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A major international study has found that drug-eluting stents, a less-invasive alternative to bypass surgery, is as safe and effective as surgery for most patients with a blockage in the left main coronary artery.

Findings from the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial were published this morning online in the New England Journal of Medicine and presented at the annual Transcatheter Cardiovascular Therapeutics conference in Washington, D.C. The trial research team included interventional cardiologists and cardiac surgeons from 126 centers in 17 countries.

Coronary artery bypass graft (CABG) surgery has long been considered the definitive treatment for patients with left main coronary artery disease (LMCAD), in which the main artery that supplies oxygen-rich blood to the heart is clogged with atherosclerotic plaques. About two-thirds of all LMCAD patients have mild to moderate disease.

“Patients with mild or moderate left main coronary artery disease who prefer a minimally invasive approach can now rest assured that a stent is as effective as bypass surgery, and may even be slightly safer,” said first author Gregg W. Stone, MD, professor of medicine at Columbia University Medical Center and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia.

Stents, which are placed into the diseased artery via a catheter that is inserted through a small opening in a blood vessel in the groin, arm, or neck, are a less-invasive treatment option for many people with coronary artery disease. However, coronary artery bypass surgery (CABG) has long been considered the definitive treatment for patients with LMCAD, which affects a large portion of the heart muscle. Previously, randomized clinical trials suggested that first-generation drug-eluting stents, which release anti-proliferative medications to prevent the artery from becoming re-occluded after stent placement, might be appropriate for patients with less severe LMCAD. The trial results, however, were inconclusive.

“Since that time, stents have gotten better, and so has CABG surgery,” said Dr. Stone. “That required us to take a fresh look at the relative safety and effectiveness of the two approaches.”

In the current study, 1,900 patients with LMCAD of low-to-intermediate complexity (as determined by scores on SYNTAX, an angiographic tool for measuring disease severity) were randomized to receive a drug-eluting stent that releases the anti-proliferative agent everolimus (XIENCE, made by Abbott Vascular of Santa Clara, CA) or bypass surgery. The patients were followed for at least two years, with a median follow-up of three years.

“We found that approximately 15 percent of patients in both groups had a heart attack or stroke or died within three years,” said Dr. Stone, lead author of the paper. “In other words, the stents were just as good as bypass surgery.”

The researchers also analyzed what happened to the patients in the first 30 days after treatment, when serious complications are most likely to occur. Within that period, stent patients had a significantly lower incidence (4.9 percent) of death, stroke, heart attack, or revascularization than those who had bypass surgery (7.9 percent).

The researchers reported that bypass surgery is still the best therapy for those with severe LMCAD, although the study did not include patients with severe disease.

“Our study establishes stents as an acceptable or preferred alternative for patients with LMCAD of low-to-intermediate complexity—or about two-thirds of all LMCAD patients,” said Dr. Stone. “While CABG is considered a more durable repair, patients may prefer a percutaneous treatment approach, which is associated with better upfront results, fewer complications, and quicker recovery.”

About Coronary Artery Disease

Coronary artery disease (CAD), the most common form of heart disease in the U.S., results from the buildup of atherosclerotic plaques in the arteries that supply oxygenated blood to the heart. CAD frequently leads to strokes or heart attacks, killing more than 370,000 people annually, according to the Centers for Disease Control and Prevention. The left main artery, the primary supply of blood to the heart, is affected in about 10 percent of people with CAD.

The study is titled, “Comparison of Everolimus-Eluting Stents and Bypass Graft Surgery in Selected Patients with Left Main Coronary Artery Disease.” The other contributors are: Joseph F. Sabik (Cleveland Clinic Foundation, Cleveland, OH); Patrick W. Serruys (International Centre for Circulatory Health, NHLI, Imperial College London, London, UK); Charles A. Simonton (Abbott Vascular, Santa Clara, CA); Philippe Généreux, Erick Schampaert, and Pierre Pagé (Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada); John Puskas and Roxana Mehran (Mount Sinai Hospital, New York, NY); Nicholas Lembo, David E. Kandzari, and W. Morris Brown, III (Piedmont Hospital, Atlanta, GA); Marie-Claude Morice (Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France); David Taggart and Adrian Banning (John Radcliffe Hospital, Oxford, UK); Béla Merkely and Ferenc Horkay (Semmelweis University, Budapest, Hungary); Piet W. Boonstra and Ad Johannes van Boven (Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands); Imre Ungi and Gabor Bogáts (University of Szeged, Szeged, Hungary); Samer Mansour and Nicolas Noiseux (Hôpital Hôtel-Dieu de Montréal, Montréal, Québec, Canada); Manel Sabaté and Jose Pomar (Hospital Clinic, Barcelona, Spain); Mark Hickey and Anthony Gershlick (University Hospitals of Leicester NHS Trust, Leicester, UK); Pawel Buszman and Andrzej Bochenek (Medical University of Silesia, Katowice, Poland and American Heart of Poland, Ustron, Poland); Ovidiu Dressler (Cardiovascular Research Center, New York, NY); Ioanna Kosmidou (NewYork-Presbyterian, New York, NY); Stuart J. Pocock (London School of Hygiene and Tropical Medicine, London, UK); and Arie Pieter Kappetein (Erasmus Medical Center, Rotterdam, The Netherlands).

The study was sponsored and funded by Abbott Vascular, Santa Clara, CA.

The authors report no other conflicts of interest.

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