Meta-Analysis Comparing Outcomes After Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Metallic Stents in Patients with Acute Coronary Syndromes

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Acute coronary syndromes (ACS) may represent an intriguing clinical scenario for implantation of bioresorbable vascular scaffold (BRS). Nevertheless, the knowledge about the performance of these devices in patients with ACS is limited. Therefore, we performed a meta-analysis of clinical studies aiming to assess the safety and efficacy of everolimus-eluting-BRS versus everolimus-eluting-metallic stents (EES) in ACS patients undergoing percutaneous coronary intervention. Six studies enrolling 2,318 patients were included and analyzed for the risk of primary safety outcome (stent or scaffold thrombosis [ST/ScT]), primary efficacy outcome (target lesion revascularisation [TLR]), and secondary outcomes (myocardial infarction, cardiac death, all-cause death). Median follow-up was 9.5 (6 to 19.5) months. Patients treated with BRS had a significantly higher risk of definite ST/ScT compared with those receiving EES (2.3% vs 1.08%, odds ratio [OR] 2.22, 95% confidence interval [CI] 1.10 to 4.45, p = 0.03, I2 = 0%). Similarly, the risk of TLR was significantly higher in the BRS compared with EES group (3.5% vs 2.5%, OR 1.79, 95% CI 1.02 to 3.16, p = 0.04, I2 = 0%). When TLRs due to thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR 1.19, 95% CI 0.48 to 2.98, p = 0.71, I2 = 25%). Risk for secondary endpoints did not differ between the 2 groups. Results were confirmed when clinical and procedural variables were tested as potential effect modifiers in the meta-regression analysis for both primary endpoints. In conclusion, compared with those receiving EES, patients with ACS treated with BRS had increased risk of definite device thrombosis and TLR at mid-term follow-up.

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Methods

This study was designed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement.14 A comprehensive MEDLINE, COCHRANE, ISI Web of Sciences, and SCOPUS search was conducted until November 15, 2017, using the following medical subject headings alone and in different combinations: “bioresorbable stent(s)”, “Absorb stent(s)”, “Everolimus-eluting stent(s)”, “acute coronary syndromes”, and “acute myocardial infarction”. Reference lists from all eligible studies

Results

Figure 1 shows the flow diagram of the study selection process. Six studied enrolling 2,318 patients with ACS who underwent PCI with either everolimus-eluting bioresorbable vascular scaffold (n = 1022) or everolimus-eluting metallic stents (n = 1296) implantation were included. Design and characteristics of the included studies are reported in Table 1. One randomized trial15 and 5 observational studies16, 17, 18, 19, 20 were included. When studies reported results from both unmatched and

Discussion

To the best of our knowledge, this is the first meta-analysis specifically investigating the efficacy and safety of everolimus-eluting BRS versus everolimus-eluting metallic stents in patients presenting with ACS. In line to what observed from clinical studies and meta-analyses performed on patients who underwent routine PCI, our results confirmed in the ACS setting a higher risk of device-failure in patients treated with BRS and support the pivotal role of device thrombosis in determining the

Disclosures

The authors have no conflicts of interest to disclose.

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