2024
Determining the Cause of Coronary Vasomotor Disorders in Patients With Ischemia and Nonobstructive Coronary Arteries: Design and Rationale of the DISCOVER INOCA Prospective, Multicenter Registry
Shah S, Tremmel J, Henry T, Smilowitz N, Prasad M, Kobayashi Y, Henry G, Samady H, Samuels B, Lerman A, Moses J, Pietras C, Zhang Z, Tirziu D, Parise H, Cristea E, Chamié D, Grubman D, Henrici K, Matmusaeva E, Latif N, Cigarroa N, Lansky A. Determining the Cause of Coronary Vasomotor Disorders in Patients With Ischemia and Nonobstructive Coronary Arteries: Design and Rationale of the DISCOVER INOCA Prospective, Multicenter Registry. Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 102046. PMID: 39132594, PMCID: PMC11308755, DOI: 10.1016/j.jscai.2024.102046.Peer-Reviewed Original ResearchCoronary function testingObstructive coronary artery diseaseCoronary artery diseaseNonobstructive coronary arteriesLong-term outcomesFollow-upVasomotor disordersEnd pointsComposite of cardiovascular deathCoronary arteryLong-term follow-upCoronary microvascular dysfunctionDiagnostic coronary angiographyCardiovascular adverse eventsAdverse cardiovascular eventsCoronary vasomotor disordersOptical coherence tomographySymptomatic myocardial bridgingShort-term end pointsAtherosclerotic plaque burdenIschemic heart diseaseLong-term end pointsINOCA patientsAcetylcholine provocationPatient-reported outcome measuresPREDICTORS AND CONSEQUENCES OF BRAIN INJURY VOLUME BY DIFFUSION-WEIGHTED MRI FOLLOWING TAVR
Grubman D, Dwyer M, Lansky A, Zivadinov R, Pietras C, Nazif T, Moses J, Shah T, Gambone L, Parise H, Messe S. PREDICTORS AND CONSEQUENCES OF BRAIN INJURY VOLUME BY DIFFUSION-WEIGHTED MRI FOLLOWING TAVR. Journal Of The American College Of Cardiology 2024, 83: 970. DOI: 10.1016/s0735-1097(24)02960-7.Peer-Reviewed Original Research800.09 Surgical Risk Does Not Predict Ischemic Stroke or Acute Infarction After TAVR: Results of a Patient-Level Pooled Analysis
Grubman D, Lansky A, Dwyer M, Zivadinov R, Pietras C, Nazif T, Moses J, Shah T, Gambone L, Leon M, Forrest J, Vora A, Parise H, Messé S. 800.09 Surgical Risk Does Not Predict Ischemic Stroke or Acute Infarction After TAVR: Results of a Patient-Level Pooled Analysis. JACC Cardiovascular Interventions 2024, 17: s67-s68. DOI: 10.1016/j.jcin.2024.01.234.Peer-Reviewed Original Research
2023
Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study.
Böhme T, Zeller T, Shishehbor M, Werner M, Brodmann M, Parise H, Holden A, Lichtenberg M, Parikh S, Kashyap V, Pietras C, Tirziu D, Beschorner U, Krishnan P, Niazi K, Wali A, Lansky A. Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study. Journal Of Endovascular Therapy 2023, 15266028231179589. PMID: 37314243, DOI: 10.1177/15266028231179589.Peer-Reviewed Original ResearchLutonix drug-coated balloonDrug-coated balloonsPrimary safety endpointDM statusFemoropopliteal diseaseDiabetes mellitusSafety endpointFemoropopliteal lesionsSimilar safetyHigh-risk patient populationFemoropopliteal artery lesionsIschemic rest painNon-DM patientsSymptomatic femoropopliteal lesionsPrimary efficacy endpointMajor adverse eventsTherapy of choiceDrug-Coated BalloonMajor amputationRest painEfficacy endpointPrimary patencyAdverse eventsArtery lesionsDiabetes statusCerebral Embolic Risk in Coronary and Structural Heart Interventions: Clinical Evidence
Tirziu D, Huang H, Parise H, Pietras C, Moses J, Messé S, Lansky A. Cerebral Embolic Risk in Coronary and Structural Heart Interventions: Clinical Evidence. Journal Of The Society For Cardiovascular Angiography & Interventions 2023, 2: 100631. PMID: 39130705, PMCID: PMC11307836, DOI: 10.1016/j.jscai.2023.100631.Peer-Reviewed Original ResearchStructural heart interventionsHeart interventionsCardiac proceduresBrain injuryLong-term neurocognitive sequelaeTranscatheter aortic valve replacement (TAVR) proceduresAortic valve replacement proceduresCerebral embolic riskIatrogenic brain injuryIschemic brain injuryRisk of thromboembolismCoronary artery diseaseEmbolic protection devicesNumber of patientsValve replacement proceduresPercutaneous transcatheter interventionsLikelihood of disabilitySymptomatic strokeCerebral embolismCerebral embolizationEmbolic riskAcute strokeNeurologic injuryArtery diseaseIschemic infarctionThe 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
Geographic Variations on the Safety and Efficacy of the Supreme Biodegradable Polymer DES: Results From PIONEER III
Garot P, Leon M, Saito S, Baumbach A, Kereiakes D, Windecker S, Pietras C, Dressler O, Issever M, Curtis M, Bertolet B, Zidar J, Smits P, Diaz V, McLaurin B, Cequier A, Hofma S, Dib N, Namiki A, Takahashi A, Kakuta T, Hirohata A, Lansky A. Geographic Variations on the Safety and Efficacy of the Supreme Biodegradable Polymer DES: Results From PIONEER III. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 2: 100515. PMID: 39132534, PMCID: PMC11308104, DOI: 10.1016/j.jscai.2022.100515.Peer-Reviewed Original ResearchDrug-eluting stentsDurable polymer everolimus-eluting stentsEverolimus-eluting stentsIII trialsLesion failureClinical outcomesMyocardial infarctionMajor adverse cardiac eventsVessel-related myocardial infarctionBiodegradable polymer drug-eluting stentsAdverse cardiac eventsOutcomes of patientsTarget lesion failureTarget lesion revascularizationLesion revascularizationCardiac eventsPatient characteristicsCardiac deathDES groupProcedural successStent thrombosisSubgroup analysisPatient outcomesNonsignificant trendEnrollment locationImpella Versus Intra-Aortic Balloon Pump for High-Risk PCI: A Propensity-Adjusted Large-Scale Claims Dataset Analysis
Lansky AJ, Tirziu D, Moses JW, Pietras C, Ohman EM, O'Neill WW, Ekono MM, Grines CL, Parise H. Impella Versus Intra-Aortic Balloon Pump for High-Risk PCI: A Propensity-Adjusted Large-Scale Claims Dataset Analysis. The American Journal Of Cardiology 2022, 185: 29-36. PMID: 36210212, DOI: 10.1016/j.amjcard.2022.08.032.Peer-Reviewed Original ResearchConceptsHigh-risk percutaneous coronary interventionIntra-aortic balloon pumpPercutaneous coronary interventionAcute kidney injuryCardiogenic shockMyocardial infarctionIABP supportKidney injuryBalloon pumpImproved survivalPropensity adjustmentAcute ST-elevation myocardial infarctionST-elevation myocardial infarctionIndex hospitalization lengthLess myocardial infarctionPremier Healthcare DatabaseHospital myocardial infarctionPropensity-adjusted analysisMechanical circulatory supportMechanical support devicesImpella useHospital survivalIndex hospitalizationCoronary interventionReal-world practiceRandomized 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 eventsCLINICAL PREDICTORS OF EMBOLIC BURDEN AFTER TAVR: AN ANALYSIS OF THE SAFEPASS 2 CLINICAL STUDY
Lansky A, White J, Stewart J, Blake J, Smyth D, Pasupati S, Nair R, Parise H, Pietras C, Webster M, Kawakami R, Virmani R, Leipsic J. CLINICAL PREDICTORS OF EMBOLIC BURDEN AFTER TAVR: AN ANALYSIS OF THE SAFEPASS 2 CLINICAL STUDY. Journal Of The American College Of Cardiology 2022, 79: 628. DOI: 10.1016/s0735-1097(22)01619-9.Peer-Reviewed Original ResearchSafety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus
Thomas A, Kereiakes D, Baumbach A, Windecker S, Pietras C, Dressler O, Issever M, Curtis M, Bertolet B, Zidar J, Smits P, Díaz V, McLaurin B, Cequier Á, Takahashi A, Cannon L, Amoroso G, Kakuta T, Saito S, Leon M, Lansky A. Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent in Patients With Diabetes Mellitus. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 1: 100033. PMID: 39132558, PMCID: PMC11307809, DOI: 10.1016/j.jscai.2022.100033.Peer-Reviewed Original ResearchTarget vessel myocardial infarctionVessel myocardial infarctionDiabetes mellitusDP-EESLesion failureIII trialsCardiac deathMyocardial infarctionBiodegradable Polymer Sirolimus-Eluting StentBiodegradable polymer sirolimus-eluting stentsTarget lesion failureTarget lesion revascularizationPercutaneous coronary interventionSirolimus-Eluting StentsLong-term inflammatory responseDiabetic subgroupsLesion revascularizationNondiabetic patientsSecondary endpointsBackground PatientsCoronary interventionPrespecified analysisComposite endpointPrimary safetyWorse outcomesOutcomes 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 intervention
2021
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
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 ResearchTCT-316 Impact of Geographic Variation on the Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent: Results From the PIONEER III Clinical Trial in North America, Europe, and Japan
Garot P, Leon M, Saito S, Baumbach A, Kereiakes D, Windecker S, Pietras C, Dressler O, Issever M, Curtis M, Bertolet B, Zidar J, Smits P, Diaz V, Mclaurin B, Cequier A, Hofma S, Dib N, Takahashi A, Kakuta T, Hirohata A, Lansky A. TCT-316 Impact of Geographic Variation on the Safety and Efficacy of the Supreme Biodegradable Polymer Sirolimus-Eluting Stent: Results From the PIONEER III Clinical Trial in North America, Europe, and Japan. Journal Of The American College Of Cardiology 2021, 78: b129-b130. DOI: 10.1016/j.jacc.2021.09.1169.Peer-Reviewed Original ResearchSIMILAR 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 ResearchNovel Supreme Drug-Eluting Stents With Early Synchronized Antiproliferative Drug Delivery to Inhibit Smooth Muscle Cell Proliferation After Drug-Eluting Stents Implantation in Coronary Artery Disease
Lansky AJ, Kereiakes DJ, Baumbach A, Windecker S, Hussain Y, Pietras C, Dressler O, Issever O, Curtis M, Bertolet B, Zidar JP, Smits PC, Díaz V, McLaurin B, Hofma S, Cequier Á, Dib N, Benit E, Mathur A, Brogno D, Berland J, Wykrzykowska J, Piegari G, Brugaletta S, Saito S, Leon MB, Investigators O. Novel Supreme Drug-Eluting Stents With Early Synchronized Antiproliferative Drug Delivery to Inhibit Smooth Muscle Cell Proliferation After Drug-Eluting Stents Implantation in Coronary Artery Disease. Circulation 2021, 143: 2143-2154. PMID: 33820424, DOI: 10.1161/circulationaha.120.052482.Peer-Reviewed Original ResearchConceptsDurable polymer everolimus-eluting stentsDrug-eluting stentsTarget lesion revascularizationAntiproliferative drug deliveryChronic coronary syndromeVessel myocardial infarctionLesion revascularizationCoronary syndromeLesion failureMyocardial infarctionDrug-Eluting Stent ImplantationTarget vessel myocardial infarctionLong-term clinical outcomesDP-EES groupPrimary end pointTarget lesion failureSmooth muscle cell proliferationPercutaneous coronary interventionSingle-blind trialCoronary artery diseaseEverolimus-eluting stentsMuscle cell proliferationLong-term inflammatory responseDrug eluting stentsCardiovascular deathRefining drug-eluting stent technologies: from engineering to basic science
Lansky A, Chun H, Pietras C, Hussain Y. Refining drug-eluting stent technologies: from engineering to basic science. European Heart Journal 2021, 42: 1770-1772. PMID: 33624813, DOI: 10.1093/eurheartj/ehab091.Peer-Reviewed Original Research
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 ResearchCerebral Embolic Protection Burden of Proof ∗
Lansky A, Pietras C, Shah T. Cerebral Embolic Protection Burden of Proof ∗. JACC Cardiovascular Interventions 2020, 13: 2156-2158. PMID: 32972579, DOI: 10.1016/j.jcin.2020.06.030.Peer-Reviewed Original Research
2018
TCT-85 Endovascular Repair of Penetrating Atherosclerotic Ulcers With the Cardiatis Multilayer Flow Modulator Implant as an Alternative to Covered Endografts to Preserve Branch Vessel Patency
Tirziu D, White R, Gray W, Pietras C, Ghare M, Lansky A. TCT-85 Endovascular Repair of Penetrating Atherosclerotic Ulcers With the Cardiatis Multilayer Flow Modulator Implant as an Alternative to Covered Endografts to Preserve Branch Vessel Patency. Journal Of The American College Of Cardiology 2018, 72: b38. DOI: 10.1016/j.jacc.2018.08.1180.Peer-Reviewed Original Research