Safety & Efficacy Of Drug Eluting Stents Confirmed In Real World Registries And Clinical Trials

Main Category: Cardiovascular / Cardiology
Article Date: 03 Dec 2007 - 3:00 PDT

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New results announced at TCT continue to demonstrate that Boston Scientific's drug-eluting stents (DES) are just as safe as and more effectiafeve than bare-metal stents (BMS) when used according with their Directions for Use.

As Safe As A BMS

- In more than 61,000 patients in seven real world registries, five (ASAN,1 MIDAS,2 Ontario,3 S.T.E.N.T4 and Western Denmark5 registries) showed significantly lower all cause mortality, and two (GHOST6 and NY State7 registries) showed similar all cause mortality with DES compared with BMS, demonstrating the excellent safety of DES.

- 28,000 patients in four real-world registries, ASAN, GHOST, S.T.E.N.T and Western Denmark registries,1,4-6 showed no significant difference in very late stent thrombosis (ST) between DES and BMS.

- Five-year data from the TAXUS I, TAXUS II-SR, TAXUS IV and TAXUS V trials continue to support the excellent safety profiles of DES with no difference in overall ST or new ST seen in the DES groups between year four and five. More importantly, the five-year cumulative adverse events data showed TAXUS Stent to be as safe as BMS, while the efficacy of DES in terms of target lesion revascularisation (TLR) was significantly better compared with BMS (p<0.001).

- In five real-world registries (ASAN,1 GHOST,6 Ontario,3 S.T.E.N.T4 and Western Denmark registries5) of 38,000 patients, one registry demonstrated a significantly lower rate of myocardial infarction (MI) in the DES group compared with the BMS group (S.T.E.N.T4 registry, p<0.001), while no significant difference was seen in ASAN,1 GHOST6 or the Ontario3 registry. In the Western Denmark5 registry the BMS group demonstrated a significantly better outcome (p=0.01).

More Effective Than BMS

- In five real-world registries of more than 42,000 patients, the rates of repeat procedures were significantly lower for DES compared with BMS in four (GHOST,6 Ontario,3 S.T.E.N.T4 and Western Denmark5 registries) and similar in the other (NY State registry7), confirming the superior efficacy of DES.

- Five-year data from the TAXUS I, TAXUS II-SR, TAXUS IV and TAXUS V trials continue to support the excellent efficacy profile of DES compared with BMS (TLR of 12.1% vs. 21.0% respectively, p<0.001).

These results reaffirm the long-term safety and efficacy of drug-eluting stents compared with bare-metal stents in both selected clinical study patients and registry real-world complex patients with multiple lesions and diabetes. These results are consistent across TAXUS stents trials, showing that DES are at least as safe, if not safer than BMS and confirm their significant benefit, representing compelling evidence for their use in both simple and complex patients.8

For further information on Boston Scientific please see: http://www.bostonscientific-international.com.

References

1. ASAN - Park SJ. Asan Medical Centre DES Registry: outcomes of drug eluting compared to bare metal stents from two academic hospitals in Korea (1-3 years follow-up). Presented at Transcatheter Cardiovascular Therapeutics (TCT) meeting, 20-25 October 2007, Washington. Registry sponsored by Cordis / Korean Ministry of Health and Welfare.

2. MIDAS - Vagaonescu T. MIDAS registry: outcomes of drug-eluting compared to bare metal stents from multiple US hospitals (2-year follow-up). Presented at Transcatheter Cardiovascular Therapeutics (TCT) meeting, 20-25 October 2007, Washington. Independent registry..

3. Ontario - Ko D. Effectiveness and safety of drug eluting stents in Ontario. Presented at Transcatheter Cardiovascular Therapeutics (TCT) meeting, 20-25 October 2007, Washington. Independent registry.

4. S.T.E.N.T - Brodie BR. STENT registry: outcomes of drug-eluting compared to bare metal stents from multiple US hospitals (2-year follow-up). Presented at Transcatheter Cardiovascular Therapeutics (TCT) meeting, 20-25 October 2007, Washington. Registry is sponsored by Carolinas Healthcare System.

5. Western Denmark - Jensen LO. Western Denmark: outcomes of drug-eluting compared to bare metal stents in Western Denmark (2-year follow-up). Presented at Transcatheter Cardiovascular Therapeutics (TCT) meeting, 20-25 October 2007, Washington. Registry is sponsored by Cordis.

6. GHOST - Harjai K. GHOST: outcomes of drug-eluting compared to bare metal stents from the Guthrie Health System (2-3 year follow-up) . Presented at Transcatheter Cardiovascular Therapeutics (TCT) meeting, 20-25 October 2007, Washington. Independent registry.

7. NY State - Hannan EL. NY State database: outcomes of drug-eluting compared with bare metal stents in New York. Presented at Transcatheter Cardiovascular Therapeutics (TCT) meeting, 20-25 October 2007, Washington. Independent registry.

8 When used for the approved indications

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