Re-evaluation of coronary stents in France

In May 2018, the French National Authority of Health, HAS, has published an update of the assessment of coronary stents.

The authors have published this paper in order to assess stents with the active release, stents coated with a non-pharmacologically active substance called "non-active stents," stents without coating metal ("bare stents") as well as those covered with a synthetic polytetrafluoroethylene membrane (“stents covered with PTFE”). The purpose of the re-evaluation is to update the indications for management and the prescription and use conditions of active, bare, non-active stents and stents covered with a synthetic membrane.

The authors have performed a systematic review of the literature found on Medline, Cochrane Library, other websites publishing guidelines or HTA reports, and on websites of competent medical societies. Only publications dating 2009-2016 were included in this review. Eventually, fifty-seven (57) publications that describe the safety and efficacy of coronary stents were incorporated.

Stents vs optimal medical treatment

The clinical situation concerned is that of disabling angina not responding to medical treatment. The data relate exclusively to active stents (2 superiority tests XIENCE, RESOLUTE, BIOMATRIX or NOBORI). The results show an 80% reduction in the risk of new hospitalization for revascularization with active stents without any difference regarding death or quality of life up to 2 years (approximately 13,000 patients in total). Current recommendations for the place of angioplasty versus medical treatment are not assessed.

Stents vs coronary bypass

The clinical situation concerned is stenoses involving more than 50% of coronary vessels and / or the left common trunk in order to treat the ischemic stroke. The data relate exclusively to active stents (3 trials of non-inferiority with a total of approximately 3,000 patients and 1 real-life study of 9,000 patients matched on propensity score evaluating XIENCE and BIOMATRIX ranges). The results show a risk of new hospitalization for revascularization 1.5 to 2.4 times higher with PCI compared to coronary bypass without concordant results between studies in terms of occurrence of IDM, death, stroke (approximately 1,000 patients in total). Current recommendations for the place of the coronary bypass is not assessed because available follow-up (3 years) is not sufficient to evaluate the benefit of angioplasty with active stent implantation.

Drug-eluting stents versus bare metal stents of equivalent generation

The clinical situation concerned is >50% stenosis, in case of stable disease or of the lesion(s) of an SCA with the aim of improving the vital prognosis. The data are only experimental and heterogeneous for population with low risk of bleeding comparing the XIENCE, PROMUS, RESOLUTE, NOBORI, BIOMATRIX, YUKON ranges to bare or non-active stents range TITAN or ENERGY (9 superiority trials in about 20,000 patients up to 6 years of follow-up) and to population at risk haemorrhagic comparing XIENCE and BIOFREEDOM ranges to bare stents (2 trials in approximately 3000 patients followed 1 year). Nevertheless, patients with complex lesional features are included in these studies (e.g. multi-node, bifurcation, STA-SCA, intrastent restenosis, total chronic occlusion, proximal IVA, or stenosis). The results are consistent between the analyzed populations with or without hemorrhagic risk. They are all in favour of active stents in terms of reducing the risk of new revascularization of the area already stented (between 50 and 70% at 1 year with maintenance after 1 year) and the occurrence of a new MI (between 20 and 50% at 1 year without support after 1 year). The risks of significant bleeding or stroke are poorly evaluated, and no difference between active and naked or non-active is observed at 1 year.

Stents covered with a synthetic membrane in the event of an accident related to angioplasty such as perforation or coronary rupture

The data are limited to case series of about 100 patients from single-center European and North American clinical trials (the number of reported implanted units ranging from 1 to 3 per patient). PTFE covered stents are part of the treatment options for the management of coronary artery perforations or ruptures, which are life-threatening complications in minutes.

See the full report in French here. See everything about the topic (notice documents, additional documents etc.) here.

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