Cassese S et al. – Janus Flex coronary stenting, followed by short dual antiplatelet therapy (DAT), is safe and feasible, without differences between 2– and 6–month DAT groups. A randomized trial confirming these encouraging data is needed.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).
- 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).