Restenosis Rate Research Articles

Intravascular Ultrasound vs. Fractional Flow Reserve for Percutaneous Coronary Intervention Optimization in Long Coronary Artery Lesions.

intravascular ultrasound (IVUS) and fractional flow reserve (FFR) have both been shown to be superior to angiography in optimizing percutaneous coronary intervention (PCI). However, there is still a lack of comparative studies between PCI optimization using physiology and intravascular imaging head-to-head. The aim of this study was to compare the effectiveness of FFR and IVUS PCI optimization strategies on the functional PCI result (assessed with FFR) immediately post-PCI and at 9-12 months after the treatment of long coronary lesions. This was a single-center study comparing post-PCI FFR between two different PCI optimization strategies (FFR and IVUS). The study included 154 patients who had hemodynamically significant long lesions, necessitating a stent length of 30 mm or more. The procedural outcomes were functional PCI result immediately post-PCI and at 9-12 months after treatment. Clinical outcomes included target vessel failure (TVF) and functional target vessel restenosis rate during follow-up. Baseline clinical characteristics and FFR (0.65 [0.55-0.71]) did not differ significantly between the two groups and the left anterior descending artery was treated in 82% of cases. The FFR optimization strategy resulted in a significantly shorter stented segment (49 mm vs. 63 mm, p = 0.001) compared to the IVUS optimization strategy. Although the rates of optimal functional PCI result (FFR > 0.9) did not significantly differ between the FFR and IVUS optimization strategies, a proportion of patients in the FFR group (12%) experienced poor post-PCI functional outcome with FFR values ≤ 0.8, which was not observed in the IVUS group. At the 9-12 month follow-up, 20% of patients in the FFR group had target-vessel-related myocardial ischemia, compared to 6% in the IVUS group. The rates of TVF and functional target vessel restenosis during follow-up were also numerically higher in the FFR optimization group. The use of FFR PCI optimization strategy in the treatment of long coronary artery lesions is associated with a higher incidence of poor functional PCI result and larger myocardial ischemia burden at follow-up compared to the IVUS optimization strategy. However, this discrepancy did not translate into a statistically significant difference in clinical outcomes. This study highlights the importance of using IVUS to optimize long lesions functional PCI outcomes.

Intravascular Ultrasound-Guided Versus Angiography-Guided Endovascular Therapy for Femoropopliteal Artery Disease: A Scoping Review.

The objective of this study was to summarize whether the application of additional intravascular ultrasound (IVUS) can change the outcomes of endovascular treatment in femoropopliteal atherosclerotic lesions compared with conventional angiography alone based on the existing study and evidence. Studies published until September 2022 were searched from PubMed, Embase, and Cochrane databases using the methods of combination of Medical Subject Headings and free text words. The outcomes included in these studies were primary patency rate or restenosis rate and freedom from clinically driven target lesion revascularization (cdTLR) rate, and most studies were concerned about the 12-month results. Two independent authors conducted the process of study selection. And the pooled analysis was attempted. Finally, the inclusion criteria were met by 4 studies (1 randomized controlled trial and 3 retrospective studies) involving 1160 patients. IVUS played its role in measuring lesions and/or guiding wiring passage. Most of the included studies showed that IVUS could achieve a higher 12-month primary patency rate (from 70% to 90%) and higher 12-month freedom from cdTLR rate (from 83.9% to 94.7%) than angiography. The tentative pooled analysis also showed that IVUS significantly improved the 12-month primary patency rate (OR: 2.21, 95%CI: [1.38-3.55], p=0.001) and the 12-month freedom from cdTLR rate (OR: 1.70, 95%CI [1.04-2.78], p=0.03) compared with angiography alone. Intravascular ultrasound-guided endovascular treatment of femoropopliteal artery lesions may have its own advantages such as higher primary patency rate and freedom from cdTLR rate at 12 months. As a novel technology, IVUS is expected to become another beneficial option to guide clinicians performing endovascular therapy in addition to angiography and may achieve better clinical outcomes. More prospective and high-quality studies are needed in the future to investigate the role of IVUS in the process of femoropopliteal artery lesions endovascular treatment. This review summarized a few available studies to promote understanding of IVUS and reveal its potential. This novel technology shows the possibility of achieving better clinical outcomes than angiography in femoropopliteal artery lesions endovascular therapy such as higher 12-month primary patency rate shown in some studies. Currently, it is important to consider suitable technologies applied to individualized treatment. IVUS seems to provide clinicians additional option in clinical practice and benefit patients well in the future. And it needs us to conduct more high-quality studies to explore its roles and advantages in endovascular treatment.

Safety and efficacy of enterprise stenting for symptomatic atherosclerotic severe posterior circulation stenosis

PurposeTo investigate the safety and efficacy of Enterprise stent angioplasty and risk factors for the prognoses in treating symptomatic severe posterior circulation atherosclerotic stenosis (SSPCAS).Materials and methodsPatients with SSPCAS who were treated with the Enterprise stent angioplasty were retrospectively enrolled. The clinical data, peri-procedural complications, postoperative residual stenosis, in-stent restenosis and recurrent stroke at follow-up were analyzed.Results262 patients with 275 stenotic lesions treated with the Enterprise stent angioplasty were enrolled. The stenosis degree was reduced from 86.3 ± 6.2% before to 19.3 ± 5.4% after stenting. Complications occurred in 14 (5.3%) patients. Clinical follow-up was performed in 245 (93.51%) patients for 16.5 ± 7.3 months. During 1 year follow-up, 7 patients (2.9%) had recurrent symptoms, including 4 patients with stenting in the intracranial vertebral artery and 3 in the basilar artery. Imaging follow-up was conducted in 223 (85.11%) patients. In-stent restenosis was present in 35 patients (15.7%), with the restenosis rate of 26.4% (n = 23) in the intracranial vertebral artery, which was significantly (P < 0.001) greater than in the basilar artery (8.8%). Six patients (17.1%) with in-stent restenosis were symptomatic. The stenotic length was the only significant (P = 0.026 and 0.024, respectively) independent risk factor for 1 year stroke or death events and in-stent restenosis.ConclusionThe Enterprise stent can be safely and efficaciously applied in the treatment of symptomatic severe posterior circulation atherosclerotic stenosis, with a relatively low rate of in-stent restenosis and recurrent stroke within 1 year. The stenotic length was the only significant independent risk factor for 1 year stroke or death events and in-stent restenosis.

The relationship between plasma atherogenic index and long-term outcomes after endovascular intervention in superficial femoral artery lesions.

Peripheral arterial disease (PAD) results from the systemic atherosclerotic process. In this study, we aimed to determine the relationship between plasma atherogenic index (AIP), a ratio of molar concentrations of triglycerides to HDL-cholesterol, and long-term outcomes after endovascular therapy (EVT) in patients with superficial femoral artery (SFA) stenosis. We retrospectively evaluated 673 patients who underwent EVT for PAD in our tertiary center between January 2015 and December 2020. In the receiver operating characteristic (ROC) curve analysis, the AIP value with the optimum cutoff value was determined as 0.576 to detect the presence of major adverse limb events (MALEs). Patients were divided into two groups according to low AIP (<0.576 as group 1) and high AIP (>0.576 as group 2). Among the major endpoints, long-term restenosis rates were significantly higher in patients in the high-AIP group than in the low-AIP group (p<.001). The lower extremity amputation rate was not statistically significant between the two groups. All-cause mortality rate (54 (31.6) versus 117 (68.4), p<.001) was significantly higher in patients in the high-AIP group than in the low-AIP group. In addition, the MALE rate (94 (29.2) versus 218 (62.1), p<.001) was significantly higher in patients in the high-AIP group than in those in the low-AIP group. In conclusion, we found that AIP is a significant independent predictor of long-term MALE in patients who underwent EVT for SFA.

Mechanisms and treatment outcomes of ostial right coronary artery in-stent restenosis.

Despite a high rate of in-stent restenosis (ISR) after stenting the right coronary artery (RCA) ostium, the mechanism of ostial RCA ISR is not well understood. We aimed to clarify the cause of ostial RCA ISR using intravascular ultrasound (IVUS). Overall, 139 ostial RCA ISR lesions were identified with IVUS, pre-revascularisation. Primary ISR mechanisms were classified as follows: 1) neointimal hyperplasia (NIH); 2) neoatherosclerosis; 3) ostium not covered by the stent; 4) stent fracture or deformation; 5) stent underexpansion (old minimum stent area <4.0 mm2 or stent expansion <50%); or 6) a protruding calcified nodule. The median duration from prior stenting was 1.2 (first quartile 0.6, third quartile 3.1) years. The primary mechanisms of ISR were NIH in 25% (n=35) of lesions, neoatherosclerosis in 22% (n=30), uncovered ostium in 6% (n=9) (biological cause 53%, n=74), stent fracture or deformation in 25% (n=35), underexpansion in 11% (n=15), and protruding calcified nodules in 11% (n=15) (mechanical cause 47%, n=65). Including secondary mechanisms, 51% (n=71) of ostial RCA ISRs had stent fractures that were associated with greater hinge motion of the ostial-aorta angle during the cardiac cycle. The Kaplan-Meier rate of target lesion failure at 1 year was 11.5%. When the mechanically caused ISRs were treated without new stents, they suffered a higher subsequent event rate (41.4%) compared with non-mechanical causes or mechanical causes treated without restenting (7.8%, unadjusted hazard ratio 6.44, 95% confidence interval: 2.33-17.78; p<0.0001). Half of the ostial RCA ISRs were due to mechanical causes. Subsequent event rates were high, especially in mechanically caused ISRs treated without the implantation of a new stent.

Laminar Flow After Percutaneous Coronary Intervention Guaranteed Lower Rate of in-Stent Restenosis: An Angiographic Imaging and Machine Learning Analysis

Laminar Flow After Percutaneous Coronary Intervention Guaranteed Lower Rate of in-Stent Restenosis: An Angiographic Imaging and Machine Learning Analysis

Restenosis Following Bronchoscopic Airway Stenting for Complex Tracheal Stenosis.

Nonsurgical patients with complex postintubation tracheal stenosis (PITS) and tracheostomy-associated tracheal stenosis (PTTS) often require airway stenting. However, the optimal approach is unknown. Identifying patients at higher risk for restenosis after stent removal may allow the treating physician to individualize the vigilance and duration of airway stenting, and help optimize outcomes. This was a single-center retrospective analysis of prospectively collected data on all patients with complex PITS and/or PTTS treated with protocolized bronchoscopic airway stenting over a consecutive 16-year period. The primary outcome analyzed was restenosis rate at 1 year after stent removal. Predictors for restenosis and factors influencing risk for death during stent therapy were also assessed. Of the 181 subjects treated with silicone airway stenting, 128 were available for analysis of the primary outcome. Restenosis by 1 year after stent removal occurred in 58%. Independent predictors for restenosis were coexisting diabetes [odd ratio (OR)=3.10, 95% confidence interval (CI)=1.04-9.24; P=0.04], morbid obesity (OR=3.13, 95% CI=1.20-8.17; P=0.02), and occurrence of stent-associated complications requiring bronchoscopic management (OR=2.13, 95% CI=1.12-4.03; P=0.02). The overall mortality during the initial stenting period was 14%, and a silicone Y-stent was associated with a higher risk of death (OR=3.58, 95% CI=1.40-9.14; P=0.008). Tracheal restenosis after silicone stent therapy for complex PITS and PTTS is common and more likely to occur in patients with diabetes, morbid obesity, and frequent stent-associated complications. Mortality risk during stent therapy is not negligible, and a Y-stent should be utilized only after careful consideration. These findings may be incorporated into the approach to bronchoscopic airway stenting in these patients.

Evaluation of an Infrapopliteal Drug-Eluting Resorbable Scaffold: Design Methodology for the LIFE-BTK Randomized Controlled Trial.

Criticallimb-threatening ischemia (CLTI) is a severe condition characterized by rest pain and ischemic tissue loss that affects 5% to 10% of people with peripheral artery disease. In the United States, there are few Food and Drug Administration-approved devices for the primary treatment of arteries below-the-knee (BTK). Unfortunately, all suffer from high restenosis rates due to intimal hyperplasia, elastic recoil, and untreated dissection because of a lack of scaffolding. The Esprit BTK system is a resorbable, drug-eluting scaffold device with the potential to address an unmet need in people suffering from CLTI because of infrapopliteal atherosclerosis. The LIFE-BTK (pivotaL Investigation of saFety and Efficacy of drug-eluting resorbable scaffold treatment-Below The Knee) randomized controlled trial (RCT) is a prospectively designed premarket evaluation of the Esprit BTK drug-eluting resorbable scaffold used in the treatment of those patients. The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years. Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.

Use of Mitomycin-C in Laryngotracheal Stenosis: A Focused Clinical Review.

Therapeutic options for managing laryngotracheal stenosis (LTS) are limited. Endoscopy is a minimally invasive approach to treating LTS, but carries a high risk of stenosis recurrence. Mitomycin C (MMC) is often used as an adjunct therapy to delay the time to symptomatic recurrence of LTS. This review synthesizes the current literature on the topic of MMC as an adjunct treatment strategy for LTS. A focused literature search was carried out from PubMed on June 12, 2022 using the terms "mitomycin c AND stenosis" in all fields with no date limitations. Evidence-based recommendations relevant to the clinical application of MMC as an adjunct therapy for LTS were formulated. Three questions were addressed: 1) efficacy of MMC, 2) single versus multiple application(s) of MMC, and 3) safety of MMC. The evidence rating and recommendation strength were guided by the GRADE system. Twenty-nine studies were reviewed. The efficacy of MMC as an adjunct therapy for LTS varied across studies. Randomized controlled trials have not shown an outcome difference with MMC use, although methodologic flaws including underpowering were noted. A meta-analysis of observational studies with a comparator arm found the unadjusted probability of remaining symptom-free for >1 year is greater with versus without MMC application (73% vs. 35%). Single versus multiple application(s) of MMC resulted in similar restenosis rates at long-term follow-up. Complications related to MMC use are rarely reported using conventional doses (0.4mg/mL). Overall, the quality of evidence was low and the recommendation for intervention was weak. The role for MMC as an adjunct therapy in LTS is uncertain. While safe in its application, the efficacy of MMC in reducing stenosis recurrence remains a matter of debate. Large, prospective studies are needed to inform future recommendations.

Effect of Herbal Medicines on Preventing Restenosis After Percutaneous Coronary Intervention: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Objective: This study was conducted to investigate the preventive effect of herbal medicines on restenosis after percutaneous coronary intervention (PCI) by reviewing randomized controlled trials (RCTs).Methods: RCTs were searched for herbal medicine treatment after PCI using eight online databases (PubMed, CNKI, Wanfang, J-STAGE, OASIS, ScienceON, KTKP, and KISS). Studies that confirmed restenosis through coronary angiography at follow-up were selected according to the inclusion and exclusion criteria. The primary outcome was the restenosis rate, and the secondary outcome was the angina recurrence rate. Data were extracted from the final selected studies according to the research methodology and then analyzed with Review Manager 5.4.1. Study quality was assessed using Cochrane’s risk-of-bias (RoB) tool.Results: Of the 252 papers obtained through the primary search, nine studies that met the selection criteria were finally selected. In these nine studies, herbal medicine combined with western medicine was used for the experimental group, and western medicine treatment was used alone for the control group. The meta-analysis result revealed that the restenosis rate and angina recurrence rate were significantly lower in the experimental group than in the control group (RR=0.34, 95% CI: 0.22-0.53, p&lt;0.00001, &lt;i&gt;I&lt;/i&gt;²=0% and RR=0.47, 95% CI: 0.29-0.78, p=0.004, &lt;i&gt;I&lt;/i&gt;²=0%, respectively). Furthermore, the quality of studies assessed by Cochrane’s RoB was low.Conclusions: This study showed that the combined treatment of herbal medicine and western medicine was effective in preventing restenosis and angina after PCI. As the number of papers included in this study was small, a large number of high-quality clinical studies should be considered in the future.

Percutaneous transluminal angioplasty and stenting of post-irradiated stenosis of subclavian artery: A matched case-control study

BackgroundAlthough radiotherapy is common for head/neck and chest cancers (HNCC), it can result in post-irradiation stenosis of the subclavian artery (PISSA). The efficacy of percutaneous transluminal angioplasty and stenting (PTAS) to treat severe PISSA is not well-clarified. AimsTo compare the technical safety and outcomes of PTAS between patients with severe PISSA (RT group) and radiation-naïve counterparts (non-RT group). MethodsDuring 2000 and 2021, we retrospectively enrolled patients with severe symptomatic stenosis (>60%) of the subclavian artery who underwent PTAS. The rate of new recent vertebrobasilar ischaemic lesions (NRVBIL), diagnosed on diffusion-weight imaging (DWI) within 24 h of postprocedural brain MRI; symptom relief; and long-term stent patency were compared between the two groups. ResultsTechnical success was achieved in all 61 patients in the two groups. Compared with the non-RT group (44 cases, 44 lesions), the RT group (17 cases, 18 lesions) had longer stenoses (22.1 vs 11.1 mm, P = 0.003), more ulcerative plaques (38.9% vs 9.1%, P = 0.010), and more medial- or distal-segment stenoses (44.4% vs 9.1%, P<0.001). The technical safety and outcome between the non-RT group and the RT group were NRVBIL on DWI of periprocedural brain MRI 30.0% vs 23.1%, P = 0.727; symptom recurrence rate (mean follow-up 67.1 ± 50.0 months) 2.3% vs 11.8%, P = 0.185; and significant in-stent restenosis rate (>50%) 2.3% vs 11.1%, P = 0.200. ConclusionThe technical safety and outcome of PTAS for PISSA were not inferior to those of radiation-naïve counterparts. PTAS for PISSA is an effective treatment for medically refractory ischaemic symptoms of HNCC patients with PISSA.

Comprehensive mechanical performance characteristics of newly developed ultra-thin coronary stents

Endovascular technologies such as percutaneous transluminal coronary angioplasty and stenting are widely used due to being minimally invasive procedures. One of the endovascular devices, a drug-eluting stent (DES), proved to be a safe and effective therapeutic option for cardiologists, substantially reducing in-stent restenosis (ISR) rates. DES consists of thin (< 200 µm) or ultra-thin (< 70 µm) struts made of Cobalt-Chromium (CoCr) or other alloys. The DES with ultra-thin struts exhibits higher longitudinal flexibility and improved trackability. It also reduces vascular injury and promotes more rapid endothelization, substantially decreasing the risk of ISR. This study evaluates comprehensive mechanical performances of two different structural designs of newly developed ultra-thin CoCr stents (i.e., strut width of 75 µm or 65 µm). These two stent designs are engineered with distinct bridge size and distribution patterns, prioritizing enhanced flexibility irrespective of the strut thickness. Computational modeling results show anticipated stress distribution with maximum local stresses, which are compared with experimental outcomes conducted in this study. ASTM guideline based in vitro experimental studies have been conducted to assess the stents’ longitudinal flexibility, radial strength, recoil and shortening, as well as crushability through this study. Three-point bending experiments have demonstrated that the stent design 1 requires less bending force compared to the design 2, showing better longitudinal flexibility of the stent design 1 in the collapsed state for the new ultra-thin DES devices. The design 1 also showed superior radial strength and recoiling phenomena, as well as smaller shortening. In short, the stent design 1 shows better mechanical performance needed for the coronary artery DES.

Polymer-coated paclitaxel-eluting stents for the treatment of stenosed native arteriovenous fistulas: Long-term results from the ELUDIA study.

Percutaneous transluminal angioplasty is the preferred treatment of stenosed failing arteriovenous fistulas (AVF) but is hampered by increasing rates of vascular restenosis because of development of myointimal hyperplasia. This multicenter observational study of polymer-coated low-dose paclitaxel-eluting stents (ELUvia stents by Boston Scientific) in stenosed AVF undergoing hemoDIAlysis (ELUDIA) was jointly conducted in three tertiary hospitals from Greece and Singapore. Failure of AVF was defined according to K-DOQI criteria and significant fistula stenosis (>50%DS by visual estimate) was determined with subtraction angiography. Patients were considered for ELUVIA stent insertion based on significant elastic recoil following balloon angioplasty for the treatment of a single vascular stenosis within a native AVF. The primary outcome measure was sustained long-term patency of the treated lesion/fistula circuit defined as successful stent placement with resumption of uninterrupted hemodialysis and without significant vascular restenosis (50%DS threshold) or other secondary interventions during follow-up. Some 23 patients received the ELUVIA paclitaxel-eluting stent (eight radiocephalic, 12 brachiocephalic, and three transposed brachiobasilic native AVFs). Mean AVF age at the time of failure was 33.9 ± 20.4 months. Treated lesions included 12 stenoses at the juxta-anastomotic segment, nine at the outflow veins, and two cephalic arch lesions with a mean diameter stenosis of 86 ± 8%. Median stent diameter and length used were 7 mm and 40 mm, respectively. After a median follow-up period of 20 months, some 18 stents out of 23 cases remained patent (cumulative rate 78.3%) without any clinical or imaging evidence of recurrent stenosis. Estimated primary patency of the ELUVIA stents was 80.6% and of the corresponding fistula circuit 65.1% at 2 years by Kaplan-Meier methods. This observational study has shown promising long-term results of polymer-coated paclitaxel-eluting stents for the treatment of failing arteriovenous fistulas. Large-scale controlled studies are necessary.

Vascular reconstruction related to the extracranial vertebral artery: the presentation of the concept and the basis for the establishment of the bypass system.

The intracranial vertebrobasilar artery system has a unique hemodynamic pattern (vessel trunk converged bilateral flow with three groups of perforators directly arising from it), is embedded within intense osseous constraints, and is located far from conventional donor vessels. Two major traditional modalities of posterior circulation revascularization encompass the superficial temporal artery to the superior cerebellar artery and the occipital artery to the posteroinferior cerebellar artery anastomosis, which are extracranial-intracranial low-flow bypass with donor arteries belonging to the anterior circulation and mainly supply focal perforators and distal vascular territories. As our understanding of flow hemodynamics has improved, the extracranial vertebral artery-related bypass has further evolved to improve the cerebral revascularization system. In this article, we propose the concept of "vascular reconstruction related to the extracranial vertebral artery" and review the design philosophy of the available innovative modalities in the respective segments. V1 transposition overcomes the issue of high rates of in-stent restenosis and provides a durable complementary alternative to endovascular treatment. V2 bypass serves as an extracranial communication pathway between the anterior and posterior circulation, providing the advantages of high-flow, short interposition grafts, orthograde flow in the vertebrobasilar system, and avoiding complex skull base manipulation. V3 bypass is characterized by profound and simultaneous vascular reconstruction of the posterior circulation, which is achieved by intracranial-intracranial or multiple bypasses in conjunction with skull base techniques. These posterior circulation vessels not only play a pivotal role in the bypass modalities designed for vertebrobasilar lesions but can also be implemented to revascularize the anterior circulation, thereby becoming a systematic methodology.

Long-term outcomes of drug-coated balloon treatment of calcified coronary artery lesions: a multicenter, retrospective, propensity matching study.

Coronary artery calcification (CAC) is associated with high rates of restenosis and adverse clinical events after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). The aim of this study was to evaluate the long-term clinical outcomes of drug-coated balloon (DCB)-only treatment for de novo lesions with and without CAC. Patients with de novo coronary disease treated with the DCB-only strategy were retrospectively enrolled from three centers and categorized into a CAC group and a non-CAC group. The primary endpoint was the target lesion failure (TLF) rate during the 3-year follow-up. Secondary endpoints included the occurrence of major adverse cardiac events (MACEs), target lesion revascularization (TLR), cardiac death, myocardial infarction (MI) and any revascularization. Propensity score matching (PSM) was conducted to assemble a cohort of patients with similar baseline characteristics. A total of 1,263 patients with 1,392 lesions were included, and 243 patients were included in each group after PSM. Compared with the non-CAC group, the incidence rates of TLF (9.52% vs. 4.94%, odds ratio [OR]: 2.080; 95% confidence interval [CI]: 1.083-3.998, P = 0.034) and TLR (7.41% vs. 2.88%, OR: 2.642; 95% CI: 1.206-5.787, P = 0.020) in the CAC group were higher. The incidence rates of MACE (12.35% vs. 7.82%, OR: 1.665; 95% CI: 0.951-2.916, P = 0.079), cardiac death (2.06% vs. 2.06%, OR: 0.995; 95% CI: 0.288-3.436, P = 0.993), MI (1.23% vs. 0.82%, OR: 2.505; 95% CI: 0.261-8.689, P = 0.652) and any revascularization (12.76% vs. 9.67%, OR: 1.256; 95% CI: 0.747-2.111, P = 0.738) were similar between groups. CAC increased the incidence of TLF and TLR without a substantial increase in the risk of MACE, cardiac death, MI, or any revascularization in patients treated with DCB-only angioplasty during the 3-year follow-up.

THE RISKS AND BENEFITS OF RENAL ARTERY STENTING IN FIBROMUSCULAR DYSPLASIA. LESSONS FROM ARCADIA-POL STUDY

Objective: Percutaneous transluminal angioplasty (PTA) is the recommended revascularization strategy in patients with renal artery stenosis (RAS) caused by fibromuscular dysplasia (FMD), limiting stenting to complications management. However this recommendation is based on cases reports and small series. The main aim of the study was to retrospectively analyze immediate and long-term results of renal stenting and PTA in FMD patients. The second aim was to evaluate the results of stenting as support of renal artery aneurysm (RAA) closure. Design and method: The study group consisted of 58 patients percutaneously treated due to significant RAS (70 arteries) and 9 patients (10 RAAs) with a history of stent implantation before aneurysm embolization, derived from 343 ARCADIA-POL registry patients. PTA was performed as initial treatment in 61 arteries (PTA-group), whereas primary stenting was done in 9 arteries (STENT-group). Stent-related complications(SRC) were defined as: in-stent restenosis (&gt;50%) or occlusion (ISR/O); stent fracture; stent underexpansion (SU) or migration. Results: In PTA-group, the first restenosis rate was 50.8%. Subsequently, 22 arteries underwent a second procedure: re-PTA(12 arteries) or stent implantation(10 arteries) . The incidence of recurrent restenosis after re-PTA was 41.7%. In the 10 arteries initially treated with PTA that underwent stenting for restenosis, complications occurred in 7 of them (70%), including 2 SUs and 5 ISR/Os . In STENT-group, SU occurred in one case (11.1%) and in-stent restenosis in 33.3% (3 of 9 stents). In combined analysis, SRC occurred following 11/19 stenting procedures (57.9%) including 3 periprocedural (SUs) and 8 late complications (ISR/Os). Finally, despite several subsequent revascularization attempts, 4 of 19 (21%) stented arteries were totally occluded and one remained significantly stenosed at follow-up imaging (Figure). In contrast to FMD-RAS procedures, there was only one intraprocedural complication (partial stent migration) and no late SRC in RAA patients. Conclusions: Renal artery stenting in FMD provides modest benefit in terms of restenosis prevention but poses high risk of immediate and late complications, including stent occlusion. Our study supports recommendations limiting stenting to the management of complications. In contrast, renal artery stenting in FMD RAA closure is associated with favorable long-term outcomes.

Safe and effective profile of the VSTENT bioresorbable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary artery lesions: a prospective, cohort, multicenter study.

The drug-eluting stent was a significant stride forward in the development of enhanced therapeutic therapy for coronary intervention, with three generations of increased advancement. VSTENT is a newly developed stent manufactured in Vietnam that aims to provide coronary artery patients with a safe, effective, and cost-efficient option. The purpose of this trial was to determine the efficacy and safety of a new bioresorbable polymer sirolimus-eluting stent called VSTENT. This is a prospective, cohort, multicenter research in 5 centers of Vietnam. A prespecified subgroup received intravascular ultrasound (IVUS) or optical coherence tomography (OCT) imaging. We determined procedure success and complications during index hospitalization. We monitored all participants for a year. Six-month and 12-month rates of major cardiovascular events were reported. All patients had coronary angiography after 6 months to detect late lumen loss (LLL). Prespecified patients also had IVUS or OCT performed. The rate of device success was 100% (95% CI: 98.3-100%; P<0.001). Major cardiovascular events were 4.7% (95% CI: 1.9-9.4%; P<0.001). The LLL over quantitative coronary angiography (QCA) was 0.08±0.19 mm (95% CI: 0.05-0.10; P<0.001) in the in-stent segment and 0.07±0.31 mm (95% CI: 0.03-0.11; P=0.002) in 5 mm within the two ends of the stent segment. The LLL recorded by IVUS and OCT at 6 months was 0.12±0.35 mm (95% CI: 0.01-0.22; P=0.028) and 0.15±0.24 mm (95% CI: 0.02-0.28; P=0.024), respectively. This study's device success rates were perfect. IVUS and OCT findings on LLL were favorable at 6-month follow-up. One-year follow-up showed low in-stent restenosis (ISR) and target lesion revascularization (TLR) rates, reflecting few significant cardiovascular events. VSTENT's safety and efficacy make it a promising percutaneous intervention option in developing nations.

Less Is More: Developments in Nanotechnology for Antirestenosis Therapies.

Despite recent advancements in vascular disease treatments, thrombosis and poor long-term vessel patency remain significant barriers to effective endovascular intervention. Current balloon angioplasty and stenting techniques effectively restore acute blood flow in occluded vessels but have persistent limitations. Damage to the arterial endothelium caused by injury during catheter tracking triggers neointimal hyperplasia and the release of proinflammatory factors leading to increased risk of thrombosis and restenosis. Antirestenotic agents commonly delivered on angioplasty balloons and stents have lowered arterial restenosis rates, but the absence of cell type selectivity significantly delays critical endothelium repair. Targeted delivery of biomolecular therapeutics, coupled with engineered nanoscale excipients, has the potential to redefine cardiovascular interventions by improving long-term efficacy, limiting off-target effects, and reducing costs compared with conventional clinical standards of care. This review analyzes current forms of localized vascular drug delivery, emerging nanoscale therapeutic and excipient strategies, and provides recommendations for future areas of study to advance the treatment of vascular disease through innovations in nanotechnology.

Sex-Related Outcomes in Asymptomatic Patients Undergoing Carotid Artery Stenting.

Aim of the study was to evaluate the influence of sex in asymptomatic patients undergoing carotid artery stenting (CAS). A retrospective observational study was conducted from January 2006 to December 2020. A total of 438 consecutive patients with asymptomatic carotid artery stenosis >70% underwent transfemoral CAS and were stratified in males (M) and females (F). Periprocedural 30-day outcomes were: stroke, death, and myocardial infarction (MI). Follow-up outcomes were: death and stroke rates (primary) and freedom from restenosis (FFR) and reintervention rates (secondary). Follow-up data were analyzed at 1, 5, and 10 years. Data were analyzed with χ2 test and Fisher's exact test and follow-up outcomes with Kaplan-Meier curves. The log-rank test was used to determine differences between the groups and univariate analysis to identify the association between risk factors and intraoperative details with mortality and restenosis rates. A total of 462 procedures were performed (M: n=321, 69.4%), in which 24 CAS were bilateral (5.5%). Mean age was 71.9±7.6 years (M: 72.1±7.8; F: 71.7±7.3). Periprocedural outcomes were: stroke rate 2.2% (n=10; M: n=5, 1.6%; F: n=5, 3.5%; p=0.176), mortality rate 0.6% (M: n=3, p=0.334), and stroke/death rate 2.8% (n=13; M: n=8, 2.5%; F: n=5, 3.5%; p=0.528); no cardiac events (MI) were recorded. A not-disabling (minor) stroke was detected in 3 males (0.9%), while a disabling (major) stroke was reported in 7 patients (1.7%) of whom 5 were ischemic events (M: n=2, 0.6%; F: n=3, 2.2%) and 2 were cerebral hemorrhages (F: 1.3%, p=0.046). Mean follow-up was 73.66±40.83 months (M: 72.66; F: 76.01; p=0.246). Overall survival rate was 96.1% (95% confidence interval [CI]: 93-98), 81.8% (95% CI: 77-86), and 45.5% (95% CI: 38-53) at 1, 5, and 10 years, respectively (p=0.236). The overall stroke rate was 0.3% (freedom from stroke [FFS]: 99.7%; 95% CI: 98-100), 0.9% (FFS: 99%; 95% CI: 98-100), and 4.3% (FFS: 95.7%; 95% CI: 89-98; M: n=6; F: n=2; p=0.774). Stroke-related mortality rate was 0.7% (FFS: 99.3%; 95% CI: 97-100) and 2.9% (FFS: 97.1%; 95% CI: 91-99) at 5 and 10 years, respectively, without differences between the groups (M: n=4; F: n=2; p=0.763). Overall FFR rate was 97.4% (95% CI: 95-99), 93.4% (95% CI: 90-96), and 89.5% (95% CI: 84-93; p=0.322). Two severe symptomatic restenosis (>70%, M) required a new endovascular revascularization. The sex variable does not influence outcomes of CAS in asymptomatic patients at short- and long-term follow-up, although females show a worst incidence of periprocedural major strokes. Carotid artery stenting may be safely proposed when a careful patient selection is applied. The sex variable has been advocated as a considerable factor that could influence the outcomes of transfemoral carotid artery stenting (CAS). Literature data are contrasting, even if different papers mainly reported that CAS is associated to worst outcomes in female patients. Our study shows that the sex-variable does not influence outcomes of CAS in asymptomatic patients at short and long-term follow-up, although females had a worst incidence of periprocedural major strokes. CAS may be safely proposed when a careful patient selection is applied.

Bypass and other modified reconstruction techniques for 'challenging' carotid cases: A comparison with conventional endarterectomy.

Standard carotid endarterectomy (CEA) is usually performed with patch closure or eversion. However, sometimes a 'modified' carotid artery revascularization (MCAR) technique is required if the lesion is complex, extended and anatomically or technically challenging. MCAR is defined as carotid artery bypass; otherwise, it is the combination of common carotid artery (CCA) primary suture or patch angioplasty, associated with internal carotid artery (ICA) patch closure or eversion. The aim of this study was to evaluate the outcomes of MCAR during complex carotid procedures, comparing them with standard CEA. A retrospective analysis of asymptomatic patients who underwent CEA during a 16-year period (June 2005 to June 2021) was performed. Patients were divided into three different groups: ECEA (eversion CEA), PCEA (CEA with patch angioplasty) and MCAR. Primary endpoints were relevant neurological complication rate (RNCR), death within 30days, freedom from ipsilateral stroke, reintervention rates and freedom from carotid artery restenosis. A total of 1,752 patients were included (ECEA: 699; PCEA: 948; MCAR: 105) in the study. Patients treated with MCAR were significantly older and had a higher SVS score for arterial hypertension compared with ECEA and PCEA groups. A long plaque in the CCA was the most common indication for MCAR (40.1%); inadequate distal plaque-end or distal dissection (25.7%) was the second most prevalent indication. Overall perioperative RNCR, defined as minor and major stroke, was 0.7% (ECEA: 0.4%; PCEA: 0.7%; MCAR: 1.9%; p = 0.22), without any significant difference among the three groups. However, patients treated with MCAR had a significantly higher rate of global central neurological complications (defined as transient ischaemic attack, minor stroke and major stroke) than the other cohorts (ECEA: 0.7%; PCEA: 1.2%; MCAR: 3.8%; p = 0.02). One patient (0.05%) died perioperatively of a major cerebral infarction. Long-term follow-up (66.7 ± 43.9) showed a significantly lower rate of freedom from ipsilateral stroke for the MCAR group (96.8%) compared with ECEA and PCEA groups (99.8% and 98.9%, respectively, p = 0.03). Similar reintervention rates (ECEA: 2.7%; PCEA: 3.3%; MCAR: 3.8%; p = 0.74) and freedom from carotid restenosis rates (ECEA: 1.3%; PCEA: 2.6%; MCAR: 1.9%; p = 0.16) were observed. Patients who underwent ICA revascularization with MCAR showed risks of perioperative death, major or minor stroke (<2%), reintervention rates and carotid restenosis rates that are comparable with PCEA or ECEA groups. Nevertheless, the MCAR group showed a significantly higher rate of global central neurological complications (considering together TIA, minor stroke and major stroke) than patients treated with standard CEA. MCAR techniques appear to be effective alternatives to standard CEAs, with an acceptable surgical risk. However, these should be performed mainly in selected cases, for example, in complex anatomy (detected in a non-negligible percentage of patients by preoperative imaging), or in the case of unexpected intraoperative technical issues.