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BACKGROUND: To eliminate some of the potential late limitations of permanent metallic stents, the bioresorbable coronary stents or 'bioresorbable vascular scaffolds' (BVS) have been developed. METHODS: We reviewed all currently available clinical data on BVS implantation. RESULTS: Since the 2015 position statement on the appropriateness of BVS in percutaneous coronary interventions, several large randomised trials have been presented. These have demonstrated that achieving adequate 1 and 2 year outcomes with these first-generation BVS is not straightforward. These first adequately powered studies in non-complex lesions showed worse results if standard implantation techniques were used for these relatively thick scaffolds. Post-hoc analyses hypothesise that outcomes similar to current drug-eluting stents are still possible if aggressive lesion preparation, adequate sizing and high-pressure postdilatation are implemented rigorously. As long as this has not been confirmed in prospective studies the usage should be restricted to experienced centres with continuous outcome monitoring. For more complex lesions, results are even more disappointing and usage should be discouraged. When developed, newer generation scaffolds with thinner struts or faster resorption rates are expected to improve outcomes. In the meantime prolonged dual antiplatelet therapy (DAPT, beyond one year) is recommended in an individualised approach for patients treated with current generation BVS. CONCLUSION: The new 2017 recommendations downgrade and limit the use of the current BVS to experienced centres within dedicated registries using the updated implantation protocol and advise the prolonged usage of DAPT. In line with these recommendations the manufacturer does not supply devices to the hospitals without such registries in place.
RESUMEN
OBJECTIVES: To investigate one-year outcomes after implantation of a bioresorbable vascular scaffold (BVS) in patients presenting with acute coronary syndrome (ACS) compared to stable angina patients. BACKGROUND: Robust data on the outcome of BVS in the setting of ACS is still scarce. METHODS: Two investigator initiated, single-center, single-arm BVS registries have been pooled for the purpose of this study, namely the BVS Expand and BVS STEMI registries. RESULTS: From September 2012-October 2014, 351 patients with a total of 428 lesions were enrolled. 255 (72.6%) were ACS patients and 99 (27.4%) presented with stable angina/silent ischemia. Mean number of scaffold/patient was 1.55±0.91 in ACS group versus 1.91±1.11 in non-ACS group (P=0.11). Pre- and post-dilatation were performed less frequent in ACS patients, 75.7% and 41.3% versus 89.0% and 62.0% respectively (P=0.05 and P=0.001). Interestingly, post-procedural acute lumen gain and percentage diameter stenosis were superior in ACS patients, 1.62±0.65mm (versus 1.22±0.49mm, P<0.001) and 15.51±8.47% (versus 18.46±9.54%, P=0.04). Major adverse cardiac events (MACE) rate at 12months was 5.5% in the ACS group (versus 5.3% in stable group, P=0.90). One-year definite scaffold thrombosis rate was comparable: 2.0% for ACS population versus 2.1% for stable population (P=0.94), however, early scaffold thromboses occurred only in ACS patients. CONCLUSIONS: One-year clinical outcomes in ACS patients treated with BVS were similar to non-ACS patients. Acute angiographic outcomes were better in ACS than in non-ACS, yet the early thrombotic events require attention and further research.