Drug-coated Balloon Research Articles

A Retrospective Comparative Study of Mid-Term Outcomes of Atherectomy, Drug-Coating Balloon Angioplasty, and Plain Old Balloon Angioplasty for Isolated Atherosclerotic Popliteal Artery Lesions.

We retrospectively reviewed the clinical data of 217 consecutive Chinese patients with isolated atherosclerotic popliteal artery lesions treated with atherectomy technique, DCB, and plain old balloon angioplasty from August 2017 to August 2022. There was no difference in the 48-month patency rate between the atherectomy, DCB, and POBA groups (65%, 56%, and 51%, respectively; p = 0.3), as well as in adjusted Cox regression. Similarly, no difference was observed in the 48-month clinically driven target lesion revascularization-free (CDTLR-free) rate among the groups (77%, 74%, and 65%; p=0.34), confirmed by adjusted Cox regression. In the 48 months, a significant difference was observed in amputation-free rates between the atherectomy, DCB, and POBA groups (97%, 91%, and 83%, respectively; p<0.05). Adjusted Cox regression indicated POBA had worse outcomes than DCB and atherectomy. In the stenosis and occlusion subgroup, the 48-month primary patency rates were 65%, 70%, and 54% (p>0.9) and 65%versus 49%versus 49% (p=0.3), showing no differences among the three groups. In the short lesion subgroup (<10cm), the 48-month primary patency rates were 65%, 66%, and 61% for atherectomy, DCB, and POBA, respectively (p=0.7). In the long lesion subgroup (≥10cm), the 48-month patency rates were higher in the atherectomy and DCB groups compared to POBA (64%, 44%, and 34%), with no significant difference among the groups (p=0.13). DCB and atherectomy demonstrate improved short- and mid-term clinical outcomes compared to POBA in Chinese patients with popliteal artery disease.

Three-Year Safety and Efficacy of Endovascular Treatment of Common Femoral Artery in 150 PAD Patients.

Background: The gold standard treatment for peripheral arterial disease (PAD) of the common femoral artery (CFA) is open common femoral endarterectomy (CFAE). Interest in the less invasive endovascular treatment (EVT) is growing due to PAD patients' frequent co-morbidities. Aims: We aimed to evaluate three-year EVT outcomes in multimorbid PAD patients with severe calcified CFA lesions. Methods: Using the prospectively maintained "all-comers" Duesseldorf PTA Registry, we analysed the three-year outcomes of 150 patients with EVT of the CFA. Between January 2017 and October 2023, 66 patients received a rotational excisional atherectomy (REA) followed by a drug-coated balloon angioplasty (DCB), and 84 patients received a DCB alone. Results: All procedures involved the CFA, 49% additionally involved the proximal superficial femoral artery (SFA), and 10% of the lesions involved the profunda femoris artery (PFA). The procedural success rate was 97% and independent of PAD stage, with a higher level of stent implantation in the DCB group (58% vs. 39%, p < 0.05). The primary patency rate at one year was 83% for REA + DCB and 87% for DCB (p = 0.576), while secondary patency after three years was 97%. The MALE rate at three years was mainly driven by cdTLR (REA + DCB: (20%) vs. DCB: (14%), p = 0.377), while major amputations were low in both groups (REA + DCB: 3% vs. DCB: 1%). Overall, the major adverse cardiovascular events (MACEs) rate at three years was low (REA + DCB: (5%) vs. DCB: (11%), p = 0.170). Conclusions: The EVT of severely calcified CFA lesions is safe and effective, with high three-year patency rates and low rates of major adverse limb events (MALEs) and MACEs. This registry demonstrates that vessel preparation with REA minimizes the need for stenting.

Clinical Efficacy of Drug-coated Balloons Applied during Percutaneous Coronary Intervention in Patients with Unstable Angina Pectoris

Clinical Efficacy of Drug-coated Balloons Applied during Percutaneous Coronary Intervention in Patients with Unstable Angina Pectoris

Is intravascular ultrasound needed to optimize drug-coated balloon angioplasty results?

Is intravascular ultrasound needed to optimize drug-coated balloon angioplasty results?

Efficacy of a novel method: VaSodilator injection via the Over-the-wire lumen during drug-coated balloon dilatation to Prevent the slow-flow phenomenon in treatment of femoropopliteal lesions.

In drug-coated balloon (DCB) angioplasty for femoropopliteal lesions, there are adverse effects of drug embolization on downstream non-target organs following the slow-flow phenomenon. We devised a novel method, known as VaSodilator injection via the Over-the-wire lumen during DCB dilatation to Prevent the slow-flow phenomenon in treatment of femoropopliteal lesions (V.S.O.P.), and evaluated its efficacy and safety. This single-center, retrospective, observational study analyzed 196 femoropopliteal lesions treated with IN.PACT Admiral between April 2018 and July 2023. The IN.PACT Admiral is a DCB consisting of a 0.035-inch over-the-wire (OTW) lumen balloon coated with high-dose paclitaxel. Regarding the V.S.O.P. method, we injected vasodilators through the OTW lumen during DCB dilation of the lesions. The cohort was classified into two groups according to the use of the V.S.O.P. method (V.S.O.P. group: n = 53; non-V.S.O.P. group: n = 143). The V.S.O.P. group had lower rates of hemodialysis (21% vs. 43%, p = 0.01) and higher rates of critical limb-threatening ischemia (56% vs. 23%, p < 0.01) and severe calcification lesions (Peripheral Arterial Calcium Scoring Systems score 3/4) (53% vs. 34%, p = 0.01) than the non-V.S.O.P. group. The occurrence of the slow-flow phenomenon was significantly lower in the V.S.O.P. group than in the non-V.S.O.P. group. The V.S.O.P. method could be an effective method for preventing the slow-flow phenomenon after DCB angioplasty for femoropopliteal lesions.

Coronary endoluminal imaging guided percutaneous drug-coated balloons intervention for patients with thrombocytopenia and acute coronary syndrome: a case report

Coronary endoluminal imaging guided percutaneous drug-coated balloons intervention for patients with thrombocytopenia and acute coronary syndrome: a case report

Feasibility of an antegrade-retrograde single-sheath inverse technique via vertical puncture in dysfunctional hemodialysis arteriovenous fistula angioplasty

BackgroundStenosis resulting in dysfunctional dialysis access may occur simultaneously on the anastomotic and central venous side. The purpose of this study was to retrospectively evaluate the feasibility of a single sheath inverse technique using the vertical puncture approach to perform bidirectional transvenous percutaneous transluminal angioplasty (PTA) from a single sheath for such dialysis access stenoses.Materials and MethodsTwenty patients (26 cases; 13 males; median age, 74 [range: 50–89] years) who underwent PTA using the sheath inverse technique for dysfunctional arteriovenous fistula stenoses between April 2019 and June 2023 were included. All procedures were performed in an outpatient setting. A 4-cm sheath (4Fr, four cases; 5Fr, 19 cases; 6Fr, three cases) was inserted by vertical puncture through a cutaneous vein in the forearm (20 cases) or upper arm (six cases). After treating one side of the lesion, the sheath was reversed to treat the lesion on the opposite side. The vessel diameter at the sheath insertion site, the success rate of sheath inversion, the number of PTA balloon catheters used, the PTA success rate, adverse events, and primary and secondary patency rates up to one year after PTA were evaluated.ResultsThe median diameter at the sheath indwelling site was 5.2 (range: 3.6–9.5) mm, and sheath inversion was successful in all cases, eliminating the need to place an additional sheath at another site for contralateral stricture treatment. The number of balloon catheters used was one and two in 17 (65%) and eight cases (31%), respectively, and three in one case wherein a drug-coated balloon was used. PTA was successful in all cases and major complications were not observed. However, in one case wherein a sheath had to be placed at the arterial needle puncture site, the skin was hard, leading to difficulty in inversion, and transient venous spasm occurred post-inversion. The primary patency rates at 3, 6 and 12 months after the PTA were 87.5%, 41.7%, and 20.8%, respectively. The secondary patency rates at 6 and 12 months were 100% and 75%, respectively.ConclusionThe single-sheath inverse technique for arteriovenous fistulas was feasible without sheath withdrawal.Graphical

The Midterm Outcomes of Endovascular Therapy for Femoropopliteal Lesions via Drug-Coated Balloon, Directional Atherectomy and Bare Metal Stent Angioplasty.

This study investigated the midterm primary patency of drug-coated balloons (DCBs), directional atherectomy plus balloon angioplasty (DA), and bare metal stent (BMS) angioplasty for the treatment of femoropopliteal lesions. This two-center retrospective cohort study included 105 patients (110 limbs) undergoing DCB, DA, and BMS angioplasty-32 patients (34 limbs), 31 patients (32 limbs), and 42 patients (44 limbs), respectively. The demographic, baseline, and procedure data were collected, and the complications and midterm outcomes (patency, amputation-free survival, and clinically driven target lesion revascularization rates) were analyzed. All three procedures achieved a 100% success rate. Significant improvements were noted in ankle brachial index, walking distance, and Rutherford classification at 30 days post-procedure (p < 0.001), with no differences or severe complications among the groups. The all-cause mortality rate during the follow-up period, was 5.5%, and amputation-free survival rates at 24 months were 97.0%, 90.6% and 90.9% in the DCB, DA, and BMS angioplasty groups, respectively. The primary patency rate for the DCB group (79.4%) exceeded those of the DA (56.2%) and BMS (52.2%) groups (p < 0.05), with no significant difference between the DA and BMS groups at 24 months. The secondary patency and clinically driven target lesion revascularization rates were similar among the three groups. A runoff number ≤1, Trans-Atlantic Intersociety Consensus (TASC) D, and severe calcification were found to be independent risk factors for primary patency. The DCB procedure demonstrated superior primary patency, compared to both BMS and DA procedures, in the treatment of femoropopliteal lesions.

Synthesis, characterization, and surface modification of degradable polar hydrophobic ionic polyurethane nanoparticles for the delivery of therapeutics to vascular tissue

Degradable polar hydrophobic ionic polyurethanes (D-PHI) are an emerging class of biomaterials with particular significance for blood-contacting applications due to their immunomodulatory effects and highly customizable block chemistry. In this manuscript, D-PHI polymer was formulated as a nanoparticle excipient for the first time by inverse emulsion polymerization. The nanoparticles were optimized with consideration of diameter, surface charge, size variability, and yield as a delivery vehicle for a custom vascular therapeutic peptide. A layer-by-layer (LBL) surface modification technique using poly-L-lysine was integrated within the nanoparticle design to optimize therapeutic loading efficiency. Solvent pH played a pivotal role in emulsion micelle formation, LBL polymer secondary structure, and the polymer functional group interactions critical for high therapeutic loading. The resulting nanoparticle platform met target size (200 ± 20 nm), polydispersity (<0.07), and storage stability standards, was nontoxic, and did not affect therapeutic peptide bioactivity in vitro. Surface-modified D-PHI nanoparticles can be reproducibly manufactured at low cost, generating a highly customizable excipient platform suitable for delivery of biomolecular therapeutics. These nanoparticles have potential applications in vascular drug delivery via localized infusion, drug eluting stents, and drug-coated angioplasty balloons. Statement of significanceNanoscale excipients have become critical in the delivery of many therapeutics to enhance drug stability and targeted biodistribution through careful design of nanoparticle composition, surface chemistry, and size. This manuscript describes the development of a nanoparticle excipient derived from an immunomodulatory degradable polar hydrophobic ionic polyurethane, in combination with a layer-by-layer surface modification approach utilizing poly-L-lysine, to transport a mimetic peptide targeting smooth muscle cell migration in vascular disease. The nanoparticle platform draws on the effect of pH to maximize drug loading and tailor particle properties. The low cost and easily reproducible system presents a highly customizable platform that can be adapted for therapeutic delivery across a wide range of clinical indications.

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.

Drug-coated balloon versus drug-eluting stent for femoropopliteal total occlusions: intraluminal versus subintimal approaches

Because there is a lack of comparative studies assessing drug-coated balloon (DCB) and drug-eluting stent (DES) outcomes with respect to intraluminal (IL) and subintimal (SI) approaches in femoropopliteal (FP) total occlusive lesions, we compared the outcomes between DCB (including bailout stenting) and DES treatments for this lesion. A total of 487 limbs (434 patients) were divided into the IL (n = 344, DCB: n = 268, DES: n = 76) and SI (n = 143, DCB: n = 83, DES: n = 60) approach groups. The primary outcome was a major adverse limb event (MALE), defined as above-ankle amputation or repeat revascularization of the index limb. Secondary outcomes included clinically driven target lesion revascularization (TLR), loss of clinical patency, and all-cause death. After adjustment, in each IL and SI approach, the 2-year rates of MALE (p = 0.180 and p = 0.236, respectively), TLR, loss of clinical patency, and all-cause death were similar between the DCB and DES groups. In the DCB and DES groups, both primary and secondary outcomes were similar between the IL and SI approaches. DCB and DES strategies for patients presenting with FP total occlusive lesions demonstrated similar outcomes regardless of the IL or SI approach.Clinical Trial Registration: NCT02748226.

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.

Theoretical Impact of Optilume Drug-Coated Balloon on Urethroplasty Education Among Society of Genitourinary Reconstructive Surgeons Fellows and United States Urology Residents.

Theoretical Impact of Optilume Drug-Coated Balloon on Urethroplasty Education Among Society of Genitourinary Reconstructive Surgeons Fellows and United States Urology Residents.

Endovascular Treatment for Transplant Renal Artery Stenosis: 10 Years' Experience from a Single Center.

Transplant renal artery stenosis (TRAS) is a common post-renal transplant complication. Although endovascular treatment is widely used to treat TRAS, previous research has been limited by small sample sizes. This article aimed to present the clinical outcomes of endovascular treatment for TRAS in a large sample. Between January 2010 and December 2019, this study included patients with TRAS who were admitted to our center. All patients' clinical symptoms, comorbidities, imaging data, treatment, and follow-up results were reviewed retrospectively. Seventy two patients participated in this study. The median time between renal transplantation and TRAS was 5.25 months. Out of 72 patients, 55 (76.4%) received balloon dilatation in conjunction with stent deployment, 10 (13.9%) received drug-coated balloon dilatation alone, and 7 (9.7%) received balloon dilatation alone. The median follow-up period was 27 months. Primary patency rates were 100%, 81.8%, 74.5%, 64.6%, and 61.8% at 1, 3, 6, 12, and 24 months. A total of 23 patients were found to have restenosis during follow-up, with 6 (26.1%) requiring reintervention and none remaining restenosis after the second treatment. In the subgroup analysis of the three types of stenosis, patients with transplant renal stenosis at the anastomosis had a significantly higher rate of primary patency. Between endovascular treatments, the primary patency rate, postoperative creatinine clearance, and mean systolic blood pressure did not differ significantly. Endovascular treatment resulted in favorable short-term patency as well as effective relief of renal dysfunction and renal hypertension in TRAS patients.

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.

Hybrid strategy of drug-eluting stent and drug-coated balloon in the treatment of de novo coronary artery disease: 1-year clinical outcomes.

The hybrid strategy of drug-eluting stent (DES) and drug-coated balloon (DCB) has been increasingly accepted for the treatment of de novo coronary artery disease. However, data regarding the clinical outcome of this practice in a Southeast Asian population are limited. We aimed to investigate the safety and clinical outcome of this hybrid strategy (DES and DCB) in the treatment of de novo coronary artery disease. The primary endpoint was target lesion failure (TLF) in the DES/DCB-treated segment at 12 months. TLF is defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR) in the DES- and/or DCB-treated segment. A total of 401 patients with 458 lesions were treated with the hybrid strategy at the National Heart Institute (IJN), Kuala Lumpur, Malaysia, from 1 July 2021 to 30 June 2022, were retrospectively enrolled in the study. A total of 38 patients (9.5%) were lost to subsequent follow-up, and the remaining 363 patients (90.5%) were included in the outcome analysis. Clinical outcomes at 1 year were analysed. In all, 219 lesions (47.8%) involved the left anterior descending artery, 146 lesions (31.9%) involved the right coronary artery, and 57 lesions (12.4%) involved the left circumflex artery. In all, 87 lesions (19%) were bifurcation lesions. A total of 8 patients (2.2%) had TLF, of whom 3 patients (0.83%) had TVMI, 3 patients (0.83%) had ID-TLR, and 2 patients (0.6%) experienced cardiac death. Four patients died of a non-cardiac cause at 1-year follow-up. A hybrid strategy of DES and DCB for the treatment of de novo coronary artery lesions appears to be feasible and clinically safe according to the 1-year outcomes.

Treatment extent of femoropopliteal disease and clinical outcomes following endovascular therapy.

Endovascular therapy (EVT) has become the preferred treatment modality for femoropopliteal disease. However, there is limited evidence regarding its procedural and clinical outcomes according to the affected area. The aim of this study is to investigate clinical outcomes and device effectiveness according to treatment extent in the superficial femoral artery (SFA), popliteal artery (PA), or both. In this study, we analysed EVT for SFA (2,404 limbs), PA (155 limbs), SFA/PA (383 limbs) using the population in the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) registry. The primary endpoint was target lesion revascularisation (TLR) at 2 years. The SFA/PA group exhibited a higher prevalence of anatomical complexity, characterised by long lesions, moderate to severe calcification, and total occlusion. The procedures were successful in 97.2% of SFA, 92.9% of PA, and 95.6% of SFA/PA EVTs. The 2-year TLR rates were 21.1%, 18.6%, and 32.7% in the SFA, PA, and SFA/PA groups, respectively. SFA/PA EVT was associated with a significantly increased risk for TLR compared to the SFA group (adjusted hazard ratio [HR] 1.48 [1.09-2.00]; p=0.008) and a trend towards an increased risk compared to the PA group (adjusted HR 1.80 [1.00-3.27]; p=0.052). After overlap weighting, the use of a drug-coated balloon (DCB) was shown to be beneficial, with the lowest TLR rate after SFA and SFA/PA EVT. In this large real-world registry, SFA/PA EVT was associated with an increased risk for TLR at 2 years compared to the SFA or PA EVT groups, with favourable outcomes when using a DCB or drug-eluting stent in the SFA/PA EVT group.

Drug-eluting devices for lower limb peripheral arterial disease.

Peripheral arterial disease is the third leading cause of cardiovascular morbidity after coronary artery disease and stroke. Lower limb peripheral arterial disease commonly involves infrainguinal arteries, may impair walking ability (intermittent claudication) and may confer a significant risk of limb loss (chronic limb-threatening ischaemia), depending on the severity of ischaemia. Endovascular treatment has become the mainstay revascularisation option in both the femoropopliteal and the below-the-knee arterial segments. After crossing and preparing the lesion, treatment results in these arterial segments can be enhanced by using drug-coated devices (drug-eluting stents and drug-coated balloons) that mitigate the occurrence of restenosis. As for other medical devices, the use of drug-eluting devices is based on their demonstrated safety and efficacy profiles when applied in the distinct segments of the lower limb vasculature. In this state-of-the-art narrative review we provide an overview of the safety and efficacy of drug-coated devices when used in the femoropopliteal and below-the-knee arterial segments.

The development and validation of a prognostic prediction modeling study in acute myocardial infarction patients after percutaneous coronary intervention: hemorrhea and major cardiovascular adverse events.

Percutaneous coronary intervention (PCI) is one of the most important diagnostic and therapeutic techniques in cardiology. At present, the traditional prediction models for postoperative events after PCI are ineffective, but machine learning has great potential in identification and prediction of risk. Machine learning can reduce overfitting through regularization techniques, cross-validation and ensemble learning, making the model more accurate in predicting large amounts of complex unknown data. This study sought to identify the risk of hemorrhea and major adverse cardiovascular events (MACEs) in patients after PCI through machine learning. The entire study population consisted of 7,931 individual patients who underwent PCI at Jiangsu Provincial Hospital and The Affiliated Wuxi Second People's Hospital from January 2007 to January 2022. The risk of postoperative hemorrhea and MACE (including cardiac death and in-stent restenosis) was predicted by 53 clinical features after admission. The population was assigned to the training set and the validation set in a specific ratio by simple randomization. Different machine learning algorithms, including eXtreme Gradient Boosting (XGBoost), random forest (RF), and deep learning neural network (DNN), were trained to build prediction models. A 5-fold cross-validation was applied to correct errors. Several evaluation indexes, including the area under the receiver operating characteristic (ROC) curve (AUC), accuracy (Acc), sensitivity (Sens), specificity (Spec), and net reclassification improvement (NRI), were used to compare the predictive performance. To improve the interpretability of the model and identify risk factors individually, SHapley Additive exPlanation (SHAP) was introduced. In this study, 306 patients (3.9%) experienced hemorrhea, 107 patients (1.3%) experienced cardiac death, and 218 patients (2.7%) developed in-stent restenosis. In the training set and validation set, except for previous PCI and statins, there were no significant differences. XGBoost was observed to be the best predictor of every event, namely hemorrhea [AUC: 0.921, 95% confidence interval (CI): 0.864-0.978, Acc: 0.845, Sens: 0.851, Spec: 0.837 and NRI: 0.140], cardiac death (AUC: 0.939, 95% CI: 0.903-0.975, Acc: 0.914, Sens: 0.950, Spec: 0.800 and NRI: 0.148), and in-stent restenosis (AUC: 0.915; 95% CI: 0.863-0.967, Acc: 0.834, Sens: 0.778, Spec: 0.902 and NRI: 0.077). SHAP showed that the number of stents had the greatest influence on hemorrhea, while age and drug-coated balloon were the main factors in cardiogenic death and stent restenosis (all P<0.05). The XGBoost model (machine learning) performed better than the traditional logistic regression model in identifying hemorrhea and MACE after PCI. Machine learning models can be used as a tool for risk prediction. The machine learning model described in this study can personalize the prediction of hemorrhea and MACE after PCI for specific patients, helping clinicians adjust intervenable features.

Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.

Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.