TY - JOUR
T1 - Treatment of Chlamydia pneumoniae infection with roxithromycin and effect on neointima proliferation after coronary stent placement (ISAR-3)
T2 - A randomised, double-blind, placebo-controlled trial
AU - Neumann, Franz Josef
AU - Kastrati, Adnan
AU - Miethke, Thomas
AU - Pogatsa-Murray, Gisela
AU - Mehilli, Julinda
AU - Valina, Christian
AU - Jogethaei, Nader
AU - Da Costa, Clarissa P.
AU - Wagner, Hermann
AU - Schömig, Albert
N1 - Funding Information:
We thank Christian Rabis and Ingrid Stallforth. The work was supported by funds from the Medical Faculty of Technische Universität München. Aventis (Bad Soden, Germany) provided the study medication and funded patient insurance and cost of reagents for titre assays.
PY - 2001/6/30
Y1 - 2001/6/30
N2 - Background: Vascular infection with Chlamydia pneumoniae might boost inflammatory responses that play a pivotal part in neointima formation, which is the main cause of restenosis after stenting. Our aim was to investigate whether or not treatment of C pneumoniae infection with antibiotics prevents restenosis after coronary stent placement. Methods: We enrolled 1010 consecutive patients with successful coronary stenting into a randomised, double-blind trial. Patients received the macrolide antibiotic roxithromycin 300 mg once daily for 28 days (506), or placebo (504). Primary endpoint was frequency of restenosis (diameter stenosis ≥50%) at follow-up angiography, and secondary endpoint was rate of target vessel revascularisation during the year after stenting. A prespecified secondary analysis addressed treatment effect with respect to titre of C pneumoniae in serum. Analysis was by intention to treat. Findings: Rate of angiographic restenosis was 31% (157 lesions) in the roxithromycin group and 29% (148) in the placebo group (relative risk 1·08 [95% CI 0·92-1·26]; p=0·43), corresponding to a rate of target vessel revascularisation of 19% (120) and 17% (105), respectively (1·13 [0·95-1·36]; p=0·30). The combined 1-year rates of death and myocardial infarction were 7% (36) in the roxithromycin group and 6% (30) in the placebo group (p=0·45). We showed a significant interaction between treatment and C pneumoniae antibody titre (p=0·038 for restenosis, p=0·006 for revascularisation), favouring roxithromycin at high titres (adjusted odds ratios at a titre of 1/512 were 0·44 [0·19-1·06] and 0·32 [0·13-0·81], respectively). Interpretation: Non-selective use of roxithromycin is inadequate for prevention of restenosis after coronary stenting. There is, however, a differential effect dependent on C pneumoniae titres. In patients with high titres, roxithromycin reduced the rate of restenosis.
AB - Background: Vascular infection with Chlamydia pneumoniae might boost inflammatory responses that play a pivotal part in neointima formation, which is the main cause of restenosis after stenting. Our aim was to investigate whether or not treatment of C pneumoniae infection with antibiotics prevents restenosis after coronary stent placement. Methods: We enrolled 1010 consecutive patients with successful coronary stenting into a randomised, double-blind trial. Patients received the macrolide antibiotic roxithromycin 300 mg once daily for 28 days (506), or placebo (504). Primary endpoint was frequency of restenosis (diameter stenosis ≥50%) at follow-up angiography, and secondary endpoint was rate of target vessel revascularisation during the year after stenting. A prespecified secondary analysis addressed treatment effect with respect to titre of C pneumoniae in serum. Analysis was by intention to treat. Findings: Rate of angiographic restenosis was 31% (157 lesions) in the roxithromycin group and 29% (148) in the placebo group (relative risk 1·08 [95% CI 0·92-1·26]; p=0·43), corresponding to a rate of target vessel revascularisation of 19% (120) and 17% (105), respectively (1·13 [0·95-1·36]; p=0·30). The combined 1-year rates of death and myocardial infarction were 7% (36) in the roxithromycin group and 6% (30) in the placebo group (p=0·45). We showed a significant interaction between treatment and C pneumoniae antibody titre (p=0·038 for restenosis, p=0·006 for revascularisation), favouring roxithromycin at high titres (adjusted odds ratios at a titre of 1/512 were 0·44 [0·19-1·06] and 0·32 [0·13-0·81], respectively). Interpretation: Non-selective use of roxithromycin is inadequate for prevention of restenosis after coronary stenting. There is, however, a differential effect dependent on C pneumoniae titres. In patients with high titres, roxithromycin reduced the rate of restenosis.
UR - http://www.scopus.com/inward/record.url?scp=0035973296&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(00)05181-3
DO - 10.1016/S0140-6736(00)05181-3
M3 - Article
C2 - 11445102
AN - SCOPUS:0035973296
SN - 0140-6736
VL - 357
SP - 2085
EP - 2089
JO - The Lancet
JF - The Lancet
IS - 9274
ER -