For Bifurcations, 1 Stent Just as Good as 2 Out to 5 Years

New Orleans, LA—For complex bifurcation lesions, a strategy of stenting only the main vessel and sparing the side branch unless necessary is just as effective as the more complex approach of routinely stenting both branches, according to data presented April 3, 2011, at the annual American College of Cardiology Scientific Session/i2 Summit.

Researchers led by Leif Thuesen, MD, of Aarhus University Hospital (Aarhus, Denmark), presented 5-year results from the Nordic Bifurcation study, which followed 405 patients treated with sirolimus-eluting stents using a 1- or 2-stent approach. Two-thirds of the patients in each group had stable angina, while slightly less than one-third had unstable angina, and the rest (< 2%) had silent ischemia.

In the single-stent group, the threshold for treating the side branch was first to dilate the vessel if TIMI flow was less than 3. The side branch was stented if TIMI flow in the vessel was 0 after dilatation.

The single-stent group had lower procedure and fluoroscopy times as well as contrast use compared with patients who were stented in both branches (table 1).

Table 1. Procedural Outcomes

 

 

Main Vessel
(n = 203)

Main Vessel Plus Side Branch
(n = 202)

P Value

Procedure Time, min

59 ± 31

75 ± 30

< 0.0001

Fluoroscopy Time, min

19 ± 19

22 ± 13

< 0.05

Contrast, mL

233 ± 94

284 ± 118

< 0.0001

 

Procedural success (defined as residual stenosis < 30% and TIMI flow 3 in the side branch) was similar between the single- (97%) and double-stent (94%) groups (P = 0.25). The side branch was stented in 4.4% of the 1-stent group, while 95% of the 2-stent group received side branch stenting (P < 0.0001). Kissing balloon inflation was also less common in the single-stent group (32% vs. 74%; P < 0.0001).

The primary endpoint of MACE-free survival at 5 years was similar in the single- and double-stent groups (85.5% vs. 80.1%; P = 0.16). Each of the individual components of MACE (cardiac death, MI, TVR, stent thrombosis), was also similar between groups as was overall mortality (table 2).

Table 2. Five-year Outcomes

 

 

Main Vessel
(n = 203)

Main Vessel Plus Side Branch
(n = 202)

P Value

Death

6.4%

9.9%

0.2

Cardiac Death

2.0%

3.0%

0.54

MI

3.4%

6.4%

0.17

TVR

13.3%

18.3%

0.18

Definite Stent Thrombosis

3.4%

1.5%

0.33

 

TVR confined to just CABG was also similar between the single- and double-stent groups (2.0% vs. 3.5%; P = 0.38), as was TLR (11.3% vs. 15.3%; P = 0.24).

“At 5-year follow-up, rates of MACE were low and did not differ significantly in patients treated with a simple vs. complex bifurcation stenting technique using sirolimus-eluting stents,” Dr. Thuesen concluded.

The study represents the latest endorsement of the simple, single-stent approach to bifurcation lesions. With the exception of the DKCRUSH study, which found double-kissing crush stenting superior to provisional stenting, the majority of comparisons—such as BBC ONE and CACTUS—have found the main-vessel-only approach to be just as effective.

“I think it’s quite clear that this study and other randomized trials have shown that you should go for a simple, optional side branch stenting technique,” Dr. Thuesen said.

Single-Stenting For All?

However, panel co-chair Roxana Mehran, MD, of the Mount Sinai School of Medicine (New York, NY), questioned whether provisional stenting could be extended to all bifurcations given Nordic Bifurcation’s limitations, especially since the 1-stent approach is not currently standard practice. Dr. Thuesen acknowledged that many of the side branches in the study were shorter than most bifurcations and that not all of the lesions were genuine bifurcations.

Nevertheless, “I think the 5-year results are important, even more so than the primary endpoints at 1 year or 6 months,” Dr. Thuesen said. “I think you are free to use whatever technique you would like, but on the average patient, surely I would go with the 1-stent technique and see what happens.”

Panel member Neal S. Kleiman, MD, of the Methodist DeBakey Heart and Vascular Center (Houston, TX), agreed. “For me the study addresses an important question that we face virtually every day in a simple and straight forward manner, and it gives an answer that is pretty clear,” endorsing the single-stent technique, he said.

Trial Casts Doubt on Dedicated Stents

All of the panel members agreed that the trial was bad news for the ongoing development of dedicated bifurcation stents.

“If there really is no difference after 5 years, it would make a pretty difficult case to justify more complex stenting for what is most likely a non-problem,” Dr. Kleiman said.

“I would concur, adding the caveat that that is why we do investigations,” said James E. Tcheng, MD, of Duke University Medical Center (Durham, NC), “because it is possible that these techniques would make a difference.”

 

Source:

Thuesen L. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: 5-year follow-up in the Nordic Bifurcation study. Presented at: American College of Cardiology Scientific Session/i2 Summit, April 3, 2011, New Orleans, LA.

Disclosures:

  • The study was supported by an unrestricted grant from Cordis.
  • Dr. Thuesen reports no relevant conflicts of interest.

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