Long-term follow-up after bioresorbable vascular scaffold implantation in STEMI patients: PRAGUE-19 study update

EuroIntervention

Volumn 12, Issue 1, 2016, Pages 23-29

  Toušek, Petr ^a   Kočka, Viktor ^a   Malý, Martin ^b   Kozel, Martin ^a   Petr, Robert ^a   Hajsl, Martin ^b   Jarkovský, Jiří ^c   Lisa, Libor ^a   Buděšínský, Tomáš ^a   Widimský, Petr ^a  

^a CHARLES UNIVERSITY   (Czech Republic)

^b CHARLES UNIVERSITY   (Czech Republic)

^c MASARYK UNIVERSITY   (Czech Republic)

Author keywords

Bioresorbable vascular scaffold; Long term follow up; Optical coherence tomography; ST elevation myocardial infarction

Indexed keywords

ADULT; ARTERY INTIMA PROLIFERATION; ARTICLE; BIORESORBABLE VASCULAR STENT; CLINICAL TRIAL; COHORT ANALYSIS; COMPUTER PROGRAM; CONTROLLED STUDY; CORONARY ANGIOGRAPHY; FEMALE; FOLLOW UP; HEART CATHETER; HEART DEATH; HEART MUSCLE REVASCULARIZATION; HEART REINFARCTION; HUMAN; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MORTALITY RATE; OPEN STUDY; OPTICAL COHERENCE TOMOGRAPHY; PILOT STUDY; PROSPECTIVE STUDY; QUANTITATIVE ANALYSIS; SCREENING TEST; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; STENT THROMBOSIS; TREATMENT OUTCOME; AGED; BIODEGRADABLE IMPLANT; DRUG ELUTING STENT; PERCUTANEOUS CORONARY INTERVENTION; PROCEDURES; PROSTHESIS DESIGN; ST ELEVATION MYOCARDIAL INFARCTION; TISSUE SCAFFOLD;

ABSORBABLE IMPLANTS; AGED; CORONARY ANGIOGRAPHY; DRUG-ELUTING STENTS; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; PERCUTANEOUS CORONARY INTERVENTION; PROSTHESIS DESIGN; ST ELEVATION MYOCARDIAL INFARCTION; TISSUE SCAFFOLDS; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME;

EID: 84969522981     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV12I1A5     Document Type: Article

References (26)

1. Iqbal J, Onuma Y, Ormiston J, Abizaid A, Waksman R, Serruys P. Bioresorbable scaffolds: rationale, current status, challenges, and future. Eur Heart J. 2014;35:765-76.
2. Abizaid A, Costa JR Jr, Bartorelli AL, Whitbourn R, van Geuns RJ, Chevalier B, Patel T, Seth A, Stuteville M, Dorange C, Cheong WF, Sudhir K, Serruys PW; ABSORB EXTEND investigators. The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention. 2014;10:1396-401.
3. Serruys PW, Chevalier B, Dudek D, Cequier A, Carrie D, Iniguez A, Dominici M, van der Schaaf RJ, Haude M, Wasungu L, Veldhof S, Peng L, Staehr P, Grundeken MJ, Ishibashi Y, Garcia-Garcia HM, Onuma Y. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385:43-54.
4. Kocka V, Maly M, Tousek P, Budesinsky T, Lisa L, Prodanov P, Jarkovsky J, Widimsky P. Bioresorbable vascular scaffolds in acute ST-segment elevation myocardial infarction: a prospective multicentre study 'Prague 19'. Eur Heart J. 2014;35:787-94.
5. Brugaletta S, Gori T, Low AF, Tousek P, Pinar E, Gomez-Lara J, Scalone G, Schulz E, Chan MY, Kocka V, Hurtado J, Gomez-Hospital JA, Munzel T, Lee CH, Cequier A, Valdes M, Widimsky P, Serruys PW, Sabaté M. Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: the BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc Interv. 2015;8:189-97.
6. Diletti R, Karanasos A, Muramatsu T, Nakatani S, Van Mieghem NM, Onuma Y, Nauta ST, Ishibashi Y, Lenzen MJ, Ligthart J, Schultz C, Regar E, de Jaegere PP, Serruys PW, Zijlstra F, van Geuns RJ. Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study. Eur Heart J. 2014;35:777-86.
7. Raber L, Zanchin T, Baumgartner S, Taniwaki M, Kalesan B, Moschovitis A, Garcia-Garcia HM, Justiz J, Pilgrim T, Wenaweser P, Meier B, Juni P, Windecker S. Differential healing response attributed to culprit lesions of patients with acute coronary syndromes and stable coronary artery after implantation of drug-eluting stents: an optical coherence tomography study. Int J Cardiol. 2014;173:259-67.
8. Serruys PW, Onuma Y, Garcia-Garcia HM, Muramatsu T, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Ormiston JA. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention. 2014;9:1271-84.
9. Serruys PW, Ormiston J, van Geuns RJ, de Bruyne B, Dudek D, Christiansen E, Chevalier B, Smits P, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Wasungu L, Ediebah D, Veldhof S, Onuma Y. A Polylactide Bioresorbable Scaffold Eluting Everolimus for Treatment of Coronary Stenosis: 5-Year Follow-Up. J Am Coll Cardiol. 2016;67:766-76.
10. Onuma Y, Dudek D, Thuesen L, Webster M, Nieman K, Garcia-Garcia HM, Ormiston JA, Serruys PW. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB cohort A trial. JACC Cardiovasc Interv. 2013;6:999-1009.
11. Widimsky P, Petr R, Tousek P, Maly M, Linkova H, Vrana J, Hajsl M, Budesinsky T, Lisa L, Kocka V. One-Year Clinical and Computed Tomography Angiographic Outcomes After Bioresorbable Vascular Scaffold Implantation During Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction: The PRAGUE-19 Study. Circ Cardiovasc Interv. 2015;8:e002933.
12. 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;115:2344-51.
13. Okamura T, Gonzalo N, Gutierrez-Chico JL, Serruys PW, Bruining N, de Winter S, Dijkstra J, Commossaris KH, van Geuns RJ, van Soest G, Ligthart J, Regar E. Reproducibility of coronary Fourier domain optical coherence tomography: quantitative analysis of in vivo stented coronary arteries using three different software packages. EuroIntervention. 2010;6:371-9.
14. Garcia-Garcia HM, Serruys PW, Campos CM, Muramatsu T, Nakatani S, Zhang YJ, Onuma Y, Stone GW. Assessing bioresorbable coronary devices: methods and parameters. JACC Cardiovasc Imaging. 2014;7:1130-48.
15. Otsuka F, Pacheco E, Perkins LE, Lane JP, Wang Q, Kamberi M, Frie M, Wang J, Sakakura K, Yahagi K, Ladich E, Rapoza RJ, Kolodgie FD, Virmani R. Long-term safety of an everolimus-eluting bioresorbable vascular scaffold and the cobalt-chromium XIENCE V stent in a porcine coronary artery model. Circ Cardiovasc Interv. 2014;7:330-42.
16. Lu C, Filion KB, Eisenberg MJ. The Safety and Efficacy of Absorb Bioresorbable Vascular Scaffold: A Systematic Review. Clin Cardiol. 2016;39:48-55.
17. Tousek P, Kocka V, Maly M, Kozel M, Robert P, Hajsl M, Jarkovsky J, Widimsky P. Two-year follow-up after bioresorbable vascular scaffold implantation in STEMI patients - Results from PRAGUE-19 study. Int J Cardiol. 2016;209:20-1.
18. Sabaté M, Windecker S, Iniguez A, Okkels-Jensen L, Cequier A, Brugaletta S, Hofma SH, Räber L, Christiansen EH, Suttorp M, Pilgrim T, Anne van Es G, Sotomi Y, Garcia-Garcia HM, Onuma Y, Serruys PW. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial. Eur Heart J. 2016;37:229-40.
19. Cassese S, Kastrati A. Bioresorbable Vascular Scaffold Technology Benefits From Healthy Skepticism. J Am Coll Cardiol. 2016;67:932-5.
20. Lipinski MJ, Escarcega RO, Baker NC, Benn HA, Gaglia MA Jr, Torguson R, Waksman R. Scaffold Thrombosis After Percutaneous Coronary Intervention With ABSORB Bioresorbable Vascular Scaffold: A Systematic Review and Meta-Analysis. JACC Cardiovasc Interv. 2016;9:12-24.
21. Rumiz Gonzalez E, Vilar Herrero JV, Berenguer Jofresa A. Very Late Thrombosis of a Bioresorbable Scaffold. Rev Esp Cardiol (Engl. Ed). 2016;69:211.
22. Räber L, Brugaletta S, Yamaji K, O'Sullivan CJ, Otsuki S, Koppara T, Taniwaki M, Onuma Y, Freixa X, Eberli FR, Serruys PW, Joner M, Sabate M, Windecker S. Very Late Scaffold Thrombosis: Intracoronary Imaging and Histopathological and Spectroscopic Findings. J Am Coll Cardiol. 2015;66:1901-14.
23. Timmers L, Stella PR, Agostoni P. Very late bioresorbable vascular scaffold thrombosis following discontinuation of antiplatelet therapy. Eur Heart J. 2015;36:393.
24. Yahagi K, Virmani R, Kesavamoorthy B. Very late scaffold thrombosis of everolimus-eluting bioresorbable scaffold following implantation in STEMI after discontinuation of dual antiplatelet therapy. Cardiovasc Interv Ther. 2015Oct 31. [Epub ahead of print].
25. Ielasi A, Cortese B, Steffenino G. Late Structural Discontinuity as a Possible Cause of Very Late Everolimus-Eluting Bioresorbable Scaffold Thrombosis. JACC Cardiovasc Interv. 2015;8:e171-2.
26. Onuma Y, Serruys PW, Muramatsu T, Nakatani S, van Geuns RJ, de Bruyne B, Dudek D, Christiansen E, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Garcia-Garcia HM, Veldhof S, Rapoza R, Ormiston JA. Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb Everolimus-Eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2014;7:1400-11.