New data reinforces safety profile of Xience V

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Two late-breaking clinical trials presented at the EuroPCR 2010 conference on 25 May 2010 reinforced clinical data supporting Xience V Everolimus Eluting Coronary Stent System (Abbott).

In the XIENCE V USA study of more than 5,000 real-world, complex patients, the device demonstrated a low rate of stent thrombosis at one year (0.84% per Academic Research Consortium [ARC] definition of definite/probable stent thrombosis). In a subset of approximately 1,800 less complex patients (referred to as “standard risk”), Xience V demonstrated a one-year stent thrombosis rate of 0.34% per ARC definition of definite/probable stent thrombosis.

 

“The low stent thrombosis rate demonstrated by Xience V is impressive given the complexity of the patient population included in the XIENCE V USA trial, and confirms that the stent thrombosis results seen with Xience V in earlier randomised clinical trials are consistent in real-world clinical practice,” said James Hermiller, director of Cardiovascular Interventions, St Vincent Hospital in Indianapolis, USA, and principal investigator of the XIENCE V USA trial.

 

The XIENCE V USA study also showed that stent thrombosis rates remained low even when dual anti-platelet therapy (DAPT) was temporarily or permanently discontinued. In the overall XIENCE V USA population, patients who interrupted DAPT usage after six months showed a subsequent late stent thrombosis rate of zero per cent. In the subset of standard risk patients, those who interrupted DAPT usage after 30 days also showed a subsequent late stent thrombosis rate of zero percent. DAPT compliance in the XIENCE V USA study was 79.4% at one year.

 

XIENCE V USA is a post-market, single-arm registry evaluating outcomes in 5,054 Xience V patients based in the United States with follow-up out to five years. The study is designed to examine the safety of the Xience V stent in an all-comers patient population from real-world clinical settings. The standard risk subset included 1,827 patients. Mitch Krucoff, director, Cardiovascular Devices Unit, Duke Clinical Research Institute in Durham, USA, is co-principal investigator of the XIENCE V USA trial.

 

SPIRIT V Diabetes Trial

Abbott also presented data from the SPIRIT V Diabetes study, an international randomised clinical trial comparing Xience V to the Taxus Liberte Paclitaxel-Eluting Coronary Stent System in 324 patients with diabetes. In the trial’s primary endpoint of in-stent late loss, Xience V demonstrated superiority to Taxus (0.19mm for Xience V vs. 0.39mm for TAXUS; p=0.0001). In-stent late loss is a measure of vessel renarrowing after a stent procedure.

 

The SPIRIT V Diabetes trial also showed encouraging observational evidence of low event rates for diabetic patients treated with Xience V including:

In the composite endpoint of cardiac death, heart attack attributed to the treated vessel (target vessel myocardial infarction) and ischaemia-driven target lesion revascularisation (TLR), Xience V demonstrated an observed 10% reduction compared to Taxus (11.2% for Xience V vs. 12.5% for TAXUS, p value=0.71).

  • In the composite endpoint of cardiac death and target vessel myocardial infarction, Xience V demonstrated an observed 61% reduction compared to Taxus (3.7% for Xience V vs. 9.6% for Taxus, p value=0.04).
  • In the endpoint of cardiac death, Xience V demonstrated an observed rate of 0.5% compared to 2.9% for Taxus (p value=0.10).
  • In the endpoint of ischaemia-driven TLR, Xience V demonstrated an observed rate of 8.4% compared to 3.8% for Taxus (p value=0.16).
  • In the endpoint of target vessel myocardial infarction, Xience V demonstrated an observed rate of 2.8% compared to 8.7% for Taxus (p value=0.04)
  • In the endpoint of stent thrombosis, Xience V demonstrated zero cases of blood clots (ARC definite/probable stent thrombosis) at one year compared to 1.9% for Taxus (p value=0.11).

The clinical outcomes from the SPIRIT V Diabetes trial are observational as the trial was not powered to analyse statistical differences in any of the clinical endpoints.

 

XIENCE V and Abbott’s next-generation Xience Prime Everolimus Eluting Coronary Stent System are approved for the treatment of patients with diabetes in CE mark countries. Xience Prime is an investigational device in the United States and is not available for sale.