Key result
Two-month dual antiplatelet therapy after Janus Flex stenting was associated with similar 12-month MACE rates compared to 6-month therapy (8.99% vs 12.47%; adjusted HR 0.47; 95% CI 0.16-1.35; P=0.16).
Why the study?
Does 2-month dual antiplatelet therapy compared to 6-month therapy reduce major adverse cardiac events in patients receiving a tacrolimus-eluting coronary stent?
Observational (n=572)
Yes
Does 2-month dual antiplatelet therapy compared to 6-month therapy reduce major adverse cardiac events in patients receiving a tacrolimus-eluting coronary stent?
A short 2-month course of dual antiplatelet therapy appears safe and feasible compared to 6 months after implantation of a polymer-free tacrolimus-eluting stent, though randomized trials are needed to confirm these findings.
May support abbreviated DAPT after tacrolimus-eluting stents; hypothesis-generating and requires randomized confirmation.
OBJECTIVES: The Multicentre registry with Antiplatelet TReatment two-sIX months (MATRIX) evaluated safety and efficacy at 12-month follow-up of Janus Flex stenting with 2- or 6-month dual antiplatelet therapy (DAT) period. BACKGROUND: There are no data of Janus Flex stent (Carbostent and Implantable Devices-CID, Saluggia, Italy), a polymer-free, tacrolimus-eluting coronary stent, followed by short-term DAT, in daily practice. METHODS: Patients were prospectively enrolled at 12 high-volume procedures centres. After stenting, four sites prescribed 2-month DAT, eight sites 6-month DAT. Major adverse cardiac events (MACE) and stent thrombosis (ST) rate was evaluated at 12-month follow-up, for entire population, as well as for 2- and 6-month DAT groups, distinctly. MACE included cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). RESULTS: From March 2007 to June 2008, 572 patients (mean age 64.91 ± 11 years, 77.45% males) were enrolled. After successful stenting, 12-month follow-up showed a 12.74% MACE occurrence (cardiac death 0.98%; MI 3.13%; TLR 8.62%), with good Janus Flex safety profile confirmed by only two (0.39%) ST. After adjustment for potential confounding, no significant differences were noted at 12-month follow-up among 2- or 6-month DAT groups (MACE-8.99% versus 12.47%, P = 0.16; cardiac death-0.54% versus 1.14%, P = 0.52; MI-2.38% versus 2.71%, P = 0.83; TLR-5.66% versus 10.60%, P = 0.20; ST-0% versus 0.55%, P = 0.99). At multivariable analysis, DAT time duration was not an independent risk factor for adverse events (adjusted HR 0.47, 95% confidence interval 0.16-1.35, P = 0.16). CONCLUSIONS: Janus Flex coronary stenting, followed by short DAT, is safe and feasible, without differences between 2- and 6-month DAT groups. A randomized trial confirming these encouraging data is needed.
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Cassese et al. (2011) conducted an observational in Coronary artery disease requiring stenting (n=572). 2-month dual antiplatelet therapy (DAT) vs. 6-month dual antiplatelet therapy (DAT) was evaluated on Major adverse cardiac events (MACE) at 12 months (adjusted HR 0.47, 95% CI 0.16-1.35, p=0.16). Two-month dual antiplatelet therapy after Janus Flex stenting was associated with similar 12-month MACE rates compared to 6-month therapy (8.99% vs 12.47%; adjusted HR 0.47; 95% CI 0.16-1.35; P=0.16).
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