title: Reduced antiplatelet therapy after drug-eluting stenting: multicenter Janus Flex carbostent implantation with short dual antiplatelet treatment for 2 or 6 months-MATRIX study.
abstract: OBJECTIVE
  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.
authors: Department of Clinical Medicine, Cardiovascular Sciences and Immunology, Federico II University of Naples, Italy.
authors: Salvatore
authors: S
authors: Cassese
authors: Giuseppe
authors: G
authors: De Luca
authors: Bruno
authors: B
authors: Villari
authors: Sergio
authors: S
authors: Berti
authors: Pietro
authors: P
authors: Bellone
authors: Alfonso
authors: A
authors: Alfieri
authors: Antonio
authors: A
authors: Montinaro
authors: Gaetano
authors: G
authors: Quaranta
authors: Paolo
authors: P
authors: Marraccini
authors: Federico
authors: F
authors: Piscione
mesh_terms: D000368:Aged; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D061847:Hospitals, High-Volume; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D016559:Tacrolimus / Q000008:administration & dosage*; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin; D016559:Tacrolimus