2024
Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story
Goldsweig A, Deng Y, Yao X, Desai N, Cohen D, Aronow H, Messé S, Ross J, Lansky A, Savitz S. Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story. Circulation Cardiovascular Quality And Outcomes 2024, 17: e010200. PMID: 38189127, PMCID: PMC10844981, DOI: 10.1161/circoutcomes.123.010200.Peer-Reviewed Original ResearchStroke/systemic embolismTransient ischemia attackPFO closureSystemic embolismIschemia attackRetrospective cohort studyTransient ischemic attackHalf of patientsOptumLabs Data WarehouseCommercial insurance enrolleesRegulatory approvalClinical trial publicationsIschemic attackRecurrent strokeCohort studyPatent foramenUnderwent closureAtrial fibrillationClinical trialsInsurance enrolleesDecompression illnessTrial publicationsOff labelPatientsProcedure volume
2023
Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable-polymer coronary stent - five-year results of the TARGET All Comers randomised clinical trial.
Lansky A, Xu B, Baumbach A, Kelbæk H, van Royen N, Zheng M, Knaapen P, Slagboom T, Johnson T, Vlachojannis G, Arkenbout K, Holmvang L, Janssens L, Brugaletta S, Naber C, Schmitz T, Anderson R, Rittger H, Berti S, Barbato E, Toth G, Maillard L, Valina C, Buszman P, Thiele H, Schächinger V, Wijns W. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable-polymer coronary stent - five-year results of the TARGET All Comers randomised clinical trial. EuroIntervention 2023, 19: e844-e855. PMID: 37860860, PMCID: PMC10687649, DOI: 10.4244/eij-d-23-00409.Peer-Reviewed Original ResearchConceptsTarget lesion failureDP-EES groupPercutaneous coronary interventionBP-SES groupBP-SESPrimary endpointDP-EESRate of TLFBiodegradable polymer sirolimus-eluting stentsST-elevation myocardial infarction (STEMI) presentationMyocardial infarction presentationSirolimus-eluting stentsFive-year resultsLong-term safetyAbluminal grooveLesion failureSecondary endpointsComers populationCoronary interventionMyocardial ischaemiaStent implantationClinical trialsTargeted therapyLandmark analysisStudy outcomesColchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical 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, Huang H, Haq F, Ahmad R, Howes C, Cambi B, Lancaster G, Cleman M, Dela Cruz C, Parise H, Lansky A. Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial. BMJ Open 2023, 13: e067910. PMID: 36828654, PMCID: PMC9971831, DOI: 10.1136/bmjopen-2022-067910.Peer-Reviewed Original ResearchConceptsStandard of careHigh-intensity rosuvastatinElectronic medical recordsCOVID-19 diseaseMedical recordsPrimary endpointThromboembolic eventsYale New Haven Health SystemSevere COVID-19 diseaseCOVID-19Prespecified primary endpointVenous thromboembolic eventsRisk of progressionCombination of colchicineSafety monitoring boardCare armHispanics/LatinosTherapeutic anticoagulationIndex hospitalisationIll patientsMedian ageFuture trialsEffect of colchicineClinical trialsMonitoring board
2022
Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients
Van Mieghem N, Deeb G, Søndergaard L, Grube E, Windecker S, Gada H, Mumtaz M, Olsen P, Heiser J, Merhi W, Kleiman N, Chetcuti S, Gleason T, Lee J, Cheng W, Makkar R, Crestanello J, George B, George I, Kodali S, Yakubov S, Serruys P, Lange R, Piazza N, Williams M, Oh J, Adams D, Li S, Reardon M, Gitter C, Meyer K, Roberts D, Bae R, Sorajja P, Sun B, Askew J, Eales F, Flavin T, Goessl M, Kshettry V, Mooney M, Pedersen W, Poulose A, Roohani P, Saeid Farivar R, Shronts R, Tarrel R, Young M, Butkus E, Pendleton K, Fry R, Heine C, La Roe K, Tran T, Weig L, Agarwal H, Langdon T, Satpathy R, Batter J, Bremer K, Indukuri U, Baas M, Oomes-Sistermans C, Smits M, Coenen C, Driesen I, Lauryssen L, Poorter M, Schaap J, Bentala M, den Heijer P, Pieter J, Remmers M, Story M, van Erven P, Verbiest H, Vos J, Bennett M, Dunaj W, Seaton D, Waller D, Khandheria B, Bajwa T, O'Hair D, Ahmed A, Allaqaband S, Gheith A, Marriott E, Qhavi A, Saxena V, Shhadeh A, Werner P, Yeomans C, Bessette L, Byrne J, Kieckhefer H, Munoz M, Russo E, Klein J, Morgan M, Byrne T, Caskey M, Amabile O, Brady K, Chung S, Dacanay K, Fang H, Franz D, Kelly C, Loli A, Payne J, Pershad A, Wang N, Lott J, Pool-Owens C, Porter C, Hennan J, Garrett H, Paulus B, Craig J, Elijovich L, Samaha J, Wolf B, Wright L, Zoghbi G, Willcott L, Roberts B, Hebeler R, Stoler R, Graybeal D, Grayburn P, Henry C, Mir O, Vallabhan R, Fanous M, Kaufman J, Chang J, Manning W, Riley M, Khabbaz K, Laham R, Popma J, Burke D, Caplan L, Chui S, Guibone K, Kumar S, Lioutas V, Liu D, Nathan S, Pinto D, Searls D, Fisher S, Guirgues L, Henderson S, Loving L, McWalters N, Patterson K, Burkart J, Carcedo B, Stacey R, Bladergroen M, Lim D, Edmonson S, Epps S, Katz M, Ng K, Sangha A, Aucoin J, Roberts M, Aubin J, Hotard C, Tassin M, Fail P, Feinberg E, Netherland D, Abben R, Allam M, Bates M, Dearman R, Gervais D, Haight E, Metes M, Naquin J, Tedesco V, Thibodeaux L, Thompson K, Aberle S, Amaro D, Grey W, Rose G, Scherer M, Rinaldi M, Skipper E, Bridges C, Downey W, Iyengar P, Martin J, Ryan L, Stiegel R, Story J, Alsabaawi K, Gheorghiu M, Singh C, Yashar J, Siegel R, Cheng W, Makkar R, Altman K, Jilaihawi H, Kar S, Khouw S, Mody C, Ramzy D, Salseth T, Stegic J, Trento A, Lazarte R, Sohn J, Hahn R, Khalique O, George I, Kodali S, Williams M, Gonzalez Castellon M, Gutierrez Contreras J, Kitago T, Kummer B, Lekic T, Miller E, Naka Y, Nazif T, Qureshi A, Rostanski S, Smith C, Willey J, Yaghi S, Abreu L, Clement E, Sabir S, Aji J, Bowen F, Kaddissi G, Mirsen T, Muntazar M, Ogbara J, Rosenbloom M, Schell W, Then R, Carl H, Huang H, Kreydi G, Wolak H, Sandidge G, Ali O, Asfaw Z, Henry S, Kafi A, Schreiber T, Andaya L, Baciewicz F, Bassett J, Choksi N, Kassas S, Munir A, Kothmeier F, Stroh A, Goppel G, Hettich I, Bleiziffer S, Hengstenberg C, Opitz A, Ruge H, Badiu C, Brenner S, Ehlmidi Y, Herold U, Kasel A, Kreuzpointner R, Lange R, Mazzitelli D, Poppert H, Seifert C, Vincze D, Voss B, Camuglia K, Cowhig D, Newbold S, Pierce C, Wootton S, Vemulapalli S, Velazquez E, Harrison J, Hughes G, Ali Y, Babi A, Banks A, Gaca J, Glower D, Gokhale S, Halim S, Hendry R, Hernandez C, Kiefer T, Klein M, Kolls B, Marrotte E, Pineda Maldonado A, Price A, Sherwood M, Swisher C, Van Wyck D, Vavalle J, Vora A, Wang A, Zeylikman Y, Amber K, Barnitt A, Lamm J, Mandelstam L, Schroeder R, Sumner R, Nair D, De A, Gaudiani V, Joye J, Brown L, Hessler C, Rammohan C, Vial C, Charles E, DeQuesada A, Kaner M, Mathewson S, Pitts K, Wheeler L, Wilson A, Davidson E, Frohwein S, Lerakis S, Merlino J, Sullivan A, Babaliaros V, Guyton R, Thourani V, Anderson A, Belagaje S, Benameur K, Devireddy C, Greene J, Harrison A, Hudson K, Leshnower B, Lieppe W, Macheers S, Mavromatis K, Miller J, Nahab F, Sanders K, Sarin E, Stewart J, Winkel D, Duininck L, Gussinklo T, Jadoenath-Oedai S, Ruiter A, van den Berg N, van der Velden-Macauley L, van Huis M, Verelst S, Geleijnse M, Vletter W, Bekker M, Kappetein A, Van Mieghem N, Bekkers J, Biesheuvel K, Birim O, Bol Raap G, Daemen J, de Jaegere P, de Lind van Wijngaarden R, Khajeh L, Kik C, Koudstaal P, Oei F, Scheele M, van de Woestijne P, van Geuns R, van Leeuwen W, Henderson A, Straight F, Schneider D, Tischler M, Dauerman H, Ittleman F, Schmoker J, Abernethy A, Alkhalil I, Azarbal A, Chava S, Commichau C, Coyle D, Denkmann J, Destephan C, Ehle G, El-Haddad M, Falduto C, Gorman M, Kadavath S, Leavitt B, Mack A, Malasana G, Moossavi S, Phuong N, Rambod M, Seecheran N, Sharma A, Terrien E, Worgan B, Zeglin-Sawczuk M, Burgess B, Killbride S, Temple A, Burnside J, Good C, Agarwal S, Casale A, Skelding K, Carter R, Cummings C, Grana V, Haegerl C, Harjai K, Holland N, Singh D, Stahl R, Stella J, Stewart B, Long D, Wood K, Alexander D, Barton S, Logtens E, Marsh A, McAdam J, Kovac J, Mariscalco G, Spyt T, Garimella S, Szostek J, Zlocha V, Kirkland L, Reid L, Reilly S, Menderhall M, Martin W, Park S, Seshiah P, Smith J, Gersch K, Hiratzka L, Kachoris J, Okum E, Cardozo M, Cyr G, Duvall W, Flynn A, Krupowies N, Parker M, Hagberg R, McKay R, Azemi T, Brown R, Fusco D, Hammond J, Hosley C, Kiernan F, Margey R, Preissler P, Sadiq I, Silverman I, Taboada S, Underhill D, Escobar J, Lopez B, Mullin S, Quesada C, Lawrence T, Naqvi T, Matthews R, Starnes V, Clavijo L, Cunningham M, Kim-Tenser M, Sanossian N, Shavelle D, DelMotte D, Henry S, Moltrassie J, Solanki A, Cooper R, Lee J, Parikh S, Wang D, Zweig B, O'Neill W, Paone G, Borgi J, Brewer R, Eng M, Greenbaum A, Guerrero M, Miller D, Mitsias P, Morgan J, Nemeh H, Alcaide Muñoz J, Medina Fernandez M, Carrasco Chinchilla F, Rodríguez Bailón I, Hernández García J, Such M, Alonso-Briales J, De La Cruz Cosme C, Dominguez-Franco A, Mataró López M, Melero J, Muñoz-Garcia A, Sanchez Espin G, Fernández Maese J, Torres M, Villa Suarez E, De La Hera J, Llosa Cortina J, Morís de la Tassa C, Avanzas Fernández P, Benavente Fernández L, Calleja S, Del Valle R, Morales Pérez C, Silva J, Bluntschli E, Keller D, Maritz S, Ruest R, Schönenberger C, Trovato M, Brugger N, Göber V, Kurmann R, Reineke S, Zürcher F, Carrel T, Windecker S, Arnold M, Balasubramaniam R, Bellwald S, Beyeler M, Broeg A, Bühlmann M, Büllesfeld L, Capek L, Chaloulos-Lakovidis P, Corpataux N, Englberger L, Gloekler S, Goldlin M, Huber C, Khattab A, Kurmann R, Lanz J, Liesirova K, Maamari B, Mattle H, Meinel T, Panos L, Praz F, Schönhoff F, Sleszak A, Spirito A, Stortecky S, Vaisnora L, Von Martial R, Wenaweser P, Zuk K, Musso I, Allen M, Gonzales M, Horton K, Doty J, Whisenant B, Caine W, Clayson S, Harkness J, Hoesch R, Huan M, Jones K, Miner E, Reid B, Sunderman E, Citro K, Fisher M, Willhide J, Corretti M, Conte J, Mandal K, Resar J, Chacko M, Hasan R, Heil B, Marsh E, Price J, Sciortino C, Shah A, Tolentino J, Bui A, Lee M, Watanabe C, Aharonian V, Moore N, Pfeffer T, Ajani Z, Mansukhani P, Sangha N, Yun K, Hylander S, Bäck M, Corbascio M, Hillebrant C, Rück A, De Palma R, Feldt K, Kostulas K, Settergren M, Yamasaki K, Anderson M, Bloomfield C, Burtonwood N, Harland C, Somers K, Ware T, Deakin S, Geldard S, Schlosshan D, Blackman D, Kaul P, Evans B, Javangula K, Limaye S, Malkin C, Wanklyn P, Farhi A, Manapat A, Maranan L, Mihelis E, Ng A, Ricketts M, Kronzon I, Perk G, Brinster D, Kliger C, Azhar S, Bonomo R, Dharva R, Fontana G, Mandel S, Mehla P, Patel N, Plestis K, Fox S, Mardell S, Novick T, Sandie K, de Jonge W, McLeod C, Mroz L, Weigand A, Chu M, Kiaii B, Teefy P, Bagur R, Debicki D, Diamantouros P, Gofton T, Mandzia J, McKenzie F, Mirsattari S, Valdis M, Young B, Klein W, Sawicki K, Dajani K, Darki A, Bakhos M, Leya F, Biller J, Lewis B, Morales-Vidal S, Schneck M, Schwartz J, Tuchek J, Biddle A, Ernst D, Haubenschild J, Howe-Clayton D, Johnson R, Mundt P, Reiter J, Bruce C, Freeman W, Kutzke K, Maalouf J, Nkomo V, Pislaru S, Sinak L, Pochettino A, Sandhu G, Alkhouli M, Best P, Bresnahan J, Eleid M, Fulgham J, Greason K, Gulati R, Holmes D, Maor E, Mathew V, Meissner I, Panaich S, Peterson A, Radford J, Raphael C, Reeder G, Sanon S, Sarraf M, Scharf E, Suri R, Swenson C, Williams L, Jiang Z, Lapierre S, Phan T, Buithieu J, de Varennes B, Piazza N, Lachapelle K, Liam D, Martucci G, Blömer H, Herder W, Van der Geest E, van der Wal M, Izaksson R, Kootstra H, Pultrum M, Walinga T, Boonstra P, van Boven A, Amrane H, Hofma S, Schuiling W, Terluin H, Timmerman M, van der Weerdt A, van Rooij F, Vossenberg T, Barnes C, Griffin S, Goldstein S, Marcus R, Wang Z, Widell J, Bafi A, Waksman R, Choi J, Corso P, Laureno R, Lin M, Lowery R, Malla P, Pichard A, Satler L, Shults C, Decklever C, Evans D, Tuttle K, Klein M, Marcus R, Chawla A, Hockmuth D, Jacoby M, Jenson B, McAllister D, Prabhakar G, Verhofste M, Morin C, Potvin L, St. Jean N, Garceau P, Asgar A, Cartier R, Bonan R, Dominquez M, Dorval J, Ibrahim R, Lavoie M, Benner A, Brunetti D, Ciprich C, Lobur E, Lonergan N, McGlew S, Oplinger J, Oster T, Polise L, Purpura J, Sentman S, Van Zile C, Arogundade O, Gillan L, Koulogiannis K, Brown J, Kipperman R, Blitz L, Cohen B, English K, Genereux P, Magovern C, Rosenberg R, Safirstein J, Slater J, Turner J, Xydas S, Jones T, Montgomery S, Barry M, Kovach T, Navas J, Patel V, Lin L, Rovin J, Arora A, Ofenloch J, Schneider J, Spriggs D, Stone L, Turner N, Basnet S, Bhat A, Fusilero M, Muthiki S, Muthyala S, Saint Vrestil N, Sharma M, Singh J, Chaudhry F, Sengupta P, Adams D, Sharma S, Tang G, Anyanwu A, Bronster D, Dangas G, Kini A, Stelzer P, Stewart A, Swain J, Annunziato S, Chan G, Delliliune D, Garzon R, Seeratan V, Rosman D, Suma V, Trost B, Hartman A, Katz S, Rutkin B, Boutis L, Carey R, DeAngelis T, DeOrchis V, Esposito R, Han M, Jauhar R, Kaplan B, Laighold S, Meraj P, Palazzo R, Parihar R, Podwall D, Wright P, Yu P, Abu M, Bavbekova S, Bowden M, Clark E, Gaudio S, Houanche P, Kalish C, Kapitman A, Lee H, Morales V, Oviedo F, Pushkar I, Robin T, Shaheen D, Sin D, Taylor Z, Tovar J, Van Daele J, Vidal S, Yung L, Saric M, Galloway A, Jilaihawi H, Attubato M, Fara M, Grossi E, Ischida K, Loulmet D, Siller K, Staniloae C, Torres J, Zhang C, Hartlev C, Huffman A, Jones D, Kellum A, Liptrot R, Orsinelli D, Ryan J, Ryan T, Crestanello J, George B, Lilly S, Rushing G, Grose N, Kilic A, Lee V, Mazzaferri E, Mutgi S, O'Neil S, Perchuk A, Sai-Sudhakar C, Slivka A, Cheatham J, Hanes S, Banowetz M, Dautenhahn D, Mehl B, Bodenhamer R, Ghani M, Raikar G, Randolph J, Tahirkheli N, Wasemiller W, Williams J, Amoroso E, Holt S, Tucker C, Martin R, Kauten J, Rajagopal V, Awad E, Brown W, Dean D, Gott J, Karmpaliotis D, Meduri C, Polsani V, Rinehart S, Russell C, Seiden L, Serbanescu A, Vannan M, Butler K, Elsessor K, Fehr B, Hancock A, Hollister R, MacFarlane D, Rodgers C, Todd A, Eubanks V, Spangler J, Wirt K, Wonders B, Bachinsky W, Gada H, Maini B, Mumtaz M, Aneja P, Loran D, Shah J, Gebhardt L, Jones U, Lauterborn M, John H, Parthier S, Schaprian K, Twelker K, Nickenig G, Welz A, Bode F, Fuchs A, Grube E, Mellert F, Petzold G, Sedaghat A, Sinning J, Vasa-Nicotera M, Werner N, Bang H, Brodersen B, Christensen P, Eriksen E, Groth S, Jensen Larsen M, Johansen M, Kristensen L, Lilleør T, Lund Larsen L, Preis A, Rieck-Broberg J, Rosenberg T, Ihlemann N, Møller J, Noerager B, Olsen P, Søndergaard L, Steinbrüchel D, Andersen H, Arendrup H, Bieliauskas G, Carranza C, De Backer O, Franzen O, Hansen K, Højgaard J, Holme S, Kjøeller M, Lund J, Perko M, Sander K, Smerup M, Thiis J, Thyregod H, Monnin K, Popelas L, Slyman M, Grewal K, Matros T, Richards D, Watson D, Yakubov S, Arshi A, Blossom G, Chapekis A, Duff S, Hicks W, Holland S, Kander N, Lyons J, Mejilla J, Reese B, Sanchez C, Vora N, Erwin S, Hall J, Hayes N, King D, Miller M, Main M, Allen K, Chhatriwalla A, Aggarwal S, Borkon M, Boutwell C, Cohen D, Davis J, Grantham A, Magalski A, Olds K, Buchanan T, Daniel M, Estrada K, Hollen M, Jensen A, Kennen J, Bechis M, Hu S, Rubenson D, Teirstein P, Tyner J, Ahmad D, Atri P, Azarbal F, Brewster S, Brown C, Foley T, Groves E, Hanna N, Kalafut M, Levisman J, Mellinger D, Odunukan O, Ong D, Oyama J, Panguluri P, Patel A, Raney A, Rao S, Schultz J, Sharma A, Stinis C, Thompson C, Wadia S, Walsh J, White J, Purrington E, Zulick C, Murillo J, Mahoney P, Newton J, Rich J, Bagameri G, Cohen D, Dimeling G, Jordan G, Mistry N, Philpott J, Sirak J, Sourbeer S, Talreja D, Zweifler R, Helm E, Postema K, Van Over E, Chilton D, Mitchell L, Heiser J, Merhi W, Berkompas D, Fanning J, Khan M, Leung Wai Sang S, Omran K, Patzelt L, Rai V, Thoits T, Vijayappa M, Kasle M, Trautman L, Dash R, Liang D, Fischbein M, Miller C, Yeung A, Fearon W, George P, Speight M, Tai W, Albersen I, Bras R, Feirabend C, Helwig-Vernooij J, Kranen G, Oostveen M, Rost I, van Deutekom I, van Weelden A, Heijmen R, ten Berg J, Bosschaert M, de Kroon T, Hilkens P, Mast E, Rensing B, Schonewille W, van den Akker A, Haag E, Jennings J, Krug P, Santiago L, Seth S, Dimsuyu N, Mihalatos D, Petrossian G, Robinson N, Bercow N, Berke A, Deutsch E, Stevens P, Brown S, Dos Santos Jardim V, Radford N, Sookhoo V, Kyereme K, Punzalan R, Reynolds R, Sculeany B, Sharma R, Stuart A, Brecker S, Jahangiri M, Alassa A, Chandrasekaran V, Clarke B, Dowling C, Moynihan B, Roy D, Sarsam M, Bess R, Henkel M, Herbert N, Cohen G, Batra S, Davis T, Aboukasm A, Cullis P, LaLonde T, Martin J, Yamasaki H, Burkert M, Kingma B, Wheatley J, Segar D, Heimansohn D, Hermiller J, Ball M, Elsner G, Hanan S, Moainie S, Nukes T, Reibold P, Robison R, Salerno C, Sampson A, Walts P, Wandel E, Li M, Sarker S, Ahmed S, Fremes S, Radhakrishnan S, Arbel Y, Christakis G, Cohen G, Czarnecki A, Elbaz-Greener G, Feld Y, Hopyan J, Komatsu I, McCraig K, Shuvy M, Toma J, Vincenzo B, Wheeler C, Wijeysundera H, Wolff R, Beck P, Cabral D, DaCosta C, Hudson L, Pastie M, Abrahams N, Altamar I, Buitrago M, Cassman G, Leibovici Z, Nelson A, Recchia K, Robbins G, Studor K, Bethea B, Beyer E, Evans S, Goodis C, Malek A, Mueller-Kronast N, Pan H, Pantoja C, Ramos A, Wells C, Youngblood C, Snelus P, Gopal D, Jackson K, Brown D, Ryan W, Brinkman W, Gopal A, Harrington K, Mack M, Nosnik P, Potluri S, Smith R, Szerlip M, Blaylock C, Brinegar P, Canter L, Green L, Green L, Hazen P, Jacobs A, Khan S, Ludwig S, Mata M, Moore T, Underwood C, Faza N, Little S, Nagueh S, Kleiman N, Reardon M, Albright K, Atkins M, Barker C, Bledsoe D, Chiu D, Goel S, Gray T, Imperial-Aubin D, Lin C, Moye S, Ramchandani M, Ramlawi B, Reul R, Reyes M, Scheinin S, Volpi J, White S, Wyler von Ballmoos M, Blackburn B, Wong R, Hart C, Whitacker P, Lau J, Spies C, Badawi R, Graner S, Nakamura D, Plank B, Salem R, Seto T, Valenta D, Cruz A, Gallagher L, Schuck L, Siki M, Weeks A, Fishman L, Schwarz T, Bavaria J, Herrmann H, Anwaruddin S, Desai N, Giri J, Khella S, Li R, McGarvery M, Messe S, Price R, Quinn C, Szeto W, Vallabhajosyula P, Sun Y, Wu L, Tsang W, Thavendiranathan D, Feindel C, Horlick E, Casaubon L, Cusimano R, Del Campo M, Osten M, Silver F, Höwisch-Pengel R, Lechner G, Steiger B, Allgeier M, Jander N, Beyersdorf F, Neumann F, Büttner H, Comberg T, Diab N, Gick M, Günkel L, Pingpoh C, Rothe H, Siepe M, Thoma M, Winker T, Hager C, Sänger U, Stader M, Biaggi P, Gruner C, Stämpfli S, Binder R, Corti R, Falk V, Holy E, Maisano F, Grünenfelder J, Holubec T, Maier W, Nietlispach F, Wegener S, Atkinson R, Davis A, Hall S, Mangene S, Mazzurco S, Hoit B, Musarra R, Costa M, Markowitz A, Asi K, Attizzani G, Chuang D, Elgudin Y, Garcia C, Jadhav V, Le S, Miller B, Serkin Z, Shams T, Sila C, Simon D, Bezerra H, Deo S, Anderson J, Greening K, Karson J, Page S, Shawgo T, Freeman J, Mulhern K, Nath J, Tadros P, Zorn G, Hockstad E, Lechtenberg C, Muehlebach G, Rippee M, Rosterman L, Sundararajan J, Wang Y, Wiley M, Atapattu S, Marin y Kall C, Lowery M, de Marchena E, Salerno T, Alfonso C, Carillo R, Ferreira A, Panos A, Romano J, Williams D, Bhatt S, Migda E, Oakley J, Warshal W, Wilcock S, Booher A, LaBounty T, Chetcuti S, Deeb G, Adelman E, Boyle M, Geml R, Grossman P, Guerin D, Hodges K, Kim K, Lammers D, McDermott M, Menees D, Pace R, Patel H, Prager R, Ramchandren S, Romano M, Stamper A, Wang M, Zahuranec D, Ziarkiewicz M, Charlebois C, Chilton C, Labinaz M, Ruel M, Glover C, Lam K, Masters R, Steffenhagen N, Enlow-Germovsek M, Konopka K, McGargle R, Travis M, Anderson K, Cavalcante J, Crock F, Edelman K, Katz W, Gleason T, Lee J, Sultan I, Aghaebrahim A, Al-Bayai A, Bonaccorsi C, Campbell D, Giurgiutiu D, Gulati D, Hawkes C, Henry L, Jadhav A, Kenmuir C, Klein B, Kliner D, Limaye K, Nanduri S, Navid F, Patel P, Rangaraju S, Rocha M, Schindler J, Shoirah H, Streib C, Tadi P, Tememe D, Totoraitis R, Walker G, Ziayee H, Caufield L, Yeager C, Forbes J, Schwart K, Knight P, Ling F, Benesch C, Bogachan S, Hicks G, Kelly A, Narins C, Stuver T, Adams K, Blair-Anton L, Haynes M, Watts C, Baker M, Mendes L, Ball S, Goel K, Kaiser C, Robbins M, Zhao D, Ahmad R, Crenshaw M, Fredi J, Hermann L, Hoff S, Kirshner H, Levack M, Mittal S, O'Duffy A, Petracek M, Baer J, Liang G, Nguyen S, Heidenreich P, Nguyen P, Burdon T, Giacomini J, Yong C, Buchbinder M, Fann J, Kilgore S, Mitchell R, McDaniel S, Pack A, White W, Young T, Burgess P, Pu M, Upadhya B, Applegate R, Kon N, Arnan M, Baghshomali S, Bishop L, Bradbury E, Gandhi S, Kincaid E, Lefkowitz D, Lisle B, Batteria M, Rerisi E, Stepinowski K, Senicola T, Goncalves J, Schubach S, Schwartz R, Antaky K, Christiansen C, Marzo K, Michel K, Misra A, Varghese P, Wirkowski E, Levesque L, Sugeng L, Cleman M, Forrest J, Hashim S, Mangi A, Amin H, Darr U, Dewar M, Faheem O, Geirsson A, Greer D, Kaleel A, Kaple R, Lansky A, MacGrory B, Pfau S, Schindler J, Thompson C, Youn T, Yuh D, Yun J. Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients. JAMA Cardiology 2022, 7: 1000-1008. PMID: 36001335, PMCID: PMC9403849, DOI: 10.1001/jamacardio.2022.2695.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementSevere aortic valve stenosisIntermediate-risk patientsAortic valve stenosisValve replacementAdverse eventsAortic stenosisValve stenosisParavalvular leakClinical trialsIndependent echocardiographic core laboratorySurgical aortic valve replacementSymptomatic severe aortic stenosisIndependent clinical events committeePrespecified secondary end pointsEchocardiographic core laboratoryIntermediate surgical riskIntermediate-risk subjectsLocal heart teamSecondary end pointsSerious adverse eventsSevere aortic stenosisSymptomatic aortic stenosisAortic valve areaDevelopment 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 confirmationBleedingPCI in Patients With Heart Failure: Current Evidence, Impact of Complete Revascularization, and Contemporary Techniques to Improve Outcomes
Ahmad Y, Petrie M, Jolicoeur E, Madhavan M, Velazquez E, Moses J, Lansky A, Stone G. PCI in Patients With Heart Failure: Current Evidence, Impact of Complete Revascularization, and Contemporary Techniques to Improve Outcomes. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 1: 100020. PMID: 39132568, PMCID: PMC11307477, DOI: 10.1016/j.jscai.2022.100020.Peer-Reviewed Original ResearchPercutaneous coronary interventionLeft ventricular systolic dysfunctionCoronary artery diseaseHeart failureComplete revascularizationMedical therapyClinical outcomesClinical trialsCoronary artery bypassVentricular systolic dysfunctionClinical trial evidenceHigh operative riskHigh-risk patientsMajor cardiac surgeryExtent of revascularizationMinority of patientsFuture clinical trialsArtery bypassCause mortalityPeriprocedural complicationsSystolic dysfunctionCoronary interventionOperative riskArtery diseaseCardiac surgery
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 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 NetworkRosuvastatinTrials
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 ResearchSex-Specific Outcomes in Cardiovascular Device Evaluations
Ghare MI, Tirziu D, Abbott JD, Altin E, Yang Y, Ng V, Grines C, Lansky A. Sex-Specific Outcomes in Cardiovascular Device Evaluations. Journal Of Women's Health 2020, 29: 1246-1255. PMID: 32543268, PMCID: PMC9545802, DOI: 10.1089/jwh.2019.8068.Peer-Reviewed Original ResearchConceptsCoronary revascularizationHeart failureClinical trialsDevice trialsMajor clinical trialsStructural heart diseaseSex-specific outcomesBenefit/risk assessmentCardiac resynchronization defibrillatorImplantable cardioverter defibrillatorVentricular assist deviceBest available careDrug eluting stentsBetter treatment recommendationsCardiovascular outcomesDevice therapyTreatment recommendationsHeart diseaseCardioverter defibrillatorDevice clinical trialsTreatment selectionAvailable careAssist deviceNarrative reviewEluting stentsDefining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology.
Chang CC, Kogame N, Onuma Y, Byrne RA, Capodanno D, Windecker S, Morel MA, Cutlip DE, Krucoff MW, Stone GW, Lansky AJ, Mehran R, Spitzer E, Fraser AG, Baumbach A, Serruys PW. Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology. EuroIntervention 2020, 15: 1190-1198. PMID: 31475907, DOI: 10.4244/eij-d-19-00552.Peer-Reviewed Original ResearchConceptsDevice success rateDrug-eluting stentsPercutaneous coronary intervention trialsCoronary intervention trialsDevice successIntervention trialsClinical trialsSuccess rateSymptomatic coronary artery diseasePercutaneous coronary interventionAdverse clinical eventsCoronary artery diseasePercutaneous Cardiovascular InterventionsDifferent trialsRevascularisation proceduresCoronary interventionAngiographic outcomesArtery diseaseClinical eventsComparative trialsEndpoint definitionsDrug AdministrationCardiovascular interventionsPerformance endpointEuropean Association
2019
2-Year Clinical Outcomes of an Abluminal Groove–Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent
Xu B, Saito Y, Baumbach A, Kelbæk H, van Royen N, Zheng M, Morel MA, Knaapen P, Slagboom T, Johnson TW, Vlachojannis G, Arkenbout KE, Holmvang L, Janssens L, Ochala A, Brugaletta S, Naber CK, Anderson R, Rittger H, Berti S, Barbato E, Toth GG, Maillard L, Valina C, Buszman P, Thiele H, Schächinger V, Lansky A, Wijns W, Investigators T. 2-Year Clinical Outcomes of an Abluminal Groove–Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent. JACC Cardiovascular Interventions 2019, 12: 1679-1687. PMID: 31129092, DOI: 10.1016/j.jcin.2019.05.001.Peer-Reviewed Original ResearchMeSH KeywordsAbsorbable ImplantsAgedCardiovascular AgentsCoronary Artery DiseaseCoronary ThrombosisDrug-Eluting StentsDual Anti-Platelet TherapyEuropeEverolimusFemaleHumansMaleMiddle AgedPercutaneous Coronary InterventionPolymersProspective StudiesProsthesis DesignRisk FactorsSirolimusTime FactorsTreatment OutcomeConceptsTarget lesion failureXIENCE stentXience groupLesion failurePrimary endpointClinical outcomesIschemia-driven target lesion revascularizationTarget vessel myocardial infarctionProbable stent thrombosisTarget lesion revascularizationVessel myocardial infarctionLong-term outcomesDurable polymer everolimusBiodegradable Polymer SirolimusAbluminal grooveFIREHAWK stentLesion revascularizationCardiac deathComparable safetyStent thrombosisMyocardial infarctionClinical trialsEfficacy profileNoninferiority trialLandmark analysisSex 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
2017 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
What is the best ST-segment recovery parameter to predict clinical outcome and myocardial infarct size? Amplitude, speed, and completeness of ST-segment recovery after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction
Kuijt WJ, Green CL, Verouden NJW, Haeck JDE, Tzivoni D, Koch KT, Stone GW, Lansky AJ, Broderick S, Tijssen JGP, de Winter RJ, Roe MT, Krucoff MW. What is the best ST-segment recovery parameter to predict clinical outcome and myocardial infarct size? Amplitude, speed, and completeness of ST-segment recovery after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Journal Of Electrocardiology 2017, 50: 952-959. PMID: 29153151, DOI: 10.1016/j.jelectrocard.2017.04.009.Peer-Reviewed Original ResearchConceptsST-segment elevation myocardial infarctionST-segment recoveryPrimary percutaneous coronary interventionPercutaneous coronary interventionElevation myocardial infarctionInfarct sizeCoronary interventionMyocardial infarctionHolter ECG monitoringMyocardial infarct sizeSingle photon emissionMultivariable adjustmentClinical outcomesRisk factorsClinical trialsNoninvasive biomarkersCore laboratoryMechanistic correlatesMortalityECG monitoringInfarctionRecovery parametersST parametersInterventionOutcomesProposed 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 proceduresComplicationsProposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials An Academic Research Consortium Initiative
Lansky AJ, Messé SR, Brickman AM, Dwyer M, van der Worp HB, 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 CS, 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 An Academic Research Consortium Initiative. Journal Of The American College Of Cardiology 2017, 69: 679-691. PMID: 28183511, DOI: 10.1016/j.jacc.2016.11.045.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
2015
The Diagnosis of CAD in Women: Addressing the Unmet Need—A Report from the National Expert Roundtable Meeting
Clarke JL, Ladapo JL, Monane M, Lansky A, Skoufalos A, Nash DB. The Diagnosis of CAD in Women: Addressing the Unmet Need—A Report from the National Expert Roundtable Meeting. Population Health Management 2015, 18: 86-92. PMID: 25714757, PMCID: PMC4410448, DOI: 10.1089/pop.2015.0006.Peer-Reviewed Original ResearchConceptsObstructive CADDiagnostic challengeCoronary Artery Disease ResultsMultiple health care stakeholdersPathophysiology of CADLow-risk womenHigh-risk womenLow pretest probabilityRecent clinical trialsDiagnosis of CADEvaluation of womenNegative predictive valueWomen's health researchHealth researchGene expression testFalse-positive findingsPatient's symptomsAtypical symptomsHealth care stakeholdersClinical trialsPretest probabilitySex-specific differencesPredictive valueDisease resultsPositive findings
2014
TCT-597 Three Year Clinical Outcomes of a Unique Sirolimus-Eluting Stent with Fully Absorbable Polymer Coating: Long-term Results from the DESSOLVE I and the DESSOLVE II Clinical Trials
Ormiston J, Lansky A, Donohoe D, Knape C, Vrolix M, Verheye S, Schoors D, Wijns W. TCT-597 Three Year Clinical Outcomes of a Unique Sirolimus-Eluting Stent with Fully Absorbable Polymer Coating: Long-term Results from the DESSOLVE I and the DESSOLVE II Clinical Trials. Journal Of The American College Of Cardiology 2014, 64: b174. DOI: 10.1016/j.jacc.2014.07.661.Peer-Reviewed Original Research