Pil Hyung Lee

Randomized Trial of Stents Versus Bypass Surgery for Left Main Coronary Artery Disease 5-Year Outcomes of the PRECOMBAT Study

BACKGROUNDnIn a previous randomized trial, we found that percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year.nnnOBJECTIVESnThis study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis.nnnMETHODSnWe randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent (n = 300) or CABG (n = 300). The primary endpoint was a major adverse cardiac or cerebrovascular event (MACCE: a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) and compared on an intention-to-treat basis.nnnRESULTSnAt 5 years, MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group (cumulative event rates of 17.5% and 14.3%, respectively; hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.84 to 1.90; p = 0.26). The 2 groups did not differ significantly in terms of death from any cause, myocardial infarction, or stroke as well as their composite (8.4% and 9.6%; HR, 0.89; 95% CI, 0.52 to 1.52; p = 0.66). Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group (11.4% and 5.5%, respectively; HR: 2.11; 95% CI: 1.16 to 3.84; p = 0.012).nnnCONCLUSIONSnDuring 5 years of follow-up, our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG. However, considering the limited power of our study, our results should be interpreted with caution. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968).

Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial

BACKGROUNDnRecent reports showing the favorable role of patent foramen ovale (PFO) closure in patients with cryptogenic stroke have raised the issue of selecting optimal candidates.nnnOBJECTIVESnThis study, DEFENSE-PFO (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale), evaluated whether the benefits of PFO closure can be determined on the basis of the morphologic characteristics of the PFO, as evaluated by transesophageal echocardiography.nnnMETHODSnPatients with cryptogenic stroke and high-risk PFO were divided between a transcatheter PFO closure and a medication-only group. High-risk PFO included PFO with atrial septal aneurysm, hypermobility (phasic septal excursion into either atriumxa0≥10xa0mm), or PFO size (maximum separation of the septum primum from the secundum)xa0≥2xa0mm. The primary endpoint was a composite of stroke, vascular death, or Thrombolysis In Myocardial Infarction-defined major bleeding during 2 years of follow-up.nnnRESULTSnFrom September 2011 until October 2017, 120 patients (mean age: 51.8 years) underwent randomization. PFO size, frequency of septal aneurysm (13.3% vs. 8.3%; pxa0=xa00.56), and hypermobility (45.0% vs. 46.7%; p > 0.99) were similar between the groups. All PFO closures were successful. The primary endpoint occurred exclusively in the medication-only group (6 of 60 patients; 2-year event rate: 12.9% [log-rank pxa0=xa00.013]; 2-year rate of ischemic stroke: 10.5% [pxa0=xa00.023]). The events in the medication-only group included ischemic stroke (nxa0=xa05), cerebral hemorrhage (nxa0=xa01), Thrombolysis In Myocardial Infarction-defined major bleeding (nxa0=xa02), and transient ischemic attack (nxa0=xa01). Nonfatal procedural complications included development of atrial fibrillation (nxa0=xa02), pericardial effusion (nxa0=xa01), and pseudoaneurysm (nxa0=xa01).nnnCONCLUSIONSnPFO closure in patients with high-risk PFO characteristics resulted in a lower rate of the primary endpoint as well as stroke recurrence. (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients Withxa0High-Risk Patent Foramen Ovale [DEFENSE-PFO]; NCT01550588).

Determinants and Prognostic Significance of Periprocedural Myocardial Injury in Patients With Successful Percutaneous Chronic Total Occlusion Interventions

OBJECTIVESnThis study sought to evaluate the determinants and prognostic implications of periprocedural myocardial injury (PMI) in successful percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs).nnnBACKGROUNDnThere are limited studies addressing the risk factors and clinical implication of PMI in patients undergoing CTO-PCI.nnnMETHODSnWe examined 1,058 consecutive CTO patients who underwent successful drug-eluting stent implantation and serial measurements of creatine kinase-myocardial band (CK-MB) values between March 2003 and August 2014. PMI was defined as elevations of CK-MB >3 times the upper reference limit (URL).nnnRESULTSnPMI occurred in 121 patients (11.4%). Multivariable analysis revealed that the presence of renal failure (odds ratio [OR]: 4.25; 95% confidence interval [CI]: 1.59 to 11.35; pxa0= 0.004), attempted retrograde approach (OR: 2.27; 95% CI: 1.34 to 3.84; pxa0= 0.002), concomitant non-target lesion intervention (OR: 1.74; 95% CI: 1.17 to 2.59; pxa0= 0.006), and stent number (OR: 1.38; 95% CI: 1.08 to 1.77; pxa0= 0.011) were predictors associated with PMI. During a median follow-up of 4.4 years, PMI was associated with an increased risk of mortality (adjusted hazard ratio: 1.86; 95% CI: 1.09 to 3.17; pxa0=xa00.02). These findings were also consistent when higher CK-MB cutoff was used to define PMI. Although there was axa0trend toward higher all-cause mortality with increasing peak CK-MB levels, in multivariable analyses, this association was statistically significant only for peak CK-MB levels of >10 times the URL.nnnCONCLUSIONSnPMI was associated with an increased risk of long-term mortality after successful CTO-PCI. Patients with renal insufficiency, those who require more stents, multiple lesion treatment, and retrograde approach have a higher likelihood of having PMI.

Prevalence, Management, and Long-Term (6-Year) Outcomes of Atrial Fibrillation Among Patients Receiving Drug-Eluting Coronary Stents

OBJECTIVESnThis 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.nnnBACKGROUNDnUncertainty exists regarding the optimal antithrombotic strategy in patients with AF who are undergoing PCI with DES.nnnMETHODSnUsing 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) amongxa0patients with AF. The primary outcome was a composite of cardiovascular death, myocardial infarction, orxa0stroke.nnnRESULTSnOverall, 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 ratherxa0than 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%; pxa0< 0.001). This trendxa0was consistent for major bleeding (4.5% vs. 1.5%; pxa0< 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% confidencexa0interval [CI]: 1.95 to 2.79; pxa0<xa00.001) and major bleeding (HR: 2.01; 95% CI: 1.32 to 3.06; pxa0= 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; pxa0=xa00.98), but triple therapy was associated with a significantlyxa0higher risk of hemorrhagic stroke (HR: 7.73; 95% CI: 2.14 to 27.91; pxa0= 0.002) and major bleeding (HR:xa04.48; 95% CI: 1.81 to 11.08; pxa0= 0.001).nnnCONCLUSIONSnAmong 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 wasxa0associated with increased bleeding risk compared to DAPT.

Safety and Effectiveness of Second-Generation Drug-Eluting Stents in Patients With Left Main Coronary Artery Disease

BACKGROUNDnLimited data are available on the relative performances between different types of drug-eluting stents (DES) for obstructive left main coronary artery disease (LMCAD).nnnOBJECTIVESnThis study sought to compare effectiveness and safety profiles of various second-generation DES for LMCAD in real-world clinical practice.nnnMETHODSnAmong 4,470 patients in 3, multicenter, prospective registries (IRIS-DES [Interventional Cardiology Researchxa0Incorporation 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.nnnRESULTSnThe 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; pxa0=xa00.15). 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%xa0confidence interval: 1.01 to 2.54; pxa0=xa00.046). 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 typesxa0of 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.nnnCONCLUSIONSnIn 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, andxa0Newxa0Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).

Full Metal Jacket With Drug-Eluting Stents for Coronary Chronic Total Occlusion

OBJECTIVESnThe aim of this study was to evaluate the long-term outcomes and predictors of adverse events followingxa0successful full metal jacket (FMJ) (stent lengthxa0≥60 mm without gap) procedures using drug-eluting stents to treat coronary chronic total occlusions (CTOs).nnnBACKGROUNDnThe FMJ stenting procedure is often required to treat CTOs, but its clinical efficacy and safety remain unknown.nnnMETHODSnIn total, 1,126 successful CTO procedures (1,107 consecutive patients) performed between May 2003 andxa0March 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.nnnRESULTSnOverall, 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 averagexa0number ofxa0stent 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. Therexa0were 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; pxa0=xa00.006) and persistent distal luminal narrowing (hazard ratio: 2.73; 95% confidence interval: 1.66 to 4.47; pxa0<xa00.001) were predictors of increased risk for target lesion failure.nnnCONCLUSIONSnThe 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.

Anatomical or Functional Evaluation as an Initial Test for Stable Coronary Artery Disease: A Propensity Score Analysis

Little data are available to compare the clinical implications of coronary angiography (CAG) or myocardial perfusion imaging (MPI) as an initial evaluation for stable coronary artery disease (CAD). Methods: From national health insurance claims data in South Korea, patients aged 18 y or older without a known history of CAD, who underwent CAG or MPI for the diagnosis of stable CAD between 2009 and 2013, were enrolled. Patients were divided into CAG (n = 117,134) and MPI (n = 19,932) groups. The primary endpoint, defined as a composite of all-cause death and myocardial infarction, was compared by a propensity score analysis between the 2 groups. Results: There was a significant increase (39%) in the annual rate of CAG from 23,985 in 2009–2010 to 33,373 in 2012–2013. However, a substantial reduction (41%) in the annual MPI rate was also noted from 6,389 in 2009–2010 to 3,790 in 2012–2013. During the follow-up period (median, 2.4 y; interquartile range, 1.5–3.5), coronary revascularization was more frequently performed in the CAG group (adjusted hazard ratio [aHR] of CAG, 24.15; 95% confidence interval [CI], 19.66–29.68; P < 0.001). However, the incidence of the primary endpoint was significantly higher in the CAG group (aHR, 1.26; 95% CI, 1.17–1.36; P < 0.001). The individual endpoints of death (aHR, 1.16; 95% CI, 1.06–1.25; P = 0.001) and myocardial infarction (aHR, 1.95; 95% CI, 1.60–2.36; P < 0.001) were also higher in the CAG group. Conclusion: As an initial diagnostic test in patients with stable CAD, MPI is associated with a better clinical outcomes than CAG.

Procedural Predictors of Angiographic Restenosis After Bifurcation Coronary Stenting (from the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch and Optimal Stenting Strategy for True Bifurcation Lesions Studies)

Most subordinate techniques accompanying bifurcation stenting have not been supported by relevant clinical trials. The aim of this study was to investigate the impact of technical specifications involved in bifurcation stenting on angiographic outcomes. We analyzed patients enrolled in a cohort consisting of the patients in 2 randomized studies: one comparing routine final kissing inflation (FKI) versus leave-alone strategy after the 1-stent technique for bifurcations without side branch (SB) stenosis (<50%) and the other comparing crush versus the 1-stent technique for lesions with SB stenosis (≥50%). The effects of subordinate techniques and devices on 8-month angiographic restenosis were studied using multivariate models. Of 514 patients whose 8-month angiograms were available, 58 (11.3%) were found to have restenosis involving, in total, 35 main branches (MBs) and 27 SBs. Using multivariate models, we identified FKI as the only independent predictor of MB restenosis in the technically modifiable variables. The effect of FKI was significantly different across subgroups defined by bifurcation lesion type and stenting technique (test for homogeneity, pxa0= 0.003): FKI was unrelated to MB restenosis in the 1-stent for diseased SB (odds ratio [OR] 0.41, 95% confidence interval [CI] 0.10 to 1.72; pxa0= 0.22) and the 2-stent groups (OR 0.14, 95% CI 0.01 to 1.36; pxa0= 0.09) but predictive of MB restenosis in the 1-stent for normal SB group (OR 4.90, 95% CI 1.58 to 15.16; pxa0= 0.006).

TCT-498 Lower mortality in patients with vasospastic angina who receive statin therapy: Data from the Asan Vasospastic Angina Registry

Statin therapy is the standard treatment for atherosclerotic cardiovascular disease. However, the benefits of statin therapy in patients with vasospastic angina (VSA) remains unknown. This study investigated the long-term benefits of statin therapy in patients with VSA.nnBetween March 1996 and

MORTALITY OF PATIENTS WITH PREVIOUS STROKE UNDERGOING DRUG-ELUTING STENT IMPLANTATION

Background: The patients with a prior history of stroke undergoing percutaneous coronary intervention (PCI) are increasing, but there are limited data about clinical outcomes.nnMethods: The authors pooled patients-level data from 3 registry trials investigating clinical outcomes of CAD treated PCI