One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study
Thomas, MR; Birkemeyer, R; Schwimmbeck, Pet al.
2015 • In EuroIntervention: Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 10, p. 1267-71
coronary stenosis; drug eluting stent; observational study; everolimus
Abstract :
[en] Aims: The PROMUS™ Element™ European Post-Approval Surveillance Study (PE-Prove) is a prospective,
open-label, multicentre observational study designed to assess outcomes following PROMUS Element
everolimus-eluting stent implantation in an unselected patient population.
Methods and results: A total of 1,010 patients were enrolled at 40 clinical sites in Europe, including 24.9%
with medically treated diabetes, 50.0% with Type B2/C lesions, 6.1% with chronic total occlusion, 17.8%
with acute myocardial infarction (MI ≤24 hours pre-procedure), and 20.1% with unstable angina. The target
lesion was the culprit for ST-segment elevation MI in 7.3% of patients. The one-year, per patient target vessel
failure rate was 6.2% (60/975), 3.4% (33) being related to the PROMUS Element stent. Rates of cardiac
death, MI, and Academic Research Consortium (ARC) definite/probable stent thrombosis were 1.7%, 3.5%,
and 0.6%, respectively. The target vessel revascularisation rate was 3.2% (31/975), 2.1% (20) being related
to the PROMUS Element stent.
Conclusions: In a large and relatively complex group of “real-world” patients, coronary artery revascularisation
with the PROMUS Element everolimus-eluting stent provides favourable results with low event rates
consistent with those reported for other contemporary drug-eluting stents.
Disciplines :
Cardiovascular & respiratory systems General & internal medicine
Author, co-author :
Thomas, MR
Birkemeyer, R
Schwimmbeck, P
LEGRAND, Victor ; Centre Hospitalier Universitaire de Liège - CHU > Cardiologie
Moreno, R
Briguori, C
Werner, N
Bramucci, E
Ungi, I
Richardt, G
Underwood, PL
Dawkins, KD
Language :
English
Title :
One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study
Publication date :
2015
Journal title :
EuroIntervention: Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Stone GW, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Allocco DJ, Dawkins KD; PLATINUM Trial Investigators. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial. J Am Coll Cardiol. 2011;57:1700-8.
Meredith IT, Teirstein PS, Bouchard A, Carrie D, Mollmann H, Oldroyd KG, Hall J, Allocco DJ, Dawkins KD, Stone GW. Three-year results comparing platinum-chromium PROMUS element and cobalt-chromium XIENCE V everolimus-eluting stents in de novo coronary artery narrowing (from the PLATINUM Trial). Am J Cardiol. 2014;113:1117-23.
De la Torre Hernandez JM, Garcia Camarero T, Lerena P, Lee DH, Sainz Laso F, Gorria GM, Zueco J. A real all-comers randomized trial comparing Xience Prime and Promus Element stents. J Invasive Cardiol. 2013;25:182-5.
Sarno G, Lagerqvist B, Carlsson J, Olivecrona G, Nilsson J, Calais F, Gotberg M, Nilsson T, Sjogren I, James S. Initial clinical experience with an everolimus eluting platinum chromium stent (Promus Element) in unselected patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Int J Cardiol. 2013;167:146-50.
Krucoff MW, Rutledge DR, Gruberg L, Jonnavithula L, Katopodis JN, Lombardi W, Mao VW, Sharma SK, Simonton CA, Tamboli HP, Wang J, Wilburn O, Zhao W, Sudhir K, Hermiller JB. A new era of prospective real-world safety evaluation: Primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study). JACC Cardiovasc Interv. 2011;4:1298-309.
Damman P, Abdel-Wahab M, Mollmann H, Richardt G, Chevalier B, Barragan P, Tijssen JG, Underwood P, Hamm CW. Comparison of twelve-month outcomes after percutanous coronary intervention with everolimus-eluting versus zotarolimus-eluting or sirolimus-eluting stents from the PROENCY (PROmus ENdeavor CYpher) registry. J Invasive Cardiol. 2012;24:495-502.
Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010;375:201-9.
Neumann FJ, Widimsky P, Belardi JA. One-year outcomes of patients with the zotarolimus-eluting coronary stent: RESOLUTE International Registry. EuroIntervention. 2012;7:1181-8.
Silber S, Windecker S, Vranckx P, Serruys PW. Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial. Lancet. 2011;377:1241-7.
von Birgelen C, Basalus MW, Tandjung K, van Houwelingen KG, Stoel MG, Louwerenburg JH, Linssen GC, Said SA, Kleijne MA, Sen H, Lowik MM, van der Palen J, Verhorst PM, de Man FH. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in realworld patients: the TWENTE trial. J Am Coll Cardiol. 2012;59: 1350-61.
Baber U, Mehran R, Sharma SK, Brar S, Yu J, Suh JW, Kim HS, Park SJ, Kastrati A, de Waha A, Krishnan P, Moreno P, Sweeny J, Kim MC, Suleman J, Pyo R, Wiley J, Kovacic J, Kini AS, Dangas GD. Impact of the everolimus-eluting stent on stent thrombosis: a meta-analysis of 13 randomized trials. J Am Coll Cardiol. 2011;58:1569-77.
The GUSTO Investigators. An international randomised trial comparing four thrombolytic strategies for acute myocardial infarction. The GUSTO investigators. N Engl J Med. 1993;329:673-82.
