РезюмеОсобую группу ятрогений составляют осложнения, связанные с различными диагностическими манипуляциями -от физикального об-следования больного до ангиографических исследований, диагностической лапароскопии или торакоскопии. В статье приводятся данные о частоте и характере диагностических ятрогений в клинической практике. Диапазон диагностических ятрогений по своим проявлениям, тяжести и прогнозу достаточно широк -от раздражения кожи гелем при проведении УЗИ до диссекции коронарной артерии во время коро-нароангиографии. В статье представлены примеры ятрогений диагностических процедур, начиная с процесса клинического обследования (сбор жалоб и анамнеза, физикальное исследование), и заканчивая сложными инвазивными обследованиями. Подробно рассмотрены ятро-гении, возникающие при применении препаратов, содержащих контраст (в частности йодсодержащих препаратов), которые достаточно ши-роко используются в клинической практике (КТ с контрастированием, ангиографии и др.) с диагностической целью. В статье рассказывается о факторах риска, знание которых и осведомленность об их наличии у пациента обязательны перед введением препаратов, содержащих контраст. Проведен обзор осложнений, возникающих при эндоскопических исследованиях. Автор напоминает, что ятрогенные события при эндоскопических процедурах могут проявляться не только осложнениями со стороны исследуемого органа (пищевод, желудок, кишечник), но зависят также и от состояния больного, его подготовки к проведению процедуры, владения специалистом техникой эндоскопии. В за-ключение автор приводит клиническое наблюдение, в котором фактором риска ятрогенного события было наличие у больной аномалии протоковых систем печени и поджелудочной железы. Автор статьи призывает коллег более внимательно относиться к процессу принятия решения о проведении диагностического исследования, всегда оценивать соотношение польза/риск с точки зрения реальной пользы диа-гностического исследования для больного и риска развития осложнения. Ключевые слова: ятрогения, контраст-индуцированная нефропатия, коронароангиография, эндоскопия, эзофагогастродуоденоско-пия, колоноскопия AbstractA special group of iatrogenic complications are associated with various diagnostic manipulations -from a physical examination of the patient to angiographic studies, diagnostic laparoscopy or thoracoscopy. The article presents data on the frequency and nature of diagnostic iatrogenic in clinical practice. The range of diagnostic iatrogenesis in terms of its manifestations, severity and prognosis is wide enough -from skin irritation with gel during ultrasound to dissection of the coronary artery during coronary angiography. The article presents examples of iatrogenic diagnostic procedures, starting with the clinical examination process (collection of complaints and anamnesis, physical examination), and ending with complex invasive examinations. Yatrogenia, which occur with the use of preparations containing contrast (in particular iodine-containing drugs), which are widely used in clinical practice (CT with contras...

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Acute coronary syndrome due to critical ULM stenosis is associated with high mortality even after successful PCI. Patients presenting with CS or STEMI are at particular risk.

TPS297 Background: Darolutamide (DARO) is a structurally distinct and highly potent androgen receptor inhibitor. In the phase 3 ARAMIS study (NCT02200614) in nonmetastatic castration-resistant prostate cancer (CRPC), DARO + ADT significantly improved metastasis-free survival and overall survival (OS) vs placebo + ADT, with a favorable tolerability and safety profile. In the phase 3 ARASENS study (NCT02799602) in metastatic hormone-sensitive prostate cancer (mHSPC), DARO + ADT + docetaxel significantly reduced the risk of death by 32.5% vs ADT + docetaxel (hazard ratio 0.68; 95% confidence interval 0.57–0.80; P<0.0001), with no additional adverse events. DARO + ADT vs ADT alone in patients (pts) with mHSPC is being evaluated in the ongoing, global (ex-US), phase 3 ARANOTE study (NCT04736199). The phase 2 ARASEC study (NCT05059236) will complement ARANOTE by evaluating DARO + ADT in US pts with mHSPC. Given that ADT alone is no longer an acceptable comparator in the US, an external control arm will be derived from a historical study. Methods: To participate in ARASEC, pts must have confirmed adenocarcinoma of the prostate, metastatic disease on conventional imaging for which they have not received prior systemic therapy, and Eastern Cooperative Oncology Group performance status (ECOG PS) 0–2. Pts will receive DARO 600 mg twice daily + ADT (luteinizing hormone-releasing hormone agonist/antagonist or orchiectomy). ADT can be started ≤4 months before DARO, and there must be no evidence of progression on ADT before DARO initiation. The external control arm will be derived from 394 pts with mHSPC treated with ADT alone in CHAARTED (NCT00309985). Pts in the active and control arms will be matched 1:1 on baseline characteristics such as age, ECOG PS, CHAARTED-defined extent of disease, prior therapy, and Gleason score. The propensity score (ie, the assessed probability that a pt is allocated to the DARO + ADT arm based on baseline profile) will be used to address bias in estimating differential effects, by matching pts with scores within a narrow window across the cohorts. The primary endpoint is progression-free survival (PFS), defined as the time from enrollment to prostate-specific antigen (PSA) progression, radiologic or symptomatic progression, clinical deterioration, or death, whichever occurs first, as defined in CHAARTED. Secondary endpoints are OS, radiographic PFS, time to CRPC, 6-month PSA response (<0.2 ng/mL), and safety. The study will continue until either the event count threshold triggering the primary endpoint analysis (161 PFS events) has been met or all pts have been followed for ≥2 years after enrollment, whichever occurs later. ARASEC is enrolling, with the first pt enrolled in November 2021. As of September 10, 2022, 59 pts have been enrolled. The target total enrollment is 200 pts at 30 sites. Clinical trial information: NCT05059236 .

e17095 Background: In ARAMIS (NCT02200614), darolutamide (DARO) significantly improved metastasis-free survival (MFS) by ~2 years (HR 0.41, 95% CI 0.34–0.50) and reduced the risk of death by 31% (HR 0.69, 95% CI 0.53–0.88) compared with placebo in men with nonmetastatic castration-resistant prostate cancer (nmCRPC), with a favorable tolerability profile. The ongoing DAROL study (NCT04122976) aims to understand the real-world safety and effectiveness of DARO in patients (pts) with nmCRPC. We report results from the pre-planned second interim analysis (IA). Methods: DAROL is a global, open-label, single-arm, non-interventional study in pts aged ≥18 years with confirmed nmCRPC for whom the decision to be treated with DARO is decided pre-enrollment. The primary endpoint is safety, including incidence, severity, and frequency of treatment-emergent adverse events (TEAEs). Secondary endpoints are patient demographics and disease characteristics, treatment duration, MFS, overall survival (OS), time to prostate-specific antigen (PSA) progression, and PSA response. Primary and secondary endpoints are reported after 300 pts completed ≥6 mo of treatment. All treated pts were assessed for safety while efficacy was evaluated in pts who did not violate any eligibility criteria and had ≥1 post-baseline assessment (cut-off October 11, 2022). Results: Of the 300 treated pts, the percentage enrolled in North America/Europe/Asia Pacific/Latin America was 45%/30%/25%/ < 1%, respectively. Median age was 80 years; 51% had a reported Gleason score > 7; 92% had a reported ECOG performance status of 0/1. Median baseline (BL) PSA was 3.9 ng/mL (range 0–248.0), with 21% of pts reporting PSA < 2 ng/mL. Median BL PSA doubling time (PSADT) was 5.3 mo (range 0–36.2), with 42% of pts reporting PSADT > 6 mo. At the data cut-off, median follow-up time was 14.8 mo (interquartile range [IQR] 10.9–19.3) and median treatment duration was 13.4 mo (IQR 9.3–17.8). The incidences of TEAEs and DARO-related TEAEs were generally low (Table), consistent with the safety profile of DARO reported in ARAMIS. Fatigue occurred in ≥5% of pts. For the 263 pts eligible for efficacy analysis, median time to PSA progression was 17.6 mo (95% CI 13.2–19.0); MFS/OS data remain immature. PSA declines from baseline of ≥30%, ≥50%, and ≥90% at any time were observed in 80%, 76%, and 54% of pts, respectively. Conclusions: In the DAROL second IA, under real-world conditions, DARO continued to show a favorable safety profile, consistent with the clinical profile of ARAMIS, with no new safety signals. Clinical trial information: NCT04122976 . [Table: see text]