PCI vs CABG for left main disease

[MD2b06]

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Looks like more and more patients with left main disease may start getting angioplasties instead of automatically going for CABG, as has been the case in the past.

Washington, DC - The first modern-day, randomized controlled study to compare unprotected left main stenting with CABG for left main disease indicates that an interventional strategy is not only feasible but may be safer [1]. The LE MANS study, presented here at the TCT 2005 meeting by Dr Pawel Buszman, showed left main stenting to improve left ventricular ejection fraction (LVEF) and decrease risk of major adverse cardiac and noncardiac events compared with CABG. Of note, target vessel revascularization (TVR) and mortality rates were no different between the two groups.

Buszman and colleagues randomized 52 patients to PCI and 53 patients to CABG with the aim of assessing LVEF, functional capacity, and angina status after 12 months—the primary end point of the study—as well as the secondary end points of major adverse cardiac events (MACE), hospital length of stay, survival, and any major adverse events (MAEs), defined as any MACE, procedure-related infection, bleeding, or renal or respiratory insufficiency.

In total, left internal mammary artery (LIMA) grafts were used in 79% of the CABG patients; in the PCI group, drug-eluting stents (DES) were used in 35% of patients. As Buszman explained during the late-breaking session today, the decision was made to use a DES only in vessels that were smaller than 3.8 mm in diameter.

Clear differences in LVEF

Strikingly, for a trial with such low numbers, change in LVEF at 12 months was significantly different between the two groups, with PCI patients experiencing a significant increase in LVEF, from about 55% to 60%, while LVEF in CABG patients remained more or less unchanged. Angina status and treadmill stress test at follow-up were similar between the two groups.

In terms of the secondary end points, rates of death, AMI, stroke, repeat revascularization, or heart failure at 30 days were no different between the two groups but, when combined (as specified by the MACE end point), were significantly more common among the CABG-treated patients. MAEs were also significantly higher, driven by the higher MACE rate, as well as a statistically different rate of infections and complications in the CABG-treated patients. Between 30 days and 12 months, however, no further statistically significant differences were seen between the two groups. Hospital stay, not surprisingly, was almost twice as long in the CABG-treated patients. TVR rates over the first 12 months postprocedure were similar between the two groups.

In an interview with heartwire, Buszman and a colleague, Dr Radoslaw Stefan (San Antonio Heart Institute, TX), pointed out that the improvement in LV function is a new and important finding, particularly since reduced LV function is often an indication for surgical revascularization over PCI. As well, other surgery studies have not necessarily included or have underestimated information on infections, bleeding, pericardial effusions, and renal function. "We don't see any of that after left main stenting," Stefan said.

Dr Antonio Colombo (EMO Centro Cuore Columbus, Milan, Italy), the scheduled discussant for LE MANS, called the trial a "good initial study."

He quibbled with some features of the trial design, including the decision to not use drug-eluting stents in all patients. " I would have liked for the sake of cleanness that every patient got a drug-eluting stent, but I don't think this is an important point."

He also took issue with the fact that Buszman did not clarify whether TVR was angiographically or clinically driven and with the use of LVEF as a primary end point.

"This is not a standard end point, and it is also hard to be blinded in a patient who has had a sternotomy," Colombo said. "This may be something to keep in mind for the future; maybe this is an important end point and we should think progressively."

Colombo also reminded the audience that the risks of CABG for left main disease are not negligible and include the risk of MI, less gain in ejection fraction, increased stroke, and death in the early postoperative period.

"I always smile when people tell me there is a risk of 1% of late stent thrombosis [with drug-eluting stents] and I say, decide: do you want to die early or late?" he quipped.

More randomized clinical trial data in the works

During a press conference, Buszman pointed out that while the ACC/AHA guidelines stipulate that PCI is not indicated for left main disease, the technology and methods for left main stenting have evolved very quickly. Nevertheless, he said, "We need two randomized clinical trials to change the guidelines showing that PCI is at least equal to CABG. I hope that LE MANS will be the first one, and others are coming soon, such as the SYTNAX trial."

As well, the multicenter, international COMBAT trial, randomizing 1000 patients to either a Cypher stent or surgery for left main disease, is poised to receive the FDA's stamp of approval, permitting it to start enrolling patients in 2006.

 

[Chief Resident]

"Down goes Frazier [CT surgery]! Down goes Frazier [CT surgery]!"

 

[Blake]

Is there any hope left for CT surgery's future in the next 50 years or is it pretty much a dying field ?

 

[Chief Resident]

Is there any hope left for CT surgery's future in the next 50 years or is it pretty much a dying field ?

Some CT programs are now (finally!) starting to train residents in the cath lab to regain ground lost to the cardiologists, but who knows how much that will help now. What's probably going to happen is some self-limiting as less surgeons take up CT fellowships and so less CT surgeons will be put out into the market each successive year until it balances out. There will always need to be CT surgeons for things cardiologists can't do, just less of them around.

 

[Pilot Doc]

Is there any hope left for CT surgery's future in the next 50 years or is it pretty much a dying field ?

1. C & T are entirely different stories. So far, the cardiologists aren't too good with lung cancer

2. There is still a need for cardiac surgery, but it will likely be a much smaller field in the future. The transition to a smaller field will be painful. Training programs need to close, and until the products of today's training program exit the market, there will be an oversupply of CT surgeons.

3. If CT can come up with an attractive new procedure (i.e. minimally invasive Maze), #2 might not happen. I don't see much future in training CT surgeons to do cath's, though. The cardiologists have that referral market well controlled.

 

[ggx12]

"Down goes Frazier [CT surgery]! Down goes Frazier [CT surgery]!"

meaning?

 

[Blake]

1. C & T are entirely different stories. So far, the cardiologists aren't too good with lung cancer

😕 CT surgeons aren't cardiologists, I never mentioned/questioned that. I know a CT surgeon who works with both lungs and heart. I suppose that's what most of them do; cardiac surgeons only (or mainly) operating the heart, thoracic surgeons working with lungs and CT surgeons working with both. Am I right ?

 

[Smoke This]

1. C & T are entirely different stories. So far, the cardiologists aren't too good with lung cancer

 

[toxic-megacolon]

😕 CT surgeons aren't cardiologists, I never mentioned/questioned that. I know a CT surgeon who works with both lungs and heart. I suppose that's what most of them do; cardiac surgeons only (or mainly) operating the heart, thoracic surgeons working with lungs and CT surgeons working with both. Am I right ?

Pretty much all cardiac surgeons (in the US) are trained to do thoracic. Not necessarily true vice versa

 

[SLUser11]

Does anybody have a reference or link to the original article discussing the LE MANS study?

 

[MD2b06]

Does anybody have a reference or link to the original article discussing the LE MANS study?

You'll have to register @ theheart.org and do a search for it.

Here's a previous articles on the topic as well:

Milan, Italy and Seoul, Korea - Two new studies this month show drug-eluting stents (DES) to be safe and effective in the treatment of unprotected left main (LM) CAD, with better results than those achieved with bare-metal stents. Both were small, nonrandomized studies, but their results suggest that even for lesions once considered the last stronghold for surgery, drug-eluting stents may have a role.

Investigators for both studies say the low complications associated with DES implantation in these difficult lesions should pave the way for larger, randomized trials comparing DES and surgery for left main (LM) disease.

One of the studies, performed by Dr Antonio Colombo's (EMO Centro Cuore Columbus, Milan, Italy) Italian group, in collaboration with Dr Goran Stankovic in Belgrade (Clinical Center of Serbia) and led by first author Dr Alaide Chieffo (San Raffaele Hospital, Milan, Italy), included 85 patients who underwent elective DES implantation and 64 who received bare-metal stents for LM CAD. Both sirolimus-eluting stents (41) and paclitaxel-eluting stents (44) were used. The decision to perform PCI instead of surgery was made on the basis of suitable anatomy and patient/physician preference or contraindications for surgery.

The authors report that despite a higher proportion of high-risk patients in the DES group, procedural success was higher in the DES group and major cardiac events were less common out to six months.


"Use of a DES to treat unprotected left main lesions appears feasible, with a very high procedural success rate (100%)," the authors write.

Their study, posted online February 7, 2005, will appear in the Feb 15, 2005 issue of Circulation.[1]


Korean study reaches similar conclusions

In a separate study, Dr Seung-Jung Park (Asan Medical Center, Seoul, Korea) and colleagues examined outcomes in 102 patients who received a sirolimus-eluting stent for unprotected LM disease, comparing these with outcomes in a historical control group that had received a bare-metal stent. Their findings appear in the February 1, 2005 issue of the Journal of the American College of Cardiology.[2]

As with Chieffo et al's study, patients receiving sirolimus-eluting stents tended to have more complicated lesions requiring more stents in Park et al's study. Nevertheless, procedural success was 100% for both groups, with no deaths, thrombosis, MI, or emergent bypass surgery. At six months, however, sirolimus-eluting-stent patients had lower late lumen loss and a lower restenosis rate than bare-metal-stent-treated patients. At 12 months, the rate of freedom from death, MI, and target lesion revascularization (TLR) was also slower in the sirolimus-eluting-stent group, driven entirely by TLR.

Of note, sirolimus-eluting-stent-treated patients had a high proportion of bifurcation lesions (71% compared with 43%), and bifurcation lesions were associated with a higher overall restenosis rate (9.8% in the sirolimus-eluting-stent group). As the authors point out, bifurcation left main coronary artery lesions "are considered inappropriate for percutaneous intervention," and their findings indicate that "treatment of bifurcation lesions remains challenging even in the era of drug-eluting stents."

Still, they add, "The present results showing very low restenosis rates in the main vessel and a very low frequency of target lesion revascularization indicate that the [left main coronary artery] bifurcation may become an inviting target for percutaneous intervention with sirolimus-eluting stents."

Overall, they conclude, "These data encourage the undertaking of a large, long-term, multicenter randomized study to compare SES implantation and bypass surgery for unprotected LM coronary artery stenosis."

Commenting on the two studies for heartwire, Dr Donald Baim (Brigham and Women's Hospital, Boston, MA) noted that the angiographic restenosis rate for the DES-treated patients in Park et al's study was lower than that seen in Chieffo et al's study, a difference partly explained by the higher proportion of distal bifurcation lesions in the latter study (88% vs 70%) and the manner in which these lesions were managed.

Overall, Baim comments, "Results of left main stenting are clearly better with DES than bare-metal stents, but the most common location (at the bifurcation) still has a variety of stent placement approaches." As well, there is "clear variability" in outcomes, as evidenced by the different angiographic restenosis rates in the two studies. "Pending a randomized trial to standardize technique and compare DES head to head with CABG, CABG should still remain the default therapy for unprotected nonostial/mid-shaft lesions in patients who are good surgical candidates," he concluded. .


So my question is are any randomized studies currently being done comparing solely DES vs CABG for Left main disease? It would've been interesting to see what the results of the LE MANS study would show if they would have used a DES in all patients. The recommendation from the AHA, based on their meeting a couple of weeks ago, is still CABG for left main disease, w/ PCI being a reasonable option for those patients not eligible for surgery. Not sure how long they'll stick with that.

 

[SLUser11]

Thanks for the reply, I registered with theheart.org.

As far as your question goes, I'm sure there are several head-to-head trials currently being conducted.

My understanding is that the main hindrance to PCI with drug-eluting stents being indicated for Left main disease is that IF there is an adverse outcome, eg vessel perforation, then you can't do much to save the patient percutaneously, and you've compromised 75% of the heart's perfusion.