Abstract Objectives This study sought to evaluate the optimal percutaneous coronary intervention techniques using drug-eluting stents for bifurcation coronary lesions. Background The optimal ...bifurcation stenting technique needs to be evaluated. Methods The trial included 2 randomization studies separated by the presence of side branch (SB) stenosis for patients having non–left main bifurcation lesions. For 306 patients without SB stenosis, the routine final kissing balloon or leave-alone approaches were compared. Another randomization study compared the crush or single-stent approaches for 419 patients with SB stenosis. Results Between the routine final kissing balloon and leave-alone groups for nondiseased SB lesions, angiographic restenosis occurred in 17.9% versus 9.3% (p = 0.064), comprising 15.1% versus 3.7% for the main branch (p = 0.004) and 2.8% versus 5.6% for the SB (p = 0.50) from 214 patients (69.9%) receiving 8-month angiographic follow-up. Incidence of major adverse cardiac events including death, myocardial infarction, or target vessel revascularization over 1 year was 14.0% versus 11.6% between the routine final kissing balloon and leave-alone groups (p = 0.57). In another randomization study for diseased SB lesions, 28.2% in the single-stent group received SB stents. From 300 patients (71.6%) receiving angiographic follow-up, between the crush and single-stent groups, angiographic restenosis rate was 8.4% versus 11.0% (p = 0.44), comprising 5.2% versus 4.8% for the main branch (p = 0.90) and 3.9% versus 8.3% for the SB (p = 0.12). One-year major adverse cardiac events rate between the crush and single-stent groups was 17.9% versus 18.5% (p = 0.84). Conclusions Angiographic and clinical outcomes were excellent after percutaneous coronary intervention using drug-eluting stents with any stent technique for non–left main bifurcation lesions once the procedure was performed successfully.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objectives The purpose of this study is to compare the efficacy of the treatment strategies for in-stent restenosis (ISR) of drug-eluting stents (DES) according to the morphologic pattern of ...restenosis. Background Optimal treatment strategies for ISR within DES have not been adequately addressed yet. Methods Patients with ISR of DES were randomized according to the lesion length to compare outcomes of sirolimus-eluting stent (SES) versus cutting balloon angioplasty for focal type (≤10 mm) and SES versus everolimus-eluting stent (EES) for diffuse type (>10 mm). The primary endpoint was in-segment late loss at 9 months. Overall 162 patients, 96 with focal ISR and 66 with diffuse ISR, were enrolled. Results In focal lesions, in-segment late loss was significantly higher in the cutting balloon group (n = 48) than in the SES group (n = 48; 0.25 mm, interquartile range IQR: −0.01 to 0.68 mm vs. 0.06 mm, IQR: −0.08 to 0.17 mm; p = 0.04). Consequently, in-segment restenosis rate tended to be higher in the cutting balloon group than in the SES group (20.7% vs. 3.1%, p = 0.06) with comparable incidences of the composite of death, myocardial infarction, or target vessel revascularization at 12 months of clinical follow up (6.3% vs. 6.3%, p > 0.99). In 66 cases of diffuse ISR, in-segment late loss (0.11 mm, IQR: −0.02 to 0.30 mm; vs. 0.00 mm, IQR: −0.08 to 0.25 mm; p = 0.64), in-segment restenosis rate (5.0% vs. 14.3%, p = 0.32), and the composite incidence of death, myocardial infarction, or target lesion revascularization (9.6% vs. 8.8%, p > 0.99) did not differ between SES group (n = 32) and EES group (n = 34). Conclusions For lesions of focal DES restenosis, repeat implantation of SES is more effective in reducing late luminal loss and subsequent restenosis rate than cutting balloon angioplasty. For diffuse DES restenosis, implantation of SES or EES is comparably effective in terms of angiographic and clinical outcomes.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Purpose A fixed-dose combination of a stain and an antihypertensive drug may be useful for the treatment of patients with hypertension and hyperlipidemia. It may also improve patient drug ...compliance to help control risk factors of cardiovascular disease. This study was designed to evaluate the blood pressure–lowering and cholesterol-lowering effect of a fixed-dose combination of irbesartan-atorvastatin compared with monotherapy by either agent over an 8-week treatment period. Methods Patients with comorbid hypertension and hypercholesterolemia were screened for this randomized, double-blind, Phase III study. Eligible study patients were randomly assigned to test groups receiving a combination of irbesartan 300 mg and atorvastatin 40 mg or 80 mg (IRB300 + ATO40 and IRB300 + ATO80). Comparator groups comprised monotherapy groups with irbesartan 300 mg (IRB300) or atorvastatin 40 mg (ATO40) or atorvastatin 80 mg (ATO80), or placebo. Patients who were eligible at screening were subjected to a 4- to 6-week washout period before commencing 8 weeks of therapy per their assigned group. The primary efficacy end points were percent change in LDL-C and sitting diastolic blood pressure (DBP) levels from baseline to end of therapy. Tolerability profiles of combination therapy were compared with other groups. Findings A total of 733 patients with comorbid hypertension and hypercholesterolemia were screened for this study; 230 eligible patients were randomized to treatment. The mean age of patients was 58.9 (8.5) years, and their mean body mass index was 25.8 (3.2) kg/m2 . More than two thirds (70.9%) of the study patients were male. Mean LDL-C and sitting DBP levels at baseline were 149.54 (29.19) mg/dL and 92.32 (6.03) mm Hg, respectively. Percent reductions in LDL-C after 8 weeks were 46.74% (2.06%) in the IRB300 + ATO40 group and 48.98% (2.12%) in the IRB300 + ATO80 group; these values were 47.13% (3.21%) and 48.30% (2.98%) in the ATO40 and ATO80 comparator groups. Similarly, a reduction in sitting DBP after 8 weeks was –8.50 (1.06) mm Hg in the IRB300 + ATO40 group and 10.66 (1.08) mm Hg in the IRB300 + ATO80 group compared with 8.40 (1.65) mm Hg in the IRB300 group. The incidence rate for treatment-emergent adverse events was 22.27% and was similar between the monotherapy and combination groups. Implications A once-daily combination product of irbesartan and atorvastatin provided an effective, safe, and more compliable treatment for patients with coexisting hypertension and hyperlipidemia. ClinicalTrials.gov identifier: NCT01442987.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
To evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation for long coronary lesions, we performed a randomized multicenter prospective study comparing ...triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol; triple group, n = 250) and dual antiplatelet therapy (aspirin and clopidogrel; standard group, n = 250) for 6 months in patients with long lesions (≥25 mm) requiring a long DES (≥32 mm). The primary end point was in-stent late loss at 6-month angiography. The 2 groups had similar baseline clinical and angiographic characteristics. In-stent late loss (0.22 ± 0.48 mm vs 0.32 ± 0.51 mm, p = 0.031) and in-segment late loss (0.34 ± 0.49 mm vs 0.51 ± 0.49 mm, p = 0.001) at 6-month follow-up angiography were significantly lower in the triple group versus the standard group. There was a trend toward lower rates of in-segment restenosis in the triple group versus the standard group (6.7% vs 11.2%, p = 0.104). Target lesion revascularization (TLR; 2.8% vs 6.8%, p = 0.036) and major adverse cardiac events (2.8% vs 7.6%, p = 0.016), including death, myocardial infarction, and TLR at 9 months were significantly lower in the triple group than in the standard group. At 9 months, the 2 groups had similar rates of stent thrombosis (0.4% vs 0.4%, p = 0.999), death (0% vs 0.8%, p = 0.499), and myocardial infarction (0.4% vs 0.4%, p = 0.999). In conclusion, cilostazol significantly reduced late loss at 6 months after DES implantation and the occurrence of TLR and major adverse cardiac events in patients with long coronary lesions.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Although cilostazol has decreased restenosis and target lesion revascularization (TLR) after drug-eluting stent implantation, it is not known if this effect is durable at 2 years. We analyzed 2 ...randomized studies (Drug-Eluting stenting followed by Cilostazol treatment reduces LAte REstenosis in patients with DIABETES mellitus and Drug-Eluting Stenting Followed by Cilostazol treatment reduces LAte REstenosis in patients with LONG native coronary lesions trials) in which 900 patients were randomly assigned to triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol; triple group, n = 450) and dual antiplatelet therapy (aspirin and clopidogrel; standard group, n = 450) for 6 months in patients with diabetes or long lesions receiving drug-eluting stents. We evaluated 2-year major adverse cardiac events (MACEs) including death, myocardial infarction (MI), and TLR. Nine-month TLRs and MACEs were significantly decreased in the triple versus standard group. At 2 years, the triple group sowed significantly decreased TLRs (4.2% vs 9.1%, hazard ratio 0.45, 95% confidence interval 0.26 to 0.78, p = 0.004) and MACEs (5.6% vs 10.4%, hazard ratio 0.52, 95% confidence interval 0.32 to 0.84, p = 0.008) compared to the standard group with no differences in death and MI. In subgroup analysis, triple antiplatelet therapy decrease of 2-year TLR was favorable in all subgroups, especially in patients with paclitaxel-eluting stents, diabetes mellitus, small vessels, long lesions, and left anterior descending coronary artery lesions. In conclusion, compared to the standard group, initial benefit in decreases of 9-month TLRs and MACEs in the triple group was sustained at 2 years with no differences in death or MI. Triple antiplatelet therapy decrease of 2-year TLR was favorable in all subgroups, especially in patients with high-risk profiles.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Drug-eluting stents (DESs) are increasingly used for treatment of acute ST-segment elevation myocardial infarction (STEMI), but there are few comparisons of outcomes of various types of DES. We ...compared the efficacy and safety of zotarolimus-eluting stents (ZESs), sirolimus-eluting stents (SESs), and paclitaxel-eluting stents (PESs) in primary intervention for STEMI. This multicenter, prospectively randomized ZEST-AMI trial included 328 patients at 12 medical centers who were randomly assigned to ZES (n = 108), SES (n = 110), or PES (n = 110) deployment. The primary end point was major adverse cardiac events (death, MI, and ischemia-driven target vessel revascularization) at 12 months. Secondary end points included the individual components of the primary end point, late loss, angiographic restenosis, and stent thrombosis. Baseline clinical and angiographic characteristics were well matched. In-segment late loss (0.28 ± 0.42 vs 0.46 ± 0.48 vs 0.47 ± 0.50 mm, respectively, p = 0.029) and restenosis rate (2.7% vs 15.9% vs 12.3%, respectively, p = 0.027) at 8 months were lowest in the SES group compared to the ZES and PES groups. At 12 months, cumulative incidence rates of primary end points in the ZES, SES, and PES groups were 11.3%, 8.2%, and 8.2%, respectively (p = 0.834). There were 2 acute (in the SES group) and 5 subacute (2 in the SES group and 3 in the PES group) stent thromboses. Incidence of death, recurrent MI, or ischemia-driven target vessel revascularization did not differ among the 3 groups. In conclusion, despite the difference in restenosis rate, the efficacy and safety of the 3 different DESs showed similar, acceptable results in the treatment of STEMI.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
A Randomized Comparison of Sirolimus- Versus Paclitaxel-Eluting Stent Implantation in Patients With Diabetes Mellitus Seung-Whan Lee, Seong-Wook Park, Young-Hak Kim, Sung-Cheol Yun, Duk-Woo Park, ...Cheol Whan Lee, Myeong-Ki Hong, Kyoung-Suk Rhee, Jei Keon Chae, Jae-Ki Ko, Jae-Hyeong Park, Jae-Hwan Lee, Si Wan Choi, Jin-Ok Jeong, In-Whan Seong, Yoon Haeng Cho, Nae-Hee Lee, June Hong Kim, Kook-Jin Chun, Hyun-Sook Kim, Seung-Jung Park To compare the effectiveness of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), we randomly compared SES (n = 200) and PES (n = 200) in patients with diabetes mellitus (DM). Six-month in-stent (3.4% vs. 18.2%, p < 0.001) and in-segment restenosis (4.0% vs. 20.8%, p < 0.001) and 9-month target lesion revascularization (2.0% vs. 7.5%, p = 0.017) were significantly lower in the SES versus the PES group. Major adverse cardiac events including death, myocardial infarction, and target lesion revascularization at 9 months (2.0% vs. 8.0%, p = 0.010) were lower in the SES versus the PES group. In conclusion, SES significantly reduced angiographic restenosis and improved clinical outcomes in diabetic patients compared with PES implantation.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Few studies have compared the ability of sodium bicarbonate plus N-acetylcysteine (NAC) and sodium chloride plus NAC to prevent contrast-induced nephropathy (CIN) in diabetic patients with impaired ...renal function undergoing coronary or endovascular angiography or intervention. Diabetic patients (n = 382) with renal disease (serum creatinine ≥1.1 mg/dl and estimated glomerular filtration rate <60 ml/min/1.73 m2 ) were randomly assigned to receive prophylactic sodium chloride (saline group, n = 189) or sodium bicarbonate (bicarbonate group, n = 193) before elective coronary or endovascular angiography or intervention. All patients received oral NAC 1,200 mg 2 times/day for 2 days. The primary end point was CIN, defined as an increase in serum creatinine >25% or an absolute increase in serum creatinine ≥0.5 mg/dl within 48 hours after contrast exposure. There were no significant between-group differences in baseline characteristics. The primary end point was met in 10 patients (5.3%) in the saline group and 17 (9.0%) in the bicarbonate group (p = 0.17), with 2 (1.1%) and 4 (2.1%), respectively, requiring hemodialysis (p = 0.69). Rates of death, myocardial infarction, and stroke did not differ significantly at 1 month and 6 months after contrast exposure. In conclusion, hydration with sodium bicarbonate is not superior to hydration with sodium chloride in preventing CIN in patients with diabetic nephropathy undergoing coronary or endovascular angiography or intervention.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Purpose The standard 60-mg dose of fimasartan, a newly developed selective angiotensin II receptor blocker, is effective and safe for use in patients with mild to moderate hypertension. This ...study aimed to compare the efficacy and safety of low-dose (30 mg) fimasartan and placebo or valsartan (80 mg) for 8 weeks in patients with mild to moderate hypertension. Methods In this randomized trial, 293 patients (219 men; mean age, 54.24 9.77 years) with mild to moderate hypertension were enrolled. After randomization to receive 30-mg fimasartan (n = 115), placebo (n = 117), or 80-mg valsartan (n = 61), the treatment dose was kept constant without dose escalation for 8 weeks. The primary end point was improvement in sitting diastolic blood pressure (SiDBP) from baseline to 8 weeks that was compared between treatments with low-dose fimasartan and placebo. The secondary end point was the overall efficacy and safety of low-dose fimasartan compared with that of placebo or valsartan. Findings At week 8, SiDBP changed by –9.93 (8.86) mm Hg in the fimasartan group and by –2.08 (9.47) mm Hg in the placebo group, which indicated significant antihypertensive efficacy ( P < 0.0001). Efficacy was shown at week 4 as measured by SiDBP (–9.96 7.73 vs –2.27 7.85 mm Hg; P < 0.0001) or sitting systolic blood pressure (SiSBP) (–16.18 14.44 vs –1.95 13.48 mmHg; P < 0.0001) and at week 8 as determined by SiSBP (–15.35 16.63 vs –2.30 14.91 mm Hg; P < 0.0001). The fimasartan group exhibited more potent antihypertensive efficacy than the valsartan group both at week 4 (SiDBP, –9.96 7.73 vs –6.53 9.58 mm Hg P = 0.0123; SiSBP, –16.18 14.4 vs –7.65 12.89 mm Hg P = 0.0002) and at week 8 (SiDBP, –9.93 8.86 vs –5.47 8.96 mm Hg P = 0.0021; SiSBP, –15.35 16.63 vs –7.49 13.68 mm Hg P = 0.0021). Most treatment-emergent adverse events (TEAEs) were mild (89 of 95), and there were no serious TEAEs. The incidence of TEAEs was 19.1% in the fimasartan group, 22.6% in the placebo group, and 13.6% in the valsartan group, with no significant differences. Implications Low-dose fimasartan (30 mg) was well tolerated during the study period with no significant TEAEs. Low-dose fimasartan had an effective blood pressure–lowering effect that was greater than that of 80-mg valsartan in patients with mild to moderate hypertension. ClinicalTrials.gov identifier: NCT01672476.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Objectives We performed this study to introduce our minimal supra-auricular approach for the surgical management of a preauricular sinus (PAS) and to evaluate the advantages of this ...drainless technique. Study design This was a retrospective study. Setting The study was done in a tertiary referral center. Methods We enrolled 94 patients (101 ears) with a PAS who underwent surgical treatment via a minimal supra-auricular approach performed by one surgeon between April 1999 and May 2010. After removing the specimen, meticulous subcutaneous suturing and no drain were used in 83 patients (89 ears) and a postoperative drain was inserted in 11 patients (12 ears). Surgical outcomes of this technique were compared between the groups with and without postoperative drain insertion. Results With a good surgical view and meticulous subcutaneous mattress sutures in our minimal supra-auricular approach for PAS excision, there was no postoperative recurrence or other serious complication. In the drain group, previous operation history was more frequent ( P = .010), and the rate of preoperative infection was higher than in the drainless group ( P = .018). Postoperatively, a compression dressing was required more frequently ( P = .002) and for longer in the drain group ( P = .001). The rate of immediate postoperative wound infection was higher in the drain group ( P = .003). Conclusion Our drainless minimal supra-auricular approach for the surgical removal of a PAS has advantage in terms of good surgical results of no recurrence and is more comfortable for patients because of the reduced need for a compression dressing. We suggest that this technique is effective and safe for PAS excision.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
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