The promise of leaving nothing behind — And how to manage its failure




Until a few years ago, the world of percutaneous coronary intervention (PCI) was clear and simple: coronary arteries require metallic stent implantation with controlled release of rapamycin analogues. Stents were introduced to cover flow-limiting dissections . Later on, it was realized that stenting creates more favorable acute results and reduces restenosis compared to angioplasty alone . Stents became standard of care despite the fact that a provisional stent rate of 20% to 40% would have been appropriate .


Interventional cardiologists trust in routine stent implantation to avoid acute vessel closure, ignoring the fact that the problem of acute and subacute stent thrombosis was relevant and predominantly solved by dual antiplatelet therapy . Drug eluting stents (DESs) were introduced to improve long-term outcome of stent implantation in reducing in-stent (re)stenosis (ISR). After early enthusiasm about a potential cure of restenosis , ISR was still present. In case of DES-ISR, two treatment options proved beneficial: the implantation of a second DES or repeated angioplasty followed by local drug delivery with a drug coated balloon (DCB) . In some of the trials, the stent-in-stent approach was associated with better angiographic outcomes at one year whereas there are hints on better long-term outcomes in hard clinical endpoints when using DCB .


A major concern with permanent implants represents neo-atherosclerosis resulting in a long-term risk of stent thrombosis at low numbers, but indefinite . Therefore, the idea of avoiding permanent implants seems to be attractive. Two approaches for this concept of ‘leaving nothing behind’ are available for clinical use (outside the US): DCB and bioresorbable vascular scaffolds (BVSs). Percutaneous coronary angioplasty (PTCA, POBA) has been improved by new balloon technologies and specialty balloons creating controlled dissections and improve acute gain. Dual antiplatelet therapy may reduce the risk for acute vessel closure. Local drug delivery by DCB addresses restenosis and allows for luminal gain over time . But as long as there are no large randomized controlled trials on the concept of ‘DCB only’ in coronary de-novo disease, the majority of interventional cardiologists will insist on primary stenting.


BVSs promised to become the final solution for PCI when combining the short- and midterm-advantages of metallic DESs with the disappearance of the long-term issues of the permanent implant . Back in reality there are increased scaffold thrombosis rates especially at longer follow-up times . In contrast to thrombosis, restenosis of BVSs seems to be comparable to metallic DESs . Frequently BVS restenosis occurs when the mechanical integrity of the scaffold starts to disappear. This situation may be the case for another BVS or a metallic DES. However, two layers of BVS mean a reduction of vessel diameter of 0.6 mm in case of a 150 μm BVS. On the other hand, a metallic DES does not follow the concept of leaving nothing behind. Therefore, the use of DCB or even POBA has been discussed . The paper by Elwany et al. reports a series of 9 patients with BVS restenosis undergoing treatment with three different types of DCB (Mostafa Elwany, Roberto Adriano Latini, Gaetano Di Palma, Pedro Silva Orrego, Bernardo Cortese’Correspondence information about the author Bernardo Cortese. First experience of drug-coated balloons for treatment of bioresorbable vascular scaffold restenosis. ). Late lumen loss of 0.68 ± 0.7 mm was similar to POBA; 2 of 9 patients underwent repeated TLR. In this series, number of patients was low and only three patients underwent treatment with a DCB having positive data from a randomized trial . Therefore, it is hard to draw any conclusions from this data set on the impact of DCB for the treatment of BVS failure.


Larger randomized trials are mandatory to identify the best treatment option for this clinical scenario (re-BVS, metallic DES, DCB, or even POBA). However, the total frequency of BVS restenosis will depend on its further use in clinical routine. At the time of writing this manuscript concerns on BVS thrombosis led to a more or less complete withdrawal of the Absorb BVS from the European market.



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Nov 13, 2017 | Posted by in CARDIOLOGY | Comments Off on The promise of leaving nothing behind — And how to manage its failure

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