TCT 2018 was host to the release of data from numerous high-impact clinical trials in the cardiovascular space. Having had some time to digest the information and assess the response from the MedTech community, DRG’s cardiovascular analysts provide their take on the most discussed coronary trials below.

 

Made-in-India stents make waves on the global stage: the TALENT trial

In the era of rapidly decreasing stent costs worldwide, the act of balancing device innovation and improved patient outcomes with device affordability has come to the forefront of the MedTech space.

“Based on the results from the TALENT trial, which showed SMTs Supraflex SES to be non-inferior to the gold standard Xience DES in terms of DOCE at 12 months in an all comers population with a lower rate of clinically-indicated TLR in the per-protocol analysis, there will certainly be some change in the competitive landscape in a few countries. Sahajanand Medical Technologies (SMT), with its direct selling capabilities and stronghold on the Indian market, is now ready to expand into more regions. I believe that the results from the TALENT trial could be instrumental in improving PCI penetration in emerging countries in APAC, ASEAN and LATAM region, particularly in countries such as India where there is a price cap on stents, as well as some European countries that follow different models of health care cost savings.” Megha Maheshwari

 

“SMT had one of the larger booths at TCT 2018, and it is clearly making a push for Supraflex SES on the back of the TALENT trial results. I’m curious as to how the existing players in the coronary stent space will respond, especially in more cost-sensitive emerging markets where SMT will represent a very attractive option.” Michael Tian

 

 

Physiology beyond the pressure-wire: emerging technology in the diagnostic space

Assessment of flow physiology remains the gold standard to answer the question of whether or not to treat a lesion. Direct measurements of physiology through pressure wires is the standard of care, but remains underpenetrated in clinical practice due to the associated procedural costs and additional procedural time.

“Non-invasive and computation calculations of FFR have arrived. Heartflow’s non-invasive FFRCT technology looks to be a big hit at TCT 2018, and Canon’s system has gotten a few mentions in these sessions as well. This technology will likely drive more patients out of the cath lab for diagnostics and subsequently into medical treatment over intervention.

Likewise, Medis Medical’s QFR and CathWork’s FFRangio look poised to move into the cath lab workflow by calculating FFR through angiograms. These software-based solutions can be incorporated into existing systems, which will be attractive to admins. Furthermore, if interventionalists are seeing equivalence in sensitivity, specificity, and accuracy as FAST-FFR showed, but with improvements in procedural time without the need to put in pressure wires, the sky will be the limit for these technologies. In fact, procedure codes for both FFRCT and FFRangio have been added this year, and will be trackable by regulatory agencies. To me, this is a clear signal of intent by all parties to get the ball rolling on these technologies that will likely represent cost savings to providers and patients alike.” Michael Tian

 

 

Can polymer-free stents free us from stent complications?

Several manufacturers have been developing polymer-free stent technology in recent years to tackle the issues of dual-antiplatelet therapy (DAPT) duration and stent thrombosis in patients. While the newest generation of DES have seen greatly reduced complication rates in many landmark clinical trials, the idea of a polymer-free solution that can aid in healing and revascularization remains attractive to practitioners and patients alike.

“Two of the trials (LEADERS FREE II and SORT OUT IX) involved Biosensors International’s BioFreedom polymer-free biolimus-coated stent. While LEADERS FREE II confirmed the superiority of BioFreedom to traditional BMS in safety and efficacy in high bleed risk patients, it failed to meet non-inferiority criteria against BIOTRONIK’s Orsiro DES in an all-comers patient population in SORT OUT IX. 

I think LEADERS FREE had already put the BMS discussion to bed, but LEADERS FREE II interested me more in that it was a single-arm pivotal study, since there was no mandate for randomization due to the ethical ramifications of offering the inferior BMS to patients in a second arm. So basically what we’ve seen with BioFreedom is that there was the definitive prospective trial (LEADERS FREE) largely conducted in centers outside the US, while the pivotal trial only had to be single-arm and was conducted in a North American setting. The fact that BioFreedom can use these results to seek regulatory approval in the US might be of interest to other competitors in this space looking to streamline the regulatory process in a complicated region.

Whether the BioFreedom will be gaining significant procedural penetration beyond the high bleed risk patient population is more debatable, especially given the results of SORT OUX IX. Several panelists didn’t seem convinced over whether they needed to switch over from existing DES due to the better efficacy and thinner struts of those devices, though the potential for shorter DAPT duration is likely to be attractive to some.” Michael Tian

 

Long-term follow up on ABSORB: what does the future hold for bioresorbable stents?

After Abbott’s ABSORB GT1 was pulled from global markets in late 2017, the initial promise of bioresorbable stents appeared to lose some of its luster. However, TCT 2018 offered both long-term data from the comprehensive ABSORB trials, as well as some new promise from many competitors still on the forefront of developing this technology.

“ABSORB IV at 1-year showed that both Absorb BVS and Xience DES outcomes can be improved with more attention to implantation technique, especially with the first-generation Absorb scaffold. Although non-inferiority was met in high-risk and complex lesions, scaffold thrombosis and myocardial infarction rate for Absorb BVS was significantly higher compared to Xience DES.” Megha Maheshwari

 

“While the implantation techniques improved, it didn’t overcome the other issues such as device thrombosis rates and target lesion failure. At present, Absorb BVS does not have an advantage over Xience. However, the BVS technology is still worth moving forward with because the real benefit will be when the scaffold gets absorbed and the artery vessel returns to normal functionality. While we might not see Absorb anytime soon, BIOTRONIK’s Magmaris is making waves with positive clinical outcomes.” Nithu Mariya Johnson

 

"Moving beyond these first-generation bioresorbable stents, we’re looking at a sea of devices with variations in technology and technical specifications. At the very least, the ABSORB trials have put the emphasis on proper implantation technique and the importance of minimizing the stent footprint in terms of strut thickness and width. Many of the trials involving BRS in development—such as Amaranth Medical’s APTITUDE, FORTITUDE, and MAGNITUDE, Meril Lifesciences’ MeRes 100, Reva Medical’s FANTOM, and a host of other Chinese BRS—have shown promising early results. Nevertheless, the technology is still in its early stages, and remains an attractive idea for interventionalists.” Michael Tian

 

 

Follow DRG’s Cardiovascular Experts on Twitter for more insights on Interventional Cardiology device markets: @cuspcancerleo, @MikeT_DRG, @nithu_22

 

 

 
Megha Maheshwari

Principal Analyst, Cardiovascular Medtech Insights

 Michael Tian

Senior Analyst, Cardiovascular Medtech Insights

 Nithu Mariya Johnson

Research Associate, Cardiovascular Medtech Insights

 

Update: The discussion on the SORT OUT IX trial has been updated to reflect corrections to the results of this trial as it was presented at TCT 2018. The identified error reversed the trial’s original primary endpoint finding that the BioFreedom was noninferior to Orsiro.

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