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ITALIC: Outcomes comparable for 6 vs. 24 months of DAPT after PCI
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CHICAGO — Rates of bleeding and thrombotic events in the ITALIC trial were not significantly different in aspirin-tolerant patients who received 6-month or 24-month dual antiplatelet therapy after PCI with a new-generation drug-eluting stent.
The ITALIC trial included patients with confirmed non-resistance to aspirin undergoing implantation of a DES (Xience V, Abbott Vascular) who were randomly assigned to receive 6-month DAPT (n=953) or 24-month DAPT (n=941). Martine Gilard, MD, PhD, and colleagues hypothesized that DAPT for 6 months may be noninferior to DAPT for 24 months in patients undergoing PCI who could tolerate aspirin. The trial was terminated prematurely because of problems with recruitment, Gilard said.
The primary outcome was a composite of death, MI, urgent target vessel revascularization, stroke and major bleeding at 12 months after DES implantation.
Patients with resistance to aspirin were excluded to make sure they would be protected by their antiplatelet therapy, Gilard, from the department of cardiology at Brest University, Brest, France, said at a press conference.
Gilard and colleagues reported no difference between the groups in the primary endpoint (24-month DAPT, 1.5% vs. 6-month DAPT, 1.6%; HR=1.072; 95% CI, 0.517-2.221; P=.85). “However, the [event] rates were very low, and we were far from the boundary,” Gilard said, noting that an event rate of 3% was expected.
The researchers demonstrated noninferiority for 6-month DAPT vs. 24-month DAPT (absolute risk difference, 0.11%; 95% CI, –1.04 to 1.26; P for noninferiority=.0002), and found no significant differences in stent thrombosis and bleeding complications.
Gilard and colleagues also conducted an analysis of 792 high-risk patients with ACS. They found no difference in the primary endpoint between patients in that population assigned 6-month or 24-month DAPT (24-month DAPT, 1% vs. 6-month DAPT, 1.8%; HR=1.773; 95% CI, 0.519-6.057; P=.361). They also found no differences in any secondary endpoints, including stent thrombosis and any kind of bleeding.
No significant interaction between DAPT duration and ACS emerged (P=.305).
“The rate of bleeding and thrombotic events was not significantly different between 6 and 24 months after PCI with a new-generation DES,” Gilard said. “Noninferiority was also observed in the group of unstable patients. However, this group of patients is small, and larger trials are needed to assess the effect of antiplatelet duration in [ACS] patients.” – by Erik Swain
For more information:
Gilard M. LBCT.01: Risk and Benefit of Dual Antiplatelet Therapy. Presented at: American Heart Association Scientific Sessions; Nov. 15-19, 2014; Chicago.
Gilard M. J Am Coll Cardiol. 2014;doi:10.1016/j.jacc.2014.11.008.
Disclosure: The study was funded by Abbott Vascular. Gilard reports no relevant financial disclosures.
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Richard C. Becker, MD, FACC
The most important takeaway from the ITALIC trial was that DAPT with clopidogrel and aspirin for 6 months performed very well in a trial using a second-generation Xience stent. It was not evident, in the patients who were studied, that there was a benefit to prolonging therapy for 24 months. Similarly, in ISAR-SAFE, 6 months vs. 12 months of DAPT led to similar outcomes. There was no signal of benefit for prolonged therapy and, as one might have expected, there was some element of bleeding-related harm administering DAPT for prolonged periods.
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