First-Generation Drug-Eluting Stent Outcomes After 10 Years

The 10-year follow-up results from the Danish Organization on Randomized Trials With Clinical Outcome (SORT OUT II; ClinicalTrials.gov identifier: NCT00388934)¹ showed no difference between 2 types of drug-eluting stents (DES) in terms of major adverse cardiac events (MACE) or stent thrombosis. The findings were reported in the Journal of the American College of Cardiology.²

Coronary DES have significantly reduced the need for repeat vascularization since the US Food and Drug Administration (FDA) approved the sirolimus-eluting stent in 2003 and the paclitaxel-eluting stent in 2004.^3,4 However, the polymer or stent material of these first-generation DES was found to cause inflammation in some cases, leading to “stent thrombosis, myocardial infarction (MI), restenosis, target lesion revascularization (TLR), and even sudden death,” the researchers wrote.

“Subsequent stent types with thinner struts, newer polymers, and different drugs with improved release kinetics have surpassed the first-generation DES with regard to both efficacy and safety,” they noted, although there are no existing guidelines on reducing the risk of late-occurring adverse events in the many patients with first-generation DES. There is also a lack of evidence regarding long-term outcomes.

The researchers examined the 10-year clinical outcomes associated with first-generation DES in participants from the SORT OUT II randomized trial.¹ A total of 2098 patients (75% men; mean age: 64 years) were randomly assigned to receive either the sirolimus-eluting stent or the paclitaxel-eluting stent.

After 10 years, 73.1% of the SORT II participants were still alive. The findings showed that 32.5% of the sirolimus group and 33.1% of the paclitaxel group experienced MACE, the primary end point (hazard ratio [HR]: 0.96; 95% CI, 0.83-1.12; P =.60), with an annual rate of 2.6% after the first year. Definite, probable, and possible stent thrombosis occurred in 13.3% of patients in both groups (HR: 1.00; 95% CI, 0.79-1.27; P =.99), with an annual rate of 1.3%.

In the sirolmus group, 27.4% of patients died compared with 26.3% of patients in the paclitaxel group (HR: 1.05; 95% CI, 0.89-1.23; P =.60). TLR occurred in 14.8% of the sirolimus and 16.4% of the paclitaxel groups (HR: 0.89; 95% CI, 0.72-1.11; P =.31), with no evidence of a late-occurring increase in the TLR rate.

“The steady annual late event rates and the absence of decline are curious and worrying, and we encourage a debate on the appropriateness of intensified surveillance of patients who have a first-generation implanted DES,” the researchers wrote.

They further suggested long-term surveillance of any new stents in unselected patients to “procure evidence-based information on the durability of stent performance.”

Disclosures: The research was funded by grants from Boston Scientific and Cordis, a Johnson and Johnson Company.

References

1. Galløe AM, Thuesen L, Kelbaek H, et al. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008;299(4):409-416. doi: 10.1001/jama.299.4.409
2. Galløe AM,  Kelbæk H, Thuesen L, et al. 10-year clinical outcome after randomization to treatment by sirolimus- or paclitaxel-eluting coronary stents. J Am Coll Cardiol. 2017;69(6):616-624. doi: 10.1016/j.jacc.2016.11.05
3. Kim YH, Park SW, Lee CW, et al. Comparison of sirolimus-eluting stent, paclitaxel-eluting stent, and bare metal stent in the treatment of long coronary lesions. Catheter Cardiovasc Interv. 2006;67(2):181-187.
4. Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007;370(9591):937-948.