Retrospective comparison of clinical and angiographic outcomes after sirolimus-eluting and bare-metal stent implantation in 312 consecutive, nonrandomized severely calcified lesions using a rotablator.

In order to compare the long-term clinical and angiographic outcomes after sirolimus-eluting stent (SES) and bare-metal stent (BMS) placement in severely calcified lesions using a rotablator under the widespread indication of SES, a nonrandomized examination of 312 consecutive lesions after successful implantation of a BMS (99 lesions in 84 patients; from January 2003) or SES (213 in 167; from September 2004) using a rotablator was conducted. The lesion-based primary endpoints (cardiac death and nonfatal recurrent myocardial infarction) and the secondary endpoint [binary restenosis (BR) (diameter stenosis > 50%) at follow-up angiography] were retrospectively determined in August 2010. The incidence of primary endpoint in the SES group (2.3%; mean follow-up period of 1289 ± 526 days) was significantly lower than that in the BMS group (7.1%; P = 0.043; 1803 ± 887 days), although the several variables related to the endpoints were present in the SES group. Cox proportional hazard model analysis revealed that SES was not significantly related to a primary endpoint [hazard ratio of 0.42 (95% CI, 0.073-2.42; P = 0.33)]. The incidence of BR in the SES group (21.3%) was not significantly different from that in the BMS group (27.1%) (P = 0.33). Multivariate logistic regression analysis revealed that SES was not a significant predictor of BR [Odds ratio of 0.78 (95% CI, 0.41-1.51; P = 0.47)]. Thus, although the results of the present retrospective nonrandomized study demonstrate the long-term safety of SES for calcified lesions using a rotablator in daily practice, SES did not show a benefit for the angiographic outcomes compared to BMS.

Predictors of target lesion revascularization and documented stent thrombosis beyond 30 days after sirolimus-eluting stent implantation: retrospective analysis in consecutive 1,070 angiographic follow-up lesions.

BACKGROUND: Outcomes after sirolimus-eluting stent (SES: Cypher) implantation remained to be elucidated in Japan. METHODS AND RESULTS: Among 1,070 consecutive angiographic follow-up lesions, 99 lesions underwent target lesion revascularization (TLR) with in-stent restenosis (ISR). Retrospective estimation by multivariate analysis including 50 variables showed that the ostiums of right coronary and left circumflex arteries, hemodialysis, calcification, non-direct stenting, ISR of SES, and non-eccentric lesion were the predictors of TLR. There was no documented late stent thrombosis (LST) among 2,166 lesions and very LST (VLST) among 1,423 lesions. CONCLUSION: Further revises are needed to implant SES to these predictive lesions. LST and VLST were very rare.

[Initial and mid-term effects of > or = 30 mm long sirolimus-eluting stents in patients with diffuse long coronary lesions: comparison with bare metal stents].

OBJECTIVES AND METHODS: Sirolimus-eluting stents (SES) can reduce restenosis and reintervention compared with bare metal stents (BMS). However, the safety and efficacy of SES for diffuse long lesions remain unknown. This study compared the efficacy of SES and BMS using the initial and mid-term outcomes of 124 patients with 130 long coronary lesions (SES lengths > or = 30 mm) compared to 141 patients with 146 lesions treated with BMS. RESULTS: Quantitative coronary arteriography parameters and initial success rate were not significantly different between the two groups. Occurrence of stent thrombosis was not different between the groups (1 case, 0.7% in group SES vs 0 case, 0% in group BMS). Restenosis and major adverse cardiac event rates at 6 months were lower in the SES group than in the BMS group (3.1% vs 34.2%, p < 0.0001, 3.8% vs 31.5%, p < 0.0001). CONCLUSIONS: Initial effects of sirolimus-eluting stents for diffuse long lesions are as useful and as safe as BMS. The mid-term outcomes for SES are superior due to the lower rates of both restenosis and major adverse cardiac event.

Pulmonary pressure-flow relation as a determinant factor of exercise capacity and symptoms in patients with regurgitant valvular heart disease.

BACKGROUND: Exertional dyspnea is a frequent limiting symptom in patients with chronic heart failure. Furthermore, dyspnea and a plateau in VO(2) (oxygen consumption) at peak exercise often co-exist in chronic heart failure, especially in patients with severe regurgitant valvular heart disease (RVHD), their relevance to hemodynamics and subjective symptoms during exercise have not been fully understood. OBJECTIVES: The purpose of this study was to examine the determinant factor of exercise capacity in patients with RVHD. METHODS: We performed a symptom-limited cardiopulmonary exercise test using a sitting cycle ergometer with right heart catheterization in 20 patients with severe RVHD. VO(2) and hemodynamics were measured at rest and during exercise, and symptomatic end-point at peak exercise was evaluated by using Borg's score. RESULTS: Of the 20 patients, 11 attained a plateau in VO(2) at peak exercise (Group 1). At peak exercise, pulmonary arterial pressure (PAP) was higher, and cardiac output (CO) and VO(2) were lower in Group 1 than in patients without a plateau in VO(2) (Group 2) (mean PAP: 60+/-10 vs. 48+/-9 mm Hg, P=0.05; CO: 8.3+/-2.6 vs. 11.2+/-2.6 l/min, P=0.01; VO(2): 1059+/-259 vs. 1359+/-328 ml/min, P=0.01). In Group 1, 6 patients complaining of dyspnea rather than leg fatigue at peak exercise had lower CO (7.1+/-1.8 vs. 9.7+/-3.0 l/min, P=0.05) and higher slope of mean PAP-CO relation (P-Q slope) (10.6+/-3.6 vs. 5.4+/-1.7, P=0.01), compared with the other 5 patients with leg fatigue. CONCLUSIONS: Development of pulmonary hypertension during exercise is the important limiting factor for exercise capacity in patients with RVHD. The limitation of increase in CO concomitant with pulmonary hypertension could be an important factor in the appearance of dyspnea.

Effects of efonidipine, an L- and T-Type dual calcium channel blocker, on heart rate and blood pressure in patients with mild to severe hypertension: an uncontrolled, open-label pilot study.

BACKGROUND: Dihydropyridines (DHPs), a type of calcium channel blocker (CCB), are commonly prescribed for the treatment of hypertension and angina pectoris. DHPs act mainly on L-type calcium channels, essentially causing reflex tachycardia (elevated heart rate [HR]), which negatively affects cardiac function. Because T-type calcium channels in the sinoatrial node attenuate reflex tachycardia, a dual L- and T-type CCB (eg, efonidipine hydrochloride) may favorably affect cardiac pacing, thereby reducing reflex tachycardia. The effect of efonidipine as a DHP on HR deserves special consideration with regard to reflex tachycardia. OBJECTIVE: The aim of this study was to determine whether the L- and T-type CCB efonidipine can decrease the elevated HR induced by prior treatment using traditional DHPs. METHODS: This uncontrolled, open-label pilot study was conducted at the Division of Cardiology, Department of Internal Medicine, The Jikei University School of Medicine (Tokyo, Japan). Patients aged 48 to 80 years with mild to severe hypertension and angina pectoris and who were receiving therapy with a DHP other than efonidipine were eligible. During an 8-week observation period, patients continued therapy with their DHP. After those 8 weeks, therapy was switched to oral efonidipine (40-mg tablet once daily) in patients whose blood pressure (BP) was stable and well controlled and whose HR was >80 bpm. BP and HR were monitored every 4 weeks of treatment with efonidipine. RESULTS: Eighteen patients (12 men, 6 women; mean [SD] age, 62.6 [12] years) were enrolled. After the switch to efonidipine, mean (SD) HR decreased significantly, from 94 (7) bpm to 86 (11) bpm at 12 weeks (P<0.05). The antihypertensive effect of efonidipine was similar to that of the DHPs used before the switch to efonidipine therapy, and reflex tachycardia was attenuated. CONCLUSION: In this study of a small sample of patients with mild to severe essential hypertension and angina pectoris, efonidipine was as effective as other DHPs. Moreover, the drug attenuated the reflex tachycardia that occurred with traditional DHPs.