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Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial.
JAMA. 2006 Apr 05; 295(13):1556-65.JAMA

Abstract

CONTEXT

Prior intravascular ultrasound (IVUS) trials have demonstrated slowing or halting of atherosclerosis progression with statin therapy but have not shown convincing evidence of regression using percent atheroma volume (PAV), the most rigorous IVUS measure of disease progression and regression.

OBJECTIVE

To assess whether very intensive statin therapy could regress coronary atherosclerosis as determined by IVUS imaging.

DESIGN AND SETTING

Prospective, open-label blinded end-points trial (A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary Atheroma Burden [ASTEROID]) was performed at 53 community and tertiary care centers in the United States, Canada, Europe, and Australia. A motorized IVUS pullback was used to assess coronary atheroma burden at baseline and after 24 months of treatment. Each pair of baseline and follow-up IVUS assessments was analyzed in a blinded fashion.

PATIENTS

Between November 2002 and October 2003, 507 patients had a baseline IVUS examination and received at least 1 dose of study drug. After 24 months, 349 patients had evaluable serial IVUS examinations.

INTERVENTION

All patients received intensive statin therapy with rosuvastatin, 40 mg/d.

MAIN OUTCOME MEASURES

Two primary efficacy parameters were prespecified: the change in PAV and the change in nominal atheroma volume in the 10-mm subsegment with the greatest disease severity at baseline. A secondary efficacy variable, change in normalized total atheroma volume for the entire artery, was also prespecified.

RESULTS

The mean (SD) baseline low-density lipoprotein cholesterol (LDL-C) level of 130.4 (34.3) mg/dL declined to 60.8 (20.0) mg/dL, a mean reduction of 53.2% (P<.001). Mean (SD) high-density lipoprotein cholesterol (HDL-C) level at baseline was 43.1 (11.1) mg/dL, increasing to 49.0 (12.6) mg/dL, an increase of 14.7% (P<.001). The mean (SD) change in PAV for the entire vessel was -0.98% (3.15%), with a median of -0.79% (97.5% CI, -1.21% to -0.53%) (P<.001 vs baseline). The mean (SD) change in atheroma volume in the most diseased 10-mm subsegment was -6.1 (10.1) mm3, with a median of -5.6 mm3 (97.5% CI, -6.8 to -4.0 mm3) (P<.001 vs baseline). Change in total atheroma volume showed a 6.8% median reduction; with a mean (SD) reduction of -14.7 (25.7) mm3, with a median of -12.5 mm3 (95% CI, -15.1 to -10.5 mm3) (P<.001 vs baseline). Adverse events were infrequent and similar to other statin trials.

CONCLUSIONS

Very high-intensity statin therapy using rosuvastatin 40 mg/d achieved an average LDL-C of 60.8 mg/dL and increased HDL-C by 14.7%, resulting in significant regression of atherosclerosis for all 3 prespecified IVUS measures of disease burden. Treatment to LDL-C levels below currently accepted guidelines, when accompanied by significant HDL-C increases, can regress atherosclerosis in coronary disease patients. Further studies are needed to determine the effect of the observed changes on clinical outcome.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT00240318.

Authors+Show Affiliations

Department of Cardiovascular Medicine, Cleveland Clinic Lerner School of Medicine, Cleveland, Ohio 44195, USA. nissens@ccf.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

16533939

Citation

Nissen, Steven E., et al. "Effect of Very High-intensity Statin Therapy On Regression of Coronary Atherosclerosis: the ASTEROID Trial." JAMA, vol. 295, no. 13, 2006, pp. 1556-65.
Nissen SE, Nicholls SJ, Sipahi I, et al. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006;295(13):1556-65.
Nissen, S. E., Nicholls, S. J., Sipahi, I., Libby, P., Raichlen, J. S., Ballantyne, C. M., Davignon, J., Erbel, R., Fruchart, J. C., Tardif, J. C., Schoenhagen, P., Crowe, T., Cain, V., Wolski, K., Goormastic, M., & Tuzcu, E. M. (2006). Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA, 295(13), 1556-65.
Nissen SE, et al. Effect of Very High-intensity Statin Therapy On Regression of Coronary Atherosclerosis: the ASTEROID Trial. JAMA. 2006 Apr 5;295(13):1556-65. PubMed PMID: 16533939.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. AU - Nissen,Steven E, AU - Nicholls,Stephen J, AU - Sipahi,Ilke, AU - Libby,Peter, AU - Raichlen,Joel S, AU - Ballantyne,Christie M, AU - Davignon,Jean, AU - Erbel,Raimund, AU - Fruchart,Jean Charles, AU - Tardif,Jean-Claude, AU - Schoenhagen,Paul, AU - Crowe,Tim, AU - Cain,Valerie, AU - Wolski,Kathy, AU - Goormastic,Marlene, AU - Tuzcu,E Murat, AU - ,, Y1 - 2006/03/13/ PY - 2006/3/15/pubmed PY - 2006/4/13/medline PY - 2006/3/15/entrez SP - 1556 EP - 65 JF - JAMA JO - JAMA VL - 295 IS - 13 N2 - CONTEXT: Prior intravascular ultrasound (IVUS) trials have demonstrated slowing or halting of atherosclerosis progression with statin therapy but have not shown convincing evidence of regression using percent atheroma volume (PAV), the most rigorous IVUS measure of disease progression and regression. OBJECTIVE: To assess whether very intensive statin therapy could regress coronary atherosclerosis as determined by IVUS imaging. DESIGN AND SETTING: Prospective, open-label blinded end-points trial (A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary Atheroma Burden [ASTEROID]) was performed at 53 community and tertiary care centers in the United States, Canada, Europe, and Australia. A motorized IVUS pullback was used to assess coronary atheroma burden at baseline and after 24 months of treatment. Each pair of baseline and follow-up IVUS assessments was analyzed in a blinded fashion. PATIENTS: Between November 2002 and October 2003, 507 patients had a baseline IVUS examination and received at least 1 dose of study drug. After 24 months, 349 patients had evaluable serial IVUS examinations. INTERVENTION: All patients received intensive statin therapy with rosuvastatin, 40 mg/d. MAIN OUTCOME MEASURES: Two primary efficacy parameters were prespecified: the change in PAV and the change in nominal atheroma volume in the 10-mm subsegment with the greatest disease severity at baseline. A secondary efficacy variable, change in normalized total atheroma volume for the entire artery, was also prespecified. RESULTS: The mean (SD) baseline low-density lipoprotein cholesterol (LDL-C) level of 130.4 (34.3) mg/dL declined to 60.8 (20.0) mg/dL, a mean reduction of 53.2% (P<.001). Mean (SD) high-density lipoprotein cholesterol (HDL-C) level at baseline was 43.1 (11.1) mg/dL, increasing to 49.0 (12.6) mg/dL, an increase of 14.7% (P<.001). The mean (SD) change in PAV for the entire vessel was -0.98% (3.15%), with a median of -0.79% (97.5% CI, -1.21% to -0.53%) (P<.001 vs baseline). The mean (SD) change in atheroma volume in the most diseased 10-mm subsegment was -6.1 (10.1) mm3, with a median of -5.6 mm3 (97.5% CI, -6.8 to -4.0 mm3) (P<.001 vs baseline). Change in total atheroma volume showed a 6.8% median reduction; with a mean (SD) reduction of -14.7 (25.7) mm3, with a median of -12.5 mm3 (95% CI, -15.1 to -10.5 mm3) (P<.001 vs baseline). Adverse events were infrequent and similar to other statin trials. CONCLUSIONS: Very high-intensity statin therapy using rosuvastatin 40 mg/d achieved an average LDL-C of 60.8 mg/dL and increased HDL-C by 14.7%, resulting in significant regression of atherosclerosis for all 3 prespecified IVUS measures of disease burden. Treatment to LDL-C levels below currently accepted guidelines, when accompanied by significant HDL-C increases, can regress atherosclerosis in coronary disease patients. Further studies are needed to determine the effect of the observed changes on clinical outcome. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00240318. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/16533939/Effect_of_very_high_intensity_statin_therapy_on_regression_of_coronary_atherosclerosis:_the_ASTEROID_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.295.13.jpc60002 DB - PRIME DP - Unbound Medicine ER -