TALENT: Indian-Made Supraflex DES Flexes Muscle Against Xience

Patrice Wendling

September 23, 2018

SAN DIEGO — The ultrathin Supraflex sirolimus-eluting stent made in India hit its primary noninferiority endpoint against the workhorse Xience everolimus-eluting stent in an all-comers patient population in the TALENT trial.

At 12 months, the composite endpoint of cardiac death, target-vessel myocardial infarction (MI), and clinically indicated target-lesion revascularization (TLR) occurred in 4.9% of patients treated with Supraflex (Sahajanand Medical Technologies) and 5.3% treated with Xience (Abbott Vascular).

This met the noninferiority margin of 4% (P < .001), but even when this "somewhat generous margin" was dropped to 2.12%, "the P value is still there; so very robust type of data," study chair Patrick W. Serruys, MD, PhD, Imperial College London, United Kingdom, and Erasmus University, Rotterdam, the Netherlands, said here at Transcatheter Cardiovascular Therapeutics (TCT) 2018.

A per-protocol analysis showed no significant differences between Supraflex and Xience in the primary endpoint components of cardiac death (7 vs 2 events) and MI (14 vs 19 events) but did show a 61% relative reduction for TLR favoring Supraflex (8 vs 21; log-rank P = .021).

"The study results have important implication in countries with capped stent prices, such as India, and in some European countries with competitive pricing and different models of healthcare cost savings," he said in the late-breaking trial session.

"Market competitiveness may influence future decisions on which stent to use."

Serruys noted that the Indian government capped stent prices in February 2017, dropping the price of drug-eluting stents (DES) from $1800 to $440 and bare-metal stents (BMS) from $670 to $110. The Indian stent market is expected to become the second largest international market after China by 2020, growing about 15% annually with 550,000 stents sold each year.

Panelist David Kandzari, MD, director of interventional cardiology and interventional research at Piedmont Heart Institute, Atlanta, Georgia, told theheart.org | Medscape Cardiology the study demonstrated clinical parity between stents but has implications independent of India because the average selling price of DES has eroded more than 60% since their introduction to the US marketplace and declined annually by 5% over the past 5 years alone.

"So when we think about innovation and studies to lead to new drug-eluting stents, the enthusiasm from the clinical community is offset by the costs of doing so from the sponsor/manufacturer perspective of loss of return on investment because the cost estimates for a new drug-eluting stent exceed $200 to $250 million," he said.  

Commenting further, Kandzari said, "The other issue is that outcomes today with our existing drug-eluting stents are so good, the opportunity to demonstrate an incremental benefit becomes increasingly challenging."

Sunil Rao, MD, Duke University Medical Center, Durham, North Carolina, made similar remarks in a press conference.

"We've already seen some manufacturers introduce very-low-cost drug-eluting stents in the US, and I think that's going to continue to push prices downward," he said. "It will be interesting, I think, to see what kind of impact that has on overall innovation in interventional cardiology because for many of these companies, stents are still the major source of revenue."

TALENT was conducted at 23 centers in seven European counties and randomly assigned 1435 patients (mean age, 65 years) with any ischemic coronary syndrome to the Supraflex (n = 720; 1046 lesions) or Xience (n = 715; 1030 lesions) stent.

About 60% of patients presented with acute coronary syndrome and 40% with stable angina. The two groups were well balanced, save for slightly more patients with prior bypass surgery in the Xience arm (7.7% vs 4.6%).

Supraflex is a cobalt-chromium stent with a highly flexible "S-link" interconnector, ultrathin struts (60 microns) across all diameters (2.0 to 4.5 mm), and a biodegradable polymer matrix, Serruys said. An initial burst releases 70% of the sirolimus within 7 days, with sustained release up to 48 days.

The device success rate (per lesion) was 97.6% with Supraflex and 99.5% with Xience (P = .0003). The 97.6% rate is quite similar to what was seen in other trials, such as RESOLUTE, TWENTE, and BIOFLOW V, he noted.

There were 21 crossovers in the Supraflex arm. "They were clustered in 7 of the 23 centers, and some investigators had a tendency to quickly cross over to more familiar stent technology," said Serruys.

Panelist Andreas Baumbach, MD, Barts Heart Centre, London, United Kingdom, asked about the deliverability of the stent and whether the crossovers were a cultural or technical issue.

Serruys replied, "The profile is one of the smallest that we have on the market, so it's not related to the profile. Flexibility of the device is excellent. The pushability is maybe an issue, but as soon as there was some resistance, even if they had three lesions to do, they achieved for the three lesions."

Panelist Francesco Prati, MD, San Giovanni Hospital, Rome, Italy, followed up by remarking the he would "have expected perhaps better  results in a setting of acute coronary syndrome due to the fact the struts are very thin."

Serruys said, "If there is one signal, which to me I think is quite unusual to find, is a signal in clinically indicated TLR…. It's small numbers, 8 vs 21, a 61% reduction, but if I had to do the exercise, I would amplify that signal in a multivessel-disease trial because then maybe it will emerge."

"In terms of acute coronary syndrome, I don't think we have any signal there."

The study was sponsored by the European Clinical Research Institute. Statistical analysis was performed by Cardialysis. Serruys reports receiving research support from Abbott and consulting fees/honoraria from Biosensors, Medtronic, Micell, Sinomedical Sciences Technology, Philips/Volcano, Xeltis, and HeartFlow, Kandzari reports institutional research grant support from Boston Scientific, Biotronic, Medtronic, and Cardinal Health and personal consulting honoraria from Boston Scientific, Biotronic, and Medtronic. Rao reports having no relevant financial relationships. Prati reports consultant fee/honoraria/speaker's bureau relationships with St. Jude, now Abbott. Baumbach reports grant support or research contracts with Abbott Vascular and consultant fee/hononoraria/speaker's bureau relationships with AstraZeneca, Microport, and Sinomed.

Transcatheter Cardiovascular Therapeutics (TCT) 2018. Presented September 22, 2018.

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