News:Excel biodegradable stents are safe and effective: Results from the CREATE trial

March 31, 2008 By Vijayalakshmi Kunadian MBBS MD MRCP [mailto:vkunadian@perfuse.org]

Dr. Yaling Han presented the results at the SCAI-i2 summit Annual Scientific Sessions in Chicago today. This presentation was followed by a commentary by Dr. John Ormiston from Auckland New Zealand.

The investigators in the CREATE (Multi-Center Registry of Excel BiodegrAdable Polymer Drug EluTing StEnt) study determined the safety and efficacy of a novel biodegradable polymer based sirolimus eluting stent (ExcelTM). The polymer on the stent is completely degraded within 6 months.

This Prospective, multi-center, post-marketing surveillance registry consisted of 2077 unselected “real world” patients, of which 386 (18.6%) had an acute infarction during the preceding 24 hours. Patients were treated with dual antiplatelet therapy for 6 months. Patients were excluded if hybrid stenting was planned, had contraindications to dual antiplatelet therapy, severe congestive heart failure (NYHA class IV) and planned surgery in the near future.

The primary endpoint of this study consisted of major adverse cardiac events including cardiac death, myocardial infarction and target lesion revascularization (TLR). The secondary endpoints consisted of MACE at 1 and 6 months, late loss, binary restenosis and thrombotic events.

The incidence of MACE at 30 days, 6 months and at one year was low (0.9% vs. 1.8% vs. 2.7%). At 9 month angiographic follow-up, the overall in-stent late loss was 0.21±0.39 and the in-stent binary restenosis rate was 3.8%. However the in-stent (8.1% vs. 2.7%, p<0.001) and in-segment (11.2% vs. 5.5%, p=0.005) binary restenosis rate was greater with off label use compared with on label use among patients with long lesions. The in-segment binary restenosis was also greater in small vessels (10.3% vs. 5%, p=0.002).

Thrombotic events occurred in 0.82% of patients during one year follow-up. There was no difference in the overall MACE between off label and on label use of the stent (3% vs. 1.2%, p=0.081) but the TLR rate tended to be high in the off label cases (1.8% vs. 0.3%, p=0.049) with no difference in the incidence of stent thrombosis (0.8% vs. 0.63%, p=0.1).

The investigators in the study concluded that the use of ExcelTM biodegradable polymer coated sirolimus eluting stents is safe and effective in reducing restenosis similar to the results from the DES trials with dual antiplatelet therapy for 6 months. Further long term results are awaited.

Source

 * 1) Late Breaking Clinical Trials Session: SCAI Annual Scientific Sessions in partnership with ACC i2 summit, March 31, 2008 Chicago