OPTIMIZE: Short-term DAPT Safe 2 Years After ZES Implantation
Three months of dual antiplatelet therapy (DAPT) matches the safety of the standard 12-month regimen out to 2 years in patients who receive zotarolimus-eluting stents (ZES), researchers reported at TCT 2014.
For the OPTIMIZE trial, Fausto Feres, MD, PhD, of the Instituto Dante Pazzanese de Cardiologia in Sao Paolo, Brazil, and colleagues randomized 3,119 patients at 33 sites in Brazil to either 3-month (n=1,563) or 12-month DAPT (n=1,556) from April 2010 to March 2012. All patients had stable CAD or history of low-risk ACS and underwent PCI with the Endeavor ZES (Medtronic).
Notably, DAPT beyond 12 months was lower than 5% in both groups. At 2 years, there were no differences between 3- and 12-month DAPT in rates of the primary endpoint of net adverse clinical and cerebral events (NACCE; all-cause death, MI, stroke or major bleeding), its individual components or death. However, the 2-year rate of MACE (death, MI, emergent CABG or target lesion revascularization) was higher in the 3-month DAPT group (see Table).
In a landmark analysis where event rates were reset after the first 3 months, 2-year NACCE rates still did not differ with 3- and 12-month DAPT duration (6.4% vs. 4.9%; P=.08).
Stent thrombosis (0.3% vs. 0.2%; P=.71) and bleeding (0.4% vs. 1.0%; P=.53) were rare, and rates were similar in both the short- and long-term DAPT groups.
Feres said the results are not surprising based on previous studies that have suggested the safety of short-term DAPT in this patient subset. “In addition, several studies with invasive imaging modalities demonstrated an absence of delayed healing or signs of local toxic reaction to the device’s components at an early phase after PCI,” he said, which gave further confidence that 3-month DAPT could be acceptable.
“Our study is one of several randomized and observational studies that suggest that shorter DAPT regimens, whether 3 or 6 months, could be considered with second-generation DES in various clinical scenarios — of course excluding STEMI,” Feres told TCT Daily. “However, such decisions are not always easy to make in clinical practice, and we have to recognize that there could be some [patients with] specific conditions that might benefit from prolonged DAPT.”
- OPTIMIZE was funded by Medtronic.
- Feres reports receiving consultant fees/honoraria from Biosensors, Eli Lilly and Medtronic.