2022
Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study)
Shishehbor MH, Zeller T, Werner M, Brodmann M, Parise H, Holden A, Lichtenberg M, Parikh SA, Kashyap VS, Pietras C, Tirziu D, Ardakani S, Beschorner U, Krishnan P, Niazi KA, Wali AU, Lansky AJ. Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study). Circulation 2022, 145: 1645-1654. PMID: 35377157, DOI: 10.1161/circulationaha.122.059646.Peer-Reviewed Original ResearchConceptsLutonix drug-coated balloonDrug-coated balloonsEnd pointPrimary efficacy end pointPrimary safety end pointIndependent clinical events committeeIschemic rest painPrimary efficacy rateEfficacy end pointPrimary end pointSafety end pointClinical events committeeMajor adverse eventsRate of restenosisDrug-Coated BalloonNoninferiority end pointSafety event rateAverage lesion lengthMajor amputationPopliteal diseaseRest painBailout stentingEfficacy ratePrimary patencyAdverse events
2016
Polymer-Free Biolimus A9-Coated Stents in the Treatment of De Novo Coronary Lesions 4- and 12-Month Angiographic Follow-Up and Final 5-Year Clinical Outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial
Costa R, Abizaid A, Mehran R, Schofer J, Schuler G, Hauptmann K, Magalhães M, Parise H, Grube E, Investigators B. Polymer-Free Biolimus A9-Coated Stents in the Treatment of De Novo Coronary Lesions 4- and 12-Month Angiographic Follow-Up and Final 5-Year Clinical Outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial. JACC Cardiovascular Interventions 2016, 9: 51-64. PMID: 26762911, DOI: 10.1016/j.jcin.2015.09.008.Peer-Reviewed Original ResearchMeSH KeywordsAgedCardiovascular AgentsCoronary AngiographyCoronary Artery DiseaseCoronary VesselsDrug-Eluting StentsFemaleGermanyHumansKaplan-Meier EstimateMaleMiddle AgedNeointimaPaclitaxelPercutaneous Coronary InterventionPredictive Value of TestsProspective StudiesProsthesis DesignRisk FactorsSingle-Blind MethodSirolimusStainless SteelSurface PropertiesTime FactorsTreatment OutcomeConceptsStent late lumen lossPaclitaxel-eluting stentsLate lumen lossDrug-coated stentsStent thrombosisBiolimus A9First-generation paclitaxel-eluting stentsDe novo coronary lesionsMajor adverse cardiac eventsPolymer-free biolimus A9Probable stent thrombosisAdverse cardiac eventsNovo coronary lesionsTarget lesion revascularizationClinical event ratesLong-term outcomesLesion revascularizationAngiographic followCardiac eventsClinical outcomesCoronary lesionsLesions 4Lumen lossStandard doseStainless steel platform
2013
Impact of Bivalirudin and Paclitaxel-Eluting Stents on Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention of the Left Anterior Descending Artery
Wöhrle J, Brodie B, Witzenbichler B, Dudek D, Kornowski R, Metzger C, Grines C, McAndrew T, Parise H, Sergie Z, Mehran R, Stone G. Impact of Bivalirudin and Paclitaxel-Eluting Stents on Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention of the Left Anterior Descending Artery. The American Journal Of Cardiology 2013, 112: 753-760. PMID: 23746479, DOI: 10.1016/j.amjcard.2013.05.006.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Agents, PhytogenicAntithrombinsCoronary AngiographyCoronary VesselsDrug-Eluting StentsElectrocardiographyFemaleFollow-Up StudiesHirudinsHumansMaleMiddle AgedMyocardial InfarctionPaclitaxelPeptide FragmentsPercutaneous Coronary InterventionProspective StudiesRecombinant ProteinsTreatment OutcomeConceptsPrimary percutaneous coronary interventionST-elevation myocardial infarctionPaclitaxel-eluting stentingImpact of bivalirudinTarget vessel revascularizationPercutaneous coronary interventionVessel revascularizationCoronary interventionCardiac deathPrimary PCIGlycoprotein IIb/IIIa inhibitorsIschemia-driven target vessel revascularizationIIb/IIIa inhibitorsLeft anterior descending (LAD) arteryHORIZONS-AMI trialMajor bleeding eventsUse of bivalirudinAnterior descending (LAD) arteryElevation myocardial infarctionBare-metal stentingSignificant lower rateLower ratesBleeding eventsCardiovascular eventsRevascularization rates
2012
Stent thrombosis: insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials.
Kedhi E, Stone G, Kereiakes D, Serruys P, Parise H, Fahy M, Simonton C, Sudhir K, Sood P, Smits P. Stent thrombosis: insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials. EuroIntervention 2012, 8: 599-606. PMID: 22995087, DOI: 10.4244/eijv8i5a92.Peer-Reviewed Original ResearchConceptsDAPT discontinuationCardiac deathSPIRIT IIST ratesDual antiplatelet therapy discontinuationDual antiplatelet therapy interruptionSPIRIT IIIAntiplatelet therapy discontinuationAntiplatelet therapy interruptionLarge pooled analysisRandomised clinical trialsTwo-year ratePatient-level databaseLog-rank testPES cohortTherapy discontinuationTherapy interruptionRandomised trialsStent thrombosisPaclitaxel-eluting stent deploymentPooled analysisClinical trialsDiscontinuationStent deploymentComposite rate
2011
Differential Clinical Responses to Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents in Patients With and Without Diabetes Mellitus
Stone G, Kedhi E, Kereiakes D, Parise H, Fahy M, Serruys P, Smits P. Differential Clinical Responses to Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents in Patients With and Without Diabetes Mellitus. Circulation 2011, 124: 893-900. PMID: 21824922, DOI: 10.1161/circulationaha.111.031070.Peer-Reviewed Original ResearchConceptsPaclitaxel-eluting stentsPercutaneous coronary interventionEverolimus-eluting stentsDiabetes mellitusLesion revascularizationCoronary interventionStent thrombosisMyocardial infarctionStent typeIschemia-driven target lesion revascularizationEnd pointDifferential clinical responseXIENCE V EverolimusEfficacy end pointTarget lesion revascularizationTreatment of patientsCoronary stent systemSignificant differencesEverolimus-ElutingCoronary revascularizationEfficacy outcomesClinical responseDiabetic statusDiabetic patientsClinical outcomesHeparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial
Stone G, Witzenbichler B, Guagliumi G, Peruga J, Brodie B, Dudek D, Kornowski R, Hartmann F, Gersh B, Pocock S, Dangas G, Wong S, Fahy M, Parise H, Mehran R, Investigators O. Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial. The Lancet 2011, 377: 2193-2204. PMID: 21665265, DOI: 10.1016/s0140-6736(11)60764-2.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, BalloonCombined Modality TherapyConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleDrug Therapy, CombinationDrug-Eluting StentsElectrocardiographyFemaleFollow-Up StudiesHeparinHirudinsHumansKaplan-Meier EstimateMaleMyocardial InfarctionPaclitaxelPeptide FragmentsPlatelet Glycoprotein GPIIb-IIIa ComplexProspective StudiesRecombinant ProteinsStentsSurvival AnalysisTime FactorsTreatment OutcomeConceptsST-segment elevation myocardial infarctionGlycoprotein IIb/IIIa inhibitorsPrimary percutaneous coronary interventionIIb/IIIa inhibitorsPercutaneous coronary interventionPaclitaxel-eluting stentsBare metal stentsBivalirudin monotherapyStent thrombosisCoronary interventionMyocardial infarctionIschaemia-driven target lesion revascularisationIschaemia-driven target vessel revascularisationMajor adverse cardiovascular eventsComposite adverse eventsHORIZONS-AMI trialPaclitaxel-eluting stentingTarget vessel revascularisationAdverse cardiovascular eventsBypass graft surgeryTarget lesion revascularisationElevation myocardial infarctionOnset of symptomsKaplan-Meier estimatesAcute myocardial infarctionPredictors of death or myocardial infarction, ischaemic-driven revascularisation, and major adverse cardiovascular events following everolimus-eluting or paclitaxel-eluting stent deployment: pooled analysis from the SPIRIT II, III, IV and COMPARE trials.
Kereiakes D, Smits P, Kedhi E, Parise H, Fahy M, Serruys P, Stone G. Predictors of death or myocardial infarction, ischaemic-driven revascularisation, and major adverse cardiovascular events following everolimus-eluting or paclitaxel-eluting stent deployment: pooled analysis from the SPIRIT II, III, IV and COMPARE trials. EuroIntervention 2011, 7: 74-83. PMID: 21550906, DOI: 10.4244/eijv7i1a14.Peer-Reviewed Original ResearchConceptsMajor adverse cardiovascular eventsAdverse cardiovascular eventsPaclitaxel-eluting stentsMyocardial infarctionIndependent predictorsID-TLRID-TVRCardiac deathCardiovascular eventsSPIRIT IIStent deploymentDrug-eluting stent deploymentPredictors of deathAdverse clinical outcomesCoronary artery diseaseSuperior clinical efficacyIschaemia-driven revascularisationNumber of lesionsArtery diseaseCoronary stentingClinical outcomesClinical efficacyAdverse outcomesPaclitaxel-eluting stent deploymentClinical trials