary artery bypass grafting (OR, 1.09; p=0.002), hypertension (OR, 1.14; p&amp;lt;0.0001), fractional flow reserve assessment during angiogram (OR, 1.47; p&amp;lt;0.0001), bifurcation PCI (OR, 3.06; p&amp;lt;0.0001), and stent implantation (OR, 19.6, p&amp;lt;0.0001). Conclusions PCIs with rotational atherectomy guided by intravascular imaging modalities (IVUS or OCT) are associated with a higher procedural success rate compared to angio-guided procedures.

Long-term clinical and imaging outcomes of patients undergoing percutaneous femoral intervention following TAVI-related vascular access complications

Abstract Introdcution: Vascular access complications (VAC) are the most common in-hospital adverse event following transcatheter aortic valve implantation (TAVI). Often, ileo-femoral VAC requires bail-out percutaneous interventions with either prolonged balloon inflation and/or stent implantation. The long-term outcomes of these procedures have not been characterized. We aim to assess the clinical and imaging outcomes of patients who underwent bailout percutaneous vascular interventions due to VAC following TAVI. Methods Single-centre prospective study including all consecutive patients with a VAC following trans-femoral TAVI, between 2015-July 2023. VAC was defined as uncontrolled bleeding, acute occlusion or flow limiting stenosis of the femoral vessel leading to percutaneous treatment. Clinical and imaging follow-up was performed with bilateral arterial ultrasound (US) Doppler to assess patency and peak systolic velocity of common femoral arteries. Results A total of 1518 patients underwent TF-TAVI, of which 107 (7%) underwent concomitant ileo-femoral percutaneous angioplasty (PTA) intervention in the same day as TAVI. In patients submitted to PTA, 7 were treated to gain access for TAVI, and 100 (7%) were performed to treat vascular access complications. At a mean follow-up time of 23±3 months, 37 patients died (37%), 6 (16%) from in-hospital complications and 31 (84%) from non-vascular causes after discharge. From the surviving 63 patients (study group) – mean age 83±6 years-old, 29% male, 46% with previous peripheral arterial disease –, 24 underwent bilateral US. Unable to perform imaging on 39 patients due to geographical or mobility issues. At a mean follow-up time of 30±23 months, only 6 patients (10%) reported intermittent claudication, of which 4 (67%) had pre-TAVI symptoms. No patient had at rest symptoms or amputation history. All but one had patent vessel on US. The mean peak systolic velocity of the treated vessel and the contralateral vessel were 71.1±22.9cm/s and 73.1±23.8cm/s, respectively, with no statistically significant difference between them in each patient (mean difference 1.9±25.4, p=0.709). We found no statistically significant differences between peak systolic velocities between both vessels in each patient, accordingly with the treated vessel (Table 2). Conclusion This prospective study shows that patients submitted to percutaneous bailout iliofemoral interventions have a very low rate of lower limb adverse events with very good patency rates at mean follow up of 2.5 years.

One-year clinical outcome of aspirin-free prasugrel monotherapy following stent implantation in patients with chronic coronary syndrome: insight from ASET-JAPAN study

Abstract Background Single antiplatelet therapy with a potent P2Y12 inhibitor without aspirin after coronary stent implantation may provide an adequate balance between ischemic and bleeding risks in selected patients. The 3-month follow-up of the Acetyl-Salicylic Elimination Trial (ASET)-Japan pilot study demonstrated the feasibility and safety of Prasugrel monotherapy without aspirin after successful percutaneous coronary intervention (PCI) in selected patients with chronic coronary syndrome (CCS). Purpose The current study aimed to evaluate the 1-year clinical outcome in the ASET-Japan. Methods The ASET-Japan pilot study was designed to demonstrate the feasibility and safety of the approved dose of prasugrel monotherapy in Japan without aspirin after optimal PCI with a platinum-chromium everolimus-eluting stent in CCS population. After successful procedure, all patients were treated with a locally approved maintenance dose of 3.75 mg/day of Prasugrel monotherapy up to 3-month. After 3-month, the choice of antiplatelet therapy was left to the discretion of the investigators. Patients were followed up to 1 year. The target lesion-related endpoint was a composite of cardiac death, spontaneous target-vessel myocardial infarction (MI) &amp;gt;48 h after the index PCI or clinical-driven target lesion revascularisation. Patient-Oriented Composite Endpoint (POCE) was defined as a composite of all cause mortality, any stroke, any MI and any revascularisation. Spontaneous MI was defined according to Forth universal definition. The event rate was estimated by the Kaplan-Meier method. The event was adjudicated by an independent clinical event committee. Results A total of 208 patients were enrolled in the study. The average anatomical SYNTAX score was 7.96 (±4.6). After procedure, prasugrel monotherapy was immediately initiated. After 3-month, Prasugrel monotherapy was continued in 88.6% up to 1-year. Aspirin monotherapy was prescribed to 10 patients (5.0%), while 6 patients (3.0%) were on DAPT at 1-year. All-cause mortality rate was 1.49%, with no occurrence of cardiovascular death. Revascularisation occurred in 4.0% (n=8) with no occurrence of TLR, while one patient (0.5%) underwent a clinical driven target vessel revascularisation. In summary, 7 out of 8 revascularisations were non-target vessel revascularisation (6 clinically-driven non-TVR). Spontaneous non TV-MI occured in 0.5% (n=1) of patients. There was no definite/probable stent thrombosis up to 1 year. The target lesion related endpoint rate at 1-year was 0%, whereas 1-year POCE rate was 7.0% (n=14). Conclusion Discontinuation of Aspirin and Prasugrel monotherapy at a low maintenance dose of 3.75 mg/day following an angiographically successful stent deployment was feasible and safe in selected patients with CCS and low SYNTAX score. This safety profile is confirmed at 1 year while the investigators, in their large majority and at their own discretion, had maintained the prasugrel treatment.

Human coronary blood single-cell sequencing combined with exosome proteomic profiling reveals the molecular mechanism of recurrent in-stent restenosis (R-ISR)

Abstract Background Percutaneous coronary intervention (PCI) is recognized as the core treatment for symptomatic myocardial ischemia and acute coronary syndrome (ACS). However, the complex pathogenesis of recurrent in-stent restenosis (R-ISR) after stent implantation is still insufficiently understood. Purpose This study reports the first single-cell RNA sequencing and proteomic profiling to characterize pathogenesis of R-ISR in humans. Methods To reveal the pathophysiology and molecular mechanism of R-ISR, we performed single-cell RNA sequencing to identify RISR-induced changes in transcriptional landscape in coronary blood mononuclear cell composition. Besides, proteomic profiling of human coronary plasma-derived exosomes was used to further screen different proteins. Transmission electron microscopy (TEM), nanoparticle tracking analysis (NTA) and western blot analysis were performed to identify exosomes. In vitro cell biology experiments were used to validate the discoveries of bioinformatics analysis. Results Compared with normal subjects, the percentage of FCGR3B high monocytes, memory T cells and plasmacytoid dendritic cells (DCs) was increased in R-ISR. Furthermore, we observed a marked increase in the expression of JUN, FOS, CXCL8, S100A8 enriched in the IL-17 signaling pathway that is known to play a crucial role in activating inflammation, mediating immune response, and even maintaining inflammation to chronicity. According to in vitro experiments, the co-cultured system demonstrated that FCGR3B high monocytes isolated from RISR patients activated the expression of inflammatory factors in endothelial cells (ECs), such as IL-1β, IL-6 and TNF-α. Inflammatory activated endothelial cells could release a large amount of exosomes, proteomic profiling of exosomes isolated from ECs observed a significant upregulation of MYLK expression, which could promote proliferation and migration of vascular smooth muscle cells (VSMCs) by activating VEGFR-2 signaling pathway. Conclusions Our study reveals a novel subset of FCGR3B high monocytes in R-ISR patients that could activate ECs inflammation via IL-17 signaling pathway. Activated ECs release exosomes rich in MYLK, which promote proliferation and migration of VSMCs, ultimately leading to repeated restenosis.

A meta-analysis of randomised controlled trials comparing optical coherence tomography-guided against angiography-guided revascularisation

Abstract Optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) offers more in-depth assessment of plaque morphology, vessel sizing and post-PCI stent deployment characteristics than angiography guidance alone. Previous studies have demonstrated superiority of OCT-guided compared to angiography-guided PCI in stent implantation and expansion, with no difference in safety outcomes. Despite this, adoption of OCT-guided PCI remains low in clinical practice due to its increased procedural time, larger contrast volume, and added cost. Two large multicentre international randomised controlled trials (RCTs) were recently published. We therefore aimed to perform an up-to-date meta-analysis of RCTs comparing OCT-guided revascularisation against angiography-guided revascularisation on hard clinical outcomes. A comprehensive search of PubMed/MEDLINE and Ovid/Embase was performed, of which only RCTs were included. Two authors identified relevant articles and extracted the data independently. Any disagreements were resolved by a third author. Clinical outcome data was extracted from each study and then pooled to determine the overall risk ratio (RR) and confidence interval (CI) collectively. This was calculated with random-effects model using the Mantel-Haenszel method. All reported P values are two-sided, with significance set at P&amp;lt;0.05. A total of ten RCTs involving a total of 5062 patients were included. After an average follow-up of 20 months, there was no significant difference in the trial-defined composite endpoint between OCT-guided versus angiography guided revascularisation [6.8% versus 7.9%, RR 0.85, 95% CI (0.69 to 1.03), P=0.10, heterogeneity (I2)=0%]. There was also no significant difference in cardiac death [1.0% versus 1.6%, RR 0.61, 95% CI (0.36 to 1.02), P=0.06, heterogeneity (I2)=0%, Figure 1a], myocardial infarction [3.2% versus 3.7%, RR 0.86, 95% CI (0.65 to 1.15), P=0.31, I2=0%, Figure 1b] and target lesion or vessel repeat revascularisation [3.8% versus 4.1%, RR 0.95, 95% CI (0.72 to 1.25), P=0.70, I2=0%, Figure 1c] between the two arms. However, the OCT-guided revascularisation arm was associated with a significantly lower rate of stent thrombosis [0.8% versus 1.5%, RR 0.57, 95% CI (0.33 to 0.97), P=0.04, I2=0%, Figure 1d] than the angiography-guided revascularisation arm. The number-needed-to-treat (NNT) by OCT-guided revascularisation to reduce one additional stent thrombosis event was 143. In conclusion, our findings show the use of OCT-guided revascularisation led to a significant reduction in stent thrombosis compared to angiography-guided revascularisation, but there was no difference in cardiac death, myocardial infarction and repeat revascularisation. The NNT for stent thrombosis was 143 patients. Further research is needed to identity those subgroups most likely to benefit from OCT-guided revascularisation before it can be more widely adopted to significantly impact on clinical care.

Thirty days clinical outcomes following stent implantation with aspirin-free prasugrel monotherapy in non-ST segment elevation myocardial infarction. Interim report from ASET-Japan pilot study

Abstract Background Dual antiplatelet therapy with a P2Y12 inhibitor, in addition to aspirin, is the standard therapy after percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) to prevent ischemic cardiovascular events. The Acetyl-Salicylic Elimination Trial (ASET) pilot studies conducted in Japan in patients with NSTE-ACS investigated the safety and feasibility of a low-dose prasugrel monotherapy after PCI. Purpose To ensure the safety of the patients, enrolment in the study was implemented only after confirmation of a successful procedure. The abstract reports our interim analysis, aimed at evaluating preliminary safety and feasibility. Methods The ASET-Japan pilot study was designed to explore the feasibility and safety of a low dose of prasugrel monotherapy (3.75mg/day), without adjunctive aspirin, after optimal PCI using Everolimus eluting stent (EES) in Japanese patients with non-ST-segment elevation acute coronary syndromes. The primary endpoint in the ASET-Japan NSTE-ACS (Phase 2) is a 12-month clinical outcome. The study is currently in the follow-up phase. All the target lesions were treated with a platinum-chromium everolimus-eluting stent. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 12-month. If more than 3 events occurred, trial enrollment would have to be terminated by the data and safety monitoring board. Results One hundred one patients were enrolled after successful index PCI and completed a 30 days follow-up. The mean age was 69.1±12.3 years and 75.2% was male. The mean anatomical SYNTAX score was 7.9±4.7. Unstable angina (UAP) and NSTEMI were seen in 24.8% (25/101) and 75.2% (75/101) patients, respectively. According to the Braunwald classification, 8 percent of the patients were categorised as Class IA UAP, 48% as Class IB, 20% as Class IIB, 4% as Class IIIA and 20% as Class IIIB. In NSTEMI patients, the median (IQR) pre-procedural troponin value (cardiac Troponin T or I) was 2.79 (1.12 – 22.27) times the Upper Limit of Normal. According to the PRECISE DAPT score, 36.6% of patients were categorised as High Bleeding Risk (HBR) with scores above 25. At one month, the primary ischemic endpoints of cardiac death, target-vessel spontaneous MI or definite Stent thrombosis did not occur. Two patients (2.0%) had BARC type 3a bleeding. Conclusion Prasugrel monotherapy in the first 30 days following platinum-chromium everolimus-eluting stent deployment is a feasible and safe strategy in NSTE-ACS patients with simple anatomy and successful PCI.

Combining fractional flow reserve and the index of microcirculatory resistance for prognosis prediction in renal artery stenosis interventions: a feasibility sub-study of FAIR-pilot trial

Abstract Background Interventional therapies for renal artery stenosis (RAS) was debatable in previous randomized trials. Fractional flow reserve (FFR), while useful in coronary interventions, does not assess microcirculatory status, which may be critical in RAS. The index of microcirculatory resistance (IMR) provides additional microvascular information, which has not been used in RAS patients. Purpose To investigate the feasibility of IMR measurement in RAS patients and the association with the outcome. Methods FAIR-pilot study is a multicenter pilot randomized controlled trial exploring the application of FFR to guide the renal artery stenting in patients with renovascular hypertension (NCT05732077). A pressure-temperature sensor guidewire was used to measure the IMR. To derive mean transit time at rest, thermodilution curves were obtained by 3 injections of 4 mL of room temperature saline down the renal artery. Hyperemia was induced using dopamine 50μg/kg bolus to the renal artery. The IMR was calculated as distal arterial pressure (Pd) x mean transit time during hyperemia (TmnH) (Figure 1). Prognostic evaluation was based on improvements in postoperative blood pressure, which was assessed using both ambulatory blood pressure monitor (ABPM) and anti-hypertensive medication number, along with renal function, as determined by the estimated glomerular filtration rate (eGFR). Results The IMR was measured among five patients enrolled in FAIR-pilot study. As shown in Table 1 and 2, stent implantation was conducted on five lesions across patients 1 to 4 based on renal FFR &amp;lt; 0.8, with each experiencing varying degrees of improved blood pressure control subsequently. Patient 5 did not receive a stent and was lost to follow-up. At three-month, the recorded decrease in systolic blood pressure ranged from a maximum of 34 mmHg to a minimum decrease of -6 mmHg among the four patients. The antihypertensive medication number showed a maximum reduction of 2 and no change as the minimum. We observed a correlation between baseline IMR and baseline renal function. No significant change in IMR was noted after interventional procedures. Preliminary findings suggest that IMR measurement is feasible in patients with RAS, while the ∆T (temperature change time) was very small, which potentially increasing the measurement bias. Conclusion The study suggests measuring IMR in patients with RAS is feasible and can offer information into the renal microvasculature. However, the small ∆T encountered during measurement may introduce increased bias, which should be considered when interpreting results.

Impact of procedural and patient-related risks on 1-year outcomes for patients with 1-month DAPT followed by P2Y12 inhibitor monotherapy after biodegradable-polymer drug-eluting stent implantation

Abstract Background While early de-escalation of dual antiplatelet therapy (DAPT) and P2Y12 inhibitor monotherapy following short DAPT are becoming standard treatments for patients after percutaneous coronary intervention (PCI), the impact of procedural and patient-related risks on clinical outcomes of PCI for patients receiving the above DAPT regimen has never been established. Purpose To evaluate the impact of procedural and patient-related risk factors on 1-year cardiovascular and bleeding outcomes in patients with 1-month DAPT followed by P2Y12 inhibitor monotherapy after biodegradable-polymer drug-eluting stent (BP-DES) implantation. Methods Using data from the multi-centre regional-wide REIWA registry, we assessed clinical outcomes according to each risk factor and compared between patients with and without either procedural or patient-related risk factors. The primary end point was net adverse clinical events (NACE), defined as a composite of cardiovascular outcomes (cardiovascular death, myocardial infarction, definite stent thrombosis, ischemic or hemorrhagic stroke) and bleeding outcomes (TIMI major or minor bleeding), which was same with that for STOPDAPT-2 trial. Procedural risk was defined as a factor of complex PCI which was previously published and included the follows: treatment of three vessels, three or more lesions, three or more stents, bifurcation with two stents, long stenting (total stent length &amp;gt;60 mm) and target of chronic total occlusion. Additionally, patient-related risk factors were defined as chronic kidney disease, anaemia, peripheral vascular disease, heart failure and advanced age (≧75 years). Results Among 1,202 patients treated BP-DES with 1-month DAPT, 276 patients (23.0%) had at least one procedural factors and 510 patients (42.4%) had one or more patient-related risks. Compared with each risk factor, patients with patient-related risk factor were more likely to have higher NACE rates, whereas low NACE rates were observed in patients with each procedural risk factor (Figure 1). In addition, during 1-year follow-up, patients with patient-related risk factors had a significantly higher incidence of NACE compared with patients without such risks (4.90 % vs. 1.73 %, p = 0.002) (Figure 2). However, no significant differences in NACE rates was observed between patients with and without procedural risk factors (2.54% vs. 3.24%, p = 0.555). Conclusion In patients undergoing BP-DES implantation and 1 month DAPT followed by P2Y12 inhibitor monotherapy, patient-related risk factors had an impact on 1-year clinical outcomes, while procedural risk factors no longer had small impact on those outcomes.

Demographic, clinical characteristics, managements strategies and in-hospital outcomes of patients enrolled in prospective nationwide SCAD registry

Abstract Spontaneous coronary artery dissection (SCAD) is an uncommon yet increasingly recognized cause of acute coronary syndrome (ACS), particularly in young to middle-aged women. This multicentric, prospective nation-wide registry aimed to elucidate the demographic characteristics, clinical presentation, management strategies, and outcomes of patients with SCAD. A total of 95 patients with SCAD were enrolled in 10 centers, with females constituting 81% of the cohort, and with an average age of 49.7±11.9 years. Among the traditional risk factors, prior hypertension was observed in 49%, followed by hyperlipidemia in 43%, diabetes mellitus in 9% and prior or current smoking in 47% of patients. The presentation of SCAD as ST-elevation myocardial infarction (STEMI) was predominant, occurring in 61% of cases, with the left anterior descending artery (LAD) being the most involved vessel (68%). Regarding the classification of SCAD, type 2 SCAD was the most frequent (53%), followed by type 1 (24%) and type 4 (16%). Notably, involvement of the distal segment of the culprit artery was observed in 68% of cases, while baseline TIMI 3 flow was noted in 52% of patients. Percutaneous coronary intervention (PCI) was performed in 52% of cases, with pre-interventional TIMI 0-2 flow (62% Vs. 28%; p&amp;lt;0.05) and proximal artery involvement (41% Vs. 13%; p&amp;lt;0.05) being more prevalent compared to conservatively managed patients. Final stent implantation was performed in 67% of PCI cases, with TIMI 3 flow restoration in 76% of patients undergoing PCI. The average left ventricular ejection fraction prior to discharge was 51±9.9%. In-hospital mortality was reported in three female patients, undergoing attempted PCI with left main and LAD involvement. The use of antiplatelet therapy was widespread, with aspirin administered to 98% and P2Y12 inhibitors to 75% of patients at discharge. Data from this prospective nationwide multicentric SCAD registry show that SCAD occurs predominantly in relatively young female patients, with moderately prevalent traditional cardiovascular risk factors, usually presents as STEMI, with good overall survival rates despite half of the patients managed conservatively. PCI was often attempted in SCAD lesion with compromised arterial flow and located proximally, with lower rates of stent implantation and procedure success compared to traditionally observed rates in primary PCI. This underscores the importance of heightened awareness and tailored management approaches for this unique subset of ACS patients in order to refine risk stratification, optimize treatment strategies, and improve outcomes in this population.