OPTIDUAL: No Clear Need to Lengthen DAPT to 4 Years After DES
LONDON, England—Extending dual antiplatelet therapy (DAPT) from 12 to 48 months provides no added protection against adverse events following DES implantation among patients with no adverse events in the first year. Nor does it up the risk of major bleeding, according to data reported August 31, 2015, at the European Society of Cardiology Congress.
For the 58-center OPTIDUAL trial, Gérard Helft, MD, PhD, of Hôpital Pitié-Salpêtrière (Paris, France), enrolled 1,385 patients who had received DES 1 year prior and were on aspirin and clopidogrel but had not experienced MACCE or bleeding. Patients were randomized to continue receiving the same DAPT or switch to aspirin alone for the next 36 months. Follow-up was conducted at 6-month intervals between 12 and 48 months after DES implantation.
Second-generation DES were used in two-thirds of cases and first-generation DES in the remaining one-third, Dr. Helft said at a press conference.
There were no differences for the primary outcome of net adverse clinical events (NACE; composite of all-cause death, nonfatal MI, stroke, or major bleeding) between extended DAPT (5.8%) and aspirin alone (7.5%; P = .17). Risks of its components also were equivalent. However, post-hoc analysis of ischemic outcomes (death, stroke, or MI) showed a hint of benefit, with event rates of 4.2% in the extended DAPT group and 6.4% in the aspirin group (table 1).
Results were consistent in various prespecified subgroups including PCI indication and stent type, Dr. Helft reported. The rate of stent thrombosis was “very low [below 0.5%] in both groups and did not differ,” he added.
Choice of DAPT Duration ‘Difficult’
The optimal duration of DAPT after DES placement “remains very debated,” Dr. Helft said. “Few studies have addressed the specific question of very long-term DAPT. Therefore, we were keen to demonstrate that, on a background of aspirin, continuing clopidogrel for up to 48 months would be superior to stopping clopidogrel at 12 months… in reducing net adverse clinical events.”
Yet that hypothesis was not fulfilled, at least not to the point of statistical significance. Asked what regimen he would choose when treating his own patients, Dr. Helft replied that the “answer remains difficult.”
Noting that the OPTIDUAL results are “consistent”with those of the study, he explained that it is hard to apply one strategy to across the board. “I think that if your patient is at low bleeding risk, you may consider extending DAPT beyond 12 months,”Dr. Helft advised. “But once again, it’s a case-by-case decision and a difficult decision.
Worth remembering, he said, is that the study population was at low risk of bleeding and that consent was obtained and patients randomized at 1 year after PCI. Thus, it is possible that physicians would be less likely to enroll patients they believed would benefit from extended PCI, Dr. Helft acknowledged.
Findings Dovetail With DAPT Trial
Following Dr. Helft’s presentation in a Hot Line session, discussant Lars Wallentin, MD, PhD, of University Hospital (Uppsala, Sweden), said that, from his perspective, the OPTIDUAL findings “definitely support the DAPT results” backing extended therapy. In addition, he said, adverse event rates are very low.
“I think we need better risk stratification when we decide on long-term treatment” that not only offers opportunity for benefit but also increases bleeding risk, Dr. Wallentin suggested. These tools are needed both in research and clinical settings and can be derived from currently available information, he said.
Another lesson from OPTIDUAL is that “independent”trials such as this one—which was terminated early due to lack of resources and to slower enrollment than anticipated—deserve greater support, Dr. Wallentin concluded. “The outcome of the OPTIDUAL trial emphasizes the need to strengthen the networks, infrastructure, resources, and funding for initiation, performance and finalization of adequately sized independent clinical trials in Europe.”
Helft G. Twelve vs 48 months of dual antiplatelet therapy after drug-eluting stent placement: the OPTIDUAL randomized trial. Presented at: European Society of Cardiology Congress; August 31, 2015; London, England.
- OPTIDUAL was funded by the French Ministry of Health. Additional unrestricted research grants from Biotronik, Boston, Cordis, Fédération Française de Cardiologie, Medtronic, and Terumo.
- Dr. Helft reports no relevant conflicts of interest.