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 eventsSex-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
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 subgroups
2009
Safety 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 reductionStents
2008
The Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: Study design and rationale
Mehran R, Brodie B, Cox DA, Grines CL, Rutherford B, Bhatt DL, Dangas G, Feit F, Ohman EM, Parise H, Fahy M, Lansky AJ, Stone GW. The Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: Study design and rationale. American Heart Journal 2008, 156: 44-56. PMID: 18585496, DOI: 10.1016/j.ahj.2008.02.008.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngioplasty, Balloon, CoronaryAnticoagulantsCombined Modality TherapyCoronary AngiographyDose-Response Relationship, DrugDrug Administration ScheduleDrug-Eluting StentsFollow-Up StudiesHeparin, Low-Molecular-WeightHirudinsHumansMaleMiddle AgedMyocardial InfarctionPeptide FragmentsPlatelet Glycoprotein GPIIb-IIIa ComplexProbabilityProspective StudiesRecombinant ProteinsReference ValuesResearch DesignRisk AssessmentStentsSurvival RateThrombosisTime FactorsConceptsPrimary PCIPrimary percutaneous coronary interventionIIb/IIIa inhibitorsAcute myocardial infarctionBare metal stentsGP IIb/IIIa inhibitorsHORIZONS-AMI trialUnfractionated heparinGlycoprotein IIb/IIIa inhibitorsIdentical bare-metal stentOverall event-free survivalAcute Myocardial Infarction trialEnd pointDirect thrombin inhibitor bivalirudinRoutine useEfficacy end pointMyocardial Infarction trialTarget lesion revascularizationEvent-free survivalClinical end pointsPercutaneous coronary interventionPaclitaxel-eluting stentsNew pharmacologic agentsThrombin inhibitor bivalirudinDrug-eluting stents