BACKGROUND: Treatment of coronary in-stent restenosis (ISR) remains challenging. PCBs are an established treatment option outside the United States with a Class I, Level of Evidence: A recommendation in the European guidelines. However, their efficacy is better in bare-metal stent (BMS) ISR compared with drug-eluting stent (DES) ISR.
METHODS: Fifty patients with DES ISR were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, 4 μg/mm2) with a clinically proven PCB (SeQuent Please Neo, 3 μg/mm2) in coronary DES ISR. The primary endpoint was angiographic late lumen loss at 6 months. Secondary endpoints included procedural success, major adverse cardiovascular events, and individual clinical endpoints such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis.
RESULTS: Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.21 ± 0.54 mm in the PCB group versus 0.17 ± 0.55 mm in the SCB group (p = NS; per-protocol analysis). Clinical events up to 12 months also did not differ between the groups.
CONCLUSIONS: This first-in-man comparison of a novel SCB with a crystalline coating shows similar angiographic outcomes in the treatment of coronary DES ISR compared with a clinically proven PCB. (Treatment of Coronary In-Stent Restenosis by a Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon [FIM LIMUS DCB]; NCT02996318).
AIM: To study factors associated with nonalcoholic steatohepatitis (NASH) and advanced fibrosis, and medical treatment of biopsy-proven nonalcoholic fatty liver disease (NAFLD) patients.
METHODS: Retrospective study of biopsy-proven NAFLD patients from centres in the GO ASIA Workgroup. Independent factors associated with NASH and with advanced fibrosis on binary logistic regression analyses in a training cohort were used for the development of their corresponding risk score, which were validated in a validation cohort.
RESULTS: We included 1008 patients from nine centres across eight countries (NASH 62.9%, advanced fibrosis 17.2%). Independent predictors of NASH were body mass index ≥30 kg/m2 , diabetes mellitus, dyslipidaemia, alanine aminotransferase ≥88 U/L and aspartate aminotransferase ≥38 U/L, constituting the Asia Pacific NASH risk score. A high score has a positive predictive value of 80%-83% for NASH. Independent predictors of advanced fibrosis were age ≥55 years, diabetes mellitus and platelet count <150 × 109 /L, constituting the Asia-Pacific NAFLD advanced fibrosis risk score. A low score has a negative predictive value of 95%-96% for advanced fibrosis. Only 1.7% of patients were referred for structured lifestyle program, 4.2% were on vitamin E, and 2.4% were on pioglitazone.
CONCLUSIONS: More severe liver disease can be suspected or ruled out based on factors identified in this study. Utilisation of structured lifestyle program, vitamin E and pioglitazone was limited despite this being a cohort of biopsy-proven NAFLD patients with majority of patients having NASH.
AIMS: This study aims to evaluate the clinical outcomes and practicality of immediately transferring stable STEMI patients back to their originating hospitals within 2 h postprimary PCI, within the Serdang STEMI Network. Specifically, it seeks to assess the in-hospital mortality rate and 30-day major adverse cardiac events (MACE) among these patients to determine the safety and feasibility of this novel early transfer strategy.
METHODS: This retrospective cohort study involved 1374 STEMI patients participating in the Serdang STEMI network from May 2015 to December 2022, including 570 patients admitted directly to Hospital Sultan Idris Shah, Serdang (HSIS) and 804 transferred from non-PCI centers.
RESULTS: Of the 804 transferred patients, 415 (52%) were transferred back to referring hospitals within 2 h of PPCI. These patients met specific criteria including hemodynamic stability, absence of procedural complications, and fit for transfer at the discretion of the attending cardiologist. The primary outcomes measured were in-hospital and 30-day mortality rates, as well as major adverse cardiac events (MACE). MACE was defined as a composite of death, myocardial infarction, stroke, or repeat revascularization. In the early return group, there was no in-hospital or 30-day mortality. No patient required repeat revascularization or readmission within 30 days.
CONCLUSIONS: Our results indicate that carefully selected patients can be safely returned to their originating hospitals very early following successful PPCI. These findings have important implications for large regional STEMI networks worldwide, particularly in areas where PPCI centers may have limited resources to handle high STEMI volumes.