Jin Sik Park

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

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

Comparison of outcomes after treatment of in-stent restenosis using newer generation drug-eluting stents versus drug-eluting balloon: Patient-level pooled analysis of Korean Multicenter in-Stent Restenosis Registry

BACKGROUND Studies comparing the drug-eluting balloon (DEB) with contemporary drug-eluting stent (DES) in the treatment of in-stent restenosis (ISR) have been scarce. We compared that the efficacy and safety of contemporary DES versus DEB in unselected, real world patients of ISR occurred in bare-metal stent or DES. METHODS Patient-level pooled analysis from nationwide multicenter registries was performed with 628 consecutive patients who underwent ISR treatment using 2nd or 3rd generation DES or DEB. Target lesion failure (TLF) and patient-oriented composite outcomes (POCO, composite of all-cause mortality, all-cause myocardial infarction, or any revascularization) at 1-year follow-up were compared between the DES and DEB groups. RESULTS A total of 628 patients with 697 ISR lesions were treated using newer generation DES (n=409) or DEB (n=219). About 55.1% presented with acute coronary syndrome, and 15.1% showed left ventricular dysfunction. The risks of TLF and POCO were significantly lower in the DES group, even after being adjusted by an inverse probability weighted model (TLF, 9.2% vs. 17.9%, HRadjust 0.22, 95% CI 0.11-0.47; POCO, 12.4% vs. 24.1%, HRadjust 0.25, 95% CI 0.13-0.48, all p-values<0.001), mainly driven by the significantly lower risk of target lesion revascularization (TLR) (7.6% vs. 13.0%, HRadjust 0.21, 95% CI 0.09-0.49, p<0.001). Treatment of ISR with DEB independently predicted TLF (HR 1.87, 95% CI 1.05-3.02, p=0.034) along with multi-vessel disease, chronic kidney disease, type B2 or C lesion, and number of treated lesion>1. CONCLUSIONS In unselected patients of ISR, clinical outcome at one year was mainly dependent on difference in TLR and found to be better with contemporary DES than DEB.

Triple antithrombotic therapy versus dual antiplatelet therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation

BackgroundThe optimal antithrombotic regimen in patients with atrial fibrillation (AF) undergoing drug-eluting stent (DES) implantation for complex coronary artery disease is unclear. We compared the net clinical outcomes of triple antithrombotic therapy (TAT; aspirin, thienopyridine, and warfarin) and dual antiplatelet therapy (DAPT; aspirin and thienopyridine) in AF patients who had undergone DES implantation. MethodsA total of 367 patients were enrolled and analyzed retrospectively; 131 patients (35.7%) received TAT and 236 patients (64.3%) received DAPT. DAPT and warfarin were maintained for a minimum of 12 and 24 months, respectively. The primary endpoint was the 2-year net clinical outcomes, a composite of major bleeding and major adverse cardiac and cerebral events (MACCE). Propensity score-matching analysis was carried out in 99 patient pairs. ResultsThe 2-year net clinical outcomes of the TAT group were worse than those of the DAPT group (34.3 vs. 21.1%, P=0.006), which was mainly due to the higher incidence of major bleeding (16.7 vs. 4.6%, P<0.001), without any significant increase in MACCE (22.1 vs. 17.7%, P=0.313). In the multivariate analysis, TAT was an independent predictor of worse net clinical outcomes (odds ratio 1.63, 95% confidence interval 1.06–2.50) and major bleeding (odds ratio 3.54, 95% confidence interval 1.65–7.58). After propensity score matching, the TAT group still had worse net clinical outcomes and a higher incidence of major bleeding compared with the DAPT group. ConclusionIn AF patients undergoing DES implantation, prolonged administration of TAT may be harmful due to the substantial increase in the risk for major bleeding without any reduction in MACCE.

INNOVATION Study (Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-Segment–Elevation Myocardial Infarction)

Background—The aim of this study was to assess whether deferred stenting (DS) reduces infarct size and microvascular obstruction (MVO) compared with immediate stenting (IS) in primary percutaneous coronary intervention for ST-segment–elevation myocardial infarction. Methods and Results—From February 2013 to August 2015, 114 patients (mean age: 69 years) were randomized into the following 2 groups: DS with an intention to stent 3 to 7 days later or IS after primary reperfusion in 2 centers. The primary and secondary end points were infarct size and the incidence of MVO, respectively, assessed by cardiac magnetic resonance imaging at 30 days after primary reperfusion. The median time to the second procedure in the DS was 72.8 hours. Six patients in the DS group were crossed over to the IS group because of progression of dissection or safety concerns after randomization. In the intention-to-treat analysis, DS did not significantly reduce infarct size (15.0% versus 19.4%; P=0.112) and the incidence of MVO (42.6% versus 57.4%; P=0.196), compared with IS. However, in anterior wall myocardial infarction, infarct size (16.1% versus 22.7%; P=0.017) and the incidence of MVO (43.8% versus 70.3%; P=0.047) were significantly reduced in the DS group. There was no urgent revascularization event during deferral period. Conclusions—A routine DS did not significantly reduce infarct size and MVO compared with IS, although it was safe. The beneficial effect of DS in patients with anterior myocardial infarction should be confirmed by larger randomized studies. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT02324348.

Impact of final kissing balloon inflation after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions in patients with acute coronary syndrome

OBJECTIVES We sought to evaluate the impact of final kissing balloon inflation (FKBI) after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions in patients with acute coronary syndrome (ACS). BACKGROUND Whether FKBI should be mandatory after simple stent implantation for the treatment of coronary bifurcation lesion is controversial. Besides, ACS patients who have undergone bifurcation percutaneous coronary intervention with simple stent implantation may experience worse prognosis compared to stable angina pectoris patients. METHODS Two hundred and fifty one eligible patients (67.7% male, mean age 61.7 ± 10.4 years) were enrolled. The study population was divided into two groups according to the performance of FKBI. The primary end points were major adverse cardiac event (MACE); target lesion revascularization (TLR), non-fatal myocardial infarction (MI) and cardiac death during the follow-up period. RESULTS Over a mean follow-up period of 3.0 ± 1.9 years, there were 29 MACEs (10 TLR, 6 non-fatal MI, and 13 cardiac deaths), representing an event rate of 11.6%. Kaplan-Meier survival analysis revealed that FBKI group had favorable outcome compared to non-FKBI group with regard to hard events (p = 0.010) as well as composite MACEs (p = 0.008). In multivariable analysis, FKBI was a significant predictor of composite MACEs [hazard ratio 0.398 (95% confidence interval 0.190-0.836, p = 0.015)] and hard events [hazard ratio 0.325 (95% confidence interval 0.130-0.811, p = 0.016)]. CONCLUSIONS In terms of prognosis, performing FKBI after simple stent implantation for the treatment of non-left main true coronary bifurcation lesions may be mandatory in ACS patients.

Numbness after Transradial Cardiac Catheterization: the Results from a Nerve Conduction Study of the Superficial Radial Nerve

Background and Objectives Numbness on the hand occurs infrequently after a transradial cardiac catheterization (TRC). The symptom resembles that of neuropathy. We, therefore, investigated the prevalence, the predicting factors and the presence of neurological abnormalities of numbness, using a nerve conduction study (NCS). Subjects and Methods From April to December 2013, all patients who underwent a TRC were prospectively enrolled. From among these, the patients who experienced numbness on the ipsilateral hand were instructed to describe their symptoms using a visual analogue scale; subsequently, NCSs were performed on these patients. Results Of the total 479 patients in the study sample, numbness occurred in nine (1.8%) following the procedure. The NCS was performed for eight out of the nine patients, four (50%) of which had an abnormal NCS result at the superficial radial nerve. A larger sheath and history of myocardial infarction (p=0.14 and 0.08 respectively) tended towards the occurrence of numbness; however, only the use of size 7 French sheaths was an independent predictor for the occurrence of numbness (odds ratio: 5.50, 95% confidence interval: 1.06-28.58, p=0.042). The symptoms disappeared for all patients but one, within four months. Conclusion A transient injury of the superficial radial nerve could be one reason for numbness after a TRC. A large sheath size was an independent predictor of numbness; therefore, large sized sheaths should be used with caution when performing a TRC.

Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent in patients with acute myocardial infarction

BACKGROUND There are limited data about long-term outcomes for biodegradable polymer biolimus-eluting stent (BES) versus durable polymer everolimus-eluting stent (EES) in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). We sought to compare the two-year efficacy and safety of BES versus EES in AMI patients. METHODS A total of 707 consecutive patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction who underwent PCI with BES (n=171) or EES (n=536) between July 2008 and June 2012 were enrolled in this study. The efficacy endpoint (target vessel failure; a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization) and the safety endpoint (a composite of all cause death, myocardial infarction, and stent thrombosis) at two years were compared in crude and propensity score-matched cohorts. RESULTS After two years, target vessel failure occurred in 13 patients treated with BES and 49 patients treated with EES (7.6% versus 9.1%; adjusted hazard ratio [HR], 1.09; 95% confidence interval [CI], 0.58-2.04; p=0.78). The rates of composite safety endpoint at two years were not different between two groups (BES 7.6% versus EES 10.8%; adjusted HR, 0.87; 95% CI, 0.47-1.62; p=0.66). The rates of stent thrombosis did not differ between two groups (BES 0.6% versus EES 1.3%; adjusted HR, 0.63; 95% CI, 0.06-6.20; p=0.69). These findings were substantiated by similar results in the propensity score-matched cohort. CONCLUSIONS In the treatment of patients with AMI, BES showed similar efficacy and safety compared to those of EES for up to two years.

Risk Scoring System to Assess Outcomes in Patients Treated with Contemporary Guideline-Adherent Optimal Therapies after Acute Myocardial Infarction

Background and Objectives A risk prediction is needed even in the contemporary era of acute myocardial infarction (AMI). We sought to develop a risk scoring specific for patients with AMI being treated with guideline-adherent optimal therapies, including percutaneous coronary intervention and all 5 medications (aspirin, thienopyridine, β-blocker, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, and statin). Methods From registries, 12,174 AMI patients were evaluated. The primary outcome was 1-year all-cause death or AMI. The Korea Working Group in Myocardial Infarction (KorMI) system was compared with the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX AMI), Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC), and Global Registry of Acute Coronary Events scores (GRACE) models. Results Ten predictors were identified: left ventricular dysfunction (hazard ratio [HR], 2.3), bare-metal stent (HR, 2.0), Killip class ≥II (HR, 1.9), renal insufficiency (HR, 1.8), previous stroke (HR, 1.6), regional wall-motion- score >20 on echocardiography (HR, 1.5), body mass index ≤24 kg/m2 (HR, 1.4), age ≥70 years (HR, 1.4), prior coronary heart disease (HR, 1.4), and diabetes (HR, 1.4). Compared with the previous models, the KorMI system had good discrimination (time-dependent C statistic, 0.759) and showed reasonable goodness-of-fit by Hosmer-Lemeshow test (p=0.84). Moreover, the continuous-net reclassification improvement varied from −27.3% to −19.1%, the integrated discrimination index varied from −2.1% to −0.9%, and the median improvement in risk score was from −1.0% to −0.4%. Conclusions The KorMI system would be a useful tool for predicting outcomes in survivors treated with guideline-adherent optimal therapies after AMI.

A comparison of clinical features of coronary artery spasm with and without thyrotoxicosis

ObjectiveSeveral reports have suggested that thyrotoxicosis may induce severe coronary artery spasm (CAS). However, there are few data regarding the differences in clinical characteristics of CAS with and without thyrotoxicosis. The aim of our study is to compare the clinical features of CAS with and without thyrotoxicosis. MethodsWe evaluated 430 consecutive patients with CAS [patients with thyrotoxicosis (N=32, group I) and those without (N=398, group II)] at a single institute between January 2001 and June 2011. We compared clinical presentations, angiographic findings, and adverse outcomes (a composite outcome of cardiac death, myocardial infarction, or rehospitalization due to cardiac cause) of both groups. ResultsThere was higher incidence of acute myocardial infarction at initial presentation in group I (15.6 vs. 5.8%, P=0.04). CAS with thyrotoxicosis was more diffuse (59.4 vs. 39.3%, P=0.03), more medically intractable (9.4 vs. 0%, P=0.001), and more frequently involved the left main vessel (25.0 vs.0.8%, P=0.001) than CAS without thyrotoxicosis. During the follow-up period (median 43 months), there were no significant differences between the two groups in terms of the risk of adverse outcomes (hazard ratio for CAS with thyrotoxicosis, 1.029; 95% confidence interval, 0.347–3.054). ConclusionClinical and angiographic presentations of CAS with thyrotoxicosis were more severe than CAS without thyrotoxicosis, but clinical outcomes were similar in both groups. Optimal vasodilator therapy is essential for the management of CAS with thyrotoxicosis. Thyroid function test should be mandatory for all patients with CAS.

Long-term effectiveness and safety of triple versus dual antiplatelet therapy after percutaneous coronary intervention for unprotected left main coronary artery disease.

ObjectivesWe sought to compare the long-term effectiveness and safety of triple antiplatelet therapy (TAPT) versus dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for unprotected left main coronary artery disease (uLMCAD). BackgroundAn additional strategy to reduce recurrent ischemia after PCI for uLMCAD is needed to improve the long-term clinical outcomes and match the efficacy of bypass surgery. MethodsWe evaluated 245 patients who underwent PCI with drug-eluting stents for uLMCA stenosis of at least 50% from the Sejong General Institute PCI database between April 2003 and December 2010. TAPT was defined as the addition of cilostazol for at least 3 months to conventional DAPT after PCI. ResultsA total of 124 patients received TAPT and 121 patients received DAPT. The TAPT group had a higher number of male patients, need for the two-stent technique, and Synergy between percutaneous coronary intervention with Taxus and Cardiac Surgery (SYNTAX) scores and longer stent length compared with the DAPT group. During a median 30.6 months, major adverse cardiac and cerebrovascular events (MACCE) occurred in 43 patients (17.6%): 23 (18.5%) in the TAPT group and 20 (16.5%) in the DAPT group (P=0.68). In the multivariate analysis, TAPT was not associated with a lower incidence of MACCE (hazard ratio: 0.69, 95% confidence interval: 0.34–1.43). Thrombolysis in myocardial infarction (TIMI) major and minor bleeding occurred at similar rates (5.6 vs. 3.3%, P=0.565, for TIMI major bleeding; and 14.5 vs. 14.9%, P=0.718, for TIMI minor bleeding). ConclusionTAPT after drug-eluting stent implantation in patients with uLMCAD did not improve the long-term clinical outcome when compared with conventional DAPT, although it was a safe strategy.