Safety and efficacy of everolimus-eluting bioresorbable vascular scaffolds versus durable polymer everolimus-eluting metallic stents assessed at 1-year follow-up: A systematic review and meta-analysis of studies

Bertrand N. Mukete, Liefke C. van der Heijden, Kenneth Tandjung, Hassan Baydoun, Kapil Yadav, Qusai A. Saleh, Carine J.M. Doggen, Nidal Abi Rafeh, Thierry H. Le Jemtel, Clemens von Birgelen

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Abstract

Background: The Absorb bioresorbable vascular scaffold (BVS) was developed to address long-term safety issues of metallic drug-eluting stents. However, it may be associated with an increased event risk during the first year.

Methods: A systematic literature search was performed (in MEDLINE/PubMed, Cochrane CENTRAL, EMBASE, and scientific meeting abstracts) to identify studies that compared BVS and cobalt-chromium durable polymer everolimus-eluting stents (EES). For randomized clinical trials and non-randomized propensity score matched studies that reported 1-year outcome data, fixed/random-effects models were used to generate pooled estimates of outcomes, presented as odds ratios (OR) with 95%-confidence intervals (CI).

Results: The 1-year follow-up data of 6 trials with 5588 patients were analyzed. A device-oriented composite endpoint (DOCE – cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization (TLR)) was reached by 308 BVS or EES patients (195/3253 vs. 113/2315). Meta-analysis showed that patients who received BVS had an increased risk of MI (4.3% vs. 2.3%; OR:1.63, 95%-CI: 1.18–2.25, p < 0.01) and definite-or-probable scaffold thrombosis (1.3% vs. 0.6%; OR:2.10, 95%-CI: 1.13–3.87, p = 0.02). However, there was no significant between-group difference in risk of DOCE (6.0% vs. 4.9%; OR:1.19, 95%-CI: 0.94–1.52, p = 0.16), cardiac death (0.8% vs. 0.7%; OR:1.14, 95%-CI: 0.54–2.39, p = 0.73), or TLR (2.5% vs. 2.5%; OR: 0.98, 95%-CI:0.69–1.40, p = 0.92).

Conclusions: During the first year of follow-up, patients treated with BVS had a higher incidence of MI and scaffold thrombosis. The risk of DOCE was not significantly different. As BVS may pay off later, future robust data on long-term clinical outcome will be of paramount importance.

Original languageEnglish
Pages (from-to)1087-1094
JournalInternational journal of cardiology
Volume221
DOIs
Publication statusPublished - 2016

Fingerprint

Stents
Blood Vessels
Meta-Analysis
Polymers
Odds Ratio
Confidence Intervals
Safety
Myocardial Infarction
Thrombosis
Propensity Score
Drug-Eluting Stents
Chromium
Cobalt
PubMed
MEDLINE
Everolimus
Equipment and Supplies
Incidence

Keywords

  • IR-100906
  • METIS-317451
  • Bioresorbable vascular scaffold
  • Biodegradable device
  • Everolimus-eluting stent
  • Stent thrombosis
  • Percutaneous coronary intervention

Cite this

Mukete, Bertrand N. ; van der Heijden, Liefke C. ; Tandjung, Kenneth ; Baydoun, Hassan ; Yadav, Kapil ; Saleh, Qusai A. ; Doggen, Carine J.M. ; Rafeh, Nidal Abi ; Le Jemtel, Thierry H. ; von Birgelen, Clemens. / Safety and efficacy of everolimus-eluting bioresorbable vascular scaffolds versus durable polymer everolimus-eluting metallic stents assessed at 1-year follow-up : A systematic review and meta-analysis of studies. In: International journal of cardiology. 2016 ; Vol. 221. pp. 1087-1094.
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title = "Safety and efficacy of everolimus-eluting bioresorbable vascular scaffolds versus durable polymer everolimus-eluting metallic stents assessed at 1-year follow-up: A systematic review and meta-analysis of studies",
abstract = "Background: The Absorb bioresorbable vascular scaffold (BVS) was developed to address long-term safety issues of metallic drug-eluting stents. However, it may be associated with an increased event risk during the first year.Methods: A systematic literature search was performed (in MEDLINE/PubMed, Cochrane CENTRAL, EMBASE, and scientific meeting abstracts) to identify studies that compared BVS and cobalt-chromium durable polymer everolimus-eluting stents (EES). For randomized clinical trials and non-randomized propensity score matched studies that reported 1-year outcome data, fixed/random-effects models were used to generate pooled estimates of outcomes, presented as odds ratios (OR) with 95{\%}-confidence intervals (CI).Results: The 1-year follow-up data of 6 trials with 5588 patients were analyzed. A device-oriented composite endpoint (DOCE – cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization (TLR)) was reached by 308 BVS or EES patients (195/3253 vs. 113/2315). Meta-analysis showed that patients who received BVS had an increased risk of MI (4.3{\%} vs. 2.3{\%}; OR:1.63, 95{\%}-CI: 1.18–2.25, p < 0.01) and definite-or-probable scaffold thrombosis (1.3{\%} vs. 0.6{\%}; OR:2.10, 95{\%}-CI: 1.13–3.87, p = 0.02). However, there was no significant between-group difference in risk of DOCE (6.0{\%} vs. 4.9{\%}; OR:1.19, 95{\%}-CI: 0.94–1.52, p = 0.16), cardiac death (0.8{\%} vs. 0.7{\%}; OR:1.14, 95{\%}-CI: 0.54–2.39, p = 0.73), or TLR (2.5{\%} vs. 2.5{\%}; OR: 0.98, 95{\%}-CI:0.69–1.40, p = 0.92).Conclusions: During the first year of follow-up, patients treated with BVS had a higher incidence of MI and scaffold thrombosis. The risk of DOCE was not significantly different. As BVS may pay off later, future robust data on long-term clinical outcome will be of paramount importance.",
keywords = "IR-100906, METIS-317451, Bioresorbable vascular scaffold, Biodegradable device, Everolimus-eluting stent, Stent thrombosis, Percutaneous coronary intervention",
author = "Mukete, {Bertrand N.} and {van der Heijden}, {Liefke C.} and Kenneth Tandjung and Hassan Baydoun and Kapil Yadav and Saleh, {Qusai A.} and Doggen, {Carine J.M.} and Rafeh, {Nidal Abi} and {Le Jemtel}, {Thierry H.} and {von Birgelen}, Clemens",
year = "2016",
doi = "10.1016/j.ijcard.2016.07.101",
language = "English",
volume = "221",
pages = "1087--1094",
journal = "International journal of cardiology",
issn = "0167-5273",
publisher = "Elsevier",

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Safety and efficacy of everolimus-eluting bioresorbable vascular scaffolds versus durable polymer everolimus-eluting metallic stents assessed at 1-year follow-up : A systematic review and meta-analysis of studies. / Mukete, Bertrand N.; van der Heijden, Liefke C.; Tandjung, Kenneth; Baydoun, Hassan; Yadav, Kapil; Saleh, Qusai A.; Doggen, Carine J.M.; Rafeh, Nidal Abi; Le Jemtel, Thierry H.; von Birgelen, Clemens.

In: International journal of cardiology, Vol. 221, 2016, p. 1087-1094.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Safety and efficacy of everolimus-eluting bioresorbable vascular scaffolds versus durable polymer everolimus-eluting metallic stents assessed at 1-year follow-up

T2 - A systematic review and meta-analysis of studies

AU - Mukete, Bertrand N.

AU - van der Heijden, Liefke C.

AU - Tandjung, Kenneth

AU - Baydoun, Hassan

AU - Yadav, Kapil

AU - Saleh, Qusai A.

AU - Doggen, Carine J.M.

AU - Rafeh, Nidal Abi

AU - Le Jemtel, Thierry H.

AU - von Birgelen, Clemens

PY - 2016

Y1 - 2016

N2 - Background: The Absorb bioresorbable vascular scaffold (BVS) was developed to address long-term safety issues of metallic drug-eluting stents. However, it may be associated with an increased event risk during the first year.Methods: A systematic literature search was performed (in MEDLINE/PubMed, Cochrane CENTRAL, EMBASE, and scientific meeting abstracts) to identify studies that compared BVS and cobalt-chromium durable polymer everolimus-eluting stents (EES). For randomized clinical trials and non-randomized propensity score matched studies that reported 1-year outcome data, fixed/random-effects models were used to generate pooled estimates of outcomes, presented as odds ratios (OR) with 95%-confidence intervals (CI).Results: The 1-year follow-up data of 6 trials with 5588 patients were analyzed. A device-oriented composite endpoint (DOCE – cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization (TLR)) was reached by 308 BVS or EES patients (195/3253 vs. 113/2315). Meta-analysis showed that patients who received BVS had an increased risk of MI (4.3% vs. 2.3%; OR:1.63, 95%-CI: 1.18–2.25, p < 0.01) and definite-or-probable scaffold thrombosis (1.3% vs. 0.6%; OR:2.10, 95%-CI: 1.13–3.87, p = 0.02). However, there was no significant between-group difference in risk of DOCE (6.0% vs. 4.9%; OR:1.19, 95%-CI: 0.94–1.52, p = 0.16), cardiac death (0.8% vs. 0.7%; OR:1.14, 95%-CI: 0.54–2.39, p = 0.73), or TLR (2.5% vs. 2.5%; OR: 0.98, 95%-CI:0.69–1.40, p = 0.92).Conclusions: During the first year of follow-up, patients treated with BVS had a higher incidence of MI and scaffold thrombosis. The risk of DOCE was not significantly different. As BVS may pay off later, future robust data on long-term clinical outcome will be of paramount importance.

AB - Background: The Absorb bioresorbable vascular scaffold (BVS) was developed to address long-term safety issues of metallic drug-eluting stents. However, it may be associated with an increased event risk during the first year.Methods: A systematic literature search was performed (in MEDLINE/PubMed, Cochrane CENTRAL, EMBASE, and scientific meeting abstracts) to identify studies that compared BVS and cobalt-chromium durable polymer everolimus-eluting stents (EES). For randomized clinical trials and non-randomized propensity score matched studies that reported 1-year outcome data, fixed/random-effects models were used to generate pooled estimates of outcomes, presented as odds ratios (OR) with 95%-confidence intervals (CI).Results: The 1-year follow-up data of 6 trials with 5588 patients were analyzed. A device-oriented composite endpoint (DOCE – cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization (TLR)) was reached by 308 BVS or EES patients (195/3253 vs. 113/2315). Meta-analysis showed that patients who received BVS had an increased risk of MI (4.3% vs. 2.3%; OR:1.63, 95%-CI: 1.18–2.25, p < 0.01) and definite-or-probable scaffold thrombosis (1.3% vs. 0.6%; OR:2.10, 95%-CI: 1.13–3.87, p = 0.02). However, there was no significant between-group difference in risk of DOCE (6.0% vs. 4.9%; OR:1.19, 95%-CI: 0.94–1.52, p = 0.16), cardiac death (0.8% vs. 0.7%; OR:1.14, 95%-CI: 0.54–2.39, p = 0.73), or TLR (2.5% vs. 2.5%; OR: 0.98, 95%-CI:0.69–1.40, p = 0.92).Conclusions: During the first year of follow-up, patients treated with BVS had a higher incidence of MI and scaffold thrombosis. The risk of DOCE was not significantly different. As BVS may pay off later, future robust data on long-term clinical outcome will be of paramount importance.

KW - IR-100906

KW - METIS-317451

KW - Bioresorbable vascular scaffold

KW - Biodegradable device

KW - Everolimus-eluting stent

KW - Stent thrombosis

KW - Percutaneous coronary intervention

U2 - 10.1016/j.ijcard.2016.07.101

DO - 10.1016/j.ijcard.2016.07.101

M3 - Article

VL - 221

SP - 1087

EP - 1094

JO - International journal of cardiology

JF - International journal of cardiology

SN - 0167-5273

ER -