title: Evaluating the safety of very short-term (10 days) dual antiplatelet therapy after Genous™ bio-engineered R stent™ implantation: the multicentre pilot Genous trial.
abstract: OBJECTIVE
  Percutaneous coronary stenting is synonymous with dual antiplatelet therapy, ranging from four weeks to lifelong. However, even short-term (four weeks) therapy with aspirin and thienopyridines is occasionally contraindicated. No study has ever appraised very short-term dual antiplatelet therapy after stenting. We thus aimed to exploit the pro-healing features of the Genous™ Bio-engineered R stent™ (Genous) (OrbusNeich Medical Technologies, Hong Kong, People's Republic of China) and evaluate the safety of a 10-day dual antiplatelet regimen after its implantation in up to 50 patients.
  
  
  RESULTS
  Forty-nine consecutive patients with de novo lesions located in vessels able to receive a 2.5 mm Genous stent were included. After stenting, they received lifelong aspirin plus clopidogrel for 10 days. The primary endpoint of the study was sudden cardiac death, myocardial infarction or angiographic evidence of stent thrombosis ascribable to the study stent. Almost 70% of patients effectively discontinued clopidogrel nine to 11 days after stenting. At three-month clinical follow-up, no patient had died or reached the primary endpoint (95%; confidence interval 0-7.3%). Repeat revascularisation occurred instead in three (6.1%[2.1-16.5%]), with target lesion revascularisation in two (4.1%[1.1-13.7%]).
  
  
  CONCLUSIONS
  Even very short-term dual antiplatelet therapy seems safe after coronary stenting with Genous in de novo coronary artery lesions located in secondary branch vessels. This preliminary exploratory study gives some support to planning a large trial to test the hypothesis of short dual antiplatelet therapy following Genous stent implantation.
authors.affiliation: Division of Cardiology, University of Modena and Reggio Emilia, Modena, Italy. gsangiorgi@gmail.com
authors.forename: Giuseppe M
authors.initials: GM
authors.lastname: Sangiorgi
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.forename: Ezio
authors.initials: E
authors.lastname: Bramucci
authors.forename: Marco
authors.initials: M
authors.lastname: Ferlini
authors.forename: Liliana
authors.initials: L
authors.lastname: Grinfeld
authors.forename: Anna S
authors.initials: AS
authors.lastname: Petronio
authors.forename: Carlo
authors.initials: C
authors.lastname: Pierli
authors.forename: Alessandro
authors.initials: A
authors.lastname: Iadanza
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Biondi-Zoccai
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D000077144:Clopidogrel; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D010865:Pilot Projects; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; 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