Introduction: Colorectal cancer (CRC) is the #2 cancer killer in the US.1 Recently, the USPSTF guidelines reduced the CRC screening age to 45 yo for normal-risk individuals.2 The adenoma detection rate (ADR) of 25% (20% F, 30% M) is an accepted benchmark of a quality colonoscopy in 50-75 yo. Since prevalence of adenomas increases with age, it has been suggested that a 1-3% reduction in ADR can be anticipated in 45-49 yo patients undergoing a screening colonoscopy.3 No studies have evaluated the ADR among 45-49 yo screened in 2021, since the integration of the new guidelines. Aim: To compare the ADR in screening colonoscopies for patients ages 45-49 yo vs. older cohorts in 2021. Methods: A retrospective analysis of records was performed on 6386 asymptomatic 45-75 yo patients who underwent a screening colonoscopy. Exclusion criteria included: (1) prior screening test, (2) incomplete colonoscopy, (3) inadequate bowel preparation, or (4) hereditary CRC syndrome/CRC family history. ADR is defined as the percentage of colonoscopies with ≥1 tubular adenoma (TA), tubulovillous adenoma (TVA), or sessile serrated adenoma (SSA).3 An advanced lesion was defined as a TA/SSA >10 mm, villous or high grade dysplasia, traditional serrated adenoma, or >5 adenomas or SSA in any combination, or cancer.3 Results: 5985 colonoscopies (2857 M,3128 F) were performed with an average withdrawal time ∼11 minutes. Table shows ADR results. The 45-49 yo cohort represented 10.9% of the screened population. The ADR in the 45-49 age range was 32.1% vs 38.7% (P< 0.0097) for the 50-75 age cohort. Conclusion: In our study, 10.9% of the screened population was between 45-49 years old. The ADR was significantly lower in the 45-49 yo cohort as compared to the 50-75 yo cohort; however, the 32% ADR remains well above the accepted benchmark of 25%. The APC is lower in 45-49 yo patients, and a larger sample size may show reduction in ADR when compared to 50-54 yo. Gastroenterologists can expect only a slightly lower ADR in the newest screening cohort (age 45-49), but it remains critical that physicians emphasize the importance of average-risk CRC in the younger demographic. Table 1. - Adenoma Detection Rates in Screening Colonoscopies 45-49 yn = 654 50-54 yn = 2563 P value(compared with 45-49) 50-75 yn = 5331 P value(compared with 45-49) Overall ADR (%) 32.1 36.2 0.1158 38.7 0.0097 ADR (%) in menn=2857 37.2 41.6 0.2951 44.2 0.0885 ADR (%) in womenn=3128 28.2 30.6 0.4586 33.6 0.0888 APC 0.56 0.69 0.0005 0.77 < 0.0001 CRC detected 1 2 0.5757 10 0.8452 ADR: adenoma detection rate; APC: adenoma per colonoscopy; CRC: colorectal cancer.
Introduction: Aspirin (ASA) is a cornerstone therapy for the secondary prevention of cardiovascular (CV) events. PA32540 is a novel fixed-dose, coordinated-delivery tablet containing enteric-coated (EC)-ASA 325 mg and immediate-release omeprazole 40 mg. PA3250 is designed to reduce the risk of adverse GI side effects and, in turn, improve adherence to ASA. Methods: Among patients from an ITT population (n=1049) of 2 identically designed, randomized, double-blind phase III trials of PA32540 vs EC-ASA 325 mg, we identified and analyzed a cohort with a history of myocardial infarction (MI) for overall adverse events and GI complication assessed by endoscopy. Patients required treatment with ASA for secondary prevention of CV or cerebrovascular events, and were either ≥55 years old or 18-54 with a history of uncomplicated gastric or duodenal ulcer within the past 5 years. . Results: Overall, 413/1049 patients had a history of MI (n=214 PA32540, n=199 EC-ASA), and 411 were included in the safety evaluation (n=2 received no study drug). Among these patients, 36 had serious treatment-emergent adverse events (TEAEs; n=19/213 [8.9%] PA32540, n=17/198 [8.6%] EC-ASA; p = NS). Cardiac TEAEs were reported in 12/213 patients (5.6%) in the PA32540 group and 9/198 patients (4.5%) in the EC-ASA group (p=NS). Adjudicated major adverse CV events were reported in 3/213 patients (1.4%) in the PA32540 group and 1/198 patients (0.5%) in the EC-ASA group (p=NS). Treatment with PA32540 was associated with lower rates of endoscopically determined gastric ulceration (5/214 [2.3%] vs 15/199 [7.5%] p=0.020) and gastroduodenal ulceration (5/214 [2.3%] vs 19/199 [9.5%]; p=0.002) vs EC-ASA. Overall, 16 patients (7.5%) in the PA32540 group and 19 patients (9.5%) in the EC-ASA group discontinued therapy due to AEs (p=NS). Conclusions: Patients treated with PA32540 and EC-ASA for secondary cardioprotection after MI had a similar occurrence of cardiac TEAEs. However, therapy with PA32540 was associated with a more favorable safety and tolerability profile and significantly lower rates of gastric and gastroduodenal ulceration than EC-ASA. These results support PA32540 as a therapeutic option for secondary prevention of CV events in patients at risk for ASA-associated gastric ulceration.
Objectives: We evaluated the role of gender on clinical and angiographic results of the everolimus‐eluting stent in the SPIRIT III trial. Background: The SPIRIT III trial demonstrated superior efficacy of the XIENCE V everolimus‐eluting stent compared with the TAXUS paclitaxel‐eluting stent. Whether these results are applicable to women is unknown. Methods: A total of 1,002 patients with coronary artery lesions of 28 mm or less long in 2.5–3.75 mm diameter vessels were prospectively randomized to receive percutaneous coronary intervention with either XIENCE V stent or TAXUS stent placement. Post hoc gender subset analysis was performed. Results: A total of 669 patients (200 women) received the XIENCE V stent, and 332 patients (114 women) were assigned to the TAXUS stent. Women were older and had more hypertension and diabetes than men. At 1 year, rates of MACE (11.1% vs. 5.7%, P = 0.004), TVF (13.7% vs. 7.5%, P = 0.003), TVR (10.8% vs. 4.6%, P = 0.0007), and TLR (7.2% vs. 2.7%, P = 0.002) were higher in women compared with men. The difference in 1 year MACE and TVF rates between men and women remained after adjusting for baseline covariates. Although the angiographic characteristics at baseline were similar among the female cohort, women assigned to XIENCE V had lower in‐stent late loss (0.19 vs. 0.42 mm, P = 0.01) compared with women treated with the TAXUS stent. Although 30‐day clinical outcomes were similar for women treated with XIENCE V and TAXUS stents, at 1 year, women with XIENCE V stents had significantly lower MACE (8.2% vs. 16.1 %, P = 0.04) and TVR (3.1% vs. 8.9%, P = 0.03) compared with those treated with TAXUS stents. Stent thrombosis rates were similar between women receiving either XIENCE V or TAXUS stents. Conclusions: Women in the SPIRIT III trial had inherently higher MACE and TVF rates than men. However, the angiographic and clinical benefits of using XIENCE V stents are generalizable to women. © 2009 Wiley‐Liss, Inc.
