Sex-Based Outcomes of P2Y12 Inhibitor Monotherapy After Three Months of Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention

Background@#In patients undergoing percutaneous coronary intervention (PCI) in the SMART-CHOICE trial, P2Y12 inhibitor monotherapy after three months of dual antiplatelet therapy (DAPT) achieved clinical outcomes comparable to those of 12 months of DAPT.Nonetheless, the effects of sex on these outcomes remain unknown. @*Methods@#This open-label, non-inferiority, randomized study, conducted in 33 hospitals in South Korea, included 2,993 patients undergoing PCI with drug-eluting stents. Patients were randomly assigned to receive DAPT (aspirin plus a P2Y12 inhibitor) for three months then P2Y12 inhibitor alone for nine months, or DAPT for the entire 12 months. The primary endpoints were major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) 12 months after the index procedure. The bleeding endpoints were Bleeding Academic Research Consortium (BARC) bleeding types 2 to 5. @*Results@#Of the patients, 795 (26.6%) were women, who were older and had a higher prevalence of hypertension, diabetes, and dyslipidemia than men. The sexes exhibited comparable primary endpoints (adjusted hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.55–1.55; P = 0.770) and bleeding endpoints (adjusted HR, 1.07; 95% CI, 0.63–1.81; P = 0.811). P2Y12 inhibitor monotherapy vs DAPT was associated with lower risk of BARC type 2 to 5 bleeding in women (adjusted HR, 0.40; 95% CI, 0.16–0.98; P = 0.045) but the difference was not statistically significant when using the Bonferroni correction. The primary endpoints were similar between treatment groups in both sexes. @*Conclusion@#In both sexes undergoing PCI, P2Y12 inhibitor monotherapy after three months of DAPT achieved similar risks of the primary endpoints and the bleeding events compared with prolonged DAPT. Therefore, the benefits of early aspirin withdrawal with ongoing P2Y12 inhibitors may be comparable in women and men.

Long-Term Clinical Outcomes of Drug-Coated Balloon Treatment for De Novo Coronary Lesions

Purpose@#Data are limited on the long-term efficacy and safety of drug-coated balloon (DCB) treatment in comparison to drugeluting stent (DES) for de novo coronary lesions. We investigated the long-term clinical outcomes of DCB treatment in percutaneous coronary intervention (PCI) for de novo coronary lesions. @*Materials and Methods@#A total of 103 patients scheduled for elective PCI for de novo non-small coronary lesions (≥2.5 mm) who were successfully treated with DCB alone were retrospectively compared with 103 propensity-matched patients treated with second-generation DES from the PTRG-DES registry (n=13160). All patients were followed for 5 years. The primary endpoint was major adverse cardiac events [MACE; cardiac death, myocardial infarction, stroke, target lesion thrombosis, target vessel revascularization (TVR), and major bleeding] at 5 years. @*Results@#At 5-year clinical follow-up, Kaplan-Meier estimates of the rate of MACE were significantly lower in the DCB group [2.9% vs. 10.7%; hazard ratio (HR): 0.26; 95% confidence interval (CI): 0.07–0.96; log-rank p=0.027]. There was a significantly lower incidence of TVR in the DCB group (1.0% vs. 7.8%; HR: 0.12; 95% CI: 0.01–0.98; long-rank p=0.015), and there was major bleeding only in the DES group (0.0% vs. 1.9%; log-rank p=0.156). @*Conclusion@#At 5-year follow-up, DCB treatment was significantly associated with reduced incidences of MACE and TVR, compared with DES implantation, for de novo coronary lesions.

Value of the Post-Operative CT in Predicting Delayed Flap Failures Following Head and Neck Cancer Surgery

OBJECTIVE: To identify post-operative computed tomography (CT) findings associated with delayed flap failures following head and neck cancer surgery. MATERIALS AND METHODS: We retrospectively reviewed 60 patients who underwent flap reconstruction after head and neck cancer surgery and post-operative (3–14 days) contrast-enhanced CT scans for suspected complications. Patients were divided into two groups: delayed flap failure patients (patients required flap revision) (n = 18) and flap success patients (n = 42). Clinical data (age, sex, T-stage, type of flap, and time interval between reconstruction surgery and CT) and post-operative CT findings of flap status (maximum dimension of the flap, intra- or peri-flap fluid collection and intra- or peri-flap air collection, fat infiltration within the flap, fistula to adjacent aerodigestive tract or skin, and enhanced vascular pedicle) were assessed and compared between the two groups. RESULTS: CT findings showed that the following flap anomalies were observed more frequently in the delayed flap failure group than in the flap success group: intra- or peri-flap fluid collection > 4 cm (61.1% vs. 23.8%, p 2 cm (61.1% vs. 2.4%, p < 0.001), and fistula to adjacent aerodigestive tract or skin (44.4% vs. 0%, p < 0.001). The maximum dimension of the flap, fat infiltration within the flap, and enhanced vascular pedicle were not associated with delayed flap failures. CONCLUSION: A large amount of fluid or air collection and fistula are the CT findings that were associated with delayed flap failures in patients with suspected post-operative complications after head and neck cancer surgery.