A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease☆

This study aims to design an asymmetric dual coating (ADC) on the stent by ultrasonic atomization to solve the problem of delayed endothelialization and late or very late stent thrombosis which caused by drug eluting stent (DES) with symmetric coating. Chitosan-loaded monoclonal platelet glycoprotein IIIa receptor antibody SZ-21 coating (CSC) was sprayed on inner surface of stents, and outer surface was sprayed CSC and poly(lactic-co-glycolic acid) (PLGA) loaded with docetaxel (DTX) coating (PDC). The coated surface was uniform without aggregation and no shedding phenomenon either before or after stent expanded. Fluorescence labeling has confirmed that the coating has an asymmetric structure. The cumulative release for SZ-21 and DTX was 40.11% and 27.22% within first 24 h, then DTX became the major released drug from 24 h to 7 d, after released for 28 d about 40% of the SZ-21 and 50% DTX still remained on the coated stent. It achieved that ADC can inhibit thrombosis at earlier period and inhibit vascular smooth muscle cells (VSMCs) proliferation at later period. And that ADC has good hemocompatibility and can significantly inhibit VSMCs proliferation. Finally, 4 and 12 weeks after the stent with ADC implanted into rabbit carotid arteries, it showed that the stent with ADC was safe and could effectively prevent thrombosis and in-stent restenosis. © 2018 Wiley Periodicals, Inc. J. Biomed. Mater. Res. Part B, 2018. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 825-837, 2019.

/pdf/an-asymmetrical-dual-coating-on-the-stent-prepared-by-5e6zuf3xzo.pdf

An asymmetrical dual coating on the stent prepared by ultrasonic atomization

ObjectiveWe aimed to investigate the association between the 5A/6A promoter polymorphism in the matrix metalloproteinase 3 (MMP3) gene and in-stent restenosis (ISR) in a regional Chinese population...

https://journals.sagepub.com/doi/pdf/10.1177/0300060519827145

Association study of matrix metalloproteinase 3 5A/6A polymorphism with in-stent restenosis after percutaneous coronary interventions in a Han Chinese population.

Background Previous studies have indicated that nicorandil can reduce perioperative myocardial injury (PMI) in patients undergoing elective percutaneous coronary intervention (ePCI), but this conclusion is still controversial. Additionally, studies reporting on the safety of nicorandil are lacking. Therefore, we performed this prospective study to evaluate the efficacy and safety of nicorandil on PMI in patients undergoing ePCI. Methods One hundred and forty-six patients with coronary heart disease (CHD) scheduled to undergo ePCI were randomly assigned to the nicorandil group (n=74) or control group (n=72). The primary outcomes were the change in cardiac troponin T (cTnT) and creatine kinase-MB (CK-MB) at 12 and 24 hours after surgery. The secondary outcome was the incidence of major adverse cardiac events (MACE), which was a composite of cardiac death, nonfatal myocardial infarction, new heart failure or coronary revascularization. Results There was no difference in age (54.76±5.93 vs 56.35±5.22) between the nicorandil group and the control group. In addition, no differences were observed in the cTnT and CK-MB levels between the two groups at admission (all P⩾0.05). Compared with those in the control group, the cTnT (0.15±0.12 vs 0.12±0.10 at 12 hours and 0.17±0.12 vs 0.13±0.10 at 24 hours) and CK-MB (15.35±8.23 vs 12.31±7.93 at 12 hours and 13.63±8.87 vs 11.13±5.71 at 24 hours) levels in the nicorandil group were significantly decreased after surgery (all P⩽0.05). Furthermore, nicorandil did not increase the incidence of MACE in the nicorandil group compared with the control group (12.16% vs 12.50%). Conclusions Nicorandil can reduce PMI in patients undergoing ePCI and does not increase the incidence of MACE. Clinical trial registration URL: http://www.chictr.org.cn/. Unique Identifier: ChiCTR-IOR-17012056.

/pdf/efficacy-and-safety-of-nicorandil-on-perioperative-1jqy6jewal.pdf

Efficacy and safety of nicorandil on perioperative myocardial injury in patients undergoing elective percutaneous coronary intervention: results of the PENMIPCI trial.

Hybrid coronary revascularization incorporates a surgical anastomosis of the left internal mammary artery to the left anterior descending coronary artery through a thoracotomy and percutaneous implantation of drug eluting stents in diseased non-left anterior descending coronary arteries. Hybrid coronary artery revascularization can be performed as a 1-stage procedure in a hybrid operating room or as a tightly scheduled 2-stage procedure. Hybrid coronary artery revascularization is seldom the selected modality for coronary revascularization due to the lack of a hybrid operating room in many hospitals, the recommended thoracotomy approach for bypass, or the rigid schedule of surgical and endovascular revascularization. A 2-stage approach, using a sternotomy as compared to standard thoracotomy, and a flexible schedule between surgical and endovascular procedures may facilitate the adoption of hybrid coronary revascularization with noncomplex multi-vessel stable coronary artery disease.

/pdf/respite-for-hybrid-coronary-revascularization-32ozi0kumh.pdf

Respite for hybrid coronary revascularization

The "Law on Doctors of the People's Republic of China," which was officially implemented on March 1, 2022, emphasizes the requirements for rational drug use and the necessity for appropriate management of off-label drug use. The safety and ethical considerations related to off-label drug use are different in children than in adults. There is so far no management guideline for pediatric off-label use of drugs in China, and the applicability of foreign guidelines is limited. Establishing a localized evidence-based management guideline for pediatric off-label use of drugs to support the national legislation and clinical practice is of critical importance.We established a guideline working group, including experts from a broad range of disciplines and developed recommendations following the guidance of the World Health Organization Handbook and the Chinese Medical Association. The following themes were identified by questionnaires and expert interviews to be of great concern in the management of off-label drug use in children: general principles and characteristics of management of pediatric off-label drug use; establishment of expert committees; evidence evaluation; risk-benefit assessment; informed consent; monitoring and assessment of the risk; and monitoring and patient education. Two rounds of Delphi surveys were organized to determine the final recommendations of this guideline. We graded the recommendations based on the body of evidence, referring to the evaluation tool of the Evidence-based management (EBMgt) and the Oxford Center for Evidence-Based Medicine: Level of Evidence (March 2009).We developed the first guideline for the management of pediatric off-label use of drugs in China.The guideline is to offer guidance for pediatricians, pharmacists, medical managers, policymakers, and primary care physicians on how to manage off-label drug use in pediatrics and to provide recommendations for Chinese healthcare policy in the future. 

/pdf/guideline-for-the-management-of-pediatric-off-label-use-of-c8dddv42.pdf

Guideline for the management of pediatric off-label use of drugs in China (2021)

Everolimus -eluting stent (EES) is common used in patients undergoing percutaneous coronary interventions (PCI). Our purpose is to evaluate long-term clinical outcomes of everolimus -eluting stent (EES) versus paclitaxel-eluting stent (PES) in patients undergoing percutaneous coronaryinterventions (PCI) in randomized controlled trials (RCTs). We searched Medline, EMBASE, Cochrane Library, CNKI, VIP and relevant websites (
 https://scholar-google-com.ezproxy.lib.usf.edu/
 ) for articles to compare outcomes between everolimus-eluting stent and paclitaxel-eluting stent without language or date restriction. RCTs that compared the use of everolimus -eluting stent and paclitaxel-eluting stent in PCI were included. Variables relating to patient, study characteristics, and clinical endpoints were extracted. Meta-analysis was performed using RevMan 5.2 software. We identified 6 published studies (from three randomized trials) more on everolimus-eluting stent (n = 3352) than paclitaxel-eluting (n = 1639), with follow-up duration ranging from 3, 4 and 5 years. Three-year outcomes of everolimus-eluting stent compared to paclitaxel-eluting were as following: the everolimus-eluting stent significantly reduced all-cause death (relative risk [RR]:0.63; 95 % confidence interval [CI]: 0.46. to 0.82), MACE (RR: 0.56; 95 % CI: 0.41 to 0.77), MI (RR: 0.64; 95 % CI: 0.48 to 0.86), TLR (RR: 0.72; 95 % CI: 0.59 to 0.88), ID-TLR (RR: 0.74; 95 % CI: 0.59 to 0.92) and ST (RR: 0.54; 95 % CI: 0.32 to 0.90). There was no difference in TVR between the everolimus-eluting and paclitaxel-eluting (RR: 0.76; 95 % CI: 0.58 to 1.10); Four-year outcomes of everolimus-eluting compared to paclitaxel-eluting: the everolimus-eluting significantly reduced MACE (RR: 0.44; 95 % CI: 0.18 to 0.98) and ID-TLR (RR: 0.47; 95 % CI: 0.23 to 0.97). There was no difference in MI (RR: 0.48; 95 % CI: 0.16 to 1.46), TLR (RR: 0.46; 95 % CI: 0.20 to1.04) and ST ((RR: 0.34; 95 % CI: 0.05 to 2.39). Five-year outcomes of everolimus-eluting stent compared to paclitaxel-eluting: There was no difference in ID-TLR (RR: 0.67; 95 % CI: 0.45 to 1.02) and ST (RR: 0.71; 95 % CI: 0.28 to1.80). In the present meta-analysis, everolimus-eluting appeared to be safe and clinically effective in patients undergoing PCI in comparison to PES in 3-year clinical outcomes; there was similar no difference in reduction of ST between EES and PES in long-term(≥4 years) clinical follow-ups. Everolimus-eluting is more safety than paclitaxel-eluting in long-term clinical follow-ups, whether these effects can be applied to different patient subgroups warrants further investigation.

/pdf/long-term-clinical-outcomes-of-everolimus-eluting-stent-rc0akdek1c.pdf

Long-term clinical outcomes of everolimus-eluting stent versus paclitaxel-eluting stent in patients undergoing percutaneous coronary interventions: a meta-analysis

Objective To examine the current prevalence and cost of paediatric off-label drug prescriptions in Gansu, China, and the potential influencing factors. Design The prevalence of off-label prescriptions in paediatrics was evaluated according to the National Medical Products Administration drug instructions in the China Pharmaceutical Reference (China Pharmaceutical Reference, MCDEX) database. The evidence of the prescription was determined by existing clinical practice guidelines and the Thomson Grade in the Micromedex 2021 compendium. We used logistic regression to investigate the characteristics that influence paediatric off-label drug use after single-factor regression analysis. Setting A multicentre cross-sectional study of outpatient paediatric prescriptions in 196 secondary and tertiary hospitals in Gansu Province, China, in March and September 2020. Results We retrieved 104 029 paediatric prescriptions, of which 39 480 (38.0%) contained off-label use. The most common diseases treated by off-label drugs were respiratory system diseases (n=15 831, 40.1%). A quarter of off-label prescriptions had adequate evidence basis (n=10 130, 25.6%). Unapproved indications were the most common type of off-label drug use (n=25 891, 65.6%). A total of 1177 different drugs were prescribed off-label, with multienzyme tablets being the most common drug (n=1790, 3.5%). The total cost of the prescribed off-label drugs was ¥106 116/day. Off-label prescriptions were less frequent in tertiary than in secondary hospitals. Topical preparations were more commonly prescribed off-label than other types of drugs. Senior-level clinicians prescribed drugs off-label more often than intermediate and junior clinicians. Conclusion Off-label drug use is widespread in paediatric practice in China. Three-quarters of the prescriptions may potentially include inappropriate medication use, resulting in a daily economic burden of about ¥81 000 in 2020 in Gansu Province with 25 million inhabitants. The management of off-label drug use in paediatrics in China needs improvement.

Paediatric off-label use of drugs in Gansu, China: a multicentre cross-sectional study

Medicine purchasing in Chinese public hospitals is decided by the hospital Pharmacy Management Committee (PMC), that is complex, subjective and requires efficient approaches to ensure transparency and consistency for the factors being considered. This study aimed to use the Evidence and Value: Impact on Decision Making (EVIDEM) framework to assess medicine in these hospitals. In this study anti-diabetic drugs DPP-4 inhibitors, which work by inhibiting the activation of the Dipeptidyl Peptidase 4 (DPP-4) inhibitors, were appraised. Following EVIDEM methodology (EVIDEM-10th), we convened an appraisal group and asked each individual to express their perspectives by assigning weights to each criterion. A systematic literature search for information of each criterion of five DPP-4 inhibitors was completed. Then the appraisal group scored for each criterion of the five DPP-4 inhibitors. The estimated value of the five DPP-4 inhibitors was obtained by Multi-Criteria Decision Analysis (MCDA) which combined individual weighting of each criterion with individual scoring for each intervention in each criterion. By assigning weights, the most important criterion was the quality of evidence (4.01±0.52), and that the comparative cost consequences-non-medical cost was the least important criterion (2.87±1.03). Criteria included disease severity, size of the affected population, comparative effectiveness, type of therapeutic/preventive benefit and cost of intervention, all of which were assigned the same weight of 3.58. After MCDA, the overall value orders for each DPP-4 inhibitor included Sitagliptin (0.45), Linagliptin (0.44), Vildagliptin (0.43), Alogliptin (0.42) and Saxagliptin (0.40). Based on EVIDEM framework and MCDA, we found that overall value of five DPP-4 inhibitors was similar. It is feasible to use the EVIDEM framework and MCDA in purchasing medicine for Chinese public hospitals.

/pdf/impact-on-decision-making-framework-for-medicine-purchasing-1m2y0ktiit.pdf

Impact on decision making framework for medicine purchasing in Chinese public hospital decision-making: determining the value of five dipeptidyl peptidase 4 (DPP-4) inhibitors.

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Papers

Guideline for the management of pediatric off-label use of drugs in China (2021)

Long-term clinical outcomes of everolimus-eluting stent versus paclitaxel-eluting stent in patients undergoing percutaneous coronary interventions: a meta-analysis

Paediatric off-label use of drugs in Gansu, China: a multicentre cross-sectional study

Impact on decision making framework for medicine purchasing in Chinese public hospital decision-making: determining the value of five dipeptidyl peptidase 4 (DPP-4) inhibitors.