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Importance: Although intravascular ultrasonography (IVUS) guidance promotes favorable outcomes after percutaneous coronary intervention (PCI), many catheterization laboratories worldwide lack access., Objective: To investigate whether systematic implementation of quantitative coronary angiography (QCA) to assist angiography-guided PCI could be an alternative strategy to IVUS guidance during stent implantation., Design, Setting, and Participants: This randomized, open-label, noninferiority clinical trial enrolled adults (aged ≥18 years) with chronic or acute coronary syndrome and angiographically confirmed native coronary artery stenosis requiring PCI. Patients were enrolled in 6 cardiac centers in Korea from February 23, 2017, to August 23, 2021, and follow-up occurred through August 25, 2022. All principal analyses were performed according to the intention-to-treat principle., Interventions: After successful guidewire crossing of the first target lesion, patients were randomized in a 1:1 ratio to receive either QCA- or IVUS-guided PCI., Main Outcomes and Measures: The primary outcome was target lesion failure at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The trial was designed assuming an event rate of 8%, with the upper limit of the 1-sided 97.5% CI of the absolute difference in 12-month target lesion failure (QCA-guided PCI minus IVUS-guided PCI) to be less than 3.5 percentage points for noninferiority., Results: The trial included 1528 patients who underwent PCI with QCA guidance (763; mean [SD] age, 64.1 [9.9] years; 574 males [75.2%]) or IVUS guidance (765; mean [SD] age, 64.6 [9.5] years; 622 males [81.3%]). The post-PCI mean (SD) minimum lumen diameter was similar between the QCA- and IVUS-guided PCI groups (2.57 [0.55] vs 2.60 [0.58] mm, P = .26). Target lesion failure at 12 months occurred in 29 of 763 patients (3.81%) in the QCA-guided PCI group and 29 of 765 patients (3.80%) in the IVUS-guided PCI group (absolute risk difference, 0.01 percentage points [95% CI, -1.91 to 1.93 percentage points]; hazard ratio, 1.00 [95% CI, 0.60-1.68]; P = .99). There was no difference in the rates of stent edge dissection (1.2% vs 0.7%, P = .25), coronary perforation (0.2% vs 0.4%, P = .41), or stent thrombosis (0.53% vs 0.66%, P = .74) between the QCA- and IVUS-guided PCI groups. The risk of the primary end point was consistent regardless of subgroup, with no significant interaction., Conclusions and Relevance: Findings of this randomized clinical trial indicate that QCA and IVUS guidance during PCI showed similar rates of target lesion failure at 12 months. However, due to the lower-than-expected rates of target lesion failure in this trial, the findings should be interpreted with caution., Trial Registration: ClinicalTrials.gov Identifier: NCT02978456.

Background: We previously reported the use of minimal stent area to predict angiographic in-stent restenosis after drug-eluting stent implantation for unprotected left main (LM) disease. We aimed to evaluate the optimal minimal stent area criteria for up-front LM 2-stenting based on long-term clinical outcomes., Methods: We identified 292 consecutive patients with LM bifurcation stenosis who were treated using the crush technique. The final minimal stent area was measured in the ostial left anterior descending artery (LAD), ostial left circumflex artery (LCX), and distal LM. The primary outcome was 5-year major adverse cardiac events, including all-cause death, myocardial infarction, and target lesion revascularization., Results: The minimal stent area cutoff values that best predicted the 5-year major adverse cardiac events were 11.8 mm 2 for distal LM (area under the curve, 0.57; P =0.15), 8.3 mm 2 for LAD ostium (area under the curve, 0.62; P =0.02), and 5.7 mm 2 for LCX ostium (area under the curve, 0.64; P =0.01). Using these criteria, the risk of 5-year major adverse cardiac events was significantly associated with stent underexpansion in the LAD ostium (hazard ratio, 3.14; [95% CI, 1.23-8.06]; P =0.02) and LCX ostium (hazard ratio, 2.60 [95% CI, 1.11-6.07]; P =0.03) but not in the distal LM (hazard ratio, 0.81 [95% CI, 0.34-1.91]; P =0.63). Patients with stent underexpansion in both ostial LAD and LCX had a significantly higher rate of 5-year major adverse cardiac events than those with no or 1 underexpanded stent of either ostium ( P <0.01)., Conclusions: Stent underexpansion in the LAD and LCX ostium was significantly associated with long-term outcomes in patients who underwent up-front 2-stenting for LM bifurcation stenosis., Competing Interests: Disclosures None.

Introduction: Angiography remains the gold standard for guiding percutaneous coronary intervention (PCI). However, it is prone to suboptimal stent results due to the visual estimation of coronary measurements. Although the benefit of intravascular ultrasound (IVUS)-guided PCI is becoming increasingly recognised, IVUS is not affordable for many catheterisation laboratories. Thus, a more practical and standardised angiography-based approach is necessary to support stent implantation., Methods and Analysis: The Quantitative Coronary Angiography versus Intravascular Ultrasound Guidance for Drug-Eluting Stent Implantation trial is a randomised, investigator-initiated, multicentre, open-label, non-inferiority trial comparing the quantitative coronary angiography (QCA)-guided PCI strategy with IVUS-guided PCI in all-comer patients with significant coronary artery disease. A novel, standardised, QCA-based PCI protocol for the QCA-guided group will be provided to all participating operators, while the PCI optimisation criteria will be predefined for both strategies. A total of 1528 patients will be randomised to either group at a 1:1 ratio. The primary endpoint is the 12-month cumulative incidence of target-lesion failure defined as a composite of cardiac death, target-vessel myocardial infarction or ischaemia-driven target-lesion revascularisation. Clinical follow-up assessments are scheduled at 1, 6 and 12 months for all patients enrolled in the study., Ethics and Dissemination: Ethics approval for this study was granted by the Institutional Review Board of Asan Medical Center (no. 2017-0060). Informed consent will be obtained from every participant. The study findings will be published in peer-reviewed journal articles and disseminated through public forums and academic conference presentations. Cost-effectiveness and secondary imaging analyses will be shared in secondary papers., Trial Registration Number: NCT02978456., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Few studies have evaluated intravascular ultrasound (IVUS) use in chronic total occlusion (CTO) percutaneous coronary intervention (PCI)., Aims: In CTO-PCI, we aimed to (1) evaluate the clinical benefits of performing post-stent IVUS in preventing adverse clinical events, and (2) identify IVUS parameters and cut-off values for prediction of target lesion revascularisation (TLR)/reocclusion., Methods: A total of 1,077 patients with 1,077 CTO lesions treated with drug-eluting stents (DES) were included. Clinical outcomes during a median follow-up of 6.3 years were compared between subjects with and those without post-stent IVUS using the inverse probability weighting method., Results: Of 1,077 patients, post-stent IVUS was performed in 838 (77.8%) cases while in the remaining 239 (22.2%) cases it was not. In the weighted population, the risk of TLR/reocclusion was significantly lower in subjects with post-stent IVUS (9.6% vs 18.9%, hazard ratio [HR] 0.54, 95% confidence interval [CI]: 0.34-0.86, p=0.01), compared with those without post-stent IVUS. Cox regression analysis showed that minimal stent area (MSA) measured by IVUS was the only parameter independently associated with TLR/reocclusion (HR 0.78, 95% CI: 0.64-0.95; p=0.01) and the optimal MSA cut-off value was 4.9 mm2 for prediction of TLR/reocclusion (area under the curve=0.632, p=0.001)., Conclusions: In CTO-PCI with DES, post-stent IVUS evaluation was associated with a lower risk of TLR/reocclusion. The final MSA was independently associated with TLR/reocclusion with a cut-off value of 4.9 mm2.

Background Several trials reported differential outcomes after percutaneous coronary intervention with drug-eluting stents (DES) and coronary-artery bypass grafting (CABG) for multivessel coronary disease according to the presence of diabetes mellitus (DM). However, it is not well recognized how DM status affects very-long-term (10-year) outcomes after DES and CABG for left main coronary artery disease. Methods and Results In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) trial, patients with LMCA were randomly assigned to undergo PCI with sirolimus-eluting stents (n=300) or CABG (n=300). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (MACCE; a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization). Outcomes were examined in patients with (n=192) and without (n=408) medically treated diabetes. The follow-up was extended to at least 10 years for all patients (median, 11.3 years). The 10-year rates of MACCE were not significantly different between DES and CABG in patients with DM (36.3% versus 26.7%, respectively; hazard ratio [HR], 1.35; 95% CI, 0.83-2.19; P =0.23) and without DM (25.3% versus 22.9%, respectively; HR, 1.15; 95% CI, 0.79-1.67; P =0.48) ( P -for-interaction=0.48). There were no significant between-group differences in composite of death, MI, or stroke, and all-cause mortality, regardless of DM status. TVR rates were consistently higher after DES than CABG. Conclusions In this 10-year extended follow-up of PRECOMBAT, we found no significant difference between DES and CABG with respect to the incidences of MACCE, serious composite outcome, and all-cause mortality in patients with and without DM with LMCA disease. However, owing to the limited number of patients and no adjustment for multiple testing, overall findings should be considered hypothesis-generating, highlighting the need for further research. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03871127 and NCT00422968.

Background: Whether the diabetic status differentially affects the clinical outcomes with different drug-eluting stents (DES) has been controversial., Methods and Results: From stent-specific, prospective DES registries, we evaluated 17,184 patients (11,428 in non-diabetics and 5,756 in diabetics) who received several contemporary DES: 3570 sirolimus-eluting stents (SES), 5,023 cobalt-chromium everolimus-eluting stents (CoCr-EES), 2,985 platinum-chromium EES (PtCr-EES), 2,913 Resolute zotarolimus-eluting stents (Re-ZES), and 2,693 biodegradable-polymer biolimus-eluting stents (BP-BES). The primary outcome was patient-oriented composite endpoint (POCE, a composite of all-cause death, any myocardial infarction, and any revascularization) at 3-year follow-up and target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) at 3 years was also evaluated. In non-diabetics, the rates of POCE were not significantly different (CoCr-EES 14.3%, PtCr-EES 13.0%, Re-ZES 14.3%, BP-BES 13.4%, and SES 14.6%; overall p = .39). In diabetics, similar results were revealed (CoCr-EES 18.4%, PtCr-EES 20.3%, Re-ZES 17.3%, BP-BES 17.7%, and SES 17.8%; overall p = .44). In multiple treatment propensity-score weighting analysis, regardless of the diabetic status, the hazard ratios for POCE between-individual comparison were similar. Target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) was also comparable except the higher ratio of Re-ZES than PtCr-EES (hazard ratio 1.25, 1.26, 95% confidence interval 1.00-1.55, p = .048) in patients without diabetes., Conclusions: In this clinical-practice registry study, regardless the diabetic status, the 3-year rates of the primary outcome were similar among different types of DES, suggesting no differential clinical response between contemporary DES in patients with or without diabetes., (© 2019 Wiley Periodicals, Inc.)

Objectives: This study compared the 3-year outcomes of intracoronary imaging-guided pre-dilation, stent sizing, and post-dilation (iPSP) for patients with complex coronary artery lesions., Background: The long-term effects of the optimal drug-eluting stent implantation technique in complex coronary artery disease have not been evaluated., Methods: From the IRIS-DES (Interventional Cardiology Research In-cooperation Society-Drug-Eluting Stents) registry, the study evaluated 9,525 patients who underwent percutaneous coronary intervention for left main, bifurcation, long or diffuse (>30 mm), or angiographically severely calcified lesions. The primary outcome was a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization. The inverse probability of treatment weighting method was used to adjust for confounding factors., Results: At the index procedure, intravascular ultrasound assessment PSP were performed in 8,522 (89.5%) patients, 5,141 (54.0%) patients, and 5,531 (58.1%) patients, respectively; overall, 3,374 (35.4%) patients underwent stent implantation using all 3 parts of the iPSP strategy and were defined as the iPSP group. At 3 years, the adjusted rate of the primary outcome was significantly lower in iPSP group (5.6% vs 7.9%; adjusted hazard ratio: 0.71; 95% confidence interval: 0.63 to 0.81; p < 0.001)., Conclusions: Among patients undergoing drug-eluting stent implantation in complex coronary artery stenosis, iPSP was associated with a lower risk of cardiac events at 3 years. Therefore, physicians should apply iPSP more actively for the treatment of complex coronary artery stenoses, even in the current era. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: Data on the comparative effectiveness of contemporary drug-eluting stents (DES) in the unrestricted, real-world setting are limited. We investigated the long-term effectiveness and safety of contemporary different drug-eluting stents by means of multiple treatment propensity score weighting., Patients and Methods: From seven stent-specific, prospective DES registries conducted between July 2007 and July 2015, we evaluated 17 196 patients who received several contemporary DES and first-generation DES: 3053 treated with cobalt-chromium everolimus-eluting stents (CoCr-EES), 2985 with platinum-chromium EES (PtCr-EES), 2922 with Resolute zotarolimus-eluting stents (Re-ZES), 789 with Biomatrix biolimus-eluting stents (Bi-BES), 1907 with Nobori biolimus-eluting stents (No-BES), 1970 with Xience Prime cobalt-chromium everolimus-eluting stents (Pr-CoCr-EES), and 3570 with sirolimus-eluting stents (SES). The primary outcome was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization) at 3 years of follow-up and major cardiovascular adverse events (a composite of all-cause death, any myocardial infarction, or any revascularization) was also evaluated., Results: The observed 3-year rates of target-vessel failure were not significantly different among different second-generation DES and SES (CoCr-EES 9.8%, PtCr-EES 9.5%, Re-ZES 9.3%, Bi-BES 9.8%, No-BES 7.7%, Pr-CoCr-EES 10.4%, SES 10.2%; overall P=0.07). In multiple treatment propensity score analysis, adjusted hazard ratios for target-vessel failure were similar in between-group comparisons of several contemporary DES. In addition, no significant differences were observed with respect of the adjusted risk of major adverse cardiac events., Conclusion: In this comparative effectiveness research using stent-specific, clinical practice registries involving unrestricted use of several contemporary DES, there were no significant between-group differences in the 3-year rates of target-vessel failure.

Background/aims: Compared with metallic drug-eluting stents (DES), bioresorbable vascular scaffolds (BVS) may further improve long-term outcomes of percutaneous coronary intervention (PCI) in patients with coronary artery disease. We report our early experience with BVS in Korea., Methods: We evaluated 105 consecutive patients with BVS implanted at Asan Medical Center, Korea between October 21, 2015 and June 3, 2016. Angiographic results, and in-hospital and 6-month clinical outcomes were assessed., Results: A total of 134 BVS were implanted to treat 115 lesions. The mean age was 62 ± 10.5 years; 85 patients (81%) were males, 26 patients (25%) were presented with acute coronary syndrome. Among 115 lesions treated with BVS, 76 (66.1%) were B2/C type, 27 (23.5%) were bifurcation lesions, and four (3.5%) were chronic total occlusion. Pre-dilation and post-dilation using high-pressure non-compliant balloon was performed in 104 lesions (90.4%) and 113 lesions (98.2%), respectively. During the procedure, intravascular imaging was used for all patients (100%; intravascular ultrasound 89 and optical coherence tomography 40 patients). Device success rate was 100%. In-segment and in-scaffold acute again were 1.1 ± 0.6 and 1.3 ± 0.5 mm, respectively. Periprocedural myocardial infraction occurred in four patients (3.8%). No deaths, stent thrombosis, or urgent revascularizations occurred either during hospitalization or the follow-up period., Conclusion: In this single-center experience, implantation of BVS with intravascular imaging support was feasible and early clinical outcomes were excellent. Evaluation of long-term efficacy and safety of BVS and its feasibility in clinical use for a broader range of lesions is warranted.

Objective: To evaluate the long-term mortality according to obesity in patients with chronic total occlusion (CTO) lesions after successful percutaneous coronary intervention (PCI)., Background: Despite the potential impact of coronary revascularization and lesion severity on the obesity paradox, the long-term survival according to obesity in CTO patients after successful PCI has been unknown., Methods and Results: Between January 2003 and September 2014, we examined 1,172 consecutive Korean patients with 1,190 CTO lesions who underwent successful drug-eluting stent (DES) implantation in two tertiary academic medical centers. The primary and secondary endpoints were all-cause and cardiac death, respectively. Obesity was defined as a body mass index ≥25.0 kg/m 2 , based on the criteria for Asians. The median follow-up time was 4.4 years. The prevalence of obesity was 54.4%. During the follow-up periods, the occurrence of all-cause (6.1 vs. 10.7%) and cardiac death (3.8 vs. 6.7%) was lower in obese patients than in non-obese patients (P <0.05, respectively). Kaplan-Meier analysis showed that obese patients had lower cumulative rates of all-cause and cardiac death than did non-obese patients (log-rank P <0.05, respectively). Univariate Cox regression analysis showed that age ≥65 years (hazard ratio [HR], 3.62), diabetes mellitus (HR, 1.94), renal dysfunction (HR, 7.03), systolic heart failure (HR, 2.61), and obesity (HR, 0.58) were associated with all-cause death (P <0.05). Multivariate Cox regression models showed that high BMI was independently associated with the decreased risk of all-cause death., Conclusions: Obese patients appear to have a lower long-term mortality than do non-obese patients in CTO after successful PCI using DES. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Background: This study sought to evaluate the optimal treatment for in-stent restenosis (ISR) of drug-eluting stents (DESs)., Methods: This is a prospective, multicenter, open-label, randomized study comparing the use of drug-eluting balloon (DEB) versus second-generation everolimus-eluting stent for the treatment of DES ISR. The primary end point was in-segment late loss at 9-month routine angiographic follow-up., Results: A total of 172 patients were enrolled, and 74 (43.0%) patients underwent the angiographic follow-up. The primary end point was not different between the 2 treatment groups (DEB group 0.15±0.49 mm vs DES group 0.19±0.41 mm, P=.54). The secondary end points of in-segment minimal luminal diameter (MLD) (1.80±0.69 mm vs 2.09±0.46 mm, P=.03), in-stent MLD (1.90±0.71 mm vs 2.29±0.48 mm, P=.005), in-segment percent diameter stenosis (34%±21% vs 26%±15%, P=.05), and in-stent percent diameter stenosis (33%±21% vs 21%±15%, P=.002) were more favorable in the DES group. The composite of death, myocardial infarction, or target lesion revascularization at 1 year was comparable between the 2 groups (DEB group 7.0% vs DES group 4.7%, P=.51)., Conclusions: Treatment of DES ISR using DEB or second-generation DES did not differ in terms of late loss at 9-month angiographic follow-up, whereas DES showed better angiographic results regarding minimal MLD and percent diameter stenosis. Both treatment strategies were safe and effective up to 1year after the procedure., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Limited data are available on the relative performances between different types of drug-eluting stents (DES) for obstructive left main coronary artery disease (LMCAD)., Objectives: This study sought to compare effectiveness and safety profiles of various second-generation DES for LMCAD in real-world clinical practice., Methods: Among 4,470 patients in 3, multicenter, prospective registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents] registry, the IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization] registry, and the PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease] study) treated between July 2007 and July 2015, the authors identified 2,692 patients with significant LMCAD who received second-generation DES; 1,254 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 232 with biodegradable polymer biolimus-eluting stents (BP-BES), 616 with platinum-chromium EES (PtCr-EES), and 590 with Resolute zotarolimus-eluting stent (Re-ZES). The primary outcome was target-vessel failure., Results: The observed 3-year rates of target-vessel failure were not significantly different for the different types of DES (16.7% for the CoCr-EES, 13.2% for the BP-BES, 18.7% for the PtCr-EES, and 14.7% for the Re-ZES; p = 0.15). In multiple treatment propensity score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were similar in between-group comparisons of the different DES, except for the PtCr-EES versus the BP-BES (reference; HR: 1.60; 95% confidence interval: 1.01 to 2.54; p = 0.046). There were no significant differences in risk of composite of all-cause death, any myocardial infarction, or any revascularization and its individual components according to the different types of DES. Although the 3-year incidence of stent thrombosis was considerably low (≤1.0%) for all types of DES, between-group differences were observed, generally favoring the EES platforms., Conclusions: In this pooled analysis of 3 prospective registries involving unrestricted use of various second-generation DES for LMCAD, we found no significant between-group differences in 3-year risk of target-vessel failure, except for a higher risk of primary outcome with PtCr-EES compared to BP-BES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

This study sought to evaluate the impact of triple antiplatelet therapy on clinical outcomes in patients treated with second-generation drug-eluting stents (DES) for coronary artery disease. There are limited data regarding the impact of triple antiplatelet therapy in patients who underwent implantation of second-generation DES. We planned to randomly assign 2,110 patients treated with second-generation DES to triple (aspirin, clopidogrel, and cilostazol) and dual (aspirin, clopidogrel, and placebo) antiplatelet therapy groups. The primary end point was a composite of death, myocardial infarction, ischemic stroke, or target vessel revascularization (TVR) at 1 year since randomization. The study was stopped early owing to slow enrollment. In total, 404 patients (202 patients each in the triple and dual antiplatelet therapy groups) were finally enrolled. At 1 year, the primary end point had occurred in 3.6% and 9.4% of patients in the triple and dual antiplatelet therapy groups, respectively (hazard ratio [HR] of the triple group 0.396; 95% confidence interval [CI] 0.166 to 0.949; p = 0.038). There was no significant difference between the 2 groups regarding the occurrence of a composite of all-cause death, myocardial infarction, or ischemic stroke (HR 0.583; 95% CI 0.229 to 1.481; p = 0.256). However, the rates of TVR were significantly lower in the triple antiplatelet therapy group than in the dual antiplatelet therapy group (HR 0.118; 95% CI 0.015 to 0.930; p = 0.043). In conclusion, triple antiplatelet therapy with cilostazol after implantation of second-generation DES improved clinical outcomes, mainly by reducing TVR., (Copyright © 2017. Published by Elsevier Inc.)

Background: The clinical outcomes for women compared with men undergoing left main PCI were sparse. We compared the characteristics and long-term outcomes in women versus men after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main CAD., Methods: We identified 2328 patients (545 women; 1783 men) with unprotected left main CAD who received PCI with DES between January 2007 and December 2013 in the Interventional Cardiology Research In-cooperation Society-left MAIN revascularization (IRIS-MAIN) registry. The primary outcome was a composite of death from any cause, myocardial infarction, or stroke., Results: The median follow-up time was 2.9years (interquartile range: 1.0-4.1years). Women were older, had a higher incidence of insulin-requiring diabetes mellitus and hypertension, and more commonly presented with acute coronary syndrome than men. Left main ostial lesion was more common in women, whereas left main bifurcation lesion with more extensive CAD was more common in men. The incidence of primary outcome was similar between the two groups (10.8% vs. 10.8%, respectively, log-rank p=0.587). The results were similar after adjustment for baseline variables and consistent across major subgroups. The need for target lesion revascularization was significantly higher in women than in men (8.8% vs. 5.7%, respectively, p<0.05) but the sex bias was not confirmed after adjusting for confounders., Conclusions: Women, as compared to men, had different clinical and lesion characteristics but similar long-term outcomes after PCI with DES for left main CAD., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: The applicability of Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores to left main coronary artery disease (CAD) has been questioned. A simplified alternative is needed for guiding decision making., Methods and Results: We evaluated the prognostic value of a simplified angiographic classification in comparison with a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score-based approach for patients with left main CAD undergoing drug-eluting stent implantation. The proposed approach classified left main CAD as either extensive (n=819), defined as left main bifurcation lesions with an involvement of ostial left circumflex artery or as any left main lesion plus multivessel CAD, or limited (n=453), defined as ostial/midshaft lesions or left main bifurcation lesions without an involvement of ostium of left circumflex artery, alone or plus 1-vessel disease. The databases from 4 prospective Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease studies were pooled, and the primary outcome was a major adverse cardiac event, defined as death, myocardial infarction, or repeat revascularization. During follow-up (median 38 months; interquartile range, 36-61 months), the risk for major adverse cardiac event was significantly higher with extensive than with limited left main CAD (adjusted hazard ratio, 2.13; 95% confidence interval, 1.54-2.94; P <0.001). The risk for a composite outcome of death or myocardial infarction was also higher with extensive left main CAD (adjusted hazard ratio, 1.75; 95% confidence interval, 1.08-2.85; P =0.02). However, Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score tertiles did not effectively stratify these 2 outcome measures., Conclusions: Compared with Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores, the simpler angiographic approach provided better discrimination for future cardiovascular events in patients with left main CAD undergoing drug-eluting stent implantation., (© 2018 American Heart Association, Inc.)

Background: Limited data are available on long-term mortality according to the extent of coronary artery disease (CAD) in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES). We assessed long-term mortality DES implantation according to the extent of CAD and the impact of left main CAD alone on mortality among patients undergoing PCI with DES., Methods and Results: A total of 18,716 patients were pooled from real-world PCI registries. The primary outcome was death from any cause. The median follow-up duration was 47.1 (interquartile range 32.8-57.9) months. The presence of left main CAD [adjusted hazard ratio (HR) 1.24, 95% confidence interval (CI) 1.05-1.46, p = 0.012] and the extent of diseased vessels (adjusted HR 1.17, 95% CI 1.08-1.27, p < 0.001) significantly increased the risk of all-cause mortality. Left main CAD alone was associated with a risk of all-cause mortality similar to one- and two-vessel CAD, whereas it was associated with a significantly lower risk of mortality compared with three-vessel CAD (adjusted HR 0.42, 95% CI 0.18-0.98, p = 0.044). Among patients with left main CAD, the risk of mortality tended to increase in proportion with the number of concomitant vessel CAD, but it did not achieve statistical significance., Conclusions: Among patients undergoing DES implantation, the risk of mortality increased in a stepwise manner according to the extent of coronary CAD. Left main CAD alone was associated with a risk of long-term mortality similar to one- and two-vessel CAD.

There are limited data on comparative outcomes and its determinants following coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for left main coronary artery disease (LMCAD) in a real-world setting., Methods: A total of 3,504 consecutive patients with LMCAD treated with CABG (n=1,301) or PCI with DES (n=2,203) from the IRIS-MAIN registry were analyzed. The relative treatment effect of one strategy over another was assessed by propensity-score matching method. The primary outcome was a composite of death, myocardial infarction, or stroke., Results: Median follow-up duration was 4.7 years. In the matched cohort, both groups demonstrated a similar risk for the primary outcome (adjusted hazard ratio [HR]: 0.94; 95% CI: 0.77-1.15; P=.54). Compared with CABG, PCI exhibited higher risks of myocardial infarction (HR: 2.11; 95% CI: 1.16-3.83; P=.01) and repeated revascularization (HR: 5.95; 95% CI: 3.94-8.98; P<.001). In the overall population, age, presence of chronic kidney disease, and low ejection fraction (<40%) were key clinical predictors of primary outcome regardless of the treatment strategy. However, factors deemed to be associated with perioperative morbidity were determinants of primary outcome in the CABG group, whereas those generally associated with the severity of atherosclerotic coronary artery disease were strong predictors in the PCI group., Conclusions: Among patients with significant LMCAD, the long-term risk of the composite outcome of death, myocardial infarction, or stroke was similar between CABG and PCI. Clinical variables that differentially predict adverse outcomes might be useful in triaging appropriate revascularization strategy., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: Patients with previous stroke are increasing among patients receiving percutaneous coronary intervention (PCI) with drug-eluting stents (DES); however, data about the influence of previous stroke on patient outcomes are limited. We evaluated whether previous stroke is associated with increased risk for mortality in coronary artery disease., Patients and Methods: A total of 18 650 patients with coronary artery disease undergoing PCI with DES were enrolled. Databases from three real-world PCI registries were merged for a patient-level meta-analysis. The primary outcome was death from any cause. The secondary outcomes were death from a cardiac cause, myocardial infarction, stent thrombosis, stroke, or repeat revascularization., Results: Patients with previous stroke (n=1361), compared with those without previous stroke (n=17 289), were older and had a higher prevalence of risk factors or comorbidities. At a median follow-up of 47.0 months, patients with previous stroke had a higher risk for death from any cause [adjusted hazard ratio (HR)=1.623; 95% confidence interval (CI): 1.342-1.962; P<0.001], death from a cardiac cause (adjusted HR=1.686; 95% CI: 1.339-2.124; P<0.001), and stroke (adjusted HR=2.456; 95% CI: 1.853-3.255; P<0.001). There were no significant differences in the risks for myocardial infarction, stent thrombosis, or repeat revascularization., Conclusion: Patients with previous stroke showed higher risks for all-cause death and stroke after PCI with DES than those without stroke. Previous stroke should be considered a risk factor for all-cause death and stroke in this patient population.

Background: Although studies have demonstrated comparable efficacy and safety profiles of everolimus- and zotarolimus-eluting stents (EES and ZES, respectively) for a broad spectrum of coronary artery diseases, there is paucity of data concerning their safety and efficacy for coronary chronic total occlusions (CTOs). This study compared the clinical performance of EES and ZES following successful percutaneous coronary intervention for CTOs., Methods: The cohort included 539 consecutive CTO patients who underwent successful PCI using EES (n=313) and ZES (n=226) between September 2006 and August 2014. The primary outcome was defined as the composite of death, myocardial infarction, and target vessel revascularization., Results: During a median follow-up of 3.3years, in both groups, the primary outcome occurred in 12.2% of patients. After multivariable adjustment, no significant difference was observed between the two groups in the risk of primary outcome [hazard ratio (HR) 1.03, 95% confidence interval (CI) 0.59-1.79, P=0.930 for ZES compared with EES]. Similarly, there were no significant differences in the risk of death (adjusted HR 0.96, 95% CI 0.43-2.15, P=925), death or myocardial infarction (adjusted HR 0.93, 95% CI 0.46-1.88, P=0.829), and target vessel failure (adjusted HR 0.96, 95% CI 0.51-1.82, P=0.902). The incidence of definite/probable stent thrombosis was relatively low [0% (ZES) vs. 1.0% (EES), P=0.19]., Conclusion: No significant differences were observed between EES and ZES in terms of clinical outcomes for coronary CTOs at 3.3years., (Copyright © 2017. Published by Elsevier B.V.)

There is limited data comparing effectiveness of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents in patients with non-ST-elevation acute coronary syndromes (NSTE-ACS). We compared the long-term outcomes of the 2 revascularization strategies in 1,246 patients presented with NSTE-ACS for left main or multivessel coronary artery disease. Data were pooled from the Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease (BEST) trial, the Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease (PRECOMBAT) trial, and the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial. The primary outcome was a composite of death from any causes, myocardial infarction, or stroke. The baseline characteristics were similar between the 2 study groups. During the median follow-up of 60 months, the rate of the primary outcome was significantly lower with CABG than with PCI (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.56 to 0.98; p = 0.036). This difference was mainly attributed to a significant reduction in the rate of myocardial infarction (HR 0.50; 95% CI 0.31 to 0.82, p = 0.006). The superiority of CABG over PCI was consistent across the major subgroups. The individual risks of death from any causes or stroke were not different between the 2 groups. In contrast, the rate of repeat revascularization was significantly lower in the CABG group than in the PCI group (HR 0.56; 95% CI 0.41 to 0.75, p <0.001). In this study, among patients with NSTE-ACS for left main or multivessel coronary artery disease, CABG significantly reduces the risk of death from any causes, myocardial infarction, or stroke compared with PCI with drug-eluting stents., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the long-term outcomes and predictors of adverse events following successful "full metal jacket" (FMJ) (stent length ≥60 mm without gap) procedures using drug-eluting stents to treat coronary chronic total occlusions (CTOs)., Background: The FMJ stenting procedure is often required to treat CTOs, but its clinical efficacy and safety remain unknown., Methods: In total, 1,126 successful CTO procedures (1,107 consecutive patients) performed between May 2003 and March 2015 were studied. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization or reocclusion., Results: Overall, 406 patients (36.7%) underwent the FMJ procedure, increasing in frequency over time (28.5% from 2003 to 2006 and 41.7% after 2011). The mean stent length was 76.8 ± 14.6 mm (range 60 to 122 mm), and the average number of stent overlaps was 2.5 ± 0.6 (range 2 to 4). A total of 127 patients (31.3%) had persistent luminal narrowing at the distal reference segment after stenting. During the median follow-up period of 5.1 years, target lesion failure occurred in 16.0% of patients. There were 17 cases of total reocclusion and 5 cases of stent thrombosis. Multivariate analysis confirmed that the number of implanted stents (hazard ratio: 1.72; 95% confidence interval: 1.16 to 2.54; p = 0.006) and persistent distal luminal narrowing (hazard ratio: 2.73; 95% confidence interval: 1.66 to 4.47; p < 0.001) were predictors of increased risk for target lesion failure., Conclusions: The FMJ procedure using drug-eluting stents for CTOs provides acceptable long-term clinical results. Persistent distal luminal narrowing increases the future likelihood of adverse events despite procedural success., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The optimal revascularization strategy for patients with significant coronary artery disease (CAD) and severe left ventricular (LV) dysfunction (ejection fraction ≤35%) remains unclear. We compared the effects of coronary artery bypass surgery (CABG, n = 442) versus percutaneous coronary intervention (PCI) with drug-eluting stents (n = 469) on long-term mortality in 911 patients with significant CAD and severe LV dysfunction using large real-world registry data. Databases of 3 real-world registries were merged for a patient-level meta-analysis. Primary outcome was death from any cause; secondary outcomes were death from cardiac causes, myocardial infarction, stroke, or repeat revascularization. At a median follow-up of 37.3 months, the risk of all-cause death (adjusted hazard ratio [HR] 0.43; 95% confidence interval [CI] 0.31 to 0.61; p <0.001) was significantly lower in the CABG group than in the PCI group after adjustment. Similar findings were observed with regard to the risks of death from cardiac cause (adjusted HR 0.49; 95% CI 0.33 to 0.73; p <0.001) and repeat revascularization (adjusted HR 0.08; 95% CI 0.03 to 0.20; p <0.001). However, there were no significant differences in the risks of myocardial infarction and stroke between the 2 groups. The superiority of CABG over PCI was particularly pronounced in patients receiving β blockers and angiotensin-converting enzyme inhibitor or angiotensin receptor blockers than those who are not. In conclusion, among patients with significant CAD and severe LV dysfunction, CABG showed a lower risk of all-cause death, cardiac-cause death, and repeat revascularization compared with PCI with drug-eluting stents., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: This study sought to investigate the incidence, management, and clinical relevance of atrial fibrillation (AF) during and after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and evaluate outcomes of different antithrombotic strategies., Background: Uncertainty exists regarding the optimal antithrombotic strategy in patients with AF who are undergoing PCI with DES., Methods: Using a consecutive series of 10,027 patients who underwent DES implantation between 2003 and 2011, we evaluated the overall prevalence and clinical impact of AF. In addition, we compared the efficacy and safety of dual antiplatelet therapy (DAPT) (aspirin plus clopidogrel) and triple therapy (DAPT plus warfarin) among patients with AF. The primary outcome was a composite of cardiovascular death, myocardial infarction, or stroke., Results: Overall, 711 (7.1%) patients had a diagnosis of AF at the index PCI. Patients with AF were older, had more comorbid conditions, and more often had a history of strokes; most patients with AF (88.4%) received DAPT rather than triple therapy (10.5%) at discharge. The rate of primary outcome after PCI during the 6-year follow-up period was significantly higher in patients with AF than in those without AF (22.1% vs. 8.0%; p < 0.001). This trend was consistent for major bleeding (4.5% vs. 1.5%; p < 0.001). After multivariable adjustment, the presence of AF was significantly associated with a higher risk of primary outcome (hazard ratio [HR]: 2.33; 95% confidence interval [CI]: 1.95 to 2.79; p < 0.001) and major bleeding (HR: 2.01; 95% CI: 1.32 to 3.06; p = 0.001). Among patients with AF, adjusted risk for the primary outcome was similar between the DAPT group and the triple therapy group (HR: 1.01; 95% CI: 0.60 to 1.69; p = 0.98), but triple therapy was associated with a significantly higher risk of hemorrhagic stroke (HR: 7.73; 95% CI: 2.14 to 27.91; p = 0.002) and major bleeding (HR: 4.48; 95% CI: 1.81 to 11.08; p = 0.001)., Conclusions: Among patients receiving DES implantation, AF was not rare and was associated with increased ischemic and bleeding risk. In patients with AF, triple therapy was not associated with decreased ischemic events but was associated with increased bleeding risk compared to DAPT., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: There are limited data comparing long-term outcomes of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in patients with high surgical risk. We evaluated 5-year outcomes following CABG versus PCI with DES in 598 patients with left main or multivessel coronary artery disease (CAD) and a high surgical risk [EuroSCORE (European system for cardiac operative risk evaluation) ≥ 6]., Methods: Databases were merged from the BEST, PRECOMBAT and SYNTAX trials. The primary outcome was a major adverse cardio-cerebral event (MACCE), defined as the composite of all-cause death, myocardial infarction, stroke or repeat revascularization., Results: During 5-year follow-up, the rates of MACCE were 29.4% in the CABG group and 43.8% in the PCI group [hazard ratio (HR), 0.64; 95% confidence interval (CI), 0.49 - 0.84; P  = 0.001]. The MACCE was significantly better with CABG than with PCI in patients with high and intermediate SYNTAX scores (34.9% vs 46.3%, P  = 0.039, and 29.7% vs 47.6%, P  = 0.010, respectively), but comparable between the two groups in those with low SYNTAX scores. The rates of all-cause death and stroke were similar between the two groups. However, CABG was associated with fewer myocardial infarctions (HR, 0.50; 95% CI, 0.27 - 0.93; P  = 0.027) and repeat revascularizations (HR, 0.32; 95% CI, 0.20 - 0.52; P  < 0.001)., Conclusions: Among high surgical risk patients with left main or multivessel CAD, CABG compared to PCI with DES was associated with a lower rate of MACCE., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Little data are available to compare coronary artery bypass graft surgery (CABG) vs percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in older adults. We evaluate the long-term outcomes of CABG vs PCI with DES in older adults with left main or multivessel coronary artery disease (CAD)., Design: Individual patient-level meta-analysis., Settings: Databases from the BEST, PRECOMBAT, and SYNTAX trials were combined., Participants: A total 1,079 adults aged 70 to 89 years were pooled., Measurements: The primary outcome was a composite of death from any causes, myocardial infarction, stroke, or repeat revascularization., Results: During a total of 6.3 (median, 4.9) years of follow-up, the primary composite outcome of all-cause mortality, myocardial infarction, stroke, or repeat revascularization occurred in 26% (141/550) and 34% (179/529) of patients in the CABG and PCI groups, respectively (hazard ratio (HR), 0.75; 95% confidence interval (CI), 0.60-0.94; P = .012). CABG was associated with fewer myocardial infarction (4% vs 8% for PCI; HR, 0.48; 95% CI, 0.29-0.80; P = .037); and repeat revascularizations (8% vs 17% for PCI; HR, 044; 95% CI, 0.31-0.64; P < .001), but had little association with all-cause mortality or stroke., Conclusion: Older adults age 70 to 89 years with left main or multivessel CAD who participated in the BEST, PRECOMBAT, and SYNTAX trials; compared to PCI, CABG was associated with lower risk of primary outcome which was mostly driven by lower risk of myocardial infarction., (© 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.)

The role of final kissing balloon (FKB) inflation after simple crossover stenting in unprotected left main (LM) bifurcation stenosis remains unknown. From the Asan Medical Center-Left Main Revascularization (ASAN-MAIN) registry, 413 patients with LM bifurcation stenosis treated by simple crossover stenting with a drug-eluting stent were identified. After simple crossover stenting, FKB inflation was performed in 95 patients (FKB group) and 318 patients finished the procedure without FKB (no-FKB group). The primary end points of the 2-year incidence of major adverse cardiac events (death, myocardial infarction, and left main target lesion revascularization [LM-TLR]) were similar between the FKB and no-FKB groups (12.5% vs 8.5%, p = 0.24). After adjustment, the risk of major adverse cardiac event was not significantly different between the FKB and the no-FKB groups (hazard ratio [HR] 1.10, 95% confidence interval [CI] 0.49 to 2.49; p = 0.82). The risk of death (HR 1.03, 95% CI 0.28 to 3.82; p = 0.98), the composite of death or myocardial infarction (HR 0.95, 95% CI 0.26 to 3.51; p = 0.96), or LM-TLR (HR 1.32, 95% CI 0.46 to 3.75; p = 0.60) were not significantly different between groups. In conclusions, for the treatment for LM bifurcation stenosis, selective, not mandatory, FKB strategy after simple crossover stenting appears to be associated with a favorable outcome., (Copyright © 2016. Published by Elsevier Inc.)

Limited data are available on the impact of concomitant left main coronary artery disease (CAD) on mortality after revascularization of multivessel coronary artery disease (MVD) alone or multivessel plus left main coronary artery disease (MVLMD). This study compared long-term mortality between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents in 2,887 patients with MVD or MVLMD. Data were pooled from the BEST, PRECOMBAT, and SYNTAX trials. The primary outcome was death due to any cause. Of the 2,887 patients, 1,975 (68.4%) were classified as having MVD and 912 (31.6%) as having MVLMD. The median follow-up duration was 60.2 months. In the patients with MVD, primary outcome rate after CABG was significantly lower than after PCI (hazard ratio [HR] 0.66; 95% confidence interval [CI] 0.49 to 0.89; p = 0.007). In the patients with MVLMD, however, CABG and PCI showed similar primary outcome rates (HR 0.98; 95% CI 0.67 to 1.43; p = 0.896). Among those who underwent CABG, primary outcome rate was lower in the patients with MVD than in those with MVLMD (HR 0.66; 95% CI 0.46 to 0.95; p = 0.024). Kaplan-Meier analysis showed a clear separation between the patients with MVD and those with MVLMD 2.5 years after the index surgery. The risk of death due to any cause was significantly lower after CABG than after PCI with drug-eluting stents in patients with MVD but not in those with MVLMD. The advantage of CABG over PCI for multivessel CAD was significantly attenuated if concomitant left main CAD was present., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: The authors undertook a patient-level meta-analysis to compare long-term outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,280 patients with left main or multivessel coronary artery disease (CAD)., Background: The relative efficacy and safety of CABG versus PCI with DES for left main or multivessel CAD remain controversial., Methods: Data were pooled from the BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease), PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery vs. Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trials. The primary outcome was a composite of all-cause death, myocardial infarction, or stroke., Results: The median follow-up was 60 months, and follow-up was completed for 96.2% of patients. The rate of primary outcome was significantly lower with CABG than with PCI (13.0% vs. 16.0%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.69 to 1.00; p = 0.046). The difference was mainly driven by reduction in myocardial infarction (HR: 0.46; 95% CI: 0.33 to 0.64; p < 0.001). There was significant interaction between treatment effect and types of CAD, showing CABG to be superior compared with PCI with DES in patients with multivessel CAD (p = 0.001), but no between-group difference in those with left main CAD (p = 0.427). The rates for all-cause death and stroke were similar between the 2 groups. By contrast, the need for repeat revascularization was significantly lower in the CABG group compared with the PCI group., Conclusions: CABG, as compared with PCI with DES, reduced long-term rates of the composite of all-cause death, myocardial infarction, or stroke in patients with left main or multivessel CAD. The advantage of CABG over PCI with DES was particularly pronounced in those with multivessel CAD., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The clinical impact of completeness of revascularization on adverse cardiovascular events remains unclear among patients with multivessel coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI)., Methods: This analysis included consecutive patients with multivessel CAD, who underwent PCI with drug-eluting stents (DES) during the period from January 1, 2003, through to December 31, 2013. We compared the outcomes in patients, who achieved complete (CR) versus incomplete revascularization (IR) at the time of PCI. The primary outcome was death from any cause. Secondary outcomes were the rates of myocardial infarction (MI), stroke, and repeat revascularization. Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics., Results: Among 3901 patients with multivessel CAD treated with DES, 1402 pairs of similar propensity scores in each group of CR and IR were identified. At a median follow-up of 4.9 years (interquartile range, 2.4-7.5), IR was associated with a similar risk of death (hazard ratio [HR], 1.03; 95% CI, 0.80-1.32; P=.83) as compared with CR. IR was also associated with similar risks of stroke (HR, 1.26; 95% CI, 0.76-2.09; P=.37) and repeat revascularization (HR, 1.15; 95% CI, 0.93-1.41; P=.19), but associated with a higher risk of MI (HR, 1.86; 95% CI, 1.08-3.19; P=.024) compared to CR., Conclusions: Among patients with multivessel CAD treated with DES, as compared with CR, IR was associated with similar risk of death. However, IR was associated with a higher risk of MI during follow-up., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: In diabetic patients with multivessel coronary artery disease (CAD), the survival difference between coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) favors CABG. However, there are few data on the mortality difference between the 2 strategies in nondiabetic patients., Objectives: This study performed a patient-level meta-analysis to compare the effect of CABG versus PCI with drug-eluting stents on long-term mortality in 1,275 nondiabetic patients with multivessel CAD., Methods: Individual patient data from the SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) and the BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials were pooled. The primary outcome was death from any cause., Results: The median follow-up time was 61 months (interquartile range: 50 months to 62 months). The risk of death from any cause was significantly lower in the CABG group than in the PCI group (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.43 to 0.98; p = 0.039). A similar finding was observed for the risk of death from cardiac causes. The superiority of CABG over PCI was consistent across the major clinical subgroups. Likewise, the rate of myocardial infarction was remarkably lower after CABG than after PCI (HR: 0.40; 95% CI: 0.24 to 0.65; p < 0.001). However, the rate of stroke was not different between the 2 groups (HR: 1.13; 95% CI: 0.59 to 2.17; p = 0.714). The need for repeat revascularization was significantly lower in the CABG group than in the PCI group (HR: 0.55; 95% CI: 0.40 to 0.75; p < 0.001)., Conclusions: CABG, as compared with PCI with drug-eluting stents, significantly reduced the long-term risk of mortality in nondiabetic patients with multivessel CAD., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Patients with previous myocardial infarction (MI) have a high risk of recurrence. Little is known about the effectiveness of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in patients with a previous MI and left main or multivessel coronary artery disease (CAD). We compared long-term outcomes of these 2 strategies in 672 patients with previous MI and left main or multivessel CAD, who underwent CABG (n = 349) or PCI with DES (n = 323). A pooled database from the BEST, PRECOMBAT, and SYNTAX trials was analyzed, and the primary outcome was a composite of death from any causes, MI, or stroke. Baseline characteristics were similar between the 2 groups. The median follow-up duration was 59.8 months. The rate of the primary outcome was significantly lower with CABG than PCI (hazard ratio [HR] 0.59, 95% CI 0.42 to 0.82; p = 0.002). This difference was driven by a marked reduction in the rate of MI (HR 0.29, 95% CI 0.16 to 0.55, p <0.001). The benefit of CABG over PCI was consistent across all major subgroups. The individual risks of death from any causes or stroke were comparable between the 2 groups. Conversely, the rate of repeat revascularization was significantly lower with CABG than PCI (HR 0.34, 95% CI 0.22 to 0.51, p <0.001). In conclusion, in the patients with previous MI and left main or multivessel CAD, compared to PCI with DES, CABG significantly reduces the risk of death from any causes, MI, or stroke., (Copyright © 2016 Elsevier Inc. All rights reserved.)

To evaluated prevalence and clinical implication of stent fracture and longitudinal compression in first- and new-generation drug-eluting stents (DES) using coronary computed tomography angiography (CCTA). The incidence of stent fracture and longitudinal compression were compared between first- and new-generation DES in 374 patients who underwent coronary stenting using DES and follow-up CCTA due to recurrent angina. 235 and 139 patients received 322 first- and 213 new-generation DES, respectively. The crude per-stent incidence of longitudinal compression (6.1 vs. 0.3 %, p < 0.001) was higher after new- than first-generation DES implantation using CCTA and the incidence of stent fracture (11.3 vs. 8.1 %, p = 0.23) was comparable. On follow-up coronary angiography for 347 stents, stent fracture (3.2 %) and longitudinal compression (0.9 %) were less detected than those on CCTA. Ostial stenting was a risk factor of longitudinal compression (p < 0.001). Stent fracture was associated with younger patients (p = 0.03), longer stent (p = 0.010), and excessively tortuous lesions (p = 0.001). The presence of stent fracture or longitudinal compression was not associated with poor clinical outcomes. The longitudinal compression more frequently occurred after new-generation DES implantation. The stent fracture was comparable between two DES. However, the occurrence of such mechanical deformities did not translate into a poor clinical outcome.

Background: The performance of contemporary second-generation drug-eluting stents (DESs) for percutaneous chronic total occlusion (CTO) intervention is not well established. The present study compared the efficacy and safety outcomes of second-generation DESs with those of first-generation DESs in CTO-percutaneous coronary intervention (PCI)., Methods: This retrospective analysis included 1049 consecutive CTO patients who underwent successful DES implantation (first-generation; 487 vs. second-generation; 562 patients) between March 2003 and August 2014. The primary endpoint was the composite of all-cause death, Q-wave myocardial infarction (MI), or target-vessel revascularization (TVR)., Results: During a follow-up of 3 years, the primary endpoint incidence was 10.1% for second- and 7.7% for first-generation DES (p=0.30). After multivariable adjustment, there was no significant difference between these groups in terms of the risk of composite of death, Q-wave MI, or TVR (Hazard ratio [HR] 1.42, 95% confidence interval [CI] 0.88-2.28, p=0.15) nor in the individual risks of death (adjusted HR 1.33, 95% CI 0.69-2.56, p=0.39), Q-wave MI (adjusted HR 1.15, 95% CI 0.30-4.47, p=0.84) and TVR (adjusted HR 1.06, 95% CI 0.52-2.15, p=0.87). The incidence of definite/probable stent thrombosis was relatively low (0.5% vs.0.9%, p=0.17) throughout the follow-up period., Conclusion: The 3-year clinical outcomes of patients treated with second-generation DESs are comparable to those treated with first-generation DESs for CTO-PCI., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Impact of fractional flow reserve guidance on revascularization strategies and outcomes for severe coronary artery disease was unclear. We evaluate changes in treatment strategy and clinical outcomes and to compare the effectiveness between percutaneous coronary intervention (PCI) with second-generation drug-eluting stents and coronary artery bypass graft surgery (CABG) in severe coronary artery disease patients before and after routine use of FFR. From January 2008 to December 2011, we enrolled 2,612 patients with significant left main coronary artery disease or 3-vessel disease. We obtained data of patients before (from January 2008 to December 2009) and after (January 2010 to December 2011) the routine use of FFR. We used propensity score matching to compare the rate of primary outcomes (death, myocardial infarction, stroke, or repeat revascularization [Major adverse cardiovascular and cerebral event; MACCE]) at 1 year. Introduction of routine FFR use reduced the proportion of patients receiving CABG from 54% to 43% (p <0.001). The risk of MACCE before routine FFR use was significantly higher in the PCI group than the CABG group (hazard ratio [HR] 1.82, 95% confidence interval [CI] 1.09 to 3.03, p = 0.021), whereas that after routine FFR use was not significantly different between the groups (HR 1.22, 95% CI 0.59 to 2.52, p = 0.59). The risk of MACCE in patients receiving revascularization lowered after routine FFR use compared with that before (HR 0.57, 95% CI 0.38 to 0.85, p = 0.005). In conclusion, routine incorporation of FFR resulted in improved PCI outcomes, comparable with concurrent CABG in patients with severe coronary artery disease who received revascularization., (Copyright © 2015 Elsevier Inc. All rights reserved.)

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., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents., Methods: We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups., Results: After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG., Conclusions: Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).

Objectives: We investigated the temporal patterns of drug-eluting stents (DES) failure and its relationship with clinical outcomes in patients with DES failure., Background: Time to DES failure is widely variable, but little information is available on the temporal patterns of DES failure and its impact on clinical outcomes., Methods: The angiographic patterns of DES failure and clinical outcomes in 633 patients with 676 lesions who presented with their first instance of DES failure were analyzed. The primary outcome was all-cause death following treatment for DES failure., Results: DES failure occurred in a median of 10.1 months after the index procedure. We identified 548 and 85 instances of DES restenosis (86.6%) and stent thrombosis (13.4%), respectively. Patients were divided into three groups according to the interval from the index procedure to DES failure: group 1 (early DES failure: <12 months), group 2 (late: 12-36 months), and group 3 (very late: ≥36 months). Acute myocardial infarction was more common in patients who developed failure after ≥12 months than patients with earlier presentations. Focal DES failure was more common in group 1, whereas nonfocal DES failure in groups 2 and 3. During follow-up after retreatment (median, 52.8 months), all-cause death was significantly higher in group 3 compared with group 1 (adjusted hazard ratio, 2.97; 95%CI, 1.31-6.74; P = 0.009). Similar findings were observed in terms of the rates of death or myocardial infarction., Conclusions: Late DES failure is more likely to progress to acute myocardial infarction, aggressive angiographic patterns, and worse outcomes following retreatment., (© 2014 Wiley Periodicals, Inc.)

Objectives: We examined long-term outcomes and predictors of major adverse cardiac events after the full metal jacket (FMJ) stent implantation., Background: The FMJ procedure has been used to treat diffuse coronary artery disease (CAD), but long-term outcomes remain unknown., Methods: The study population consisted of 347 consecutive patients (352 lesions) who had been treated for de novo diffuse CAD with FMJ stents (stent length ≥ 60 mm)., Results: The mean age was 61.0 ± 10.1 years, and the stent length was 71.9 ± 13.7 mm. The procedural success rate was 97.7%. Major in-hospital complications (one death and two acute stent thromboses) occurred in three patients (0.7%). The median follow-up was 101 months (interquartile range, 95-108 months). During follow-up, there were 60 deaths (33 cardiac), 20 myocardial infarctions, and 94 revascularizations. Definite stent thrombosis occurred in 12 patients. The event-free survival rate for cardiac death, cardiac death/myocardial infarction, or cardiac death/myocardial infarction/target lesion revascularization was 90.5 ± 1.6, 85.8 ± 1.9, and 71.6 ± 2.5% at 8 years, respectively. Left ventricular dysfunction (ejection fraction < 45%) was an independent predictor of cardiac death (OR: 4.88; 95% CI: 1.81-13.13; P = 0.002). Left ventricular dysfunction and a stent length > 80 mm were significantly related to cardiac death/myocardial infarction. Likewise, a stent length > 80 mm was an independent predictor of cardiac death/myocardial infarction/target lesion revascularization (OR: 2.45; 95% CI: 1.16-5.19; P = 0.019)., Conclusion: Long-term outcomes appear favorable after FMJ procedures, and left ventricular dysfunction and a stent length > 80 mm are major predictors of major adverse cardiac events. These findings might be useful in identifying the most suitable treatments for patients with very diffuse CAD. © 2013 Wiley Periodicals, Inc., (© 2013 Wiley Periodicals, Inc.)

Cardiac rehabilitation (CR) can reduce cardiovascular mortality and morbidity in coronary artery disease. Long coronary artery lesions may be associated with adverse outcomes after drug-eluting stent (DES) implantation. The purpose of this study was to evaluate angiographic outcomes after a comprehensive CR program in patients with DESs for long coronary artery lesions. A total of 576 patients treated with DESs for long (≥25 mm) coronary lesions were enrolled in this prospective CR registry. Comprehensive CR programs were successfully performed in 288 patients (50%). The primary end point was in-stent late luminal loss at the 9-month angiographic follow-up. There were few significant differences between the CR and non-CR groups in terms of baseline characteristics, including clinical, angiographic, and procedural variables. The rate of in-stent late luminal loss in the CR group was 35% less than in the usual care group (0.19 ± 0.33 mm in CR vs 0.29 ± 0.45 mm in non-CR, difference 0.08 mm, 95% confidence interval 0.01 to 0.16, p = 0.02) at the 9-month follow-up. After propensity-matched analysis (224 pairs), the results were consistent (0.18 ± 0.31 mm in CR vs 0.28 ± 0.41 mm in non-CR, difference 0.10 mm, 95% confidence interval 0.02 to 0.18, p = 0.02). The CR group showed a significant improvement in the overall risk profile compared with the non-CR group, including current smoking, biochemical profiles, depression, obesity, and exercise capacity. In conclusion, the comprehensive CR program significantly reduced late luminal loss after DES implantation for long coronary lesions. This may be associated with significant improvements in exercise capacity and overall risk profile., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo percutaneous coronary intervention. The current study, therefore, evaluated 2 innovative drug-eluting stents for the management of long-lesion coronary artery disease., Methods and Results: This randomized, multicenter, prospective trial, called the Long Drug-Eluting Stent (LONG-DES) V trial, compared the biodegradable polymer-based biolimus A9-eluting stent (BES) and the durable polymer-based platinum chromium everolimus-eluting stent (PtCr-EES) in 500 patients with long (≥ 25 mm) coronary lesions. The primary end point of the trial was in-segment late luminal loss at the 9-month angiographic follow-up. The BES and PtCr-EES groups had similar baseline characteristics, with a slightly shorter lesion length in the BES group versus the PtCr-EES group (29.24 ± 12.17 versus 32.27 ± 13.84 mm; P = 0.016). In-segment late luminal loss was comparable between the 2 groups at the 9-month angiographic follow-up (BES, 0.14 ± 0.38 versus PtCr-EES, 0.11 ± 0.37 mm; difference, 0.031; 95% confidence interval, -0.053 to 0.091; P = 0.03 for a noninferiority margin of 0.11, P = 0.45 for superiority), as was in-stent late luminal loss (0.20 ± 0.41 versus 0.24 ± 0.38 mm; P = 0.29). The incidence of in-segment (6.1% versus 4.9%; P = 0.63) and in-stent (3.7% versus 4.9%; P = 0.59) binary restenosis was also similar between the groups. There was no significant between-group difference in the rate of composite outcome of death, myocardial infarction, and target vessel revascularization (41, 16.7% in BES versus 42, 16.5% in PtCr-EES; P=0.94)., Conclusions: BES and PtCr-EES implantation showed analogous angiographic and clinical outcomes for patients with de novo long coronary lesions., Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique identifier: NCT01186120., (© 2014 American Heart Association, Inc.)

Many studies have reported comparable risk of hard end points between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for unprotected left main coronary artery (ULMCA) stenosis. However, there are limited data regarding the morbidity associated with ULMCA revascularization. This study sought to compare the cause and risk of readmissions after PCI and CABG for ULMCA stenosis. We evaluated the unadjusted and adjusted risk of readmissions in 1,352 patients (783 PCI treated and 569 CABG treated) who were consecutively enrolled in a multicenter registry of patients with ULMCA stenosis, named the Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease trial. Overall, 206 PCI-treated patients (26.3%) experienced at least 1 readmission after the index procedure during 48.7 ± 16.0 months of follow-up compared with 84 CABG-treated patients (14.8%, p <0.001). The most frequent causes of readmission were repeat revascularization after PCI (41%) and noncardiac readmissions after CABG (48%). Through repeated events analysis, PCI was associated with more frequent readmissions than CABG (hazard ratio 2.037, 95% confidence interval 1.542 to 2.692, p <0.001), being an independent predictor of readmission (hazard ratio 1.820, 95% confidence interval 1.420 to 2.331, p <0.001). Except for the acute period, defined as the first 3 months, when there was no significant difference in readmission rate, a higher readmission rate after PCI was consistently observed over the remainder of the follow-up period. In conclusion, PCI was shown to be associated with a higher risk of readmission than CABG in treating ULMCA disease. This higher risk was attributable to more frequent revascularization in the PCI group., (Copyright © 2014 Elsevier Inc. All rights reserved.)

There are conflicting data regarding the benefit of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) over angiography-guided PCI. Since the last meta-analysis was published, several new studies have been reported. We performed a comprehensive meta-analysis to evaluate the clinical impact of IVUS-guided PCI with drug-eluting stent compared with conventional angiography-guided PCI. This meta-analysis included 26,503 patients from 3 randomized and 14 observational studies; 12,499 patients underwent IVUS-guided PCI and 14,004 underwent angiography-guided PCI. Main outcome measures were total mortality, myocardial infarction (MI), stent thrombosis, and target lesion revascularization (TLR). IVUS-guided PCI was significantly associated with more stents, longer stents, and larger stents. Regarding clinical outcomes, IVUS-guided PCI was associated with a significantly lower risk of TLR (odds ratio [OR] 0.81, 95% confidence interval [CI] 0.66 to 1.00, p=0.046). In addition, the risk of death (OR 0.61, 95% CI 0.48 to 0.79, p<0.001), MI (OR 0.57, 95% CI 0.44 to 0.75, p<0.001), and stent thrombosis (OR 0.59, 95% CI 0.47 to 0.75, p<0.001) were also decreased. In conclusion, our meta-analysis demonstrated that IVUS-guided PCI was associated with lower risk of death, MI, TLR, and stent thrombosis after drug-eluting stent implantation., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Periprocedural myocardial infarction (MI) can be induced by several angiographic mechanisms. However, there are limited data on whether these mechanisms differentially affect clinical outcomes. The purpose of our study was to investigate the impact of periprocedural MI on mortality according to the underlying angiographic mechanisms after drug-eluting stent (DES) implantation. We pooled the databases from 7 coronary stent trials using DES. Periprocedural MI was classified according to its underlying angiographic mechanisms as type 1 (due to side-branch occlusion), type 2 (due to other angiographic complications), or type 3 (without angiographically identifiable causes). Among 10,889 patients treated with DES, 768 (7.1%) experienced periprocedural MI; 463 cases (60.3%) were driven by type 1 cause, 138 (18.0%) by type 2 cause, and 167 (21.7%) by type 3 cause. Mortality rates at 2 years were higher in patients with periprocedural MI than in those without (3.5% vs 2.1%, respectively). Significant differences in mortality were observed according to the angiographic mechanisms of MI (type 1: 2.8% vs type 2: 6.1% vs type 3: 3.1%). After multivariable adjustment, type 2 MI was significantly associated with an increased risk of mortality (hazard ratio 2.65, 95% confidence interval 1.77 to 3.96), whereas type 1 and type 3 MI were not related with increased mortality. In conclusion, among patients receiving DES implantation, periprocedural MI was associated with increased mortality, and there were differential associations with mortality according to the underlying angiographic mechanisms., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Aims: Mechanical complications contribute to bare metal and first-generation drug-eluting stent (DES) failure. However, the importance of the mechanical complications of second-generation DES remains unclear. We report mechanical complications associated with everolimus-eluting stent (EES) failures., Methods and Results: We retrospectively analysed 177 consecutive EES-treated lesions in 136 patients who underwent intravascular ultrasound (IVUS) at follow-up. Mechanical complications were identified in 17 patients (five stable angina, 10 unstable angina, two non-ST-elevation myocardial infarction [NSTEMI] without angiographic thrombus). Fifteen (88.2%) were treated with repeat revascularisation. By IVUS, there were 16 focal (94.1%) and one diffuse (5.9%) in-stent restenoses. Complete stent fracture with separation was seen in only one, partial stent fracture with separation was seen in three, and in 13 there was longitudinal deformation (n=2) or stent strut fracture (n=11) with overlapping of the proximal and distal stent fragments. In 13 EES with evidence of overlapping in the setting of either fracture or deformation, there was a 35.5±12.2% smaller stent area compared to the adjacent proximal and distal stent fragments, and >50% neointimal hyperplasia in 12 (92.3%)., Conclusions: We found EES mechanical complications, often followed by longitudinal deformation or fracture leading to excessive neointimal hyperplasia, in-stent restenosis, and repeat revascularisation.

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.

There are no practical criteria for the use of triple antiplatelet therapy after drug-eluting stent (DES) implantation. In our present report, pooled analysis of 3 randomized studies in patients with diabetes mellitus (Drug-Eluting Stenting Followed by Cilostazol treatment reduces LAte Restenosis in patients with diabetes mellitus trial) and long coronary narrowings (Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients with Long Coronary Lesions trials I and II) compared triple (aspirin, clopidogrel, and cilostazol; triple group, n = 700) and dual antiplatelet therapies (aspirin and clopidogrel; dual group, n = 699) after DES implantation. Among pooled population (n = 1,399 patients), 1,173 patients with follow-up angiography were divided into 3 stent length categories (≤20, 20 to 40, and >40 mm). There was no statistical significance of in-stent restenosis (ISR) in ≤20- and 20- to 40-mm categories between 2 groups. However, ISR rate was significantly reduced in triple versus dual group in >40-mm stent length category (12.4% vs 22.1%, p = 0.008). In diabetic patients, triple group also showed significant reduction in the ISR rate in >40-mm stent length category (15.4% vs 32.3%, p = 0.003). According to postprocedural minimal lumen diameter, triple group showed a trend toward a lower ISR than that of the dual group in all categories (p = 0.033 for ≤2.5 mm, p = 0.087 for 2.5 to 3.0 mm, and p = 0.119 for >3.0 mm). In conclusion, the triple group had a significantly reduced ISR in patients with >40-mm stent length after DES implantation compared with the dual group. Therefore, this suggestion for use of triple antiplatelet therapy could be easily applied after DES implantation in routine clinical practice., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Angiographic and clinical outcomes remain relatively unfavorable for diabetic patients even after the use of drug-eluting stent. This prospective, multicenter, randomized study compared the relative efficacy and safety of resolute zotarolimus-eluting stent (R-ZES) and sirolimus-eluting stent (SES) implantation in diabetic patients with coronary artery disease. The primary end point was noninferiority of angiographic in-segment late loss at 9 months. Clinical events were also monitored for at least 12 months. Patient recruitment was prematurely stopped after enrollment of 256 patients (127 in R-ZES group and 129 in SES) because of discontinuing production of SES. The R-ZES was noninferior to the SES for 9-month in-segment late loss (0.34 ± 0.30 vs 0.39 ± 0.43 mm; difference -0.048; 95% confidence interval -0.157 to 0.061; upper 1-sided 95% confidence interval 0.044; p <0.001 for noninferiority). In addition, in-stent late loss (0.22 ± 0.29 vs 0.21 ± 0.40 mm, p = 0.849) and the rates of in-segment (1.2% vs 6.7%, p = 0.119) and in-stent (1.2% vs 3.3%, p = 0.621) binary restenoses were similar between the 2 groups. At 12 months, there were no statistical differences between the 2 groups in the incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, ischemia-driven target lesion revascularization, ischemia-driven target vessel revascularization, and composite outcomes). In conclusion, despite having reduced power because of early study termination, our study suggests that the R-ZES has noninferior angiographic outcomes at 9 months to the SES in diabetic patients with coronary artery disease., (Crown Copyright © 2013. Published by Elsevier Inc. All rights reserved.)

Even in the drug-eluting stent era, restenosis has remained an unresolved issue, particularly in the treatment of complex coronary lesions. In this study, patient-level data from 3 randomized trials (Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus [DECLARE-DIABETES] and Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Long Native Coronary Lesions [DECLARE-LONG] I and II) were pooled to estimate the differential antirestenotic efficacy of add-on cilostazol according to the implanted drug-eluting stent in patients at high risk for restenosis. A total of 1,399 patients underwent sirolimus-eluting stent (SES; n = 450), paclitaxel-eluting stent (n = 450), and zotarolimus-eluting stent (n = 499) implantation and received triple-antiplatelet therapy (TAT; aspirin, clopidogrel, and cilostazol, n = 700) and dual-antiplatelet therapy (aspirin and clopidogrel, n = 699). Randomization of antiplatelet regimen was stratified by stent type. In-stent late loss after TAT was significantly lower than that after dual-antiplatelet therapy, regardless of implanted stent type. However, the incidence of in-segment restenosis after TAT was significantly lower with SES (0.5% vs 6.7%, p = 0.014) and zotarolimus-eluting stent (12.2% vs 20.0%, p = 0.028) implantation but not paclitaxel-eluting stent implantation (14.4% vs 20.0%, p = 0.244). A significant interaction was present between stent type and antiplatelet regimen for the risk for in-segment restenosis (p = 0.004). Post hoc analysis using bootstrap resampling methods showed that the relative risk reduction for in-segment restenosis after TAT was most prominent with SES implantation. In conclusion, add-on cilostazol effectively reduced restenosis in patients at high risk for restenosis, particularly in those receiving SES, suggesting the sustainable utility of add-on cilostazol therapy in newer generation drug-eluting stents with comparable efficacy with that of SES., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objectives: To evaluate the differential treatment effects of zotarolimus-eluting stents (ZES), sirolimus-eluting stents (SES), and paclitaxel-eluting stents (PES) according to diabetic status., Background: Diabetic patients have a higher risk of ischemic complications after stenting than nondiabetic patients., Methods: Using data from the ZEST randomized trial, comparing ZES with SES and PES, we evaluated relative outcomes among stents in diabetic and nondiabetic patients. The primary outcome was a major adverse cardiac event (MACE), defined as a composite of death, myocardial infarction, or ischemia-driven target-vessel revascularization., Results: Of the 2,645 patients enrolled in the ZEST trial, 760 (29%) had diabetes mellitus. Baseline clinical and angiographic characteristics were similar in the three stent groups, regardless of diabetic status. In diabetic patients, ZES showed similar rates of MACE as compared to PES (13.8% vs. 15.3%, P = 0.58), but higher rates of MACE than SES (13.8% vs. 7.7%, P = 0.05). In nondiabetic patients, ZES showed similar rates of MACE as compared to SES (10.3% vs. 10.8%, P = 0.72), whereas significantly lower rates of MACE compared to PES (10.3% vs. 15.3%, P = 0.01). In comparing the ZES and SES groups, there was a substantial interaction between diabetic status and stent types on MACE occurrence (Interaction P = 0.07). However, in comparison of ZES and PES, there were no significant interactions between diabetes and stent type on MACE (Interaction P = 0.25)., Conclusions: In diabetic patients, SES showed the lowest rate of MACE compared with ZES and PES. But, in nondiabetic patients, SES and ZES showed significantly lower rates of MACE than PES. ZES shows a diabetes-related interaction on MACE compared with SES, but not with PES., (Copyright © 2012 Wiley Periodicals, Inc.)