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Reduced antiplatelet therapy after drug‐eluting stenting: Multicenter janus flex carbostent implantation with short dual antiplatelet treatment for 2 or 6 months—matrix study

2011; Wiley; Volume: 80; Issue: 3 Linguagem: Inglês

10.1002/ccd.23223

1522-726X

Salvatore Cassese, Giuseppe De Luca, Bruno Villari, Sérgio Berti, Pietro Bellone, Alfonso Alfieri, Antonio Montinaro, Gaetano Quaranta, Paolo Marraccini, Federico Piscione,

Acute Myocardial Infarction Research

Abstract 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. © 2011 Wiley Periodicals, Inc.