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ISAR-SAFE: Net clinical outcomes no different for 6-month, 12-month DAPT after PCI
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CHICAGO — Patients assigned 6 months of dual antiplatelet therapy had similar net clinical outcomes compared with patients assigned 12 months of dual antiplatelet therapy after PCI with a drug-eluting stent, according to new data from the ISAR-SAFE study.
Researchers randomly assigned patients undergoing PCI with a DES to receive 12 months of clopidogrel or 6 months of clopidogrel on the background of aspirin. The intended enrollment in the double blind, placebo-controlled trial was 6,000 patients at 40 centers worldwide, but a blinded analysis showing a much lower-than-expected event rate and slow recruitment led the steering committee to decide to halt enrollment at 4,000 patients, Stefanie Schüpke, MD, from Deutsches Herzzentrum München in Munich, said at a press conference.
The primary endpoint was a composite of death, MI, stent thrombosis, stroke and TIMI major bleeding at 9 months after randomization.
Schüpke reported no difference between the groups in the primary endpoint [6-month group, 1.5%; 12-month group, 1.6%; HR=0.91; 95% CI, 0.55-1.5; P=.7], and 6 months of DAPT was noninferior to 12 months of DAPT (P for inferiority <.001).
The composite outcome of death, MI, stent thrombosis and stroke was also similar between the groups [HR=0.87; 95% CI, 0.51-1.47; P=.59], as was the composite of TIMI major or minor bleeding [HR=0.46; 95% CI, 0.18-1.21; P=.12], Schüpke said. In addition, none of the individual components of the primary endpoint showed a statistically significant difference between the groups, she said.
However, in additional analyses there was a numerical but nonsignificant increase in TIMI minor bleeding and a significant increase in Bleeding Academic Research Consortium (BARC) Class 2 or higher bleeding associated with prolonged therapy.
“After DES implantation, 6 months of clopidogrel therapy is noninferior to 12 months of clopidogrel regarding net clinical outcome,” Schüpke said. “However, the results of the trial must be considered in view of its premature termination and lower-than-expected event rates.” – by Erik Swain
For more information:
Schüpke S. LBCT.01: Risk and Benefit of Dual Antiplatelet Therapy. Presented at: American Heart Association Scientific Sessions; Nov. 15-19, 2014; Chicago.
Disclosure: The study was supported by the German Federal Ministry of Education and Research and Abbott Vascular. Schüpke reports no relevant financial disclosures.
Perspective
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Robert O. Bonow, MD, MS, MACC, FAHA
Both of the European DAPT trials presented, ISAR-SAFE and ITALIC, were small, and must be taken in the context of a relatively small number of patients. I feel comfortable stopping DAPT early if my patient has higher bleeding risks or if they need to have noncardiac surgery; we have been concerned about stopping therapy in patients who need to come off therapy for noncardiac surgical procedures. We do not want to do that in the first month or two of stent implantation, but it appears to be safe to do that after 4 to 6 months if there’s a reason to come off or if there are other bleeding risks. In patients who are doing well otherwise, I think continuing therapy should be strongly considered even beyond 12 months to reduce the risk for stent-related and non–stent-related coronary events. The guidelines are going to have to start assimilating all of these new data.
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