Results of the 30-day ABSORB IV, 3-year ABSORB III and 4-year ABSORB II Late Breaking Trials: TCT 2017

Reported from the TCT 2017 Scientific Sessions in Denver, United States

After the presentation of the data coming from 30-day ABSORB IV, 3-year ABSORB III and 4-year ABSORB II, the interventional cardiology community is even more divided into those in favor or not of Bioresorbable Scaffold (BRS) technology. Many interesting points of discussion arise from these data.

When looking at the 30-day results of the ABSORB IV trial, use of a standardized PSP technique seems to have played a role in reaching the primary endpoint of no-inferiority of the ABSORB vs. Xience arm. However, many other findings are difficult to explain. Rate of scaffold thrombosis and TLR indeed seem still higher in the ABSORB than in Xience arm and only restricting the analysis to those patients with ABSORB-III like characteristics, some role of optimal implantation technique can be seen in reducing scaffold thrombosis (from 1.1% of the ABSORB III to 0.4% in the ABSORB IV at 30-days).

However, despite the optimal implantation technique, a lower final MLD was present in the ABSORB vs. Xience arm; for this reason, it should be determined if implantation techniques should be further improved (e.g. mandatory post-dilatation and use of intravascular imaging in all the patients) or if it is time to think about some improvements in the mechanical properties of the bioresorbable platform, making it comparable to a metallic platform.

In the 3-year data of ABSORB III, a trend towards a higher rate of TLF in the ABSORB arm as compared to the Xience arm (13.4% vs. 10.4%) was shown, with a significantly higher rate of device thrombosis (2.3% vs. 0.7%). Although these results were not surprising given the previous 2-year data, it is interesting to see that this scaffold thrombosis rate is consistent with that of the 3-year ABSORB II data. As the optimal implantation technique was still evolving during both ABSORB II or ABSORB III initiation and enrollment, it may represent a common pattern explain this consistency in scaffold thrombosis rate between the two studies.

4-year ABSORB II data showed a higher rate of target lesion failure (11.1% vs. 5.6%) in the ABSORB vs. Xience arm. However, this finding should be considered hereditary from the 3-year follow-up; by looking at the landmark analysis from 3 to 4-years, it seems that not many events were present in any of the two groups with in particular a 0% rate of stent/scaffold thrombosis. Although this does not represent the beginning of a clinical benefit, it may be interpreted at least as the end of the increasing risk of events seen so far with ABSORB as compared to Xience.

As benefits of BVS would lie not in the short term, but rather beyond 3 years when, theoretically, the scaffold is gone, the 4-year data of ABSORB II may help us to understand in which direction we should go. ABSORB III and IV will be pooled together to analyze a final primary endpoint of TLR landmark between 3 and 7-10 years. We therefore still need to wait many years before understanding if a clinical benefit  - beyond its bioresorption - can come from BRS technology.

1 comment

  • marcelo ribeiro 03 Nov 2017

    It really leaves us with mixed feelings... I guess, as an interventional cardiologist who has used the Absorb device in real world patients, the feeling of putting a temporary cage is unmatchable by the current metallic stent technology, especially in case of very long lesions or ACS patients. Also the satisfaction of the patients was great, knowing they would not be carrying forever a foreign body. Obviously we also experienced the limitations of the device, the thick struts caused more biomarker elevation , the frailty of the device architecture restricted its use to less complex bifurcations, for example, and above all we are anxious about overcoming the 3 year follow up in our patients. But we remain cautiously hopeful for the future.

Disclaimer

This case report does not reflect the opinion of PCR or PCRonline, nor does it engage their responsibility.

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