Dataset Information

Mid-term outcomes of bioresorbable vascular scaffolds vs second-generation drug-eluting stents in patients with acute coronary syndromes: A systematic review and meta-analysis.

ABSTRACT:

Background

Everolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome data for BVS and second-generation drug-eluting stents (DES) in the treatment of acute coronary syndromes.

Methods

We searched PubMed, Embase, the Cochrane Library, Web of Science, and relevant web sites for studies with a follow-up of ? 1 years that studied percutaneous coronary interventions with BVS vs second-generation DES in acute coronary syndromes. A meta-analysis was performed with the software RevMan following the standards of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0.

Results

Five studies, 2 randomized controlled trials, and 3 observational studies, with a total of 1758 patients (BVS n?=?917; DES n?=?841) and a median follow-up duration of 24 months, were included. BVS, when compared with DES, resulted in higher rates of target lesion revascularization (TLR) (OR, 2.20; 95% CI, 1.12-3.64; P?=?.02) and stent/scaffold thrombosis (ST/ScT) (OR?=?2.35, 95% CI: 1.13-4.89, P?=?.02). When TLR due to device thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR: 1.67, 95% CI: 0.73-3.82, P?=?.22). The risk for all-cause death (OR?=?1.32 95% CI: 0.61-2.88, P?=?.48), cardiac death (OR?=?1.29, 95% CI: 0.58-2.86 P?=?.52), target vessel myocardial infarction (OR?=?1.50, 95% CI: 0.86-2.61, P?=?.15), and target lesion failure (OR?=?1.34, 95% CI: 0.76-2.35, P?=?.31) did not differ between BVS and DES groups.

Conclusion

At mid-term follow-up, BVS had a higher risk of TLR and ST/ScT than the second-generation DES in patients with acute coronary syndromes. ST/ScT was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.

SUBMITTER: Ke J

PROVIDER: S-EPMC7478480 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Publications

Mid-term outcomes of bioresorbable vascular scaffolds vs second-generation drug-eluting stents in patients with acute coronary syndromes: A systematic review and meta-analysis.

Ke Junsong J Zhang Hongyu H Huang Jun J Lv Ping P Yan Jumei J

Medicine 20200301 10

<h4>Background</h4>Everolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome ...[more]

PMID: 32150103

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Project description:BackgroundBioresorbable vascular scaffolds (BVS) were designed to reduce the rate of late adverse events observed in conventional drug-eluting stents (DES) by dissolving once they have restored lasting patency.ObjectivesCompare the safety and efficacy of BVS versus DES in patients receiving percutaneous coronary intervention for coronary artery disease across a complete range of randomised controlled trial (RCT) follow-up intervals.MethodsA systematic review and meta-analysis was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. MEDLINE, EMBASE and Web of Science were searched from inception through 5 January 2022 for RCTs comparing the clinical outcomes of BVS versus DES. The primary safety outcome was stent/scaffold thrombosis (ST), and the primary efficacy outcome was target lesion failure (TLF: composite of cardiac death, target vessel myocardial infarction (TVMI) and ischaemia-driven target lesion revascularisation (ID-TLR)). Secondary outcomes were patient-oriented composite endpoint (combining all-death, all-MI and all-revascularisation), its individual components and those of TLF. Studies were appraised using Cochrane's Risk of Bias tool and meta-analysis was performed using RevMan V.5.4.Results11 919 patients were randomised to receive either BVS (n=6438) or DES (n=5481) across 17 trials (differing follow-up intervals from 3 months to 5 years). BVS demonstrated increased risk of ST across all timepoints (peaking at 2 years with risk ratio (RR): 3.47; 95% CI 1.80 to 6.70; p=0.0002). Similarly, they showed increased risk of TLF (peaking at 3 years, RR: 1.35; 95% CI 1.07 to 1.70; p=0.01) resulting from high rates of TVMI and ID-TLR. Though improvements were observed after device dissolution (5-year follow-up), these were non-significant. All other outcomes were statistically equivalent. Applicability to all BVS is limited by 91% of the BVS group receiving Abbott's Absorb.ConclusionThis meta-analysis demonstrates that current BVS are inferior to contemporary DES throughout the first 5 years at minimum.

Project description:Objective To compare the efficacy and safety of bioresorbable scaffolds (BRS) with drug-eluting stents (DES) in patients with myocardial infarction undergoing percutaneous coronary interventions (PCI). Methods We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing BRS with DES on clinical outcomes with at least 12 months follow-up. Electronic databases of PubMed, CENTRAL, EMBASE, and Web of Science from inception to 1 March 2022 were systematically searched to identify relevant studies. The primary outcome of this study was the device-oriented composite endpoint (DOCE) consisting of cardiac death, target-vessel myocardial infarction, and target lesion revascularization. Secondary outcomes were a composite of major adverse cardiac events (MACE, all-cause death, target-vessel myocardial infarction, or target vessel revascularization) and the patient-oriented composite endpoint (POCE, defined as a composite of all-cause death, myocardial infarction, or revascularization). The safety outcomes were definite/probable device thrombosis and adverse events. Results Four randomized clinical trials including 803 participants with a mean age of 60.5 ± 10.8 years were included in this analysis. Patients treated with BRS had a higher risk of the DOCE (RR 1.62, 95% CI: 1.02–2.57, P = 0.04) and MACE (RR 1.77, 95% CI: 1.02–3.08, P = 0.04) compared with patients treated with DES. No significant difference on the POCE (RR 1.33, 95% CI: 0.89–1.98, P = 0.16) and the definite/probable device thrombosis (RR 1.31, 95% CI: 0.46–3.77, P = 0.61) were observed between BRS and DES. No treatment-related serious adverse events were reported. Conclusion BRS was associated with a higher risk of DOCE and MACE compared with DES in patients undergoing PCI for myocardial infarction. Although this seems less effective in preventing DOCE, BRS appears as safe as DES. Systematic review registration [https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=321501], identifier [CRD 42022321501].

Dataset Information

Mid-term outcomes of bioresorbable vascular scaffolds vs second-generation drug-eluting stents in patients with acute coronary syndromes: A systematic review and meta-analysis.

Background

Methods

Results

Conclusion

Publications

Mid-term outcomes of bioresorbable vascular scaffolds vs second-generation drug-eluting stents in patients with acute coronary syndromes: A systematic review and meta-analysis.

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