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

Manel Sabaté, Stephan Windecker, Andres Iñiguez, Lisette Okkels-Jensen, Angel Cequier, Salvatore Brugaletta, Sjoerd H Hofma, Lorenz Räber, Evald Høi Christiansen, Maarten Suttorp, Thomas Pilgrim, Gerrit Anne van Es, Yohei Sotomi, Hector M García-García, Yoshinobu Onuma, Patrick W Serruys

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

AIMS: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI.

METHODS AND RESULTS: ABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) -1.06 (-1.96, -0.16); Pnon-inferiority <0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns).

CONCLUSION: Stenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials.

OriginalsprogEngelsk
TidsskriftEuropean Heart Journal
Vol/bind37
Udgave nummer3
Sider (fra-til)229-40
Antal sider12
ISSN0195-668X
DOI
StatusUdgivet - 14. jan. 2016

Fingeraftryk

Stents
ST Elevation Myocardial Infarction
Everolimus
Equipment and Supplies
Safety
Research

Citer dette

Sabaté, Manel ; Windecker, Stephan ; Iñiguez, Andres ; Okkels-Jensen, Lisette ; Cequier, Angel ; Brugaletta, Salvatore ; Hofma, Sjoerd H ; Räber, Lorenz ; Christiansen, Evald Høi ; Suttorp, Maarten ; Pilgrim, Thomas ; Anne van Es, Gerrit ; Sotomi, Yohei ; García-García, Hector M ; Onuma, Yoshinobu ; Serruys, Patrick W. / 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. I: European Heart Journal. 2016 ; Bind 37, Nr. 3. s. 229-40.
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title = "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",
abstract = "AIMS: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI.METHODS AND RESULTS: ABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8{\%} females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90{\%} CI) -1.06 (-1.96, -0.16); Pnon-inferiority <0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1{\%} Absorb vs. 0{\%} EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1{\%} vs. 0{\%} EES; P = ns).CONCLUSION: Stenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials.",
author = "Manel Sabat{\'e} and Stephan Windecker and Andres I{\~n}iguez and Lisette Okkels-Jensen and Angel Cequier and Salvatore Brugaletta and Hofma, {Sjoerd H} and Lorenz R{\"a}ber and Christiansen, {Evald H{\o}i} and Maarten Suttorp and Thomas Pilgrim and {Anne van Es}, Gerrit and Yohei Sotomi and Garc{\'i}a-Garc{\'i}a, {Hector M} and Yoshinobu Onuma and Serruys, {Patrick W}",
note = "{\circledC} The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.",
year = "2016",
month = "1",
day = "14",
doi = "10.1093/eurheartj/ehv500",
language = "English",
volume = "37",
pages = "229--40",
journal = "European Heart Journal",
issn = "0195-668X",
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number = "3",

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Sabaté, M, Windecker, S, Iñiguez, A, Okkels-Jensen, L, Cequier, A, Brugaletta, S, Hofma, SH, Räber, L, Christiansen, EH, Suttorp, M, Pilgrim, T, Anne van Es, G, Sotomi, Y, García-García, HM, Onuma, Y & Serruys, PW 2016, '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', European Heart Journal, bind 37, nr. 3, s. 229-40. https://doi.org/10.1093/eurheartj/ehv500

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. / Sabaté, Manel; Windecker, Stephan; Iñiguez, Andres; Okkels-Jensen, Lisette; Cequier, Angel; Brugaletta, Salvatore; Hofma, Sjoerd H; Räber, Lorenz; Christiansen, Evald Høi; Suttorp, Maarten; Pilgrim, Thomas; Anne van Es, Gerrit; Sotomi, Yohei; García-García, Hector M; Onuma, Yoshinobu; Serruys, Patrick W.

I: European Heart Journal, Bind 37, Nr. 3, 14.01.2016, s. 229-40.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction

T2 - results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial

AU - Sabaté, Manel

AU - Windecker, Stephan

AU - Iñiguez, Andres

AU - Okkels-Jensen, Lisette

AU - Cequier, Angel

AU - Brugaletta, Salvatore

AU - Hofma, Sjoerd H

AU - Räber, Lorenz

AU - Christiansen, Evald Høi

AU - Suttorp, Maarten

AU - Pilgrim, Thomas

AU - Anne van Es, Gerrit

AU - Sotomi, Yohei

AU - García-García, Hector M

AU - Onuma, Yoshinobu

AU - Serruys, Patrick W

N1 - © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

PY - 2016/1/14

Y1 - 2016/1/14

N2 - AIMS: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI.METHODS AND RESULTS: ABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) -1.06 (-1.96, -0.16); Pnon-inferiority <0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns).CONCLUSION: Stenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials.

AB - AIMS: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI.METHODS AND RESULTS: ABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) -1.06 (-1.96, -0.16); Pnon-inferiority <0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns).CONCLUSION: Stenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials.

U2 - 10.1093/eurheartj/ehv500

DO - 10.1093/eurheartj/ehv500

M3 - Journal article

C2 - 26405232

VL - 37

SP - 229

EP - 240

JO - European Heart Journal

JF - European Heart Journal

SN - 0195-668X

IS - 3

ER -