PROTECT Confirms Long-Term Safety of DES

August 27, 2012—The 3-year results of the PROTECT trial were presented at the 2012 European Society of Cardiology (ESC) congress in Munich, Germany, confirming the long-term safety of drug-eluting stents in the treatment of coronary artery disease in real-world clinical practice. William Wijns, MD, one of the study's co-principal investigators, presented the data as part of a late-breaking session. The results were simultaneously published online in The Lancet. 

PROTECT is an open-label, multicenter, randomized, superiority trial involving more than 8,700 patients at 196 centers in 36 countries, and looked at the occurrence of stent thrombosis. Patients (N = 8,709) were randomly assigned to receive the Endeavor zotarolimus-eluting stent (Medtronic, Inc., Minneapolis, MN) or the Cypher sirolimus-eluting stent (Cordis Corporation, Bridgewater, NJ) in equal numbers. The investigators reported a low rate of definite/probable stent thrombosis with no statistically significant difference in cumulative rates through 3 years of follow-up (1.42% for Endeavor; 1.79% for Cypher; P = .224). Stent thrombosis rates after 1 year (very late stent thrombosis), however, were said to be significantly lower with the Endeavor stent (0.3%) compared to the Cypher stent (1.1%) (P < .001).

“Based on its excellent clinical outcomes and low rates of stent thrombosis through 3 years of follow-up, PROTECT confirms the long-term safety of percutaneous coronary intervention with these drug-eluting stents,” said Dr. Wijns, an interventional cardiologist and co-director of the Cardiovascular Center in Aalst, Belgium in a Medtronic press release. “The decline in stent thrombosis rates since the initial concern emerged at ESC 2006 cannot be denied. This likely results from a combination of factors: improvements in patient selection and procedural techniques, and duration and/or compliance with dual-antiplatelet therapy.”

Dual-antiplatelet therapy usage in PROTECT followed current ESC and AHA/ACC/SCAI guidelines, with 88% of patients remaining on dual-antiplatelet therapy at 1 year and 30% of patients at 3 years.

PROTECT's secondary endpoints resulted in low, comparable rates of death and large, nonfatal myocardial infarction through 3 years of patient follow-up (5.3% for Endeavor; 6% for Cypher; P = .16). Also of note were the low rates of target vessel revascularization at 3 years (8.2% for Endeavor; 7.1% for Cypher; P = .03).