Standardized End Point Definitions for Coronary Intervention Trials

European Heart Journal

Volumn 39, Issue 23, 2018, Pages 2192-2207

  Garcia Garcia, Hector M ^a,b   McFadden, Eugène P ^c   Farb, Andrew ^d   Mehran, Roxana ^e   Stone, Gregg W ^f   Spertus, John ^g   Onuma, Yoshinobu ^a   Morel, Marie Angèle ^a   Van Es, Gerrit Anne ^a   Zuckerman, Bram ^d   Fearon, William F ^h   Taggart, David ⁱ   Kappetein, Arie Pieter ^j   Krucoff, Mitchell W ^k   Vranckx, Pascal ^l   Windecker, Stephan ^m   Cutlip, Donald ^n,p   Serruys, Patrick W ^o  

^a CARDIALYSIS   (Netherlands)

^b WASHINGTON HOSPITAL CENTER   (United States)

^c University College Cork and INFANT Centre   (Ireland)

^d CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^e MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^f NewYork Presbyterian Hospital   (United States)

^g UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

^h STANFORD UNIVERSITY MEDICAL CENTER   (United States)

ⁱ UNIVERSITY OF OXFORD   (United Kingdom)

^j ERASMUS MEDICAL CENTER   (Netherlands)

^k DUKE UNIVERSITY MEDICAL CENTER   (United States)

^l HASSELT UNIVERSITY   (Belgium)

^m UNIVERSITY OF BERN   (Switzerland)

ⁿ HARVARD CLINICAL RESEARCH INSTITUTE   (United States)

^o IMPERIAL COLLEGE LONDON   (United Kingdom)

^p BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

more..

Author keywords

controlled clinical trials; myocardial infarction; revascularization; scaffold; stents

Indexed keywords

ALL CAUSE MORTALITY; ANGIOGRAPHY; ARTICLE; BLEEDING; CEREBROVASCULAR ACCIDENT; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; CLINICAL OUTCOME; CLINICAL PROTOCOL; CORONARY ARTERY BYPASS GRAFT; DEVICE SAFETY; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; QUALITY OF LIFE; REVASCULARIZATION; STENT THROMBOSIS; ASIA; BIODEGRADABLE IMPLANT; CLINICAL TRIAL (TOPIC); CONSENSUS DEVELOPMENT; CORONARY ARTERY DISEASE; DEVICES; EUROPE; OUTCOME ASSESSMENT; PATIENT-REPORTED OUTCOME; STENT; TISSUE SCAFFOLD; UNITED STATES;

ABSORBABLE IMPLANTS; ASIA; CLINICAL TRIALS AS TOPIC; CORONARY ARTERY DISEASE; EQUIPMENT AND SUPPLIES; EUROPE; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT REPORTED OUTCOME MEASURES; STENTS; TISSUE SCAFFOLDS; UNITED STATES;

EID: 85048809870     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehy223     Document Type: Article

References (29)

1. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344-2351.
2. De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engström T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nüesch E, Jüni P. FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med 2014; 371:1208-1217.
3. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. Third universal definition of myocardial infarction. Circulation 2012;126:2020-2035.
4. Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J 2012;33:2551-2567.
5. Moussa ID, Klein LW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, Stone GW. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol. 2013;62:1563-1570.
6. Hicks KA, Tcheng JE, Bozkurt B, Chaitman BR, Cutlip DE, Farb A, Fonarow GC, Jacobs JP, Jaff MR, Lichtman JH, Limacher MC, Mahaffey KW, Mehran R, Nissen SE, Smith EE, Targum SL. 2014 ACC/AHA key data elements and definitions for cardiovascular endpoint events in clinical trials: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). J Am Coll Cardiol 2015;66:403-469.
7. Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P. 2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Rev Esp Cardiol. 2017;70:1082.
8. Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S. ESC Scientific Document Group. 2015 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016;37:267-315.
9. Apple FS, Sandoval Y, Jaffe AS, Ordonez-Llanos J. IFCC Task Force on Clinical Applications of Cardiac Bio-Markers. Cardiac troponin assays: guide to understanding analytical characteristics and their impact on clinical care. Clin Chem. 2017;63:73-81.
10. Novack V, Pencina M, Cohen DJ, Kleiman NS, Yen CH, Saucedo JF, Berger PB, Cutlip DE. Troponin criteria for myocardial infarction after percutaneous coronary intervention. Arch Intern Med 2012;172:502-508.
11. Giannitsis E, Kurz K, Hallermayer K, Jarausch J, Jaffe AS, Katus HA. Analytical validation of a high-sensitivity cardiac troponin T assay. Clin Chem 2010;56:254-261. doi: 10.1373/clinchem.2009.132654.
12. Lansky AJ, Messe SR, Brickman AM, Dwyer M, Bart 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, Scala 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. Eur Heart J 2018;39:1687-1697.
13. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 2011;123: 2736-2747.
14. Byrne RA, Serruys PW, Baumbach A, Escaned J, Fajadet J, James S, Joner M, Oktay S, Jüni P, Kastrati A, Sianos G, Stefanini GG, Wijns W, Windecker S. Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions Task Force on the Evaluation of Coronary Stents in Europe: executive summary. Eur Heart J 2015;36:2608-2620.
15. Farb A, Zuckerman BD. Clinical event adjudication in cardiovascular device trials: an Food and Drug Administration perspective. Am Heart J 2017;191:62-64.
16. Cutlip DE, Nakazawa G, Krucoff MW, Vorpahl M, Mehran R, Finn AV, Vranckx P, Kimmelstiel C, Berger C, Petersen JL, Palabrica T, Virmani R. Autopsy validation study of the academic research consortium stent thrombosis definition. JACC Cardiovasc Interv 2011;4:554-559.
17. Chieffo A, Bonizzoni E, Orlic D, Stankovic G, Rogacka R, Airoldi F, Mikhail GW, Montorfano M, Michev I, Carlino M, Colombo A. Intraprocedural stent thrombosis during implantation of sirolimus-eluting stents. Circulation 2004;109: 2732-2736.
18. Généreux P, Stone GW, Harrington RA, Gibson CM, Steg PG, Brener SJ, Angiolillo DJ, Price MJ, Prats J, Lasalle L, Liu T, Todd M, Skerjanec S, Hamm CW, Mahaffey KW, White HD, Bhatt DL. CHAMPION PHOENIX Investigators. Impact of intraprocedural stent thrombosis during percutaneous coronary intervention: insights from the CHAMPION PHOENIX Trial (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). J Am Coll Cardiol 2014;63:619-629.
19. Spertus JA, Salisbury AC, Jones PG, Conaway DG, Thompson RC. Predictors of quality-of-life benefit after percutaneous coronary intervention. Circulation 2004; 110:3789-3794.
20. Spertus J. Assessing patients' improvement in clinical trials. BMJ 2008;336: 1258-1259.
21. Spertus JA. Evolving applications for patient-centered health status measures. Circulation 2008;118:2103-2110.
22. Porter ME, Larsson S, Lee TH. Standardizing patient outcomes measurement. N Engl J Med 2016;374:504-506.
23. Arnold SV, Masoudi FA, Rumsfeld JS, Li Y, Jones PG, Spertus JA. Derivation and validation of a risk standardization model for benchmarking hospital performance for health-related quality of life outcomes after acute myocardial infarction. Circulation 2014;129:313-320.
24. US Food and Drug Administration. Guidance for Industry Patient-Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims. https:// www.fda.gov/downloads/drugs/guidances/ucm193282.pdf. Accessed May 1, 2018.
25. Arnold SV, Kosiborod M, Li Y, Jones PG, Yue P, Belardinelli L, Spertus JA. Comparison of the Seattle Angina Questionnaire with daily angina diary in the TERISA Clinical Trial. Circ Cardiovasc Qual Outcomes. 2014;7:844-850.
26. Spertus JA, Jones P, McDonell M, Fan V, Fihn SD. Health status predicts longterm outcome in outpatients with coronary disease. Circulation. 2002;106:43-49.
27. Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Fihn SD. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol 1994;74:1240-1244.
28. Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonell M, Fihn SD. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol 1995;25:333-341.
29. Chan PS, Jones PG, Arnold SA, Spertus JA. Development and validation of a short version of the Seattle angina questionnaire. Circ Cardiovasc Qual Outcomes 2014;7:640-647.