Paris, France - Dr DS Gambhir (Kailash Heart Institute, Noida, India) surprised many at the EuroPCR meeting here today with trial results that experts say may yield a solid competitor to the Cypher and TAXUS stents sooner than anticipated in many countries. Following Gambhir's presentation of the Safety and Efficacy of the Infinnium Paclitaxel-Eluting Stent (SIMPLE-1) trial results, session comoderator Dr Martin Leon called the findings "exciting and somewhat surprising."
The first-in-man SIMPLE 1 trial used the Indian-manufactured Infinnium stent loaded with four layers of biodegradable polymer, three of which are impregnated with paclitaxel eluted according to different release kinetics within their respective layers. The overall potency of the stent is 3 g/mm2.
As Gambhir told delegates, 80 patients in India received the study stent in lengths ranging from 16 mm to 18 mm. Importantly, although the lesion lengths were slightly shorter than those seen in RAVEL, reference vessel diameters were very small, at a mean of 2.45 mm (By contrast, RAVEL's were a mean of 2.62 mm while mean reference vessel diameter in TAXUS II ranged from 2.72 mm to 2.78 mm). In addition, 19% of patients in the SIMPLE-1 trial were diabetic, reflecting a difficult patient population.
At six-month follow-up, Gambhir reported that clinical events were minimal, with an event-free survival of 93.7%. Quantitative coronary angiography (QCA) results, available only in 39 patients at six months, showed an in-stent mean luminal diameter (MLD) of 2.17 mm, a late loss of 0.22 mm, a diameter stenosis of 19.5%, and a binary restenosis rate of 4.4%, results that were not substantially changed when the peri-stent zones were included in the analysis.
"This is the first indigenously developed and evaluated drug-eluting stent from Asia, and the safety and efficacy we've demonstrated is quite comparable to other drug-eluting stents," Gambhir emphasized. "A key point is also that this stent is far less costly than the TAXUS or the CYPHER."How cheap is cheap?
Pressed during question period to specify just how cheap this stent could be, Gambhir declined to speculate, but in an interview with heartwire , Dr Patrick Serruys (Erasmus University Hospital, Rotterdam, the Netherlands) confirmed that he was confident this stent would be considerably less costly.
"I've said many, many times that I'm not worried about the price of drug-eluting stents," he told heartwire . He believes the Infinnium paclitaxel stent and others currently being explored in Asia will prove highly competitive, particularly in European markets.
"These trial results are a very important development. You must realize that you have an American monopoly on drug-eluting stents, and these American companies will not take care of the lowering of the price."
Serruys went on to note that the American market is based on roughly 900 000 procedures per year, producing stent revenues in the billions. "[The drug companies'] priority is the American market, where they don't need to lower the price. I believe that we need an alternative technology coming from the Far East, and we are also discussing the possibility of building a sirolimus stent in India. The guarantee of quality is therethese people have been trained in Harvard and MIT, they know their job, there are good facilities, and we should not neglect that." He continued, "This particular trial is not perfect and it was done in very difficult patientsI've never seen such small vessels with such diffuse diseasebut despite that, they seem to have something that seems reasonable."
A larger randomized trial of the Infinnium paclitaxel eluting stent is scheduled to start in July 2003.
Heartwire from Medscape © 2003
Cite this: Indian trial holds promise of less expensive drug-eluting stent - Medscape - May 24, 2003.