Author + information
- Antonio Colombo, MD⁎ ( and )
- Azeem Latib, MD
- ↵⁎EMO-GVM Centro Cuore Columbus, Via Buonarroti 48, Milan 20145, Italy
We thank Dr. White and colleagues and Dr. Alfonso and colleagues for their interest in the BELLO (Balloon Elution and Late Loss Optimization) study, which is to date the largest randomized trial to compare drug-eluting balloons (DEB) with drug-eluting stents in de novo small-vessel disease (1). We agree that there is an intrinsic methodological weakness in comparing late loss with a device known to produce a large immediate gain (stent) versus a device producing a smaller initial gain (balloon) and therefore a lower late loss. This situation has been demonstrated historically in the seminal studies of stent versus balloon angioplasty (2,3), in which the late loss after balloon angioplasty was about one-half of the late loss with a bare-metal stent (about 0.3 mm vs. 0.6 mm). In our study, we face a similar situation but with a difference in the fourth magnitude. This finding cannot be dismissed by the simple statement that the “lower you gain, the less you lose.” The fact that the late loss after DEB was 4 times lower than after drug-eluting stents suggests, as expected, that other mechanisms (the drug on the balloon) are in action to lower the percentage of late loss compared with the small gain. This fact is further supported by the lack of difference in binary restenosis numerically and statistically.
Furthermore, we would like to take the opportunity to highlight the absolute value of late loss after DEB in BELLO (0.08 ± 0.38 mm). This value is considerably lower than the values seen with competitor DEBs in de novo disease: 0.32 ± 0.56 mm overall and 0.18 ± 0.38 mm for DEB only in the PEPCAD I (Paclitaxel-Eluting PTCA-Balloon to Treat Small Vessel) study (4) or the 0.38 ± 0.39 mm (personal communication, January 2013, from Eurocor GmbH) result found in the Valentines Trial II. We want to take the opportunity in this letter to reaffirm that we are not claiming superiority of a balloon procedure compared with a drug-eluting stent procedure regarding final and follow-up lumen dimensions. Instead, our goal is to provide data supporting the possibility of using an alternative procedure (DEB) in situations in which stenting may not be considered ideal.
- American College of Cardiology Foundation