Keun Bae Lee

Duration of dual antiplatelet therapy after implantation of drug-eluting stents.

BACKGROUND The potential benefits and risks of the use of dual antiplatelet therapy beyond a 12-month period in patients receiving drug-eluting stents have not been clearly established. METHODS In two trials, we randomly assigned a total of 2701 patients who had received drug-eluting stents and had been free of major adverse cardiac or cerebrovascular events and major bleeding for a period of at least 12 months to receive clopidogrel plus aspirin or aspirin alone. The primary end point was a composite of myocardial infarction or death from cardiac causes. Data from the two trials were merged for analysis. RESULTS The median duration of follow-up was 19.2 months. The cumulative risk of the primary outcome at 2 years was 1.8% with dual antiplatelet therapy, as compared with 1.2% with aspirin monotherapy (hazard ratio, 1.65; 95% confidence interval [CI], 0.80 to 3.36; P=0.17). The individual risks of myocardial infarction, stroke, stent thrombosis, need for repeat revascularization, major bleeding, and death from any cause did not differ significantly between the two groups. However, in the dual-therapy group as compared with the aspirin-alone group, there was a nonsignificant increase in the composite risk of myocardial infarction, stroke, or death from any cause (hazard ratio, 1.73; 95% CI, 0.99 to 3.00; P=0.051) and in the composite risk of myocardial infarction, stroke, or death from cardiac causes (hazard ratio, 1.84; 95% CI, 0.99 to 3.45; P=0.06). CONCLUSIONS The use of dual antiplatelet therapy for a period longer than 12 months in patients who had received drug-eluting stents was not significantly more effective than aspirin monotherapy in reducing the rate of myocardial infarction or death from cardiac causes. These findings should be confirmed or refuted through larger, randomized clinical trials with longer-term follow-up. (ClinicalTrials.gov numbers, NCT00484926 and NCT00590174.)

Optimal Duration of Dual Antiplatelet Therapy after Drug-Eluting Stent Implantation: A Randomized Controlled Trial

Background— The risks and benefits of long-term dual antiplatelet therapy remain unclear. Methods and Results— This prospective, multicenter, open-label, randomized comparison trial was conducted in 24 clinical centers in Korea. In total, 5045 patients who received drug-eluting stents and were free of major adverse cardiovascular events and major bleeding for at least 12 months after stent placement were enrolled between July 2007 and July 2011. Patients were randomized to receive aspirin alone (n=2514) or clopidogrel plus aspirin (n=2531). The primary end point was a composite of death resulting from cardiac causes, myocardial infarction, or stroke 24 months after randomization. At 24 months, the primary end point occurred in 57 aspirin-alone group patients (2.4%) and 61 dual-therapy group patients (2.6%; hazard ratio, 0.94; 95% confidence interval, 0.66–1.35; P=0.75). The 2 groups did not differ significantly in terms of the individual risks of death resulting from any cause, myocardial infarction, stent thrombosis, or stroke. Major bleeding occurred in 24 (1.1%) and 34 (1.4%) of the aspirin-alone group and dual-therapy group patients, respectively (hazard ratio, 0.71; 95% confidence interval, 0.42–1.20; P=0.20). Conclusions— Among patients who were on 12-month dual antiplatelet therapy without complications, an additional 24 months of dual antiplatelet therapy versus aspirin alone did not reduce the risk of the composite end point of death from cardiac causes, myocardial infarction, or stroke. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186146.

Randomized Comparison of Everolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery Disease in Patients With Diabetes Mellitus (ESSENCE-DIABETES) Results From the ESSENCE-DIABETES Trial

Background— Drug-eluting stents significantly improved angiographic and clinical outcomes compared with bare metal stents in diabetic patients. However, a comparison of everolimus-eluting stents and sirolimus-eluting stents in diabetic patients has not been evaluated. Therefore we compared effectiveness of everolimus-eluting stents and sirolimus-eluting stents in patients with diabetes mellitus. Methods and Results— This prospective, multicenter, randomized study compared everolimus-eluting stent (n=149) and sirolimus-eluting stent (n=151) implantation in diabetic patients. The primary end point was noninferiority of angiographic in-segment late loss at 8 months. Clinical events were also monitored for at least 12 months. Everolimus-eluting stents were noninferior to sirolimus-eluting stents for 8-month in-segment late loss (0.23±0.27 versus 0.37±0.52 mm; difference, −0.13 mm; 95% confidence interval, −0.25 to −0.02; upper 1-sided 95% confidence interval, −0.04; P<0.001 for noninferiority), with reductions in in-stent restenosis (0% versus 4.7%; P=0.029) and in-segment restenosis (0.9% versus 6.5%; P=0.035). However, in-stent late loss (0.11±0.26 versus 0.20±0.49 mm; P=0.114) was not statistically different between the 2 groups. At 12 months, ischemia-driven target lesion revascularization (0.7% versus 2.6%; P=0.317), death (1.3% versus 3.3%; P=0.448), and myocardial infarction (0% versus 1.3%; P=0.498) were not statistically different between the 2 groups. Major adverse cardiac events, including death, myocardial infarction, and ischemia-driven target lesion revascularization (2.0% versus 5.3%; P=0.218), were also not statistically different between the 2 groups. Conclusions— Everolimus-eluting stents were noninferior to sirolimus-eluting stents in reducing in-segment late loss and reduced angiographic restenosis at 8 months in patients with diabetes mellitus and coronary artery disease. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00997763.

A Randomized, Double-Blind, Multicenter Comparison Study of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy to Reduce Restenosis After Drug-Eluting Stent Implantation in Long Coronary Lesions: Results From the DECLARE-LONG II (Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients with Long Coronary Lesions) Trial

OBJECTIVES The purpose of this study was to determine whether cilostazol reduces intimal hyperplasia in patients undergoing long zotarolimus-eluting stent implantation (stent length: ≥ 30 mm) for native long coronary lesions (length: ≥ 25 mm). BACKGROUND Restenosis after drug-eluting stent implantation remains a significant clinical problem in long coronary lesions. METHODS Patients (n = 499) were assigned randomly to triple (aspirin, clopidogrel, and cilostazol, triple group: n = 250) or dual antiplatelet therapy (aspirin and clopidogrel and placebo, dual group: n = 249) for 8 months after long zotarolimus-eluting stent implantation. The primary end point was in-stent late loss at the 8-month angiography according to the intention-to-treat principle. RESULTS The 2 groups had similar baseline characteristics. The in-stent (0.56 ± 0.55 mm vs. 0.68 ± 0.59 mm, p = 0.045) and in-segment (0.32 ± 0.54 mm vs. 0.47 ± 0.54 mm, p = 0.006) late loss were significantly lower in the triple versus dual group, as were 8-month in-stent restenosis (10.8% vs. 19.1%, p = 0.016), in-segment restenosis (12.2% vs. 20.0%, p = 0.028), and 12-month ischemic-driven target lesion revascularization (5.2% vs. 10.0%, p = 0.042) rates. At 12 months, major adverse cardiac events including death, myocardial infarction, and ischemic-driven target lesion revascularization tended to be lower in the triple group than the dual group (7.2% vs. 12.0%, p = 0.07). Percent intimal hyperplasia volume by volumetric intravascular ultrasound analysis was reduced from 27.1 ± 13.2% for the dual group to 22.1 ± 9.9% for the triple group (p = 0.017). CONCLUSIONS Patients receiving triple antiplatelet therapy after long zotarolimus-eluting stent implantation had decreased extent of late luminal loss, percent intimal hyperplasia volume, and angiographic restenosis, resulting in a reduced risk of 12-month target lesion revascularization compared with patients receiving dual antiplatelet therapy. (Triple Versus Dual Antiplatelet Therapy after ABT578-Eluting Stent; NCT00589927).

Biomechanical Test Comparing the Load to Failure of the Biodegradable Meniscus Arrow Versus Meniscal Suture

The biodegradable Meniscus Arrow (Bionx, Blue Bell, PA) is a newly introduced method for repair of meniscal injury. However, because of a lack of studies, there is still little understanding of its biomechanical behavior. Biomechanical test was carried out to evaluate the load to failure and failure modes of the Meniscus Arrow and to compare the results with those of three traditionally used methods. Thirty-five lateral menisci obtained from Yorkshire pigs were incised longitudinally, simulating a peripheral longitudinal tear, and were repaired by means of Meniscus Arrows (one-point and two-point fixation), as well as with the techniques of knot-end, horizontal, and vertical suture using No. I PDS II monofilament suture. Tensile strength testing was performed according to each repair method with the Instron tensometer (Model No. 5569; Instron, Canton, MA) and its results were analyzed using a computerized statistical program. The average maximal tensile strengths were 113.9 +/- 14.6 N in vertical suture, 75.1 +/- 18.4 N in horizontal suture, 53.9 +/- 6.4 N in knot-end suture, 38.3 +/- 4.3 N in one-point fixation Meniscus Arrow repair, and 56.5 +/- 3.5 N in two-point fixation Meniscus Arrow repair. The initial failure strength for two-point fixation Meniscus Arrow repair is comparable to that of a knot-end suture. Following the results of this study, meticulous caution should be taken when meniscal tears are repaired with Meniscus Arrows.

Comparison of Everolimus- and Sirolimus-Eluting Stents in Patients With Long Coronary Artery Lesions: A Randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial

OBJECTIVES This study compared everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) for long coronary lesions. BACKGROUND Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments. METHODS This randomized, multicenter, prospective trial compared the use of long EES with SES in 450 patients with long (≥ 25 mm) native coronary lesions. The primary endpoint of the trial was in-segment late luminal loss at 9-month angiographic follow-up. RESULTS The EES and SES groups had similar baseline characteristics. Lesion length was 34.0 ± 15.4 mm in the EES group and 34.3 ± 13.5 mm in the SES group (p = 0.85). Nine-month angiographic follow-up was performed in 80% of the EES group and 81% of the SES group (p = 0.69). In-segment late loss as the primary study endpoint was significantly larger in the EES group than in the SES group (0.17 ± 0.41 mm vs. 0.09 ± 0.30 mm, p for noninferiority = 0.96, p for superiority = 0.04). The in-segment binary restenosis rate was also higher in the EES group than in the SES group (7.3% vs. 2.7%, p = 0.046). However, in-stent late loss (0.22 ± 0.43 mm vs. 0.18 ± 0.28 mm, p = 0.29) and in-stent binary restenosis rate (3.9% vs. 2.7%, p = 0.53) were similar among the 2 groups. The incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes) was not statistically different between the 2 groups. CONCLUSIONS For patients with long native coronary artery disease, EES implantation was associated with greater angiographic in-segment late loss and higher rates of in-segment restenosis compared with SES implantation. However, clinical outcomes were both excellent and not statistically different.

Distal Chevron Osteotomy with Distal Soft Tissue Procedure for Moderate to Severe Hallux Valgus Deformity

Background: Distal chevron osteotomy has been widely employed to treat mild to moderate hallux valgus deformity. The purpose of the present study was to evaluate the outcomes of distal chevron osteotomy with a distal soft tissue procedure for the correction of moderate to severe hallux valgus. Materials and Methods: We reviewed 76 patients (86 feet) that underwent distal chevron osteotomy with a distal soft tissue procedure for symptomatic moderate to severe hallux valgus deformity. At a mean followup of 31 months, all patients were evaluated using subjective, objective and radiographic measurements. Results: Ninety-four percent of the patients were very satisfied or satisfied. Average AOFAS score improved from 54.7 points preoperatively to 92.9 at final followup. Average hallux valgus angle changed from 36.2 degrees preoperatively to 12.4 degrees at final followup, and average first-second intermetatarsal angle changed from 17.1 to 7.3 degrees. Average tibial sesamoid position changed from 2.4 preoperatively to 1.2 at final followup. Dorsal angulation of the head was observed in two feet, and plantaflexion of the head in four feet. There were no cases of avascular necrosis of the metatarsal head. Conclusion: Our results indicate that distal chevron osteotomy with a distal soft tissue procedure provides an effective and reliable means of correcting moderate to severe hallux valgus deformity, and that it does so with high levels of patient satisfaction and low incidence of complications. Level of Evidence: IV, Retrospective Case Series

A Clinical Comparison of Screw and Suture Fixation of Anterior Cruciate Ligament Tibial Avulsion Fractures

Background Screw and suture fixations are the most commonly used methods of fixation in treatment of anterior cruciate ligament tibial avulsion fractures. Even though a few biomechanical studies have compared the stability of the 2 fixation techniques, a clinical comparison has not yet been reported. Hypothesis The authors hypothesized that both fixations would be identical in all studied clinical outcome measures at a minimum 2-year follow-up. Study Design Cohort study; Level of evidence, 3. Materials and Methods Thirty-three patients treated with either screw fixation (16 patients) or suture fixation (17 patients) within 1 month of the anterior cruciate ligament tibial avulsion fracture (type II or III) without associated ligamentous injury were included. All patients were evaluated at a minimum 2-year follow-up in terms of Lysholm knee scores and return to preinjury activities. Knee stability was compared based on the Lachman test and stress radiography. Results No significant differences were found between the 2 groups in terms of average Lysholm knee scores (91.7 in the screw group and 92.7 in the suture group, P = .413) at follow-up. All patients except 2 (1 in each group) returned to preinjury activity levels. However, flexion contractures (5° to 10°) were found in 3 patients in the screw group and 2 patients in the suture group without significant intergroup difference. Stabilities based on the Lachman test and instrumented stress radiography were also similar between the 2 groups at follow-up. However, 2 patients in the screw group and 1 in the suture group showed more than 5 mm laxity compared with the contralateral knee on stress radiographs. Conclusion Both the screw and suture fixation techniques for the anterior cruciate ligament tibial avulsion fracture produced relatively good results in terms of functional outcomes and stability without any significant differences. However, some patients in both groups showed residual laxity or flexion contractures.

Randomized Trial of Optimal Treatment Strategies for In-Stent Restenosis After Drug-Eluting Stent Implantation

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.

Subtalar Arthroscopy for Sinus Tarsi Syndrome: Arthroscopic Findings and Clinical Outcomes of 33 Consecutive Cases

PURPOSE The purposes of this study were to identify the pathologic findings of sinus tarsi syndrome (STS) by subtalar arthroscopy and to evaluate the results of arthroscopic treatments in 33 consecutive cases. METHODS A retrospective review was performed in 31 consecutive patients (33 cases) who underwent subtalar arthroscopic treatment for STS. The mean follow-up duration was 24 months (range, 18 to 36 months). Patients were evaluated by use of arthroscopic findings (recorded on videotapes and photographs) and clinical outcomes, which included visual analog scale and American Orthopaedic Foot and Ankle Society ankle-hindfoot scores. RESULTS Arthroscopic findings showed partial tear of the interosseous talocalcaneal ligament in 29 cases (88%), synovitis in 18 (55%), partial tear of the cervical ligament in 11 (33%), arthrofibrosis in 8 (24%), and soft-tissue impingement in 7 (21%). The mean visual analog scale score improved from 7.3 points (range, 6 to 9 points) preoperatively to 2.7 points (range, 1 to 4 points) postoperatively (P < .005), and the mean American Orthopaedic Foot and Ankle Society ankle-hindfoot score improved from 43.1 points (range, 21 to 65 points) preoperatively to 86.2 points (range, 72 to 100 points) postoperatively (P < .005). Of the cases, 16 (48%) had an excellent result, 13 (39%) had a good result, and 4 (12%) had a fair result. CONCLUSIONS Subtalar arthroscopy identified pathologies in the subtalar joint in patients with STS and showed that treatment of these pathologies led to improved function. LEVEL OF EVIDENCE Level IV, therapeutic case series.