Joo Yong Hahn

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.nnMethods 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.nnConclusions— 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.nnClinical Trial Registration— URL: . Unique identifier: [NCT00698607][1].nn# Clinical Perspective {#article-title-31}nn [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.

Ischemic postconditioning during primary percutaneous coronary intervention: the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction (POST) randomized trial.

Background— Ischemic postconditioning has been reported to reduce infarct size in patients with ST-segment–elevation myocardial infarction. However, cardioprotective effects of postconditioning have not been demonstrated in a large-scale trial. Methods and Results— We performed a multicenter, prospective, randomized, open-label, blinded end-point trial. A total of 700 patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment–elevation myocardial infarction within 12 hours after symptom onset were randomly assigned to the postconditioning group or to the conventional primary PCI group in a 1:1 ratio. Postconditioning was performed immediately after restoration of coronary flow as follows: The angioplasty balloon was positioned at the culprit lesion and inflated 4 times for 1 minute with low-pressure (<6 atm) inflations, each separated by 1 minute of deflation. The primary end point was complete ST-segment resolution (percentage resolution of ST-segment elevation >70%) measured at 30 minutes after PCI. Complete ST-segment resolution occurred in 40.5% of patients in the postconditioning group and 41.5% of patients in the conventional PCI group (absolute difference, −1.0%; 95% confidence interval, −8.4 to 6.4; P=0.79). The rate of myocardial blush grade of 0 or 1 and the rate of major adverse cardiac events (a composite of death, myocardial infarction, severe heart failure, or stent thrombosis) at 30 days did not differ significantly between the postconditioning group and the conventional PCI group (17.2% versus 22.4% [P=0.20] and 4.3% versus 3.7% [P=0.70], respectively). Conclusion— Ischemic postconditioning did not improve myocardial reperfusion in patients with ST-segment–elevation myocardial infarction undergoing primary PCI with current standard practice. Clinical Trial Registration— URL: http://clinicaltrials.gov. Unique identifier: NCT00942500.Background —Ischemic postconditioning has been reported to reduce infarct size in patients with ST-segment elevation myocardial infarction (STEMI). However, cardioprotective effects of postconditioning have not been demonstrated in a large-scale trial. nnMethods and Results —We performed a multicenter, prospective, randomized, open-label, blinded endpoint trial. A total of 700 patients undergoing primary percutaneous coronary intervention (PCI) for STEMI within 12 hours after symptom onset were randomly assigned to the postconditioning group or the conventional primary PCI group in a 1:1 ratio. Postconditioning was performed immediately after restoration of coronary flow as follows: the angioplasty balloon was positioned at the culprit lesion, and inflated 4 times for 1 minute with low-pressure ( 70%) measured at 30 minutes after PCI. Complete ST-segment resolution occurred in 40.5% of patients in the postconditioning group and 41.5% of patients in the conventional PCI group (absolute difference, -1.0%; 95% confidence interval, -8.4% to 6.4%; P =0.79). The rate of myocardial blush grade of 0 or 1 and the major adverse cardiac events (a composite of death, myocardial infarction, severe heart failure, or stent thrombosis) at 30 days did not differ significantly between the postconditioning group and the conventional PCI group (17.2% versus 22.4%, P =0.20, and 4.3% versus 3.7%, P =0.70, respectively). nnConclusions —Ischemic postconditioning did not improve myocardial reperfusion in patients with STEMI undergoing primary PCI with current standard practice. nnClinical Trial Registration Information —http://ClinicalTrials.gov. Identifier: [NCT00942500][1].nn [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00942500&atom=%2Fcirculationaha%2Fearly%2F2013%2F09%2F25%2FCIRCULATIONAHA.113.001690.atom

Predictors and Outcomes of Side Branch Occlusion After Main Vessel Stenting in Coronary Bifurcation Lesions: Results From the COBIS II Registry (COronary BIfurcation Stenting)

OBJECTIVESnThis study sought to investigate the predictors and outcomes of side branch (SB) occlusion after main vessel (MV) stenting in coronary bifurcation lesions.nnnBACKGROUNDnSB occlusion is a serious complication that occurs during percutaneous coronary intervention (PCI) for bifurcation lesions.nnnMETHODSnConsecutive patients undergoing PCI using drug-eluting stents for bifurcation lesions with SB ≥2.3 mm were enrolled. We selected patients treated with the 1-stent technique or MV stenting first strategy. SB occlusion after MV stenting was defined as Thrombolysis in Myocardial Infarction flow grade <3.nnnRESULTSnSB occlusion occurred in 187 (8.4%) of 2,227 bifurcation lesions. In multivariate analysis, independent predictors of SB occlusion were pre-procedural percent diameter stenosis of the SB ≥50% (odds ratio [OR]: 2.34; 95% confidence interval [CI]: 1.59 to 3.43; p < 0.001) and the proximal MV ≥50% (OR: 2.34; 95% CI: 1.57 to 3.50; p < 0.001), SB lesion length (OR: 1.03; 95% CI: 1.003 to 1.06; p = 0.03), and acute coronary syndrome (OR: 1.53; 95% CI: 1.06 to 2.19; p = 0.02). Of 187 occluded SBs, flow was restored spontaneously in 26 (13.9%) and by SB intervention in 103 (55.1%) but not in 58 (31.0%). Jailed wire in the SB was associated with flow recovery (74.8% vs. 57.8%, p = 0.02). Cardiac death or myocardial infarction occurred more frequently in patients with SB occlusion than in those without SB occlusion (adjusted hazard ratio: 2.34; 95% CI: 1.15 to 4.77; p = 0.02).nnnCONCLUSIONSnAngiographic findings of SB, proximal MV stenosis, and clinical presentation are predictive of SB occlusion after MV stenting. Occlusion of sizable SB is associated with adverse clinical outcomes..

Impact of intravascular ultrasound guidance on long-term clinical outcomes in patients treated with drug-eluting stent for bifurcation lesions: Data from a Korean multicenter bifurcation registry

BACKGROUNDnalthough intravascular ultrasound (IVUS) has been widely used for complex lesions during coronary intervention, IVUS for stenting at bifurcation lesions has not been sufficiently assessed. The aim of this study was to investigate the impact of IVUS guidance on long-term clinical outcomes during drug-eluting stent (DES) implantation for bifurcation lesions.nnnMETHODSnthe Korean multicenter bifurcation registry listed 1,668 patients with non-left main de novo bifurcation lesions who underwent DES implantation between January 2004 and June 2006. Using propensity score matching with clinical and angiographic characteristics, 487 patients with IVUS guidance and 487 patients with angiography guidance were selected. The long-term clinical outcomes were compared between the 2 groups.nnnRESULTSnbaseline clinical and angiographic characteristics were well matched and showed no significant differences between the 2 groups. Two-stent technique and final kissing ballooning angioplasty were more frequently performed in the IVUS-guided group. Maximal stent diameters at both the main vessel and the side branch were larger in the IVUS-guided group. Periprocedural creatine kinase-MB elevation (>3 times of upper normal limits) was frequently observed in the angiography-guided group. The incidence of death or myocardial infarction was significantly lower in the IVUS-guided group compared to the angiography-guided group (3.8% vs 7.8%, log rank test P = .03, hazard ratio 0.44, 95% CI 0.12-0.96, Cox model P = .04).nnnCONCLUSIONSnintravascular ultrasound guidance during DES implantation at bifurcation lesions may be helpful to improve long-term clinical outcomes by reducing the occurrence of death or myocardial infarction.

Modified T-stenting with intentional protrusion of the side-branch stent within the main vessel stent to ensure ostial coverage and facilitate final kissing balloon: The T-stenting and small protrusion technique (TAP-stenting). Report of bench testing and first clinical Italian-Korean two-centre experience†

To describe a novel modification of the T‐stenting technique and to report the bench test as well as the first clinical results obtained.

Frequency of Myocardial Infarction and Its Relationship to Angiographic Collateral Flow in Territories Supplied by Chronically Occluded Coronary Arteries

Background— Despite complete interruption of antegrade coronary artery flow in the setting of a chronic total occlusion (CTO), clinical recognition of myocardial infarction is often challenging. Using cardiac MRI, we investigated the frequency and extent of myocardial infarction in patients with CTO, and assessed their relationship with regional systolic function and the extent of angiographic collateral flow. Methods and Results— We included 170 consecutive patients (median age, 62 years) with angiographically documented CTO. Regional late gadolinium enhancement and wall motion score index were assessed by cardiac MRI with the use of a 17-segment model. Angiographic collateral flow was assessed by the collateral connection grade and the Rentrop score. Evidence of previous myocardial infarction was found in 25% of patients by ECG Q waves, in 69% by regional wall motion abnormality, and in 86% of patients by late gadolinium enhancement. Increased angiographic collateral flow was associated with a lower frequency of Q waves on ECG, and a lower regional wall motion score index, late gadolinium enhancement volume (%), and degree of late gadolinium enhancement transmurality (all P<0.001), as well. Conclusions— The frequency of myocardial infarction in territories subtended by CTO is significantly higher than previously recognized. The degree of myocardial injury downstream epicardial CTO is inversely correlated with the degree of angiographic collaterals.

Sirolimus- Versus Paclitaxel-Eluting Stents for the Treatment of Coronary Bifurcations: Results From the COBIS (Coronary Bifurcation Stenting) Registry

OBJECTIVESnWe aimed to compare the long-term clinical outcomes of patients treated with sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) for coronary bifurcation lesions.nnnBACKGROUNDnThere are limited data regarding comparisons of SES and PES for the treatment of bifurcation lesions.nnnMETHODSnPatients who received percutaneous coronary intervention for non-left main bifurcation lesions were enrolled from 16 centers in Korea between January 2004 and June 2006. We compared major adverse cardiac events (MACE [cardiac death, myocardial infarction, or target lesion revascularization]) between the SES and PES groups in patients overall and in 407 patient pairs generated by propensity-score matching.nnnRESULTSnWe evaluated 1,033 patients with bifurcation lesions treated with SES and 562 patients treated with PES. The median follow-up duration was 22 months. Treatment with SES was associated with a lower incidence of MACE (hazard ratio [HR]: 0.53, 95% confidence interval [CI]: 0.32 to 0.89, p < 0.01) and target lesion revascularization (HR: 0.55, 95% CI: 0.31 to 0.97, p = 0.02), but not of cardiac death (HR: 2.77, 95% CI: 0.40 to 18.99, p = 0.62) and cardiac death or myocardial infarction (HR: 0.97, 95% CI: 0.38 to 2.49, p = 0.94). After propensity-score matching, patients with SES still had fewer MACE and target lesion revascularization incidences than did patients with PES (HR: 0.52, 95% CI: 0.30 to 0.91, p = 0.02, and HR: 0.48, 95% CI: 0.25 to 0.91, p = 0.02, respectively). There was no significant difference in the occurrences of stent thrombosis between the groups (0.7% vs. 0.7%, p = 0.94).nnnCONCLUSIONSnIn patients with bifurcation lesions, the use of SES resulted in better long-term outcomes than did the use of PES, primarily by decreasing the rate of repeat revascularization. (Coronary Bifurcation Stenting Registry in South Korea [COBIS]; NCT00851526).

ComparisOn of neointimal coVerage betwEen zotaRolimus-eluting stent and everolimus-eluting stent using Optical Coherence Tomography (COVER OCT)

BACKGROUNDnData on strut surface coverage of second-generation drug-eluting stents (DES) are limited. We investigated stent strut coverage of resolute zotarolimus-eluting stent (ZES-R) or everolimus-eluting stent (EES) at 9 months after implantation using optical coherence tomography (OCT).nnnMETHODSnComparisOn of neointimal coVerage betwEen zotaRolimus-eluting stent and everolimus-eluting stent using Optical Coherence Tomography (COVER OCT) is a prospective, randomized, multicenter trial comparing ZES-R to EES using OCT at 9 months after stent implantation. The primary end point was the rate of stent strut coverage at 9 months.nnnRESULTSnA total of 51 patients were randomized to receive either ZES-R (ZES-R group) or EES (EES group), and 47 stents (24 ZES-R and 23 EES) in 44 of 51 patients were evaluated by OCT both immediately after stent implantation and at 9 months. The neointimal thickness was not significantly different between the 2 groups at 9 months (ZES-R vs EES: 139 ± 58 vs 124 ± 42 μm, P = .31). The mean percentages of uncovered stent struts were 3.3% for ZES-R versus 3.4% for EES at 9 months (P = .51). The proportions of malapposed struts immediately after stent implantation (P = .89) and at 9-month follow-up (P = .34) were 0.8% and 0.7% for ZES-R versus 1.0% and 0.1% for EES, respectively. Thrombi were documented in 1 stent (1 [4.2%] in ZES-R vs 0 [0%] in EES).nnnCONCLUSIONnAccording to the sequential OCT evaluation, ZES-R and EES showed comparable neointimal thickness and the rate of uncovered stent strut at 9 months after stent implantation.

Differential prognostic impact of treatment strategy among patients with left main versus non-left main bifurcation lesions undergoing percutaneous coronary intervention: results from the COBIS (Coronary Bifurcation Stenting) Registry II.

OBJECTIVESnThe authors sought to investigate whether the impact of treatment strategies on clinical outcomes differed between patients with left main (LM) bifurcation lesions and those with non-LM bifurcation lesions.nnnBACKGROUNDnFew studies have considered anatomic location when comparing 1- and 2-stent strategies for bifurcation lesions.nnnMETHODSnWe compared the prognostic impact of treatment strategies on clinical outcomes in 2,044 patients with non-LM bifurcation lesions and 853 with LM bifurcation lesions. The primary outcome was target lesion failure (TLF) defined as a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization.nnnRESULTSnThe 2-stent strategy was used more frequently in the LM bifurcation group than in the non-LM bifurcation group (40.3% vs. 20.8%, p < 0.01). During a median follow-up of 36 months, the 2-stent strategy was not associated with a higher incidence of cardiac death (hazard ratio [HR]: 1.24; 95% confidence interval [CI]: 0.72 to 2.14; pxa0= 0.44), cardiac death or MI (HR: 1.12; 95% CI: 0.58 to 2.19; pxa0=xa00.73), or TLF (HR: 1.39; 95% CI: 0.99 to 1.94; pxa0= 0.06) in the non-LM bifurcation group. In contrast, in patients with LM bifurcation lesions, the 2-stent strategy was associated with a higher incidence of cardiac death (HR: 2.43; 95% CI: 1.05 to 5.59; pxa0= 0.04), cardiac death or MI (HR: 2.09; 95% CI: 1.08 to 4.04; pxa0= 0.03), as well as TLF (HR: 2.38; 95% CI: 1.60 to 3.55; p < 0.01). Significant interactions were present between treatment strategies and bifurcation lesion locations for TLF (pxa0= 0.01).nnnCONCLUSIONSnThe 1-stent strategy, if possible, should initially be considered the preferred approach for the treatment of coronary bifurcation lesions, especially LM bifurcation lesions. (Korean Coronary Bifurcation Stenting [COBIS] Registry II; NCT01642992).

Association of Beta-Blocker Therapy at Discharge With Clinical Outcomes in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

OBJECTIVESnThis study sought to investigate the association of beta-blocker therapy at discharge with clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PCI).nnnBACKGROUNDnLimited data are available on the efficacy of beta-blocker therapy for secondary prevention in STEMI patients.nnnMETHODSnBetween November 1, 2005 and September 30, 2010, 20,344 patients were enrolled in nationwide, prospective, multicenter registries. Among these, we studied STEMI patients undergoing primary PCI who were discharged alive (n = 8,510). We classified patients into the beta-blocker group (n = 6,873) and no-beta-blocker group (n = 1,637) according to the use of beta-blockers at discharge. Propensity-score matching analysis was also performed in 1,325 patient triplets. The primary outcome was all-cause death.nnnRESULTSnThe median follow-up duration was 367 days (interquartile range: 157 to 440 days). All-cause death occurred in 146 patients (2.1%) of the beta-blocker group versus 59 patients (3.6%) of the no-beta-blocker group (p < 0.001). After 2:1 propensity-score matching, beta-blocker therapy was associated with a lower incidence of all-cause death (2.8% vs. 4.1%, adjusted hazard ratio: 0.46, 95% confidence interval: 0.27 to 0.78, p = 0.004). The association with better outcome of beta-blocker therapy in terms of all-cause death was consistent across various subgroups, including patients with relatively low-risk profiles such as ejection fraction >40% or single-vessel disease.nnnCONCLUSIONSnBeta-blocker therapy at discharge was associated with improved survival in STEMI patients treated with primary PCI. Our results support the current American College of Cardiology/American Heart Association guidelines, which recommend long-term beta-blocker therapy in all patients with STEMI regardless of reperfusion therapy or risk profile.