Safety Of Stents Research Articles

A Snapshot on Clinical Trials on Zotarolimus DES: A Repurposing Drug against Myocardial Infarction

AbstractMyocardial infarction is the permanent death (necrosis) of heart muscle caused by a lack of oxygen for an extended period of time (ischemia). Since the very first percutaneous transluminal coronary angioplasty was done 40 years ago, the science of interventional cardiology has advanced dramatically. The above progression began with a balloon catheter attached to a fixed wire, advancing to bare-metal stents, first-generation drug-eluting stents (DES), second- and third-generation biodegradable polymer-based DES. Ultimately, bioabsorbable stents are still in development. Zotarolimus is a new pharmacologic therapy with a similar reprint address; for example, the antirestenosis agent sirolimus has recently been investigated as part of a stent platform combined with a biomimetic phosphorylcholine and BioLINX polymer for its biological activity, as well as its usefulness as an antiproliferative agent. Several clinical trials have been conducted to assess the safety and efficacy of the zotarolimus drug-eluting stent (Z-DES). Medtronic Medical Devices, a global leader in medical technology (United States), and Abbot Global Health Care and Research began clinical trials on the Z-DES in 2002 and will continue through 2021 (INDIA). Endeavor (E-Zes), Resolute (R-Zes), Resolute Integrity (I-Zes), and Resolute Onyx are the different forms of Z-DES that Medtronic has tested in clinical trials. In comparison to other DES, Z-DES was found to be safe in these clinical trials done across multiple nations and in a diverse demographic. This review helps understand the overall clinical trial of Z-DES.

Ductal stenting for retraining the left ventricle in patients with transposition of great arteries with intact ventricular septum: a single-centre experience.

Ductal stenting in late presenters with transposition of great arteries with intact ventricular septum retrains the left ventricle before arterial switch operation. However, the experience is limited for its efficacy and safety. This study aims to highlight the efficacy and safety of ductal stenting for retraining the left ventricle. Eight children with transposition of great arteries-intact ventricular septum and regressed left ventricle underwent ductal stenting. Serial echocardiographic measurements of left ventricle shape, mass, volume, free wall thickness, and function were done, and arterial switch operation was performed once the left ventricle was adequately prepared. Post-operative outcome in terms of duration of mechanical ventilation, ICU stay, and improvement in left ventricle function were monitored. The procedure was successful in all patients. Babies were divided into two groups on basis of age at ductal stenting (group 1 age less than 90 days and group 2 age more than 90 days) and were evaluated for the degree of left ventricle retraining as evidenced by echocardiographic parameters and post-operative variables. The left ventricle posterior wall thickness and mass index after ductal stenting increased significantly in both the groups. Postoperatively, one baby of group two expired after seven days due to severe left ventricle dysfunction. Rest babies had an uneventful post-operative ICU stay with no statistical difference in the duration of invasive mechanical ventilation or ICU stay. On six-month follow-up, all surviving babies were doing well with normal left ventricle function. Ductal stenting is a good alternative measure as compared to surgical procedures for left ventricle retraining in transposition of great arteries with regressed left ventricle.

Impact of a novel-covered colonic stent in obstructive colon cancer.

Although the short-term outcomes of bridge-to-surgery (BTS) procedures using self-expandable metal stents are favorable, concerns remain regarding worsened prognosis due to tissue injury in the tumor area. Herein, we describe a newly developed covered stent, the Kawasumi Jabara colonic stent™, designed to reduce tissue damage/injury associated with stent-related complications in BTS procedures. This study aimed to evaluate the efficacy and safety of the Kawasumi Jabara colonic stent as a BTS for obstructive colorectal cancer (OCC). This multicenter retrospective observational study included 44 OCC patients who underwent BTS with stents at four facilities between September 2020 and November 2022. The groups of patients receiving the Kawasumi Jabara and non-covered colonic stents were designated Groups C and NC, respectively. Treatment outcomes related to stent placement and surgery were compared using propensity score matching (PSM) analysis. Groups NC and C (n = 34 and 10, respectively) showed no significant differences in sex, age, tumor location, histological type, Colorectal Obstruction Scoring System (CROSS) score, or cStage; however, the stent placement duration was shorter in Group C. No significant differences were found in terms of the technical and clinical success rates for stent placement. Stent dislocation was observed in 0 and 2 cases in Groups C and NC, respectively. PSM analysis between eight cases, each from Groups C and NC, revealed no significant differences in stent-related or surgical outcomes between the groups. However, regarding the gross injury score in the resected specimens, Group C had a lower score than Group NC (1.8 vs. 5.5), and the proportion of pathological tissue injury involving deeper layers was also lower in Group C (37.5% vs. 100%). Compared to conventional non-covered stents, the Kawasumi Jabara colonic stent™ demonstrated favorable safety during stent insertion, retention, and surgery, with only mild tissue injury.

De Novo Atherosclerotic Renal Artery Stenosis Covered Stent Treatment for Resistant Hypertension (ARTISAN) Results

BackgroundAtherosclerotic renal artery stenosis (ARAS) may provoke hypertension and/or impaired kidney function. Some patients develop uncontrolled hypertension and deteriorating kidney function despite optimal medical therapy. In these patients, endovascular treatment is an important therapeutic option. ARTISAN was a prospective, open-label, single-arm, multicenter clinical trial to evaluate the safety and effectiveness of the iCast RX covered stent both functionally for reestablishing renal artery flow, and clinically for controlling resistant hypertension. MethodsPatients considered for enrollment had average systolic blood pressure (SBP) ≥155 mm Hg despite taking 3 antihypertensive medications. Prior to enrollment and covered stent placement, angiographic confirmation of ARAS ≥80% with physiologic significance was required. Clinical assessments were performed at 30 days, 9 months, and annually through 36 months. Covered stent safety and efficacy were based on 9-month coprimary end points, including primary vessel patency and SBP improvement at 9 months. Secondary outcomes included target lesion revascularization, major adverse events, and secondary patency. ResultsSixty-eight of the planned 138 subjects were enrolled. Primary patency was seen in 94.3% of subject lesions; the mean SBP reduction was 15.7 mm Hg. The functional and clinical end points met prespecified performance goals of 70% primary patency (P < .0001) and ≥10 mm Hg SBP decrease (P = .0192), respectively, at 9 months. Six subjects (8.8%) experienced 7 major adverse events within 36 months. The clinically driven target lesion revascularization rate was 7.3% at 36 months. ConclusionsThe high primary patency and improvement in SBP, persisting through 36 months, suggest that the iCast RX covered stent is safe and effective for the treatment of appropriately selected patients with ARAS.

COMPARISON OF DRUG-ELUTING STENTS VERSUS BARE-METAL STENTS FOR THE TREATMENT OF CORONARY ARTERY DISEASE

Coronary artery disease is a condition that affects millions of people worldwide and can lead to serious complications such as heart attack or stroke. Objectives: The study compares drug-eluting stents to bare-metal stents for treating coronary artery disease. Methods: The present study aimed to compare the efficacy and safety of drug-eluting stents (1) versus bare metal stents (BMS) for the treatment of coronary artery disease (CAD). The study was conducted at Cardiology Department Hayat Abad Medical Complex Peshawar Pakistan, from 01 January 2022 till 30 June 2022. The study included a total of 384 patients with CAD who underwent percutaneous coronary intervention (PCI) with either DES or BMS. Results: The study included a total of 384 patients with CAD who underwent PCI with either DES or BMS. The mean age of the study participants was 58.2 ± 9.4 years, and 75.8% were male. The baseline characteristics, including demographic data, clinical presentation, cardiovascular risk factors, and angiographic findings, were comparable between the two groups. Conclusion: In conclusion, our study contrasting medication-eluting stents versus exposed metal stents for the treatment of coronary supply route sickness found that drug-eluting stents were related to a lower chance of unfriendly heart occasions, including objective vessel revascularization, myocardial dead tissue, and cardiovascular demise, contrasted with uncovered metal stents.

Efficacy and safety of a novel polytetrafluoroethylene-coated self-expandable metal stent for distal malignant biliary obstruction.

Stent migration and sludge formation remain significant problems associated with covered self-expandable metal stents (CSEMSs). The EGIS biliary stent fully covered flare type (EGIS biliary stent), a new type of polytetrafluoroethylene-coated self-expandable metal stent with low axial force and an anti-migration system, was developed to overcome these disadvantages. We conducted this study to evaluate the efficacy and safety of this stent in comparison with conventional CSEMS (c-CSEMS). We retrospectively analyzed consecutive patients with unresectable pancreatic cancer who received initial CSEMS for distal malignant biliary obstruction. The primary outcome was time to recurrent biliary obstruction (RBO). Secondary outcomes included technical success rate, functional success rate, stent-related adverse events, causes of RBO, and re-intervention. A total of 40 patients were included (EGIS group: 20; c-CSEMS group: 20). The technical and functional success rates were similar between the two groups. Stent-related adverse event rates (20% vs. 15%, p > 0.99) and overall RBO rates (56% vs. 50%, p > 0.99) were not significantly different between the two groups. Stent migration was the most common cause of RBO in the EGIS group, while stent occlusion was in the c-CSEMS group. The median time to RBO (102 vs. 434 days, p = 0.10) was not significantly different between the two groups. Endoscopic transpapillary re-intervention was successful in most patients in both groups. The EGIS biliary stent was not associated with a longer time to RBO compared to c-CSEMS. Further improvements, especially against stent migration, are needed to improve its efficacy.

Clinical safety and performance of the world's thinnest-strut Evermine50 everolimus-eluting stent: a 24-month follow-up of the Evermine 50 EES - 1 study.

Ultrathin-strut stents are considered the future of percutaneous coronary intervention for treating coronary artery disease (CAD). These drug-eluting stents with biodegradable-polymer technology have the potential to improve clinical outcomes in CAD patients. This study aimed to evaluate the safety and performance of newer-generation ultrathin-strut (50 µm) Evermine50 everolimus-eluting stents (EES) in patients with single or multiple long lesions. This is a prospective, single-arm, multicentre study conducted in India that enrolled 118 patients with de novo coronary lesions. The endpoints were defined based on the major adverse cardiac events (MACE; composite of cardiac death, myocardial infarction [MI] and clinically driven target lesion revascularisation) up to 24-month follow-up. A subset of patients (n=21) underwent angiographic follow-up for a mean follow-up period of 12 mon. A total of 138 lesions were successfully treated in 118 patients, the majority of whom were males (80.51%). The average stent length and diameter deployed were 26.02±9.24 mm and 2.97±0.36 mm, respectively. The results exhibited low MACE at 24-month follow-up (0.87%) with no stent thrombosis and 1 death (0.87%, which was cardiac). The core lab angiographic assessment showed in-segment and in-device late lumen loss of 0.12±0.31 mm and 0.17±0.31 mm, respectively, at a mean follow-up of 12 months, with clinically acceptable outcomes. The Evermine50 EES showed satisfactory primary clinical as well as angiographic outcomes, reaffirming the safety and performance of the world's thinnest-strut stent by exhibiting low rates of MACE at 24-month follow-up with an absence of any stent thrombosis and MI. Clinical Trials Registry-India (CTRI) number: CTRI/2017/02/007781.

Real-world evidence of BioMime sirolimus-eluting stent in obstructive coronary artery disease: the meriT-2 trial.

The efficacy and safety of the ultrathin BioMime sirolimus-eluting coronary stent (SES) system in treating single or multiple de novo native coronary lesions, in-stent restenosis, and bifurcation lesions have been evidenced at 1 year. We sought to investigate the long-term safety and efficacy of the BioMime SES in a real-world population with obstructive coronary artery disease (CAD). The prospective, single-arm, multicentre meriT-2 trial enrolled 250 patients from 11 sites across India. The safety endpoint was the cumulative frequency of major adverse cardiovascular events (MACE) at 5 years, defined as a composite of cardiac death, myocardial infarction (MI), emergent coronary artery bypass grafting or clinically indicated target lesion revascularisation (CI-TLR). Stent thrombosis (ST) was evaluated according to the Academic Research Consortium definitions. A total of 214 (85.6%) subjects completed the 5-year follow-up. The mean age of patients was 57.44±10.75 years, and 82.71% were males. A total of 308 lesions were treated with BioMime SES. Most of the lesions were localised in the left anterior descending artery (45.46%) and were type B2 lesions (44.81%). The cumulative MACE rate at 5 years was 8.9% (n=19), including 0.9% cardiac deaths, 1.9% MI and 6.1% CI-TLR. The rate of ST was only 0.5%. The Kaplan-Meier survivor analysis revealed actuarial survivorship of 95.6% for the intention-to-treat population (n=250) over 5 years. The long-term clinical outcomes of the meriT-2 trial established the safety and efficacy of the ultrathin-strut biodegradable-polymer-based BioMime SES with satisfactory clinical outcomes at 5 years.

WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts—study protocol for a multicentre randomised non-inferiority trial

BackgroundEndoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts.MethodsThe WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator’s discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs.DiscussionThe WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population.Trial registrationClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.

Safety and Efficacy of Direct Stenting versus Balloon Pre Dilatation in Patients with Chronic Coronary Syndrome

Safety and Efficacy of Direct Stenting versus Balloon Pre Dilatation in Patients with Chronic Coronary Syndrome

Optimizing the outcome of non-pre-stented flexible ureteroscopic lithotripsy regarding the quality of life, when to remove the stent?

ObjectivesTo investigate the safety of short-term stenting following flexible ureteroscopic lithotripsy (fURL) for patients without preoperative stents. Retaining double-J stent for 1–2 weeks after fURL is a common practice. At present, data on short-term stenting after non-pre-stented fURL is still lacking.Methods182 patients who met inclusion criteria were retrospectively divided into the 2-days group (2-day removal, 76 cases) and the 1-week group (1-week removal, 106 cases). The study endpoint was stent-associated adverse symptoms assessed by follow-up and completed validated questionnaires on postoperative days (POD) 7 and 12. A postoperative imaging review was performed 1 month after the surgery.ResultsNo statistical differences were found in the patients’ demographic and stone-related characteristics. The 2-days group showed fewer urinary tract symptoms and lower scores on the ureteral stent symptom questionnaire on POD 7: less backache during urination (p = 0.004), less hematuria (p = 0.031), less frequent urination (p = 0.004), lower urinary symptoms index (p < 0.001), lower general health index (p < 0.001), and lower performance index (p < 0.001). There were no significant differences in fever (p = 0.372), visual analogue scale score (p = 0.760), and painkiller requirements (p = 0.160) on POD 7. The average general health score and work performance score remained significantly higher in the 1-week group patients at 5 days after removal compared to the 2-days group patients at 5 days after removal. (p < 0.001, p = 0.005). Five patients in the 2-days group and 15 patients in the 1-week group returned to the emergency department for additional treatments. No patient required rehospitalization. Stone-free rates were 85.5% in the 2-days group and 80.2% in the 1-week group (p = 0.499), respectively, and none of the patients got aggravating hydronephrosis.ConclusionsCompared to the common 1-week stent removal option, short-term stenting after non-pre-stented fURL is safe, which can enhance the patient’s quality of life.

Efficacy and safety of self-expandable metallic stents for management of benign gastric outlet obstruction-A prospective study.

We aimed at evaluating the safety and efficacy of self-expandable metallic stent (SEMS) insertion for managing patients with benign gastric outlet obstruction (GOO). This prospective interventional study included 23 patients. All consecutive treatment-naïve symptomatic patients with benign GOO were recruited. Fully covered SEMS were deployed across the stricture under fluoroscopic and endoscopic guidance. Technical success, clinical success and sustained treatment response (STR) were assessed. Technical success was defined as the successful deployment of SEMS at the desired anatomic location. Clinical success was defined as the resolution of symptoms and an increase in Gastric Outlet Obstruction Scoring System (GOOSS) of at least 1 point from the baseline score on Day 7. STR was assessed at four and eightweeks post stent removal in patients who had a response at week four. Factors associated with stent migration and non-response at week four were also assessed. The median age of the study population was 30years (range 19-65years). Males constituted 65.22%. Most patients presented with vomiting (100%) and abdominal pain (95.65%). Peptic stricture was most common etiology for GOO (60.9%) followed by tubercular (26.1%) and corrosive (13%). Most common site of obstruction was junction of first and second part of duodenum (69.57%) followed by pyloric (30.43%). Median length of stricture was 2cm (range 1.5-4). Technical success was achieved in all 23 patients (100%). Clinical success was achieved in 21 patients (91.3%). Response at Day 28 was seen in 20 patients (86.95%). Eighteen of 20 (90%) patients who had a response at week four had STR at week four and week eight after stent removal. Stent migration occurred in five (21.7%) patients. On univariate analysis, stricture length, calibre and stent length were found to predict migration. Fully covered SEMS was an effective and safe management modality in patients with benign GOO. Stent migration remains a troublesome disadvantage.

Short-term outcomes of the iCover balloon-expandable covered stent for iliac artery lesions.

To describe the short-term follow-up results of the recently introduced iCover balloon-expandable covered stents for iliac artery lesions. All consecutive patients treated with iCover balloon-expandable covered stents between March 2022 and August 2023 were retrospectively reviewed. The primary endpoint was target lesion revascularization (TLR) at 6 months. Secondary endpoints included major adverse events, freedom from TLR throughout the follow-up period, primary and secondary patency, and clinical and technical success. In the study population of 40 adult patients (87.5% men, mean age: 63.5 ± 11 years), the mean follow-up period was 6.2 ± 2.8 months. A total of 98 stents of various sizes were implanted. The technical success rate was 100%. Freedom from TLR was 95.8% [95%, confidence interval (CI): 95%- 96.6%], the primary patency rate was 91.7% (95%, CI: 89.8%-93.6%), and the secondary patency rate was 95.8% (95%, CI: 95%-96.6%) at 6 months. The all-cause mortality rate was 5%. These real-world data demonstrate a high technical and clinical success rate, a high 6-month primary patency rate, and a low requirement for TLR. These are promising indicators for the safety and efficacy of iCover stents. Balloon-expandable covered stents are frequently used in iliac artery atherosclerotic disease. This study shows that the short-term follow-up results of the new iCover stent are satisfactory, indicating its safety and efficacy.

Stenting versus medical treatment alone for symptomatic intracranial artery stenosis: a preplanned pooled individual patient data analysis

BackgroundWhether the safety and efficacy of percutaneous transluminal angioplasty and stenting (PTAS) is significantly different from that of medical treatment alone for symptomatic intracranial arterial stenosis (ICAS) is debatable. A...

Study on in vivo and in vitro degradation of polydioxanone weaving tracheal stents

The appropriate degradation characteristics of polydioxanone (PDO) are necessary for the safety and effectiveness of stents. This study aimed to investigate the degradation of PDO weaving tracheal stents (PW stents)in vitroandin vivo. The degradation solution ofS. aureus(SAU),E. coli(ECO),P. aeruginosa(PAE), and control (N) were prepared, and the PW stents were immersed for 12 weeks. Then, the radial support force, weight retention, pH, molecular structure, thermal performance, and morphology were determined. Furthermore, the PW stents were implanted into the abdominal cavity of rabbits, and omentum was embedded. At feeding for 16 weeks, the mechanical properties, and morphology were measured. During the first 8 weeks, the radial support force in all groups was progressively decreased. At week 2, the decline rate of radial support force in the experimental groups was significantly faster compared to the N group, and the difference was narrowed thereafter. The infrared spectrum showed that during the whole degradation process, SAU, ECO and PAE solution did not lead to the formation of new functional groups in PW stents.In vitroscanning electron microscope observation showed that SAU and ECO were more likely to gather and multiply at the weaving points of the PW stents, forming colonies.In vivoexperiments showed that the degradation in the concavity of weaving points of PW stents was more rapid and severe. The radial support loss rate reached more than 70% at week 4, and the radial support force was no longer measurable after week 8. In omentum, multinuclear giant cells and foreign giant cells were found to infiltrate. PW stents have good biocompatibility. The degradation rate of PW stents in the aseptic conditionsin vivowas faster than in the bacteriological environmentin vitro.

Safety and efficacy of drug-eluting stents versus heparin-bonded stents in treatment of femoropopliteal peripheral artery disease: study protocol for a multicentre, prospective randomised controlled trial in China (ELITE trial)

IntroductionEndovascular therapy has emerged as a prominent strategy for managing femoropopliteal peripheral artery disease, offering acceptable safety and efficacy compared with open surgical bypass. Both paclitaxel-eluting stents and heparin-bonded covered...

Safety and effectiveness of LEO stents for dual stent-assisted embolization combined with IA and IV intra-procedural infusion of tirofiban in the treatment of wide-necked intracranial bifurcation aneurysms.

To evaluate the safety and efficacy of employing LEO stents in dual stent-assisted embolization (DSAE) for wide-necked intracranial bifurcation aneurysms, and to assess the effectiveness of combined IA and IV intra-procedural infusion of tirofiban in mitigating perioperative complications. Clinical data and follow-up images from 562 patients with wide-necked intracranial bifurcation aneurysms treated at First Affiliated Hospital of Army Medical University from 2018-2022 were collected. Among them, 65 received DSAE with LEO stents. The study observed treatment success rates, procedure-related complications, perioperative thromboembolic events (TEs) and hemorrhagic events (HEs), immediate postoperative modified Raymond-Roy classification (mRR), and follow-up imaging. Glasgow Outcome Scale (GOS) at discharge and clinical follow-ups were recorded. The study enrolled 65 patients (mean age: 56.77 ± 10.07) with wide-necked intracranial bifurcation aneurysms. Among them, 58 had unruptured aneurysms, 7 ruptured (Hunt-Hess II-III). All aneurysms were successfully embolized without significant stent or bleeding complications. Only one case had intraoprative thrombosis; two postoperative ischemic incidents occurred within three days, no severe bleeding events. Immediate imaging showed modified Raymond-Roy classification: mRRC I (92.3%), mRRC II (4.6%), mRRC III b (3.1%). A total of 43 patients were followed up postoperatively with DSA. Among them, 41 patients exhibited mRRC I, while 2 patients exhibited mRRC II. No aneurysm was recanalized. Discharge GOS: GOS 5-60, GOS 4-1, GOS 3-4. One patient, GOS 1, died from lung cancer; others improved. The utilization of LEO stents for dual stent-assisted embolization of wide-necked intracranial bifurcation aneurysms demonstrated remarkable success and safety, yielding favorable postoperative outcomes and no instances of aneurysm recurrence. The concomitant administration of perioperative antiplatelet medications alongside IA and IV intra-procedural infusion of tirofiban effectively attenuated thromboembolic events (TEs) without concomitant elevations in bleeding risks.

Treatment Strategies for Asymptomatic Carotid Stenosis: A Systematic Review and Bayesian Network Meta-Analysis.

To compare the safety and efficacy of carotid endarterectomy (CEA), carotid stenting (CAS), and optimal medical therapy (OMT) in patients with asymptomatic carotid stenosis. Relevant randomized controlled trials were researched with PubMed, Web of Science, and the Cochrane Library databases. Fixed-effects model and random-effects model were used to estimate the relative risks and the hazard ratios (HRs). The results of the probabilistic analysis were reported as surfaces under the cumulative ranking curve. Eight randomized controlled trials were included. Data from 10 348 patients (CEA: n = 4758; CAS: n = 3919; OMT: n = 1673) were evaluated. Compared with the previous OMT, CEA, CAS, and the current OMT (c-OMT) were all effective in reducing the risk of stroke (CEA: HR, 0.52; CI, 0.40-0.66; CAS: HR, 0.58; CI, 0.42-0.81; c-OMT: HR, 0.40; CI, 0.15-0.94); CEA and CAS reduced the risk of ipsilateral stroke (CEA: HR, 0.41; CI, 0.28-0.59; CAS: HR, 0.51; CI, 0.31-0.84), and the risk of fatal or disabling stroke (CEA: HR, 0.59; CI, 0.43-0.81; CAS: HR, 0.57; CI, 0.34-0.95). Regarding reducing the risk of stroke, only CEA was statistically significant in patients with any degree of stenosis compared with the previous medical treatment (<80%: HR, 0.48; CI, 0.33%-0.70%; 80%-99%: HR, 0.53; CI, 0.38-0.73). In the treatment of asymptomatic carotid stenosis, the perioperative outcomes of CAS were similar to that of CEA; CEA, CAS, and c-OMT shared similar long-term outcomes; and CEA and CAS may be more effective in patients with high levels of asymptomatic stenosis.

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.

Navigating complexity with low-crossing profile dual-layer micromesh carotid stent: implications for contemporary carotid artery stenting outcomes (ROADSAVER study insights).

The safety and efficacy of carotid artery stenting (CAS) can be affected by certain technical and anatomical factors. However, it is not known whether the use of a dual-layer micromesh stent (DLMS) with a low-crossing profile could reduce the risks associated with complex vascular anatomies during CAS. This study involved 1965 asymptomatic or symptomatic carotid artery stenosis patients who received the Roadsaver DLMS during CAS, as part of a prospective, multicenter observational ROADSAVER study, conducted from January 2018 to February 2021. The primary outcome was the 30-day rate of major adverse events (MAE; i.e. any death or stroke) after CAS. Procedural details and outcomes were compared between patients with complex anatomical features and those without. One or more complex anatomical characteristics were identified in 1639 (83.4%) patents. Patients with complex anatomies were older and had a higher prevalence of arterial hypertension, cardiovascular disease, and prior stroke. Between patients with or without complex anatomical features, no significant differences were found either in procedural techniques, or in 30-day MAE (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.76 (0.35, 1.66); p=0.4905) and any stroke (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.89 (0.37, 2.17); p=0.8032) incidence. Furthermore, neither the presence of specific types of anatomic complexity nor their number (per patient) markedly influenced the 30-day MAE and any stroke incidence. In this real-world cohort of patients undergoing CAS with the Roadsaver DLMS, no significant difference in the occurrence of 30-day MAE and any stroke was observed between patients with or without high-risk anatomical features.