1.Five-year outcomes of biodegradable versus second-generation durable polymer drug-eluting stents used in complex percutaneous coronary intervention.
Na XU ; Lin JIANG ; Yi YAO ; Jingjing XU ; Ru LIU ; Huanhuan WANG ; Ying SONG ; Lijian GAO ; Zhan GAO ; Xueyan ZHAO ; Bo XU ; Yaling HAN ; Jinqing YUAN
Chinese Medical Journal 2023;136(3):322-330
BACKGROUND:
There are few data comparing clinical outcomes of complex percutaneous coronary intervention (CPCI) when using biodegradable polymer drug-eluting stents (BP-DES) or second-generation durable polymer drug-eluting stents (DP-DES). The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up.
METHODS:
Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence. CPCI included at least one of the following features: unprotected left main lesion, ≥2 lesions treated, ≥2 stents implanted, total stent length >40 mm, moderate-to-severe calcified lesion, chronic total occlusion, or bifurcated target lesion. The primary endpoint was major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction, and total coronary revascularization (target lesion revascularization, target vessel revascularization [TVR], and non-TVR) during the 5-year follow-up. The secondary endpoint was total coronary revascularization.
RESULTS:
Among the 7712 patients included, 4882 (63.3%) underwent CPCI. Compared with non-CPCI patients, CPCI patients had higher 2- and 5-year incidences of MACE and total coronary revascularization. Following multivariable adjustment including stent type, CPCI was an independent predictor of MACE (adjusted hazard ratio [aHR]: 1.151; 95% confidence interval [CI]: 1.017-1.303, P = 0.026) and total coronary revascularization (aHR: 1.199; 95% CI: 1.037-1.388, P = 0.014) at 5 years. The results were consistent at the 2-year endpoints. In patients with CPCI, BP-DES use was associated with significantly higher MACE rates at 5 years (aHR: 1.256; 95% CI: 1.078-1.462, P = 0.003) and total coronary revascularization (aHR: 1.257; 95% CI: 1.052-1.502, P = 0.012) compared with that of DP-DES, but there was a similar risk at 2 years. However, BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years.
CONCLUSIONS
Patients underwent CPCI remained at a higher risk of mid- to long-term adverse events regardless of the stent type. The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.
Humans
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Drug-Eluting Stents/adverse effects*
;
Myocardial Infarction/complications*
;
Polymers/therapeutic use*
;
Treatment Outcome
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Coronary Artery Disease/complications*
;
Percutaneous Coronary Intervention/adverse effects*
;
Absorbable Implants
;
Prosthesis Design
2.Treatment of Steroid-induced Osteonecrosis of Femoral Head by Porous Tantalum Rod and Gugutou Huaisiyu Capsule.
Xu-yi TAN ; Fei-fei GAO ; Shu-tu GAO ; You-wen LIU ; Xian-tao CHEN ; Li-yun LIU
Chinese Journal of Integrated Traditional and Western Medicine 2016;36(1):40-43
OBJECTIVETo observe the curative effect of porous tantalum rod and Gugutou Huaisiyu Capsule (GHC) for steroid-induced osteonecrosis of femoral head (SONFH).
METHODSA total 60 hips of 50 SONFH patients were randomly assigned to the treatment group and the control group according to grouping time, 25 in each group (30 hips). Patients in the control group were implanted with porous tantalum rod, while those in the treatment group additionally took GHC (5 pills each time, three time per day for 2 successive months; and then twice per day for 4 successive months). Then all patients were followed-up to observe Harris hip score. The curative effect and the femoral head survival time were assessed.
RESULTSA total of 49 patients (59 hips) were followed-up. The Harris hip score of the two groups at the final follow-up was significantly improved after treatment, with statistical difference when compared with before treatment (P < 0.01). Besides, it was higher in the treatment group than in the control group. The curative effect and the survival time were superior in the treatment group, with statistical difference when compared with the control group (P < 0.05).
CONCLUSIONSPorous tantalum rod combined GHC got better effect in treating SONFH. It could significantly improve the function of affected hips and prolong the survival time of femoral head.
Capsules ; Drugs, Chinese Herbal ; administration & dosage ; pharmacology ; therapeutic use ; Femur Head Necrosis ; drug therapy ; Humans ; Prostheses and Implants ; Steroids ; adverse effects ; Tantalum
4.Effects of progestagen exposure duration on estrus synchronization and conception rates of crossbreed ewes undergoing fixed time artificial insemination.
Wanessa BLASCHI ; Paula A LUNARDELLI ; Luciana S R MARINHO ; Marilu C MAX ; Gustavo M G SANTOS ; Katia C SILVA-SANTOS ; Fabiana A MELO-STERZA ; Hernan BALDASSARRE ; Thales R RIGO ; Marcelo M SENEDA
Journal of Veterinary Science 2014;15(3):433-437
Synchronization of estrus and ovulation are of paramount importance in modern livestock improvement programs. These methods are critical for assisted reproduction technologies, including artificial insemination and embryo transfer, that can increase productivity. In the current study, subcutaneous implants containing norgestomet were placed for long (14 days), medium (9 days), and short (5 days) periods of time in 70 crossbred ewes undergoing fixed-time artificial insemination. The resulting effects on estrus synchronization and conception rates were subsequently evaluated. Among the synchronized ewes, 85.7% (60/70) underwent estrus over a period of 72 h after progestagen treatment ceased. The shortest mean interval between withdrawal of the device and onset of estrus (34.2 +/- 8.9 h) was observed in the G14 days of P4 group (p < 0.05). The conception rate of the G14 days of P4 group was statistically higher than that of the other groups (83.3% vs. 60.9% vs. 47.8%; p < 0.05). In conclusion, 14 days of norgestomet treatment produced higher conception rates and a greater number of pregnancies at the beginning of the breeding season.
Animals
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Drug Implants/therapeutic use
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Estrus Synchronization/drug effects/*methods
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Female
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Fertilization/drug effects
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Insemination, Artificial/methods/*veterinary
;
Pregnenediones/administration & dosage/*pharmacology
;
Sheep
5.Investigation of long-term implantation of BuMA stent in a porcine coronary model.
Ming CHEN ; Xin-gang WANG ; Bo ZHENG ; Hong-yu PENG ; Xiao-yan ZHANG ; Bin ZHANG ; Yong HUO
Chinese Medical Journal 2012;125(22):4083-4087
BACKGROUNDStent-based delivery of sirolimus has been shown to reduce neointimal hyperplasia significantly. However, the long-term effect of the polymer is thought to initiate and sustain an inflammatory response and contribute to the occurrence of late complications. Our study aimed to evaluate the efficacy and safety of the BuMA biodegradable drug-coated sirolimus-eluting stent (BSES) for inhibiting neointimal hyperplasia in a porcine coronary model.
METHODSFour types of stents were implanted at random in different coronary arteries of the same pig: BSES (n = 24), bare metal stent (BMS) (n = 24), biodegradable polymer coated stent without drug (PCS) (n = 24) and only poly (n-butyl methacrylate) base layer coated stent (EGS) (n = 23). In total, 26 animals underwent successful random placement of 95 oversized stents in the coronary arteries. Coronary angiography was performed after 28 days, 90 days and 240 days of stent implantation. After 14 days, 28 days, 90 days and 240 days, 6 animals at each timepoint were sacrificed for histomorphologic analysis.
RESULTSThe 28-day, 90-day and 240-day results of quantitative coronary angiography (QCA) showed reduction in luminal loss (LL) in the BSES group when compared with the BMS group; (0.20 ± 0.35) mm vs. (0.82 ± 0.51) mm (P = 0.035), (0.20 ± 0.30) mm vs. (0.93 ± 0.51) mm (P = 0.013), and (0.18 ± 0.16) mm vs. (0.19 ± 0.24) mm (P = 0.889), respectively. By 28-day, 90-day and 240-day histomorphomeric analysis results, there was also a corresponding significant reduction in neointimal tissue proliferation with similar injury scores of BSES compared with the BMS control; average neointimal area (0.90 ± 0.49) mm(2) vs. (2.16 ± 1.29) mm(2) (P = 0.049), (1.53 ± 0.84) mm(2) vs. (3.41 ± 1.55) mm(2) (P = 0.026), and (2.43 ± 0.95) mm(2) vs. (3.12 ± 1.16) mm(2) (P = 0.228), respectively. High magnification histomorphologic examination revealed similar inflammation scores and endothelialization scores in both the BSES and BMS groups.
CONCLUSIONSThe BuMA biodegradable drug-coated sirolimus-eluting stents can significantly reduce neointimal hyperplasia and in-stent restenosis. Re-endothelialization of the BuMA stent is as good as that of the BMS in the porcine coronary model due to the reduced inflammation response to the BuMA stent.
Absorbable Implants ; Animals ; Coronary Angiography ; Drug-Eluting Stents ; Female ; Hyperplasia ; pathology ; Neointima ; prevention & control ; Polymers ; chemistry ; Sirolimus ; therapeutic use ; Swine
6.Postoperative pain of hemorrhoid treated with thread embedding at Changqiang (GV 1).
Chinese Acupuncture & Moxibustion 2012;32(4):313-315
OBJECTIVETo compare the therapeutic effect of postoperative pain of hemorrhoid treated with thread embedding at Changqiang (GV 1) and Indometacin suppository.
METHODSEighty cases were randomly divided into an acupoint catgut-embedding group (group A) and an Indometacin group (group B), forty case in each group. In group A, thread embedding at Changqiang (GV 1) was applied, and Indometacin suppository was put into rectum in group B. The pain intensity after 6, 12, 24, 72 hours of treatment and the the maximum scores of VAS in 24 hours (T24max VAS) of 1-3 days of postopration were evaluated with pain Visual Analogue Scale (VAS); the quantity demanded of analgesic and the adverse reaction were observed.
RESULTSThe scores of VAS after 6, 12, 24, 72 hours of treatment in group A were obviously lower than those in group B (all P < 0.05); the T24max VAS scores in group A were obviously lower than those in group B (all P < 0.05). Six cases in group A and 14 cases in group B were treated with non-steroidal anti-inflammatory drug as well. The total effective rate of 87.5% (35/40) in group A was superior to that of 62.5% (25/40) in group B, indicating the statistically significant differences between two groups (P < 0.05). There was no obvious adverse reaction in group A; in group B, headache, dizziness, nausea, vomiting, distention of chest and palpitation appeared, accounting for 11 cases.
CONCLUSIONThe therapeutic effect of postoperative pain of hemorrhoid treated with thread embedding at Changqiang (GV 1) is favorable, it can reduce the quantity of analgesic, the adverse reaction, its effect is better than that of Indometacin suppository.
Acupuncture Points ; Adult ; Aged ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Hemorrhoids ; complications ; Humans ; Male ; Middle Aged ; Pain, Postoperative ; drug therapy ; etiology ; Prostheses and Implants ; Young Adult
7.Comparison of paclitaxal vs. sirolimus eluting stents with bio-degradable polymer for the treatment of coronary bifurcation lesions: subgroup analysis from DKCRUSH-I and DKCRUSH-II studies.
Shao-Liang CHEN ; Gary MINTZ ; Teguh SANTOSO ; Jun-Jie ZHANG ; Fei YE ; Ya-Wei XU ; Qiang FU ; Jing KAN ; Chitprapai PAIBOON ; Yong ZHOU ; Shi-Qin DING ; Tak W KWAN
Chinese Medical Journal 2012;125(19):3382-3387
BACKGROUNDThe difference in clinical outcome between paclitaxal-eluting stents (PES) and sirolimus-eluting stents with bio-degradable polymer (SES-BDP) for bifurcation lesions remains unclear. The present study aimed to investigate the one-year clinical outcome after DK crush stenting using PES (Taxus(TM)) vs. SES-BDP (Excel(TM)) from our database.
METHODSA total of 275 patients (90 from the DKCRUSH-I and 185 from the DKCRUSH-II study) were studied. The primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12 months; including cardiac death, myocardial infarction (MI), or target vessel revascularization (TVR). The rate of binary restenosis and stent thrombosis served as secondary endpoints.
RESULTSAt follow-up, minimal luminal diameter (MLD) in the Taxus group was (2.11 ± 0.66) mm, with resultant increased target lesion revascularization (TLR) 12.2% and TVR 14.4%, significantly different from the Excel group; (2.47 ± 0.56) mm, P < 0.001, 3.2%, P = 0.006, 4.9%, P = 0.019, respectively. As a result there was a significant difference in MACE between the Taxus (20.0%) and Excel (10.3%, P = 0.038) groups. Overall stent thrombosis was monitored in 11 patients (4.0%), with five in the Excel group (2.7%) and six in the Taxus group (6.7%). All stent thrombosis in the Excel group was classified as early, and all were defined as late in the Taxus group.
CONCLUSIONThe Excel stent had lower rate of stent thrombosis, TLR, TVR, and composite MACE at 12-month after an indexed stenting procedure, compared to the Taxus stent.
Absorbable Implants ; Aged ; Coronary Artery Disease ; therapy ; Drug-Eluting Stents ; adverse effects ; Female ; Humans ; Male ; Middle Aged ; Paclitaxel ; therapeutic use ; Polymers ; Sirolimus ; therapeutic use
8.Recent advance in research of platelet-rich fibrin (correction of plasma).
Chinese Journal of Stomatology 2011;46(6):382-383
Animals
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Blood Platelets
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Cell Proliferation
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drug effects
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Dental Implants
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Fibrin
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chemistry
;
history
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pharmacology
;
therapeutic use
;
Gingival Recession
;
therapy
;
History, 20th Century
;
Humans
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Mesenchymal Stromal Cells
;
cytology
;
drug effects
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Osteoblasts
;
cytology
;
drug effects
;
Sinus Floor Augmentation
;
methods
9.The role of slow-release 5-fluorouracil implantation in treatment of unresectable pancreatic cancer.
Cheng-feng WANG ; Ping ZHAO ; Yi SHAN ; Dong-bing ZHAO ; Yan-tao TIAN ; Xiao-feng BAI ; Yue-min SUN ; Xu CHE ; Hui QU ; Yi-bin XIE
Chinese Journal of Oncology 2010;32(9):706-708
OBJECTIVETo study the role of slow-release 5-fluorouracil implantation in treatment of unresectable pancreatic cancer.
METHODS85 cases of untreated patients with locally advanced pancreatic cancer (LAPC) were randomized into two groups: Trial group: slow-release 5-fluorouracil implantation (50 patients) and control group (35 patients). Observing the objective tumor response, clinical benefit response, toxicity, complications and survival of patients of the two groups.
RESULTSIn the trial group the overall response rate (PR + NC) was 76.0%, and the clinical benefit response rate was 52.0%. No toxicity was observed. Pancreatic fistula occurred in 2 patients. The median survival time of the two groups was 9.0 months and 4.0 months, respectively. The survival rates of 6- and 12-month were 56.8% vs. 31.4% and 22.9% vs. 2.9% in the two groups, respectively (P = 0.012).
CONCLUSIONSlow-release 5-fluorouracil implantation is a simple, safe and effective method in treatment of LAPC.
Antimetabolites, Antineoplastic ; administration & dosage ; therapeutic use ; Drug Implants ; adverse effects ; Female ; Fluorouracil ; administration & dosage ; therapeutic use ; Follow-Up Studies ; Humans ; Male ; Microspheres ; Middle Aged ; Neoplasm Staging ; Pancreatic Fistula ; etiology ; Pancreatic Neoplasms ; drug therapy ; pathology ; Prospective Studies ; Remission Induction ; Survival Rate
10.Preparation and osteoinduction capacity of collagen/bone morphogenetic protein composites.
Weiqiang TAN ; Jinghong XU ; Youshan LIU ; Jun LIN ; Huiming WANG
Chinese Journal of Biotechnology 2008;24(2):272-277
Collagen/bone morphogenetic protein composites were prepared with collagen type I sponge and bone morphogenetic protein-2 (BMP-2). The composites were implanted into Latissimus dorsi muscles pouches of rabbits. Samples were studied with ALP staining, Von Kossa staining, HE staining, toluidine blue staining and CD31 histochemical labeling of microvessel. Bony samples were then used to repair mandibular defect. The effects were evaluated by X-ray, compressive strength, economycin fluorescence labeling, HE staining, toluidine blue staining and bone quantity analysis. Bone formation induced by collagen/BMP composites was found as woven bone between 4 and 6 weeks; cartilaginous osteogenesis was the main type of bone formation; microvessels could be seen in the bony tissues; and the bone defects were healed completely 6 weeks after operation. Bone formation induced by collagen/BMP composites in the muscles can be used as a donor to repair the bone defect.
Animals
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Bone Morphogenetic Protein 2
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chemistry
;
therapeutic use
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Bone Regeneration
;
drug effects
;
Bone Transplantation
;
methods
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Collagen Type I
;
chemistry
;
therapeutic use
;
Female
;
Implants, Experimental
;
Male
;
Mandibular Injuries
;
surgery
;
Muscle, Skeletal
;
surgery
;
Rabbits
;
Random Allocation

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