2023
Predictors of Cerebral Embolic Debris During Transcatheter Aortic Valve Replacement: The SafePass 2 First-in-Human Study
Grubman D, Ahmad Y, Leipsic J, Blanke P, Pasupati S, Webster M, Nazif T, Parise H, Lansky A. Predictors of Cerebral Embolic Debris During Transcatheter Aortic Valve Replacement: The SafePass 2 First-in-Human Study. The American Journal Of Cardiology 2023, 207: 28-34. PMID: 37722198, DOI: 10.1016/j.amjcard.2023.08.137.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementValve replacementAtrial fibrillationHuman studiesEmbolic protection device useHigh embolic riskPrimary end pointHigh-risk patientsIndependent core laboratorySelf-expanding valvesComputed tomography angiographyProtection device useCerebral embolizationCerebrovascular eventsEmbolic riskAcute thrombusEmbolic burdenAngiography featuresTechnical successTomography angiographyEmbolic debrisValve useCore laboratoryEnd pointThe Supreme Biodegradable Polymer DES in Acute and Chronic Coronary Syndromes: A PIONEER III Substudy
Hussain Y, Saito S, Curtis M, Kereiakes D, Baumbach A, Zidar J, McLaurin B, Dib N, Smits P, Díaz V, Cequier Á, Hofma S, Pietras C, Dressler O, Issever M, Windecker S, Leon M, Lansky A, Investigators I. The Supreme Biodegradable Polymer DES in Acute and Chronic Coronary Syndromes: A PIONEER III Substudy. Journal Of The Society For Cardiovascular Angiography & Interventions 2023, 2: 100629. PMID: 39130696, PMCID: PMC11307614, DOI: 10.1016/j.jscai.2023.100629.Peer-Reviewed Original ResearchTarget lesion failureAcute coronary syndromeChronic coronary syndromePrimary end pointCoronary syndromeDP-EESClinical presentationMajor adverse cardiac eventsEnd pointAdverse cardiac eventsBiodegradable polymer DESPrevious revascularizationLesion failureCardiac eventsCurrent smokersIII trialsLess diabetesCCS groupStent thrombosisPatientsRelative safetyDurable polymerSyndromeMonthsInteraction P
2022
Development and validation of an automated algorithm for end point adjudication for a large U.S. national registry
Friedman DJ, Pierre D, Wang Y, Gambone L, Koutras C, Segawa C, Farb A, Vemulapalli S, Varosy PD, Masoudi FA, Lansky A, Curtis JP, Freeman JV. Development and validation of an automated algorithm for end point adjudication for a large U.S. national registry. American Heart Journal 2022, 254: 102-111. PMID: 36007567, DOI: 10.1016/j.ahj.2022.08.006.Peer-Reviewed Original ResearchConceptsEnd point adjudicationCEC adjudicationEnd pointLarge registriesClinical trialsNational Cardiovascular Data RegistryMajor vascular complicationsU.S. National RegistryPost-discharge eventsAgreement rateMajor bleedingNeurologic eventsVascular complicationsNational registryEvent adjudicationData registryRegistryCommittee's evaluationsPercent agreementGold standardAgreement thresholdHospitalTrialsFurther confirmationBleedingEarly Surgery for Patients With Asymptomatic Severe Aortic Stenosis: A Meta-Analysis of Randomized Controlled Trials
Ahmad Y, Howard J, Seligman H, Arnold A, Madhavan M, Forrest J, Geirsson A, Mack M, Lansky A, Leon M. Early Surgery for Patients With Asymptomatic Severe Aortic Stenosis: A Meta-Analysis of Randomized Controlled Trials. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 1: 100383. PMID: 39131941, PMCID: PMC11307849, DOI: 10.1016/j.jscai.2022.100383.Peer-Reviewed Original ResearchSurgical aortic valve replacementAsymptomatic severe aortic stenosisSevere aortic stenosisAortic stenosisHF hospitalizationCause mortalityEjection fractionPrespecified primary end pointSevere asymptomatic aortic stenosisSymptomatic severe aortic stenosisEnd pointAortic valve interventionAsymptomatic aortic stenosisHeart failure hospitalizationPrimary end pointAortic valve replacementClass I recommendationCornerstone of managementInitial conservative managementNormal ejection fractionRandomized Controlled TrialsCurrent treatment standardsIndividual end pointsAsymptomatic patientsEarly surgeryRandomized 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 eventsOutcomes of the Novel Supreme Drug-Eluting Stent in Complex Coronary Lesions: A PIONEER III Substudy
Patel K, Lansky A, Kereiakes D, Windecker S, Cristea E, Pietras C, Dressler O, Issever M, Curtis M, Bertolet B, Zidar J, Smits P, Díaz V, McLaurin B, Brogno D, Janssens L, Vrolix M, Gómez-Blázquez I, Sahul Z, Kabour A, Salido L, Cleman M, Saito S, Leon M, Baumbach A, Investigators I. Outcomes of the Novel Supreme Drug-Eluting Stent in Complex Coronary Lesions: A PIONEER III Substudy. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 1: 100004. PMID: 39130138, PMCID: PMC11308031, DOI: 10.1016/j.jscai.2021.100004.Peer-Reviewed Original ResearchDrug-eluting stentsTarget lesion failureDP-EESComplex lesionsLesion failureAdverse eventsLesion complexityMajor adverse cardiac eventsSingle-blind clinical trialEnd pointAdverse cardiac eventsChronic coronary syndromePrimary end pointSecondary end pointsTarget lesion revascularizationTarget vessel failureComplex coronary lesionsPercutaneous coronary interventionEverolimus-eluting stentsDrug eluting stentsHigh rateLesion revascularizationCoronary syndromeCardiac eventsCoronary interventionSex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies
Hussain Y, Kearney K, Abbott J, Kereiakes D, Di Mario C, Saito S, Cristea E, Riley R, Fajadet J, Shlofmitz R, Ali Z, Klein A, Price M, Hill J, Stone G, Lansky A. Sex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 1: 100011. PMID: 39130137, PMCID: PMC11307712, DOI: 10.1016/j.jscai.2021.100011.Peer-Reviewed Original ResearchPrimary efficacy end pointPrimary safety end pointMajor adverse cardiovascular eventsAdverse cardiovascular eventsEfficacy end pointSafety end pointIntravascular lithotripsyEnd pointCardiovascular eventsMyocardial infarctionHospital major adverse cardiovascular eventsMean reference vessel diameterCoronary intravascular lithotripsySevere coronary calcificationCoronary artery calcificationReference vessel diameterPercutaneous coronary interventionPrior myocardial infarctionSex-based outcomesSex-specific outcomesSide branch involvementPatient-level analysisSmall vessel sizeAngiographic complicationsLesion predilatation
2019
Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses
Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses. Circulation Cardiovascular Interventions 2019, 12: e008434. PMID: 31553205, DOI: 10.1161/circinterventions.119.008434.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overCardiac CatheterizationCoronary AngiographyCoronary StenosisEuropeFemaleHumansLithotripsyMaleMiddle AgedPatient SafetyPercutaneous Coronary InterventionProspective StudiesRisk FactorsSeverity of Illness IndexStentsTime FactorsTomography, Optical CoherenceTreatment OutcomeUnited StatesVascular CalcificationConceptsSevere coronary artery calcificationCoronary artery calcificationMajor adverse cardiac eventsAdverse cardiac eventsPrimary end pointIntravascular lithotripsyOptical coherence tomographyCardiac eventsStent implantationPlaque fractureHospital major adverse cardiac eventsNon-Q-wave myocardial infarctionOptical coherence tomography substudyIndependent clinical events committeeCoherence tomographyDrug-eluting stent implantationEnd pointCoronary intravascular lithotripsyClinical events committeeHigh procedural successIndependent core laboratoryAcute luminal gainPost-approval studiesMechanism of actionCalcium fracture
2016
Safety and Efficacy of Bivalirudin in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention: From the REPLACE-2, ACUITY and HORIZONS-AMI Trials
Giustino G, Mehran R, Bansilal S, Feit F, Lincoff M, Deliargyris EN, Kirtane AJ, Généreux P, Redfors B, Prats J, Bernstein D, Brener SJ, Skerjanec S, Lansky AJ, Francese DP, Dangas GD, Stone GW. Safety and Efficacy of Bivalirudin in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention: From the REPLACE-2, ACUITY and HORIZONS-AMI Trials. The American Journal Of Cardiology 2016, 118: 6-16. PMID: 27181566, DOI: 10.1016/j.amjcard.2016.04.005.Peer-Reviewed Original ResearchConceptsGlycoprotein IIb/IIIa inhibitorsPercutaneous coronary interventionMajor adverse cardiac eventsEfficacy of bivalirudinAdverse cardiac eventsDiabetes mellitusMajor bleedingCoronary interventionBivalirudin treatmentCause mortalityCardiac eventsNon-coronary artery bypass graft-related major bleedingPrimary efficacy end pointPrimary safety end pointUrgent Intervention Triage StrategyAcute Myocardial Infarction trialIIb/IIIa inhibitorsEnd pointHORIZONS-AMI trialPCI Linking AngiomaxComposite of deathEfficacy end pointMyocardial Infarction trialSafety end pointPatient-level data
2014
First-generation versus second-generation drug-eluting stents in current clinical practice: updated evidence from a comprehensive meta-analysis of randomised clinical trials comprising 31 379 patients
Navarese EP, Kowalewski M, Kandzari D, Lansky A, Górny B, Kołtowski Ł, Waksman R, Berti S, Musumeci G, Limbruno U, van der Schaaf RJ, Kelm M, Kubica J, Suryapranata H. First-generation versus second-generation drug-eluting stents in current clinical practice: updated evidence from a comprehensive meta-analysis of randomised clinical trials comprising 31 379 patients. Open Heart 2014, 1: e000064. PMID: 25332803, PMCID: PMC4189321, DOI: 10.1136/openhrt-2014-000064.Peer-Reviewed Original ResearchSecond-generation drug-eluting stentsPaclitaxel-eluting stentsDrug-eluting stentsSecond-generation EESCoronary artery diseaseMyocardial infarctionEnd pointArtery diseaseClinical trialsPrespecified safety end pointsStable coronary artery diseaseIncidence of MIFirst-generation drug-eluting stentsFirst-generation SESReduction of oddsEfficacy end pointSafety end pointTarget lesion revascularisationAcute coronary syndromeComposite end pointSafe drug-eluting stentCurrent clinical practiceLong-term safetyVessel revascularisationCardiac mortality
2012
Targeted anti-inflammatory systemic therapy for restenosis: The Biorest Liposomal Alendronate with Stenting sTudy (BLAST)—a double blind, randomized clinical trial
Banai S, Finkelstein A, Almagor Y, Assali A, Hasin Y, Rosenschein U, Apruzzese P, Lansky AJ, Kume T, Edelman ER. Targeted anti-inflammatory systemic therapy for restenosis: The Biorest Liposomal Alendronate with Stenting sTudy (BLAST)—a double blind, randomized clinical trial. American Heart Journal 2012, 165: 234-240.e1. PMID: 23351827, PMCID: PMC4637940, DOI: 10.1016/j.ahj.2012.10.023.Peer-Reviewed Original ResearchConceptsPercutaneous coronary interventionLate lossCoronary interventionDiabetes mellitusPrimary efficacy end pointBare metal stent implantationEnd pointSystemic innate immunityEfficacy end pointPlacebo-controlled trialPrimary end pointAcute coronary syndromeStent late lossMetal stent implantationSingle intravenous bolusVascular injury sitesAverage late lossBaseline monocyteLiposomal alendronateCoronary syndromePlacebo groupStudy drugCoronary narrowingOverall cohortPrespecified subgroupsComparison of clinical and angiographic prognostic risk scores in patients with acute coronary syndromes: Analysis from the Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY) trial
Palmerini T, Caixeta A, Genereux P, Cristea E, Lansky A, Mehran R, Dangas G, Lazar D, Sanchez R, Fahy M, Xu K, Stone GW. Comparison of clinical and angiographic prognostic risk scores in patients with acute coronary syndromes: Analysis from the Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY) trial. American Heart Journal 2012, 163: 383-391.e5. PMID: 22424008, DOI: 10.1016/j.ahj.2011.11.010.Peer-Reviewed Original ResearchConceptsPercutaneous coronary interventionCardiac Surgery (SYNTAX) scoreNet reclassification improvementAcute coronary syndromePrognostic risk scoreMyocardial infarctionRisk scoreAngiographic variablesVessel revascularizationCardiac mortalityCoronary syndromeEnd pointSurgery scoreSegment elevation acute coronary syndromesUrgent Intervention Triage Strategy (ACUITY) trialAcute Coronary Events (GRACE) scoreElevation acute coronary syndromeNew risk stratification scoreEjection fraction (ACEF) scoreIschemic end pointsMyocardial Infarction (TIMI) scoreTarget vessel revascularizationRisk stratification scoresCoronary artery diseaseMost end points
2011
5-Year Follow-Up of Polytetrafluoroethylene-Covered Stents Compared With Bare-Metal Stents in Aortocoronary Saphenous Vein Grafts The Randomized BARRICADE (Barrier Approach to Restenosis: Restrict Intima to Curtail Adverse Events) Trial
Stone GW, Goldberg S, O'Shaughnessy C, Midei M, Siegel RM, Cristea E, Dangas G, Lansky AJ, Mehran R. 5-Year Follow-Up of Polytetrafluoroethylene-Covered Stents Compared With Bare-Metal Stents in Aortocoronary Saphenous Vein Grafts The Randomized BARRICADE (Barrier Approach to Restenosis: Restrict Intima to Curtail Adverse Events) Trial. JACC Cardiovascular Interventions 2011, 4: 300-309. PMID: 21435608, DOI: 10.1016/j.jcin.2010.11.013.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryChi-Square DistributionCoated Materials, BiocompatibleCoronary AngiographyCoronary Artery BypassCoronary RestenosisFemaleGraft Occlusion, VascularHumansKaplan-Meier EstimateMaleMetalsMiddle AgedMyocardial InfarctionPlatelet Aggregation InhibitorsPolytetrafluoroethyleneProspective StudiesProsthesis DesignRisk AssessmentRisk FactorsSaphenous VeinStentsThrombosisTime FactorsTreatment OutcomeUnited StatesConceptsSaphenous vein graftsBare metal stentsPercutaneous coronary interventionDiseased saphenous vein graftsHigh-pressure implantationDual antiplatelet therapyTarget vessel failureAntiplatelet therapyMajor secondary end pointEnd pointPrimary end pointSecondary end pointsLong-term prognosisBinary restenosisBMS patientsCoronary interventionVein graftsVessel failureInferior outcomesSaphenous veinDiscrete lesionsPatientsPrior trialsJostentLesionsRationale and design of the INFUSE-AMI study: A 2 × 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction
Gibson CM, Maehara A, Lansky AJ, Wohrle J, Stuckey T, Dave R, Cox D, Grines C, Dudek D, Steg G, Parise H, Wolff SD, Cristea E, Stone GW. Rationale and design of the INFUSE-AMI study: A 2 × 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction. American Heart Journal 2011, 161: 478-486.e7. PMID: 21392601, DOI: 10.1016/j.ahj.2010.10.006.Peer-Reviewed Original ResearchMeSH KeywordsAbciximabAngioplasty, Balloon, CoronaryAntibodies, MonoclonalAntithrombinsCoronary OcclusionCoronary ThrombosisEndpoint DeterminationHirudinsHumansImmunoglobulin Fab FragmentsInfusions, Intra-ArterialMagnetic Resonance Imaging, CineMyocardial InfarctionPatient SelectionPeptide FragmentsPlatelet Aggregation InhibitorsRecombinant ProteinsResearch DesignThrombectomyConceptsPrimary percutaneous coronary interventionST-elevation myocardial infarctionPrimary PCIAnterior ST-elevation myocardial infarctionExport aspiration catheterPercutaneous coronary interventionLocal infusionThrombus aspirationInfarct sizeINFUSE-AMIEnd pointCoronary interventionAspiration catheterMyocardial infarctionInfusion catheterAnterior ST-segment elevation myocardial infarctionST-segment elevation myocardial infarctionSingle-blind randomized studyCardiac magnetic resonance imagingMyocardial infarction 0Mid-left anteriorPrimary end pointSafety end pointSecondary end pointsST-segment resolution
2010
Everolimus-Eluting versus Paclitaxel-Eluting Stents in Coronary Artery Disease
Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ. Everolimus-Eluting versus Paclitaxel-Eluting Stents in Coronary Artery Disease. New England Journal Of Medicine 2010, 362: 1663-1674. PMID: 20445180, DOI: 10.1056/nejmoa0910496.Peer-Reviewed Original ResearchConceptsPaclitaxel-eluting stentsTarget lesion failureEverolimus-eluting stentsMajor secondary end pointPrimary end pointSecondary end pointsEnd pointMyocardial infarctionIschemia-driven target lesion revascularizationRoutine follow-up angiographyTarget vessel myocardial infarctionComposite rateTarget lesion revascularizationClinical end pointsCoronary artery diseaseSubgroup of patientsFollow-up angiographyEverolimus-ElutingAngiographic findingsPrespecified subgroupsArtery diseaseCardiac deathStent thrombosisPatientsStents
2009
SPIRIT IV trial design: A large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease
Nikolsky E, Lansky AJ, Sudhir K, Doostzadeh J, Cutlip DE, Piana R, Su X, White R, Simonton CA, Stone GW. SPIRIT IV trial design: A large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease. American Heart Journal 2009, 158: 520-526.e2. PMID: 19781409, DOI: 10.1016/j.ahj.2009.07.025.Peer-Reviewed Original ResearchConceptsPaclitaxel-eluting stentsTarget lesion revascularizationCoronary artery diseaseSPIRIT IVLesion revascularizationArtery diseaseDiabetes mellitusIschemia-driven target lesion revascularizationNovo native coronary artery lesionsMajor adverse cardiac eventsNative coronary artery diseaseNative coronary artery lesionsTarget vessel myocardial infarctionEnd pointUS clinical sitesAdverse cardiac eventsPrimary end pointTarget lesion failureTarget vessel failureVessel myocardial infarctionCoronary artery lesionsReference vessel diameterClinical end pointsMulticenter clinical trialAngiographic late lossSafety and Efficacy of Drug-Eluting and Bare Metal Stents
Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, Brodie B, Hannan E, Harjai K, Jensen LO, Park SJ, Perry R, Racz M, Saia F, Tu JV, Waksman R, Lansky AJ, Mehran R, Stone GW. Safety and Efficacy of Drug-Eluting and Bare Metal Stents. Circulation 2009, 119: 3198-3206. PMID: 19528338, DOI: 10.1161/circulationaha.108.826479.Peer-Reviewed Original ResearchConceptsBare metal stentsDrug-eluting stentsTarget vessel revascularizationMyocardial infarctionVessel revascularizationObservational studyMetal stentsEfficacy end pointTotal patientsOverall mortalityDrug-ElutingDES useLabel indicationsLabel useResidual confoundingBMS useRCTsPatientsDrug AdministrationInfarctionRevascularizationEnd pointMortality dataComparable reductionStentsPaclitaxel-Eluting Stents versus Bare-Metal Stents in Acute Myocardial Infarction
Stone GW, Lansky AJ, Pocock SJ, Gersh BJ, Dangas G, Wong SC, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Möckel M, Ochala A, Kellock A, Parise H, Mehran R. Paclitaxel-Eluting Stents versus Bare-Metal Stents in Acute Myocardial Infarction. New England Journal Of Medicine 2009, 360: 1946-1959. PMID: 19420364, DOI: 10.1056/nejmoa0810116.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngioplasty, Balloon, CoronaryCombined Modality TherapyCoronary AngiographyCoronary RestenosisCoronary StenosisDrug-Eluting StentsFemaleFibrinolytic AgentsFollow-Up StudiesHumansKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionPaclitaxelRecurrenceRetreatmentRiskStentsSwedenConceptsST-segment elevation myocardial infarctionPrimary percutaneous coronary interventionPaclitaxel-eluting stentsBare metal stentsElevation myocardial infarctionTarget lesion revascularizationMyocardial infarctionAngiographic evidenceEnd pointStent thrombosisIschemia-driven target lesion revascularizationPrimary PCIComposite safety end pointIdentical bare-metal stentMajor secondary end pointPrimary end pointSafety end pointSecondary end pointsTarget vessel revascularizationPercutaneous coronary interventionRepeat revascularization proceduresAcute myocardial infarctionSafety outcome measuresDrug-eluting stentsBinary restenosisThe GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) Trial
Verheye S, Agostoni P, Dawkins KD, Dens J, Rutsch W, Carrie D, Schofer J, Lotan C, Dubois CL, Cohen SA, Fitzgerald PJ, Lansky AJ. The GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) Trial. JACC Cardiovascular Interventions 2009, 2: 205-214. PMID: 19463427, DOI: 10.1016/j.jcin.2008.12.011.Peer-Reviewed Original ResearchConceptsPaclitaxel-eluting stentsMajor adverse cardiac event ratesAdverse cardiac event ratesSingle de novo lesionsMajor adverse clinical eventsStent late lumen lossEnd pointBinary angiographic restenosisCardiac event ratePrimary end pointSecondary end pointsDe novo lesionsRandomized multicenter trialAdverse clinical eventsStent late lossLate lumen lossNative coronary arteriesStent restenosis rateBare metal stentsAngiographic restenosisNovo lesionsCoronary angiographyMulticenter trialRestenosis rateLumen loss9-Month Clinical, Angiographic, and Intravascular Ultrasound Results of a Prospective Evaluation of the Axxess Self-Expanding Biolimus A9-Eluting Stent in Coronary Bifurcation Lesions The DIVERGE (Drug-Eluting Stent Intervention for Treating Side Branches Effectively) Study
Verheye S, Agostoni P, Dubois CL, Dens J, Ormiston J, Worthley S, Trauthen B, Hasegawa T, Koo BK, Fitzgerald PJ, Mehran R, Lansky AJ. 9-Month Clinical, Angiographic, and Intravascular Ultrasound Results of a Prospective Evaluation of the Axxess Self-Expanding Biolimus A9-Eluting Stent in Coronary Bifurcation Lesions The DIVERGE (Drug-Eluting Stent Intervention for Treating Side Branches Effectively) Study. Journal Of The American College Of Cardiology 2009, 53: 1031-1039. PMID: 19298915, DOI: 10.1016/j.jacc.2008.12.012.Peer-Reviewed Original ResearchConceptsPercent neointimal volume obstructionMajor adverse cardiac eventsNeointimal volume obstructionCoronary bifurcation lesionsBifurcation lesionsAXXESS stentVolume obstructionMulticenter studyMyocardial infarctionLate lossParent vesselDe novo bifurcation lesionsEnd pointIntravascular ultrasound resultsNovo bifurcation lesionsAdverse cardiac eventsComposite of deathPrimary end pointSecondary end pointsProspective multicenter studySirolimus-eluting stentsAdverse late outcomesSide branchesDrug-eluting stentsLate stent thrombosis