Do coronary stent policies affect the cost-effectiveness of percutaneous coronary intervention among patients with acute coronary syndrome in Shanghai? A retrospective cohort study based on real-world and propensity score-matched data

Objectives
This study aimed to assess whether the national centralised volume-based procurement policy and the Shanghai government’s supportive measures (coronary stent policies) implemented in Shanghai, China, on 20 January 2021 affected the cost-effectiveness of percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) in the year after surgery.

Design
A retrospective cohort study based on real-world data and propensity score (PS)-matched data was conducted to compare the cost-effectiveness of PCI before and after policy implementation.

Patients and setting
Patients with ACS who had undergone first-time PCI over 1 year previously in hospitals in Shanghai and were discharged between 1 March 2019 and 30 April 2022 were included in the study.

Outcome measures
In the present study, cost was defined as total direct medical expenses, and effectiveness was defined as the prevention of major adverse cardiac events (MACEs). Incremental cost-effectiveness ratios (ICERs) were used to measure the cost-effectiveness of PCI in patients with ACS 1 year after surgery.

Results
The study included 31 760 patients. According to real-world and PS-matched data, the implementation of coronary stent policies in Shanghai reduced the total medical cost of patients with ACS 1 year after PCI by 24.39% (p

Leggi
Giugno 2024

Preoperative pancreatic stent placement before the enucleation of insulinoma located in the head and neck of the pancreas in proximity to the main pancreatic duct: study protocol for a multicentre randomised clinical trial in Chinese tertiary medical centres

Introduction
The surgical intervention approach to insulinomas in proximity to the main pancreatic duct remains controversial. Standard pancreatic resection is recommended by several guidelines; however, enucleation (EN) still attracts surgeons with less risk of late exocrine/endocrine insufficiency, despite a higher postoperative pancreatic fistula (POPF) rate. Recently, the efficacy and safety of preoperative pancreatic stent placement before the EN have been demonstrated. Thus, a multicentre open-label study is being conducted to evaluate the efficacy and safety of stent placement in improving the outcome of EN of insulinomas in proximity to the main pancreatic duct.

Methods and analysis
This is a prospective, randomised, open-label, superiority clinical trial conducted at multiple tertiary centres in China. The major eligibility criterion is the presence of insulinoma located in the head and neck of the pancreas in proximity (≤2 mm) to the main pancreatic duct. Blocked randomisation will be performed to allocate patients into the stent EN group and the direct EN group. Patients in the stent EN group will go through stent placement by the endoscopist within 24 hours before the EN surgery, whereas other patients will receive EN surgery directly. The primary outcome is the assessment of the superiority of stent placement in reducing POPF rate measured by the International Study Group of Pancreatic Surgery standard. Both interventions will be performed in an inpatient setting and regular follow-up will be performed. The primary outcome (POPF rate) will be tested for superiority with the X2 test. The difference in secondary outcomes between the two groups will be analysed using appropriate tests.

Ethics and dissemination
The study has been approved by the Peking Union Medical College Hospital Institutional Review Board (K23C0195), Ruijin Hospital Ethics Committee (2023-314), Peking University First Hospital Ethics Committee (2024033-001), Institutional Review Board of Xuanwu Hospital of Capital Medical University (2023223-002), Ethics Committee of the First Affiliated Hospital of Xi’an Jiaotong University (XJTU1AF2023LSK-473), Institutional Review Board of Tongji Medical College Tongji Hospital (TJ-IRB202402059), Ethics Committee of Tongji Medical College Union Hospital (2023-0929) and Shanghai Cancer Center Institutional Review Board (2309282-16). The results of the study will be published in an international peer-reviewed journal.

Trial registration number
NCT05523778.

Leggi
Aprile 2024

Drug-Coated Balloons for In-Stent Restenosis—Finally Leaving Nothing Behind for US Patients

Over the past 2 decades, percutaneous coronary intervention (PCI) with placement of metallic drug-eluting stents (DES) has revolutionized the management of coronary artery disease and stands as one of the most performed therapeutic procedures in modern medicine. The use of metallic stents, however, comes with inherent limitations from permanently placing foreign material within the coronary artery, most notably thrombus formation and vascular inflammation, both of which lead to new tissue growth (neointimal hyperplasia) resulting in some degree of vessel renarrowing. Despite thinner stent struts and antiproliferative drugs, this process occasionally becomes pathologic from extensive neointimal tissue formation early (restenosis) or atherosclerosis late (neoatherosclerosis). Although the latest generation of drug-eluting stents has low rates of in-stent restenosis (6%-8%) that occurs primarily in the first year, it is estimated that after the first year, drug-eluting stents have an adverse ischemic event rate of 2% per year with no discernible plateau. As a result, interventions to treat in-stent restenosis account for nearly 10% of all PCIs performed in the US and can present a therapeutic challenge with suboptimal long-term outcomes. Although the best management strategy is still a matter of debate, in-stent restenosis in the US is most commonly treated with repeat drug-eluting stent placement (ie, stent within a stent).

Leggi
Marzo 2024