Taehoon Ahn

Stents versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease

BACKGROUND Several studies have compared the treatment effects of coronary stenting and coronary-artery bypass grafting (CABG). However, there are limited data regarding the long-term outcomes of these two interventions for patients with unprotected left main coronary artery disease. METHODS We evaluated 1102 patients with unprotected left main coronary artery disease who underwent stent implantation and 1138 patients who underwent CABG in Korea between January 2000 and June 2006. We compared adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction, or stroke; and target-vessel revascularization) with the use of propensity-score matching in the overall cohort and in separate subgroups according to type of stent. RESULTS In the overall matched cohort, there was no significant difference between the stenting and CABG groups in the risk of death (hazard ratio for the stenting group, 1.18; 95% confidence interval [CI], 0.77 to 1.80) or the risk of the composite outcome (hazard ratio for the stenting group, 1.10; 95% CI, 0.75 to 1.62). The rates of target-vessel revascularization were significantly higher in the group that received stents than in the group that underwent CABG (hazard ratio, 4.76; 95% CI, 2.80 to 8.11). Comparisons of the group that received bare-metal stents with the group that underwent CABG and of the group that received drug-eluting stents with the group that underwent CABG produced similar results, although there was a trend toward higher rates of death and the composite end point in the group that received drug-eluting stents. CONCLUSIONS In a cohort of patients with unprotected left main coronary artery disease, we found no significant difference in rates of death or of the composite end point of death, Q-wave myocardial infarction, or stroke between patients receiving stents and those undergoing CABG. However, stenting, even with drug-eluting stents, was associated with higher rates of target-vessel revascularization than was CABG.

Six-Month Versus 12-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents The Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) Randomized, Multicenter Study

Background— The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents. Methods and Results— We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P =0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72–49.96; P =0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60–2.47; P =0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42–7.03; P =0.005) among diabetic patients. Conclusions— Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials. Clinical Trial Registration— URL: . Unique identifier: [NCT00698607][1]. # Clinical Perspective {#article-title-31} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00698607&atom=%2Fcirculationaha%2F125%2F3%2F505.atomBackground— The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents. Methods and Results— We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P=0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72–49.96; P=0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60–2.47; P=0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42–7.03; P=0.005) among diabetic patients. Conclusions— Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607.

Long-term safety and efficacy of stenting versus coronary artery bypass grafting for unprotected left main coronary artery disease: 5-year results from the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization) registry.

OBJECTIVES We performed the long-term follow-up of a large cohort of patients in a multicenter study receiving left main coronary artery (LMCA) revascularization. BACKGROUND Limited information is available on long-term outcomes for patients with unprotected LMCA disease who underwent coronary stent procedure or coronary artery bypass grafting (CABG). METHODS We evaluated 2,240 patients with unprotected LMCA disease who received coronary stents (n = 1,102; 318 with bare-metal stents and 784 with drug-eluting stents) or underwent CABG (n = 1,138) between 2000 and 2006 and for whom complete follow-up data were available for at least 3 to 9 years (median 5.2 years). The 5-year adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction [MI], or stroke; and target vessel revascularization [TVR]) were compared with the use of the inverse probability of treatment weighted method and propensity-score matching. RESULTS After adjustment for differences in baseline risk factors with the inverse probability of treatment weighting, the 5-year risk of death (hazard ratio [HR]: 1.13; 95% confidence interval [CI]: 0.88 to 1.44, p = 0.35) and the combined risk of death, Q-wave MI, or stroke (HR: 1.07; 95% CI: 0.84 to 1.37, p = 0.59) were not significantly different for patients undergoing stenting versus CABG. The risk of TVR was significantly higher in the stenting group than in the CABG group (HR: 5.11; 95% CI: 3.52 to 7.42, p < 0.001). Similar results were obtained in comparisons of bare-metal stent with concurrent CABG and of drug-eluting stent with concurrent CABG. In further analysis with propensity-score matching, overall findings were consistent. CONCLUSIONS During 5-year follow-up, stenting showed similar rates of mortality and of the composite of death, Q-wave MI, or stroke but higher rates of TVR as compared with CABG for patients with unprotected LMCA disease.

Everolimus-Eluting Versus Sirolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention The EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) Randomized Trial

OBJECTIVES The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner. BACKGROUND EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined. METHODS This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee. RESULTS Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38). CONCLUSIONS EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607).

Long-Term Safety and Effectiveness of Unprotected Left Main Coronary Stenting With Drug-Eluting Stents Compared With Bare-Metal Stents

Background— Limited information is available on long-term outcomes for patients with unprotected left main coronary artery disease who received drug-eluting stents (DES). Methods and Results— In the multicenter registry evaluating outcomes among patients with unprotected left main coronary artery stenosis undergoing stenting with either bare metal stents (BMS) or DES, 1217 consecutive patients were divided into 2 groups: 353 who received only BMS and 864 who received at least 1 DES. The 3-year outcomes were compared by use of the adjustment of inverse-probability-of-treatment-weighted method. Patients receiving DES were older and had a higher prevalence of diabetes mellitus, hypertension, hyperlipidemia, and multivessel disease. In the overall population, with the use of DES, the 3-year adjusted risk of death (8.0% versus 9.5%; hazard ratio, 0.71; 95% confidence interval, 0.36 to 1.40; P=0.976) or death or myocardial infarction (14.3% versus 14.9%; hazard ratio, 0.83; 95% confidence interval, 0.49 to 1.40; P=0.479) was similar compared with BMS. However, the risk of target lesion revascularization was significantly lower with the use of DES than BMS (5.4% versus 12.1%; hazard ratio, 0.40; 95% confidence interval, 0.22 to 0.73; P=0.003). When patients were classified according to lesion location, DES was still associated with lower risk of target lesion revascularization in patients with bifurcation (6.9% versus 16.3%; hazard ratio, 0.38; 95% confidence interval, 0.18 to 0.78; P=0.009) or nonbifurcation (3.4% versus 10.3%; hazard ratio, 0.39; 95% confidence interval, 0.17 to 0.88; P=0.024) lesions with a comparable risk of death or myocardial infarction. Conclusions— Compared with BMS, DES was associated with a reduction in the need for repeat revascularization without increasing the risk of death or myocardial infarction for patients with unprotected left main coronary artery stenosis.

Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial: Study design and rationale of a Korean multicenter prospective randomized trial

BACKGROUND The everolimus-eluting stent (EES) is a newly developed drug-eluting stent using the MULTILINK VISION stent platform combined with the drug everolimus contained in a polymer coating. Recently reported randomized trials have shown the noninferiority and subsequent superiority of the EES compared with the paclitaxel-eluting stent regarding in-stent late loss (LL) at 180 days. However, there have been no studies comparing head to head the EES with the sirolimus-eluting stent (SES), which has shown the least amount of LL among the previously released drug-eluting stent (DES). In addition, adjunctive antiplatelet therapy is a critical factor in optimizing long-term DES safety. Despite the recommendation of the American Heart Association/American College of Cardiology to maintain 12 months of dual antiplatelet therapy, there have been no prospective randomized trials comparing the efficacy and safety of different durations. STUDY DESIGN In the Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial, approximately 1,400 patients are being prospectively and randomly assigned in a 2 x 2 factorial design according to the type of stent (EES vs SES) and the duration of dual antiplatelet therapy (6 vs 12 months). The primary end point is in-segment LL at 9 months for comparison of type of stent, and the coprimary end point is target vessel failure at 12 months for comparison of dual antiplatelet therapy duration. SUMMARY The EXCELLENT trial is the largest study yet performed to directly compare the efficacy and safety of the EES versus the SES. In addition, this study will also address the issue of a 6- versus 12-month duration of dual antiplatelet therapy for post-percutaneous coronary intervention management.

Comparison of zotarolimus-eluting stents versus sirolimus-eluting stents versus paclitaxel-eluting stents for primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction: results from the Korean Multicentre Endeavor (KOMER) acute myocardial infarction (AMI) trial

AIMS The aim of this study was to compare the efficacy and safety of zotarolimus-eluting stents (ZES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). METHODS AND RESULTS This study was a prospective, single-blind, multicentre, randomised trial. The primary endpoint was major adverse cardiac events (MACE) at 12 months post-procedure, defined as cardiac death, recurrent myocardial infarction (MI), or ischaemia-driven target lesion revascularisation (TLR). An angiographic substudy was performed at nine months among 348 patients. From October 2006 to April 2008, 611 patients with STEMI undergoing primary PCI were randomly assigned to treatment with ZES (n=205), SES (n=204), or PES (n=202). The cumulative incidence of MACE was 5.9% in the ZES group, 3.4% in the SES group and 5.7% in the PES group at 12-month follow-up (p=0.457). There was a trend towards a lower rate of ischaemia-driven TLR at 12- (p=0.092) and 18-month (p=0.080) follow-up in the SES group compared to the ZES and PES groups. No difference was observed in rates of cardiac death, recurrent MI and combined death and/or recurrent MI among three groups at 12- and 18-month follow-up. The rate of stent thrombosis was similar among the three groups (2.0% in each group, p=1.000). CONCLUSIONS As compared with SES and PES, the use of ZES in patients with STEMI undergoing primary PCI, showed similar rates of MACE, cardiac death and recurrent MI at 12 and 18 months. There was a trend towards a higher rate of TLR with ZES or PES compared to SES.

Outcomes After Unrestricted Use of Everolimus-Eluting and Sirolimus-Eluting Stents in Routine Clinical Practice A Multicenter, Prospective Cohort Study

Background— It remains unclear whether there are differences in the safety and efficacy outcomes between everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in contemporary practice. Methods and Results— We prospectively enrolled 6166 consecutive patients who received EES (3081 patients) and SES (3085 patients) between April 2008 and June 2010, using data from the Interventional Cardiology Research In-Cooperation Society-Drug-Eluting Stents Registry. The primary end point was a composite of death, nonfatal myocardial infarction (MI), or target-vessel revascularization (TVR). At 2 years of follow-up, the 2 study groups did not differ significantly in crude risk of the primary end point (12.1% for EES versus 12.4% for SES; HR, 0.97; 95% CI, 0.84–1.12, P=0.66). After adjustment for differences in baseline risk factors, the adjusted risk for the primary end point remained similar for the 2 stent types (HR, 0.96; 95% CI, 0.82–1.12, P=0.60). There were also no differences between the stent groups in the adjusted risks of the individual component of death (HR, 0.93; 95% CI, 0.67–1.30, P=0.68), MI (HR, 0.97; 95% CI, 0.79–1.18, P=0.74), and TVR (HR, 1.10; 95% CI, 0.82–1.49, P=0.51). The adjusted risk of stent thrombosis also was similar (HR, 1.16; 95% CI, 0.47–2.84, P=0.75). Conclusions— In contemporary practice of percutaneous coronary intervention procedures, the unrestricted use of EES and SES showed similar rates of safety and efficacy outcomes with regard to death, MI, sent thrombosis, and TVR. Future longer-term follow-up is needed to better define the relative benefits of these drug-eluting stents. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01070420.

Serum transaminase determined in the emergency room predicts outcomes in patients with acute ST-segment elevation myocardial infarction who undergo primary percutaneous coronary intervention.

BACKGROUND Elevated serum aspartate and alanine aminotransferase (AST and ALT) are often observed in patients with acute ST-segment elevation myocardial infarction (STEMI) and the condition is ascribed to liver hypoperfusion. We evaluated the prevalence and prognostic implication of hypoxic liver injury (HLI) in STEMI. METHODS Patients with STEMI and no preexisting liver disease who underwent primary percutaneous coronary intervention (PCI) were enrolled. A blood test was performed at the time of presentation and transthoracic echocardiography was performed after the index PCI. We reviewed medical records and contacted families of the patients by telephone to assess outcomes. RESULTS Of 456 patients (age 60 ± 13 years, 370 males), 31 patients (7%) died during follow-up (duration: 754 ± 540 days). Those patients were older (72 ± 10 vs. 59 ± 13 years), had higher AST (179 ± 224 vs. 64 ± 103 U/L), ALT (56 ± 79 vs. 35 ± 33 U/L), blood urea nitrogen (25 ± 15 vs. 17 ± 7 mg/dL), uric acid (6.9 ± 2.9 vs. 5.8 ± 1.6 mg/dL), creatine kinase-myocardial band isoenzyme (76 ± 104 vs. 41 ± 79 ng/mL), troponin I (19.9 ± 23.0 vs. 10.8 ± 19.1 ng/mL), and lower albumin (4.0 ± 0.5 vs. 4.2 ± 0.4 g/dL) at the time of presentation (p<0.05 for all). Particularly, AST independently predicted all-cause mortality (per 10 U/L increase, hazard ratio: 1.06, 95% confidence interval: 1.02-1.10, p=0.007), whereas cardiac markers did not. HLI (>2-fold elevation of AST or ALT upper normal limits) showed close correlation with reduced left ventricular ejection fraction (β=-0.12, p=0.03) and patients with the condition (n=100 [20%]) had poorer survival than the others (Log-Rank, p=0.005). CONCLUSION The presence of HLI predicts mortality in patients with STEMI who undergo successful primary PCIs.

Efficacy and safety of aspirin, clopidogrel, and warfarin after coronary artery stenting in Korean patients with atrial fibrillation.

There are limited data on the optimal antithrombotic therapy for patients with atrial fibrillation (AF) who undergoing coronary stenting. We reviewed 203 patients (62.6 % men, mean age 68.3 ± 10.1 years) between 2003 and 2012, and recorded clinical and demographic characteristics of the patients. Clinical follow-up included major adverse cardiac and cerebrovascular events (MACCE) (cardiac death, myocardial infarction, target lesion revascularization, and stroke), stent thrombosis, and bleeding. The most commonly associated comorbidities were hypertension (70.4 %), diabetes mellitus (35.5 %), and congestive heart failure (26.6 %). Sixty-three percent of patients had stroke risk higher than CHADS2 score 2. At discharge, dual-antiplatelet therapy (aspirin, clopidogrel) was used in 166 patients (81.8 %; Group I), whereas 37 patients (18.2 %) were discharged with triple therapy (aspirin, clopidogrel, warfarin; Group II). The mean follow-up period was 42.0 ± 29.0 months. The mean international normalized ratio (INR) in group II was 1.83 ± 0.41. The total MACCE was 16.3 %, with stroke in 3.4 %. Compared with the group II, the incidence of MACCE (2.7 % vs 19.3 %, P = 0.012) and cardiac death (0 % vs 11.4 %, P = 0.028) were higher in the group I. Major and any bleeding, however, did not differ between the two groups. In multivariate analysis, no warfarin therapy (odds ratio 7.8, 95 % confidence interval 1.02–59.35; P = 0.048) was an independent predictor of MACCE. By Kaplan–Meier survival analysis, warfarin therapy was associated with a lower risk of MACCE (P = 0.024). In patients with AF undergoing coronary artery stenting, MACCE were reduced by warfarin therapy without increased bleeding, which might be related to tighter control with a lower INR value.