Abstract 17066: Is Premature Thienopyridine Discontinuation Safe with Everolimus-Eluting Stents? Analysis from the SPIRIT IV Trial
Background: Low rates of stent thrombosis (ST) have been reported with the XIENCE V everolimus-eluting stent (EES). In the SPIRIT III trial, only 2 of 294 EES pts (0.68%) in whom thienopyridines were discontinued after 6 months developed ST within 3 yrs. To further assess the safety of premature thienopyridine discontinuation (TD) with EES, we examined the results from the large-scale SPIRIT IV trial.
Methods: In SPIRIT IV, 3,687 pts were randomized 2:1 to EES vs. paclitaxel-eluting stents. Treatment of up to 3 native de novo coronary lesions in 3 vessels were allowed, each with reference vessel diameter ≥2.5 – ≤3.75 mm and length ≤28 mm. Major exclusion criteria included recent MI, unprotected LM, large bifurcation with ostial side branch stenosis >50%, CTO, and thrombus. Dual antiplatelet therapy was required for ≥12 months. Rates of ARC definite or probable ST within 1 yr were assessed according to premature TD.
Results: Among 2,410 pts assigned to EES who either developed ST or had complete 1 yr follow-up, thienopyridines were never discontinued in 2083 pts, 3 of whom (0.14%) developed ST within 1 yr. Among 322 pts in whom thienopyridines were discontinued before 1 yr, ST developed after TD in 3 pts (0.93% P=0.03 vs. no TD). The mean duration off thienopyridines in pts with TD beginning at <1, 1–3, 3–6 and 6–12 months were 94 ± 121, 86 ± 117, 64 ± 82, and 38 ± 47 days, respectively. ST rates within 1 yr according to the timing of TD appear in the Figure. Of note, among 271 pts with TD between 3 and 12 months, ST developed in only 1 (0.37%), and was ARC probable. In this group, the ST rates were 0% (0/49) and 0.45% (1/222) among pts with TD for ≥3 and <3 months respectively.
Conclusions: The results of SPIRIT IV confirm SPIRIT III, and suggest that in pts receiving EES for simple and moderately complex lesions without ACS, ST may be uncommon in pts with TD beyond 3 months. Longer-term follow-up and ultimately randomized trials are required to verify these observations.
- © 2010 by American Heart Association, Inc.