TALENT trial shows equivalence of Indian stent SUPRAFLEX with the market leader Xiance
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Dr Upendra Kaul, Chairman Cardiology BHMRC co-chairs a path breaking study
In the first randomized trial of an Indian-made stent versus the best-in-class Xience stent (Abbott) conducted in Europe, the Supraflex sirolimus-eluting stent (SMT; Surat, India) proved itself to be a worthy competitor in results presented here at TCT 2018.
In the TALENT trial, the rate of a device-oriented composite endpoint of cardiac death, target-vessel MI, and clinically indicated TLR at 12 months was 4.9% with Supraflex and 5.3% with Xience, a difference that met criteria for noninferiority (P < 0.001), study chair Patrick Serruys, MD, PhD (Imperial College London, England, and Erasmus University, Rotterdam, the Netherlands), reported.
Though there were no significant differences between groups for any of the components of the composite outcome, a per-protocol analysis suggested that TLR might be lower with Supraflex, which is not available in the United States but has received CE Mark approval in Europe.
“The study results have important economic implications in countries with capped stent prices such as India, and in some European countries with competitive pricing and different models of healthcare cost savings,” Serruys said.
“Since clinical outcomes of contemporary drug-eluting stents are reaching a safety plateau, it is likely that cost-effectiveness will influence, in the near future, the stent market,” he added.
Giulio Stefanini (Humanitas University Rozzano, Milan, Italy), who served as a panelist during Serruys’ presentation, agreed. “I think the cost-effectiveness will certainly play a role in the future in the decision of which device to pick in our cath labs,” he said. “What I want to stress is the importance of having adequate clinical data to support the use of a cheaper device, and studies like this one are very important because we cannot just use a device because it’s cheaper. We need to have a randomized controlled trial that shows noninferior efficacy as compared to standard of care. I think that this is a very important message, because we Europeans will have more and more CE marked products that do not have adequate evaluation in terms of safety and efficacy, so we need these kinds of trials.”
Vigorously Testing Indian-Made Stents
Serruys provided some background on the use of coronary stents in India, pointing out that about 550,000 stents are used there annually, with the market growing by about 15% each year. In fact, India is expected to become the second-largest international market after China in the next few years.
In February 2017, the Indian government decided to cap prices on coronary stents: at $440 for DES and $110 for BMS (in US dollars). That represents a dramatic reduction in prices, from an average of $1,800 for DES and $670 for BMS.
At that time, TALENT co-chair Upendra Kaul, MD (Batra Hospital and Medical Research Center, New Delhi, India), told TCTMD, use of Indian-made stents increased. However, as he also highlighted in a June 2017 editorial in EuroIntervention, there remained a perception that stents produced outside of India were superior to homegrown devices. Kaul called for Indian manufacturers to prove that their devices are comparable to those made elsewhere in robust clinical trials.
TALENT is the first such trial to yield results. It was designed as a noninferiority trial to compare the sirolimus-eluting Supraflex—which has ultrathin struts (60 microns) and a biodegradable polymer—with the everolimus-eluting, durable-polymer Xience. Investigators enrolled 1,435 patients from 23 centers in seven European countries. It was an all-comers population, with about 40% of patients presenting with stable angina and 60% with ACS. Mean patient age was 65 years, and about three-quarters were men.
Device success per target lesion was slightly lower with Supraflex than with Xience (97.6% vs 99.5%), but Serruys noted that the rate with Supraflex is in line with results from other all-comers DES trials (with rates ranging from 92.4% to 98.6%).
In a per-protocol analysis, Supraflex had a significantly lower rate of TLR (1.2% vs 3.1%; P = 0.021) and a nonsignificantly higher rate of cardiac death (1.1% vs 0.3%; P = 0.084).
Regarding the mortality finding, Kaul said the trial investigators discussed the issue, deciding it was likely just a play of chance. The causes of the deaths in the Supraflex arm included one definite stent thrombosis, two procedural issues, two cases of heart failure, and two unexplained deaths. In the Xience arm, there was one death from definite stent thrombosis and one related to the no-reflow phenomenon in a patient with STEMI.
Serruys noted that the 1-year all-cause mortality rate in the Xience arm was very low at 0.6%; in other all-comers trials, the rate ranged from 2.2% to 2.8%.
Dr Upendra Kaul, Chairman Cardiology BHMRC co-chairs a path breaking study
In the first randomized trial of an Indian-made stent versus the best-in-class Xience stent (Abbott) conducted in Europe, the Supraflex sirolimus-eluting stent (SMT; Surat, India) proved itself to be a worthy competitor in results presented here at TCT 2018.
In the TALENT trial, the rate of a device-oriented composite endpoint of cardiac death, target-vessel MI, and clinically indicated TLR at 12 months was 4.9% with Supraflex and 5.3% with Xience, a difference that met criteria for noninferiority (P < 0.001), study chair Patrick Serruys, MD, PhD (Imperial College London, England, and Erasmus University, Rotterdam, the Netherlands), reported.
Though there were no significant differences between groups for any of the components of the composite outcome, a per-protocol analysis suggested that TLR might be lower with Supraflex, which is not available in the United States but has received CE Mark approval in Europe.
“The study results have important economic implications in countries with capped stent prices such as India, and in some European countries with competitive pricing and different models of healthcare cost savings,” Serruys said.
“Since clinical outcomes of contemporary drug-eluting stents are reaching a safety plateau, it is likely that cost-effectiveness will influence, in the near future, the stent market,” he added.
Giulio Stefanini (Humanitas University Rozzano, Milan, Italy), who served as a panelist during Serruys’ presentation, agreed. “I think the cost-effectiveness will certainly play a role in the future in the decision of which device to pick in our cath labs,” he said. “What I want to stress is the importance of having adequate clinical data to support the use of a cheaper device, and studies like this one are very important because we cannot just use a device because it’s cheaper. We need to have a randomized controlled trial that shows noninferior efficacy as compared to standard of care. I think that this is a very important message, because we Europeans will have more and more CE marked products that do not have adequate evaluation in terms of safety and efficacy, so we need these kinds of trials.”
Vigorously Testing Indian-Made Stents
Serruys provided some background on the use of coronary stents in India, pointing out that about 550,000 stents are used there annually, with the market growing by about 15% each year. In fact, India is expected to become the second-largest international market after China in the next few years.
In February 2017, the Indian government decided to cap prices on coronary stents: at $440 for DES and $110 for BMS (in US dollars). That represents a dramatic reduction in prices, from an average of $1,800 for DES and $670 for BMS.
At that time, TALENT co-chair Upendra Kaul, MD (Batra Hospital and Medical Research Center, New Delhi, India), told TCTMD, use of Indian-made stents increased. However, as he also highlighted in a June 2017 editorial in EuroIntervention, there remained a perception that stents produced outside of India were superior to homegrown devices. Kaul called for Indian manufacturers to prove that their devices are comparable to those made elsewhere in robust clinical trials.
TALENT is the first such trial to yield results. It was designed as a noninferiority trial to compare the sirolimus-eluting Supraflex—which has ultrathin struts (60 microns) and a biodegradable polymer—with the everolimus-eluting, durable-polymer Xience. Investigators enrolled 1,435 patients from 23 centers in seven European countries. It was an all-comers population, with about 40% of patients presenting with stable angina and 60% with ACS. Mean patient age was 65 years, and about three-quarters were men.
Device success per target lesion was slightly lower with Supraflex than with Xience (97.6% vs 99.5%), but Serruys noted that the rate with Supraflex is in line with results from other all-comers DES trials (with rates ranging from 92.4% to 98.6%).
In a per-protocol analysis, Supraflex had a significantly lower rate of TLR (1.2% vs 3.1%; P = 0.021) and a nonsignificantly higher rate of cardiac death (1.1% vs 0.3%; P = 0.084).
Regarding the mortality finding, Kaul said the trial investigators discussed the issue, deciding it was likely just a play of chance. The causes of the deaths in the Supraflex arm included one definite stent thrombosis, two procedural issues, two cases of heart failure, and two unexplained deaths. In the Xience arm, there was one death from definite stent thrombosis and one related to the no-reflow phenomenon in a patient with STEMI.
Serruys noted that the 1-year all-cause mortality rate in the Xience arm was very low at 0.6%; in other all-comers trials, the rate ranged from 2.2% to 2.8%.
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