Author + information
- Antonio Colombo, MD, FACC⁎ (, )
- Flavio Airoldi, MD,
- Ioannis Iakovou, MD,
- Goran Stankovic, MD, FACC and
- Lei Ge, MD
- ↵⁎EMO Centro Cuore Columbus, Cardiac Catheterization Laboratory, Via Buonarroti 48 Milan, Lombardia 20145, Italy
We thank Dr. Pristipino and colleagues for their interesting comments about our report. The opportunity to answer their comments will allow clarification of some concerns regarding this innovative approach.
Worse outcome compared to provisional T stenting (PTS).Our report of the crush stenting experience is not meant to be directly compared to the PTS as already reported by us (1). A number of bifurcations with severe narrowing occur in both branches where PTS is not conceivable as an intention-to-treat approach; the crush technique is specifically designed for these types of lesions. It is always misleading to try to compare different studies performed on different types of bifurcations with a variety of different inclusion criteria. We recognize that there is no substitute for appropriately designed prospective randomized studies. This is the main reason why we launched the Coronary bifurcations: Application of the Crushing Technique Using Sirolimus-eluting stents (CACTUS) trial, which prospectively evaluated the PTS technique versus the crush technique (CT) in true bifurcational lesions.
Incidence of stent thrombosis of 4.4% with the CT.A 4.4% incidence in 181 patients bears a 95% confidence interval of 2.3% to 8.5%. In addition, it is important to point out that in three patients the thrombosis was intraprocedural and possibly related to suboptimal anticoagulant or antiplatelet therapy, whereas two other events occurred in a patient who prematurely stopped antiplatelet therapy.
Very recently, we reported a 3.6% rate of cumulative stent thrombosis after drug-eluting stent (DES) implantation in bifurcations in a prospective observational cohort study that included 2,229 patients treated with DESs (2). In this study, bifurcation lesion treatment was identified as an independent predictor of subacute (postprocedure to 30 days), late (>30 days), and cumulative thrombosis. However, no significant differences existed regarding the incidence of thrombosis in bifurcations treated with one versus two stents.
Kissing balloon inflation and success in recrossing.In our initial experience with the CT we did not believe that recrossing into the side branch so as to perform kissing balloon inflation was a mandatory step. We performed kissing balloon inflation in about one-third of cases when the angiographic result was not optimal. The relatively high angiographic restenosis prompted us to always recross into the side branch and perform final kissing inflation. Our success in recrossing into the side branch in the experience reported was 100% and continues to remain high. Availability of improved wires and low-profile balloons makes recrossing into the side branch and performance of balloon inflations a step that adds only a few minutes to the procedure.
The modest results … and the three layers of struts.Ever since the institution of routine high-pressure inflation into the side branch and kissing balloon inflation, as reported in the study, we saw an angiographic restenosis in the side branch of 11.1%, and in many instances focal restenosis at the ostium of the side branch is not clinically relevant. The problem of multiple layers of struts appears more theoretical than practical owing to the fact that the struts’ overlap is limited to 1 or 2 mm. Intravascular ultrasound studies did not demonstrate any lumen compromise at the level of the overlap in the main branch, and the real issue is frequently an incomplete expansion of the lesion at the ostium of the side branch (3).
Usage of off-label technique.We fully agree that any usage of a device for an unlabeled indication must be very carefully performed after having evaluated alternative solutions. The field of invasive cardiology is full of situations in which devices are used outside the labeling instructions; these responsible decisions allow treatment of many patients who would otherwise receive a suboptimal therapy. Careful off-label usage is essential to give initial information to plan prospective studies designed to demonstrate safety and efficacy. Coronary stenting in acute myocardial infarction is a typical example of this path. The results we reported were obtained from analyzing stenting in bifurcational lesions using the optimal technique according to the operator. This experience was not a predesigned study to compare different techniques. This type of evaluation does not require a dedicated consent form in addition to the one for the procedure being done. Using feedback from many other operators, the CT, if applied to the appropriate bifurcations and if properly performed, remains a valuable tool to treat bifurcational lesions. Of course, we hope that dedicated stents specifically designed for this lesion subset may further improve the results in this important area of interventional cardiology.
- American College of Cardiology Foundation
- Ge L.,
- Airoldi F.,
- Iakovou I.,
- et al.
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