Heart & Vascular Institute Physician eNewsletter - Fall 2011
Surgery has always been the go-to treatment for patients with left main disease, which can compromise up to 70 percent of blood flow to the heart. But percutaneous coronary intervention could be an option for well-selected patients with the disease, and neutral outcomes from recent randomized trials where patients received angioplasty and stents further position interventional therapy as a viable option for some patients.
Cleveland Clinic’s Stephen Ellis, MD, Section Head of Invasive and Interventional Cardiology in the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the Sydell and Arnold Miller Family Heart & Vascular Institute, assembled the largest international registry of left main stenting in the late 1990s. Here, he shares how Cleveland Clinic has been at the forefront of exploring percutaneous coronary intervention for left main and other high-complexity lesions, including embarking on the largest trial of its kind, called EXCEL: the definitive unprotected left main randomized trial.
The EXCEL trial, which is led in part by Dr. Joseph Sabik, surgical co-principal investigator of the trial and chairman of Thoracic and Cardiovascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute, will include 2,500 consenting patients with simple and intermediate anatomic complexity. The patients will be randomly assigned to undergo surgery or stenting. This large trial follows two moderate-sized trials that began to validate Cleveland Clinic's work in carefully selecting patients with left main blockages who would perform well with percutaneous coronary intervention rather than surgery.
"Up until about three years ago, treatment of left main blockages was largely considered in the domain of open heart surgery because it had been shown in previous randomized trials to be better than medical therapy, and because of hazards posed with angioplasty and stenting if anything went wrong," Dr. Ellis says, noting that the risk is greater because of the complexity of left main blockages and because so much heart muscle is at stake.
Still, clinical trials are proving that interventional therapy can as good or better for some patients with significant blockages. One of the first was SYNTAX, which randomized patients with left main disease between surgery and angioplasty with stenting. SYNTAX included about 800 patients, and left main disease was one of the two components of the study. "The study was largely a draw," Dr. Ellis says of the clinical outcomes of patients who had surgery vs. those with angioplasty and stenting. "It suggested that stenting was reasonably safe."
Patients involved in SYNTAX were followed for three years, for death, heart attack, stroke and need for further revascularization. Those patients involved also had relatively simple and complex anatomy. "It turns out that those with complex anatomy did better with the surgery whereas patients with more simple and intermediate anatomy tended to perform well with stenting," Dr. Ellis shares. Another randomized trial called PRECOMBAT – performed in Asia after the Syntax trial – confirmed those findings.
Meanwhile, further investigations have suggested that the anatomic score of simple, intermediate and complex blockages – guidelines set by the American College of Cardiology and American Heart Association for patient management – don’t tell the whole story of whether a patient is a candidate for surgery or angioplasty/stenting. In fact, new guidelines that will be released later this year likely will suggest that patients with a grading of 2A are candidates for stenting, compared to the current 2B classification.
Regardless, Dr. Ellis says, "Sophisticated clinicians and surgeons will make decisions based on that anatomic complexity and the array of clinical findings that are generally encompassed by the EURO score."
Surgery is still the gold standard for many patients suffering from left main disease. But physicians should have a measured discussion with patients and families about interventional alternatives, Dr. Ellis says. "Stenting must be done in the right context and with the right form of patient consent," he says.
As with other interventional therapies, patients with left main blockages who receive angioplasty and stenting experience faster recovery times, shorter hospital stays and can return to daily activities sooner.
"When you look at medicine as a whole, there has been a trend toward less invasive procedures and you see that across a whole breadth of surgery," Dr. Ellis says. "This is an example of the less invasive procedure becoming safer and safer. At Cleveland Clinic, we have been at or near the forefront of exploring this treatment option and it’s nice to see it validated in a large trial."