2024
Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9—Pragmatic Research and Innovation through Multinational Experimentation
Omerovic E, Petrie M, Redfors B, Fremes S, Murphy G, Marquis-Gravel G, Lansky A, Velazquez E, Perera D, Reid C, Smith J, van der Meer P, Lipsic E, Juni P, McMurray J, Bauersachs J, Køber L, Rouleau J, Doenst T. Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9—Pragmatic Research and Innovation through Multinational Experimentation. Trials 2024, 25: 80. PMID: 38263138, PMCID: PMC10807265, DOI: 10.1186/s13063-024-07935-y.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative PersonnelEvidence-Based MedicineHumansRandomized Controlled Trials as TopicResearch DesignSample SizeConceptsRandomized controlled trialsValue-based health careHealth policy decision-makingResearch priority settingQuality of healthcareHealthcare delivery systemValue-based healthcareDiverse practice settingsEffectiveness of interventionsPragmatic clinical trialsDiverse patient populationsPublic health impactEvidence-based medicineHealthcare qualityHealth outcomesHealth careHealthcare settingsDecision-making questionsPractice settingsPriority settingDecision-makingAlternative interventionsHealthcareStudy designPRCTsIntravascular Imaging–Guided Versus Angiography‐Guided Percutaneous Coronary Intervention: A Systematic Review and Meta‐Analysis of Randomized Trials
Sreenivasan J, Reddy R, Jamil Y, Malik A, Chamie D, Howard J, Nanna M, Mintz G, Maehara A, Ali Z, Moses J, Chen S, Chieffo A, Colombo A, Leon M, Lansky A, Ahmad Y. Intravascular Imaging–Guided Versus Angiography‐Guided Percutaneous Coronary Intervention: A Systematic Review and Meta‐Analysis of Randomized Trials. Journal Of The American Heart Association 2024, 13: e031111. PMID: 38214263, PMCID: PMC10926835, DOI: 10.1161/jaha.123.031111.Peer-Reviewed Original ResearchMeSH KeywordsCoronary AngiographyCoronary Artery DiseaseDeathHumansPercutaneous Coronary InterventionRandomized Controlled Trials as TopicThrombosisTreatment OutcomeUltrasonography, InterventionalConceptsAdverse cardiac eventsPercutaneous coronary interventionAngiography-guided percutaneous coronary interventionTarget vessel revascularizationTarget-lesion revascularizationCardiac eventsCardiac deathImaging-guided percutaneous coronary interventionWeighted mean follow-up durationMeta-analysisPrimary outcomeMean follow-up durationStent thrombosisMeta-analysis of randomized trialsStudy-level meta-analysisComplex lesion subsetsIntravascular imagingAll-cause deathRandom-effects meta-analysisStandard of careIntention-to-treat principleUpdates of clinical guidelinesMixed-effects meta-regressionComplex percutaneous coronary interventionIntravascular imaging-guided percutaneous coronary intervention
2023
Effects of Elective Coronary Revascularization vs Medical Therapy Alone on Noncardiac Mortality A Meta-Analysis
Navarese E, Lansky A, Farkouh M, Grzelakowska K, Bonaca M, Gorog D, Raggi P, Kelm M, Yeo B, Umińska J, Curzen N, Kubica J, Wijns W, Kereiakes D. Effects of Elective Coronary Revascularization vs Medical Therapy Alone on Noncardiac Mortality A Meta-Analysis. JACC Cardiovascular Interventions 2023, 16: 1144-1156. PMID: 37225285, DOI: 10.1016/j.jcin.2023.02.030.Peer-Reviewed Original ResearchMeSH KeywordsBayes TheoremHeartHumansRandomized Controlled Trials as TopicReproducibility of ResultsSyndromeTreatment OutcomeConceptsChronic coronary syndromeElective coronary revascularizationNoncardiac mortalityMedical therapyCoronary revascularizationTrial sequential analysisCumulative Z-curveRate ratioA Meta-AnalysisRandom-effects modelMeta-analysis findingsCoronary syndromeISCHEMIA trialRandomized trialsTrial evidenceRevascularizationTreatment groupsPrespecified endpointsMeta-AnalysisPatientsMortalityFutility boundariesDeath rateTrialsTreatment effects
2021
Long term outcomes of ultrathin versus standard thickness second‐generation drug eluting stents: Meta‐analysis of randomized trials
Hussain Y, Gaston S, Kluger J, Shah T, Yang Y, Tirziu D, Lansky A. Long term outcomes of ultrathin versus standard thickness second‐generation drug eluting stents: Meta‐analysis of randomized trials. Catheterization And Cardiovascular Interventions 2021, 99: 563-574. PMID: 34236755, DOI: 10.1002/ccd.29866.Peer-Reviewed Original ResearchMeSH KeywordsCoronary Artery DiseaseDrug-Eluting StentsHumansPercutaneous Coronary InterventionProsthesis DesignRandomized Controlled Trials as TopicRisk FactorsTreatment OutcomeConceptsSecond generation drug eluting stentsTarget lesion failureDrug eluting stentsLong-term outcomesEluting stentsTerm outcomesRisk ratioIschemia-driven target vessel revascularizationTarget vessel myocardial infarctionLong-term clinical outcomesProbable stent thrombosisTarget vessel revascularizationTerm clinical outcomesVessel myocardial infarctionPercutaneous coronary interventionCoronary artery diseaseConfidence intervalsFirst generation drug eluting stentsRandom-effects modelLesion failureVessel revascularizationCoronary interventionSecondary outcomesArtery diseaseCardiac deathCardiac mortality in patients randomised to elective coronary revascularisation plus medical therapy or medical therapy alone: a systematic review and meta-analysis
Navarese EP, Lansky AJ, Kereiakes DJ, Kubica J, Gurbel PA, Gorog DA, Valgimigli M, Curzen N, Kandzari DE, Bonaca MP, Brouwer M, Umińska J, Jaguszewski MJ, Raggi P, Waksman R, Leon MB, Wijns W, Andreotti F. Cardiac mortality in patients randomised to elective coronary revascularisation plus medical therapy or medical therapy alone: a systematic review and meta-analysis. European Heart Journal 2021, 42: 4638-4651. PMID: 34002203, PMCID: PMC8669551, DOI: 10.1093/eurheartj/ehab246.Peer-Reviewed Original ResearchMeSH KeywordsCause of DeathCoronary Artery DiseaseHumansMyocardial InfarctionMyocardial RevascularizationRandomized Controlled Trials as TopicReproducibility of ResultsConceptsSpontaneous myocardial infarctionStable coronary artery disease patientsCoronary artery disease patientsElective coronary revascularisationMedical therapyCardiac mortalityMyocardial infarctionCoronary revascularisationCause mortalityDisease patientsPre-specified primary endpointCoronary artery diseaseRate ratioDeath risk reductionRandom-effects modelMultivessel diseaseMortality findingsPrimary endpointSecondary endpointsStable patientsStroke riskSurvival benefitArtery diseaseCardiac deathRevascularisation
2020
Survival After Coronary Revascularization With Paclitaxel-Coated Balloons
Scheller B, Vukadinovic D, Jeger R, Rissanen TT, Scholz SS, Byrne R, Kleber FX, Latib A, Clever YP, Ewen S, Böhm M, Yang Y, Lansky A, Mahfoud F. Survival After Coronary Revascularization With Paclitaxel-Coated Balloons. Journal Of The American College Of Cardiology 2020, 75: 1017-1028. PMID: 32138961, DOI: 10.1016/j.jacc.2019.11.065.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, Balloon, CoronaryAntineoplastic Agents, PhytogenicHumansPaclitaxelRandomized Controlled Trials as TopicConceptsDrug-coated balloonsPaclitaxel-coated balloonRisk of deathCause mortalityRisk ratioStent restenosisPaclitaxel drug-coated balloonPaclitaxel-coated devicesDe novo lesionsCoronary artery diseaseSuperficial femoral arteryCochrane Library databasesConfidence intervalsNumber of patientsWeb of ScienceCardiac mortalityCoronary revascularizationNovo lesionsCoronary interventionDCB groupDifferent time pointsArtery diseasePrimary outcomeFemoral arteryPeripheral arteriesRevascularization Options for Females With Multivessel Coronary Artery Disease A Meta-Analysis of Randomized Controlled Trials
Gul B, Shah T, Head SJ, Chieffo A, Hu X, Li F, Brackett A, Gesick C, Bisarya PK, Lansky A. Revascularization Options for Females With Multivessel Coronary Artery Disease A Meta-Analysis of Randomized Controlled Trials. JACC Cardiovascular Interventions 2020, 13: 1009-1010. PMID: 32113933, DOI: 10.1016/j.jcin.2019.12.036.Peer-Reviewed Original ResearchMeSH KeywordsCoronary Artery BypassCoronary Artery DiseaseFemaleHumansPercutaneous Coronary InterventionRandomized Controlled Trials as TopicRisk AssessmentRisk FactorsSex FactorsTreatment Outcome
2019
Paclitaxel-coated balloons: a safe alternative to drug-eluting stents for coronary in-stent restenosis
Lansky A, Grubman D, Scheller B. Paclitaxel-coated balloons: a safe alternative to drug-eluting stents for coronary in-stent restenosis. European Heart Journal 2019, 41: 3729-3731. PMID: 31702784, DOI: 10.1093/eurheartj/ehz731.Peer-Reviewed Original ResearchCoronary RestenosisDrug-Eluting StentsHumansPaclitaxelPharmaceutical PreparationsRandomized Controlled Trials as TopicStents
2016
Clinical outcomes after PCI treatment of very long lesions with the XIENCE V everolimus eluting stent; Pooled analysis from the SPIRIT and XIENCE V USA prospective multicenter trials
Bouras G, Jhamnani S, Ng VG, Haimi I, Mao V, Deible R, Cao S, Sudhir K, Lansky AJ. Clinical outcomes after PCI treatment of very long lesions with the XIENCE V everolimus eluting stent; Pooled analysis from the SPIRIT and XIENCE V USA prospective multicenter trials. Catheterization And Cardiovascular Interventions 2016, 89: 984-991. PMID: 27545721, DOI: 10.1002/ccd.26711.Peer-Reviewed Original ResearchConceptsMajor adverse cardiac eventsLong coronary lesionsTarget lesion failurePercutaneous coronary interventionAcademic Research ConsortiumMean lesion lengthCoronary lesionsXIENCE VCoronary interventionStent thrombosisLesion lengthRate of TLFControl groupSecond generation drug eluting stentsLong lesion groupAdverse cardiac eventsProbable stent thrombosisPrimary outcome measureCoronary stent systemDrug eluting stentsLesion failureCardiac eventsPooled analysisWorse outcomesLesion group
2015
Will this trial change my practice? TOTAL: a randomised trial of thrombus aspiration in ST-elevation myocardial infarction.
Behan MW, Haude M, Oldroyd KG, Lansky AJ, James S, Baumbach A. Will this trial change my practice? TOTAL: a randomised trial of thrombus aspiration in ST-elevation myocardial infarction. EuroIntervention 2015, 11: 361-3. PMID: 26196756, DOI: 10.4244/eijv11i3a70.Peer-Reviewed Original ResearchSafety and efficacy of a novel abluminal groove‐filled biodegradable polymer sirolimus‐eluting stent for the treatment of de novo coronary lesions: Two‐year results from a prospective patient‐level pooled analysis of TARGET trials
Gao Z, Zhang R, Xu B, Yang Y, Ma C, Li H, Chen S, Han Y, Yuan Z, Lansky AJ, Guan C, Leon MB, Gao R, Investigators F. Safety and efficacy of a novel abluminal groove‐filled biodegradable polymer sirolimus‐eluting stent for the treatment of de novo coronary lesions: Two‐year results from a prospective patient‐level pooled analysis of TARGET trials. Catheterization And Cardiovascular Interventions 2015, 85: 734-743. PMID: 25678281, DOI: 10.1002/ccd.25861.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAgedCardiovascular AgentsChinaCoronary Artery DiseaseDrug-Eluting StentsFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionPolymersProspective StudiesProsthesis DesignRandomized Controlled Trials as TopicRegistriesRisk FactorsSirolimusTime FactorsTreatment OutcomeConceptsTarget lesion failureFIREHAWK stentStent thrombosisCoronary lesionsMyocardial infarctionNovel abluminal groove-filled biodegradable polymer sirolimus-eluting stentDe novo native coronary lesionsBiodegradable polymer sirolimus-eluting stentsDe novo coronary lesionsPatient-level pooled analysisTarget vessel myocardial infarctionNew drug-eluting stentsNative coronary lesionsNovo coronary lesionsProbable stent thrombosisTarget lesion revascularizationVessel myocardial infarctionSirolimus-eluting stentsPatient-level analysisPatient-level dataLong-term safetyDrug-eluting stentsTwo-year resultsObjective performance criteriaLesion revascularization
2014
Will this trial change my practice? TASTE - a randomised registry on thrombus aspiration in primary PCI with a 30-day endpoint.
Behan MW, Lansky AJ, Jolly S, Baumbach A. Will this trial change my practice? TASTE - a randomised registry on thrombus aspiration in primary PCI with a 30-day endpoint. EuroIntervention 2014, 10: 406-7. PMID: 25042270, DOI: 10.4244/eijv10i3a68.Peer-Reviewed Original ResearchWill this trial change my practice? PRAMI - treatment of bystander coronary lesions in patients undergoing primary PCI for acute STEMI.
Toth GG, Kala P, Lansky A, Baumbach A. Will this trial change my practice? PRAMI - treatment of bystander coronary lesions in patients undergoing primary PCI for acute STEMI. EuroIntervention 2014, 10: 411-2. PMID: 25042272, DOI: 10.4244/eijv10i3a70.Peer-Reviewed Original ResearchShort and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients
Navarese EP, Kowalewski M, Cortese B, Kandzari D, Dias S, Wojakowski W, Buffon A, Lansky A, Angelini P, Torguson R, Kubica J, Kelm M, de Boer MJ, Waksman R, Suryapranata H. Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients. Atherosclerosis 2014, 233: 224-231. PMID: 24529148, DOI: 10.1016/j.atherosclerosis.2013.12.024.Peer-Reviewed Original ResearchMeSH KeywordsDrug-Eluting StentsHumansMyocardial InfarctionPolymersProbucolRandomized Controlled Trials as TopicSirolimusStentsThrombosisTreatment OutcomeConceptsDurable polymer drug-eluting stentsDrug-eluting stentsStent thrombosisPolymer-free drug-eluting stentsRandomized trialsMyocardial infarctionMain efficacy endpointLong-term safetyLesion revascularizationEfficacy endpointSafety endpointVessel revascularizationMI ratesLong followCochrane DatabaseSafety profileClinical practiceRCTsGoogle ScholarConflicting resultsRevascularizationSignificant differencesEfficacyPatientsEndpoint
2013
Meta-Analysis of Everolimus-Eluting Versus Paclitaxel-Eluting Stents in Coronary Artery Disease Final 3-Year Results of the SPIRIT Clinical Trials Program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)
Dangas GD, Serruys PW, Kereiakes DJ, Hermiller J, Rizvi A, Newman W, Sudhir K, Smith RS, Cao S, Theodoropoulos K, Cutlip DE, Lansky AJ, Stone GW. Meta-Analysis of Everolimus-Eluting Versus Paclitaxel-Eluting Stents in Coronary Artery Disease Final 3-Year Results of the SPIRIT Clinical Trials Program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovascular Interventions 2013, 6: 914-922. PMID: 24050859, DOI: 10.1016/j.jcin.2013.05.005.Peer-Reviewed Original ResearchMeSH KeywordsAgedCardiovascular AgentsCoronary Artery DiseaseCoronary RestenosisCoronary ThrombosisDrug-Eluting StentsEverolimusFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMulticenter Studies as TopicMultivariate AnalysisMyocardial InfarctionPaclitaxelPercutaneous Coronary InterventionProportional Hazards ModelsProsthesis DesignRandomized Controlled Trials as TopicRisk FactorsSirolimusTime FactorsTreatment OutcomeConceptsPaclitaxel-eluting stentsIschemia-driven target lesion revascularizationMajor adverse cardiac eventsAdverse cardiac eventsTarget lesion revascularizationLesion failureMyocardial infarctionLesion revascularizationCause mortalityCardiac eventsStent thrombosisStent typeEvent ratesTarget lesion failureClinical trial programException of diabetesIndividual patient dataIndividual clinical outcomesCardiac deathComposite endpointClinical outcomesSPIRIT IIClinical trialsCoronary implantationTrial programDrug-eluting balloon for instent restenosis
Bahl R, Indermuehle A, Froehlich GM, Lansky AJ, Knapp G, Timmis A, Meier P. Drug-eluting balloon for instent restenosis. Heart 2013, 99: 1874. PMID: 23958757, DOI: 10.1136/heartjnl-2013-304722.Peer-Reviewed Original ResearchAngioplasty, Balloon, CoronaryCoronary RestenosisDrug-Eluting StentsHumansRandomized Controlled Trials as TopicDrug eluting balloons for de novocoronary lesions – a systematic review and meta-analysis
Fröhlich GM, Lansky AJ, Ko DT, Archangelidi O, De Palma R, Timmis A, Meier P. Drug eluting balloons for de novocoronary lesions – a systematic review and meta-analysis. BMC Medicine 2013, 11: 123. PMID: 23657123, PMCID: PMC3648374, DOI: 10.1186/1741-7015-11-123.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular AgentsCoronary Artery DiseaseDrug Delivery SystemsHumansPaclitaxelRandomized Controlled Trials as TopicTreatment OutcomeConceptsMajor adverse cardiac eventsNovo coronary lesionsTarget lesion revascularizationBare metal stentsLate lumen lossDrug-eluting balloonsDe novo coronary lesionsCurrent standard therapyDrug-Eluting BalloonRelative riskCoronary lesionsStent thrombosisMyocardial infarctionStandard therapyStent restenosisSystematic reviewLower late lumen lossAdverse cardiac eventsPooled relative riskRandom-effects modelLesion revascularizationSegment restenosisCardiac eventsComparator treatmentResultsEight studiesLow-dose of oral factor Xa inhibitors in patients with a recent acute coronary syndrome: A systematic review and meta-analysis of randomized trials
Obonska K, Navarese EP, Lansky A, Tarantini G, Rossini R, Kozinski M, Musumeci G, Di Pasquale G, Górny B, Szczesniak A, Kowalewski M, Gurbel PA, Kubica J. Low-dose of oral factor Xa inhibitors in patients with a recent acute coronary syndrome: A systematic review and meta-analysis of randomized trials. Atherosclerosis 2013, 229: 482-488. PMID: 23672879, DOI: 10.1016/j.atherosclerosis.2013.04.022.Peer-Reviewed Original ResearchMeSH KeywordsAcute Coronary SyndromeAdministration, OralAnticoagulantsDose-Response Relationship, DrugFactor Xa InhibitorsHumansRandomized Controlled Trials as TopicRisk FactorsConceptsAcute coronary syndromeRecent acute coronary syndromeOral factor Xa inhibitorsMajor bleeding complicationsNew oral anticoagulantsFactor Xa inhibitorsBleeding complicationsMajor bleedingCoronary syndromeOral anticoagulantsStandard therapyMyocardial infarctionOdds ratioXa inhibitorsSetting of ACSSystematic reviewAnti-Xa groupIntracranial bleeding ratesRecurrent MI ratesSecondary efficacy endpointsNew myocardial infarctionFactor X inhibitorsDose-related increaseEfficacy endpointPrimary endpointPlaque shift and distal embolism in patients with acute myocardial infarction
Wu X, Maehara A, He Y, Xu K, Oviedo C, Witzenbichler B, Lansky AJ, Dressler O, Parise H, Stone GW, Mintz GS. Plaque shift and distal embolism in patients with acute myocardial infarction. Catheterization And Cardiovascular Interventions 2013, 82: 203-209. PMID: 22936619, DOI: 10.1002/ccd.24644.Peer-Reviewed Original ResearchMeSH KeywordsAgedBiomarkersChi-Square DistributionCoronary AngiographyCoronary Artery DiseaseCoronary ThrombosisCoronary VesselsCreatine Kinase, MB FormEmbolismFemaleHumansLinear ModelsMaleMiddle AgedMyocardial InfarctionNo-Reflow PhenomenonPercutaneous Coronary InterventionPlaque, AtheroscleroticPredictive Value of TestsProsthesis DesignRandomized Controlled Trials as TopicRetrospective StudiesStentsTreatment OutcomeUltrasonography, InterventionalConceptsThrombus groupCK-MBAngiographic thrombusPlaque shiftReference segmentsAxial plaque redistributionDistal plaque embolizationDistal reference segmentsHORIZONS-AMI trialNative coronary lesionsM volumeAcute myocardial infarctionVolumetric intravascular ultrasoundBare metal stentsOverall plaque volumePeriprocedural elevationPlaque redistributionDistal embolismCoronary lesionsPlaque embolizationMyocardial infarctionStent implantationPlaque volumeInfarction lesionsIntravascular ultrasoundDrug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials
Indermuehle A, Bahl R, Lansky AJ, Froehlich GM, Knapp G, Timmis A, Meier P. Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials. Heart 2013, 99: 327. PMID: 23335497, DOI: 10.1136/heartjnl-2012-302945.Peer-Reviewed Original ResearchMeSH KeywordsAngioplasty, Balloon, CoronaryCoronary AngiographyCoronary RestenosisDrug-Eluting StentsHumansProsthesis DesignRandomized Controlled Trials as TopicTreatment OutcomeConceptsMajor adverse cardiac eventsDrug-eluting balloonsDrug-eluting balloon angioplastyBalloon angioplastyStent restenosisStent thrombosisMyocardial infarctionRelative riskSegment restenosisTreatment optionsSystematic reviewIncidence of MIRisk of STAdverse cardiac eventsPooled relative riskPlain balloon angioplastyOptimal treatment optionsPromising treatment optionDrug-eluting stentsRandom-effects modelLesion revascularisationCardiac eventsCoronary angioplastyMain endpointClinical trials