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ISAR TRIPLE: Shorter duration of triple therapy not superior to longer duration
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WASHINGTON — Six weeks of triple therapy after DES implantation failed to improve on 6 months of that regimen in terms of net clinical outcomes, according to findings presented at TCT 2014.
The prospective, open label study included 614 patients who were randomly assigned to either 6 weeks (n=307) or 6 months (n=307) of triple therapy, defined as clopidogrel, aspirin and an oral anticoagulant. The follow-up rate was 98.7%.
Nikolaus Sarafoff, MD, from Deutsches Herzzentrum, Technische Universität, Munich, explained the clinical conundrum that prompted the study. “Physicians are in a clinical dilemma because when we do not give oral anticoagulation, patients are at risk for stroke and thromboembolism,” Sarafoff said during a press conference. “But if we don’t give dual antiplatelet therapy, patients are at high risk for stent thrombosis or ischemia. If we give triple therapy, we know that there is a higher risk of bleeding.”
A composite of death, MI, definite stent thrombosis, stroke or TIMI major bleeding at 9 months follow-up served as the study’s primary outcome measure. Bleeding complications and a composite ischemic endpoint of cardiac death, MI, definite stent thrombosis or ischemic stroke served as secondary endpoints.
Nine-month follow-up indicated that the primary endpoint occurred in 9.8% of patients in the 6-week group and 8.8% of patients who received 6 months of therapy (P=.63).
The secondary endpoint of the composite ischemic endpoint occurred in 4% of patients in the 6-week group and 4.3% of those in the 6-month group (P=.87).
TIMI major bleeding occurred in 5.3% of patients receiving 6 weeks of therapy and 4% of patients receiving 6 months of therapy (P=.44).
“There was no difference in any BARC bleeding between the two groups,” Sarafoff added, noting that this event occurred in 37.6% of patients receiving 6 weeks of triple therapy and 40.2% of those receiving 6 months of therapy (P=.63). However, results of a post-hoc landmark analysis of any BARC bleeding before and after 6 weeks indicated a reduction in this outcome in the shorter therapy group. In this analysis, BARC bleeding occurred in 20.5% of patients in the 6-week group and 27.9% of those in the 6-month group (P=.04).
“Shortening the duration of triple therapy neither reduced the incidence of TIMI major bleeding nor increased the incidence of the composite of ischemic events,” Sarafoff concluded.
Patient accrual occurred at three centers in Europe from December 2008 to December 2013. DES implantation and indication for oral anticoagulation were the main inclusion criteria, whereas patients with previous stent thrombosis and DES in the left main coronary artery were excluded. All patients were receiving vitamin K antagonists.
For more information:
Sarafoff N. Plenary Session XIX: Late-Breaking Clinical Trials No. 3. Presented at: TCT 2014; Sept. 13-17, 2014; Washington, D.C.
Disclosure: Sarafoff reports financial disclosures with Bayer Healthcare, Biotronik, Boehringer Ingelheim, Boston Scientific, Eli Lilly/Daiichi Sankyo and Medtronic.