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MILLION: Combined BP, cholesterol lowering reduces coronary plaque volume
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SAN DIEGO — Among patients with CAD, an aggressive or standard approach of combined BP and cholesterol lowering after successful PCI resulted in similar reductions in coronary plaque volume, according to results of the MILLION study presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
“This is the first multicenter study performed in a Japanese population using IVUS to evaluate the effects of simultaneous lipid and blood pressure to control the progression and regression of coronary atherosclerosis,” Masa-aki Kawashiri, MD, associate professor of medicine in the division of cardiovascular medicine at Kanazawa University, Japan, said during a presentation.
Masa-aki Kawashiri
For the open-label, multicenter MILLION study, researchers randomly assigned 68 patients with CAD to aggressive (n = 35) or standard treatment (n = 33) after successful PCI. All patients had LDL > 100 mg/dL after PCI, regardless of lipid-lowering therapy, and had at least one coronary artery blockage other than the one treated via PCI.
Aggressive therapy was defined as a target LDL of 70 mg/dL and target BP of 120/70 mm Hg while receiving 10 mg atorvastatin (Lipitor, Pfizer) and 5 mg amlodipine. Standard therapy was defined as a target LDL of 100 mg/dL and target BP of 140/90 mm Hg while receiving 5 mg atorvastatin and 2.5 mg amlodipine.
The primary endpoint was percent change to coronary atheroma volume, as measured by IVUS at baseline and at 18 to 24 months after initiation of therapy. The mean reduction in coronary plaque volume was 9.37% in the standard-therapy group compared with 8.74% in the aggressive-therapy group.
“Both standard and aggressive intervention on BP and LDL significantly regressed coronary plaque volume [to] the same degree,” Kawashiri said.
Both groups achieved target BP and LDL within the follow-up period: mean BP was 124/76 mm Hg in the standard-therapy group vs. 114/66 mm Hg in the aggressive-therapy group; mean LDL was 75 mg/dL in the standard-therapy group vs. 64 mg/dL in the aggressive-therapy group. However, absolute decreases in BP and LDL were significantly greater among patients assigned aggressive therapy compared with standard therapy (7.5/9.5 mm Hg and 6.1 mg/dL), Kawashiri said.
In other results, the mean percent change to vessel volume on IVUS decreased by –3.39% in the standard-therapy group and increased by 0.03% in the aggressive-therapy group and the mean percent change to lumen volume increased by 3.25% and 9.41%, respectively.
“Aggressive LDL and BP medication treatment does not provide additional benefit in reducing atherosclerosis. Combined therapy aimed at standard LDL and BP targets provides similar benefit as more aggressive treatment,” Kawashiri said. – by Adam Taliercio
Reference:
Kawashiri M, et al. Late-Breaking Clinical Trial. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions: May 6-9, 2015; San Diego.
Disclosure: Kawashiri reports no relevant financial disclosures. The study group received research grants from Pfizer.
Perspective
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Payam Dehghani, MD, FRCP(C), FACC, FSCAI
Does combining intensive LDL reduction (< 70 mg/dL) with aggressive BP reduction (< 120/70 mm Hg) reduce plaque volume as measured by IVUS in nonculprit plaques of Japanese patients undergoing PCI? The answer is yes — a 9% reduction, to be exact, in volume plaque after 18 to 24 months of therapy. However, this 9% reduction in plaque volume was also achieved in patients with moderate LDL reduction (< 100 mg/dL) and standard BP reduction (< 140/90 mm Hg). These different targets were achieved with different doses of amlodipine and atorvastatin in standard and aggressive regimens (mean, 4.9 mg vs. 6.4 mg in amlodipine arm and 6.3 mg vs. 14.1 mg in atorvastatin arm, respectively). As both standard and aggressive therapies led to similar reduction in plaque volume, this Japanese study by Kawashiri and colleagues did not meet its primary endpoint. It is conceivable that a larger sample size (the current sample size was only 97 patients) and a longer follow-up may have shown a difference. However, the more important question, not addressed by this study, is whether there was a change in plaque composition. The pendulum has now swung towards understanding fibrous cap thickness and amount of lipid core.
Even though this trial did not meet its primary endpoint, it is still highly instructive for reminding our patients that current guideline-driven targets lead to close to 10% reduction in plaque volume.
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