Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion.

BACKGROUND: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. METHODS: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. RESULTS: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. CONCLUSIONS: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial.

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.

P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent: The SHARE Randomized Clinical Trial.

Importance: P2Y12 inhibitor monotherapy after dual antiplatelet therapy (DAPT; a P2Y12 inhibitor plus aspirin) for a brief duration has recently emerged as an attractive alternative for patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent. Objective: To investigate whether P2Y12 inhibitor monotherapy after 3 months of DAPT was noninferior to 12 months of DAPT following PCI with a drug-eluting stent. Design, Setting, and Participants: The Short-Term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-Eluting Stent (SHARE) open-label, noninferiority randomized clinical trial was conducted from December 15, 2017, through December 14, 2020. Final 1-year clinical follow-up was completed in January 2022. This study was a multicenter trial that was conducted at 20 hospitals in South Korea. Patients who underwent successful PCI with bioabsorbable polymer everolimus-eluting stents were enrolled. Interventions: Patients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (n = 694) or 12 months of DAPT (n = 693). Main Outcomes and Measures: The primary outcome was a net adverse clinical event, a composite of major bleeding (based on Bleeding Academic Research Consortium type 3 or type 5 bleeding) and major adverse cardiac and cerebrovascular events (cardiac death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target lesion revascularization) between 3 and 12 months after the index PCI. The major secondary outcomes were major adverse cardiac and cerebrovascular events and major bleeding. The noninferiority margin was 3.0%. Results: Of the total 1452 eligible patients, 65 patients were excluded before the 3-month follow-up, and 1387 patients (mean [SD] age, 63.0 [10.7] years; 1055 men [76.1%]) were assigned to P2Y12 inhibitor monotherapy (n = 694) or DAPT (n = 693). Between 3 and 12 months of follow-up, the primary outcome (using Kaplan-Meier estimates) occurred in 9 patients (1.7%) in the P2Y12 inhibitor monotherapy group and in 16 patients (2.6%) in the DAPT group (absolute difference, -0.93 [1-sided 95% CI, -2.64 to 0.77] percentage points; P < .001 for noninferiority). For the major secondary outcomes (using Kaplan-Meier estimates), major adverse cardiac and cerebrovascular events occurred in 8 patients (1.5%) in the P2Y12 inhibitor monotherapy group and in 12 patients (2.0%) in the DAPT group (absolute difference, -0.49 [95% CI, -2.07 to 1.09] percentage points; P = .54). Major bleeding occurred in 1 patient (0.2%) in the P2Y12 inhibitor monotherapy group and in 5 patients (0.8%) in the DAPT group (absolute difference, -0.60 [95% CI, -1.33 to 0.12] percentage points; P = .10). Conclusions and Relevance: In patients with coronary artery disease undergoing PCI with the latest generation of drug-eluting stents, P2Y12 inhibitor monotherapy after 3-month DAPT was not inferior to 12-month DAPT for net adverse clinical events. Considering the study population and lower-than-expected event rates, further research is required in other populations. Trial Registration: ClinicalTrials.gov Identifier: NCT03447379.

Duration of dual antiplatelet therapy after implantation of drug-eluting stents.

BACKGROUND: The potential benefits and risks of the use of dual antiplatelet therapy beyond a 12-month period in patients receiving drug-eluting stents have not been clearly established. METHODS: In two trials, we randomly assigned a total of 2701 patients who had received drug-eluting stents and had been free of major adverse cardiac or cerebrovascular events and major bleeding for a period of at least 12 months to receive clopidogrel plus aspirin or aspirin alone. The primary end point was a composite of myocardial infarction or death from cardiac causes. Data from the two trials were merged for analysis. RESULTS: The median duration of follow-up was 19.2 months. The cumulative risk of the primary outcome at 2 years was 1.8% with dual antiplatelet therapy, as compared with 1.2% with aspirin monotherapy (hazard ratio, 1.65; 95% confidence interval [CI], 0.80 to 3.36; P=0.17). The individual risks of myocardial infarction, stroke, stent thrombosis, need for repeat revascularization, major bleeding, and death from any cause did not differ significantly between the two groups. However, in the dual-therapy group as compared with the aspirin-alone group, there was a nonsignificant increase in the composite risk of myocardial infarction, stroke, or death from any cause (hazard ratio, 1.73; 95% CI, 0.99 to 3.00; P=0.051) and in the composite risk of myocardial infarction, stroke, or death from cardiac causes (hazard ratio, 1.84; 95% CI, 0.99 to 3.45; P=0.06). CONCLUSIONS: The use of dual antiplatelet therapy for a period longer than 12 months in patients who had received drug-eluting stents was not significantly more effective than aspirin monotherapy in reducing the rate of myocardial infarction or death from cardiac causes. These findings should be confirmed or refuted through larger, randomized clinical trials with longer-term follow-up. (ClinicalTrials.gov numbers, NCT00484926 and NCT00590174.)

Study design and rationale of "a multicenter, open-labeled, randomized controlled trial comparing three 2nd-generation drug-eluting stents in real-world practice" (CHOICE trial).

BACKGROUND: The second-generation drug-eluting stents (DES) have shown superiority in many studies relating to safety and efficacy when compared with the first-generation DES. However, it is unclear whether there are differences in efficacy and safety among the second-generation DES after long-term follow-up. METHODS: This multicenter, prospective, randomized, open-labeled trial will directly compare the efficacy and safety among the patients treated with either everolimus-eluting stent (EES), zotarolimus-eluting stent with biolinx polymer (ZES-R), or biolimus-eluting stent (BES) with minimal exclusion criteria. The primary end point is a patient-oriented composite consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel and clinically indicated target lesion revascularization at 24-month clinical follow-up post-index procedure. With the hypothesis that "BES is non-inferior to EES" or "BES is non-inferior to ZES-R" in primary end point, approximately 2,600 patients will be assigned to one of the types of stents using a web-based randomization system. CONCLUSIONS: The CHOICE trial will directly compare the efficacy and safety of EES, ZES-R, and BES in everyday clinical practice for long-term follow-up.

Randomized comparison of everolimus-eluting stent versus sirolimus-eluting stent implantation for de novo coronary artery disease in patients with diabetes mellitus (ESSENCE-DIABETES): results from the ESSENCE-DIABETES trial.

BACKGROUND: Drug-eluting stents significantly improved angiographic and clinical outcomes compared with bare metal stents in diabetic patients. However, a comparison of everolimus-eluting stents and sirolimus-eluting stents in diabetic patients has not been evaluated. Therefore we compared effectiveness of everolimus-eluting stents and sirolimus-eluting stents in patients with diabetes mellitus. METHODS AND RESULTS: This prospective, multicenter, randomized study compared everolimus-eluting stent (n=149) and sirolimus-eluting stent (n=151) implantation in diabetic patients. The primary end point was noninferiority of angiographic in-segment late loss at 8 months. Clinical events were also monitored for at least 12 months. Everolimus-eluting stents were noninferior to sirolimus-eluting stents for 8-month in-segment late loss (0.23 ± 0.27 versus 0.37 ± 0.52 mm; difference, -0.13 mm; 95% confidence interval, -0.25 to -0.02; upper 1-sided 95% confidence interval, -0.04; P<0.001 for noninferiority), with reductions in in-stent restenosis (0% versus 4.7%; P=0.029) and in-segment restenosis (0.9% versus 6.5%; P=0.035). However, in-stent late loss (0.11 ± 0.26 versus 0.20 ± 0.49 mm; P=0.114) was not statistically different between the 2 groups. At 12 months, ischemia-driven target lesion revascularization (0.7% versus 2.6%; P=0.317), death (1.3% versus 3.3%; P=0.448), and myocardial infarction (0% versus 1.3%; P=0.498) were not statistically different between the 2 groups. Major adverse cardiac events, including death, myocardial infarction, and ischemia-driven target lesion revascularization (2.0% versus 5.3%; P=0.218), were also not statistically different between the 2 groups. CONCLUSION: Everolimus-eluting stents were noninferior to sirolimus-eluting stents in reducing in-segment late loss and reduced angiographic restenosis at 8 months in patients with diabetes mellitus and coronary artery disease.

Comparison of the efficacy and safety of paclitaxel-eluting coroflex please stents and paclitaxel-eluting stents in patients with coronary artery disease: a randomized PIPA trial.

OBJECTIVES: To compare the safety and efficacy of the new Coroflex™ Please stents with conventional Taxus™ Liberte stents in patients with coronary artery lesions. BACKGROUND: The Coroflex™ Please stent is a new version of paclitaxel-eluting stent, and observational cohort studies have reported similar angiographic and clinical outcomes as with the first-generation stents. However, it has not been directly compared with the early generation paclitaxel-eluting stents in a multicenter, prospective, and randomized study. METHODS: We randomly assigned 319 patients to receive Coroflex™ Please stents (159 patients; 198 lesions) or Taxus™ Liberte stents (160 patients; 232 lesions). The primary end point was angiographic in-segment late luminal loss at 9 months. RESULTS: Most baseline clinical and angiographic characteristics were similar between these two groups. The Coroflex™ Please and Taxus™ Liberte stents showed similar in-segment late loss (0.40 ± 0.53 mm vs. 0.39 ± 0.52 mm, P = 0.98) and rates of in-segment binary restenosis (22.2% vs. 18.8%, P = 0.48) at 9 months. After clinical follow-up for 12 months, the two groups had similar rates of death (1.3% vs. 1.3%, P > 0.99), myocardial infarction (3.8% vs. 7.5%, P = 0.22), stent thrombosis (2.5% vs. 1.9%, P = 0.72), and target-lesion revascularization (7.5% vs. 7.5%, P = 0.99). CONCLUSIONS: The Coroflex™ Please stent resulted in similar angiographic and clinical outcomes as the Taxus™ Liberte stent in patients with coronary artery lesions.

Diagnostic and Prognostic Value of Ergonovine Echocardiography for Noninvasive Diagnosis of Coronary Vasospasm.

OBJECTIVES: This study sought to obtain large-scale evidence supporting the clinical usefulness of ergonovine echocardiography. BACKGROUND: The role of noninvasive ergonovine provocation testing with echocardiographic monitoring of ventricular wall motion (ergonovine echocardiography) needs to be defined. METHODS: Clinical data of patients who underwent ergonovine echocardiography in 3 tertiary referral hospitals in South Korea were analyzed. RESULTS: Ergonovine echocardiography was performed in 14,012 patients (mean age 52.8 ± 11.1 years; 6,213 [44.3%] women) after exclusion of significant coronary arterial stenosis by functional (treadmill or perfusion scan, n = 9,824) or anatomic test (invasive or computerized tomographic coronary angiography, n = 4,188). Premature termination developed in 0.4% (n = 51), and a positive result was observed in 2,144 patients (15.3%), with variable frequencies according to the diagnosis (acute coronary syndrome [38.2%], variant angina [31.8%], effort angina [14.9%], aborted sudden cardiac death [17.6%], syncope [9.9%]). There was no mortality or development of myocardial infarction during the test. During median follow-up of 11.4 (interquartile range: 7.2 to 15.8) years, death of any cause and cardiovascular death occurred in 494 and 143 patients, respectively. The 10-year overall (96.7 ± 0.2% vs. 91.5 ± 0.6%; p < 0.0001) and cardiovascular mortality-free (99.2 ± 0.1% vs. 96.7 ± 0.4%; p < 0.0001) survival rates were lower in patients with positive ergonovine echocardiography. Regarding patients with positive test results, the functional test group and the anatomic test group did not show a significant difference in the survival rates. After adjustment of age and male sex, a positive test was an independent risk factor associated with all-cause mortality (hazard ratio: 1.879, 95% confidence interval: 1.548 to 2.280; p < 0.001) and cardiovascular death (hazard ratio: 2.903, 95% confidence interval: 2.061 to 4.089; p < 0.001). CONCLUSIONS: Ergonovine echocardiography for coronary vasospasm diagnosis could be safely performed even without angiographic documentation of fixed coronary stenosis depending on the clinical presentation, and provided important prognostic implication. Ergonovine echocardiography can replace the invasive spasm provocation testing, which has been overlooked unfairly.

A three-vessel virtual histology intravascular ultrasound analysis of frequency and distribution of thin-cap fibroatheromas in patients with acute coronary syndrome or stable angina pectoris.

The frequency and distribution of thin-cap fibroatheromas (TCFA) have important clinical implications. We evaluated the frequency and distribution of TCFA identified by virtual histology intravascular ultrasound (VH-IVUS) in acute coronary syndrome (ACS) and stable angina pectoris (SAP). Preintervention 3-vessel VH-IVUS was performed in 105 patients with ACS and 107 with SAP. The length of left anterior descending artery imaged was 72 +/- 16 mm-54 +/- 12 mm in the left circumflex and 92 +/- 19 mm in the right coronary. VH-IVUS-derived TCFA (VH-TCFA) had a necrotic core > or =10% of plaque area without overlying fibrous tissue in a plaque burden > or =40%. There were 76 ruptured plaques (55 in ACS and 21 in SAP) and 439 VH-TCFA (262 in ACS and 177 in SAP, 2.5 +/- 1.5 vs 1.7 +/- 1.1 TCFA per patient with ACS and with SAP, respectively; p <0.001). Twelve patients with ACS and 1 with SAP had multiple ruptured plaques (p <0.001); 76 patients with ACS and 58 with SAP had multiple VH-TCFA (p = 0.009). Presentation of ACS was the only independent predictor for multiple ruptured plaques (p = 0.013) or multiple VH-TCFA (p = 0.011). Eighty-three percent of VH-TCFA were located within 40 mm of the coronary: 111 < or =10 (25%), 110 from 11 to 20 (25%), 83 from 21 to 30 (19%), and 61 from 31 to 40 mm (14%). The axial distribution of VH-TCFA was similar in patients with ACS and those with SAP and was similar to the axial distribution of ruptured plaques. In conclusion, 3-vessel VH-IVUS imaging showed a higher frequency of VH-TCFA in primary and secondary lesions in patients with ACS compared with those with SAP, but showed a similar clustering of VH-TCFA in the proximal 40 mm of each coronary artery.

Late target lesion revascularization after implantation of sirolimus-eluting stent.

OBJECTIVES: We evaluated the incidence, clinical presentation, and angiographic in-stent restenosis (ISR) pattern of late target lesion revascularization (TLR) after sirolimus-eluting stent (SES) implantation. BACKGROUND: Late TLR is an unusual finding beyond 6-9 months after bare-metal stent implantation. However, late TLR after SES implantation has not been sufficiently evaluated. METHODS: The study population consisted of 804 patients with 1,020 native lesions that were patent at 6-month follow-up angiogram after SES implantation. RESULTS: Late TLR was performed in 18 patients with 18 lesions (1.8%) at 24.1 +/- 2.6 months (range; 18-30 months) after SES implantation. Clinical presentation of late TLR patients was silent ischemia in eight patients and recurrent angina in 10 patients, but none had an acute coronary syndrome. Angiographic ISR pattern of late TLR lesions were focal ISR in 12 lesions (67%) and diffuse ISR in six lesions (33%). Serial quantitative coronary angiographic analysis of these lesions showed a minimal lumen diameter of 2.6 +/- 0.5 mm immediately after SES implantation, 2.4 +/- 0.4 mm at 6-month follow-up and 0.7 +/- 0.6 mm at 24-month follow-up (ANOVA P < 0.001). By stepwise multiple logistic regression analysis, the only independent predictor of late TLR was stent length (P < 0.001, OR = 1.040, 95% CI = 1.019-1.061). CONCLUSIONS: Late TLR was performed in 1.8% of 1,020 native lesions that were patent at 6-month follow-up angiogram. Clinical presentations of late TLR was either silent ischemia or recurrent angina, but not acute coronary syndrome. Two-thirds of late TLR lesions had a focal angiographic ISR pattern.

High-intensity Statin Treatments in Clinically Stable Patients on Aspirin Monotherapy 12 Months After Drug-eluting Stent Implantation: A Randomized Study.

INTRODUCTION AND OBJECTIVES: Current guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. METHODS: Clinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40mg atorvastatin, n = 1000) or low-intensity (20mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). RESULTS: The primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. CONCLUSIONS: Among clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01557075.

Late stent malapposition after drug-eluting stent implantation: an intravascular ultrasound analysis with long-term follow-up.

BACKGROUND: Late stent malapposition (LSM) after drug-eluting stent (DES) implantation has not been evaluated sufficiently in real-world practice. METHODS AND RESULTS: We evaluated the incidence, mechanisms, predictors, and long-term prognosis of LSM after DES implantation in 557 patients (705 native lesions; sirolimus-eluting stent in 538 lesions and paclitaxel-eluting stent in 167 lesions) in whom intravascular ultrasound was performed at index and 6-month follow-up. LSM occurred in 82 patients with 85 lesions (12.1% overall, 95% CI 9.7% to 14.5%, 71 lesions (13.2%) in sirolimus-eluting stents and 14 lesions [8.4%] in paclitaxel-eluting stents, P=0.12]; the incidence was 25.0% (4/16) after directional coronary atherectomy before stenting, 27.5% (14/51) in chronic total occlusion lesions, and 31.8% (7/22) after primary stenting in acute myocardial infarction (P=0.13, P<0.001, and P=0.001, respectively, versus elective stenting with conventional balloon predilation, 9.7% [60/616]). There was an increase of external elastic membrane area (from 17.1+/-3.6 to 21.4+/-4.8 mm2, P<0.001) that was greater than the increase in plaque area (from 9.3+/-2.5 to 10.5+/-2.7 mm2, P<0.001). Independent predictors of LSM were total stent length, primary stenting in acute myocardial infarction, and chronic total occlusion lesions. Except for 1 death in the non-LSM group, there were no major adverse cardiac events in either LSM or non-LSM patients during a mean 10-month follow-up after detection of LSM. CONCLUSIONS: LSM occurs in 12% of cases after DES implantation. The predictors of LSM are total stent length, primary stenting in acute myocardial infarction, and chronic total occlusion lesions. LSM after DES implantation was not associated with any major adverse cardiac events during a subsequent 10-month (mean) follow-up.

Serial intravascular ultrasound evidence of both plaque stabilization and lesion progression in patients with ruptured coronary plaques: effects of statin therapy on ruptured coronary plaque.

Using serial intravascular ultrasound (IVUS), we evaluated the natural evolution of non-culprit/non-target lesion ruptured coronary plaques and assessed the impact of statin therapy. Twenty-eight patients with non-stenotic ruptured plaques underwent baseline and 12-month follow-up IVUS studies; half were treated with statins. Standard IVUS analyses were performed. Complete healing of ruptured plaques was observed in four (29%) statin-treated patients and no non-statin-treated patients (p=0.049). Statin-treated patients had an increase in lumen area of 0.4+/-0.8 mm2 (versus a decrease in lumen area of -0.6+/-1.0 mm2 in non-statin-treated patients, p=0.007) and no change in plaque area (versus an increase in plaque area of 0.6+/-0.9 mm2, p=0.051). During 1-year follow-up, target lesion revascularization was performed in three non-statin-treated patients (21%) and no statin-treated patient (p=0.11). Compared to lesions that did not require revascularization, lesions requiring revascularization had a decrease in lumen area (-1.7+/-1.4 mm2 versus 0.1+/-0.8 mm2, p=0.001) as well as an increase in plaque area (1.6+/-1.0 mm2 versus 0.1+/-0.7 mm2, p=0.002). In conclusion, the current observational follow-up IVUS study showed beneficial effects of statin treatment on reduction of revascularization rates and stabilization of non-culprit/non-target lesion plaque ruptures without significant stenosis. Conversely, healing of non-statin-treated non-culprit/non-target lesion plaque ruptures can be responsible for lesion progression requiring revascularization.

Comparison of virtual histology to intravascular ultrasound of culprit coronary lesions in acute coronary syndrome and target coronary lesions in stable angina pectoris.

Coronary plaque composition cannot be assessed accurately using gray-scale intravascular ultrasound (IVUS). Using virtual histology IVUS (VH-IVUS), a comparison of coronary plaque composition between acute coronary syndromes (ACS) and stable angina pectoris (SAP) was performed. Preintervention IVUS of de novo culprit and target lesions was performed in 318 patients (123 with ACS and 195 with SAP). Using VH-IVUS, plaque was characterized as fibrotic, fibrofatty, dense calcium, and necrotic core. VH-IVUS-derived thin-cap fibroatheroma (VH-TCFA) was defined as necrotic core>or=10% of plaque area without overlying fibrous tissue in a plaque burden>or=40%. Lesions were classified into 3 groups: ruptured, VH-TCFA, and non-VH-TCFA plaque. Unstable lesions were defined as either VH-TCFA or ruptured plaque. Compared with patients with SAP, those with ACS had significantly more unstable lesions (89% vs 62%, p<0.001). Planar VH-IVUS analysis at the minimum luminal site and at the largest necrotic core site and volumetric analysis over a 10-mm-long segment centered at the minimum luminal site showed that the percentage of necrotic core was significantly greater and that the percentage of fibrofatty plaque was significantly smaller in patients with ACS. The percentages of fibrotic and fibrofatty plaque areas and volumes were smaller, and the percentages of necrotic core areas and volumes were larger in VH-TCFAs compared with non-TCFAs. Ruptured plaques in VH-IVUS analyses showed intermediate findings between VH-TCFAs and non-VH-TCFAs. In conclusion, culprit lesions in patients with ACS were more unstable and had greater amounts of necrotic core and smaller amounts of fibrofatty plaque compared with target lesions in patients with SAP.

The site of plaque rupture in native coronary arteries: a three-vessel intravascular ultrasound analysis.

OBJECTIVES: We evaluated the axial location of plaque ruptures in native coronary arteries. BACKGROUND: It is clinically important to understand the potential sites of plaque rupture. METHODS: We performed three-vessel intravascular ultrasound (IVUS) examination in 392 patients; 231 had acute coronary syndrome (ACS) and 161 had stable angina pectoris (SAP). The IVUS detected plaque ruptures in 206 patients: 158 ACS patients and 48 SAP patients. The distance between each coronary plaque rupture segment and the respective coronary ostium was measured with motorized IVUS transducer pullback in all three coronary arteries. RESULTS: There were a total of 273 plaque ruptures in these 206 patients; 143 in the left anterior descending artery (LAD), 40 in the left circumflex artery (LCX), and 90 in the right coronary artery (RCA). There were 67 plaque ruptures in SAP patients and 206 in ACS patients; there were 197 culprit/target lesion plaque ruptures and 76 non-culprit/non-target lesion plaque ruptures. The LAD plaque ruptures were predominantly located between 10 and 40 mm from the LAD ostium (83%, 119 of 143). The LCX plaque ruptures were evenly distributed in the entire LCX tree. Most RCA plaque ruptures were located in segments between 10 and 40 mm (48%, 43 of 90) and in segments >70 mm from the ostium (32%, 29 of 90). CONCLUSIONS: Three-vessel IVUS imaging showed that plaque ruptures occurred mainly in proximal segments of the LAD (83% of LAD plaque rupture), the proximal and distal segments of the RCA (48% and 32% of RCA plaque ruptures, respectively), and the entire LCX.

Usefulness of follow-up low-density lipoprotein cholesterol level as an independent predictor of changes of coronary atherosclerotic plaque size as determined by intravascular ultrasound analysis after statin (atorvastatin or simvastatin) therapy.

Using serial intravascular ultrasound (IVUS), we identified independent predictors of changes in coronary plaque size in relation to serum lipid levels. One hundred three patients with nonstenotic coronary plaques underwent baseline and 12-month follow-up IVUS studies; 54 patients (52%) were treated with statins. Standard IVUS analyses were performed. Baseline IVUS study showed no statistical differences in mean external elastic membrane, lumen, and plaque/media (P&M) area between statin-treated and nonstatin-treated patients. Although there was an increase in mean P&M cross-sectional area in nonstatin-treated patients, mean P&M cross-sectional area decreased in statin-treated patients (0.11 +/- 0.24 vs -0.20 +/- 0.30 mm(2), p <0.001). There was a positive relation between changes in mean P&M area and follow-up low-density lipoprotein (LDL) cholesterol level (r = 0.430, p <0.001), follow-up total cholesterol level (r = 0.365, p <0.001), changes in LDL cholesterol level (r = 0.312, p = 0.002), and changes in total cholesterol level (r = 0.252, p = 0.012). In multivariate linear regression analysis, the only independent predictor of changes in mean P&M area was follow-up LDL cholesterol level (r = 0.469, p <0.001, 95% confidence interval 0.003 to 0.006). The cut-off value of follow-up LDL cholesterol for no change or a decrease in mean P&M area was <100 mg/dl at regression analysis. In conclusion, the present 12-month follow-up IVUS study showed that follow-up LDL cholesterol level was the only independent predictor of changes in coronary plaque size. When patients achieved a follow-up LDL cholesterol level <100 mg/dl, regression or no progression of coronary plaque was expected. Aggressive lipid-lowering treatments with statins to decrease the follow-up LDL cholesterol level to <100 mg/dl are recommended.

Comparison of Transradial and Transfemoral Approaches for Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome and Anemia.

Anemia is an independent predictor of bleeding complications and poor clinical outcomes after percutaneous coronary intervention. Percutaneous coronary transradial intervention (TRI) is better than percutaneous coronary transfemoral intervention (TFI) in terms of reducing bleeding complications that can affect the prognosis. This study aims to investigate the clinical outcomes between TRI and TFI for patients with anemia. We analyzed periprocedure complications, in-hospital mortality, and major adverse cardiac events for one year in the Korean TRI registry from January 2013 to April 2014. Patients with chronic kidney disease for whom TFI is preferred were excluded. Anemia was defined as hemoglobin <13 g/dl for men and <12 g/dl for women. A total of 1,279 patients were finally enrolled. Of these, 348 patients had anemia. Among them, 253 patients (72.7%) underwent TRI and 95 patients (27.3%) underwent TFI. There were no significant differences of baseline demographic characteristics between the TRI and TFI groups, except for the incidence of dyslipidemia (TRI 23.7% vs TFI 12.6%, p = 0.023). Multivariate logistic regression analysis revealed lower incidence of composite severe bleeding complications (hazard ratio 0.34, 95% CI 0.12 to 0.99, p = 0.049) and lower incidence of in-hospital mortality than TFI group (hazard ratio 0.74, 95% CI 0.62 to 0.88, p = 0.042). In conclusion, this study suggests that the TRI for patients with anemia may be translated into better prognosis in terms of lower rates of bleeding complications and in-hospital mortality.

Impact of diabetes mellitus on angiographic and clinical outcomes in the drug-eluting stents era.

The effect of diabetes mellitus (DM) on angiographic restenosis and clinical outcomes after implantation of drug-eluting stents (DESs) has not been investigated in real-world practice. This study consisted of 226 patients who had DM and 560 patients who did not who underwent DES implantation between February 2003 and December 2003. We retrospectively compared the incidence of 6-month angiographic restenosis and 9-month major adverse cardiac events (MACEs), defined as cardiac death, myocardial infarction, and target lesion revascularization, between patients with and without DM. The 6-month angiographic restenotic rate (10.1% vs 8.2%, p = 0.41) and late loss (0.41 +/- 0.63 vs 0.36 +/- 0.65, p = 0.31) were similar between patients with and without DM. In addition, incidences of MACEs (4.9% vs 4.8%, p = 1.00) and target lesion revascularization (4.4% vs 4.1%, p = 0.84) were similar. Patients who had insulin-dependent DM manifested higher prevalences of restenosis (25.0% vs 8.5%, p = 0.04) and MACEs (17.2% vs 3.1%, p = 0.01) compared with patients who had non-insulin-dependent DM. In conclusion, in this study of real-world patients who underwent DES implantation, patients who had DM had restenotic rates and clinical outcomes that were similar to those in patients who did not have DM.

Current Practice of Transradial Coronary Angiography and Intervention: Results from the Korean Transradial Intervention Prospective Registry.

BACKGROUND AND OBJECTIVES: Although increasing evidence has indicated that radial access is a beneficial technique, few studies have focused on Korean subjects. The aim of this study was to evaluate current practice of coronary angiography (CAG) and percutaneous coronary intervention (PCI) using radial access in South Korea. SUBJECTS AND METHODS: A total of 6338 subjects were analyzed from Korean Transradial Intervention prospective registry that was conducted at 20 centers in Korea. After evaluating the initial access, subjects intended for radial access were assessed for their baseline, procedure-related, and complication data. Subjects were categorized into three groups: group of overall subjects (n=5554); group of subjects who underwent PCI (n=1780); and group of subjects who underwent primary percutaneous coronary intervention (PPCI) (n=167). RESULTS: The rate of radial artery as an initial access and the rate of access site crossover was 87.6% and 4.4%, respectively, in overall subjects. Those rates were 82.4% and 8.1%, respectively, in subjects who underwent PCI, and 60.1% and 4.8%, respectively, in subjects who underwent PPCI. For subjects who underwent CAG, a 6-F introducer sheath and a 5-F angiographic catheter was the most commonly used. During PCI, a 6-F introducer sheath (90.6%) and a 6-F guiding catheter were standardly used. CONCLUSION: The large prospective registry allowed us to present the current practice of CAG and PCI using radial access. These data provides evidence to achieve consensus on radial access in CAG and PCI in the Korean population.