Search

Background: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stents and coronary artery bypass grafting (CABG) are limited in patients with multivessel coronary artery disease. Methods: This prospective, multicenter, randomized controlled trial was conducted in 27 international heart centers and was designed to randomly assign 1776 patients with angiographic multivessel coronary artery disease to receive PCI with everolimus-eluting stents or CABG. After inclusion of 880 patients (438 in the PCI group and 442 in the CABG group) between July 2008 and September 2013, the study was terminated early because of slow enrollment. The primary end point was the composite of death from any cause, myocardial infarction, or target vessel revascularization. Results: During a median follow-up of 11.8 years (interquartile range, 10.6–12.5 years; maximum, 13.7 years), the primary end point occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio [HR], 1.18 [95% CI, 0.88–1.56]; P =0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%; HR, 1.07 [95% CI, 0.75–1.53]; P =0.70), as well as the occurrence of death from any cause (20.5% and 19.9%; HR, 1.04 [95% CI, 0.65–1.67]; P =0.86). However, spontaneous myocardial infarction (7.1% and 3.8%; HR, 1.86 [95% CI, 1.06–3.27]; P =0.031) and any repeat revascularization (22.6% and 12.7%; HR, 1.92 [95% CI, 1.58–2.32]; P Conclusions: In patients with multivessel coronary artery disease, there were no significant differences between PCI and CABG in the incidence of major adverse cardiac events, the safety composite end point, and all-cause mortality during the extended follow-up. Registration: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT05125367 and NCT00997828.

Background: It is unknown whether the direct oral anticoagulant edoxaban can reduce leaflet thrombosis and the accompanying cerebral thromboembolic risk after transcatheter aortic valve replacement. In addition, the causal relationship of subclinical leaflet thrombosis with cerebral thromboembolism and neurological or neurocognitive dysfunction remains unclear. Methods: We conducted a multicenter, open-label randomized trial comparing edoxaban with dual antiplatelet therapy (aspirin plus clopidogrel) in patients who had undergone successful transcatheter aortic valve replacement and did not have an indication for anticoagulation. The primary end point was an incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months. Key secondary end points were the number and volume of new cerebral lesions on brain magnetic resonance imaging and the serial changes of neurological and neurocognitive function between 6 months and immediately after transcatheter aortic valve replacement. Results: A total of 229 patients were included in the final intention-to-treat population. There was a trend toward a lower incidence of leaflet thrombosis in the edoxaban group compared with the dual antiplatelet therapy group (9.8% versus 18.4%; absolute difference, −8.5% [95% CI, −17.8% to 0.8%]; P =0.076). The percentage of patients with new cerebral lesions on brain magnetic resonance imaging (edoxaban versus dual antiplatelet therapy, 25.0% versus 20.2%; difference, 4.8%; 95% CI, −6.4% to 16.0%) and median total new lesion number and volume were not different between the 2 groups. In addition, the percentages of patients with worsening of neurological and neurocognitive function were not different between the groups. The incidence of any or major bleeding events was not different between the 2 groups. We found no significant association between the presence or extent of leaflet thrombosis with new cerebral lesions and a change of neurological or neurocognitive function. Conclusions: In patients without an indication for long-term anticoagulation after successful transcatheter aortic valve replacement, the incidence of leaflet thrombosis was numerically lower with edoxaban than with dual antiplatelet therapy, but this was not statistically significant. The effects on new cerebral thromboembolism and neurological or neurocognitive function were also not different between the 2 groups. Because the study was underpowered, the results should be considered hypothesis generating, highlighting the need for further research. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03284827.

Introduction: Single center data suggest that the index of microcirculatory resistance (IMR) measured early after heart transplantation predicts subsequent acute cellular rejection. Hypothesis: To validate whether IMR measured early after transplantation can predict subsequent acute cellular rejection and long-term outcome in a large multicenter cohort. Methods: From 5 international heart transplantation cohorts, 237 patients who underwent IMR measurement early after transplantation were enrolled. The primary outcome was biopsy-proven acute cellular rejection of grade 2 or 3 within 1 year after transplantation. A key secondary outcome was major adverse cardiac events (MACE, the composite of death, re-transplantation, myocardial infarction, stroke, graft dysfunction, and readmission due to a cardiac cause) at 10 years. Results: IMR was measured at a median of 7 weeks (interquartile range: 3 to 10 weeks) post-transplantation. Patients with acute cellular rejection grade 2 or 3 at the time of IMR assessment were excluded. At 1 year, the incidence of acute cellular rejection was 14.0%. IMR was associated proportionally with the risk of acute cellular rejection (per increase of 1-unit IMR; adjusted hazard ratio [aHR], 1.04; 95% confidence interval [CI], 1.01-1.06; P=0.002). The incidence of acute cellular rejection in patients with IMR ≥ 18 was 23.8%, while the incidence of acute cellular rejection in those with IMR < 18 was 5.5% (aHR, 4.09; 95% CI, 1.67-10.0; P=0.002). At 10 years, MACE occurred in 86 (36.3%) patients. IMR was significantly associated with the risk of MACE (per increase of 1-unit IMR; aHR, 1.03; 95% CI, 1.01-1.05; P=0.002). Conclusions: IMR measured early after heart transplantation is associated with subsequent acute cellular rejection at 1 year and clinical events at 10 years. Early IMR measurement after transplantation identifies patients at higher risk and may guide personalized post-transplantation management.

Background: Myocardial viability test to guide revascularization remains uncertain in patients with ischemic cardiomyopathy. We aimed to evaluate the different impacts of revascularization on cardiac mortality according to the extent of myocardial scar assessed by cardiac magnetic resonance with late gadolinium enhancement (LGE-CMR) in patients with ischemic cardiomyopathy. Methods: A total of 404 consecutive patients with significant coronary artery disease and an ejection fraction ≤35% were assessed by LGE-CMR before revascularization. Of them, 306 patients underwent revascularization and 98 patients received medical treatment alone. The primary outcome was cardiac death. Results: During a median follow-up of 6.3 years, cardiac death occurred in 158 (39.1%) patients. Revascularization was associated with a significantly lower risk of cardiac death than medical treatment alone in the overall population (adjusted hazard ratio [aHR], 0.29; 95% confidence interval [CI], 0.19-0.45; P < 0.001). There was a significant interaction between the number of segments with 76%-100% transmural LGE and revascularization on the risk of cardiac death (P = 0.037 for interaction). In patients with limited myocardial scar (< 6 segments with 76%-100% transmural LGE, N = 354), revascularization had a significantly lower risk of cardiac death than medical treatment alone (aHR, 0.24; 95% CI, 0.15-0.37; P < 0.001); in patients with extensive myocardial scar (≥ 6 segments with 76-100% transmural LGE, N = 50), there was no significant difference between revascularization and medical treatment alone regarding the risk of cardiac death (aHR, 1.33; 95% CI, 0.46-3.80; P = 0.60). Conclusions: Assessment of myocardial scar by LGE-CMR may be helpful in the decision-making process for revascularization in patients with ischemic cardiomyopathy.

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.

Objective: Post cardiac arrest patients experience neurologic and systemic ischemic-reperfusion injury. Uric acid (UA) can be a marker of oxidative stress and severity of various cardiogenic diseases, but also has antioxidant capacity with neuroprotective effects. We aimed to evaluate the association between initial UA and neurologic outcomes of survivors of non-cardiogenic and cardiogenic causes of cardiac arrest. Methods: This was a retrospective observational study of out of hospital post cardiac arrest patients who had initial UA at admission. Association between UA and cardiogenic cause of arrest was analyzed by linear regression. Then neurologic outcome and UA was assessed with multivariate logistic regression analysis by cardiogenic and non-cardiogenic cause of arrest. Results: A total of 126 patients were analyzed. UA was significantly lower in the poor neurologic outcome group than in the good neurologic outcome group [7.9 (1.6) vs. 7.0 (1.8), P Conclusion: With respect to neurologic outcome by cardiogenic cause of arrest, lower uric acid was associated with poor neurologic outcomes in non-cardiogenic causes of arrest.

Background: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents and coronary-artery bypass grafting (CABG) for left main coronary artery disease are highly debated. Methods: In the PRECOMBAT trial (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease), patients with unprotected left main coronary artery disease were randomly assigned to undergo PCI with sirolimus-eluting stents (n=300) or CABG (n=300) in 13 hospitals in Korea from April 2004 to August 2009. The follow-up was extended to at least 10 years for all patients (median, 11.3 years). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization). Results: At 10 years, a primary outcome event occurred in 29.8% of the PCI group and in 24.7% of the CABG group (hazard ratio [HR] with PCI vs CABG, 1.25 [95% CI, 0.93–1.69]). The 10-year incidence of the composite of death, myocardial infarction, or stroke (18.2% vs 17.5%; HR 1.00 [95% CI, 0.70–1.44]) and all-cause mortality (14.5% vs 13.8%; HR 1.13 [95% CI, 0.75–1.70]) were not significantly different between the PCI and CABG groups. Ischemia-driven target-vessel revascularization was more frequent after PCI than after CABG (16.1% vs 8.0%; HR 1.98 [95% CI, 1.21–3.21). Conclusions: Ten-year follow-up of the PRECOMBAT trial of patients with left main coronary artery disease randomized to PCI or CABG did not demonstrate significant difference in the incidence of major adverse cardiac or cerebrovascular events. Because the study was underpowered, the results should be considered hypothesis-generating, highlighting the need for further research. Registration: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT03871127 and NCT00422968.

Background: Poor nutrition is associated with mortality in critically ill patients. Also overweight BMI, low albumin is known to be associated with poor neurologic outcome in post cardiac arrest patients. We aimed to assess the association between initial nutritional status and poor neurologic outcome in post cardiac arrest patients. Methods: The nutrition support team(NST) initially assesse all patients admitted to the ICU in 24 hours of admission. All patients are screened for initial nutrition status with age, height, weight, laboratory results, signs of poor nutrition, nutrition risk comorbidities into consideration. We retrospectively analyzed the nutrition risk from the initial nutrition risk record assessed by NST and compared the nutrition risk between outcome groups. Furthermore, we did a multivariate logistic regression correcting for confounding variables to investigate the association between the initial nutrition risk and neurologic outcome. Results: High nutrition risk was associated with poor neurologic outcome (OR 3.03 [1.25-7.33], p=0.01) compared to the low nutritional risk group after adjusting for age, sex, CPR duration and initial shockable rhythm. Conclusion: High initial nutrition risk was associated with poor neurologic outcomes in our study.

Background: Owing to the differential propensity for bleeding and ischemic events with response to antiplatelet therapy, the safety and effectiveness of potent P2Y12 inhibitor ticagrelor in East Asian populations remain uncertain. Methods: In this multicenter trial, 800 Korean patients hospitalized for acute coronary syndromes with or without ST elevation and intended for invasive management were randomly assigned to receive, in a 1:1 ratio, ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (600 mg loading dose, 75 mg daily thereafter). The primary safety outcome was clinically significant bleeding (a composite of major bleeding or minor bleeding according to PLATO (Platelet Inhibition and Patient Outcomes) criteria at 12 months. Results: At 12 months, the incidence of clinically significant bleeding was significantly higher in the ticagrelor group than in the clopidogrel group (11.7% [45/400] vs 5.3% [21/400]; hazard ratio [HR], 2.26; 95% confidence interval [CI], 1.34 to 3.79; P =0.002). The incidences of major bleeding (7.5% [29/400] vs 4.1% [16/400], P =0.04) and fatal bleeding (1% [4/400] vs 0%, P =0.04) were also higher in the ticagrelor group. The incidence of death from cardiovascular causes, myocardial infarction, or stroke was not significantly different between the ticagrelor group and the clopidogrel group (9.2% [36/400] vs 5.8% [23/400]; HR, 1.62; 95% CI, 0.96 to 2.74; P =0.07). Overall safety and effectiveness findings were similar with the use of several different analytic methods and in multiple subgroups. Conclusions: In Korean acute coronary syndrome patients intended to receive early invasive management, standard-dose ticagrelor as compared with clopidogrel was associated with a higher incidence of clinically significant bleeding. The numerically higher incidence of ischemic events should be interpreted with caution, given the present trial was underpowered to draw any conclusion regarding efficacy. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02094963.

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.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.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.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.URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

We thank Drs Jin-Shan and Xue-Bin for their interest and thoughtful questions on our work.1 First, they asked the indication of fractional flow reserve (FFR) measurement. American practice guideline suggests that FFR measurement is reasonable to assess angiographic intermediate coronary stenosis (50%–70% diameter stenosis). A more recent consensus document has extended FFR use up to 90% diameter stenosis because ≈20% of coronary stenoses with 70% to 90% diameter stenosis are functionally insignificant.2 In addition, although diameter stenosis is

Background: We evaluated the prognosis of deferred and revascularized coronary stenoses after fractional flow reserve (FFR) measurement to assess its revascularization threshold in clinical practice. Methods: The IRIS-FFR registry (Interventional Cardiology Research In-cooperation Society Fractional Flow Reserve) prospectively enrolled 5846 patients with ≥1coronary lesion with FFR measurement. Revascularization was deferred in 6468 lesions and performed in 2165 lesions after FFR assessment. The primary end point was major adverse cardiac events (cardiac death, myocardial infarction, and repeat revascularization) at a median follow-up of 1.9 years and analyzed on a per-lesion basis. A marginal Cox model accounted for correlated data in patients with multiple lesions, and a model to predict per-lesion outcomes was adjusted for confounding factors. Results: For deferred lesions, the risk of major adverse cardiac events demonstrated a significant, inverse relationship with FFR (adjusted hazard ratio, 1.06; 95% confidence interval, 1.05–1.08; P P =0.70). For lesions with FFR ≥0.76, the risk of major adverse cardiac events was not significantly different between deferred and revascularized lesions. Conversely, in lesions with FFR ≤0.75, the risk of major adverse cardiac events was significantly lower in revascularized lesions than in deferred lesions (for FFR 0.71–0.75, adjusted hazard ratio, 0.47; 95% confidence interval, 0.24–0.89; P =0.021; for FFR ≤0.70, adjusted hazard ratio 0.47; 95% confidence interval, 0.26–0.84; P =0.012). Conclusions: This large, prospective registry showed that the FFR value was linearly associated with the risk of cardiac events in deferred lesions. In addition, revascularization for coronary artery stenosis with a low FFR (≤0.75) was associated with better outcomes than the deferral, whereas for a stenosis with a high FFR (≥0.76), medical treatment would be a reasonable and safe treatment strategy. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01366404.

Background— We report findings from optical coherence tomography (OCT) of in-stent neoatherosclerosis as a cause of drug-eluting stent (DES) failure. Methods and Results— Optical coherence tomography and grayscale and virtual histology intravascular ultrasound were performed in 50 patients (30 stable, 20 unstable angina) with 50 DES in-stent restenosis lesions and intimal hyperplasia >50% of stent area. Median follow-up time was 32.2 months. Overall, 26 lesions (52%) had at least 1 OCT-defined in-stent thin-cap fibroatheroma (TCFA)–containing neointima and 29 (58%) had at least 1 in-stent neointimal rupture. Patients presenting with unstable angina showed a thinner fibrous cap (55 μm [interquartile range 42 to 105 μm] versus 100 μm [interquartile range 60 to 205 μm], P =0.006) and higher incidence of OCT-defined TCFA-containing neointima (75% versus 37%, P =0.008), intimal rupture (75% versus 47%, P =0.044), thrombi (80% versus 43%, P =0.010), and red thrombi (30% versus 3%, P =0.012) than stable patients. Fibrous cap thickness negatively correlated with follow-up time ( r =−0.318, P =0.024). Compared with DES P =0.012) and red thrombi (27% versus 0%, P =0.007). Patients with unstable (versus stable) angina had an increasing number of unstable OCT findings including TCFA-containing neointima, neointima rupture, and thrombus ( P =0.027). The rate of agreement between grayscale intravascular ultrasound and OCT for detecting intimal rupture was 50% and for detecting thrombus was 44%. The agreement between virtual histology intravascular ultrasound and OCT for identifying TCFA-containing neointima was 78%. Conclusions— In-stent neoatherosclerosis may be an important mechanism of DES failure, especially late after implantation.

Background— This study sought to evaluate the clinical impact of angiographic complete revascularization (CR) after drug-eluting stent implantation or coronary artery bypass graft surgery for multivessel coronary disease. Methods and Results— A total of 1914 consecutive patients with multivessel coronary disease undergoing drug-eluting stent implantation (1400 patients) or coronary artery bypass graft surgery (514 patients) were enrolled. Angiographic CR was defined as revascularization in all diseased segments according to the Synergy Between PCI With Taxus and Cardiac Surgery classification. The outcomes of patients undergoing CR were compared with those undergoing incomplete revascularization (IR) after adjustments with the inverse-probability-of-treatment weighting method. Angiographic CR was performed in 917 patients (47.9%) including 573 percutaneous coronary intervention (40.9%) and 344 coronary artery bypass graft (66.9%) patients. CR patients were younger and had more extensive coronary disease than IR patients. Over 5 years, CR patients had comparable incidences of death (8.9% versus 8.9%; adjusted hazard ratio, 1.04; 95% confidence interval, 0.76 to 1.43; P =0.81), the composite of death, myocardial infarction, and stroke (12.1% versus 11.9%; adjusted hazard ratio, 1.04; 95% confidence interval, 0.79 to 1.36; P =0.80), and the composite of death, myocardial infarction, stroke, and repeat revascularization (22.4% versus 24.9%; adjusted hazard ratio, 0.91; 95% confidence interval, 0.75 to 1.10; P =0.32) compared with IR patients. However, 368 patients (19.2%) with multivessel IR had a greater tendency toward higher risk of death, myocardial infarction, stroke, or repeat revascularization (30.3% versus 22.1%; adjusted hazard ratio, 1.27; 95% confidence interval, 0.97 to 1.66; P =0.079) than those without multivessel IR. Conclusions— Angiographic CR with drug-eluting stent implantation or coronary artery bypass grafting did not improve long-term clinical outcomes in patients with multivessel disease. This finding supports the strategy of ischemia-guided revascularization.

Background— Although C-reactive protein (CRP) has been proposed as a useful biomarker for predicting atherothrombosis, the association between CRP and stent thrombosis after drug-eluting stent implantation has not been defined. Methods and Results— We prospectively evaluated 2691 patients treated with drug-eluting stents who had a baseline CRP measurement. The primary outcome was stent thrombosis; secondary outcomes were death, myocardial infarction (MI), death or MI, and target vessel revascularization. During follow-up (median, 3.9 years), 32 patients had definite or probable stent thrombosis, 137 patients died, 227 had an MI, and 195 underwent target vessel revascularization. In multivariable Cox proportional-hazards models, elevated levels of CRP were significantly associated with increased risk of stent thrombosis (hazard ratio, 3.86; 95% confidence interval, 1.82 to 8.18; P P =0.008), MI (hazard ratio, 1.63; 95% confidence interval, 1.25 to 2.12; P =0.001), and death or MI (hazard ratio, 1.61; 95% confidence interval, 1.29 to 2.00; P P =0.21). The incorporation of CRP into a model with patient, lesion, and procedural factors resulted in a significant increase in the C statistic for the prediction of stent thrombosis, MI, and the composite of death or MI. Conclusions— Elevated CRP levels were significantly associated with increased risks of stent thrombosis, death, and MI in patients receiving drug-eluting stents, suggesting the usefulness of inflammatory risk assessment with CRP. Given the relatively infrequent occurrence of stent thrombosis, death, and MI, larger studies with longer-term follow-up are required to confirm the novel relationship.

Background— Limited information is available on long-term outcomes for patients with unprotected left main coronary artery disease who received drug-eluting stents (DES). Methods and Results— In the multicenter registry evaluating outcomes among patients with unprotected left main coronary artery stenosis undergoing stenting with either bare metal stents (BMS) or DES, 1217 consecutive patients were divided into 2 groups: 353 who received only BMS and 864 who received at least 1 DES. The 3-year outcomes were compared by use of the adjustment of inverse-probability-of-treatment-weighted method. Patients receiving DES were older and had a higher prevalence of diabetes mellitus, hypertension, hyperlipidemia, and multivessel disease. In the overall population, with the use of DES, the 3-year adjusted risk of death (8.0% versus 9.5%; hazard ratio, 0.71; 95% confidence interval, 0.36 to 1.40; P =0.976) or death or myocardial infarction (14.3% versus 14.9%; hazard ratio, 0.83; 95% confidence interval, 0.49 to 1.40; P =0.479) was similar compared with BMS. However, the risk of target lesion revascularization was significantly lower with the use of DES than BMS (5.4% versus 12.1%; hazard ratio, 0.40; 95% confidence interval, 0.22 to 0.73; P =0.003). When patients were classified according to lesion location, DES was still associated with lower risk of target lesion revascularization in patients with bifurcation (6.9% versus 16.3%; hazard ratio, 0.38; 95% confidence interval, 0.18 to 0.78; P =0.009) or nonbifurcation (3.4% versus 10.3%; hazard ratio, 0.39; 95% confidence interval, 0.17 to 0.88; P =0.024) lesions with a comparable risk of death or myocardial infarction. Conclusions— Compared with BMS, DES was associated with a reduction in the need for repeat revascularization without increasing the risk of death or myocardial infarction for patients with unprotected left main coronary artery stenosis.

Background— The safety and efficacy of drug-eluting stents (DES) among more generalized “real-world” patients than those enrolled in pivotal randomized controlled trials (RCTs) are controversial. We sought to perform a meta-analysis of DES studies to estimate the relative impact of DES versus bare metal stents (BMS) on safety and efficacy end points, particularly for non–Food and Drug Administration–labeled indications. Methods and Results— Comparative DES versus BMS studies published or presented through February 2008 with ≥100 total patients and reporting mortality data with cumulative follow-up of ≥1 year were identified. Data were abstracted from studies comparing DES with BMS; original source data were used when available. Data from 9470 patients in 22 RCTs and from 182 901 patients in 34 observational studies were included. RCT and observational data were analyzed separately. In RCTs, DES (compared with BMS) were associated with no detectable differences in overall mortality (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.81 to 1.15; P =0.72) or myocardial infarction (HR, 0.95; 95% CI, 0.79 to 1.13; P =0.54), with a significant 55% reduction in target vessel revascularization (HR, 0.45; 95% CI, 0.37 to 0.54; P Conclusions— In RCTs, no significant differences were observed in the long-term rates of death or myocardial infarction after DES or BMS use for either off-label or on-label indications. In real-world nonrandomized observational studies with greater numbers of patients but the admitted potential for selection bias and residual confounding, DES use was associated with reduced death and myocardial infarction. Both RCTs and observational studies demonstrated marked and comparable reductions in target vessel revascularization with DES compared with BMS. These data in aggregate suggest that DES are safe and efficacious in both on-label and off-label use but highlight differences between RCT and observational data comparing DES and BMS.

Background— Although previous studies have compared the treatment effects of percutaneous coronary intervention and coronary artery bypass grafting (CABG), the long-term outcomes beyond 1 year among patients with multivessel coronary artery disease who underwent percutaneous coronary intervention with drug-eluting stents (DES) or CABG have not been evaluated. Methods and Results— Between January 2003 and December 2005, 3042 patients with multivessel disease underwent coronary implantation of DES (n=1547) or CABG (n=1495). The primary end point was all-cause mortality. In a crude analysis, the rate of long-term mortality was significantly higher in patients who underwent CABG than in those who underwent DES implantation (3-year unadjusted mortality rate, 7.0% for CABG versus 4.4% for percutaneous coronary intervention; P =0.01). However, after adjustment for baseline differences, the overall risks of death were similar among all patients (hazard ratio, 0.85; 95% confidence interval [CI], 0.56 to 1.30; P =0.45), diabetic patients (hazard ratio, 1.76; 95% CI, 0.82 to 3.78; P =0.15), and patients with compromised ventricular function (hazard ratio, 1.39; 95% CI, 0.41 to 4.65; P =0.60). In the anatomic subgroups, mortality benefit with DES implantation was noted in patients with 2-vessel disease with involvement of the nonproximal left anterior descending artery (hazard ratio, 0.23; 95% CI, 0.01 to 0.78; P =0.016). The rate of revascularization was significantly higher in the DES than in the CABG group (hazard ratio, 2.81; 95% CI, 2.11 to 3.75; P Conclusions— For the treatment of multivessel coronary artery disease, percutaneous coronary intervention with DES implantation showed equivalent long-term mortality as CABG.

Objective: No significant evidence basis exists for who and when a preoperative cardiac consultation should be obtained. We sought to define the variation in preoperative cardiology for patients requiring a vascular surgical procedure and determine whether this was associated with differences in perioperative myocardial infarction (poMI) or death. Methods: A 29 hospital statewide QI collaborative were queried for open aortic aneurysm repair, EVAR, and open vascular bypass procedures. Preprocedure documented cardiac consultation as well as stress testing was determined as part of the database. The primary outcome was poMI and death. Results: Among 5191 patients, 48% had a documented preoperative cardiac cardiology consultation, with the poMI rate of 2.1% and a 1.3% death rate. Across hospitals, preoperative cardiac consultation varied from 50%) cardiology consultation rates as compared to lower consultation hospitals. Discussion: Preoperative cardiology consultation for vascular surgical patients varies greatly between institutions. Cardiology consultation was not associated with better utilization of cardioprotective medications nor was it associated with a lower incidence of death or myocardial infarction. MI Frequency by Cardiac Consultation

Introduction: Percutaneous mitral commissurotomy (PMC) using either the Inoue or the double balloon technique showed similar, excellent 7-year outcomes, but very late results after successful PMC have been unknown. Hypothesis: We assessed late results of PMC up to 20 years in a randomized trial comparing Inoue versus double-balloon technique. Methods: Between 1989 and 1995, a total of 302 patients (77 men, 41±11 years) with severe mitral stenosis were randomly assigned to undergo PMC using Inoue (n=152; group I) or double-balloon technique (n=150; group D). The end points were the composite clinical events of death, mitral surgery, repeat PMC, or deterioration of NYHA class ≥3 that occurred after enrollment. Results: The successful immediate results [post-PMC mitral valve area (MVA) ≥1.5 cm 2 and mitral regurgitation (MR) grade ≤2] were achieved in 127 (84%) patients of group I and 122 (81%) patients of group D (p= NS). During median follow-up of 20.7 years (IQR, 18.9 to 22.9), clinical events occurred in 82 (53.9%) patients of group I (37 deaths, 44 mitral surgeries, 9 repeat PMCs and 3 NYHA class ≥3) and 79 (52.7%) patients of group I (34 deaths, 51 mitral surgeries, 5 repeat PMCs and 4 NYHA class ≥3). The event-free survival rates were not significantly different between group I and group D (49.3% and 55.3% at 20 years, respectively; HR, 1.22; 95% CI, 0.88-1.70; p=0.23) (Figure). On multivariate Cox analysis, absence of commissural MR (HR, 1.75; 95% CI, 1.22-2.51; p=0.002), immediate post-PMC MVA 2 (HR, 1.54; 95% CI, 1.04-2.27; p=0.03), and atrial fibrillation (HR, 1.53; 95% CI, 1.04-2.23; p=0.03) were independently related with clinical events after successful PMC. Conclusions: In this randomized trial, the Inoue and double-balloon methods showed similar, good outcomes up to 20 years, and the achievement of effective commissurotomy with development of commissural MR or immediate post-PMC MVA ≥1.8cm 2 is important in optimizing the late results of PMC.

Background: There is a paucity of data comparing pharmacoinvasive treatment (PI) versus primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI) in real world patients. Methods: We employed the Korea Acute Myocardial Infarction Registry to identify patients with STEMI who received either PI defined as fibrinolysis followed by PCI (rescue/urgent or elective) or PPCI. Patients receiving facilitated PCI within 3 hours from fibrinolysis were excluded. Propensity-matched 12-month clinical outcome was compared between the 2 groups. Results: In all patients (n = 9,586), PI group (n = 708) was younger, more often male, smokers, more likely to have typical chest pain and off-hour hospital arrival. PPCI group (n = 8,878) was more likely to have diabetes, lower blood pressure, higher Killip class and to receive glycoprotein IIb/IIIa inhibitors. PI group had shorter symptom-to-first medical contact (FMC) time (60 min vs. 80 min, p < 0.001), symptom-to-reperfusion time (165 min vs. 255 min, p < 0.001), and higher rate of pre-PCI Thrombolysis In Myocardial Infarction (TIMI) 3 (50.6% vs. 13.6%, p < 0.001). However, rate of post-PCI TIMI 3 was similar between the 2 groups. After propensity matching (n = 708 for each group), PI group had similar symptom-to-FMC time but had shorter symptom-to-reperfusion time (165 min vs. 240 min, p < 0.001), higher pre-PCI TIMI 3 rate (15.8% vs. 50.6%, p < 0.001) with similar post-PCI TIMI 3 rate. In all patients, PI group had lower rates of 12-month death (4.4% vs. 6.4%, hazard ratio [HR]: 0.64, 95% confidence interval [CI]: 0.44 to 0.92, p = 0.015) and major adverse cardiac events (MACE: composite of death, recurrent myocardial infarction, repeat revascularization) (7.5% vs. 9.5%, HR: 0.69, 95% CI: 0.52 to 0.92, p = 0.010). In propensity-matched cohorts, 12-month mortality and MACE were similar between PI and PPCI: 4.4% vs. 2.8%, HR: 1.60, 95% CI: 0.91 to 2.84, p = 0.105 and 7.5% vs. 7.6%, HR: 0.96, 95% CI: 0.65 to 1.41, p = 0.827, respectively. Conclusions: In this large observational study with propensity-matched analysis, STEMI patients receiving PI, compared to PPCI, had shorter symptom-to-reperfusion time, higher culprit-vessel patency, and similar 12-month clinical outcome.

Background— Mild commissural mitral regurgitation (MR) is associated with significantly higher restenosis-free survival after percutaneous mitral valvuloplasty (PMV), which suggests that different mechanisms of significant MR after PMV may have different clinical courses. We therefore analyzed long-term prognostic factors of significant MR after PMV. Methods and Results— Echocardiographic and clinical follow-up data on 380 patients were analyzed (286 women, mean age 44±11 years) who underwent PMV with the Inoue balloon technique between 1995 and 2000. Significant MR developed in 47 patients (12.4%). The survival rate at 8 years was 96±3% and 98±10% in patients with and without significant MR, respectively ( P =0.084). The most frequent mechanism was commissural MR, or MR that originated at the site of successful commissurotomy, which occurred in 27 of 47 patients (57%), whereas noncommissural MR occurred in 20 (43%) patients, 12 (26%) with subvalvular damage resulting in chordae rupture and flail motion and 8 (17%) with leaflet laceration. The 8-year event-free survival rate was significantly lower in patients with significant MR than in those without (47±8% versus 83±3%, P P P P =0.038), mean mitral gradient immediately after PMV (odds ratio, 1.5; 95% CI, 1.1 to 2.0; P =0.009), and the mechanism of MR (odds ratio, 16.7; 95% CI, 2.3 to 122.2; P =0.005) were independent factors associated with mitral valve replacement. Conclusions— Clinical outcome of patients with significant MR after PMV varied according to MR mechanism and the adequacy of hemodynamic improvement, which is easily assessed by echocardiography immediately after PMV.

Background— Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments. This study compared sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) for long coronary lesions. Methods and Results— The present randomized, multicenter, prospective study compared the use of long (≥32 mm) SES with PES in 500 patients with long (≥25 mm) native coronary lesions. The primary end point of the trial was the rate of binary in-segment restenosis according to follow-up angiography at 6 months. The SES and PES groups had similar baseline characteristics. Lesion length was 33.9±11.6 mm in the SES group and 34.5±12.6 mm in the PES group ( P =0.527). The in-segment binary restenosis rate was significantly lower in the SES group than in the PES group (3.3% versus 14.6%; relative risk 0.23; P P P =0.031). Consequently, SES patients had a lower rate of target-lesion revascularization at 9 months (2.4% versus 7.2%, P =0.012). The incidence of death (0.8% in SES versus 0% in PES, P =0.499) or myocardial infarction (8.8% in SES versus 10.8% in PES, P =0.452) at 9 months of follow-up was not statistically different between the 2 groups. Conclusions— For patients with long native coronary artery disease, SES implantation was associated with a reduced incidence of angiographic restenosis and a reduced need for target-lesion revascularization compared with PES implantation.

The anatomic Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) score is a stratification score illustrating the complexity of angiographic stenosis. It was considered a surrogate for poor prognosis after percutaneous coronary intervention (PCI).1 Accordingly, in patients with a high baseline SYNTAX score (bSS) requiring coronary revascularization, coronary artery bypass graft surgery was chosen over PCI in the current guidelines.2,3 The mechanism by which bSS is a good surrogate for long-term prognosis is evident. Patients with a high bSS compared with those with a low bSS have more complex comorbidities such as old age, diabetes mellitus, multiple stenoses, and low left ventricular function. Subsequently, they receive more complex procedures using multiple stents and devices. Since the SYNTAX score II was revised by taking into consideration clinical risk factors, the function of the scoring model in choosing between PCI and coronary artery bypass graft surgery and prognosis prediction has improved.4 Article see p 141 The residual SYNTAX score (rSS), which is a variant of the SYNTAX score, was recently constructed to represent the extent of untreated coronary lesions after revascularization treatment. In the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) study, comprising patients with acute coronary syndrome, there was a stepwise increase in the rate of major adverse cardiac events, including death, myocardial infarction, and unplanned revascularization, in patients with an rSS of 0 (16.3%), >0 to 2 (18.0%), >2 to 8 (20.0%), and >8 (22.4%).5 In particular, for patients with …

Background— We evaluated the incidence and predictors of single and multiple plaque ruptures in acute myocardial infarction (AMI) and stable angina pectoris (SAP). Methods and Results— We performed 3-vessel intravascular ultrasound (IVUS) examination in 235 patients: 122 had AMI, and 113 had SAP. Plaque rupture of infarct-related or target lesions occurred in 80 AMI patients (66%) and in 31 SAP patients (27%) ( P P =0.008). Multiple plaque ruptures were observed in 24 AMI (20%) and 7 SAP patients (6%) ( P =0.004). Therefore, at least 1 plaque rupture in any coronary artery was noted in 84 AMI patients (69%) and 35 SAP patients (31%) ( P P P =0.035; OR, 2.139; 95% CI, 1.053 to 4.343). Conversely, in SAP patients, the only independent clinical predictor of plaque rupture was diabetes mellitus ( P =0.034; OR, 2.553; 95% CI, 1.071 to 6.085). The only independent clinical predictor of multiple plaque ruptures was AMI ( P =0.003; OR, 3.752; 95% CI, 1.546 to 9.105). Conclusions— Three-vessel IVUS imaging showed that culprit lesion plaque rupture, secondary remote plaque ruptures, and multiple plaque ruptures were all more common in AMI patients than SAP patients. In AMI patients, plaque rupture was associated with a high CRP level, whereas in SAP patients, plaque rupture was more common in those with diabetes.

Background—Inflammation plays a crucial role in atherosclerosis. An elevated serum C-reactive protein (CRP) level is a strong marker for future atherosclerotic cardiovascular diseases. In addition, recent data suggest that CRP may directly promote atherogenesis. In this study, we investigated whether CRP can directly activate human circulating monocytes.Methods and Results—Incubation of THP-1 monocytes with CRP (10 μg/mL) increased CC chemokine receptor 2 (CCR2) expression at both the protein and transcript levels, which in turn enhanced chemotaxis mediated by monocyte chemoattractant protein-1 (MCP-1) up to 2-fold. The CRP-induced upregulation of CCR2 expression involved binding of CRP to the FcγR, most notably FcγRI, and phospholipase D1 activation. Serum high-sensitivity CRP levels in 52 normocholesterolemic human subjects were positively correlated with CCR2 surface expression on circulating monocytes (r=0.62,Pr=0.53,PConclusions—Elevated blood CRP levels may promote accumulation of monocytes in the atherogenic arterial wall by increasing chemotactic activities of monocytes in response to MCP-1.

Background— Predictors and long-term prognosis of late stent malapposition (LSM) after bare-metal stent (BMS) implantation are unknown. Methods and Results— We evaluated the incidence, mechanisms, predictors, and long-term prognosis of LSM after BMS implantation in 881 patients (992 native lesions) in whom intravascular ultrasound was performed at index and 6-month follow-up. LSM was defined as a separation of stent struts from the intimal surface of the arterial wall that was not presented at stent implantation. LSM occurred in 54 patients with 54 lesions (5.4% overall); the incidence was 10.3% (9 of 87) after directional coronary atherectomy (DCA) before stenting and 11.5% (11 of 96) after primary stenting in acute myocardial infarction ( P =0.031 and P =0.007, respectively, versus elective stenting with conventional balloon pre-dilation, 4.3% [30 of 692]). There was an increase of external elastic membrane area (18.9±3.9 to 24.5±5.1 mm 2 , P 2 , P P =0.023, OR=2.55, 95% CI=1.14 to 5.69) and DCA before stenting ( P =0.025, OR=3.02, 95% CI=1.15 to 7.96). There were no significant differences in major adverse cardiac events between LSM and non-LSM groups during mean 3-year follow-up (1.9% versus 1.8%, respectively, P =NS). Conclusions— LSM occurs in ≈5% after BMS implantation. The predictors of LSM are primary stenting in acute myocardial infarction and DCA before stenting. Compared with complete stent apposition at follow-up, LSM after BMS implantation is not associated with any major adverse cardiac events during a mean 3-year follow-up after detection of LSM.

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 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. Conclusions— 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. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00997763.

Background— This study used serial volumetric intravascular ultrasound (IVUS) to evaluate the effect of preinterventional arterial remodeling on in-stent intimal hyperplasia (IH) after implantation of non–polymer-encapsulated paclitaxel-coated stents. Methods and Results— Patients were randomized to placebo or one of two doses of paclitaxel (low dose, 1.28 μg/mm 2 ; high dose, 3.10 μg/mm 2 ). Complete preinterventional, post–stent implantation, and follow-up IVUS were available in 18 low-dose and 21 high-dose patients. IH volumes were similar in low-dose and high-dose patients: 17.6±15.1 mm 3 in low-dose patients and 13.1±13.3 mm 3 in high-dose patients ( P =0.3). Therefore, IVUS findings in low- and high-dose patients were combined. Preinterventional remodeling was assessed by comparing lesion site to proximal and distal reference arterial area: positive remodeling (lesion>proximal reference, n=13), intermediate remodeling (distal reference3 ; P =0.0067) and in intermediate remodeling lesions (from 97±28 to 76±31 mm 3 ; P =0.0004), but not in negative remodeling lesions (99±27 versus 92±32 mm 3 ; P =0.15). The follow-up IH volume was lower in negative remodeling lesions (5±7 mm 3 ) compared with positive remodeling (20±14 mm 3 ; P =0.0051) and intermediate remodeling lesions (20±15 mm 3 ; P =0.0043); however, IH volume was virtually identical in positive and intermediate remodeling lesions. Multivariate linear regression analysis determined that remodeling and inflation pressure were independent predictors of IH volume; variables tested in the model included diabetes, acute coronary syndromes, dose, remodeling, and preinterventional plaque burden. Conclusions— Preinterventional arterial remodeling, especially negative remodeling, influences neointimal hyperplasia suppression after implantation of non–polymer-encapsulated paclitaxel-coated stents.

Background— The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effect of a paclitaxel coating on in-stent intimal hyperplasia (IH). Methods and Results— Patients were randomized to placebo (bare metal stents) or 1 of 2 doses of paclitaxel (low dose: 1.28 μg/mm 2 ; high dose: 3.10 μg/mm 2 ). Complete post-stent implantation and follow-up IVUS were available in 81 patients, including 25 control patients and in 28 receiving a low-dose and 28 receiving a high dose. Volumetric analysis of the stented segment and of both reference segments was performed. Baseline stent measurements and both reference measurements were similar among the groups. With increasing doses, there was a stepwise reduction in IH accumulation within the stented segment (31±22 mm 3 in control, 18±15 mm 3 in low dose, and 13±14 mm 3 in high dose, P P =0.009 and P P =0.2). Focal late malapposition was seen in 1 high-dose patient. With increasing doses, there was no significant change in the reference segments. Conclusions— Paclitaxel-coated stents are effective in reducing in-stent neointimal tissue proliferation in humans. They are not associated with edge restenosis or significant late malapposition.

We thank Dr Sardar and colleagues for their interest in our recent article1 and appreciate the opportunity to reply. We agree that medication adherence is associated with clinical outcomes and remains an important issue in clinical drug trials. Unfortunately, there are no definite methods for assessing adherence to medications. In our study, pill count was used to determine medication adherence, and pharmacy data were electronically checked by medical insurance system. Medical adherence in this type of study is considered generally poor. Even in the Platelet Inhibition and Patient Outcome (PLATO) trial, medical adherence was ≈80%.2 In this context, we believe that medical adherence in our study seems to be acceptable. Time from index procedure to randomization was rather variable, but most patients were enrolled between 12 …

Introduction: Optical coherence tomography (OCT) was introduced to optimize percutaneous coronary intervention (PCI). Due to its unprecedented resolution, complications are frequently visualized. The exact incidence and clinical significance of these OCT detected complications are unknown. Object: The aims of this study were 1) to evaluate the incidence of acute stent complications by OCT, 2) to correlate these complications with clinical outcome at 1 year, and 3) to identify the OCT predictors for major adverse cardiac events (MACE) including death, acute myocardial infarction (AMI), stent thrombosis, and target lesion revascularizations (TLR). Methods and Results: A total of 409 patients with 473 drug eluting stents (DES) who had post stent OCT imaging were included in this study. The incidence of stent edge dissection was 36.4% and of intra stent dissection was 72.3%. Incomplete stent apposition was detected in 36.4% of stents. The incidence of smooth protrusion, fibrous flap or disrupted fibrous plaque, irregular protrusion and thrombus were 93.7%, 56.0%, 55.2%, and 33.4%, respectively. Minimal stent underexpansion defined by minimal stent area (MSA) < 1.0 of reference area and severe stent underexpansion defined by MSA< 0.8 of reference area were observed in 84.8% and 37.8% of stents. MACE occurred in 3.7% of cases at 1 year follow up. There was no death. AMI, stent thrombosis, and TLR occurred in 0.7%, 0.2%, and 3.2%. Univariate analysis showed small MSA (MSA< 5 mm2) and irregular protrusion were correlated with MACE at 1year follow up (P=0.003 and P=0.044). Following adjustment of stent edge dissection, incomplete stent apposition, irregular protrusion, small MSA, stent type, and clinical presentations, small MSA and irregular protrusion remain as independent predictors of MACE (P=0.004 and P=0.037). Conclusions: OCT-detected stent complication rate is high. Small MSA and irregular protrusion are independent predictors of MACE at 1 year.

Introduction: Autopsy studies in sudden cardiac death subjects showed female had higher incidence of erosion. However, the incidence of erosion in patients with acute myocardial infarction (AMI) has not been systematically studied. Hypothesis: This study was to study the gender difference in the prevalence and morphological characteristics of the culprit lesion in patients with AMI using intravascular optical coherence tomography (OCT). Methods: A total of 79 patients (65 male and 14 female) with AMI who underwent pre-intervention OCT imaging of the culprit lesion were included. Results: Baseline characteristics between the two groups were similar. In OCT findings, the incidence of thin-cap fibroatheroma (TCFA) was slightly lower and the fibrous cap thickness was slightly thicker in female than in male, but the differences were not significant. Defining underlying plaque morphology by genders, plaque erosion was more prevalent in female than in male, whereas plaque rupture was more frequent in male (Table). Conclusions: Erosion was the most frequent cause of AMI in female patients, whereas plaque rupture is the predominant underlying pathology of AMI in male patients.

Introduction: The risks and benefits of long-term dual antiplatelet therapy (DAPT) beyond 12 months in patients receiving drug-eluting stents (DES) and with high-risk clinical and angiographic features are unclear. Hypothesis: We try to determine whether extended use of DAPT is beneficial among patients with off-label use of DES. Methods: A total of 5,045 patients were included in the DES LATE trial and stratified according to randomized treatments (aspirin-alone or dual-therapy) and whether use was standard or off-label. Off-label was defined as use in renal insufficiency, ejection fraction ≤30%, acute myocardial infarction (MI), multivessel stenting, total stent length ≥36 mm, or ostial, bifurcation, grafts, left main, restenotic, thrombus, or totally occluded lesions. The primary endpoint was a composite of death from cardiac causes, MI, or stroke at 24 months after randomization. Results: Off-label use occurred in 68.6% of all patients. Among patients with off-label use, the risk of primary endpoint at 2 years was similar between aspirin-alone and dual-therapy group (2.6% vs. 3.1%; hazard ratio: 0.89; 95% confidence interval: 0.59 to 1.34, P = 0.59). In addition, no significant differences were observed between 2 treatment groups for individual and combined risks of efficacy and safety endpoints (death, MI, stroke, stent thrombosis, repeat revascularization, or major bleeding). These findings were consistent in patients with on-label use of DES (Figure). Conclusions: Extended use of DAPT beyond 12 months was not significantly more effective than aspirin monotherapy in reducing the risk of death from cardiac causes, MI, or stroke, regardless of off-label or on-label use of DES.

Background: Although cardiac rehabilitation (CR) is recommended after coronary artery bypass grafting (CABG) surgery, there are still deficient data about the long-term benefit of CR after CABG. Methods: We analyzed a single-center prospective registry, which included patients who had undergone CABG between 2000 and 2011. We evaluated the relationship between participation in CR and long-term survival. We identified 3975 patients (62.4±9.1 years old, 74.3% male) who survived for at least 3 months after surgery. Results: Of these, 2419 (60.9%) participated in phase I of CR while hospitalized, and 383 (9.6%) participated in phase II of CR at an outpatient clinic. During a median follow-up of 6.0 years (IQR, 4.3 to 9.5), the all-cause Kaplan-Meier mortality rate was 28.8% (616 deaths). Based on the propensity score matching method, participation in phase I CR was associated with a 20% relative risk reduction in all-cause mortality (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.64 to 0.98; p=0.043) and a 40% reduction in all-cause mortality after participation in phase II CR (HR, 0.60; 95% CI, 0.40 to 0.90; p=0.012). After multivariate Cox-proportional analysis, participation in any CR phase was associated with a significant reduction in mortality (HR, 0.77; 95% CI, 0.64 to 0.93; p=0.006 in phase I CR and HR, 0.57; 95% CI, 0.39 to 0.84, p=0.004 in phase II CR). Conclusions: CR participation is associated with a significant reduction in all-cause mortality after CABG. As well as outpatient CR participation, early CR during hospitalization has a beneficial impact in reducing mortality.

A 15-year-old male patient with no previous medical history was brought to the emergency room after an assault. He was mentally confused, and his vital signs were as follows: blood pressure, 80/40 mm Hg; heart rate, 120 bpm; respiration rate, 22 breaths per minute; and body temperature, 36.5°C. The patient suffered multiple contusions all over his body with no evidence of fracture or bleeding. On auscultation, a subtle holosystolic murmur was heard at the left lower parasternal border. A chest x-ray demonstrated mild cardiomegaly, and an ECG showed sinus tachycardia with complete right bundle-branch block (Figure 1). Laboratory test results were as follows: serum creatinine phosphokinase, 5057 IU/L (normal range: 22–269 IU/L); creatinine phosphokinase-MB, 272.6 ng/mL (normal range: 0–7.2 ng/mL); troponin-I, >50 ng/mL (normal range: 0–0.3 ng/mL); serum myoglobin, >1200 ng/mL (normal range: 0–154 ng/mL); and urine myoglobin, >4000 ng/mL (normal range: 0–10 ng/mL). Transthoracic echocardiography revealed a moderate tricuspid regurgitation (TR) with a flail septal leaflet caused by chordae rupture (Figure 2 and Movie I in the online-only Data Supplement). However, …

Background Percutaneous coronary revascularization (PCI) has been increasingly applied to unprotected left main trunk (LMT) lesions, with varied long-term success. This study attempts to define the predictors of outcome in this population. Methods and Results Two hundred seventy-nine consecutive patients who had LMT PCI at 1 of 25 sites between 1993 and 1998 were studied. Forty-six percent of these patients were deemed inoperable or at high surgical risk. Thirty-eight patients (13.7%) died in hospital, and the rest were followed up for a mean of 19 months. The 1-year incidence was 24.2% for all-cause mortality, 20.2% for cardiac mortality, 9.8% for myocardial infarction, and 9.4% for CABG. Independent correlates of all-cause mortality were left ventricular ejection fraction ≤30%, mitral regurgitation grade 3 or 4, presentation with myocardial infarction and shock, creatinine ≥2.0 mg/dL, and severe lesion calcification. For the 32% of patients 30% and without shock, the prevalence of these adverse risk factors was low. No periprocedural deaths were observed in this low-risk subset, and the 1-year mortality was only 3.4%. Conclusions Patients undergoing unprotected LMT PCI have frequent serious comorbidities and consequently have high event rates. PCI may be an alternative to CABG for a select proportion of elective patients and may also be appropriate for highly symptomatic inoperable patients. Meticulous follow-up of hospital survivors is required because of the rather high mortality during the first few months after treatment.

A 34-year-old man presented with monomorphic ventricular tachycardia (VT) accompanying syncope (Figure 1A). Frequent episodes of sustained VT after paroxysmal elevation of heart rate and blood pressure were noted during his stay in the intensive care unit. He had no family or personal history of syncope or cardiac arrest. Coronary angiography and echocardiographic examination revealed no significant abnormalities. Chest and adrenal computed tomography scans revealed a left adrenal mass (7.2×5.3 cm), lymph node enlargement, and several pulmonary nodules (Figure 2A–2D). Elevated levels of 24-hour urinary catecholamines (Figure 3) and abnormal uptake on I-123 metaiodobenzylguanidine (MIBG) imaging (Figure 2E) suggested a malignant pheochromocytoma with lymph node and pulmonary metastasis. Figure 1. A , The initial ECG showed very rapid monomorphic ventricular tachycardia (VT) with right bundle-branch block morphology and left-axis deviation. B , Nonsustained and sustained ventricular tachycardia recurred although the patient was treated with an α-blocker. C , Pulseless sustained VT accompanied by syncope developed when the oral β-blocker was skipped immediately after the adrenalectomy. D , Implantable cardioverter-defibrillator interrogation showed successful termination of fast …

We appreciate Nakano et al's interest and concern regarding the inconsistent frequency of in-stent neoatherosclerosis between the pathological and optical coherence tomography (OCT) data. In their autopsy study, Nakazawa et al reported the frequency of neoatherosclerosis in 41% of drug-eluting stent (DES) lesions with a follow-up time of 2–6 years.1 To the contrary, our recent OCT data showed lipid-containing and thin-cap fibroatheroma-containing neointima in 90% and 52% of DES lesions with in-stent restenosis at median follow-up of 32 months.2 With regard to this discrepancy, we fully agree with the plausible explanations …

Background— The proper way of revascularization remains controversial in patients with ischemic mitral regurgitation (IMR). We sought to compare the long-term results of percutaneous coronary intervention (PCI) and surgical revascularization in IMR. Methods and Results— From 1996 to 2008, 185 consecutive patients (132 men; age, 63±9 years) with significant IMR underwent PCI (PCI group) (n=66) or coronary artery bypass graft surgery (OP group) (n=119). In the OP group, 68 (57%) patients also underwent concomitant mitral annuloplasty. Significant IMR was defined as functional MR occurring >1 week after myocardial infarction with an effective regurgitant orifice area ≥0.2 cm 2 . During a median follow-up of 54 months, there were 2 operative mortalities, 26 cardiac deaths, and 11 heart failure hospitalizations in the OP group and 22 cardiac deaths and 10 heart failure hospitalizations in the PCI group. The survival and cardiac mortality rates were not significantly different between the 2 groups, but event-free survival rates were significantly higher in the OP group. For the 45 propensity score-matched pairs, the risk of cardiac events was significantly lower in the OP group than in the PCI group (hazard ratio, 0.499; 95% CI, 0.251 to 0.990; P =0.043). Compared with patients who underwent coronary artery bypass graft surgery alone, event-free survival rates were significantly higher in those who underwent additional mitral annuloplasty. Conclusions— Compared with PCI, surgical revascularization is associated with an improved long-term event-free survival, and concomitant mitral annuloplasty should be considered in patients with significant IMR.

Inducible myocardial ischemia during functional testing has crucial prognostic significance in determining whether or not to treat coronary artery stenosis.1–3 In real-world practice, however, fewer than half of all patients are evaluated noninvasively for myocardial ischemia before revascularization therapy.4 Thus, coronary angiograms are still frequently used as a cornerstone of decision making, despite the substantial discrepancy between the angiographic and functional severity of stenosis. Therefore, adjuvant technologies such as fractional flow reserve (FFR) and intravascular ultrasound (IVUS) are considered in daily practice to overcome the limitations of coronary angiography for diagnostic and interventional procedures. The present review evaluates the roles of FFR and IVUS in coronary stenosis and their incorporation into practice in contemporary catheterization laboratories. In contrast to the benefits of percutaneous coronary intervention (PCI) in patients with unstable angina and myocardial infarction, the benefits of PCI in patients with stable angina are less clear.5,6 Nevertheless, recent advances in drug-eluting stents (DES) and adjuvant pharmacological agents may reduce the thresholds for revascularization therapy in the absence of firm evidence of objective ischemia. Thus, consideration is sometimes given to treating stenoses of intermediate degree without consideration of their functional significance.7 In addition, although most surgical recommendations for patients with multivessel coronary artery disease are to bypass all lesions with diameter stenosis of >50% for complete revascularization, the patency rate of vein grafts on vessels with functionally insignificant proximal stenosis has been in question.8 Because revascularization treatment based on ischemia may improve patient outcomes, guidelines have recommended noninvasive functional evaluation before revascularization treatment.3,9 Despite these recommendations, however, noninvasive functional evaluations before revascularization are underutilized in real-world practice. Twenty years ago, Topol et al10 reported that of a total of 2101 patients who underwent coronary angioplasty, only 29% had …

On the basis of our previous findings,1 we propose a readily available and simple marker, C-reactive protein, for the prediction of stent thrombosis after implantation of drug-eluting stents.2 A priori sample size was determined by use of the assumption of exponential survival curves for the primary end point (definite or probable stent thrombosis). Using Cox regression of the log hazard ratio on a binary covariate (elevated versus nonelevated C-reactive protein) with a ≥30% prevalence, a sample of 2600 observations achieves 80% power at a 0.05 significance level to detect a regression coefficient equal …

To the Editor: We read with interest the work by Chen et al,1 which reported that triple antiplatelet therapy seems to be superior to dual antiplatelet therapy in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention with drug-eluting stents. Chen et al1 reported the mortality benefits of triple antiplatelet therapy obtained mainly within 30 days after STEMI, reflecting the importance of the addition of cilostazol to aspirin and clopidogrel before stenting. Meanwhile, …

Background— Whether triple antiplatelet therapy is superior or similar to dual antiplatelet therapy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention in the era of drug-eluting stents remains unclear. Methods and Results— A total of 4203 ST-segment elevation myocardial infarction patients who underwent primary percutaneous coronary intervention with drug-eluting stents were analyzed retrospectively in the Korean Acute Myocardial Infarction Registry (KAMIR). They received either dual (aspirin plus clopidogrel; dual group; n=2569) or triple (aspirin plus clopidogrel plus cilostazol; triple group; n=1634) antiplatelet therapy. The triple group received additional cilostazol at least for 1 month. Various major adverse cardiac events at 8 months were compared between these 2 groups. Compared with the dual group, the triple group had a similar incidence of major bleeding events but a significantly lower incidence of in-hospital mortality. Clinical outcomes at 8 months showed that the triple group had significantly lower incidences of cardiac death (adjusted odds ratio, 0.52; 95% confidence interval, 0.32 to 0.84; P =0.007), total death (adjusted odds ratio, 0.60; 95% confidence interval, 0.41 to 0.89; P =0.010), and total major adverse cardiac events (adjusted odds ratio, 0.74; 95% confidence interval, 0.58 to 0.95; P =0.019) than the dual group. Subgroup analysis showed that older (>65 years old), female, and diabetic patients got more benefits from triple antiplatelet therapy than their counterparts who received dual antiplatelet therapy. Conclusions— Triple antiplatelet therapy seems to be superior to dual antiplatelet therapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with drug-eluting stents. These results may provide the rationale for the use of triple antiplatelet therapy in these patients.

In the last 3 decades, there has been a revolutionary change in the treatment of coronary artery disease. Through advances in equipment and technical skills, percutaneous coronary intervention (PCI) is being applied to increasingly more complex patients and lesions. In particular, coronary stenting has emerged as an effective strategy to prevent recurrence after PCI. However, restenosis in the stented segment remained a major issue in coronary stenting.1 The recent introduction of drug-eluting stents (DES) has dramatically reduced restenosis rates compared with bare metal stent (BMS) use. Large randomized clinical trials have confirmed the benefits of DES over BMS in terms of decreasing the incidence of in-stent restenosis and the need for repeat revascularization.2–4 As a result, there has been a very rapid worldwide shift in the treatment of coronary stenosis from BMS to DES, including in most Asian countries. However, concern remains over late-occurring stent thrombosis after DES implantation.5–7 The prevalence of coronary artery disease has increased considerably in Asian countries over the past several decades as a result of shifts toward a more “westernized” lifestyle. Accordingly, PCI with stents is a common procedure in Asia, with >300 000 cases performed each year.8,9 The present article describes the current status of DES use in Asian countries using both published and unpublished data. A few randomized studies have been performed in Asian countries, allowing the examination of pertinent registries to explore issues relating to DES in Asian countries. However, this review article cannot cover the disparities of patient demographics, practice pattern, and outcomes in all the different Asian countries because of a striking lack of published data. In addition, within the scope of the current review, the majority of data may reflect the performance of advanced centers in which PCI is practiced by experienced operators. Although several …

Late functional deterioration after percutaneous mitral valvuloplasty (PMV) has raised the issue of comparing long-term outcomes between PMV and open-heart surgery (OHS). The study evaluated 402 patients who underwent PMV and 159 patients who underwent OHS between January 1, 1995, and December 31, 2000. The rates of cardiovascular death or repeated intervention (redo-PMV or OHS) were determined over a median follow-up of 109 months (mean±SD 106±27). The therapeutic effects on adverse outcomes were estimated using Cox’s proportional hazards model adjusting differences in the severity of illness before intervention, and the effects of the cardiac rhythm and echocardiographic score were also tested. The observed (unadjusted) event-free survival rate was similar for both groups, and the hazard ratio for the clinical events after PMV as compared with after OHS was 1.510 (95% confidence interval [CI], 0.914 –2.496, p=0.1079). However, the adjusted hazard ratio was 3.729 (95% CI, 1.963–7.082, p