2023
TCT-641 Intravascular Imaging-Guided Versus Angiography-Guided Percutaneous Coronary Intervention: A 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. TCT-641 Intravascular Imaging-Guided Versus Angiography-Guided Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Trials. Journal Of The American College Of Cardiology 2023, 82: b258. DOI: 10.1016/j.jacc.2023.09.652.Peer-Reviewed Original ResearchEffects 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 ResearchConceptsChronic 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 effectsRevascularisation, periprocedural events and survival - and the survival of the randomised controlled trial.
Lansky A, Ahmad Y. Revascularisation, periprocedural events and survival - and the survival of the randomised controlled trial. EuroIntervention 2023, 18: 1218-1219. PMID: 36939109, PMCID: PMC10018286, DOI: 10.4244/eij-e-23-00004.Peer-Reviewed Original ResearchAntiplatelet Strategies Following PCI: A Review of Trials Informing Current and Future Therapies
Thomas A, Gitto M, Shah S, Saito Y, Tirziu D, Chieffo A, Stefanini G, Lansky A. Antiplatelet Strategies Following PCI: A Review of Trials Informing Current and Future Therapies. Journal Of The Society For Cardiovascular Angiography & Interventions 2023, 2: 100607. PMID: 39130709, PMCID: PMC11307978, DOI: 10.1016/j.jscai.2023.100607.Peer-Reviewed Original ResearchDual antiplatelet therapyAntiplatelet regimensPatient-specific risk profileShorter DAPT durationDuration of therapyPercutaneous coronary interventionDAPT strategyIschemic riskAntiplatelet therapyDAPT durationAntiplatelet strategiesCoronary interventionOngoing trialsMajor trialsRecent trialsPractice guidelinesFuture therapiesRisk profileTherapyStent technologyTrialsRegimensNumber of trialsSignificant reductionSignificant changes
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 confirmationBleeding
2021
TCT-489 Three-Year Outcomes of Patients Treated With the Firehawk Stent Versus XIENCE Stent on the Basis of Diabetes Status: Subgroup Analysis of the TARGET All Comers Trial
Hussain Y, Wijns W, Xu B, Kelbæk H, Knaapen P, Zheng M, Slagboom T, Johnson T, Smits P, Arkenbout K, Holmvang L, Janssens L, Ochala A, Brugaletta S, Schmitz T, Anderson R, Rittger H, Berti S, Barbato E, Toth G, Maillard L, Valina C, Buszman P, Thiele H, Schachinger V, Baumbach A, Lansky A. TCT-489 Three-Year Outcomes of Patients Treated With the Firehawk Stent Versus XIENCE Stent on the Basis of Diabetes Status: Subgroup Analysis of the TARGET All Comers Trial. Journal Of The American College Of Cardiology 2021, 78: b200. DOI: 10.1016/j.jacc.2021.09.1342.Peer-Reviewed Original ResearchTCT-290 Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus: Results From the PIONEER III Clinical Trial
Thomas A, Kereiakes D, Leon M, Baumbach A, Windecker S, Pietras C, Dressler O, Issever M, Curtis M, Bertolet B, Zidar J, Smits P, Diaz V, Mclaurin B, Cequier A, Takahashi A, Amoroso G, Kakuta T, Carney R, Saito S, Lansky A. TCT-290 Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus: Results From the PIONEER III Clinical Trial. Journal Of The American College Of Cardiology 2021, 78: b119. DOI: 10.1016/j.jacc.2021.09.1143.Peer-Reviewed Original ResearchDesign and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial
Shah T, McCarthy M, Nasir I, Archer H, Ragheb E, Kluger J, Kashyap N, Paredes C, Patel P, Lu J, Kandel P, Song C, Khan M, Ul Haq F, Ahmad R, Howes C, Cambi B, Lancaster G, Cleman M, Dela Cruz CS, Parise H, Lansky A. Design and rationale of the colchicine/statin for the prevention of COVID-19 complications (COLSTAT) trial. Contemporary Clinical Trials 2021, 110: 106547. PMID: 34461322, PMCID: PMC8397504, DOI: 10.1016/j.cct.2021.106547.Peer-Reviewed Original ResearchConceptsHospitalized COVID-19 patientsCOVID-19 patientsStandard of careElectronic health recordsComplications TrialSevere COVID-19 diseaseWorld Health Organization (WHO) ordinal scaleVenous thromboembolic eventsHealth recordsCombination of colchicineRates of morbidityCOVID-19 diseaseCost-effective treatmentPrimary endpointRespiratory failureThromboembolic eventsClinical improvementMyocardial injuryPragmatic trialClinical trialsPatientsEvent ascertainmentHealth NetworkRosuvastatinTrialsSIMILAR OUTCOMES WITH THE SUPREME™BIODEGRADABLE DRUG COATED CORONARY STENT SYSTEM IN ACUTE CORONARY SYNDROME AND CHRONIC CORONARY SYNDROMES: RESULTS OF THE PROSPECTIVE MULTICENTER RANDOMIZED CONTROLLED PIONEER III TRIAL
Lansky A, Saito S, Curtis M, Kereiakes D, Baumbach A, Bertolet B, Zidar J, McLaurin B, Dib N, Smits P, Diaz V, Cequier A, Hofma S, Pietras C, Windecker S, Leon M. SIMILAR OUTCOMES WITH THE SUPREME™BIODEGRADABLE DRUG COATED CORONARY STENT SYSTEM IN ACUTE CORONARY SYNDROME AND CHRONIC CORONARY SYNDROMES: RESULTS OF THE PROSPECTIVE MULTICENTER RANDOMIZED CONTROLLED PIONEER III TRIAL. Journal Of The American College Of Cardiology 2021, 77: 1211. DOI: 10.1016/s0735-1097(21)02570-5.Peer-Reviewed Original ResearchRandomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II
Nazif TM, Moses J, Sharma R, Dhoble A, Rovin J, Brown D, Horwitz P, Makkar R, Stoler R, Forrest J, Messé S, Dickerman S, Brennan J, Zivadinov R, Dwyer MG, Lansky AJ, Investigators R. Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II. JACC Cardiovascular Interventions 2021, 14: 515-527. PMID: 33663779, DOI: 10.1016/j.jcin.2020.11.011.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementSafety endpointValve replacementProcedure-related ischemic strokeCerebral embolic protectionComposite efficacy endpointPrimary safety endpointCerebral embolizationCerebral protectionEfficacy endpointII trialCerebral injuryIschemic strokeEmbolic protectionPatientsDrug AdministrationUS sitesU.S. FoodEndpointData reviewTrialsMulticenterEmbolizationInjury
2020
Immediate and long-term impact of the COVID-19 pandemic on cardiovascular clinical trials: considerations for study conduct and endpoint determination.
Lansky A, Shah T, Wijns W, Stefanini GG, Farb A, Kaplan A, Xu B, Pietras C, Velazquez E, Serruys PW, Mahfoud F, Baumbach A. Immediate and long-term impact of the COVID-19 pandemic on cardiovascular clinical trials: considerations for study conduct and endpoint determination. EuroIntervention 2020, 16: 787-793. PMID: 33215993, DOI: 10.4244/eijv16i10a147.Peer-Reviewed Original ResearchRevascularization 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 Research
2019
TCT-287 Impact of Eligibility Criteria on Clinical Outcomes of Firehawk and XIENCE Coronary Drug-Eluting Stent in an All-Comers Randomized Trial
Saito Y, Wijns W, Baumbach A, Xu B, Kelbæk H, van Royen N, Zheng M, Knaapen P, Slagboom T, Johnson T, Vlachojannis G, Holmvang L, Janssens L, Ochala A, Brugaletta S, Anderson R, Rittger H, Berti S, Barbato E, Toth G, Maillard L, Valina C, Buszman P, Thiele H, Lansky A. TCT-287 Impact of Eligibility Criteria on Clinical Outcomes of Firehawk and XIENCE Coronary Drug-Eluting Stent in an All-Comers Randomized Trial. Journal Of The American College Of Cardiology 2019, 74: b286. DOI: 10.1016/j.jacc.2019.08.361.Peer-Reviewed Original ResearchTCT-237 Revascularization Options for Women With Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials
Shah T, Gul B, Head S, Abbott J, Chieffo A, Baumbach A, Hu X, Li F, Brackett A, Gesick C, Bisarya P, Mehran R, Grines C, Geirsson A, Mehilli J, Lansky A. TCT-237 Revascularization Options for Women With Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials. Journal Of The American College Of Cardiology 2019, 74: b236. DOI: 10.1016/j.jacc.2019.08.303.Peer-Reviewed Original ResearchSex Disparities in Cardiovascular Device Evaluations Strategies for Recruitment and Retention of Female Patients in Clinical Device Trials
Ghare MI, Chandrasekhar J, Mehran R, Ng V, Grines C, Lansky A. Sex Disparities in Cardiovascular Device Evaluations Strategies for Recruitment and Retention of Female Patients in Clinical Device Trials. JACC Cardiovascular Interventions 2019, 12: 301-308. PMID: 30732736, DOI: 10.1016/j.jcin.2018.10.048.Peer-Reviewed Original ResearchConceptsTrial participationClinical trialsClinical trial participationUnderrepresentation of womenMultistakeholder engagementGovernment agenciesFemale patientsFemale enrollmentCardiovascular trialsClinical research personnelNarrative reviewDevice trialsTrialsWomenParticipationPublic awarenessEducation campaigns
2018
TCT-624 A prospective multicenter randomized post-market trial evaluating a novel Cobalt Chrome Rapamycin Drug Eluting Stent: Subgroup Analysis of the TARGET All Comers Trial
Lansky A, Wijns W, Xu B, Kelbaek H, van Royen N, Zheng M, Artus-Jacenko L, Knaapen P, Slagboom T, Vlachojannis G, Arkenbout K, Holmvang L, Janssens L, Ochala A, Brugaletta S, Bruder O, Berti S, Barbato E, Toth G, Maillard L, Valina C, Buszman P, Johnson T, Thiele H, Baumbach A. TCT-624 A prospective multicenter randomized post-market trial evaluating a novel Cobalt Chrome Rapamycin Drug Eluting Stent: Subgroup Analysis of the TARGET All Comers Trial. Journal Of The American College Of Cardiology 2018, 72: b249-b250. DOI: 10.1016/j.jacc.2018.08.1826.Peer-Reviewed Original ResearchTCT-132 Balloon-Expandable ePTFE-Covered Stent for Obstructive Lesions in the Iliac Artery: 24-Month Results from the BOLSTER Trial
Bouras G, Laird J, Zeller T, Holden A, Zhou S, Mena-Hurtado C, Cristea E, Lansky A, Lansky A. TCT-132 Balloon-Expandable ePTFE-Covered Stent for Obstructive Lesions in the Iliac Artery: 24-Month Results from the BOLSTER Trial. Journal Of The American College Of Cardiology 2018, 72: b57. DOI: 10.1016/j.jacc.2018.08.1238.Peer-Reviewed Original Research2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai M, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O’Connor C, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ, Initiative S, Fitter H, Illoh K, Cavanaugh K, Scirica B, Irony I, Kichline R, Levine J, Park A, Sacks L, Szarfman A, Unger E, Wachter L, Zuckerman B, Mitchel Y, Peddicord D, Shook T, Kisler B, Jaffe C, Bartley R, DeMets D, Mencini M, Janning C, Bai S, Lawrence J, D’Agostino R, Pocock S. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. Journal Of The American College Of Cardiology 2018, 71: 1021-1034. PMID: 29495982, DOI: 10.1016/j.jacc.2017.12.048.Peer-Reviewed Original ResearchConceptsClinical trialsStandardized data collectionTrials InitiativeProspective data collectionEffectiveness of drugsClinical care processesCardiovascular safetyStroke outcomeEndpoint definitionsWriting committeeDrug AdministrationCare processesU.S. FoodTrialsFurther studiesUniform definitionMedical product development programsMultiple trialsFDAData collectionCardiovascularAdministration2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. Circulation 2018, 137: 961-972. PMID: 29483172, DOI: 10.1161/circulationaha.117.033502.Peer-Reviewed Original ResearchConceptsClinical trialsStandardized data collectionTrials InitiativeProspective data collectionEffectiveness of drugsClinical care processesCardiovascular safetyStroke outcomeEndpoint definitionsWriting committeeUS FoodDrug AdministrationCare processesTrialsFurther studiesUniform definitionMedical product development programsMultiple trialsFDAData collectionCardiovascularAdministration
2017
Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials
Lansky AJ, Messé SR, Brickman AM, Dwyer M, van der Worp H, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy C, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials. European Heart Journal 2017, 39: 1687-1697. PMID: 28171522, PMCID: PMC6251670, DOI: 10.1093/eurheartj/ehx037.Peer-Reviewed Original ResearchConceptsCardiovascular proceduresClinical trialsNeurological endpointsAcademic Research ConsortiumBenefit-risk assessmentAdjunctive pharmacologyNeurological complicationsNeurological outcomePreventive therapyClinical effectsNeurovascular injuryNeurological injuryNeurological riskEndpoint definitionsCardiovascular interventionsAscertainment methodsTherapyInjuryResearch ConsortiumRiskTrialsEndpointInherent risksSuch proceduresComplications