TCT: OPTIMIZE supports 3-month DAPT in some patients

SAN FRANCISCO—Some patients implanted with a newer generation drug-eluting stent (DES) may safely discontinue dual antiplatelet therapy (DAPT) at three months, results from the OPTIMIZE trial presented Oct. 31 at the Transcatheter Cardiovascular Therapeutics (TCT) scientific session in San Francisco showed.  

“With this kind of stent, we might not always require DAPT to reduce the risk of adverse thrombotic events,” lead investigator Fausto Feres, MD of the Instituto Dante Pazzanese de Cardiologia in São Paulo, Brazil, told Cardiovascular Business. “We are not saying stop at three months, but if you need to do that, you can do that safely.”

OPTIMIZE (OPTIMIzed Duration of Clopidogrel Therapy Following Treatment with the Endeavor Zotarolimus-Eluting Stent in Real-World Clinical Practice) is a prospective, multicenter, randomized noninferiority clinical trial designed to compare two different durations of aspirin plus clopidogrel (Plavix, Bristol Myers-Squibb/Sanofi Aventis). Guidelines recommend one year of DAPT after implantation of DES, but research is emerging that challenges a prolonged duration.

The OPTIMIZE trial enrolled 3,120 patients with stable coronary artery disease and randomized them to receive either a three-month term of DAPT or a 12 month term. PCI was performed using the Endeavor (Medtronic) zotarolimus-eluting stent, a second-generation device. The primary endpoint was a composite of net adverse clinical and cerebral events (NACCE), which included death from any cause, MI, stroke or major bleeding at one year follow-up.

One-year results showed that short-term DAPT appeared to be safe. Patients in the short-term group had a NACCE rate of 6 percent compared with 5.8 percent in the long-term group.

“We have proven that short-term [DAPT] is not inferior to 12-month [DAPT],” he said at a press conference. “Our prospective, randomized trial showed that second-generation DES might not always require 12 months DAPT to reduce the risk of adverse thrombotic events.”

Patients who are at high risk of bleeding complications, such as elderly patients with a history of bleeding or those in need of noncardiac surgery within a year of their procedure, likely will benefit from the findings. “The benefit of our study will be for patients at high risk for bleeding, although we did not study them here,” Feres said in the interview.

At the press conference, discussant Cindy L. Grimes, MD, of the Detroit Medical Center in Michigan, said the findings will be helpful in practice. “I try to individualize,” she said. A patient with long stents or risk factors such as diabetes or acute coronary syndrome would benefit from the longer duration DAPT. “I see this as being helpful for the short, more focal stents that you think are not high risk for stent thrombosis. If you follow the protocol, I think this would be safe in low-risk patients to stop at three months.”

Pieter Kappetein, MD, PhD, of the Thoraxcenter at Erasmus Medical Center in Rotterdam, The Netherlands, said as a cardiac surgeon, he welcomed the results. “The sooner you can stop the better for us,” he said. “If we operate on these patients with dual antiplatelet therapy there is always [the risk of] more bleeding events.”

The study will include follow-up to three years. It was funded by Medtronic Comercial in São Paulo, Brazil.