Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial.

Importance: Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States. Objective: To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. Design, Setting, and Participants: AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023. Interventions: Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon. Main Outcomes and Measures: The primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority. Results: Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups, respectively. Conclusions and Relevance: Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT04647253.

Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry.

BACKGROUND: The outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons. AIMS: To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India). METHODS: We conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2-5 bleedings. RESULTS: Among 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91-2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95-3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92-1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09-4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status. CONCLUSIONS: In the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.

Drug-Coated Balloons for Treatment of Internal Carotid Artery Restenosis After Stenting: A Single-Center Mid-Term Outcome Study.

PURPOSE: Endovascular and surgical treatments of stenosis of the extracranial internal carotid artery (ICA) are common procedures, yet both introduce a risk of restenosis due to endothelial hyperplasia. Drug-coated balloons (DCBs) are designed to decrease neointimal hyperplasia, however rarely used in the neurovascular setting. This study retrospectively analyzes mid-term results of DCB-treated in-stent restenosis (ISR) of the ICA. MATERIALS AND METHODS: The medical history, comorbidities, and periprocedural data of patients receiving DCB treatment for > 50% ISR of the ICA after carotid artery stenting were analyzed. Follow-up after DCB treatment was performed with Doppler ultrasound. Suspicious cases were checked with CT- or MR-angiography and-if there was agreement between the modalities-validated with digital subtraction angiography. Potential risk factors for restenosis and differences in outcomes after PTA with three types of DCB balloons were evaluated. RESULTS: DCB treatment was performed in 109 cases, 0.9% of which involved in-hospital major stroke; no minor strokes occurred. A total of 17 patients (15.6%) had recurrent ISR after DCB treatment, after a mean time of 30.2 months (7-85 months). Tobacco use was significantly associated with a higher incidence of recurrent ISR. CONCLUSION: DCB angioplasty for ISR is an effective treatment that may delay and decrease restenosis. Treating comorbidities and adopting lifestyle changes may additionally help prevent ISR.

Morphological characteristics of in-stent restenosis with different degrees of area stenosis: an optical coherence tomography study.

The morphological characteristics of in-stent restenosis (ISR) in relation to varying degrees of area stenosis have not been comprehensively examined. This study aimed to explore the tissue characteristics of patients experiencing ISR with different degrees of area stenosis through the utilization of optical coherence tomography (OCT). In total, 230 patients with ISR who underwent OCT were divided into the following three groups: area stenosis (AS) < 70% (n = 26); 70-80% (n = 119) and AS ≥ 80% (n = 85). Among the 230 patients, the clinical presentation as stable angina was 61.5% in AS < 70%, followed by 47.2% in 70% < AS ≤ 80%, and 31.8% in AS ≥ 80% (P = 0.010). The OCT findings showed that heterogeneous neointima, ISNA, LRP, neointima rupture, TCFA-like pattern, macrophage infiltration, red and white thrombus was more common with AS increased. Ordinal logistic regression analysis showed that higher AS was associated with previous dyslipidemia (odds ratio [OR], 4.754; 95% confidence interval [CI], 1.419-15.927, P = 0.011), neointimal rupture (OR: 3.640; 95% CI, 1.169-11.325, P = 0.026), red thrombus (OR: 4.482; 95% CI, 1.269-15.816, P = 0.020) and white thrombus (OR: 5.259; 95% CI, 1.660-16.659, P = 0.005). Patients with higher degrees of area stenosis in the context of ISR exhibited a greater number of discernible morphological characteristics as identified through OCT analysis. Furthermore, previous dyslipidemia, neointimal rupture, white thrombus and red thrombus were highly associated with and the progression of ISR lesions.

Drug-coated balloon therapy for in-stent restenosis in patients with iliofemoral deep vein thrombosis: A single-arm observational study.

BACKGROUND: Iliofemoral deep vein thrombosis (IFDVT) causes severe symptoms and affect the quality of life to a great extent. Endovascular thrombectomy and stent implantation have been a feasible strategie to alleviate the signs and symptoms of IFDVT. However, venous in-stent restenosis (ISR) has become an emerging non-negligible problem. METHODS: To evaluate the histological characteristics of venous ISR, neointima of arterial and venous ISR patients were collected and examed. To explore the effect of drug-coated balloon (DCB) on venous ISR lesions, we conducted a single-center retrospective case series study involving IFDVT patients with ISR after venous stenting who were treated with paclitaxel-coated balloon dilatation. RESULTS: We found a collagen-rich matrix but not elastin, as well as fewer cells and less neovascularization in venous intimal hyperplasia compared with neointima in arteries. Thirteen IFDVT patients were involved in the study, with average preoperative stenosis degree of 87.69% ± 13.48%. After intervention, the stenosis degree was significantly reduced to 14.6% ± 14.36% immediately (p < 0.0001) and to 16.54% ± 15.73% during follow-up (p < 0.0001). During follow-up, the VEINES-QOL scores (p < 0.0001), VEINES-Sym scores (p < 0.0001), and Villalta scores (p = 0.04) of patients was improved significantly compared with those before intervention. No major adverse events were observed. CONCLUSIONS: The use of DCB may have a positive effect in the treatment of venous ISR by targeting intimal hyperplasia. Moreover, the application of DCB dilatation in IFDVT stenting patients with ISR is deemed safe and effective.

Long term clinical outcome of sirolimus drug coated balloons in large coronary vessels.

BACKGROUND: Studies evaluating the safety and efficacy of drug coating balloons (DCB) for the treatment of lesions in large coronary vessel are limited. AIMS: Our study aimed to evaluate the performance of a sirolimus DCB in large coronary arteries. METHODS: We analyzed all the procedures included in the EASTBOURNE Registry (NCT03085823) enrolling patients with a clinical indication to percutaneous coronary intervention performed by a sirolimus DCB according to investigator judgment. In the present analysis, a cut-off of 2.75 mm was used to define large coronary arteries. Primary endpoint of the study was clinically driven target lesion revascularization (TLR) at 24 months whereas secondary endpoint included procedural success, myocardial infarction (MI), cardiac death and total mortality. RESULTS: Among the 2123 patients and 2440 lesions enrolled in the EASTBOURNE study between 2016 and 2020, 757 patients/810 lesions fulfilled the criteria for the present analysis. Mean reference vessel diameter was 3.2 ± 0.3 mm with mean lesion length of 22 ± 7 mm. Procedural success was high (96%) and at 2-year follow up the device showed a good efficacy with a TLR rate of 9%. There were 34 deaths (4.5%), 30 MIs (4%) and 8 BARC type 3-5 bleedings (1.1%). In-stent restenosis (629 lesions) and de novo lesions (181) were associated with 11% and 4% rates of TLR at 2 years, respectively (p = 0.003). CONCLUSIONS: Clinical performance of a sirolimus DCB in large coronary artery vessels shows promising signals at 2-year follow up, both in de novo and in-stent restenosis lesions.

Triglyceride-glucose index for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents.

OBJECTIVE: To evaluate the triglyceride-glucose index (TyG index) for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents. PATIENTS AND METHODS: Subjects with iliac artery stenosis, who underwent an iliac stent intervention and were followed up for at least 2 years were included in the study. Subjects were grouped according to TyG index (Group A, TyG index ≤8.848; Group B 8.849 ≤TyG index ≤9.382 and Group C TyG index ≥9.383). The subject's baseline characteristics, blood parameters, claudication distance, Transatlantic Intersociety Consensus classification, target lesion localization, stent direction, number of stents that were applied, and stent type were noted. Pre- and 1st and 2nd-year post-procedure Rutherford statuses, ankle-brachial index, and stenosis degree were recorded. To calculate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), Group B and Group C were combined and compared with Group A. RESULTS: In total, 255 subjects were evaluated (female, n=77-30.2%, male, n=178-69.8%). The mean age of the subjects was 66.00±10.00 years (range from 39 to 90 years). The pre-procedure Rutherford measurements were significantly different among the groups (p=0.001). The rates of mild claudication and resting pain in Group A were higher than those in Groups B and C. The rate of moderate claudication in Group C was higher than that in Groups A and B. The rate of severe claudication in Group B was higher than that in Groups A and C. One year after the procedure, there were more asymptomatic cases in Group A than in Groups B and C (p=0.001). The rate of mild claudication in Group C was lower than that in Groups A and B. The rate of moderate claudication in Group C was higher than that in Group A. The rate of severe claudication in Group C was higher than that in Groups A and B. Two years after the procedure, the Rutherford measurements and the rates of mild claudication in Groups A and B were higher than those in Group C. The rate of severe claudication in Group C was higher than that in Groups A and B (p=0.001). One year after the procedure, the computed tomography angiography (CTA) measurements and the rate of full patency in Group A were higher than that in Groups B and C. The rate of 0-50% stenosis in Group B was higher than that in Groups A and C. The rate of 50-70% stenosis in Group C was higher than that in Group A. Two years after the procedure, the CTA measurements and the rates of 70-99% stenosis and 100% occlusion in Group C were higher than those in Groups A and B. The TyG index has high specificity and NPV. However, specificity and PPV levels were found to be quite low. CONCLUSIONS: The TyG index was found to be an easy-to-use marker for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents.

Intrastent Restenosis: A Comprehensive Review.

The primary objective of this paper is to delineate and elucidate the contemporary advancements, developments, and prevailing trajectories concerning intrastent restenosis (ISR). We aim to provide a thorough overview of the most recent developments in this area, covering various aspects such as pathophysiological insights, therapeutic approaches, and new strategies for tackling the complex challenges of ISR in modern clinical settings. The authors have undertaken a study to address a relatively new medical challenge, recognizing its significant impact on the morbidity and mortality of individuals with cardiovascular diseases. This effort is driven by the need to fully understand, analyze, and possibly improve the outcomes of this emerging medical issue within the cardiovascular disease field. We acknowledge its considerable clinical implications and the necessity for innovative methods to mitigate its effects on patient outcomes. Therefore, our emphasis was directed towards elucidating the principal facets of the condition's prevalence, expounding upon the foundational mechanisms underscoring conspicuous restenosis, and delineating the risk factors relevant in shaping the contemporary landscape of diagnostic and therapeutic modalities. This thorough examination aims to provide a comprehensive understanding of the various dimensions of the condition, including epidemiological data, pathophysiological complexities, and clinical considerations critical for evaluating and enhancing current diagnostic and treatment approaches.

Risk factors for instent restenosis of sirolimus-coated stents in coronary intervention for patients with unstable angina.

To investigate the instent restenosis rate of sirolimus-coated stents in percutaneous coronary intervention (PCI) and risk factors for in-stent restenosis, patients with unstable angina (UA) caused by coronary artery stenosis were enrolled, and all clinical and imaging data were analyzed. Among 143 enrolled patients with UA aged 35-83 (mean 60.9 ± 10.0) years enrolled, there were 114 (79.7%) male and 29 (20.3%) female patients. Arterial stenosis was present in one coronary artery in 6 (4.2%) patients, in two coronary arteries in 20 (14.0%) patients, in three arteries in 116 (81.1%), and in four coronary arteries in 1 (0.7%) patient. Stenting was successfully performed in all (100%) patients, and 181 stents were deployed. The quantitative flow ratio (QFR) was 0.92 ± 0.03 (range 0.84-0.96) immediately after stenting, and the TIMI was grade 3 in all patients. The diameter of the stents deployed ranged 2.25-4 mm (mean 3.04 ± 0.44) with a length ranging 10 mm to 104 mm (mean 32.73 ± 15.5). Follow-up angiography was performed in all patients with a duration of 1-92 (mean 15.0 ± 18.8) months. Instent restenosis ≥ 50% occurred in 25 (17.5%) patients. In univariate logistic regression analysis, significant (P < 0.05) risk factors for instent restenosis ≥ 50% were QFR (OR 0.036, 95% CI 0.13-0.97), stent diameter (OR 0.43, 95% CI 0.18-0.92), hypertension (OR 3.16, 95% CI 1.02-9.82), smoking (OR 0.31, 95% CI 0.11-0.89), and neutrophil count (OR 2.22, 95% CI 1.10-5.44). In multivariate analysis, QFR (OR 0.02, 95% CI 0.002-0.19), stent diameter (OR 0.06, 95% CI 0.005-0.59), hypertension (OR 6.75, 95% CI 1.83-35.72) and neutrophil count (OR 276.07, 95% CI 12.32-10,959.95) were significant (P < 0.05) independent risk factors for instent restenosis ≥ 50%. In conclusion, certain instent restenosis rates occurs after the sirolimus-eluted coronary stent deployment for the treatment of coronary artery stenosis in patients with UA, and quantitative flow ratio after stenting, stent diameter, hypertension, and neutrophil count are significant risk factors for instent restenosis of the sirolimus-coated stents in coronary intervention.

Association Between Serum Uric Acid Levels and Neoatherosclerosis.

Neoatherosclerosis is a major cause of stent failure after percutaneous coronary intervention. Metabolism such as hyperuricemia is associated with in-stent restenosis (ISR). However, the association between serum uric acid (sUA) levels and in-stent neoatherosclerosis (ISNA) has never been validated.A total of 216 patients with 220 ISR lesions who had undergone optical coherence tomography (OCT) of culprit stents were included in this study. According to their sUA levels, eligible patients were divided into two groups [normal-sUA group: sUA < 7 mg/dL, n = 126, and high-sUA group: sUA ≥ 7 mg/dL, n = 90]. OCT findings were analyzed and compared between the normal- and high-sUA groups.The incidence of ISNA (63.0% versus 43.0%, P = 0.004) was significantly higher in the high-sUA group than in the normal-sUA group. Lipid plaques (66.3% versus 43.0%, P < 0.001) and thin-cap fibroatheroma (38.0% versus 18.0%, P = 0.001) were observed more frequently in the restenotic tissue structure in patients in the high-sUA group than in those in the normal-sUA group. Meanwhile, univariate (OR: 1.208, 95% CI: 1.037-1.407; P = 0.015) and multivariate (OR: 1.254, 95% CI: 1.048-1.501; P = 0.013) logistic regression analyses indicated that sUA levels were an independent risk factor for ISNA after adjusting for relevant risk factors.The high-sUA levels were an independent risk factor for the occurrence of neoatherosclerosis in patients with ISR via OCT.

Systemic immune inflammation index and its implication on in-stent restenosis among patients with acute coronary syndrome.

OBJECTIVE: This study aims to assess the predictive value of the Systemic Immune Inflammation Index (SII) in determining in-stent restenosis (ISR) likelihood in patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI). METHODS: The study enrolled 903 ACS patients undergoing PCI, categorized into ISR (+) and ISR (-) groups based on control coronary angiography results. Demographic, clinical, laboratory, and angiographic-procedural characteristics were systematically compared. RESULTS: The ISR (+) group encompassed 264 individuals (29.2%), while the ISR (-) group comprised 639 individuals (70.8%). Patients had a mean age of 55.8 ±â€…10.2 years, with 69% being male. The ISR (+) group had higher diabetes and smoking prevalence and notably larger stent dimensions. Lab parameters showed significantly elevated creatinine, total cholesterol, red cell distribution width, white blood cell and neutrophil counts, SII index and C-reactive protein (CRP) in the ISR (+) group, while lymphocyte levels were lower. Binary logistic regression identified stent diameter (odds ratio [OR]: 0.598, 95% confidence interval [CI]: 0.383-0.935; P  = 0.024), stent length (OR: 1.166, 95% CI: 1.132-1.200; P  < 0.001), creatinine (OR: 0.366, 95% CI: 0.166-0.771; P  = 0.003), CRP (OR: 1.075, 95% CI: 1.042-1.110; P  = 0.031), and SII index (OR: 1.014, 95% CI: 1.001-1.023; P  < 0.001) as independent ISR predictors. CONCLUSION: The SII index exhibits potential as a predictive marker for ISR in ACS patients post-PCI, indicating systemic inflammation and heightened restenosis risk. Integrating the SII index into risk models could identify high-risk patients for targeted interventions.

Hypercholesterolemia exacerbates in-stent restenosis in rabbits: Studies of the mitigating effect of stent surface modification with a CD47-derived peptide.

BACKGROUND AND AIMS: Hypercholesterolemia (HC) has previously been shown to augment the restenotic response in animal models and humans. However, the mechanistic aspects of in-stent restenosis (ISR) on a hypercholesterolemic background, including potential augmentation of systemic and local inflammation precipitated by HC, are not completely understood. CD47 is a transmembrane protein known to abort crucial inflammatory pathways. Our studies have examined the interrelation between HC, inflammation, and ISR and investigated the therapeutic potential of stents coated with a CD47-derived peptide (pepCD47) in the hypercholesterolemic rabbit model. METHODS: PepCD47 was immobilized on metal foils and stents using polybisphosphonate coordination chemistry and pyridyldithio/thiol conjugation. Cytokine expression in buffy coat-derived cells cultured over bare metal (BM) and pepCD47-derivatized foils demonstrated an M2/M1 macrophage shift with pepCD47 coating. HC and normocholesterolemic (NC) rabbit cohorts underwent bilateral implantation of BM and pepCD47 stents (HC) or BM stents only (NC) in the iliac location. RESULTS: A 40 % inhibition of cell attachment to pepCD47-modified compared to BM surfaces was observed. HC increased neointimal growth at 4 weeks post BM stenting. These untoward outcomes were mitigated in hypercholesterolemic rabbits treated with pepCD47-derivatized stents. Compared to NC animals, inflammatory cytokine immunopositivity and macrophage infiltration of peri-strut areas increased in HC animals and were attenuated in HC rabbits treated with pepCD47 stents. CONCLUSIONS: Augmented inflammatory responses underlie severe ISR morphology in hypercholesterolemic rabbits. Blockage of initial platelet and leukocyte attachment to stent struts through CD47 functionalization of stents mitigates the pro-restenotic effects of hypercholesterolemia.

Prognostic impact of in-stent restenosis in normal weight, overweight, and obese patients undergoing percutaneous coronary intervention.

BACKGROUND: Among patients undergoing percutaneous coronary intervention (PCI), in-stent restenosis (ISR) is related with a worse prognosis, while higher body mass index (BMI) values are associated with better outcomes. It is unclear whether the prognostic impact of ISR varies in function of BMI. METHODS: Patients undergoing PCI at a large center from 2012 to 2019 not presenting with an acute myocardial infarction (MI) were included. Subjects with BMI < 18.5 kg/m2 or treated with bare metal stents were excluded. Patients were stratified according to type of lesion treated (ISR vs. no-ISR) and into four BMI categories: normal weight (BMI 18.5-25 kg/m2 ), overweight (25.0-29.9 kg/m2 ), class I obesity (30.0-34.9 kg/m2 ), class II-III obesity (≥35.0 kg/m2 ). The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, MI, and target vessel revascularization (TVR) at 1 year. RESULTS: Out of 16,234 patients, 3694 (23%) underwent PCI for ISR. ISR as compared to no-ISR was associated with a consistent increased risk of MACE within the normal weight (18.8% vs. 7.8%, adj. hazard ratio (HR): 1.99, 95% confidence interval [CI]: 1.51-2.64), overweight (19.1% vs. 6.4%, adj. HR: 2.35, 95% CI: 1.91-2.88), class I obesity (18.3% vs. 6.8%, adj. HR: 1.95, 95% CI: 1.47-2.57), and class II-III obesity (16.4% vs. 7.4%, adj. HR: 1.61, 95% CI: 1.09-2.37) groups (interaction p-value: 0.192). The ISR-related risks were mostly driven by an excess of TVR. CONCLUSIONS: At 1 year, ISR was associated with an increased risk of MACE irrespective of BMI, mostly due to an excess of TVR after ISR.

Comprehensive clinical outcomes of drug-coated balloon treatment for coronary artery disease. Insights from a single-center experience.

BACKGROUND: Some clinical trials have verified the efficacy and safety of paclitaxel drug-coated balloon (DCB) for small vessel coronary artery disease. However, nonsmall vessel and calcified lesions received less attention. AIMS: This study aimed to investigate the efficacy of DCB treatment for various types of coronary artery lesions, including not only small vessel disease but also nonsmall vessel disease and calcified lesions. In this real-world clinical practice study, in-stent restenosis was excluded. METHODS: This study consecutively included 934 patients with 1751 nonstented lesions who received DCB at a cardiovascular center in Kyoto Katsura Hospital in Japan between 2009 and 2012 and 2014 to 2019. This study enrolled and retrospectively analyzed all of the patients. Eligible patients routinely underwent follow-up angiography at 6-8 months after percutaneous coronary intervention. The primary endpoint includes target lesion revascularization (TLR) during follow-up. Further, this study calculated the predictor of TLR using multivariate analysis. RESULTS: This study included the lesions involving 46.4% of type B2/C, 26.9% with severe calcification, and 6.0% with DCB restenosis. Mean DCB diameter and length were 2.75 ± 0.51 mm and 24.2 ± 9.6 mm, respectively. The median follow-up duration was 18 months. Follow-up angiography revealed a TLR rate of 9% and a restenosis rate of 9%. This study identified hemodialysis and current smoking as independent TLR predictors. CONCLUSION: In routine clinical practice, the effectiveness of DCB was observed consistently across various types of coronary artery disease.

A case of repeated in-stent restenosis of coronary artery as a primary manifestation of seronegative antiphospholipid antibody syndrome.

BACKGROUND: Antiphospholipid antibody syndrome (APS) is a multisystemic autoimmune disorder which affects many organs or systems; however, coronary artery is relatively less frequently involved. CASE PRESENTATION: A 65-year-old female with effort chest pain was hospitalized for unstable angina in Janurary, 2015. Coronary angiography revealed sub-total occlusion of proximal left anterior descending (LAD) coronary artery, where a drug-eluting stent was successfully deployed. The patient experienced multiple in-stent stenosis at LAD coronary artery and coronary artery bypass graft (CABG) surgery was advised. Subsequently, severe stenosis of left circumflex (LCX) coronary artery emerged, and the patient suffered persistent in-stent restenosis. Eventually, the patient was diagnosed with seronegative antiphospholipid antibody syndrome and salvaged by immunosuppressants. CONCLUSIONS: Repeated in-stent restenosis could be a primary manifestation of seronegative antiphospholipid antibody syndrome, and suppression of autoimmune activity and inflammation other than purely coronary revascularization might be a better option.

Recurrent Revascularization at 10 Years After Percutaneous Treatment of Drug-Eluting Stent Restenosis.

BACKGROUND: Treatment of patients with recurrence of in-stent restenosis (ISR) remains particularly challenging, with data and guideline recommendations for repeat percutaneous coronary intervention being scant. OBJECTIVES: The aim of this study was to investigate the long-term incidence of recurrent revascularization events after percutaneous treatment of drug-eluting stent (DES) ISR. METHODS: In this post hoc analysis, 402 patients (500 lesions) assigned to plain balloon (PB), drug-coated balloon (DCB), or DES treatment in the randomized ISAR-DESIRE 3 (Efficacy Study of Paclitaxel-Eluting Balloon, -Stent vs. Plain Angioplasty for Drug-Eluting Stent Restenosis) trial were followed up over a median of 10.3 years. The primary endpoint was total repeat target lesion revascularization (R-TLR) including all, first and recurrent, events. RESULTS: At the end of follow-up, first R-TLR was required in 204 lesions, 82 in the PB group, 70 in the DCB group, and 52 in the DES group. The total number of R-TLRs was 373: 162 in the PB group, 124 in the DCB group, and 87 in the DES group. During the first year of follow-up, the risk for total R-TLR was reduced by DCB (HR: 0.36; 95% CI: 0.24-0.54) and DES (HR: 0.23; 95% CI: 0.14-0.38) treatment compared with PB treatment. After 1 year, the risk for total R-TLR was nonsignificantly reduced by DCB treatment (HR: 0.77; 95% CI: 0.51-1.16) and significantly reduced by DES treatment (HR: 0.61; 95% CI: 0.39-0.95) compared with PB treatment. Risk in the DCB and DES groups was similar during (HR: 1.54; 95% CI: 0.89-2.69) and after (HR: 1.26; 95% CI: 0.82-1.92) 1 year. CONCLUSIONS: The total number of R-TLRs over 10 years after treatment of patients with DES ISR was high. DCBs and particularly DES were able to reduce the need for both first and recurrent revascularization compared with PB treatment.