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240
LATIB ET AL.
(O)
Figure 11 (
Sideguard
Continued
A second multicenter nonrandomized trial has been completed with the next-generation
TM
)
device (SG-2). The new SideguardTMdevice has undergone minor changes to the SDS and a major change to the stent design. The stent has a mixed open and closed cell design with a new mid-distal open cell that acts as a built-in anchoring system preventing the Sideguard 93 patients enrolled in the Sideguard
TM
from migrating following deployment. The technical success overall in the
TM
FIM trials is 86%; however with design changes men­tioned above, the device success increased to 97%. Interim results from the combined SG-1 and SG-2 FIM trialsshowed a MACE rate of4.8% at 30 days and 10.8% atsix months. An interesting IVUS substudy performed on 11 patients suggests furtherstent expansion at thecarina preserv­ing ostial lumen dimensions (30). The SB stent area (at the carina) increased from 3.9 ± 1.2 to
4.6 ± 1.1 mm p =0.77) despitean intimalhyperplasia areaof 0.6 ±0.7 mm expansion due to the self-expanding nitinol properties of the Sideguard
2
(p = 0.04), resulting in no change in lumen area (3.9 ± 1.3 vs. 4.0 ± 1.3 mm2,
2
. Thisdata suggestthat chronicstent
TM
may be sufficient to
compensate for the late loss that occurs with this bare-metal stent.
TrytonTM(Tryton Medical)
The Tryton
TM
SB stent (Fig. 12) is a slotted tube, cobalt chromium balloon expandable stent designed to be implanted in the SB of a bifurcation. The stent consists of three zones: a distal SB zone (that treats the disease in the SB); a transition zone (positioned at the SB ostium); and an MB zone. The central transition zone has a specific geometry, which contains three panels, each of which can be deformed in an independent fashion. The proximal MB zone is composed of three fronds that are connected proximally to the transitional panel and terminate in a circumferential band and the distal zone has the design characteristics of a standard slotted tube workhorse stent. Treatment of a bifurcation with the Tryton
TM
stent generally commits the
operator to implant two stents in the bifurcation, and the technique is identical in approach
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
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241
when performing the Culotte technique. The TrytonTMstent is deployed across the SB ostium first. The initial FIM experience has shown that predilatation of the Tryton allow a MB stent to be advanced through the Tryton then tracked through the proximal MB zone of the Tryton
TM
struts (31,32). A standard MB stent is
TM
into the distal MB and deployed.
TM
The MB stent struts then have to be recrossed in order to perform a final kissing inflation.
(A)
(B)
Figure 12 (A) The design features and characteristics of the TrytonTMSB stent. Baseline angiography demon- strating a complex true bifurcation lesion of the left anterior descending artery and large first diagonal branch (B). Both branches of the bifurcation were wired and predilated (C and D). (E) The result after predilatation. The
TM
Tr y to n straddle the ostium of the SB (preferably 3/4 of this central transition zone should be in the SB and 1/4 in the MB). The Tryton artery was then easily rewired and the proximal MB zone of the Tryton then advanced into the MB and deployed across the bifurcation (G and H). The SB was then rewired and final kissing inflation performed. (I) The final angiographic result. IVUS performed at the carina confirmed good stent expansion and ostial coverage (J).
stent was then positioned on the diagonal branch (F) utilizing the two central markers, which should
TM
was then deployed at nominal pressure and the SDS removed. The left anterior descending
Source
: Photos courtesy of Dr. Antonio Bartorelli.
TM
postdilated. A drug-eluting stent was
(
Continued on pages 242–244
)
(C)
(D) (E)
(F)
Figure 12 (
Continued
)
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
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(G)
243
(H)
(I)
Figure 12 (
Continued
)
244
LATIB ET AL.
(J)
Figure 12 (
conjunction with a standardDES in30 patients(31,32). TheTryton
Continued
The Tryton I FIM trial assessed the safety and performance of the TrytonTMSB stent in
)
TM
was successfully implanted in all but 1 patient (96.7% angiographic success), and at 6-month follow-up, 3 (9.9%) patients had experienceda MACE. There were two re-interventions at thebifurcation (TLR =6.6%), only one of which was in the Tryton
TM
stent whereas the other was in the MB stent. Angiographic follow-up was performed in 78% of patients and demonstrated a late loss of 0.17 ± 0.35 mm and in-segment restenosis in one patient (4.3%) in the MB proximal to the stent. There are also four other ongoing trials with Tryton
TM
: (a) Tryton II or IUVANT (Intravascular Ultrasound Evaluation of Tryton Stent) study, a single-center IVUS study in 30 patients; (b) Tryton III, a single-center OCT study in 15 patients; (c) Tryton IV, a multicenter left main coronary artery feasibility study in 30 patients; and (d) E-Tryton 150 Registry, a multicenter registry to assess the Tryton
Biguard
The Biguard
TM
in real-world patients.
TM
(Lepu Medical Ltd.)
TM
is also a SB specific stent (Fig. 13) designed specifically for coverage of ostial SB disease while allowing the exchange of devices in the MB (33). The Biguard is a stainless-steel sirolimus-eluting stent that has only three stent struts in the proximal segment that are 3 mm in length and separated by 120 degrees. Thus the space between these three struts is large enough to allow theadvancement of guidewires, balloons, or stents. The stent has three markers: two at the proximal and distalpoints, and another oneat the intersectionsite providing SB positioning. The stent is placed from the MB to SB with the middle marker positioned at the carina. The Biguard the culotte technique when stenting of both branches is required, similar to the Tryton
Axxess Plus
The Axxess Plus
TM
was thus designed to treat isolated ostial SB lesions (Medina 0.0.1) and to facilitate
TM
(Devax Inc)
TM
stent (Fig. 14) was the first of these dedicated bifurcation stents designed to
TM
.
elute an antirestenotic drug. It delivers Biolimus-A9, a sirolimus derivative, via a bio-erodable polylactic acid (PLA) polymer carrier. The AxxessTMis a self-expanding, nickel-titanium (Nitinol) alloy, conically shaped stent that is placed at the level of the carina. It has a rapid­exchange delivery system with hydrophilic coating with controlled deployment upon with­drawal of acover sheath using the actuator. However, the Axxess
TM
stent may be limited bythe
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
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Figure 13 Lateral view of the Biguard stent demonstrating that there are only three strut strings (3 mm in length) separated by every 120 degrees at its proximal segment. The middle marker ( the SB during positioning of the stent.
Source
: Adapted from Ref. 33.
arrow
) is aligned with the ostium of
245
fact that it needs to be precisely nested at the carina to be effective and in majority cases will need another stent to fully treat the bifurcation.
Grube et al. have published the results of the prospective multicenter single-arm Axxess
Plus trial that enrolled 139 patients (34). The Axxess
TM
stent was successfully implanted in the MB in 93.5% of cases with 80% of the patients receiving an additional stent to the MB or SB and 42% of patients requiring three stents to completely treat the bifurcation. Six of the 9 device failures were due to improper alignment when the stent was placed distal or proximal to the intended location. At six-month follow-up, the in-stent late loss was 0.09 ± 0.56 mm, in-stent restenosis within the Axxess stent was 4.8% and the overall TLR rate was 7.5%. The Axxess
TM
AXXESS PLUS CONCEPT
Axxess stent is implanted first.
A successful implant will span the ostia of both branching vessels, indicated by the presence of one marker in each branch vessel.
Stents for the branch vessels are selected to match the length and diameter of the disease.
The Axxess distal markers provide a reference point to guide the placement of distal stents.
(A)
Figure 14 Panel (A) shows a picture of an expanded Axxess bifurcation stenting where three stents will be required to fully treat a severely diseased true bifurcation. (B and C) A significant true bifurcation lesion (Medina type 1.1.1) involving the proximal left anterior descending artery and a large first diagonal branch. Final angiographic result, in the left anterior oblique caudal (D) and in the right anterior oblique cranial (E) views, after deployment of the Axxess Cypher sirolimus-eluting stents (Cordis Corp, Johnson & Johnson, Warren, NJ), with the V-stenting technique, in the two branches of the bifurcation. The three distal markers of the Axxess branches of the bifurcation. “StentBoost Subtract” enhanced sequence view of the stented bifurcation in the right anterior oblique cranial views (F).
Source
: Adapted from Ref. 40.
TM
stent and demonstrates the Axxess concept of
TM
stent in the proximal part of the bifurcation and two
TM
stent are clearly deep in the two
Continued on page 246
(
)
246
LATIB ET AL.
(B) (C)
(F)
(D) (E)
Figure 14 (
Continued
)
stent and Axxess technique of bifurcation stenting then underwent evaluation in the large multicenter single-arm DIVERGE (Drug-Eluting Stent Intervention for Treating Side Branches Effectively) Study that enrolled 302 patients with de novo coronary bifurcations (35). The
TM
Axxess
stent was deployed at the level of the carina followed by additional sirolimus-eluting
stents in the distal MB and/or SB. The primary endpoint was the nine-month rate of MACE,
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
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247
a composite of death, MI, and TLR. Primary device success was obtained in 297 (98.3%) of 302 patients and placement of the Axxess laboratory in 93% of cases. In keeping with the Axxess concept, 88% of patients required an additional stent to the Axxess
TM
: 67% in both branches, 17.7% in the distal MB, and 4% only
TM
in the SB. The cumulative nine-month MACE rate was 7.7%, including 0.7% death, 4.3% MI, and 4.3% TLR. Subacute and late stent thrombosis occurred in 0.7% and 0.3% of patients. In-bifurcation restenosis occurred in 9 (6.4%) of the 140 patients who underwent angiographic follow-up. These low ratesof restenosis are certainly promisingfor this new bifurcation-specific technology. Devax the Axxess-LM of the bifurcation. In the multicenter AXXENT (AXXESS Stent in Left Main Coronary Artery Bifurcation Lesions) Trial, the safety and efficacy of the Axxess-LM coronary artery was evaluated in 33 patients using a three stent technique of implanting the Axxess-LM circumflex arteries (36,37).At six-month follow-up, there was minimallate loss (0.01 ±0.34 mm) and norestenosis in the Axxess
TM
have also developed a larger version of this self-expanding conical stent,
TM
stent that was designed to cover the left main coronary artery and ostium
TM
stent in the left main
TM
in the distal left main and two Cypher stents in the left anterior descending and
TM
stent, whereas the restenosis rate was6.9% for the leftanterior descending artery and 16.1% for the circumflex artery. The overall TLR rate was 9.1% and there were no cases of stent thrombosis in this small pilot study. An IVUS study on 26 patients of the AXXENT trial demonstrated that Axxess
TM
stent in the LMCA showed enlargement during the six-month follow-up, with a 12.4% increase in stent volume at follow-up compared with postprocedure (p = 0.04) (36). Thus, once again confirming that chronic passive expansion occurs with these self-expanding stents. The Axxess
TM
also resulted in significant neointimal suppression with a percent neointimal volume obstruction of 3.0 ± 4.1%. It would also appear that relatively inadequate stent expansion and greater neointimal formation may have contributed to the luminal narrowing and higher restenosis rates at the left circumflex ostium.
REGULATORY CHALLENGES FACING DEDICATED BIFURCATION STENT SYSTEMS
A number of these devices are CE marked and commercially available in Europe, including at the time of writing this chapter: Axxess
TM
Stentys
, and AntaresTM. However, none of these devices are FDA approved for use in the
TM
, Twin-RailTM, Nile CroCoTM, SideguardTM,TrytonTM,
United States. The FDA requirement for approval of any of these devices will most likely be an adequately powered noninferiority trial compared to provisional SB stenting with superiority of the dedicated device for procedural data. As for the dedicated stents that mandate stenting of both branches, a superiority trial for angiographic outcomes will be essential.
CONCLUSION
Dedicated bifurcation stent systems are an exciting technology, as they are an attempt to find specific technological solutions to a specific subset of coronary lesions. These devices have undergone a rapid evolution from the pioneering dedicated stents that were bulky and imprac­tical. The newer devices are rapidly changing with second- and third-generation devices enter­ing the market and more clinical data becoming available. The new devices have a lower profile but adequate lesion preparation remains vital to ensure their implantation success. There are still a number of devices that require two wires to be delivered, and wire wrap and bias remain important reasonsfor failure. Also there are some devices that have a poor placement tolerance, or where accurate placement is vital to the success of the device. Many devices rely on passive rotation for their accurate placement questioning their utility in highly complex lesions. Drug­eluting versions have been an essential advancement for the future of many of these devices whose first-generation bare-metal versions were hampered by high degrees of restenosis.
Given the innate variability of bifurcation anatomy, no single device will be utilizable in all lesions, and a “family” of dedicated bifurcation stents may be required to optimally treat highly variable bifurcation lesions. There is clearly a learning curve with all of these devices, and the interventionalist will have to gain experience by performing a number of implants that are proctored before optimal results and device success are achieved. However, these innovative devices also carry many possible advantages including “decomplexifying” bifurcationPCI byfacilitating boththe provisionaland double-stentingapproaches. Thepromise of dedicated bifurcation devices is procedures that are less complex, with shorter procedural
248
LATIB ET AL.
times, less contrast usage, a lower risk of SB closure, and possibly improved angiographic and clinical outcomes. However, before dedicated stents become approved, they will have to show significant advantages over current techniques either with regard to procedural variables or clinical outcomes-–this will require adequately powered randomized controlled trials.
ACKNOWLEDGMENTS
The authors would like to acknowledge the following persons for their invaluable assistance in providing up-to-date clinical information, images, and/or clinical cases of these new ded­icated bifurcation stents: Dr. P. Agostoni (The Netherlands), Dr. J. Ormiston (New Zealand), Dr. R. Costa, and Dr. A. Abizaid (Brazil), Dr. R. Albiero (Italy), Dr. A. Bartorelli (Italy), M. Secerov (Minvasys Inc), G. Ong (Trireme Medical Inc), O. Delporte (Tryton Inc), M. Paguin and M. Gilmore (Cappella Inc), E. Ravanelli (Invatec), and P. Geudens (Stentys).
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