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Risk for very late stent thrombosis, late TLR rose steadily up to 5 years after stenting

Issue: April 2012

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After implantation of sirolimus-eluting stents, the risk for very late stent thrombosis and late target lesion revascularization remained steady up to 5 years, according to study data from the j-Cypher Registry.

From August 2004 to November 2006, Takeshi Kimura, MD, of Kyoto University in Japan, and colleagues evaluated 12,812 patients undergoing sirolimus-eluting stent implantation. Incidence of stent thrombosis, MI, target lesion revascularization (TLR) and all-cause death were followed for 5 years.

Overall, researchers found a low cumulative incidence of definite stent thrombosis (30 days=0.3%; 1 year=0.6%; and 5 years=1.6%). However, late and very late stent thrombosis continued to occur without attentuation through 5 years after implantation (0.26% per year). According to study results, “[Stent thrombosis] was the cause of MI during follow-up in 37% of 410 MI episodes.” Eighty-eight percent (n=151) of events resulted in MI.

Researchers found different risk factors for stent thrombosis depending on the timing of onset. Acute coronary syndrome and target of proximal left anterior descending coronary artery were risk factors for early stent thrombosis; side-branch stenting, diabetes and end-stage renal disease with or without hemodialysis were risk factors for late stent thrombosis; and current smoking status and total stent length of more than 28 mm were risk factors for very late stent thrombosis.

Cumulative incidence of TLR within the first year was low (7.3%). Beyond 1 year, late TLR continued to occur without attenuation (2.2% per year), with a cumulative incidence of 15.9% at 5 years. Independent risk factors were similar for early and late TLR beyond 1 year.

In an accompanying editorial, David Faxon, MD, of Brigham and Woman’s Hospital, said he was concerned about the steady continued rate of very late stent thrombosis without any evidence of a plateau at 5 years, adding that the problem of increasing rates may continue indefinitely after stenting.

“The observation that very late [stent thrombosis] and target lesion revascularization continue at a steady rate up to 5 years is sobering and suggests that there may be no end in sight for these serious events,” Faxon, who is also a Cardiology Today Editorial Board member, said. “The hope is that through a better understanding of the processes responsible, targeted therapy can improve the long-term durability and safety of drug-eluting stents.”

For more information:

• Faxon DP. Circulation. 2011;doi:10.1161/CIRCULATIONAHA.111.079731.
• Kimura T. Circulation. 2011;doi:10.1161/CIRCULATIONAHA.111.046599.

Disclosure: Drs. Kimura and Miyazaki serve as advisory board members for Cordis Japan and received honoraria from Cordis Japan. Dr. Nakagawa received honoraria from Cordis Japan. Dr. Faxon reports no relevant financial disclosures.

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