Mock Jury Votes on DAPT Duration: 12 Months Remains Best Option for Most Patients

SAN FRANCISCO, CALIF.—A 12-member panel of a mock trial on dual antiplatelet therapy treatment duration voted 7-5 in support of guidelines that recommend 12 months of therapy following DES implantation.

As part of the session titled International Debating Chamber: Interventional Cardiology on Trial, Marco Valgimigli, MD, PhD, of Ferrara Cardiovasuclar Institute, Ferrara, Italy, and Daniel I. Simon, MD, of the University Hospitals Case Medical Center, Cleveland, provided pros and cons regarding the duration of DAPT for patients undergoing PCI with DES.

Con

Valgimigli argued in favor of the motion that current guidelines are wrong and that prolonged DAPT is unnecessary for most patients undergoing PCI with DES.

“Current guidelines recommendations have most likely overemphasized the benefit over the risk of long-term treatment with aspirin and clopidogrel [Plavix, Sanofi-Aventis/Bristol-Myers Squibb],” Valgimigli said. “Six months of DAPT after DES implantation is reasonable and should become the standard of care in patients who are not at low bleeding risk.”

Pro

Simon argued against the motion and said the more potent the therapy, the better it is for the patient, adding that evidence does exist from adequately powered trials. Simon said there are far more studies to support longer use of DAPT (≥12 months) compared with studies that support shorter duration of therapy (6 months).

According to Simon, the CREDO, CHARISMA, CURE, TRITON-TIMI 38 and PLATO trials have patient populations totaling more than 59,000 and all support longer therapy. “However, only the EXCELLENT and PRODIGY studies, with a patient population of about 3,400 patients, support the shorter duration,” he said.

After the panel members discussed various issues that can affect treatment duration, C. Michael Gibson, MD, of Beth Israel Deaconess Medical Center, Boston, concluded the session by summarizing the comments from the debate. An important point, he told the audience, is to “not focus too strongly on the shape of the Kaplan-Meier curves but to become more quantitative.”

Regarding the 59,000 patients that Simon mentioned as evidence for treating the patient with DAPT for 12 months, Gibson advised the panel members and audience not to be swayed too strongly.

“The data [on the 59,000 patients] looks quantitative but it is not randomized. When comparing it with randomized data on 3,000 patients, I would still side with the randomized data,” Gibson said. “I find that much more compelling.”

Predicting the weather

Gibson also said physicians must be diligent about understanding the risk of each patient rather than the risk of implanting a certain stent.

“Different stents in different patients may have different outcomes,” he said. “Trying to predict who is going to develop stent thrombosis is like trying to predict the weather. It may be cloudy, but I can’t tell you if there will be lightning and I sure can’t tell you where that lightning bolt is going to strike.”

While there are currently no tools to predict and guide physicians on which stent to use in which patient, there may be some on the horizon, according to Gibson. He also said the panel deliberation and vote provided more evidence that additional studies are needed on duration of treatment of 6 months vs. 12 months.

“I think the jury is still out,” Gibson said.