The BVS was expected to represent fourth revolution in interventional cardiology as it offers a new technology by transient scaffolding the vessel and eluting an antiproliferative drug [13].
Cohort B study, which tested the second generation of BVS, showed a MACE rate of 9.0% [17]. The follow-up after 3 years in ABSORB II revealed a higher rate of target lesion failure (TLF) in the BVS group (7%) [6].
A safety alert was issued after Food and Drug Administration (FDA) reviewed the 2-year data from the ABSORB III trial showing a rate of 11% in major cardiac events in patients treated with BVS in comparison to a rate of 7.9% in patients treated with Everolimus eluting stent (EES) [16].
Thrombosis was the key limitation of the BVS. This was very evident in the Absorb II trial. Specifically, 6 events occurred beyond the first year. The analysis of the 6 cases showed that the main reasons of such events were very late scaffold thrombosis and undersized scaffolds [3].
Amsterdam Investigator-Initiated Absorb Strategy All-Comers Trial (AIDA) found that there was no significant difference in the rate of target-vessel failure (TVF) between the BVS group and the stent group. There was a higher incidence of device thrombosis with BVS throughout the 2-year follow-up period [20].
Optimal management for BVS failure is still a topic for research. Different coronary devices were used to address this issue. Restenosis was successfully managed by percutaneous balloon angioplasty (POBA) and DCB [11] [7, 9].
The FDA recommended the PSP technique for BVS implantation. This technique includes 3 steps: the first step is the lesion preparation with a 1:1 balloon-to-artery ratio using a non-compliant balloon. The second step is the appropriate sizing of the vessel with liberal use of intravascular imaging or quantitative coronary angiography (QCA). The third step is the postdilatation to high pressure using a non-compliant balloon up to 0.5 mm above nominal scaffold diameter. The operators were also advised to use the BVS in vessels with a reference diameter of ≥ 2.5 mm and ≤ 3.75 [18].
There are a number of advantages in DCBs make them of great use in SB management in the setting of bifurcation PCI. First, the homogeneous administration of the drug; second, high concentrations of drug are delivered into the vessel wall at the moment of injury; third, original anatomy of the carina is respected [2].
Early experiences have shown how leaving a dissection after plain old balloon angioplasty was associated with increased rates of thrombotic events, early reocclusion, and recurrence of restenosis, and this was one of the main indications for the use of stents in an earlier era. Paclitaxel, when correctly delivered to the vessel wall, may have a role in facilitating the healing of coronary vessels. If the dissection is of low-medium grade, it seems safe to leave it untreated. In fact, data from the literature show how any stent strategy associated with DCB use is unsafe or yields unsatisfactory results. In a consecutive series of patients treated with new-generation DCB for native coronary artery disease and with a final non-flow-limiting dissection, these lesions tended to heal despite their initial severity. After DCB angioplasty, a strategy of bailout stenting should be reserved to more severe, flow-limiting dissections, and in our study, all the dissections were non-flow-limiting, so no DES were needed [5].
In the time-varying outcomes with the absorb bioresorbable vascular scaffold during a 5-year follow-up: a systematic meta-analysis and individual patient data pooled study
Target lesion failure occurred in 11.6% of BVS-treated patients vs 7.9% of EES-treated patients between 0 and 3 years (HR, 1.42; 95% CI, 1.12–1.80), and 4.3% of BVS-treated patients vs 4.5% of EES-treated patients between 3 and 5 years (HR, 0.92; 95% CI, 0.64–1.31) (P for interaction = .046). Device thrombosis occurred in 2.4% of BVS-treated patients vs 0.6% of EES-treated patients between 0 and 3 years (HR, 3.86; 95% CI, 1.75–8.50) and 0.1% of BVS-treated patients vs 0.3% of EES-treated patients between 3 and 5 years (HR, 0.44; 95% CI, 0.07–2.70) (P for interaction = .03). This study shows that despite the worse performance of the BVS as regards TLR and scaffold thrombosis over 0–3 years, their performance was non-inferior to DES or even better as regards TLR and thrombosis over 3–5 years. This gives a hope for the return of the BVS to routine clinical practice after overcoming the technical and procedural issues that influence its safety and efficacy [19].
The idea of “leaving nothing behind” after PCI is a very exciting concept in modern interventional cardiology especially in bifurcation lesions. This dream started to come true with the introduction of BVS and DCB to the field of interventional cardiology which are still understudied and they open the door for further research in these technologies.