Angioplasty Research Articles

Achalasia in an Eight-Week-Old Infant Successfully Managed by CRE Balloon Dilatation: A Case Report and Literature Review

Achalasia in an Eight-Week-Old Infant Successfully Managed by CRE Balloon Dilatation: A Case Report and Literature Review

A novel intrauterine estrogen-releasing system for preventing the postoperative recurrence of intrauterine adhesion: a multicenter randomized controlled study

BackgroundTranscervical resection of adhesions (TCRA) is the standard treatment for intrauterine adhesion (IUA). Previous studies have shown that postoperative oral estrogen or an intrauterine physical barrier could reduce the recurrence of IUA by promoting the proliferation of the endometrium or inhibiting the reformation of adhesions. Our team designed an intrauterine stent that can release estrogen within the uterine cavity slowly. In this study, we aimed to investigate the efficacy and safety of the estrogen-releasing intrauterine system in preventing the recurrence of moderate to severe IUA.MethodsThis was a multicenter prospective randomized controlled 2-arm parallel trial that included patients who were diagnosed with moderate to severe IUA and who received TCRA. A total of 250 patients were randomly assigned, at a 1:1 ratio, to receive the intrauterine estrogen-releasing system or a Foley catheter balloon combined with oral estrogen therapy after surgery. The primary outcome was the rate of adhesion reduction in the two groups. The secondary outcomes included endometrial thickness at the ovulation period, menstrual improvement rates, and other reported adverse events during follow-up.ResultsThe average daily drug release amount for all the tested stents was 0.21 mg/day. At 60 days postoperatively, the rate of adhesion reduction was significantly greater in the experimental group than in the control group (93.33% vs. 58.56%, p < 0.001). The endometrium of the experimental group was thicker than that of the control group (p < 0.001). Consistently, the rate of improvement in menstruation was greater in the experimental group than in the control group (p = 0.010). No grade 3–4 adverse events were found in the two groups during the 1-year follow-up.ConclusionsIn the cohort of patients with moderate to severe IUA, the intrauterine estrogen-releasing system was more effective at reducing adhesion than traditional oral estrogen combined with an intrauterine Foley catheter after TCRA. This novel intrauterine system provides a new option for the management of IUA after surgery.Trial registrationThe registration number is NCT04972032. Date of registration: August 15, 2021.

COMPARISON OF DIRECT STENTING VERSUS PRE-DILATION OUTCOMES IN PRIMARY PCI AT A MAJOR HOSPITAL

Stents are utilized in over 95% of percutaneous coronary interventions (PCIs), and advancements in balloon and stent technologies have fostered the development of direct stent (DS) delivery. This approach, which bypasses pre-dilatation, may offer distinct advantages over conventional stenting (CS), which includes balloon dilation before stenting. Objective: To evaluate the angiographic and short-term clinical outcomes of direct stent placement compared to traditional stenting following balloon dilation in patients undergoing primary percutaneous coronary interventions. Methods: This cross-sectional study was conducted from December 2023 to May 2024 at Hayatabad Medical Complex, Pakistan. One hundred patients undergoing primary PCI were randomly assigned to two groups: Group A (n=50) received direct stent placement, and Group B (n=50) underwent stenting following balloon dilation. Data collection included demographic details, coronary intervention details, and procedural outcomes from medical records. Statistical analyses were performed using SPSS software, with Independent samples t-tests used to compare fluoroscopy times, procedure durations, and contrast usage, considering a P-value &lt; 0.05 as significant. Results: The study enrolled 100 patients, with a mean age of 52.8 ± 11.0 years; 76% were male. The most commonly treated vessel was the left anterior descending artery. Group A demonstrated a significantly shorter fluoroscopy time (4.6 ± 2.9 minutes vs. 6.9 ± 4.1 minutes, P=0.001) and total procedure duration (24.4 ± 12.4 minutes vs. 34.6 ± 13.5 minutes, P=0.008) compared to Group B. Furthermore, Group A used less contrast material than Group B. Conclusion: Direct stenting offers a safer, quicker, and more cost-effective alternative to conventional stenting with balloon dilation in primary PCI. This method reduces radiation exposure, procedural costs, and operational time, potentially enhancing outcomes for patients and healthcare teams.

Sex/Gender Differences in Esophageal Motility Disorders

Esophageal motility disorders are relatively rare and are attributed to an imbalance between the excitatory and inhibitory nerves that innervate the esophagus. These disorders include achalasia, distal esophageal spasms, and jackhammer esophagus. The prevalence of achalasia is equal in men and women; however, lower esophageal hypermotility disorders are slightly more common in women. Women with achalasia experience chest pain more frequently, whereas men tend to have high lower esophageal sphincter pressure. Additionally, women with achalasia respond better to pneumatic balloon dilatation than men. However, research on sex and gender differences in the outcomes of peroral endoscopic myotomy remains insufficient. Future studies should investigate the differences in outcomes, complications, and long-term effects to ensure optimal treatment in men and women with esophageal motility disorders. This research will be useful to develop sex-tailored treatments for esophageal motility disorders.

Endoscopic Management of Lower Gastrointestinal Tract Anastomosis Strictures: A Meta-Analysis and Systematic Review of the Literature.

Anastomotic strictures following colectomy and proctectomy are a significant cause of benign lower gastrointestinal tract (LGIT) obstruction, with a reported incidence of up to 30%. Endoscopic interventions such as balloon dilation, stricturotomy, mechanical dilation, electrocautery incision, and stent placement are utilized for management. This meta-analysis aimed to evaluate the efficacy and safety of endoscopic interventions for the management of benign LGIT anastomotic strictures. Literature search was performed for published full-text articles using the Embase, Pubmed, Web of Sciences, and Cochrane databases for endoscopic management of anastomosis strictures and related terms including endoscopic balloon dilation (EBD), stricturotomy (EST), mechanical dilation, electrocautery incision (ECI), and stent placement. A total of 1363 patients from 33 studies were included. The most common indication for anastomosis was colorectal cancer (92%). Overall technical success (ability to pass the endoscope) was achieved in 93% of cases, with immediate clinical success in 85% and sustained success in 81% at follow-up. ECI demonstrated the highest clinical success rates (98% immediate, 91% at the end of follow-up). Adverse events occurred in 6% of patients, most commonly perforation, which was most frequent with EBD. Stent placement showed high initial success but had issues with stent migration and adverse events. Overall, EBD and ECI were the most effective, with ECI showing the highest success rates. Despite its technical challenges, EST was both effective and safe. This study underscores the need for further prospective research comparing various endoscopic interventions to improve management strategies for LGIT anastomotic strictures.

Successful treatment of chronic venous in-stent restenosis using a Phoenix atherectomy device.

Although endovascular treatment of venous obstruction with percutaneous transluminal angioplasty (PTA) and stenting is a safe and effective alternative to conservative treatment, the overall prevalence of in-stent restenosis (ISR) remains high in this patient population. This study reports a novel treatment option for patients with chronic ISR (C-ISR). At our center, all patients with ISR were treated based on the time since the initial intervention. Acute in-stent restenosis (A-ISR) was preferably treated with catheter-directed thrombolysis or a pharmacomechanical peripheral thrombectomy device and PTA. Selected patients with chronic ISR (C-ISR) (greater than 30 days) were treated with a catheter- guided unidirectional atherectomy in addition to PTA, under the assumption of a non-thrombotic mechanism in the development of C-ISR. We demonstrate a safe and practical treatment option for chronic ISR using a catheter- guided technical approach with the Phoenix atherectomy device in four patients. Technical success was achieved in every case, and mid-term patency was restored in three out of four patients. Restenosis following venous stenting is highly complex. Patients must be treated individually, with a focus on anticoagulation and antiplatelet therapy regimens, as well as the appropriate interventional treatment. Catheter- guided atherectomy is a viable option for this heterogeneous group of patients. Further studies are required to understand the etiology of chronic ISR.

Endoscopic balloon dilatation of primary obstructive megaureter: An effective first line management in children

Endoscopic balloon dilatation of primary obstructive megaureter: An effective first line management in children

Pressure-responsive pH-triggered layer-by-layer coating of paclitaxel-eluting balloon catheters for instant high-dose drug delivery for percutaneous coronary artery intervention

Pressure-responsive pH-triggered layer-by-layer coating of paclitaxel-eluting balloon catheters for instant high-dose drug delivery for percutaneous coronary artery intervention

Multicenter randomized controlled trial to assess the effectiveness of PASSEO-LUX DCB® drug coated balloon compared to plain balloon angioplasty of arteriovenous fistulae for hemodialysis: Two-years results.

To compare primary patency after angioplasty with drug-coated balloon (DCB)-Passeo-18Lux, BIOTRONIK versus uncoated balloon in dysfunctional peripheral vascular access (PVA) for hemodialysis. A total of 133 patients from four hospitals were randomized to receive DCB or plain old balloon angioplasty (POBA) after satisfactory treatment (residual stenosis <30%) with high pressure balloon (HPB). The primary endpoint was clinical patency of PVA 2 years after angioplasty. Secondary endpoints included the relationship between the location of stenosis and patency and also, other covariates. Mortality at 2 years was compared between both groups. Patency measured in days after angioplasty was higher in fistulae dilated with DCB than HPB. Kaplan-Meier survival curves showed the next percent of success (free time restenosis) after DCB versus POBA at 6 months-77.1% versus 58.2% (160.41-143.72 days until restenosis), 12 months-51.4% versus 44.3% (274.1-237.23), 18 months-38.6% versus 38% (350.74-305.18), and 24 months-37.1% versus 30.4% (419.04-369.1). At 6 months, this difference was statistically significant (p = 0.018), but not at 12 (p = 0.225), 18 (p = 0.471), or 24 months (p = 0.236). Mortality was similar in both groups. DCB angioplasty resulted in superior target lesion primary patency (TLPP)-free survival at 6 months of follow-up. No significant improvements in TLPP-free survival long term were observed. Mortality observed at 1 and 2 years was similar in DCB and POBA: there was no significant difference, and a safety study demonstrated no difference between the two groups (complications and mortality): DCB is safe to use in stenosis treatment in patients who are PVA carriers. Level Ia, therapeutic study, RCT. EBM ratings will be based on a scale of 1-5.

Procedural safety of rotational atherectomy and modified balloon angioplasty: insights from a German national registry.

Modified balloons (MB) and rotational atherectomy (RA) are recommended tools for treatment of coronary plaques with superficial calcium. Knowledge about in-hospital safety is limited. Patients with coronary artery disease who underwent coronary angiography with RA or MB angioplasty in Germany were identified via ICD and OPS codes from 2017 to 2020. Acute coronary syndromes were excluded. Since patients were not randomized toward MB or RA, potential confounding factors were taken into account using the propensity score methods. Thereby, inverse probability weighting was applied. Ten thousand.ninety-twopatients underwent RA with an increasing trend from 1817 in 2017 toward 3166 in 2020. MBs were used in 22,378 patients also with an increasing trend from 4771 in 2017 toward 6078 in 2020. Patients receiving RA were older (74.23 ± 8.68 vs. 71.86 ± 10.02, p < 0.001), had a higher Charlson Comorbidity Index (2.07 ± 1.75 vs. 1.99 ± 1.76, p = 0.001) and more frequently left main (17.96% vs. 12.91%, p < 0.001) or three vessel disease (66.25% vs. 58.10%, p < 0.001). Adjusted procedural risk of major adverse cardiac and cerebrovascular events (MACCE) was similar in both groups, while pericardial effusion (RR 2.69; 95% CI 1.88-3.86, p < 0.001), pericardial puncture/pericardiotomy/pericardial tamponade (RR 2.66; 95% CI 1.85-3.81, p < 0.001) and bleeding (RR 1.65; 95% CI 1.12-2.43, p < 0.011) occurred more frequently in patients receiving RA. Patients treated with RA at high volume centers were hospitalized shorter (p = 0.005) and had a lower rate of acute cerebrovascular events (p < 0.001). Rate of MACCE, bleeding and pericardial puncture were not influenced by the annual RA numbers per center. MBs had a lower risk of bleeding and pericardial puncture. Patients treated at centers with high annual RA procedure numbers had a lower risk of acute cerebrovascular events and were hospitalized shorter.

Long-term efficacy of drug-coated balloon-only angioplasty for IgG4-related coronary artery disease: A case report

Abstract Background Although coronary artery involvement in patients with IgG4-related disease (IgG4-RD) is rare, emergency revascularisation is recommended for managing acute coronary syndrome. However, coronary aneurysm formation and stent migration after sirolimus-eluting stent implantation have been reported for this disease. Thus, new treatment modalities are warranted for the management of coronary artery disease in this vasculitis. Case summary A 70-year-old male who experienced progressive chest discomfort for 1 month underwent cardiac examination. Coronary computed tomography angiography (CCTA) revealed right coronary artery hypoplasia, coronary artery aneurysm with severely calcified stenosis in the proximal left anterior descending artery (LAD), and subtotal obstruction in the mid-LAD. The left circumflex artery (LCX) also had stenosis and dilated lesions. Additionally, diffuse perivascular soft tissue thickening was observed in the mid-LCX. Percutaneous coronary intervention was performed for the proximal- and mid-LAD lesions. Rotational atherectomy with low-pressure drug-coated balloon (DCB) dilation was considered for these lesions owing to suspicion of vasculitis. The patient was later diagnosed with Sjögren's syndrome and IgG4-RD overlap syndrome. Oral steroids and immunosuppressive drugs were initiated. In a follow-up at 7 and 26 months, late lumen enlargement was observed in the treated area of the LAD, without enlargement of the adjacent aneurysm. CCTA performed after 26 months revealed resolution of the diffuse perivascular soft tissue thickening in the mid-LCX. Discussion To our knowledge, this is the first case report demonstrating favourable outcomes for treatment of a coronary artery lesion attributed to IgG4-RD with DCB, leaving nothing implanted in the coronary artery tree.

Pulmonary Artery Endograft Implantation Using a Parallel Stent Grafting Technique to Enable the Treatment of a Bronchial Anastomosis Complication After Lung Transplantation.

Bronchial stenosis associated with bronchial anastomosis dehiscence after lung transplantation is a catastrophic complication following lung transplantation with a paucity of therapeutic solutions. To describe an adaptation of the parallel stent grafting technique in the pulmonary arterial territory to treat this challenging situation. This is a case report of a 52-year-old patient who presented bronchus stenosis and bronchial anastomosis dehiscence after lung transplantion. Bronchial stenting and lung retransplantation were contraindicated. Therefore, an endovascular approach using pulmonary artery endograft placement to prevent bleeding during repeated right bronchial balloon dilation was propposed. The technique consists of the deployment of an aortic extender endoprosthesis in the right main pulmonary artery and a balloon expandable stent in the upper lobe pulmonary artery (using a parallel graft configuration) through the common femoral and right internal jugular veins, respectively. Intraoperative transesophageal echocardiogram and one-lung ventilatory ventilation are needed. The patient underwent a new bronchoscopy 16 days after the procedure, that showed epithelization at the previous eroded zone, enabling bronchocopic balloon dialtion to be safely performed. A post-operative contrast-enhanced CT scan revealed an adequate positioning of the stent grafts. Despite all eforts, the patient succumbed to ventilator associated pneumonia on postoperative day 108. The technique's advantages include its feasibility even in situations in which other techniques may be contraindicated and its potential use in emergencies. Its limitations include the need for experienced interventionists to perform it, and the potential risk of acute tricuspid regurgitation. This study illustrates the early feasibility of the parallel stent grafting technique applied to the pulmonary artery territory. However, it's safety profile regarding infectious risk was not demontrated.

Patency and factors related to patency after percutaneous transluminal angioplasty for inflow arterial stenosis in native arteriovenous fistula dysfunction: a single-center retrospective study

Controversy still exists regarding how much the inflow arterial percutaneous transluminal angioplasty (PTA) contributed to maintaining fistula function for hemodialysis. We aimed to analyze patency and risk factors after inflow arterial PTA. Hemodialysis patients with inflow arterial primary stenosis who were admitted to our institution from January 2017 to December 2022 were examined. One group had arterial-venous fistula with inflow artery stenosis alone (AVF + iAS) and another group had AVF with inflow artery stenosis and any vein stenosis (AVF + iAS + VS). The characteristics of patients, stenotic lesions, and PTA procedures were recorded. Kaplan–Meier analysis was used to compare primary patency, assisted primary patency, and secondary patency in the two groups. Cox proportional hazard analysis was used to identify risk factors associated with patency. We examined 213 patients, 53 in the AVF + iAS group (51 radial arterial stenosis and 2 ulnar arterial stenosis) and 160 in the AVF + iAS + VS group (159 radial arterial stenosis and 1 ulnar arterial stenosis). Kaplan–Meier analysis indicated the AVF + iAS group had better primary patency and assisted primary patency (both P < 0.05), but the groups had similar secondary patency. Cox proportional hazard analysis indicated that none of the analyzed clinical and biochemical indexes had clinically meaningful effects on primary patency, assisted primary patency, or secondary patency in either group. The patency and safety after PTA for inflow arterial stenosis were satisfactory, and none of the examined risk factors had a major clinical impact on patency. We recommend PTA as treatment for inflow stenosis of an AVF.

The safety and efficacy of through-and-through wire technique for ureteral Double-J stent placement

Objective: To evaluate the efficacy and safety of the through-and-through wire (TTW) technique for antegrade ureteral Double-J stent placement after failure of either antegrade or retrograde ureteral stent placement. Method: This retrospective study analyzed the medical records of consecutive patients who underwent Double-J stent placement with the TTW technique at Asan Medical Center and Gil Medical Center between January 2016 and February 2023. Patient histories, reasons for employing the TTW technique, TTW pathways, and complications were reviewed. Eight patients were included in the study. The reasons for using the TTW technique were failure to advance a larger-diameter catheter, balloon catheter, or Double-J stent passing over the guidewire beyond the stricture (6/8, 75.0%); failure to negotiate the stricture with a guidewire (1/8, 12.5%); and guidewire passing through a ureteropelvic junction defect (1/8, 12.5%). Results: TTW was applied either between a percutaneous nephrostomy (PCN) and the urethral orifice (n=4), between a PCN and an ileostomy pouch (n=3), or between a left and right PCN (n = 1). Urologic assistance was required for retrograde ureteral cannulation in one male patient (12.5%). Subsequently, balloon dilation and/or Double-J stent placement were performed in all eight patients, resulting in 100% technical success. No major or minor complications occurred. Conclusions: The TTW technique was safe and effective in the undertaking of PCN and antegrade Double-J stent placement in patients for whom either antegrade or retrograde access had failed. doi: https://doi.org/10.12669/pjms.40.9.9424 How to cite this: Chen CS, Zeng CH, Shin JH, Park S, Li HL, Li FK. The safety and efficacy of through-and-through wire technique for ureteral Double-J stent placement. Pak J Med Sci. 2024;40(9):---------. doi: https://doi.org/10.12669/pjms.40.9.9424 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Modified Floating Wire: A Novel Aorto-Ostial Coronary Stenting Technique

: We present a modified floating wire technique for aorto-ostial coronary stenting. This novel approach ensures accurate ostial alignment without stent protrusion. The technique involves using a second wire as a marker at the true ostium to guide optimal stent placement. A balloon catheter is advanced on the floating wire to delineate the aorto-ostial plane. This method reduces the need for contrast media, prevents deep intubation of the guide catheter, and resembles the stent draw-back technique. The modified floating wire technique offers a safe and effective method for aorto-ostial coronary stenting and has potential for broader clinical application.

A Retrospective Review of the Management of Impacted Coin Ingested in Children.

Accidental coin ingestion is a common presentation amongst paediatric patients in emergency departments (ED) worldwide, necessitating prompt management to prevent complications. This study aimed to describe the clinical features of paediatric patients with impacted oesophageal coins at Dr. George Mukhari Academic Hospital ED and compare outcomes between the balloon catheter and oesophagoscopic techniques for coin extraction. This was a retrospective review of the medical records of patients aged ≤12 years over 5 years. Data were collected from the hospital records and analysed using SAS® (SAS Institute Inc, Cary, NC), Release 9.3, running under Microsoft Windows. The analysis included 95 patients (51 females, 44 males) with a median age of 3 years, ranging from 0.70 to 10 years. Coins were predominantly located in the upper oesophagus (71.6%). Thirty-five (36%) children presented 8 h after the ingestion of the coin. At presentation, 82 (86.3%) patients were asymptomatic. The most observed symptoms were hypersalivation in 17 (17.9%) patients and vomiting in eight (8.4%) patients. Of the 62 patients for whom the balloon catheter was solely used, it was successful in 77.4% of the cases. Rigid oesophagoscopy was used in 33 patients as the first procedure (34.7%), and its overall success rate was 100% (44 patients). This study contributes valuable insights into the management of oesophageal coin ingestion in a resource-constrained setting, emphasising the safety and efficacy of the balloon catheter and the role of rigid oesophagoscopy in cases of failure or delayed presentation.

Transurethral balloon dilation safety and efficacy in patients with recurrent bladder neck contracture after transurethral interventions

Introduction. Currently, urologists are divided on which method is most effective for treating bladder neck contracture (BNC) after surgery: transurethral resection (TUR) or incision.Objective. The study aimed to assess the balloon dilation safety and success in patients with recurrent bladder neck contracture (BNC) after endoscopic surgery for benign prostatic hyperplasia (BPH).Materials &amp; Methods. This study involved 110 patients with recurrent BNC after transurethral interventions for BPH. All patients underwent TUR of the bladder neck and were divided into 2 groups: group A (n = 45) included men who, after TUR, additionally underwent repeated balloon dilation, while the control group B (n = 65) included men who were treated with alpha-blockers alone.Results. In 9 months after TUR and 3 months after the fourth balloon dilation procedure in group A, the mean international prostate symptom score (IPSS) decreased from 20.1 ± 8.4 to 17.2 ± 7.4, and the IPSS-quality of life (QoL) was 4.2 ± 1.2 (p &gt; 0.05). In group B, they were 21.7 ± 7.7 and 4.7 ± 1.1 (p &gt; 0.05), respectively. Additionally, the mean flow rate in group A was 13.2 ± 5.4 ml/s, while in group B, it was 8.7 ± 4.9 ml/s (p &lt; 0.05). There was a significant decrease in the post-void residual urine volume (PVR) from 76.2 ± 96.1 ml to 37.6 ± 55.1 ml in group A, whereas, in group B, it increased from 63.0 ± 36.9 ml to 79.4 ± 71.6 ml (p &gt; 0.05). Also, 28.0% of patients of group B, and 13.3% of patients of group A underwent repeated TUR of the bladder neck in 9 months follow-up period (p &lt; 0.05).Conclusion. Balloon dilation procedure is a relatively safe less invasive procedure and can reduce the BNC recurrence rate and consequently the rate of repeated transurethral interventions.

Frequent use of percutaneous transluminal angioplasty is not associated with reduced vascular access recreation in a longitudinal ecology study

The frequency of percutaneous transluminal angioplasty (PTA) procedures has substantially increased, but its effect on vascular access recreation (VAR) remains inconclusive. We conducted a population-based retrospective analysis of Taiwan hemodialysis (HD) centers from 2004 to 2012. Data was accumulated into center-level characteristics, including patients' demographics, baseline characteristics, PTA procedures, and VAR. Center-level characteristics were summarized annually using appropriate measures. A mixed model assessed the association between PTA frequency and VAR rates, considering within-center correlation and adjusting for potential confounders. A total of 82,005 patients (mean age 62.7 ± 13.9 years, 50.5% male, 48.5% with diabetes mellitus) from 820 HD centers were analyzed. From 2004 to 2012, PTA frequency significantly increased from 1.24 to 3.23 per 1000 HD sessions, while VAR rates did not decline as expected (0.5–0.8 per 1000 HD sessions). Compared with the HD centers of infrequent use of PTA (annual lowest quartile, range 0.39–1.20 per 1000 HD sessions), the ones of frequent use (annual highest quartile, range 2.52–5.10 per 1000 HD sessions) didn't have lower VAR (range 0.54–0.99 vs. 0.50–0.91 per 1000 HD sessions, respectively). After controlling the potential confounders, the HD centers' PTA rates were not significantly associated with lower VAR rates (− 2.6, 95% confidence interval: − 30.3; 25.0, p = 0.85). Frequent use of PTA does not seem to improve VA patency at the center level, with no significant association identified with lower VAR. The indication of PTA in daily practice should be re-evaluated in terms of its efficiency in lowering VAR.

Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial

The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions. REC-CAGEFREE I was an open-label, randomised, non-inferiority trial conducted at 43 sites in China. After successful lesion pre-dilatation, patients aged 18 years or older with de novo, non-complex coronary artery disease (irrespective of target vessel diameter) and an indication for percutaneous coronary intervention were randomly assigned (1:1), via a web-based centralised system with block randomisation (block size of two, four, or six) and stratified by site, to paclitaxel-coated balloon angioplasty with the option of rescue stenting due to an unsatisfactory result (DCB group) or intended deployment of second-generation thin-strut sirolimus-eluting stents (DES group). The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation) assessed at 24 months in the intention-to-treat (ITT) population (ie, all participants randomly assigned to treatment). Non-inferiority was established if the upper limit of the one-sided 95% CI for the absolute risk difference was smaller than 2·68%. Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT04561739. It is closed to accrual and extended follow-up is ongoing. Between Feb 5, 2021, and May 1, 2022, 2272 patients were randomly assigned to the DCB group (1133 [50%]) or the DES group (1139 [50%]). Median age at the time of randomisation was 62 years (IQR 54-69), 1574 (69·3%) of 2272 were male, 698 (30·7%) were female, and all patients were of Chinese ethnicity. 106 (9·4%) of 1133 patients in the DCB group received rescue DES after unsatisfactory DCB angioplasty. As of data cutoff (May 1, 2024), median follow-up was 734 days (IQR 731-739). At 24 months, the DoCE occurred in 72 (6·4%) of 1133 patients in the DCB group and 38 (3·4%) of 1139 in the DES group, with a risk difference of 3·04% in the cumulative event rate (upper boundary of the one-sided 95% CI 4·52; pnon-inferiority=0·65; two-sided 95% CI 1·27-4·81; p=0·0008); the criterion for non-inferiority was not met. During intervention, no acute vessel closures occurred in the DCB group and one (0·1%) of 1139 patients in the DES group had acute vessel closure. Periprocedural myocardial infarction occurred in ten (0·9%) of 1133 patients in the DCB group and nine (0·8%) in the DES group. In patients with de novo, non-complex coronary artery disease, irrespective of vessel diameter, a strategy of DCB angioplasty with rescue stenting did not achieve non-inferiority compared with the intended DES implantation in terms of the DoCE at 2 years, which indicates that DES should remain the preferred treatment for this patient population. Xijing Hospital and Shenqi Medical. For the Chinese translation of the abstract see Supplementary Materials section.

Endovascular Treatment of Delayed Cerebral Vasospasms

Delayed cerebral vasospasm is a major complication following subarachnoid hemorrhage and a primary cause of delayed cerebral ischemia. While various preventive treatments exist, some patients still develop severe vasospasm, highlighting the need for better rescue therapies. This article explores endovascular treatment as a rescue option for vasospasm, focusing on the clinical characteristics and roles of intra-arterial vasodilator injection therapy and percutaneous transluminal angioplasty(PTA). Despite a lack of strong evidence from large clinical trials, advancements in endovascular technology have positioned both intra-arterial vasodilator injection therapy and PTA as promising and safe rescue options for severe vasospasm. Careful selection of the appropriate approach is crucial for achieving optimal clinical outcomes, considering the unique characteristics, advantages, and limitations of each method. Further clinical trials are necessary to definitively confirm this hypothesis.