Drug-eluting Stents Research Articles

Evaluation of microcirculatory protection in percutaneous revascularisation: A stent implantation technique and device comparison.

Coronary microvascular dysfunction (CMD) after percutaneous coronary intervention (PCI) is prognostically important and may also be a cause of persistent angina. The stent balloon inflation technique or material properties may influence the degree of CMD post-PCI. Thirty-six patients with stable angina attending for elective PCI were randomized to either slow drug eluting stent (DES) implantation technique (DES slow group): +2 atm. every 5 s., maintained for a further 30 s or a standard stent implantation technique (DES std group): rapid inflation and deflation. PressureWire X with thermodilution at rest and hyperemia and optical coherence tomography (OCT) were performed pre- and post-PCI. Combined primary endpoints were changes in index of microvascular resistance (delta IMR) and coronary flow reserve (delta CFR) following PCI. The secondary endpoints included differences in cardiac troponinI (delta cTnI) at 6 hpost-PCI, Seattle angina questionnaire (SAQ) at 1, 3, 6, and 12 months and OCT measures of stent results immediately post-PCI and at 3 months. Both groups were well matched, with similar baseline characteristics and OCT-defined plaque characteristics. Delta IMR was significantly better in the DES slow PCI arm with a median difference of -4.14 (95%CI -10.49, -0.39, p = 0.04). Delta CFR was also numerically higher with a median difference of 0.47 (95% CI -0.52, 1.31, p = 0.46). This did not translate to improved delta median cTnI(1.5 (34.8) vs. 0 (27.5) ng/L, p = 0.75) or median SAQ scoreat 3 months, (85 (20) vs. 95 (17.5), p = 0.47). Slow stent implantation is associated with less CMD after elective PCI in patients with stable angina.

Paclitaxel-coated versus sirolimus-coated balloon angioplasty for coronary artery disease: A systematic review and meta-analysis.

Although use of sirolimus-based analogs has shown superiority over paclitaxel in drug-eluting stents, the relative efficacy of these two agents released from drug-coated balloons (DCB) is unclear. The present meta-analysis is aimed to compare outcomes after percutaneous coronary intervention (PCI) with paclitaxel-coated balloons (PCB) versus sirolimus-coated balloons (SCB) for either in-stent restenosis or native de novo lesions. The study outcomes were 1) target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization, and 2) follow-up angiographic parameters including late lumen loss (LLL), diameter stenosis, and minimal lumen diameter (MLD). Pooled odds ratios (OR) and weighted mean differences (WMD) with 95% confidence intervals (CI) were calculated by using random-effects models. A search of PubMed, EMBASE, and Cochrane Library from their inception to January 2024 identified five randomized clinical trials and three observational studies with a total of 1861 patients (889 in PCB and 972 in SCB groups). During 9-12 months of follow-up, there was no significant difference in TLF (OR 1.01, 95% CI 0.75-1.35) between the two groups. On follow-up angiography at 6-9 months, MLD (WMD 0.10, 95% CI 0.02-0.17) was larger in PCB but there was no statistically significant difference in LLL (WMD -0.11, 95% CI -0.23-0.02) and diameter stenosis (WMD -3.33, 95% CI -8.11-1.45). Among patients undergoing DCB-only PCI, the risk of TLF was similar during 9-12 months of follow-up after PCB and SCB treatment. However, the MLD was larger favoring PCB over SCB on follow-up angiography.

The “buddy stent technique” to overcome poor support for cover stent implantation to treat coronary perforation

An 86-year-old woman was managed for a non-ST-segment elevation myocardial infarction. Coronary angiography revealed significant stenoses at the left anterior descending, left ostial circumflex (LCX), obtuse first marginal, and a Medina 1.0.1 bifurcation lesion at the middle LCX/ second obtuse marginal (OM2). During percutaneous coronary intervention, the rupture of the pre-dilatation balloon was complicated by a type III coronary perforation at the level of the LCX/OM2 bifurcation, leading to cardiac tamponade. Hemodynamics were stabilized by percutaneous pericardial drainage. The placement of a covered stent (BeGraft, Bentley InnoMed), to seal the coronary perforation, was not possible due to its great rigidity and the angulation towards the OM2, even with the use of a guiding catheter extension (Guidezilla, Boston Scientific). To further increase support, we decided to use the flexibility of a regular drug-eluting stent which we implanted from the LCX to the OM2, thereby creating a rail-like path in which the covered stent could then be positioned and deployed successfully, allowing the perforation to be sealed with a good final result. This is what we called the “buddy stent technique”.

An Overview of Novel Drug Delivery Systems for Cardiovascular Diseases Application

Progress in nanotechnology and immunotherapy has facilitated the development of drugloaded nanocarriers through encapsulation techniques that are aimed at treating cardiovascular disease (CVD). While these drug delivery systems have exhibited promising outcomes, several clinical limitations necessitate identification and resolution. This overview emphasizes novel drug delivery systems, particularly ghost stents, mesenchymal extracellular vesicles, microbubble therapy, and aptamers, tailored for CVD management. Moreover, we explore the drug release kinetics associated with these systems to discern their release profiles in human blood, operating on specific stimuli to maintain stable plasma drug concentrations. Presently, advanced drug delivery modalities such as polymeric nanoparticles, natural metallic nanoparticles, aptamers, microbubbles, exosomes, polymeric micelles, and drug-eluting stents are employed in CVD treatment. These systems effectively circumvent immune responses and enhance the quality of life for patients with cardiovascular disorders, thereby improving patient adherence and treatment efficacy. The described systems offer a promising avenue for drug delivery, presenting a potential strategy to enhance the efficacy of current therapies.

Efficacy of Supera Stent in the Treatment of Complex Femoropopliteal Artery Lesions: A Short-Term Result Analysis of Real-World Evidence

When dealing with complex femoropopliteal lesions, there is a growing preference for the utilization of drug-coated balloons (DCB) or stents. However, in real-world scenarios, a greater number of elderly patients with longer lesion lengths are encountered. The purpose of our study was to compare the efficacy and safety of different interventional strategies, including the utilization of Supera stent and DCB, in a real-world setting. This was a retrospective study that collected treatment and follow-up data of patients with complex femoropopliteal artery lesions treated between January 2019 and March 2022. All patients were categorized into three groups: "non-Supera stent group,""Supera stent group," and "Supera stent + DCB group." The primary effectiveness outcome was primary patency at 12 months, defined as duplex ultrasound peak systolic velocity ratio<2.5 at the 12-month visit. Other outcomes included improvements in Rutherford categories and safety. A total of 162 patients were enrolled in this study. Compared to non-Supera group (47.6%) in the primary patency rate at 12 months, Supera group (58.7%) or Supera + DCB group (60.0%) showed no significant difference. There were no significant differences in all-cause death, major amputation of the target limb, and target lesion revascularization (TLR) between the groups. Supera group showed a significant improvement in Rutherford category without TLR at 12 months compared to non-Supera group (73.3% vs. 54.8%, P=0.041). In 12-month follow-up, over 65% of patients maintained a Rutherford category of 3 or below, particularly in Supera group where 74.7% of patients had mild symptoms. The Supera stent has demonstrated its efficacy and safety in treating complex peripheral artery disease. However, combining Supera stent with DCB did not provide a significant advantage. Further research is necessary to validate these findings in a larger patient population.

Immediate Destiny of Bifurcation Lesions Treated with Biomatrix Alpha Stents.

About 15% of coronary artery interventions are performed on coronary artery bifurcation. Managing these lesions presents a significant therapeutic obstacle in the context of coronary artery issues. Addressing both immediate and lasting side effects of these lesions demands ongoing monitoring and action. The introduction of drug-eluting stents has raised hopes for better outcomes in patients experiencing cardiovascular events. In this study, we selected 51 patients (out of 850) who had received ≥1 cobalt-chromium, biodegradable polymer, Biolimus A9-eluting stent (CoCr-BP-BES) Biomatrix Alpha stent. Immediately after stenting, thrombolysis in myocardial infarction (TIMI) flow score in the coronary artery and its bypass branch, plaque shift, and lateral dissection immediately after angioplasty were evaluated. The mean age for patients was 65 (±10.35) years, where 49.02% of them were male and 45.1% had diabetes. No lateral dissection and death were reported in any of the patients. Also, the TIMI flow grade was 3 for the main branch in all patients. Plaque shifts were compared at different degrees of the TIMI flow coronary artery bypass graft. A statistical study revealed a noteworthy distinction between the groups. There was no discernible change when gender, diabetes, systolic and diastolic blood pressure with plaque changes were all controlled for. We discovered that the Biomatrix Alpha stents' instant clinical results are admissible. Our findings confirm the clinical utility of the recently developed biolimus-eluting (BES) stent technology, which combines the BA-9 medication, a thin-strut CoCr stent platform, and a biodegradable polymer. This aligns with the existing body of research on the most recent generation of drug-eluting stents (DES).

COMPARATIVE ANALYSIS OF IN-STENT RESTENOSIS IN DIABETIC AND NON-DIABETIC PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION IN PAKISTAN

Coronary artery disease (CAD) is a major global killer. Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) has improved CAD treatment. However, in-stent restenosis (ISR) remains a significant issue, especially for diabetic patients. Objective: This study aimed to compare ISR rates between diabetic and non-diabetic patients after PCI in a Pakistani hospital. Methods: We conducted a cross-sectional survey at Hayatabad Medical Complex, Peshawar, from January to December 2023. The study involved 273 patients aged 40-85 who underwent PCI with DES. Participants were split into diabetic and non-diabetic groups. Those with chronic kidney disease, previous coronary artery bypass graft surgery, or incomplete follow-up data were excluded. Data were gathered from medical records. ISR was marked by a luminal diameter reduction of more than 50% within the stent or 5 mm of its edges. We used chi-square tests and logistic regression for analysis, employing SPSS version 26.0. Results: The ISR rate was 23% overall. Diabetic patients showed a higher ISR rate (30%) than non-diabetic patients (16%). Logistic regression revealed diabetes (OR = 2.1, 95% CI: 1.3-3.2, p &lt; 0.01), hypertension (OR = 1.8, 95% CI: 1.1-2.9, p &lt; 0.05), and smoking (OR = 1.6, 95% CI: 1.0-2.5, p &lt; 0.05) as significant predictors of ISR. Conclusion: This study highlights a higher ISR incidence in diabetic patients post-PCI. It underscores the need for meticulous monitoring and tailored strategies for this high-risk group. Managing hypertension, smoking, and dyslipidemia is essential to lower ISR rates and enhance outcomes.

Impact of 12-Month Angioscopic Thrombi and Yellow Plaque After Drug-Eluting Stent Implantation.

Coronary angioscopy (CAS) has 2 unique abilities: direct visualization of thrombi and plaque color. However, in the recent drug-eluting stent (DES) era, serial CAS findings after DES implantation have not been fully elucidated. We investigated the impact of CAS findings after implantation of a polymer-free biolimus A9-coated stent (PF-BCS) or durable polymer everolimus-eluting stent (DP-EES).Methods and Results: We investigated serial CAS and optical coherence tomography (OCT) findings at 1 and 12 months in 99 patients who underwent PF-BCS or DP-EES implantation. We evaluated factors correlated with angioscopic thrombi and yellow plaque, and the clinical impact of both thrombi and yellow plaque at 12 months (BTY). The BTY group included 17 (22%) patients. The incidence and grade of thrombi and yellow plaque decreased from 1 to 12 months. Although no patients had newly appearing thrombi at 12 months, 2 DP-EES patients had newly appearing yellow plaque at 12 months. Multivariable analysis revealed HbA1c, minimum stent area, and adequate strut coverage were significant factors correlated with 12-month angioscopic thrombi, and DP-EESs were significantly correlated with 12-month yellow plaque. However, BTY was not correlated with clinical events. The management of diabetes, stent area, and adequate stent coverage are important for intrastent thrombogenicity and polymer-free stents are useful for stabilizing plaque vulnerability.

Self-expanding intracranial drug-eluting stent system in patients with symptomatic intracranial atherosclerotic stenosis: initial experience and midterm angiographic follow-up.

Symptomatic intracranial atherosclerotic stenosis (ICAS) is a major cause of ischemic stroke worldwide. In patients undergoing endovascular treatment for ICAS, in-stent restenosis (ISR) is associated with ischemic stroke recurrence. Intracranial drug-eluting self-expanding stent systems (COMETIU; Sinomed Neurovita Technology Inc., CHN) are new devices for treating ICAS. This study evaluated the perioperative experience and medium-term outcomes of COMETIU in 16 patients. We prospectively analyzed 16 patients with ICAS (≥ 70% stenosis) who underwent intravascular therapy between September 4, 2022, and February 1, 2023. The primary outcome was the incidence of ISR at 6 months postoperatively. The secondary efficacy outcomes were device and technical success rates. The secondary safety outcomes included stroke or death within 30 days after the procedure and the cumulative annual rate of recurrent ischemic stroke in the target-vessel territory from 31 days to 6 months and 1 year. A total of 16 patients with 16 intracranial atherosclerotic lesions were treated with 16 COMETIUs. All procedures were performed under general anesthesia with 100% device and technical success rates, with no cases of periprocedural stroke or death. The mean radiographic follow-up duration was at least 6 months postoperatively, and all patients presented for radiographic and clinical follow-up. There were no reported ischemic or hemorrhagic strokes. Angiographic follow-up for all patients revealed no cases of ISR. COMETIU is safe and effective for treating ICAS, with minimal risk during the procedure and a low rate of ISR during medium-term follow-up.

Cucurbitacins mitigate vascular neointimal hyperplasia by suppressing cyclin A2 expression and inhibiting VSMC proliferation.

Restenosis frequently occurs after percutaneous angioplasty in patients with vascular occlusion and seriously threatens their health. Substantial evidence has revealed that preventing vascular smooth muscle cell proliferation using a drug-eluting stent is an effective approach to improve restenosis. Cucurbitacins have been demonstrated to exert an anti-proliferation effect in various tumors and a hypotensive effect. This study aims to investigate the role of cucurbitacins extracted from Cucumis melo L. (CuECs) and cucurbitacin B (CuB) on restenosis. C57BL/6 mice were subjected to left carotid artery ligation and subcutaneously injected with CuECs or CuB for 4 weeks. Hematoxylin-Eosin, immunofluorescence and immunohistochemistry staining were used to evaluate the effect of CuECs and CuB on neointimal hyperplasia. Western blot, real-time PCR, flow cytometry analysis, EdU staining and cellular immunofluorescence assay were employed to measure the effects of CuECs and CuB on cell proliferation and the cell cycle invitro. The potential interactions of CuECs with cyclin A2 were performed by molecular docking. The results demonstrated that both CuECs and CuB exhibited significant inhibitory effects on neointimal hyperplasia and proliferation of vascular smooth muscle cells. Furthermore, CuECs and CuB mediated cell cycle arrest at the S phase. Autodocking analysis demonstrated that CuB, CuD, CuE and CuI had high binding energy for cyclin A2. Our study also showed that CuECs and CuB dramatically inhibited FBS-induced cyclin A2 expression. Moreover, the expression of cyclin A2 in CuEC- and CuB-treated neointima was downregulated. CuECs, especially CuB, exert an anti-proliferation effect in VSMCs and may be potential drugs to prevent restenosis.

Study on Mechanical Properties of Nanopores in CoCrFeMnNi High-Entropy Alloy Used as Drug-Eluting Stent.

The CoCrFeMnNi high-entropy alloy is commonly used for vascular stents due to its excellent mechanical support and ductility. However, as high-entropy alloy stents can cause inflammation in the blood vessels, leading to their re-narrowing, drug-eluting stents have been developed. These stents have nanopores on their surfaces that can carry drug particles to inhibit inflammation and effectively prevent re-narrowing of the blood vessels. To optimize the mechanical properties and drug-carrying capacity of high-entropy alloy stents, a high-entropy alloy system with different wide and deep square-shaped nanopore distributions is created using molecular dynamics. The mechanical characteristics and dislocation evolution mechanism of different nanopore high-entropy alloy systems under tensile stress were studied. The results showed that the CoCrFeMnNi high-entropy alloy with a rational nanopore distribution can effectively maintain the mechanical support required for a vascular stent. This research provides a new direction for the manufacturing process of nanopores on the surfaces of high-entropy alloy stents.

Advantages and disadvantages of coronary drug-eluting stent: a 23-year journey of randomized clinical trials

Advantages and disadvantages of coronary drug-eluting stent: a 23-year journey of randomized clinical trials

Elucidating the Relationship between Neutrophil-Lymphocyte Ratio and Plaque Composition in Patients with Drug-Eluting Stent Restenosis by Virtual Histology-Intravascular Ultrasound.

(1) Background: In-stent Restenosis (ISR) is a major factor influencing the prognosis and revascularization of target lesions. The plaque composition is unclear; therefore, it is critical to investigate ISR composition to identify clinical intervention markers. (2) Methods: This study was conducted on 36 patients with drug-eluting stent restenosis. The patients were classified into a Low Neutrophil-Lymphocyte Ratio (L-NLR) and High Neutrophil-Lymphocyte Ratio (H-NLR) according to the median NLR level of 36 patients. Discrepancies in the current information such as baseline data, biochemical examination, cardiac ultrasound data, etc., were examined to identify the underlying risk factors, and a multifactorial linear regression analysis of plaque properties was conducted. (3) Results: NLR = 2.64 was utilized to classify 18 patients into the L-NLR group and 18 patients into the H-NLR group. There were statistically significant differences in age, a pre-percutaneous coronary intervention (PCI) SYNTAX II score, a C-reactive protein (CRP), interleukin (IL)-6, plaque loading, a fibro-lipid tissue area, calcified nubs, and virtual histology-thin fibrous cap atherosclerotic (VH-TCFA). The significant impacts of variations in age, neutrophil-lymphocyte ratio (NLR) levels, and IL-6 levels on the plaque stress and percentage of the fibro-lipid tissue in virtual histology-intravascular ultrasound (VH-IVUS) were identified through multifactorial linear regression. (4) Conclusions: The high NLR group demonstrated increased myocardial injury severity, consistent with higher SYNTAX II scores, a higher plaque burden, and higher proportions of vulnerable components. NLR proved to be a risk factor for both the plaque load and the proportion of the fibro-lipid tissue in ISR.

Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients.

Drug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, data regarding performance in the treatment of de novo, large vessel CAD (LV-CAD) is still lacking. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting. A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to January 24, 2024, for studies which compared the efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels (≥ 2.5mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all-cause death (ACD), and late lumen loss (LLL) at follow-up. The effect size was estimated using a random effects model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI). A total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2888 patients (DCB n = 1334; DES n = 1533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. No differences were observed between DCB and DES in terms of CVD (RR 0.49; 95% CI [0.23-1.03]; p = 0.06), MI (RR 0.48; 95% CI [0.16-1.45]; p = 0.89), TLR (RR 0.73; 95% CI [0.40-1.34]; p = 0.32), ACD (RR 0.78; 95% CI [0.57-1.07]; p = 0.12), and LLL (MD - 0.14; 95% CI [- 0.30 to 0.02]; p = 0.10) at follow-up. DES proved a higher mean acute gain versus DCB [1.94 (1.73, 2.14) vs 1.31 (1.02, 1.60); p = 0.0006]. Our meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a "metal-free" strategy in this subset of CAD.

Does one size really fit all? The case for personalized antiplatelet therapy in interventional cardiology.

Cardiovascular disease is the leading cause of death worldwide. Dual antiplatelet therapy (DAPT), with aspirin plus a P2Y12 inhibitor, is currently recommended as a default for patients after acute coronary syndrome (ACS) and following percutaneous coronary intervention (PCI). However, controversies arise over the role of aspirin, the optimal duration of DAPT after drug-eluting stent (DES) implantation, the choice of P2Y12 inhibitor and the variability in individual responses to antiplatelet agents. Recent data indicate that monotherapy with a P2Y12 inhibitor may have adequate anti-ischemic effects with lower bleeding risk. Additionally, discrepancies in DAPT duration recommendations and the optimal P2Y12 inhibitor, provides more uncertainty. We ask the question "does one size really fits all?" or should a more personalized strategy should be implemented.

Restenosis rates for drug-eluting stents used in treating small vessel cardiac allograft vasculopathy after orthotopic heart transplantation

BackgroundCardiac allograft vasculopathy (CAV) is associated with increased mortality in patients with orthotopic heart transplantation (OHT). In addition to immunosuppression, CAV can be treated with percutaneous coronary intervention (PCI) with drug eluting stents (DES) for focal lesions. There is a paucity of data on the rate of DES restenosis in patients with small vessel CAV. MethodsThis was a retrospective observational study of 101 coronary vessels treated with a DES diameter of 2.5 mm or less (small vessels) in 61 OHT patients compared to 72 coronary vessels treated with a DES diameter of >2.5 mm (large vessels) in 44 OHT patients at a single center between 2004 and 2022. Baseline demographic data, angiographic characteristics, and clinical outcomes were analyzed. ResultsAt an average of 1.6 years after DES placement, follow-up angiography revealed in-stent restenosis in 36 (39 %) small vessel interventions and 11 (17 %) large vessel interventions (p = 0.003). Long term mortality did not differ between the groups (59 % vs 59 % at a median of 4.7 [IQR 2.4–7.8] years follow up). ConclusionDES restenosis rates are high in small vessel CAV. Additional studies specifically examining PCI in small vessel CAV as well as the potential role for newer treatment strategies for CAV are warranted.

A risk score for predicting in-stent restenosis in patients with premature acute myocardial infarction undergoing percutaneous coronary intervention with drug-eluting stent

BackgroundThis study aimed at developing and validating a risk score to predict in-stent restenosis (ISR) in patients with premature acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES). MethodsThis was a two-center retrospective study. A total of 2185 patients firstly diagnosed with premature AMI (age ≥18 years and <55 years in men, <65 years in women) from Xinjiang cohort were retrospectively analyzed. After filtering by exclusion criteria, patients were randomly divided into training cohort (n = 434) and internal validation cohort (n = 186) at a 7:3 ratio. Several candidate variables associated with ISR in the training cohort were assessed by the least absolute shrinkage and selection operator and logistic regression analysis. The ISR risk nomogram score based on the superior predictors was finally developed, and then validated in the internal validation cohort and in an independent Chengdu external validation cohort (n = 192). The higher total nomogram score, the greater the ISR risk. ResultsThe eight variables in the final risk nomogram score, cardiovascular-kidney-metabolic (CKM) score included age, diabetes mellitus (DM), body mass index (BMI), systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDLC), estimated glomerular filtration rate (eGFR), stent in left anterior descending coronary artery, minimum stent diameter <3 mm. The areas under the curve (AUC) and C-statistics [training cohort: 0.834 (95%CI: 0.787 to 0.882); internal validation cohort: 0.852 (95%CI: 0.784 to 0.921); Chengdu external validation cohort: 0.787 (95%CI: 0.692 to 0.882), respectively)] demonstrated the good discrimination of the CKM score. The Hosmer-Lemeshow test (χ2 = 7.86, P = 0.448; χ2 = 5.17, P = 0.740; χ2 = 6.35, P = 0.608, respectively) and the calibration curve confirmed the good calibration of the CKM score. Decision curve analysis (DCA) testified the clinical net benefit of the CKM score in the training and validation cohort. ConclusionThis study provided a well-developed and validated risk nomogram score, the CKM score to predict ISR in patients with premature AMI undergoing PCI with DES. Given that these variables are readily available and practical, the CKM score should be widely adopted for individualized assessment and management of premature AMI.

Safety and efficacy of single antiplatelet therapy in a large cohort of patients treated with sirolimus-coated balloon: Post hoc analysis from the prospective EASTBOURNE registry

BackgroundDrug coated balloons (DCB) are potentially less thrombogenic than drug eluting stents (DES). AimsTo explore the safety and the feasibility of single antiplatelet therapy in percutaneous coronary intervention with sirolimus-coated balloons. MethodsThe All-comers Sirolimus-coated Balloon European Registry (EASTBOURNE) is a prospective investigator-driven registry assessing the performance of a novel sirolimus-coated balloon (SCB) in a real-world population. This prespecified post hoc analysis aimed at comparing the outcome in patients prescribed either single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT); choice of antiplatelet agent and duration of the regimen were at operator's discretion in both groups. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were bleeding grade 3–5 according to The Bleeding Academic Research Consortium (BARC) criteria and major adverse cardiovascular events (MACE) at 12 months follow-up. ResultsAmong 2123 patients enrolled in the study between September 2016 and November 2020, 113 patients (5.8 %) received SAPT while 1826 patients (94.1 %) received DAPT after SCB. The majority of the patients underwent DCB PCI for de novo lesions (n = 1091, 56.3 %) while 848 patients (47.7 %) had DCB revascularization for in-stent restenosis. No cases of TLR occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. Moreover, no differences in terms of TLR were observed between SAPT vs DAPT regimens nor in case of de novo treatment with an overall rate of TLR at 12 months of 7.7 % for SAPT and 5.6 % for DAPT (p = 0.6). The cumulative rate of MACE at 12 months was not different between SAPT and DAPT regimens (n = 12 [11.2 %] vs. n = 162 [8.9 %], p = 0.4), and results were consistent in the de novo and in-stent restenosis groups. ConclusionsOur post hoc analysis of the EASTBOURNE registry suggests that the use of single antiplatelet agent after sirolimus-DCB PCI for both de novo or in-stent restenosis lesions is safe and effective and can help to contain the risk of bleeding in a selected population. Condensed abstractThe manuscript aims to explore the feasibility of a single antiplatelet regimen following angioplasty using drug coated balloon with sirolimus. Among 2123 patients treated with sirolimus coated balloon (SCB), 113 patients (5.8 %) received a single antiplatelet therapy (SAPT) while 1826 patients (94.1 %) received dual antiplatelet therapy DAPT. No cases of target lesion revascularization occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. The cumulative rate of major adverse cardiovascular events at 12 months was not different between SAPT and DAPT regimens and results were consistent in the de novo and in-stent restenosis groups.

Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial.

The treatment of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains challenging in current clinical practice. The study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB). This was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients. A total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was -0.02 (95% confidence interval [CI]: -0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm2 in the BCB group compared to 2.37±0.93 mm2 in the PCB group; the mean difference between the groups was -0.09 (95% CI: -0.94 to 0.76) mm2; p=non-significant. This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov: NCT04733443).

Long-term outcomes of IVUS-guided and angiography-guided drug-eluting stent implantation for left main coronary artery disease: a retrospective consort study

BackgroundIn patients with unprotected left main coronary artery disease (ULMCAD), this study compared the long-term prognosis of drug-eluting stent insertion guided by intravascular ultrasonography (IVUS) vs. angiography.Patients and methodsThis retrospective consort investigation was performed in December 2021. This analysis included 199 patients who underwent IVUS-guided (IVUS group, n = 81) or angiography-guided (angiography group, n = 118) drug-eluting stent implantation at the Affiliated Hospital of Inner Mongolia Medical University between September 2013 and September 2018. Major adverse cardiac events (MACE) were defined as cardiovascular death, sudden cardiac death, myocardial infarction.ResultsThe IVUS group had considerably lower proportions of MACE within 1 year postoperatively (P = 0.002) and cardiac mortality within 3 years postoperatively (P = 0.018) compared to the angiography group. However, after adjusting for confounding variables, the hazard ratio for 3-year cardiac mortality was similar between the two groups (P = 0.28). In the IVUS group, there was considerably greater minimum lumen diameter (MLD) (P = 0.046), and reduced frequencies of target vessel restenosis (P < 0.050) and myocardial infarction (MI) (P = 0.024) compared to the angiography group. Cox regression analysis for 3-year cardiac mortality found that MSD was independently associated with low cardiac mortality (HR = 0.1, 95% CI: 0.01–14.92, P = 0.030).ConclusionIVUS-guided drug-eluting stent implantation may lead to better long-term prognosis in patients with ULMCAD, and MSD may be a predictor for lower cardiac mortality.