The results after a year of trial EVOLVE confirm that safety and effectiveness of the SYNERGY â„¢ Boston Scientific stent data are comparable with the of the PROMUS Element â„¢ stent of cromo platino

Natick, Massachusetts, 2012-may Boston Scientific Corporation (NYSE: BS) announces that SYNERGY ™, the eluting Coronary stent everolimus, cromo-platino, covered with a polymer absorbable, showed results of non-inferiority in the treatment of injuries of novo in the coronary arteries within one year in comparison with PROMUS Element ™Another cromo-platino in the study EVOLVE everolimus,-eluting stent that has used this system for the first time in humans. In the study there have been corresponding to one-year clinical outcomes and results of intravascular Ultrasound (IVUS) over a period of six months, to assess the safety and effectiveness of the stent SYNERGY, covered with a polymer abluminal absorbable. Dr. Stefan Verheye, interventional cardiologist of Antwerp Cardiovascular Institute, ZNA Middelheim Hospital in Belgium, today presented the results at the annual EuroPCR Congress, in Paris.

The study EVOLVE had given to know the main evaluation criteria previously angiographic and clinical of non inferiority of the stent SYNERGY PROMUS Element in late 6-month loss and failure in the treated lesion (TLF) within 30 days. Data within 1 year of the study EVOLVE has shown that both versions of the stent (one loaded with the total dose and another) SYNERGY with half dose of everolimús are not clinically inferior to the PROMUS Element stent. There were significant differences between the groups in all parameters of the intravascular ultrasound at 6 months, including the area of the neoíntima, the area of the stent or light, the net volume of obstruction, the incomplete stent apposition or the minimum diameter of the light.

«intravascular ultrasound at 6 months data suggest that antirreestenótica activity remains with the stent SYNERGY even after four months, when the drug and polymer coating have been designed to be absorbed.» It is important to note that the SYNERGY stent has also shown equivalent to the of the stent PROMUS Element, according to the data of the study EVOLVE clinical safety and effectiveness. «Continue to note very low rates of revascularization and very few deaths from cardiac causes or thrombosis of the stent with the SYNERGY system within a year», said Dr. Verheye. «the EVOLVE data show the effectiveness of the release of the drug, segregated by the slim abluminal of this innovative platform for coronary stent absorbable polymer».

After a year, the failure of the injury treated in the two groups was not statistically different from the observed with the PROMUS Element stent (4.4%, 4.2% and 5.1% with Stenting SYNERGY of total dose, the average dose SYNERGY stent and the PROMUS Element stent respectively; p = 1.00 compared superiority between the version of SYNERGY with the PROMUS Element stent). The failure of the treated lesion is defined as the glass-related cardiovascular death diana, a heart attack related to the diana glass or a bypass of the lesion treated of ischaemic origin. Clinical follow-up after a year showed that there had been no death of cardiac origin, no myocardial infarction with Q wave or no thrombosis of the stent in none of the groups receiving devices. In a patient in the group treated with stent SYNERGY of total dose and three patients treated with stent SYNERGY to average doses had been previously non-Q wave myocardial infarctions; There were other two myocardial infarctions without Q wave within between 6 and 12 months in the group treated with the SYNERGY of total dose. However, considered that these strokes were not related to the stent. Rates of non-Q wave myocardial infarction were not statistically significant between the groups at any time of the period of one year (3.3% with total dose SYNERGY [p = 0.11], 3.2% with SYNERGY to average dose [p = 0.12], compared with 0.0% with PROMUS Element). Revascularization of the treated lesion was 1.1 per cent with both doses of SYNERGY compared with 5.1 per cent with the PROMUS Element system (p = 0.21). In addition, Revascularization of the treated glass was less numerically with the stent SYNERGY, but the difference was not statistically significant (3.3% with total dose SYNERGY [p = 0.09] and 4.2% with average dose SYNERGY [p = 0.17], compared with 9.2 per cent with PROMUS Element).

«SYNERGY is an eluting stent of new generation everolimús, which combines the same alloy of cromo-platino and a design similar to that used in the PROMUS Element system, but with a new coating that is designed to significantly reduce the amount of polymer and drug that exposes the vessel wall»«, without affecting the inhibition of the growth of the neoíntima», explains Dr. Keith D. Dawkins, medical Chief of Boston Scientific. «SYNERGY has been designed to overcome the limitations arising from the lining durable polymer used in stents current farmacoactivos, such as problems with the discontinuation of dual antiplatelet therapy and duration. remain satisfied with excellent clinical outcomes and angiographic study EVOLVE with this advanced technology of coronary stents.

Data from the study EVOLVE is expected to support the adoption of the CE marking of the stent SYNERGY (scheduled for the end of this year), and larger studies will be undertaken to evaluate more in-depth clinical episodes rates and the potential for reducing the treatment of platelet antiagregación double with this new stent technology.

SYNERGY is a device in research phase. Therefore, under existing laws, its use is limited to the context of the investigation and is not available in the market.

On stent SYNERGY

SYNERGY uses the combination of a polymer of lactic acid and glycolic (PLGA) absorbable and drug everolimús to create a uniform and slim coating applied to the outer surface (abluminal) stent. Once the drug has been released, the design of the absorbable lining makes it is absorbed within the period of four months to the implant, which is only the metal stent of PtCr. This technology is designed to provide the same level of reduction than a conventional farmacoactivo stent Restenosis, and at the same time provide a more rapid and complete vessel healing after the implant stent, which could reduce the duration of the treatment of double platelet antiagregación after intervention, or allowing the withdrawal of the same with greater security. SYNERGY has the same patented alloy cromo-platino and a design similar to that used in the PROMUS Element stent, which allows the use of a thinner structure and a greater malleability, navigability and flexibility, while maintaining a low degree of recoil and excellent visibility.

The study EVOLVE of use for the first time in human

EVOLVE is a prospective study, randomized, with simple masking, to assess the inferiority of the stent SYNERGY, which uses a polymer slim absorbable applied to the outer surface of the stent (abluminal) compared to the PROMUS Element stent, which uses a durable and permanent polymer applied to the entire surface of your structure. In the study are randomly 291 patients allocated to one of three groups: a group treated with stent SYNERGY of dose complete (with the same dose of everolimús than the PROMUS Element stent), a group treated with stent SYNERGY of half dose (half the dose of everolimús than the PROMUS Element stent), or a third group dealt with the already marketed PROMUS Element stent. The three stent uses a similar profile for the release of the drug.

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