Lack of association between dual antiplatelet therapy use and stent thrombosis
between 1 and 12 months following resolute zotarolimus-eluting stent implantation.
The target lesion revascularization rate remained constant at four percent, with no new MACE events, and no late stent thrombosis
The evidence indicates late stent thrombosis
can unpredictably occur long after the prescribed period of protection with clopidogrel plus aspirin is over, he added.
The results showed that the pooled rate of stent thrombosis
Involving more than 8,700 patients at 196 centers in 36 countries across five continents, PROTECT was initiated to study the occurrence of a rare but serious adverse event known as stent thrombosis
the formation of a blood clot inside the stent, which serves as a scaffold to keep the artery open.
Under the new Dublin/Academic Research Consortium (ARC) definition of late-stent thrombosis
(blood clotting events in stents), which was developed to eliminate variability in the definitions across various drug-eluting stent trials, the late stent thrombosis
rate with XIENCE V in the SPIRIT II trial out to one year was zero percent for XIENCE V (0/220 patients treated with XIENCE V) and 1.
Key endpoints of the study include assessments of safety -- MACE and stent thrombosis
(blood clot formation) rates -- at 30, 180 and 270 days, with an annual follow-up for up to five years, and successful deployment of the bioabsorbable drug-eluting stent.
Some of the most exciting of the drug-eluting stent platforms working through the developmental pipeline have the potential to curb the vexing problem of late stent thrombosis
is a potentially devastating complication of coronary artery stenting, and significant uncertainty currently exists amongst clinicians worldwide regarding the risks of stent thrombosis
as compared to the potential bleeding risks associated with prolonged dual antiplatelet therapy," said Professor Meredith.
In addition, XIENCE V demonstrated a 77% lower rate of stent thrombosis
, defined as definite or probable according to ARC (0.
Abbott also presented new positive nine-month safety data from the SPIRIT II trial, which showed no additional occurrences of MACE (Major Adverse Cardiac Event) or stent thrombosis
between six and nine months.
4% Target Lesion Failure (TLF), the lowest reported TLF in a contemporary US pivotal study and a 0% rate of late stent thrombosis
at 12 months, according to the companies.