Effect of pioglitazone on cardiometabolic profiles and safety in patients with type 2 diabetes undergoing percutaneous coronary artery intervention: a prospective, multicenter, randomized trial.

Pioglitazone has superior antiatherosclerotic effects compared with other classes of antidiabetic agents, and there is substantial evidence that pioglitazone improves cardiovascular (CV) outcomes. However, there is also a potential risk of worsening heart failure (HF). Therefore, it is clinically important to determine whether pioglitazone is safe in patients with type 2 diabetes mellitus (T2DM) who require treatment for secondary prevention of CV disease, since they have an intrinsically higher risk of HF. This prospective, multicenter, open-label, randomized study investigated the effects of pioglitazone on cardiometabolic profiles and CV safety in T2DM patients undergoing elective percutaneous coronary intervention (PCI) using bare-metal stents or first-generation drug-eluting stents. A total of 94 eligible patients were randomly assigned to either a pioglitazone or conventional (control) group, and pioglitazone was started the day before PCI. Cardiometabolic profiles were evaluated before PCI and at primary follow-up coronary angiography (5-8 months). Pioglitazone treatment reduced HbA1c levels to a similar degree as conventional treatment (pioglitazone group 6.5 to 6.0%, P < 0.01; control group 6.5 to 5.9%, P < 0.001), without body weight gain. Levels of high-molecular weight adiponectin increased more in the pioglitazone group than the control group (P < 0.001), and the changes were irrespective of baseline glycemic control. Furthermore, pioglitazone significantly reduced plasma levels of natriuretic peptides and preserved cardiac systolic and diastolic function (assessed by echocardiography) without incident hospitalization for worsening HF. The incidence of clinical adverse events was also comparable between the groups. These results indicate that pioglitazone treatment before and after elective PCI may be tolerable and clinically safe and may improve cardiometabolic profiles in T2DM patients.

Sirolimus-eluting stent versus balloon angioplasty for sirolimus-eluting stent restenosis: Insights from the j-Cypher Registry.

BACKGROUND: Optimal treatment strategies for restenosis of sirolimus-eluting stents (SES) have not been adequately addressed yet. METHODS AND RESULTS: During the 3-year follow-up of 12 824 patients enrolled in the j-Cypher registry, 1456 lesions in 1298 patients underwent target-lesion revascularization (TLR). Excluding 362 lesions undergoing TLR for stent thrombosis or TLR using treatment modalities other than SES or balloon angioplasty (BA), 1094 lesions with SES-associated restenosis in 990 patients treated with either SES (537 lesions) or BA (557 lesions) constituted the study population for the analysis of recurrent TLR and stent thrombosis after the first TLR. Excluding 24 patients with both SES- and BA-treated lesions, 966 patients constituted the analysis set for the mortality outcome. Cumulative incidence of recurrent TLR in the SES-treated restenosis lesions was significantly lower than that in the BA-treated restenosis lesions (23.8% versus 37.7% at 2 years after the first TLR; P<0.0001). Among 33 baseline variables evaluated, only hemodialysis was identified to be the independent risk factor for recurrent TLR by a multivariable logistic regression analysis. After adjusting for confounders, repeated SES implantation was associated with a strong treatment effect in preventing recurrent TLR over BA (odds ratio, 0.44; 95% confidence interval, 0.32 to 0.61; P<0.0001). The 2-year mortality and stent thrombosis rates between the SES- and the BA-treated groups were 10.4% versus 10.8% (P=0.4) and 0.6% versus 0.6%, respectively. CONCLUSIONS: Repeated implantation of SES for SES-associated restenosis is more effective in preventing recurrent TLR than treatment with BA, without evidence of safety concerns.

[Disease activities and serum C-reactive protein levels in patients with vasospastic angina pectoris].

OBJECTIVES: To evaluate the relationship between serum C-reactive protein (CRP) levels and disease activities of vasospastic angina pectoris. METHODS: We reviewed 284 consecutive patients who underwent the coronary artery vasospasm provocation test with intracoronary administration of acetylcholine. No patient had significant organic stenosis in the coronary artery on control angiography. No patient was given nitrates, calcium channel blockers, aspirin or statins before the provocation test. Serum CRP levels were measured on the day before the provocation test. RESULTS: Significant transient coronary artery stenoses associated with chest symptoms and ST-T changes in electrocardiogram was found in 132 patients (positive group), but the remaining 152 showed no spasm (negative group). Serum CRP levels were significantly higher in the positive group than in the negative group (0.29 +/- 0.12 vs 0.08 +/- 0.06mg/dl, p < 0.01). Furthermore, high frequency of angina pectoris ( > or = 3 times/week), low dose of acetylcholine required to induce vasospasm, provocation of total occlusion and provocation of multivessel spasm were associated with significantly higher serum CRP levels in the positive group. Multivariate logistic regression analysis showed low dose of acetylcholine required to induce vasospasm as the strongest predictor of elevated levels of serum CRP (p < 0.001, odds ratio 4.52, 95% confidence interval 2.00-10.44). CONCLUSIONS: Serum CRP levels were related to the inductivity of coronary artery spasm in patients clinically suspected of having vasospastic angina pectoris. Inflammation may be important in the disease activity through the endothelial dysfunction of coronary artery trees.

[Does percutaneous coronary intervention in non-culprit vessels improve the prognosis of acute myocardial infarction complicated by pump failure?].

OBJECTIVES: To evaluate whether percutaneous coronary intervention (PCI)in non-culprit vessel lesions improves the short-term prognosis of acute myocardial infarction complicated by pump failure. METHODS: Fifty-six patients with acute myocardial infarction in hemodynamic subset 4 of Forrester's classification at hospitalization underwent PCI for multiple vessel lesions within 12 hr (6.1 +/- 3.4 hr) of the onset of acute myocardial infarction. No patients had left main trunk lesion. Twenty patients also underwent PCI for non-culprit vessel lesions (multivessel PCI group: M-PCI), but the remaining 36 did not (culprit vessel PCI group: C-PCI). The in-hospital prognosis was investigated from the hospital records. RESULTS: Complete revascularization was accomplished in 18 patients(90%)in the M-PCI. The rates of all in-hospital death were almost equivalent in both groups (M-PCI 30% vs C-PCI 42%, p = 0.21), but the rate of cardiac deaths was higher in the C-PCI than in the M-PCI (42% vs 15%, p < 0.05). Overall major adverse cardiac events occurred more often in the C-PCI than in the M-PCI(58% vs 25%, p < 0.05). Multivariate logistic regression analysis showed complete revascularization(odds ratio 0.11, 95% confidence interval 0.02-0.95, p < 0.05)and duration from onset of acute myocardial infarction to PCI < 6 hr (odds ratio 0.25, 95% confidence interval 0.06-0.98, p < 0.05) were negative predictors of in-hospital cardiac death, and prior myocardial infarction (odds ratio 4.97, 95% confidence interval 1.09-22.67, p < 0.05) was a positive predictor. CONCLUSIONS: PCI of non-culprit vessel lesions might improve the short-term prognosis of patients with acute myocardial infarction and pump failure.

[Early initiation of statin therapy in patients with acute myocardial infarction after successful percutaneous coronary intervention].

OBJECTIVES: To evaluate the effect of statins on the prognosis of acute myocardial infarction after percutaneous coronary intervention (PCI). METHODS: We reviewed 280 patients with acute myocardial infarction who underwent PCI within 12 hr after the onset of symptoms. Statin therapy was initiated in 72 patients within 8.6 +/- 7.6 days after the onset (statin group) but not in the remaining 208 (no statin group). The time sequential changes of low-density lipoprotein cholesterol (LDL-C) and C-reactive protein (CRP) levels, and the angiographic findings at 6 months after PCI were compared. RESULTS: At onset, LDL-C levels in the statin group were significantly higher than those in the no statin group (140 +/- 35 vs 118 +/- 28 mg/dl, p < 0.01). However, at restudy, the values were similar between the two groups (113 +/- 19 vs 118 +/- 21 mg/dl, p = 0.19). CRP levels at restudy tended to be lower in the statin group than in the no statin group (0.11 +/- 0.12 vs 0.14 +/- 0.13 mg/dl, p = 0.07). Although the binary restenosis rates of the culprit lesion were almost equivalent (statin group 29% vs no statin group 23%, p = 0.30), new lesions in the non-culprit vessels tended to be found more frequently in the no statin group than in the statin group (13% vs 4%, p = 0.07). CRP levels at restudy were significantly higher in the patients with new lesions (n = 27) than in those without (n = 253; 0.25 +/- 0.17 vs 0.11 +/- 0.19 mg/dl, p < 0.01), whereas LDL-C levels were similar between the two groups (117 +/- 20 vs 113 +/- 27 mg/dl, p = 0.75). LDL-C, CRP at restudy and the rates of new lesions were similar in the patients receiving water-soluble statins (n = 42) and liposoluble statins (n = 30). CONCLUSIONS: Statin therapy initiated at the early phase of acute myocardial infarction might prevent the development of new lesions in non-culprit vessels without any influence on the restenosis rate of the culprit lesion.

[Clinical significance of early percutaneous coronary intervention in patients with Braunwald III-B type unstable angina pectoris].

OBJECTIVES: To assess the efficacy of early invasive strategy for the treatment of Braunwald III-B type unstable angina pectoris. METHODS: This study included 573 consecutive patients of whom 267 underwent percutaneous coronary intervention (PCI) (312 lesions). The patients were divided into two groups, 95 treated with the early invasive strategy of coronary angiography within 24 hr of admission (Group PCI-I) and the remaining 172 treated with the early conservative strategy of coronary angiography 24 hr after admission (Group PCI-C). RESULTS: No significant differences were noted in the baseline characteristics of the two groups except for ST segment elevation on electrocardiography at presentation, which occurred significantly less frequently in Group PCI-C (36.8% vs 8.1%, p < 0.0001). The initial success rate of percutaneous coronary intervention was sufficiently high in both groups (Group PCI-I: 96.9% vs Group PCI-C: 97.7%, NS). Acute myocardial infarction occurred in six patients of Group PCI-C (3.5%) because of the side branch occlusion. There was no in-hospital death or emergent coronary artery bypass grafting. During the 6-month follow-up, there were no significant differences in the death rates (2.1% vs 1.7%), the death or myocardial infarction rates (5.3% vs 5.8%) and the target lesion revascularization ratio (26.0% vs 25.7%) between Group PCI-I and Group PCI-C. CONCLUSIONS: The clinical outcomes of the early invasive strategy for unstable angina pectoris were almost equivalent to those of the early conservative strategy, despite more frequent ST segmental elevation at admission in Group PCI-I. These findings suggest that the early invasive strategy for unstable angina pectoris may be acceptable even in the current Japanese clinical setting without the use of GP IIb/IIIa receptor antagonist, low molecular weight heparin or clopidogrel.

[Electrocardiographic discrimination of infarct-related artery between left circumflex and right coronary artery: comparison of ST elevation between leads II and III].

OBJECTIVES: Admission electrocardiography was evaluated to discriminate left circumflex artery (LCX) versus right coronary artery (RCA) as the cause of acute myocardial infarction. METHODS: Electrocardiographic findings were assessed in patients with RCA (n = 60) and LCX (n = 60) occlusion. RESULTS: ST segment elevation in the inferior leads or right precordial leads was more common in the RCA group. ST segment depression or negative T wave was more common in leads I, aVL in the RCA group. ST segment elevation was more common in leads V5, V6 in the LCX group. ST segment was elevated in inferior leads in 55 patients in the RCA group and 27 patients in the LCX group. Mean ST level was higher in lead III than in lead II in the RCA group, but not in the LCX group. The ST level was higher in lead III than in lead II in 78% of the RCA group, but only 44% of the LCX group (p < 0.01). CONCLUSIONS: Comparison of ST levels between leads II and III, and a three-dimensional analysis in 12-lead electrocardiography is useful for discriminating the left circumflex artery from the right coronary artery as the cause of acute myocardial infarction.