Author + information
- Christian Pristipino, MD⁎ (, )
- Vincenzo Pasceri, MD and
- Giuseppe Richichi, MD
- ↵⁎Coronary Intervention Unit, San Filippo Neri Hospital, Via Borgorose, 5, 00189 Rome, Italy
Ge et al. (1) reported the results of a prospective study on long-term outcomes of “crush technique” (CT) with drug-eluting stents. This study raises, in our opinion, two main issues.
First, as pointed out by Williams and Abbott in their editorial (2), this study reports a clearly worse outcome as compared to studies with “provisional T stenting” (PTS) and serious concerns about safety profile (4.4% incidence of stent thrombosis). Moreover, the success rate in recrossing the stent struts for final kissing balloon is not reported in the study. Because 36% of patients did not undergo final kissing balloon postdilation, we may assume that, at least in some of them, it was not possible to recross the stent struts. This is an important limitation as any further therapy of side-branch restenosis in “unrecrossable” patients (40% incidence) becomes virtually impossible by means of percutaneous coronary intervention (PCI). From this perspective, PTS appears also to be superior as a second stent is needed in only 15% to 33% of cases, and final kissing balloon is possible in >95% of cases (3). Additionally, in case of side-branch restenosis it is always possible to perform additional PCI. Taken together these limitations may “crush” down the clinical role of CT, a conclusion not clearly underlined by the investigators.
Second, the modest results of CT reported in the study by Ge et al. (1) are not surprising. In fact, CT results in three drug-eluting stent (DES) layers crushed on an arterial wall at a site of high hemodynamic turbulence, with high chances of the stents’ incomplete expansion where the coverage should be maximal. This is likely to bring high restenosis incidence and strong local thrombogenic stimuli. Therefore, based on previous studies, a pre-hoc possibility of important adverse events was predictable. As widely accepted, off-label and potentially harmful techniques should be used with great caution, selecting patients on an individual basis and informing them of the experimental nature of the technique. The study does not report whether a clinical selection of patients was performed or whether an approval from the local ethics committee and a specific informed consent were obtained. It is our strong belief that conduction of a study on a new therapeutic off-label technique with potentially severe concerns should bear the same obligations as all other studies investigating new drugs, devices, or a new indication for them. Therefore, a research-oriented informed consent from the patients and an ethical committee approval should be mandatory and clearly stated in reports relating to these subjects.
- American College of Cardiology Foundation
- Ge L.,
- Airoldi F.,
- Iakovou I.,
- et al.
- Williams D.O.,
- Abbott J.D.
- Louvard Y.,
- Lefevre T.,
- Maurice M.C.