Target Lesion Research Articles

Relacorilant plus nab-paclitaxel for the treatment of metastatic pancreatic ductal adenocarcinoma: results from the open-label RELIANT study.

Modulation of glucocorticoid receptor (GR) activity in tumor cells enhances chemotherapy efficacy. We evaluated the selective GR modulator relacorilant plus nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who had received at least 2 prior therapy lines. In this open-label, single-arm, phase III study, patients received once-daily oral relacorilant (100mg, titrated to 150mg in 25mg increments/cycle) and nab-paclitaxel (80mg/m2) on days 1, 8, and 15 of 28-day cycles. The primary efficacy endpoint was objective response rate (ORR) by blinded independent central review. Progression-free survival (PFS), overall survival (OS), target gene modulation, and safety were also assessed. Of 43 patients enrolled, 31 were evaluable for ORR (12 did not reach first postbaseline radiographic assessment). An interim analysis to assess whether ORR was ≥10% showed no confirmed responses and the study was discontinued. Two (6.5%) patients attained unconfirmed partial responses and 15 (48.4%) had stable disease. Fourteen of 31 (45.2%) patients had reductions in target lesion size, despite prior nab-paclitaxel exposure in 12 of the 14. Median PFS and OS were 2.4 months (95% CI, 1.4-4.2) and 3.9 months (95% CI, 2.8-4.9), respectively. The most common adverse events were fatigue and nausea. RNA analysis confirmed that relacorilant plus nab-paclitaxel suppressed 8 cortisol target genes of interest. Relacorilant plus nab-paclitaxel showed modest antitumor activity in heavily pretreated patients with mPDAC, with no new safety signals. Studies of this combination in other indications with a high unmet medical need are ongoing.

Measure of 90Y-glass microspheres residue post-TARE using PET/CT and potential impact on tumor absorbed dose in comparison 99mTc-MAA SPECT/CT dosimetry

BackgroundTransarterial radio-embolization (TARE) became a routine procedure for non-resectable liver tumor mainly hepatocellular carcinoma (HCC). Personalized dosimetry to the index lesion increased tumor response rate. However, there is no requirement to measure the precise activity injected during TARE. We measured 90Y-glass microspheres residue (90Y-Res) in the application system after TARE and assessed its potential impact on the tumor absorbed dose (AD) previously planned with 99mTc MAA SPECT/CT.MethodsWe measured 90Y-Res using PET/CT in all patients that underwent TARE using 90Y-glass-microspheres for non-resectable liver tumors over one year.Results90Y-Res was measured in 34 patients (HCC n = 22) with 61 injections, 93.1 ± 94.6 MBq [2–437] that was 4.8 ± 3.5% [0.2–13.7] in comparison to the activity measured in the sealed TheraSphere™ vial (ρ = 0.697; p < 0.001).ConclusionWe reported an average of 5% 90Y-Res using PET/CT after TARE with the strongest association to the activity in the TheraSphere™ vial. Therefore, when a high 90Y-Res is suspected on the survey meter, a 90Y-PET/CT scan of 90Y-Res might be useful as a first step to estimate if the target lesion received the recommended AD, especially in HCC patients with borderline tumor dosimetry on the pre-treatment 99mTc-MAA SPECT/CT.

Inter- and Intra-observer Agreement of the Peripheral Arterial Calcium Scoring System in Patients Undergoing (Infra)Popliteal Endovascular Interventions

PurposePeripheral arterial calcification is an important predictor of outcomes after both conservative and endovascular treatment. Digital subtraction angiography (DSA)-based calcification scores are limited by low sensitivity and inter-observer agreement. The Peripheral Arterial Calcium Scoring System (PACSS) assesses the severity of target lesion calcification. The newly introduced modified PACSS (mPACSS) also evaluates target vessel calcification. This study aimed to assess the inter- and intra-observer reliability of PACSS and mPACSS on computed tomography angiography (CTA) in (infra)popliteal endovascular interventions.MethodsA random sample of 50 limbs from the prospective multicenter Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) were included. Three experienced independent raters scored PACSS on CTA. Three months later, one blinded rater assessed the same 50 CTA scans, keeping track of assessment time. The reliability of the original 5-step PACSS, a simplified binary PACSS (0–2 vs 3–4) and the 7-step mPACSS were tested using Cohen’s and Fleiss’ kappa statistics.ResultsIn total, 50 limbs (mean age 70.1 ± 11.0, 29 men) with 41 popliteal and 40 infrapopliteal lesions were scored. Inter-observer agreement of PACSS and binary PACSS were moderate (κ = 0.60) and substantial (κ = 0.72), respectively, while intra-observer agreement was almost perfect in both scores (κ = 0.86). Inter- and intra-observer agreement of mPACSS were moderate (κ = 0.48) and substantial (κ = 0.77), respectively. Mean assessment time for an experienced rater was 3.43 ± 0.93 min per CTA scan.ConclusionBoth the semi-quantitative PACSS and mPACSS scores for (infra)popliteal arteries can be performed reliably on pre-operative CTA.Graphic

Ultrasound guided percutaneous sharp recanalization for restoring patency from peripheral chronic total occlusions of hemodialysis accesses.

Resistant chronic total occlusion (CTO) lesions present an ongoing challenge for conventional endovascular interventions to restore functional hemodialysis (HD) access. This study endeavors to present a novel endovascular approach utilizing ultrasound (USG)-guided percutaneous sharp recanalization to cross the resistant occlusions and evaluates its effectiveness. This is a multi-center retrospective review of consecutive patients received USG guided sharp recanalization for the treatment of resistant CTO lesions of their HD access between 1st January 2019 and 31st July 2023. Data encompassing patient demographics, access and lesion characteristics, procedural specifics, associated complications, immediate clinical outcomes, and outcomes during follow-up were collected. The procedural technical and clinical success, Kaplan-Meier estimated target lesion (TLPP), access circuit primary patency (ACPP), and index access secondary patency (SP) were reported. During the study period, 22 patients underwent USG-guided sharp recanalization procedures in the three participating centers with median follow-up of 14.5 months. Both the technical and clinical success were 100%. Only two patients experienced minor complications of localized hematoma over the access, with no instances of major complication. Kaplan-Meier estimated TLPP and ACPP at 3-, 6-, and 12 months were 90.9%, 68.2%, 56.8%, and 90.9%, 63.6%, 52.1% respectively. The SP rates were 100%, 95.5%, and 84.1% at 3-, 6-, and 12 months respectively. USG guided percutaneous sharp recanalization is an effective and safe endovascular approach to treat resistant CTO lesions of dysfunctional HD access.

Feasibility and safety study of ultrasound-guided percutaneous microwave ablation for sub-cardiac liver cancers without artificial ascites assistance.

To investigate the efficacy and safety of ultrasound (US)-guided microwave ablation (MWA) without artificial ascites (AA) inpatients with sub-cardiac (SC) liver cancers. This retrospective study included patients with the left lobe and caudate lobe of the liver cancer who underwent US-guided MWA in our institute from January 2020 to December 2022. According to whether the target lesion was located ≤5 mm from the pericardium, patients were divided into the SC group and the non-sub-cardiac (NSC) group. In the SC group, AA was not employed during the ablation procedure. The results of technical success, technical efficiency, local tumour progression (LTP), and major complications were recorded. A total of 79 patients with 87 lesions were enrolled. There were 38 patients with 38 lesions in the SC group and 41 patients with 49 lesions in the NSC group. The median follow-up of all patients was 15 (range, 3-44) months. There was no significant difference in technical success rates (100% vs 100%), technique efficiency rates (100% vs 95.7%), LTP rates (2.63% vs 0%,), and major complication rates (2.63% vs 7.32%) between the SC group and the NSC group (P > .05). No cardiac-related complications occurred. US-guided MWA without AA for SC liver cancers was safe and effective. The clinical prognosis of thermal ablation without AA in the treatment of SC liver cancers is still unclear. The finding of this study provided evidence supporting the efficacy and safety of US-guided MWA without AA for treating this tricky location.

PD-1 inhibitor combined with SBRT, GM-CSF, and thymosin alpha-1 in metastatic breast cancer: A case report and literature review.

Triple-negative breast cancer is characterized by a worse prognosis compared with other breast cancer subtypes, especially in the case of pretreated metastatic triple-negative breast cancer (mTNBC). Because of the limited treatment options and suboptimal response rates, there is a pressing need to explore novel treatment protocols. A 48-year-old female patient diagnosed with mTNBC who had not responded to multiple lines of therapy (including surgery, chemotherapy, and radiotherapy) but demonstrated significant efficacy and abscopal effects after enrolling in our clinical trial. Triple-negative breast cancer with lung metastases. The clinical trial combined stereotactic body radiotherapy, immunotherapy, granulocyte-macrophage colony-stimulating factor, and thymosin alpha-1 to treat previously treated metastatic solid cancers. This combined treatment regimen implemented in this clinical trial yielded the patient's notable efficacy, accompanied by abscopal effects. The target lesion and the 3 observed lesions achieved a partial response according to the RECIST v1.1 criteria. reevaluation scans after 2 cycles of immunotherapy indicated a regression rate of -78.97% for the target lesion and -56.73% for the observed lesions. Hematological indexes were stable, and there was no apparent myelosuppression. Also, the tumor marker CA-199 exhibited a downward trend. During the course of treatment, the patient experienced a grade 2 skin reaction, which improved after receiving antiallergic treatment. No further adverse effects were observed. This treatment regimen may offer a promising treatment strategy for patients with mTNBC and other metastatic solid cancers.

Cleavage of Homonuclear Chalcogen-Chalcogen Bonds in a Hybrid Platform in Response to X-ray Radiation Potentiates Tumor Radiochemotherapy.

Chalcogens are used as sensitive redox-responsive reagents in tumor therapy. However, chalcogen bonds triggered by external ionizing radiation, rather than by internal environmental stimuli, enable site-directed and real-time drug degradation in target lesions. This approach helps to bypass chemoresistance and global systemic toxicity, presenting a significant advancement over traditional chemoradiotherapy. In this study, we fabricated a hybrid monodisperse organosilica nanoprodrug based on homonuclear single bonds (disulfide bonds (S-S, approximately 240 kJ/mol), diselenium bonds (Se-Se, approximately 172 kJ/mol), and tellurium bonds (Te-Te, 126 kJ/mol)), including ditelluride-bond-bridged MONs (DTeMSNs), diselenide-bond-bridged MONs (DSeMSNs) and disulfide-bond-bridged MONs (DSMSNs). The results demonstrated that differences in electronegativities and atomic radii influenced their oxidation sensitivities and reactivities. Tellurium, with the lowest electronegativity, showed the highest sensitivity, followed by selenium and sulfur. DTeMSNs exhibited highly responsive cleavage upon exposure to X-rays, resulting in oxidation to TeO32-. Furthermore, chalcogen-hybridized organosilica was loaded with manganese ions (Mn2+) to enhance the release of Mn2+ during radiotherapy, thereby activating the the stimulator of interferon genes (STING) pathway and enhancing the tumor immune response to inhibit tumor growth. This investigation of hybrid organosilica deepens our understanding of chalcogens response characteristics to radiotherapy and enriches the design principles for nanomedicine based on prodrugs.

Impact of radiomics features, pulmonary emphysema score and muscle mass on the rate of pneumothorax and chest tube insertion in CT-guided lung biopsies

Iatrogenic pneumothorax is a relevant complication of computed tomography (CT)-guided percutaneous lung biopsy. The aim of the present study was to analyze the prognostic significance of texture analysis, emphysema score and muscle mass derived from CT-imaging to predict postinterventional pneumothorax after CT-guided lung biopsy. Consecutive patients undergoing CT-guided percutaneous lung biopsy between 2012 and 2021 were analyzed. Multivariate logistic regression analysis included clinical risk factors and CT-imaging features to detect associations with pneumothorax development. Overall, 479 patients (178 females, mean age 65 ± 11.7 years) underwent CT-guided percutaneous lung biopsy of which 180 patients (37.5%) developed pneumothorax including 55 patients (11.5%) requiring chest tube placement. Risk factors associated with pneumothorax were chronic-obstructive pulmonary disease (COPD) (p = 0.03), age (p = 0.02), total lung capacity (p < 0.01) and residual volume (p = 0.01) as well as interventional parameters needle length inside the lung (p < 0.001), target lesion attached to pleura (p = 0.04), and intervention duration (p < 0.001). The combined model demonstrated a prediction accuracy of the occurrence of pneumothorax with an AUC of 0.78 [95%CI: 0.70–0.86] with a resulting sensitivity 0.80 and a specificity of 0.66. In conclusion, radiomics features of the target lesion and the lung lobe CT-emphysema score are predictive for the occurrence of pneumothorax and need for chest insertion after CT-guided lung biopsy.

Efficacy and Outcomes of Stenting Versus Balloon Angioplasty for Chronic Limb-Threatening Ischemia in Infrapopliteal Peripheral Arterial Disease: A Meta-Analysis of Randomized Controlled Trials.

Peripheral arterial disease (PAD) and its severe complication, chronic limb-threatening ischemia (CLTI) are associated with significant morbidity and mortality worldwide. Conventionally, balloon angioplasty has been regarded as superior to stenting in CLTI associated with infrapopliteal PAD. Stenting is often considered a "rescue" or "bail-out" procedure in managing CLTI. However, stenting using newer generation stents coated with antiproliferative drugs such as paclitaxel has demonstrated noninferior results compared with balloon angioplasty in terms of risk of restenosis. However, the current data comparing stenting to balloon angioplasty for other outcomes is rather inconsistent. Major bibliographic databases were searched systematically to identify randomized controlled trials (RCTs) comparing stenting to balloon angioplasty in CLTI in infrapopliteal PAD patients. Risk ratios (RR) with 95% confidence intervals (CI) were pooled in a random-effects model with statistical significance considered at P < 0.05. 9 RCTs with 1125 patients (634, stenting; 491, balloon angioplasty) were included. Stenting was associated with a statistically significant reduction in the risk of binary restenosis (RR, 0.61; 95% CI, 0.38-0.97; P = 0.04] compared with balloon angioplasty. However, no statistically significant difference in technical success, all-cause mortality, clinically driven target lesion revascularization, major limb amputation, and primary patency was observed between the 2 groups. In infrapopliteal PAD associated with CLTI, stenting is noninferior to balloon angioplasty. Future large multicentric RCTs are warranted, particularly evaluating the newer generation drug-eluting stents, in a diverse patient population with longer follow-up periods to corroborate the results of this meta-analysis.

Comparison of efficacy and safety of sarpogrelate-based anti-platelet therapy with clopidogrel-based anti-platelet therapy following arterial endovascular therapy: A systematic review

Objective: Sarpogrelate is a selective serotonin/5-hydroxytryptamine 2A receptor antagonist used in the management of peripheral artery disease (PAD). The drug has emerged as a promising choice for medical management post-endovascular therapy (EVT) due to its anti-platelet aggregation, vasoconstriction, and anti-vascular smooth muscle proliferation properties. The aim of the meta-analysis is to evaluate the efficacy and safety of sarpogrelate-based APT following arterial EVTs in PAD. Material and Methods: PubMed, Google Scholar, Scopus, and the Cochrane were systematically searched from inception to December 2023. Any randomized controlled trial studies in English that evaluated the efficacy and safety of sarpogrelate-based APT after EVT in patients with PAD was included. Data on the restenosis rate, target lesion revascularization (TLR), and safety parameters were extracted and studied. The pooled differences in efficacy and safety parameters between sarpogrelate-based APT and non-sarpogrelate-based APT was calculated using the relative risk (RR) with a 95% CI. Results: A total of three randomized controlled trials were included out of 354 articles obtained through a literature search. No significant differences were observed in the risk of restenosis (RR=0.74, 95% C.I.= 0.55- 1.00, P=0.954) and TLR (RR=0.76, 95% C.I.= 0.47- 1.23 , P=0.476) among patients being treated with sarpogrelate and non-sarpogrelate based APT. Likewise, sarpogrelate-based APT had similar safety profile as non-sarpogrelate-based APT. Conclusion: Sarpogrelate-based APT can be considered an effective alternative to clopidogrel-based conventional APT after EVTs. However, there is a huge need for a larger multicenter, multinational, and multiethnic global trial with sufficient participants in order to produce generalizable findings.

Percutaneous coronary interventions for aneurysmatic right coronary artery in acute coronary syndrome: RIGHTMARE registry outcomes

BackgroundThe optimal strategy during percutaneous coronary intervention (PCI) of aneurysmatic right coronary artery (ARCA) remains uncertain and has never been tested in the acute setting. ObjectivesTo compare the in-hospital and long-term outcomes of immediate and staged PCI strategies for ARCA as culprit lesions during acute coronary syndrome (ACS). MethodsAmong 102.376 PCIs performed in 18 European centers, a total of 85 patients presenting with acute coronary syndrome undergoing ARCA PCI were finally included in the analysis. PCI strategy (stenting performed during the immediate vs staged procedure) and pharmacological approach adopted were collected. The primary outcome was procedural success (technical success without in-hospital MACE). ResultsThe primary outcome occurred in 48.2 % of cases, with no significant differences observed between the immediate and staged PCI groups (50.9 % vs 43.3 %, p = 0.504). Patients in the staged-PCI group had a significantly higher rate of intravenous anticoagulant use (83.3 % vs 48.1 %, p = 0.002), BARC type 3 and 5 bleedings (12.9 % vs 1.9 %, p = 0.037), and longer in-hospital stay (7.40 ± 5.11 vs 9.5 ± 5.25 days, p = 0.049). After multivariate analysis, no independent predictors for procedural success were found in either group. Target lesion failure occurred in 24.1 % of cases without differences between groups at a median follow-up of three years. ConclusionsAmong patients undergoing ARCA PCI in the setting of ACS, immediate or staged PCI were associated with similar in-hospital and long-term outcomes. However, staged PCI was associated with a higher risk of major bleeding events and longer length of stay compared to immediate PCI strategy.

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.

Outcomes of drug-coated balloon angioplasty in patients with dyslipidemia in the BIOLUX P-III registry: A subgroup analysis.

The aim of this study was to assess the mid-term outcomes of the use of drug-coated balloons (DCBs) to treat infrainguinal peripheral arterial disease (PAD) in patients with dyslipidemia. BIOLUX P-III is a prospective, international, multicenter, all-comers registry-based study that was conducted at 44 sites with follow-ups at 6, 12 and 24 months. The present study is a subgroup analysis comparing the outcomes associated with endovascular revascularization with those associated with Passeo-18 lux DCBs in patients with and without dyslipidemia. The proportions of patients free from major adverse events (defined as device- or procedure-related mortality within 30 days, clinically driven target lesion revascularization (CD-TLR) and major target limb amputation), target vessel revascularization, and patient-reported outcomes within 24 months postintervention were compared between the two groups. A total of 876 patients with symptomatic PAD who underwent peripheral revascularization with DCBs and had information on their dyslipidemia status were included; 588 of those patients had dyslipidemia. There was no difference in the proportion of patients free from MAEs between the groups. The percentages of patients who were 6, 12 and 24 months free from CD-TLR were significantly lower in the dyslipidemia group than in the nondyslipidemia group (86.3% vs 91.9% at 2 years, p = .0183). Similarly, the percentage of patients free from target vessel revascularization was lower in the dyslipidemia group at all timepoints (83.3% vs 89.3% at 2 years, p = .0203). There was no difference in mortality or major or minor limb amputation rates. Other secondary outcomes were similar between the groups. Compared to those without dyslipidemia, patients with symptomatic PAD and dyslipidemia who underwent revascularization with a Passeo-18 lux DCB had greater rates of CD-TLR and TVR. However, having dyslipidemia did not increase the risk of mortality or limb amputation. NCT02276313.

Long-term clinical efficacy of drug-coated balloon angioplasty for TASCII C/D femoropopliteal lesions in older patients with chronic limb-threatening ischemia: A retrospective study.

This study aimed to evaluate the long-term clinical outcomes of drug-coated drug (DCB) angioplasty for long femoropopliteal lesions in older patients with chronic limb-threatening ischemia (CLTI). In this multi-center retrospective study, we enrolled 119 patients with CLTI due to Trans-Atlantic Inter-Society Consensus (TASCII) C/D femoropopliteal lesions who underwent DCB angioplasty. A total of 119 patients with 122 limbs (TASCII C = 67, 54.9%; TASCII D = 55, 45.1%) were enrolled. At 36-month follow-up, primary patency, assisted primary patency, secondary patency, and freedom from target lesion revascularization were 47.3%, 49.8%, 59.5%, and 62.7%, respectively, and there was a significant improvement over baseline in Rutherford class (P < .001) and ankle-brachial index measurements (P < .001). Complex target lesions (P = .017) and 1 stenosis-free outflow vessel (P = .001) were risk predictors of freedom from clinically driven target lesion revascularization. Complex target lesions (P = .044), diabetes (P = .007), and 1 stenosis-free outflow vessel (P = .003) were risk predictors of restenosis. At 2 months, the ulcer healing rate was 96.3% (26/27). At 36 months, the limb salvage and survival rates were 85.8% and 83.3%, respectively. DCB angioplasty were safe and effective for older patients with CLTI attributable to femoropopliteal TASCII C/D lesions.

Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial.

Drug-coated balloons (DCBs) have demonstrated favourable outcomes following endovascular therapy for femoropopliteal artery (FPA) disease. However, uncertainty remains whether the use of intravascular ultrasound (IVUS) can improve the outcomes of DCBs. This prospective, multicentre, randomized trial, conducted at seven centres in South Korea, compared the outcomes of IVUS-guided vs. angiography-guided angioplasty for treating FPA disease with DCBs. Patients were assigned to receive IVUS-guided (n = 119) or angiography-guided (n = 118) angioplasty using DCBs. The primary endpoint was 12-month primary patency. Between May 2016 and August 2022, 237 patients were enrolled and 204 (86.0%) completed the trial (median follow-up; 363 days). The IVUS guidance group showed significantly higher primary patency [83.8% vs. 70.1%; cumulative difference 19.6% (95% confidence interval 6.8 to 32.3); P = .01] and increased freedom from clinically driven target lesion revascularization [92.4% vs. 83.0%; difference 11.6% (95% confidence interval 3.1 to 20.1); P = .02], sustained clinical improvement (89.1% vs. 76.3%, P = .01), and haemodynamic improvement (82.4% vs. 66.9%, P = .01) at 12 months compared with the angiography guidance group. The IVUS group utilized larger balloon diameters and pressures for pre-dilation, more frequent post-dilation, and higher pressures for post-dilation, resulting in a greater post-procedural minimum lumen diameter (3.90 ± 0.59 vs. 3.71 ± 0.73 mm, P = .03). Intravascular ultrasound guidance significantly improved the outcomes of DCBs for FPA disease in terms of primary patency, freedom from clinically driven target lesion revascularization, and sustained clinical and haemodynamic improvement at 12 months. These benefits may be attributed to IVUS-guided optimization of the lesion before and after DCB treatment.

Sirolimus-coated balloon versus drug-eluting stent for complex coronary lesions. A propensity matched comparison

IntroductionPercutaneous coronary intervention (PCI) with drug-eluting stents (DES) in complex coronary artery disease (CAD) has been established as the standard of care, but stent-related events are not uncommon. Sirolimus-Coated Balloon (SCB)-based angioplasty is an emerging technology, although it needs to be thoroughly evaluated compared with DES in the complex PCI setting. This study aimed to investigate the safety and efficacy of SCB-based angioplasty compared with new-generation DES in complex PCI. MethodsNet adverse cardiovascular events (NACE: all-cause death, target lesion revascularization, non-fatal myocardial infarction, and major bleedings according to BARC classification), as a primary study endpoint was compared between SCB and new-generation DES for complex coronary lesions. ResultsAmong 1782 patients with complex CAD, 1076 were treated with a sirolimus-coated balloon (EASTBOURNE Registry) and 706 with new-generation DES (COMPLEX Registry). After propensity score matching, a total of 512 patients in both groups were analyzed. NACE occurred more significantly in the DES group during the 1-year follow-up (10.5% vs. 3.9%, p = 0.003), mainly due to a higher risk of bleeding (6.6% vs. 0.4%, p = 0.001). The Cox model adjusted for lesion length showed a significantly lower hazard of NACE (HR: 0.23, CI [0.10, 0.52], p < 0.001) and all-cause mortality (HR: 0.07, CI [0.01, 0.66], p = 0.020) in SCB compared to DES group. ConclusionsSCB angioplasty has an advantage over DES for the treatment of complex CAD regarding NACE, significantly reducing the incidence of major bleeding without increasing ischemic endpoints. SCB may be an alternative to DES in selected patients with complex coronary lesions.

High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment.

Clinical trials have demonstrated that high-dose drug-coated balloon (HD-DCB) and polymer-based drug-eluting stent (PB-DES) treatments for femoropopliteal (FP) artery disease have favorable outcomes. However, which one would be better remained unrevealed. This study used the databases of 2 large-scale multicenter prospective drug-coated balloon (DCB) and drug-eluting stent (DES) registries. The study included 2470 patients with symptomatic FP lesion treated with IN.PACT Admiral DCB or Eluvia DES at 69 centers. A propensity-score-based paired analysis was conducted. Primary endpoint was 1-year restenosis rate. Secondary endpoints were 1-year reocclusion rate, target lesion revascularization (TLR), acute thrombosis, bypass conversion, major amputation, major adverse limb event (MALE), and all-cause death. A total of 1535 patients were treated with HD-DCB, and 935 patients were treated with PB-DES. The propensity-score matching extracted 678 pairs, with no remarkable intergroup difference in baseline characteristics. The 1-year restenosis rate was significantly lower in the PB-DES group than in the HD-DCB group (16.0% vs 22.0%, p=0.016). The other endpoints (reocclusion rate, TLR, acute thrombosis, bypass conversion, major amputation, MALE, and all-cause death) did not differ between the groups. No baseline characteristics had any significant interaction effect on the association of HD-DCB vs PB-DES with restenosis risk (all p>0.05). This study demonstrated that the 1-year TLR, reocclusion rate, and other endpoints did not differ between the PB-DES group and the HD-DCB group despite the lower restenosis in the PB-DES group. One-year restenosis rate was significantly lower in the polymer-based DES group than in the high-dose DCB group for foemoropopliteal disease. However, there is no difference in the other endpoints between two groups.

Increased Incidence of Adverse Events in Diabetes Mellitus Patients with Combined Multiple Vulnerable Plaque Features. New Insights From the COMBINE OCT-FFR trial.

To evaluate the individual as well as combined impact of OCT-detected vulnerability features (OCT-VFs) in the prediction of major adverse cardiovascular events (MACE) in non-ischemic lesions in patients with diabetes mellitus (DM). The COMBINE OCT-FFR (NCT02989740) was a prospective, double-blind, international, natural history study that included patients with DM having ≥1 lesions with a fractional flow reserve >0.80, undergoing systematic OCT assessment. Pre-specified OCT-VFs included TCFA, r-MLA, h-PB, and CP. The primary endpoint (MACE) was a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or hospitalization for unstable angina up to 5 years, analyzed according to the presence of these OCT-VFs, both individually and in combination. TCFA, r-MLA, h-PB and CP were identified in 98 (25.1%), 159 (40.8%), 56 (14.4%), and 116 (29.8%) patients, respectively. The primary endpoint rate increased progressively from 6.9% to 50.0% (HR=10.10; 95%CI, 3.37 to 30.25, p<0.001) in patients without OCT-VFs compared to those with concomitant h-PB, r-MLA, CP, and TCFA. Importantly, while TCFA, h-PB, r-MLA and CP were individually associated with the primary endpoint, the presence of two or more OCT-VFs significantly increased the likelihood of adverse events at 5 years. In patients with DM and non-ischemic lesions, TCFA, h-PB, r-MLA and CP were predictors of adverse events. However, the presence of two or more OCT-VFs significantly increased the likelihood of MACE at 5 years. Further studies are warranted to confirm these findings and their potential clinical implications in a randomized fashion.

ESR Essentials: response assessment criteria in oncologic imaging-practice recommendations by the European Society of Oncologic Imaging.

Assessing the response to oncological treatments is paramount for determining the prognosis and defining the best treatment for each patient. Several biomarkers, including imaging, can be used, but standardization is fundamental for consistency and reliability. Tumor response evaluation criteria have been defined by international groups for application in pharmaceutical clinical trials evaluating new drugs or therapeutic strategies. RECIST 1.1 criteria are exclusively based on unidimensional lesion measurements; changes in tumor size are used as surrogate imaging biomarkers to correlate with patient outcomes. However, increased tumor size does not always reflect tumor progression. The introduction of immunotherapy has led to the development of new criteria (iRECIST, Level of Evidence (LoE) Ib) that consider the possibility that an increase in disease burden is secondary to the immune response instead of progression, with the new concept of Unconfirmed Progressive Disease (a first progression event which must be confirmed on follow-up). Specific criteria were devised for HCC (mRECIST, LoE IV), which measure only enhancing HCC portions to account for changes after local therapy. For GIST treated with imatinib, criteria were developed to account for the possible increase in size reflecting a response rather than a progression by assessing both tumor size and density on CT (Choi, LoE II). This article provides concise and relevant practice recommendations aimed at general radiologists to help choose and apply the most appropriate criteria for assessing response to treatment in different oncologic scenarios. Though these criteria were developed for clinical trials, they may be applied in clinical practice as a guide for day-to-day interpretation. KEY POINTS: Response evaluation criteria, designed for use in clinical trials, might serve as a surrogate biomarker for overall survival. RECIST 1.1 defines measurable and non-measurable disease among which target lesions and non-target lesions are selected at baseline as reference for follow-ups. Some therapies and/or cancers require the use of different criteria, such as iRECIST, mRECIST, and Choi criteria.

Drug-coated balloon angioplasty versus drug-eluting stent implantation in ACS patients with different angiographic patterns of in-stent restenosis

BackgroundDrug-coated balloon (DCB) angioplasty and drug-eluting stents (DES) are two widely used treatments for in-stent restenosis (ISR). Focal and non-focal types of ISR affect the clinical outcomes. The present study aims to compare DES reimplantation versus DCB angioplasty in acute coronary syndrome (ACS) patients with focal ISR and non-focal ISR lesions. MethodsPatients with ISR lesions underwent percutaneous coronary intervention (PCI) were retrospectively evaluated and divided into DES group and DCB group. The primary endpoint was the incidence of target lesion failure (TLF) at 24 months follow up. Propensity score matching (PSM) was conducted to balance the baseline characteristics. ResultsFor focal ISR, TLF was comparable in the DES and DCB groups at 24 months of follow-up (Before PSM, hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.39–1.27; p = 0.244; After PSM, HR: 0.83; 95% CI: 0.40–1.73; p = 0.625). For non-focal ISR, TLF was significantly decreased in DES compared with DCB group (Before PSM, HR: 0.43; 95% CI: 0.29–0.63; p < 0.001; After PSM, HR: 0.33; 95% CI: 0.19–0.59; p < 0.001), which was mainly attributed to the lower incidence of clinically indicated target lesion revascularization (CD-TLR) (Before PSM, HR: 0.39; 95% CI: 0.26–0.59; p < 0.001; After PSM, HR: 0.28; 95% CI: 0.15–0.54; p < 0.001). ConclusionsThe clinical outcomes for DES and DCB treatment are similar in focal type of ISR lesions. For non-focal ISR, the treatment of DES showed a significant decrease in TLF which was mainly attributed to a lower incidence of CD-TLR.