Drug eluting BALLoon angioplasty to prime bifuRcation lesiOns for stenting: a prOspective randoMized trial

The optimal endovascular approach to treat coronary artery bifurcation lesions
remains challenging. Bifurcation stenting is associated with a high rate of
restenosis (1) The use of drug eluting stents has effectuated a major
reduction of restenosis in simple and more complicated coronary lesions (2-9)
Together with 2 other randomized studies, the Nordic bifurcation study reported
excellent clinical and angiographic results using a sirolimus stent in de novo
coronary artery bifurcation lesions. Consequently the simple bifurcation stent
strategy (stenting of the main vessel and optional stenting of the side branch)
was recommended as a routine bifurcation technique (2,7,10).
Interventional cardiologists are still in search of the optimal treatment of
bifurcation lesions. Many techniques have been investigated up till now. The
unique anatomical configuration of every bifurcation creates an abnormal flow
pattern, which could be considered the cornerstone in the pathofysiology of
restenosis (11). Furthermore, in bifurcation lesions a complete coverage of the
circumferential vessel with stent struts seems almost inconceivable , once
more responsible for a higher restenosis rate (11).
In the Nordic bifurcation trial a provisional T stenting strategy was proven
safe and feasible. However, further improvement of the technique is mandated
to decrease the restenosis rate consistently. Colombo (presented on the
euroPCR congress). demonstrated that the crush technique is not superior to
provisional T stenting technique. On the other hand, Bavry emphasized the risk
of late stent thrombosis when using a DES(12).

Recently a new technique was introduced using paclitaxel eluting balloons (13).
The drug eluting balloon was successfully used for treating in-stent restenosis
of bare metal stents (13). Furthermore, it was proven to be feasible and safe
to treat a bifurcation lesion with drug eluting balloon angioplasty followed by
bare metal stent implantation of the main vessel (11). No late stent
thrombosis was reported after angioplasty with a drug eluting balloon.
The OASIS V trial has showed bleeding complications are very important in
predicting 1 year survival (14). By using the combination of a drug eluting
balloon and bare metal stents the duration of clopidogrel therapy can be
reduced significantly to one month.

The study will assess the hypothesis that for treating a bifurcation lesion in
a coronary artery the combination of a drug eluting balloon and a bare metal
stent is non inferior to the standard provisional T-stenting technique using a
drug eluting stent. Using this new strategy we intend to combine the
advantages of the drugs preventing restenosis and the shorter administration
of clopidogrel diminishing major bleeding.

Open label randomized controlled trial with two groups : group A Elutax drug
eluting balloon + bare metal stent, group B conventional provisional T-stenting
using a drug eluting stent

Group A:
In the drug eluting stent (DES) group, a similar approach ,as used in the
Nordic bifurcation study, is requested. The SES "Cypher Select" (Cordis/Johnson
& Johnson, Miami Lakes, Fla) is used in the study. The target lesion can be pre
-and postdilated at the operators discretion. The operators are requested to
avoid predilation not covered by stent in the main vessel segment. Different
types of drug-eluting stents in the same vessel will not be allowed.

In the DES group the main treatment principles are (1) stenting of main vessel;
(2) side branch dilatation if there is TIMI (Thrombolysis In Myocardial
Infarction )flow <3 in the side branch; and (3) side branch stenting if TIMI
flow=0 in the side branch after dilatation.

Group B:
In the Elutax drug eluting balloon (DEB)group the main treatment principles are
(1) placing of a guide wire in the target vessel and in the side branch, (2)
balloon pre-dilatation with standard undersized, compliant, coronary balloons
of both vessels at low pressure (6-8 atm), (3) sequential Elutax drug eluting
balloon inflations (8atm, 60sec) in the main and side branch respectively, (4)
bare metal stent deployment in the main vessel, (5) recrossing wires and
performing a final kissing balloon deployment. (6) the procedure is completed
when the criterium of angiographic success is achieved (TIMI III flow in the
main vessel and side branch with a diameter stenosis < 10% and < 40%
respectively). Both operator and patient will be aware of the assigned
treatment

included patients may be at risk for an instent restenosis if allocated to the
group treated with bare metal stent; they are to undergo the risk(allthough
low) of second catheterisation; however the latter group of patients wil not be
at risk for late stentthrombosis and will be able to stop antiplatelet therapy
earlier then patients treated following standard procedure.