The TARGET All Comer Clinical Trial (G-IC-001) V1.0 (27Aug2015)

• Research type

  Research Study

• Full title

  A prospective multicenter post market trial to assess the safety and effectiveness of the Firehawk™ rapamycin target eluting cobalt chromium coronary stent system (Firehawk™ stent system) for the treatment of atherosclerotic lesion(s)

• IRAS ID

  184197

• Sponsor organisation

  MicroPort Medical (Group) Co., Ltd.

• Clinicaltrials.gov Identifier

  NCT02520180

• Duration of Study in the UK

  6 years, 1 months, 20 days

• Research summary

  Summary of Research
  This study plans to determine if the Firehawk stent or the Xience family of stents (A stent is a metallic scaffold that is expanded and “plastered” against the blood vessel wall to keep it open) are better after 12 months in reducing the death due to heart problems (Cardiac death) or any blockage of the blood vessel that had the stent put in at the start of the study. The Firehawk type of stent is a biodegrdable type, after 9 months part of the stent breaks down and all that is left is the bare metal "scaffold" of the stent.

  The study will recruit patients who are at least 18 years old, have one or more coronary artery stenoses which is 50% or more blocked that is suitable for coronary stent implantation and they are able to provide informed consent and are willing to participate in 5 year followup period. The patients cannot have an intolerance to any of the drugs or stents they will receive, they cannot be planning to have any surgery within 6 months of entering the study, they cannot have a history of bleeding or not want to accept any future blood transfusions and they cannot be pregnant or planning to get pregnant for 12 months after the first stent is put in.

  Summary of Results
  The final 5-year results of the TARGET All Comer trial confirm that the comparable safety and efficacy profile of the Firehawk coronary stent system in comparison with the XIENCE family of EES that was demonstrated at 1 year is maintained through 5 years of follow-up. The updated primary endpoint analysis of the TLF rates at 1 year continued to demonstrate non-inferiority of the Firehawk coronary stent compared to the Xience EES (6.0% [Firehawk] vs. 5.8% [Xience], Pnon-inferiority=0.003). In a broad all-comers patient population, the incidence of TLF up to 5-year follow-up was comparable for both treatment groups: 17.1% (Firehawk) vs. 16.3% (Xience), (P=0.68), with numerically fewer very late definite or probable stent thromboses in the Firehawk arm: 11 subjects (1.4%) as compared to 15 subjects (1.9%) in the Xience arm (P=0.45). At 5-year follow-up the POCE occurrence was also not significantly different between groups: 34.0% of subjects in the Firehawk arm vs. 32.7% of subjects in the Xience arm (P=0.58).
  The safety and effectiveness of the Firehawk stent through 5 years of follow-up are consistent with the results reported for other contemporary biodegradable polymer DES. As with all DES, very late stent-related adverse events continue to accrue with long-term follow-up. A large-scale, individual patient data pooled study (n=25032) estimated that between 1 and 5 years after PCI, very-late stent related events (cardiac death, target vessel MI, and ischemia-driven TLR) continue to accrue at a rate of ~2% per year.4

• REC name

  Wales REC 6

• REC reference

  15/WA/0360

• Date of REC Opinion

  5 Nov 2015

• REC opinion

  Further Information Favourable Opinion