This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 Cardiac death from cardiogenic shock after the procedure was reported in 1 patient in a case series of 11 patients despite percutaneous coronary intervention (PCI) and inotropic support.
5.2 Definite or probable in-stent/scaffold thrombosis occurred in 2 patients with bioresorbable stents and 1 patient with a drug-eluting stent during the index procedure, and in another patient in each group within 30 days after stent implantation, in the comparative case series of 253 patients.
5.3 Sub-acute scaffold thrombosis was observed in 2 patients (1 on day 6 at the site of overlapping scaffolds, and 1 on day 27 after discontinuation of dual antiplatelet therapy) in a case series of 450 patients. Late scaffold thromboses occurred in 2 patients (1 on day 75 in a patient with resistance to clopidogrel and 1 on day 239) in the same case series.
5.4 Scaffold dislodgement was reported in 3 patients in the case series of 450 patients. All scaffold dislodgements occurred in the left circumflex, and in 2 patients dislodgement was observed after reinsertion of the same device.
5.5 Destruction of scaffold after balloon dilatation (not apparent on cineangiography) was reported in 1 patient in a case series of 44 patients. Further details were not reported.
5.6 The specialist advisers stated that theoretical adverse effects are the same as for other forms of PCI and include dissection, perforation of coronary vessels, acute myocardial infarction, late or very late thrombosis and restenosis. One adviser stated that there is a theoretical possibility of device hypersensitivity with polymer-based stents.