Ali, Muhammad Abdullah

Despite advances in percutaneous coronary procedures, in-stent restenosis remains a significant challenge. Although sirolimus- and paclitaxel-coated balloons are promising alternatives, their comparative safety and efficacy remain uncertain. PubMed, Embase, and Cochrane databases were searched using relevant keywords from inception until August 2025. A total of 11 studies (7 randomized controlled trials and 4 observational cohort studies) were included, comprising 3633 participants overall. The primary outcomes assessed were target lesion revascularization and target lesion failure. Meanwhile, the Secondary outcomes included stent thrombosis, all-cause mortality, myocardial infarction, major adverse cardiovascular events, survival, binary restenosis, and angiographic endpoints (acute gain, diameter stenosis, in-segment late lumen loss, in-lesion late lumen loss, and in-segment minimal lumen diameter). Interstudy heterogeneity was assessed using I ² and X ² statistics ( I ²>50% = significant heterogeneity). Interstudy heterogeneity was low for most outcomes, including all primary clinical endpoints, with moderate heterogeneity observed only for select angiographic measures (notably in-segment late lumen loss and diameter stenosis). Statistical analysis was conducted using R software and RStudio (version 4.4.2), with a P value of < 0.05 indicating statistical significance. This meta-analysis examined studies that compared paclitaxel-coated balloon (PCB) versus standard balloon [sirolimus-coated balloon (SCB)] angioplasty. Regarding primary outcomes, there were no notable variations in target lesion failure [risk ratio (RR), 1.08, 95% CI, 0.90–1.29, P = 0.36] or target lesion revascularization (RR, 1.16, 95% CI, 0.98–1.37, P = 0.08). With all aggregated estimates being nonsignificant, secondary outcomes such as stent thrombosis, all-cause mortality, myocardial infarction, major adverse cardiovascular events, and survival were similar between groups. Angiographic endpoints revealed no discernible variations in late lumen loss (in-lesion and in-segment), acute gain, or diameter stenosis. Nonetheless, the SCB group’s minimal lumen diameter was significantly smaller than that of the PCB group (MD, −0.08 mm, 95% CI, −0.14 to −0.01, P = 0.02). In treating coronary in-stent restenosis, SCB and PCBs show similar overall safety and effectiveness; lesion-specific angiographic variations indicate that customized selection may improve patient outcomes.

e17089 Background: Prostate cancer (PC) is often treated with androgen-deprivation therapy (ADT), but progression remains a challenge. Darolutamide, a next-generation androgen receptor inhibitor, may improve outcomes when combined with ADT. This systematic review and meta-analysis evaluates the efficacy and safety of darolutamide plus ADT in hormone-sensitive (HSPC) and castration-resistant prostate cancer (CRPC). Methods: A comprehensive search of PubMed, Cochrane, Clinicaltrials.gov, Embase, and Scopus was conducted through January 11, 2025. Randomized controlled trials (RCTs) comparing darolutamide plus ADT vs. placebo or control in prostate cancer were included. Data on overall survival, metastatic progression, antineoplastic therapy initiation, pain progression, bone fractures, hypertension, adverse events and serious adverse events were analyzed. Outcomes were pooled as risk ratios (RR) with 95% confidence intervals (CI) using a random-effects model. Heterogeneity was assessed via Higgins I², with subgroup analyses for HSPC and CRPC. Results: Four RCTs with 4,992 patients (darolutamide + ADT=3007; control=1985) were further included for quantitative analysis. Our pooled analysis showed a statistically significant decrease in the development of metastatic CRPC across both HSPC and CRPC (RR: 0.38 [0.19, 0.77], p=0.007). Similarly, progression to pain (RR: 0.81 [0.71, 0.92], p=0.001) and the use of antineoplastic therapy (RR: 0.46 [0.38, 0.57], p<0.0001) was significantly delayed across all PC, indicating slower disease progression. While a slightly higher overall survival was noted in the CRPC subgroup (RR: 1.08 [1.01, 1.14], p=0.007), no significant differences were reported on the use of combination therapy across HSPC and overall PC (RR: 0.71 [0.39, 1.31], p=0.28). While a significantly higher risk of developing adverse events (RR: 1.08 [1.03, 1.14], p=0.002) and serious adverse events (RR:1.2 [0.99, 1.45], p=0.07) was noted in the CRPC subgroup, a slight increase was reported in the overall cohort and HSPC, although with statistical insignificance. Bone fractures (RR: 1.52 [1.12, 2.07], p=0.008) and hypertension risk (RR: 1.28 [1.03, 1.59], p=0.03) were elevated, while rates of rash, fatigue, falls, and mental impairment were similar. Conclusions: Combination therapy of darolutamide and ADT reduced metastatic progression and slowed tumor growth but did not significantly improve overall survival. Adverse events were more common, particularly in CRPC cohort. Longer follow-up studies are needed to assess long-term efficacy and weigh tumor control against adverse event risks.