Abbott Labs (ABT) presented results on XIENCE V Everolimus Eluting Coronary Stent System from the SPIRIT IV trial yesterday at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco.

Results showed that XIENCE V achieved superiority in the key safety and efficacy measures of target lesion failure (TLF) and target lesion revascularization (TLR) compared to Boston Scientific’s (BSX) Taxus Express2 Paclitaxel-Eluting Coronary Stent System at one year. The study was conducted with about 3,690 patients.

XIENCE V demonstrated a statistically significant 38% reduction in TLF compared to Taxus. Target lesion failure occurred in 4.2% of the XIENCE V patients compared to 6.8% of the patients in the Taxus arm. XIENCE V also demonstrated a statistically significant 46% reduction in TLR compared to Taxus. Target lesion revascularization occurred in 2.5% of the XIENCE V patients compared to 4.6% of the patients in the Taxus arm.

Importantly, XIENCE V demonstrated an impressive low rate of stent thrombosis (blood clots) at one year. XIENCE V demonstrated an observed 80% reduction in stent thrombosis compared to Taxus (0.17% for XIENCE V vs. 0.85% for Taxus) at one year. Risk of blood clots has been a cause of major concern for interventional cardiologists.

While the above results reinforce the safety and effectiveness of XIENCE, we note that XIENCE failed to achieve statistical significance in a sub-group of diabetic patients. Diabetes patients are typically sicker and have more challenging artery diseases. Results showed that there was no difference in TLF between XIENCE V and Taxus at one year (6.4% for XIENCE V vs. 6.9% for Taxus). Statistically significant results in this sub-group would have helped XIENCE V gain additional share from Taxus.

Following the launch of XIENCE V, Abbott has become a major player in the drug-eluting stent (DES) market, where it competes primarily with Taxus, Medtronic’s (MDT) Endeavor, and Johnson & Johnson’s (JNJ) Cypher (sirolimus-eluting system) drug-eluting stents. Abbott’s Vascular Products segment should continue posting robust growth mainly due to the strong performance of XIENCE V. We have a Neutral rating on Abbott.
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