Author + information
- David R. Holmes Jr, MD⁎ ( and )
- Paul Teirstein, MD
- ↵⁎Mayo Clinic, Cardiovascular Diseases and Internal Medicine, 200 First Street, SW, MB 4-523, Rochester, Minnesota 55905
We thank Drs. Rodriguez and Waksman for the interest in our study (1). Certainly, caution is always mandated as we evaluate the longer-term outcome of strategies of care. Longer-term follow-up was very important for the field of vascular brachytherapy because it documented the late catch-up phenomenon that decreased the long-term effect of vascular brachytherapy and was one of the reasons vascular brachytherapy is rarely used today.
Drs. Rodriguez and Waksman reiterate our published comment that this “trial was neither powered nor designed for long-term follow-up” (1). It was powered for the primary 9-month end point. Although by protocol, patients continue to be followed up for 5 years.
Given the sample size of the population, the usual statistical analysis did not document a significant difference in cardiac mortality. Obviously, longer-term follow-up to 5 years will be important to see if trends emerge.
Drs. Rodriguez and Waksman are correct in that target lesion revascularization was indeed lower in the sirolimus-eluting stent group. There was a difference in absolute percentage of stent thrombosis. We reported any Academic Research Consortium (ARC) thrombosis as well as the other definitions of thrombosis. Drs. Rodriguez and Waksman choose to focus on any ARC thrombosis. However, most investigators prefer to use definite or probable ARC thrombosis rates, which occurred in 2.4% of vascular brachytherapy and 3.5% of sirolimus-eluting stents (p = 0.758).
Drs. Rodriguez and Waksman also support our belief that restenosis after bare-metal stents is not benign. This is not a new finding and we provided references (36) to (38) as further support (see Holmes et al. ).
Finally, we share the concerns of Drs. Rodriguez and Waksman. In an era of bare-metal stent in-stent restenosis treated with drug-eluting stents, our patients continue to need vigilant follow-up. More data is certainly needed.
We do appreciate the concerns raised and believe they will only be adequately addressed by larger numbers of patients with very careful follow-up.
- American College of Cardiology Foundation