Weighing Revascularization Options in Multivessel Disease

Experts agree: PCI and CABG equally effective in select patients with multivessel disease.

Despite the evolution of technological and clinical advancements in PCI and CABG for revascularization among patients with multivessel disease, significant challenges remain.

	David P. Faxon

“The primary interventional issues relate to the anticipated success and risk of the procedure,” David P. Faxon, MD, vice chair of medicine for strategic planning at Brigham and Women’s Hospital, Harvard Medical School, Boston, and Cardiology Today Intervention Editorial Board member, said in an interview. “These patients have multiple lesions that are often more complex and require a carefully laid out strategy to obtain the goal of therapy.”

Such goals, according to Faxon, include delaying and/or preventing complications of CAD and ultimately prolonging life and improving patient’s quality of life by decreasing symptoms.

Making the Right Choice

	Dean J. Kereiakes

The choice of revascularization procedure needs to be weighed carefully, both in terms of approaching multivessel cases and choosing the optimal device, said Dean J. Kereiakes, MD, medical director of The Christ Hospital Heart and Vascular Center in Cincinnati.

“You need not [choose] first-generation, but second- and third-generation drug-eluting stents that have more flexibility and deliverability,” Kereiakes said. “We need to try to achieve optimal stent deployment and complete revascularization, and at the same time not forget the importance of adjunct pharmacotherapy, which is procedural and post-procedural,” he told Cardiology Today Intervention.

Stenting vs. surgery depends on many factors that remain a challenge for the interventional cardiologist’s effort to care. Such factors can include the number of blockages the patient has; severity and complexity of their condition; left ventricular ejection fraction; degree of revascularization; severity of atherosclerosis; and numerous other clinical factors, such as the patient’s age and various comorbidities, including diabetes.

“In general, complete revascularization of all ischemic territories is optimal, but in some circumstances, it may not be possible due to the anatomy or needed when a clear culprit can be identified and the goal is relief of symptoms,” Faxon said.

A number of studies to date are showing that PCI is equal to CABG in select patients with multivessel disease, such as those with low SYNTAX scores.

According to Gregg W. Stone, MD, professor of medicine at Columbia University Medical Center, New York, and Editorial Board member of Cardiology Today Intervention, whether to perform PCI or CABG presents a major challenge in treating patients with multivessel disease. “Both PCI and CABG play a very important role in patients with multivessel disease, and revascularization is warranted in patients with significant symptoms and/or at least moderate ischemia,” Stone said. “The SYNTAX score has proven useful to differentiate patients who do better with either PCI or CABG.”

	Gregg W. Stone

Ultimately, determining the right revascularization method should be a decision made by the interventionalist, referring cardiologist, surgeon and patient, all weighing the risks and benefits of each procedure for the individual patient, according to Stone.

“Once the option is decided upon, we need to use the appropriate devices, pharmacologic agents and techniques to ensure safe, early and long-lasting outcomes,” he said. “Moreover, both surgeons and interventionalists need to ensure that all patients are treated with optimal medical therapy, in addition to either PCI or CABG.”

A Closer Look at PCI vs. CABG

A number of trials have compared PCI to CABG, including the SYNTAX trial, which recently debuted 4-year follow-up results at the 23rd Annual Transcatheter Cardiovascular Therapeutics in San Francisco. According to results, patients with three-vessel disease exemplified more benefit from CABG than PCI; however, among those with left main disease, both treatment options were equally effective.

Patrick W. Serruys, MD, PhD, professor of interventional cardiology, Thoraxcenter, Erasmus Medical Center in Rotterdam, the Netherlands, presented overall results of the SYNTAX trial, showing that among patients with three-vessel disease, those who received CABG had superior results at 4 years.

In addition, in a subset of patients with left main disease, MACCE in the PCI group (Taxus Express, Boston Scientific) was 33.2% compared with 27.8% in the CABG group (P=.14). Safety outcomes, a composite of death, CV accident and MI, were comparable as well (PCI, 17.1% vs. CABG, 17.7%; P=.25). There was a higher rate of repeat revascularization among those in the PCI group (23.5% vs. 14.6%; P=.003), while a higher rate of CV accidents was observed in the CABG arm (4.3% vs. 1.5%; P=.03).

Overall, Marie-Claude Morice, MD, director of interventional cardiology, Institute Hospitalier Jacques Cartier, Massy, France, and fellow SYNTAX investigator, concluded during her presentation at TCT 2011 that revascularization with PCI has comparable safety and efficacy outcomes to CABG. “PCI is therefore a reasonable treatment alternative in [patients with three-vessel disease], in particular when the SYNTAX score is low (< 22) or intermediate (22-32),” she said.

Stone commented that these results of the SYNTAX trial showed that overall, “for eligible patients with left main disease, the results are favorable for PCI compared with surgery at 4-year follow-up, although patients with [the] highest SYNTAX score did have better outcomes with surgery.”

On the Horizon

Improving outcomes of PCI in general is a hot topic in the interventionalist’s arena, according to Stone. And, although treatment with DES is improving with lower rates of stent thrombosis and restenosis, Faxon said the effect of newer DES in multivessel disease is still not clear.

“If these newer devices can reduce risk of stent thrombosis and improve outcomes, then there may be a bigger role of multivessel stenting,” Faxon said. “In addition, we do not know if complete revascularization is an advantage in patients with ACS, particularly among STEMI patients where culprit lesion angioplasty has been the norm.”

Using the best tool that improves safety and efficacy when tackling the most complex disease also remains an issue, Kereiakes said, specifically when it comes to DES.

“Multivessel PCI is a moving target. As we speak, there are improvements in DES platforms, and it is important to remember that not all DES are created equally. There are also improvements in adjunct pharmacotherapy, and in our understanding of optimizing procedural and late outcomes of PCI,” he said. “Finally, there are improvements in surgical techniques and outcomes in CABG as well.”

Anticipated results of numerous studies may help pave the way for which road to take in the treatment of patients with multivessel disease.

Results of the FREEDOM trial, which randomly assigned patients with diabetes and multivessel disease to DES vs. surgery, are scheduled for presentation sometime in 2012, as well as the 5-year results of the SYNTAX trial, which are expected to show an even stronger advantage for CABG.

In addition, the FAME2, EXCEL and NOBLE trials are all eagerly awaited and ongoing, according to Stone and Kereiakes. FAME2 will look at fractional flow reserve-guided PCI plus optimal medical treatment (OMT) vs. OMT alone in patients with stable CAD; EXCEL will examine DES vs. CABG in patients with unprotected left main CAD; and NOBLE will investigate DES vs. CABG in patients with unprotected left main stenosis.

“We will be gaining more insight from studies demonstrating the importance of ischemia or abnormal fractional flow reserve, how to better choose the devices and drugs we are using, and how to enhance procedural safety and long-term outcomes for patients,” Stone said.

All in all, experts agree that aggressive efforts to reduce risk factors for CHD — such as low-dose aspirin, avoiding smoking, controlling glucose levels in patients with diabetes and properly treating hypertension and lipid levels — are an important precursor to the decision of PCI or CABG.

For Kereiakes, this is all part of the process of the evolution taking place right now in the treatment of coronary disease. However, “I am, even with second-generation stent technology, still challenged by complex multivessel disease … and I hope that we don’t become complacent in the evolution of stent platform technology,” he said. – by Tara Grassia

References:

• Baber U. J Am Coll Cardiol. 2011;58:1569-1577.

• Kereiakes DJ. J Am Coll Cardiol. 2011;57:E1643.

• Kereiakes DJ. J Am Coll Cardiol Intv. 2010;3;1229-1239.

• Kushner FG. Circulation. 2009;120:2271-2306.

• Serruys PW. J Am Coll Cardiol. 2011;58:B15.

• Wijns W. Eur Heart J. 2010;31:2501-2555.

Disclosure: Drs. Faxon, Morice and Serruys report no relevant financial disclosures; Dr. Kereiakes is on the scientific advisory boards for Abbott Vascular, Boston Scientific, Reva Medical, and is a consultant for Medtronic; Dr. Stone is a consultant for Abbott Vascular, Boston Scientific and Medtronic.