title: Incidence, time course and predictors of early vs. late target lesion revascularisation after everolimus-eluting stent implantation: a SPIRIT V substudy.
abstract: OBJECTIVE
  To evaluate the incidence, time course and predictors of late target lesion revascularisation (TLR) (between one and two years) as compared to early TLR (<1 year) following everolimus-eluting stent implantation in patients enrolled in the SPIRIT V study.
  
  
  RESULTS
  The SPIRIT V single-arm study enrolled a total of 2,700 patients (n=2,663 intent-to-treat) with de novo coronary artery lesions undergoing EES implantation. Patients were evaluated at 30 days, one year and two years following the index procedure. All patients who had a clinically driven TLR (not associated with stent thrombosis) were allocated to either the early or the late group. Clinical, angiographic and procedural data were recorded and predictors of early vs. late TLR were assessed by logistic regression analysis. There were no significant differences in baseline demographics and risk factors between the two groups with the exception that patients in the late TLR group were significantly older (68.5 ± 8.5 years vs. 63.5 ± 8.9 years, p=0.022). At two years, only 2.7% (70/2,562) experienced a TLR unrelated to a stent thrombosis event with 1.6% (43/2,627) occurring within one year of the index procedure and 1.1% (27/2,562) occurring between one and two years. There were no differences between the groups in terms of clinical outcomes. Age ≥70 years was the only variable which independently predicted late TLR (OR=4.80 [1.69-13.63], p=0.0032).
  
  
  CONCLUSIONS
  In this large registry without angiographic follow-up, early (<1 year) and late (>1 year) TLR rates were exceedingly low and thereby confirm the previous findings of randomised controlled studies. Age (>70 years) emerged as the only predictor of late TLR.
authors.affiliation: Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy. gniccoli73@hotmail.it
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Niccoli
authors.forename: Marrianne
authors.initials: M
authors.lastname: Stuteville
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
authors.forename: Dong
authors.initials: D
authors.lastname: Li
authors.forename: Rocco A
authors.initials: RA
authors.lastname: Montone
authors.forename: Leonardo
authors.initials: L
authors.lastname: Bolognese
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
mesh_terms: D000367:Age Factors; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology* / Q000628:therapy; D003328:Coronary Thrombosis / Q000453:epidemiology; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus