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 language | English |
|---|---|
| Pages (from-to) | 1087-1094 |
| Journal | International journal of cardiology |
| Volume | 221 |
| DOIs | |
| Publication status | Published - 2016 |
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Keywords
- IR-100906
- METIS-317451
- Bioresorbable vascular scaffold
- Biodegradable device
- Everolimus-eluting stent
- Stent thrombosis
- Percutaneous coronary intervention
Cite this
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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 journal › Article › Academic › peer-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 -