简介:AbstractBackground:Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions.Methods:Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses.Results:At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ± 0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group.Conclusions:In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.Trial registration:ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov
简介:Background:Thesafetyandefficacyofcoronaryarterybypassgrafting(CABG)andsecond-generationdrug-elutingstents(DESs)inpatientswithcoronaryarterydisease(CAD)remaincontroversial.ThereforeweaimedtocomparetheoutcomesofCADpatientstreatedwithCABGandsecond-generationDESs.Methods:WesystematicallysearchedthePubMed,CochraneLibrary,Ovid,andElsevierdatabases.Studiescomparingsecond-generationDESswithCABGinCADpatientswereincluded.RevMan5.3wasusedtoextractandpoolthedatafromtheapplicablestudies.Results:Sixtrials(N=6604participants)wereincludedinthismeta-analysis.AmongalloftheCADpatients,second-generationDESswereassociatedwithnodifferencesintherisksofall-causedeath[riskratio(RR)1.18,95%confidenceinterval(CI)0.98–1.43,P=0.09],cardiovasculardeath(RR1.14,95%CI0.81–1.59,P=0.45),myocardialinfarction(RR1.22,95%CI0.98–1.54,P=0.08),andstroke(RR0.83,95%CI0.59–1.17,P=0.29),butincreasedtherisksofrevascularization(RR1.95,95%CI1.66–2.30,P<0.001)andmajoradversecardiacandcerebrovascularevents(RR1.72,95%CI:1.31–2.26,P<0.001)whencomparedwithCABG.Conclusions:InthetreatmentofCADpatients,second-generationDESswasnotassociatedwithincreasedrisksofall-causedeath,cardiovasculardeath,myocardialinfarction,andstroke,butincreasedtherisksofrevascularizationandmajoradversecardiacandcerebrovasculareventswhencomparedwithCABG.
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简介:AbstractBackground:The mechanism and characteristics of early and late drug-eluting stent in-stent restenosis (DES-ISR) have not been fully clarified. Whether there are different outcomes among those patients being irrespective of their repeated treatments remain a knowledge gap.Methods:A total of 250 patients who underwent initial stent implantation in our hospital, and then were readmitted to receive treatment for the reason of recurrent significant DES-ISR in 2016 were involved. The patients were categorized as early ISR (<12 months; E-ISR; n = 32) and late ISR (≥12 months; L-ISR; n = 218). Associations between patient characteristics and clinical performance, as well as clinical outcomes after a repeated percutaneous coronary intervention (PCI) were evaluated. Primary composite endpoint of major adverse cardiac events (MACEs) included cardiac death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR).Results:Most baseline characteristics are similar in both groups, except for the period of ISR, initial pre-procedure thrombolysis in myocardial infarction, and some serum biochemical indicators. The incidence of MACE (37.5% vs. 5.5%; P < 0.001) and TLR (37.5% vs. 5.0%; P < 0.001) is higher in the E-ISR group. After multivariate analysis, E-ISR (odds ratio [OR], 13.267; [95% CI 4.984-35.311]; P < 0.001) and left ventricular systolic dysfunction (odds ratio [OR], 6.317; [95% CI 1.145-34.843]; P = 0.034) are the independent predictors for MACE among DES-ISR patients in the mid-term follow-up of 12 months.Conclusions:Early ISR and left ventricular systolic dysfunction are associated with MACE during the mid-term follow-up period for DES-ISR patients. The results may benefit the risk stratification and secondary prevention for DES-ISR patients in clinical practice.
简介:BackgroundCreatinekinase-MB(CK-MB)elevationafterpercutaneouscoronaryintervention(PCI)hasbeenassociatedwithincreasedriskformortality.Althoughmoststudieshavedefinedperiproceduralmyocardialinfarction(pMI)asanelevationinCK-MB>3×upperlimitofnormal(ULN),useofdifferentCK-MBassaysandvariationinsite-specificdefinitionsoftheULNmaylimitthevalueofsuchrelativethresholds.MethodsandResultsWeuseddatafromthemulticenterEvaluationofDrug-ElutingStentsandIschemicEvents(EVENT)registrytoexaminetheimpactofvariationsinsite-specificthresholdsforCK-MBelevationontheincidenceofpMIaswellastherelationshipbetweenabsolutepeaklevelsofCK-MBafterPCIand1-yearmortality.Thestudycohortconsistedof6347patientswhounderwentnonemergentPCIandhadnormalCK-MBatbaseline.Acrossthe59studycenters,theULNforCK-MBrangedfrom2.6to10.4ng/mL(median,5.0ng/mL),andtherewasaninverserelationshipbetweenthesite-specificULNandtheincidenceofpMI(definedasCK-MBelevation>3×ULN).AlthoughanypostprocedureelevationofCK-MBwasassociatedwithanadverseprognosis,incategoricalanalyses,onlyCK-MB≥50ng/mLwasindependentlyassociatedwithincreased1-yearmortality(hazardratio,4.71;95%confidenceinterval,2.42to9.13;P<0.001).SplineanalysisusingpeakCK-MBasacontinuousvariablesuggestedagraded,nonlinearrelationshipwith1-yearmortality,withaninflectionpointat≈30ng/mL.ConclusionsAmongunselectedpatientsundergoingPCI,thereisagradedrelationshipbetweenCK-MBelevationafterPCIand1-yearmortalitythatisparticularlystrongforlargeCK-MBelevations(>30to50ng/mL).FuturestudiesthatincludepMIasaclinicalendpointshouldconsiderusingacorelaboratorytoassessCK-MB(toensureconsistency)andraisingthethresholdfordefiningpMIabovecurrentlevels(toenhanceclinicalrelevance).
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简介:BackgroundPriorrandomizedtrialshaveshownreducedbleedingwithbivalirudincomparedwithunfractionatedheparin(UFH)inpatientsundergoingpercutaneouscoronaryintervention(PCI).However,itisnotknownifthisbenefitisalsopresentwhenUFHdosesaremoretightlycontrolled(asmeasuredbyactivatedclot-tingtime,ACT).MethodsandResultsPatientsenrolledintheEVENT(EvaluationofDrug-ElutingStentsandIschemicEvents)registry,weredividedinto3groups,basedontheantithromboticdrugusedduringPCI(UFHmonotherapy,UFH+glycoproteinIIb-IIIareceptorinhibitor[GPI],orbivalirudinalone).Propensityscorematchingwasusedtoadjustformeasuredcovariates(89variables)andtocomparebivalirudinversusUFHmonotherapyandbivalirudinversusUFH+GPIgroups.TheUFHgroupswerestratifiedbasedonACTachieved(optimalACTdefinedas250-300forUFHmonotherapyand200-250whenGPIwasalsoused).Theprimarybleedingoutcomewasin-hospitalcompositebleeding,definedaseventsofaccesssitebleeding,ThrombolysisInMyocardialInfarctionmajor/minorbleeding,ortransfusion.Primary(in-hospitaldeath/myocardialinfarction)andsecondaryischemicoutcomes(death/MI/unplannedrepeatrevascularizationat12months)werealsoevaluated.Propensityscorematchingyielded3022patientsfortheUFHmonotherapyversusbivalirudincomparisonand3520patientsfortheUFH+GPIversusbivalirudincomparison.BivalirudinusewasassociatedwithnumericallylowerbleedingratesatallcategoriesofachievedACTwhencomparedwithUFH(low,optimal,highACT:2.5%versus4.7%,1.9%versus6.0%,3.1%versus4.8%,respectively)orheparin+GPIgroups(low,optimal,highACT:0.0%versus2.7%,2.7%versus5.2%,2.4%versus6.1%,respectively)andwasnotassociatedwithanystatisticallysignificantincreaseineitherprimaryorsecondaryischemicoutcomes.ConclusionsAmongunselectedpatientsundergoingPCI,bivalirudinuseduringPCIwasassociatedwithalowerriskofbleedingatall
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简介:Theballoon-basedcathetersareattractivefortheminimallyinvasiveproceduresbecausethesecatheterscanbeconfiguredtomatchrequirementsonsizeandshapefortheinteractionwiththesofttissue.Ananalyticalmechanicmodelisdevelopedforthedeformedballoontodeterminetheshapeoftheinflatedcatheter.Thebridgesalonglatitudinaldirectionshouldbehighstretchableduetothehighelongationalongthelatitudeoftheinflatablecatheter.Theseresultsagreewellwiththefiniteelementmethodwithoutanyparameterfitting.
简介:TheobjectiveofthisstudyistoexploreapotentiallyeffectivetrainingmethodforthehospitalprofessionalstoeducatedrugusersandtoenhancetheirknowledgeofHIVinfection.Onehundredandsixtyonesubjects,whocamefrom13differentprovincesandwereadmittedinadrugreliefhospitalinBeijing,wererecruitedforthisstudy.Theaverageageofthesesubjectswas35.21±6.24yearold.Theaveragenumbersofyearsfordrugaddictionwere7years,andtheaveragenumbersofdrugrelieftreatmentreceivedinthepastwas5.5times.ThelevelofAIDSknowledgeofthesesubjects,includingpathogenicfactors,sourceofinfection,routeoftransmissionandpreventivemeasures,wereevaluatedbeforeandafterreceivingtheAIDSeducationaltrainingtothesedrugusers.Ourresultsshowedthattherewasastatisticallysignificantincrease(P<0.01)intheknowledgeofHIVinfectionandpreventionamongthesesubjects.PositiveattitudeandbehavioraltendenciestowardHIVpreventionwerealsoimproved.Therefore,itisimperativeforthemedicalprofessionalstoincorporateAIDSeducationintodrugrelieftreatmenttoachievethemaximumeffectontheknowledgeofAIDSandimprovementofpositiveattitudesandbehaviorstowardHIVpreventionamongdrugusers.
简介:AbstractBackground:Drug-coated balloons (DCBs) have emerged as potential alternatives to drug-eluting stents in specific lesion subsets for de novo coronary lesions. Quantitative flow ratio (QFR) is a method based on the three-dimensional quantitative coronary angiography and contrast flow velocity during coronary angiography (CAG), obviating the need for an invasive fractional flow reserve procedural. This study aimed to assess the serial angiographic changes of de novo lesions post-DCB therapy and further explore the cut-off values of lesion and vessel QFR, which predict vessel restenosis (diameter stenosis [DS] ≥50%) at mid-term follow-up.Methods:The data of patients who underwent DCB therapy between January 2014 and December 2019 from the multicenter hospital were retrospectively collected for QFR analysis. From their QFR performances, which were analyzed by CAG images at follow-up, we divided them into two groups: group A, showing target vessel DS ≥50%, and group B, showing target vessel DS <50%. The median follow-up time was 287 days in group A and 227 days in group B. We compared the clinical characteristics, parameters during DCB therapy, and QFR performances, which were analyzed by CAG images between the two groups, in need to explore the cut-off value of lesion/vessel QFR which can predict vessel restenosis. Student’s t test was used for the comparison of normally distributed continuous data, Mann-Whitney U test for the comparison of non-normally distributed continuous data, and receiver operating characteristic (ROC) curves for the evaluation of QFR performance which can predict vessel restenosis (DS ≥50%) at mid-term follow-up using the area under the curve (AUC).Results:A total of 112 patients with 112 target vessels were enrolled in this study. Group A had 41 patients, while group B had 71. Vessel QFR and lesion QFR were lower in group A than in group B post-DCB therapy, and the cut-off values of lesion QFR and vessel QFR in the ROC analysis to predict target vessel DS ≥50% post-DCB therapy were 0.905 (AUC, 0.741 [95% confidence interval, CI: 0.645, 0.837]; sensitivity, 0.817; specificity, 0.561; P < 0.001) and 0.890 (AUC, 0.796 [95% CI: 0.709, 0.882]; sensitivity, 0.746; specificity, 0.780; P < 0.001).Conclusions:The cut-off values of lesion QFR and vessel QFR can assist in predicting the angiographic changes post-DCB therapy. When lesion/vessel QFR values are <0.905/0.890 post-DCB therapy, a higher risk of vessel restenosis is potentially predicted at follow-up.
简介:Drugdevelopmentinoncologyisundergoingasubstantialshiftnowadays.Thedriversforthisaremulti-factorial.Ontheoneside,drugdevelopmentisperformedmorerationallythanever,profitingfromthescientificadvancesinmolecularbiologyingeneralandtheelucidationofthevarious'omes'fromgenometometabolomeinparticular.Ontheotherside,itisbasedonenormoustechnologicalprogress,e.g.,inthefieldofgenome
简介:AIM:Todeterminethehypothesisthatinflatingtheballoonsintheduodenalpapilladetermineschangesinthebiochemicalmarkersofpancreatitis.METHODS:Fourgroupsofpigswereused:Grouppapilla(GP),theovertube’sballoonwasinflatedintheareaofthepapilla;GP+doubleballoonenteroscopy(GP+DBE),theovertube’sballoonwaskeptinflatedintheareaofthepapillafor20minbeforeaDBE;GroupDBE(GDBE),DBEwascarriedoutafterinsuringtheballoon’sinflationfarfromthepancreaticpapilla;andGroupcontrol(GC).Serumconcentrationsofamylase,lipaseandC-reactiveprotein(CRP)wereevaluated.Pancreaseswereprocessedforhistopathologyexamination.RESULTS:Mainchangesoccurred24haftertheprocedurecomparedwithbaselinelevels.AmylaselevelsincreasedsignificantlyinGP(59.2%higher)andweremoderatelyhigheringroupsGP+DBEandGDBE(22.7%and20%,respectively).LipaseincreasedinGPandGP+DBE,whereasithardlychangedinGDBEandinGC.CRPincreasedsignificantlyinGP,GP+DBEandGDBE,whilenochangeswerereportedforGC.NostatisticallysignificantdifferencebetweengroupsGPandGP+DBEwasfoundforthehistopathologicalfindings,exceptforvacuolizationandnecrosisofthepancreaticparenchymathatwashigherinGPthaninGP+DBE.CONCLUSION:Themanipulationoftheduodenalpapillabytheinflatedovertube’sballoonduringDBEcausespancreaticstructuraldamageandincreasedbiochemicalmarkersassociatedwithpancreatitis.
简介:INTRODUCTIONSincetheirintroductioninmid-1980s,polyamidoamide(PAMAM)dendrimershaveattractedconsiderableattentionbecauseoftheiruniquestructuresandproperties.Accordingtopreliminarystudiesinanimals,PAMAMdendrimersarenon-immunogenic,verylowinvivotoxicityandcanbeexcretedbyurineandfeces.
简介:AnewclassofcrosslinkingpolyphosphatesweresynthesizedandcharacterizedbyIR^1HNMR,^31PNMRspectroscopyaswellaselementalanalysis.InvitrodegradationofthepolyphosphatesobtainedandthereleaseofantineoplasticdrugMethotrexate(MTX)andcontraceptiveLevonorgestrel(LNG)byusingthesepolymersasmatrixwerestudied.ZeroorderreleaseratewasobservedinthecaseofLNGrelease.
简介:Thisworkaimstoinvestigatetheeffectsofdosingregimentsondrugdeliveryinsolidtumorsandtovalidatethemwithexperimentsonrats.Thelumpedparametermodelsofpharmacokineticsandofdrugdeliveryintumorweredevelopedtosimulatetimecoursesofaveragedrugconcentration(Ct)oftumorinterstitiumintwotypesofdosingregiments(i.e.,single-shotandtriple-shotones).Thetworegimentswereperformedviaantitumordrug,hydroxycamptothecin(HCPT),onrats,tomeasurethedrugconcentrationinthetumor.Thesimulationsofthedrugconcentrationinthetumorofthetwodosingregimentswereconductedandcomparedwiththeexperimentaldataonrats.Thecoefficientsinthemodelswereinvestigated.Itisconcludedthatthetriple-shotmethodismoreeffectivethanthatofsingle-shotinjection.Thepresentlumped-parametermodelisquantitativelycompetentfordrugdeliveryinsolidtumor.
简介:Wepresentthreecasesofself-expandablemetallicstent(SEMS)placementusingaballoonenteroscope(BE)anditsovertube(OT)formalignantobstructionofsurgicallyreconstructedintestine.ABEiseffectivefortheinsertionofanendoscopeintothedeepbowel.However,SEMSplacementisimpossiblethroughtheworkingchannel,becausetheworkingchannelofBEistoosmallandtoolongforthestentdevice.Therefore,weusedatechniqueinwhichtheBEisinsertedasfarasthestenoticarea;thereafter,theBEisremoved,leavingonlytheOT,andthenthestentisplacedbyinsertingthestentdevicethroughtheOT.Inthepresentthreecases,amodificationofthistechniqueresultedinthesuccessfulplacementoftheSEMSforobstructionofsurgicallyreconstructedintestine,andtheprocedureswereperformedwithoutseriouscomplications.Weconsiderthatthepresentprocedureisextremelyeffectiveasapalliativetreatmentfordistalbowelstenosis,suchasinthesurgicallyreconstructedintestine.