title: Four-year clinical outcomes of the OLIVUS-Ex (impact of Olmesartan on progression of coronary atherosclerosis: evaluation by intravascular ultrasound) extension trial.
abstract: BACKGROUND
  The previous OLIVUS trial reported a positive role in achieving a lower rate of coronary atheroma progression through the administration of olmesartan, an angiotension-II receptor blocking agent (ARB), for stable angina pectoris (SAP) patients requiring percutaneous coronary intervention (PCI). However, the benefits between ARB administration on long-term clinical outcomes and serial atheroma changes by IVUS remain unclear. Thus, we examined the 4-year clinical outcomes from OLIVUS according to treatment strategy with olmesartan.
  
  
  METHODS
  Serial volumetric IVUS examinations (baseline and 14 months) were performed in 247 patients with hypertension and SAP. When these patients underwent PCI for culprit lesions, IVUS was performed in their non-culprit vessels. Patients were randomly assigned to receive 20-40mg of olmesartan or control, and treated with a combination of β-blockers, calcium channel blockers, glycemic control agents and/or statins per physician's guidance. Four-year clinical outcomes and annual progression rate of atherosclerosis, assessed by serial IVUS, were compared with major adverse cardio- and cerebrovascular events (MACCE).
  
  
  RESULTS
  Cumulative event-free survival was significantly higher in the olmesartan group than in the control group (p=0.04; log-rank test). By adjusting for validated prognosticators, olmesartan administration was identified as a good predictor of MACCE (p=0.041). On the other hand, patients with adverse events (n=31) had larger annual atheroma progression than the rest of the population (23.8% vs. 2.1%, p<0.001).
  
  
  CONCLUSIONS
  Olmesartan therapy appears to confer improved long-term clinical outcomes. Atheroma volume changes, assessed by IVUS, seem to be a reliable surrogate for future major adverse cardio- and cerebrovascular events in this study cohort.
authors: The Sakakibara Heart Institute of Okayama, Japan. hirohata@tg7.so-net.ne.jp
authors: Atsushi
authors: A
authors: Hirohata
authors: Keizo
authors: K
authors: Yamamoto
authors: Toru
authors: T
authors: Miyoshi
authors: Kunihiko
authors: K
authors: Hatanaka
authors: Satoshi
authors: S
authors: Hirohata
authors: Hitoshi
authors: H
authors: Yamawaki
authors: Issei
authors: I
authors: Komatsubara
authors: Eiki
authors: E
authors: Hirose
authors: Yuhei
authors: Y
authors: Kobayashi
authors: Keisuke
authors: K
authors: Ohkawa
authors: Minako
authors: M
authors: Ohara
authors: Hiroya
authors: H
authors: Takafuji
authors: Fumihiko
authors: F
authors: Sano
authors: Yuko
authors: Y
authors: Toyama
authors: Shozo
authors: S
authors: Kusachi
authors: Tohru
authors: T
authors: Ohe
authors: Hiroshi
authors: H
authors: Ito
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000401:mortality; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D002561:Cerebrovascular Disorders / Q000209:etiology; D016009:Chi-Square Distribution; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006331:Heart Diseases / Q000209:etiology; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D007093:Imidazoles; D013777:Tetrazoles; C437965:olmesartan