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Short-term DAPT after PCI with DES deemed safe, but further study needed
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After implantation of a drug-eluting stent with a biodegradable abluminal coating, 6-month dual antiplatelet therapy was noninferior to 18 months of dual antiplatelet therapy.
The results of the NIPPON study, however, showed a wide noninferiority margin, so the researchers wrote that they should be interpreted with caution.
“On the basis of current knowledge, the combination of short-term DAPT and a second-generation DES with a biodegradable abluminal coating should simultaneously minimize the incidence of thrombotic events and bleeding complications,” Masato Nakamura, MD, PhD, from the division of cardiology at Toho University Ohashi Medical Center in Tokyo, and colleagues wrote. “Therefore, we hypothesized that a short duration of DAPT might be acceptable with this new type of stent.
Researchers enrolled 3,773 patients with stable CAD or ACS undergoing implantation of the DES with a biodegradable abluminal coating (Nobori, Terumo) in the multicenter randomized controlled trial.
Patients were randomly assigned to either 6-month or 18-month DAPT.
Net adverse clinical and cerebrovascular events including all-cause mortality, MI, stroke and major bleeding from 6 to 18 months after stenting was the primary endpoint.
A total of 3,307 patients underwent intention-to-treat analysis for at least 6 months.
There was an occurrence of net adverse clinical and cerebrovascular events in 2.1% and 1.5% of patients receiving short-term and long-term DAPT, respectively (difference, 0.6%; 95% CI, 1.5-0.3).
Noninferiority of short-term DAPT was confirmed due to the 95% CI being inside thespecified margin of –2%.
There was a mortality rate of 1% with short-term DAPT vs. 0.4% with long-term DAPT, an MI rate of 0.2% vs. 0.1%, and a major bleeding occurrence rate of 0.7% vs. 0.7%, respectively.
According to the researchers, the estimated probability of net adverse clinical and cerebrovascular events was lower in those assigned long-term DAPT vs. short-term DAPT (HR = 1.44; 95% CI, 0.86-2.43).
“The results need to be interpreted with caution due to premature termination of enrollment and the open-label design with a wide noninferiority margin,” Nakamura and colleagues wrote.
In a related editorial, John A. Bittl, MD, from the Munroe Regional Medical Center in Ocala, Florida, and colleagues wrote that the trial is inconclusive.
“Although prematurely stopped trials may provide useful information about the safety of new treatments, they are underpowered and often add statistical noise to systematic reviews,” they wrote. “Future research should determine whether the present findings are relevant only to trials of DAPT duration or whether a prematurely stopped trial in other disciplines differs from a completed trial.” – by Dave Quaile
Disclosures: Nakamura reports receiving grants and honoraria from Daiichi-Sankyo, Sanofi and Toranomon. Please see the full study for a list of the other researchers’ relevant financial disclosures. The editorial authors report no relevant financial disclosures.
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