Immediate versus staged complete revascularization in patients with ST-segment elevation myocardial infarction and multivessel coronary artery disease: results from a prematurely discontinued randomized multicenter trial.

BACKGROUND: We aimed to compare clinical outcomes between immediate and staged complete revascularization in primary percutaneous coronary intervention (PCI) for treating ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD). METHODS: A total of 248 patients were enrolled in a prospective, randomized, and multicenter registry. Immediate revascularization was defined as one-time PCI of culprit and non-culprit lesions at the initial procedure. Staged revascularization was defined as PCI of non-culprit lesions at a later date (mean, 4.4 days; interquartile range, 1-11.4), following initial culprit revascularization. The end points were major adverse cardiovascular events (MACE; composite of total death, recurrent myocardial infarction, and revascularization), any individual components of MACE, cardiac death, stent thrombosis, and stroke at 12 months. RESULTS: During a follow-up of 1 year, MACE occurred in 12 patients (11.6%) in the immediate revascularization group and in 8 patients (7.5%) in staged revascularization group (hazard ratio [HR] 1.60, 95% confidence interval [CI] 0.65-3.91). The incidence of total death was numerically higher in the immediate group than in the staged group (9.7% vs 2.8%, HR 3.53, 95% CI 0.97-12.84); There were no significant differences between the 2 groups in risks of any individual component of MACE, cardiac death, stroke, and in-hospital complications, such as need for transfusion, bleeding, acute renal failure, and acute heart failure. This study was prematurely terminated due to halt of production of everolimus-eluting stents (manufactured as PROMUS Element by Boston Scientific, Natick, Massachusetts). CONCLUSIONS: Due to its limited power, no definite conclusion can be drawn regarding complete revascularization strategy from the present study. Further large randomized clinical trials would be warranted to confirm optimal timing of complete revascularization for patients with STEMI and MVD.

Comparison of 6-Month and Prolonged Dual Antiplatelet Therapy after Percutaneous Coronary Intervention with Biodegradable Polymer Everolimus-Eluting Stent.

Background: The optimal duration of dual antiplatelet therapy (DAPT) after biodegradable-polymer (BP) everolimus-eluting stent (EES) implantation remains uncertain. Methods: This study analyzed 793 patients who underwent percutaneous coronary intervention (PCI) with BP-EES in 10 cardiovascular centers in Korea between July 2016 and January 2018. Using the prescription data at 6 months post-PCI, we divided these patients into two groups, namely, short-DAPT and prolonged-DAPT groups, which underwent DAPT for 6 and > 6 months of PCI, respectively. The primary endpoint, which included mortality, myocardial infarction, or target-vessel revascularization at 2 years, was compared by propensity score (PS) matching between the two groups. Results: Out of the 793 patients, 283 matched pairs were identified by PS matching. Out of this matched population, 405 (71.6%) patients had an acute coronary syndrome. The primary endpoint did not differ in 2 years between the short-DAPT and prolonged-DAPT groups (7.5% vs. 8.3%; hazard ratio, 0.87; 95% confidential interval, 0.47-1.60; P = 0.648). Likewise, no difference was found regarding mortality, cardiac mortality, myocardial infarction, target-lesion failure, target-vessel failure, and bleeding events defined by the Bleeding Academic Research Consortium and Thrombolysis In the Myocardial Infarction classification. Meanwhile, one patient in the short-DAPT group had definite stent thrombosis at 364 days post-PCI. Subgroup analysis showed that several anatomical and procedural factors were not significantly related to DAPT duration. Most patients (77.4%) in both groups were prescribed clopidogrel at discharge. Conclusions: In real-world patients undergoing PCI with BP-EES, the ischemic and bleeding endpoints demonstrated no difference between 6-month and prolonged (>6 months) DAPT.

Stenting versus balloon angioplasty alone in patients with below-the-knee disease: A propensity score-matched analysis.

Percutaneous transluminal angioplasty (PTA) is considered an effective treatment in patients with critical limb ischemia (CLI). However, the long-term durability of below-the-knee (BTK) PTA is known to be limited. This study sought to compare the 1-year clinical outcomes following stenting versus balloon angioplasty alone in BTK lesions. This study included 357 consecutive patients (400 limbs, 697 lesions) with BTK lesions who underwent PTA from September 2010 to December 2016. All enrolled patients were treated either by stenting (stent group; 111 limbs of 102 patients) or plain old balloon angioplasty (POBA group; 289 limbs of 255 patients). Stent group includes both primary and provisional stenting. Angiographic outcomes, procedural success, complications, and clinical outcomes were compared between the two groups up to 1 year. After propensity score matching (PSM) analysis, 56 pairs were generated, and the baseline and angiographic characteristics were balanced. The procedural success and complications were similar between the two groups; however, the incidence of procedure-related perforation was higher in the POBA group than in the stenting group [5(11.9%) vs.1 (0.9%), P = 0.009]. Six- to 9-month computed tomography or angiographic follow-up showed similar incidences of binary restenosis, primary patency, and secondary patency. In the 1-year clinical follow-up, there were similar incidences of individual hard endpoints, including mortality, myocardial infarction, limb salvage, and amputation rate, with the exception of target extremity revascularization (TER), which tended to be higher in the stenting group than in the POBA group [21 (20.8%) vs. 11 (10.9%), P = 0.054]. Although there was a trend toward a higher incidence of TER risk in the stenting group, stent implantation, particularly in bail-out stenting seemed to have acceptable 1-year safety and efficacy compared to POBA alone in patients undergoing BTK PTA.

Impact of genetic variants on major bleeding after percutaneous coronary intervention based on a prospective multicenter registry.

Although dual antiplatelet therapy is essential for patients who undergo percutaneous coronary interventions, the risk of bleeding remains an unsolved problem, and there is limited information on the potential relationship between genetic variants and major bleeding. We analyzed the correlations between four major single nucleotide polymorphisms (CYP2C19, ABCB1, PON1, and P2Y12 G52T polymorphisms) and clinical outcomes in 4489 patients from a prospective multicenter registry. The primary endpoint was major bleeding, defined as a Bleeding Academic Research Consortium ≥ 3 bleeding event. The allelic frequencies of ABCB1, PON1, and both individual and combined CYP2C19 variants did not differ significantly between patient groups with and without major bleeding. However, the allelic frequency of the P2Y12 variant differed significantly between the two groups. Focusing on the P2Y12 G52T variant, patients in the TT group had a significantly higher rate of major bleeding (6.4%; adjusted hazard ratio [HR] 2.51; 95% confidence interval [CI] 1.08-5.84; p = 0.033) than patients in the other groups (GG [2.9%] or GT [1.9%]). Therefore, the TT variant of the P2Y12 G52T polymorphism may be an independent predictor of major bleeding.Trial registration: NCT02707445 ( https://clinicaltrials.gov/ct2/show/NCT02707445?term=02707445&draw=2&rank=1 ).

The Current Status of Intervention for Intermediate Coronary Stenosis in the Korean Percutaneous Coronary Intervention (K-PCI) Registry.

BACKGROUND AND OBJECTIVES: Intermediate coronary lesion that can be under- or over-estimated by visual estimation frequently results in stenting of functionally nonsignificant lesions or deferral of percutaneous coronary intervention (PCI) of significant lesions inappropriately. We evaluated current status of PCI for intermediate lesions from a standardized database in Korea. METHODS: We analyzed the Korean percutaneous coronary intervention (K-PCI) registry data which collected a standardized PCI database of the participating hospitals throughout the country from January 1, 2014, through December 31, 2014. Intermediate lesion was defined as a luminal narrowing between 50% and 70% by visual estimation and then compared whether the invasive physiologic or imaging study was performed or not. RESULTS: Physiology-guided PCI for intermediate lesions was performed in 16.8% for left anterior descending artery (LAD), 9.8% for left circumflex artery (LCX), 13.2% for right coronary artery (RCA). PCI was more frequently performed using intravascular ultrasound (IVUS) than using fractional flow reserve (FFR) for coronary artery segments (27.7% vs. 13.9% for LAD, 32.9% vs. 8.1% for LCX, and 33.8% vs. 10.8% for RCA). In accordance with or without FFR, PCI for intermediate lesions was more frequently performed in the hospitals with available FFR device than without FFR, especially in left main artery (LM), proximal LAD lesion (40.9% vs. 5.9% for LM, 24.6% vs 7.6% for proximal LAD). CONCLUSIONS: These data provide the current PCI practice pattern with the use of FFR and IVUS in intermediate lesion. More common use of FFR for intermediate lesion should be encouraged.

Long-Term Sirolimus for Primary Immunosuppression in Heart Transplant Recipients.

BACKGROUND: Small studies have reported superiority of sirolimus (SRL) over calcineurin inhibitor (CNI) in mitigating cardiac allograft vasculopathy (CAV) after heart transplantation (HT). However, data on the long-term effect on CAV progression and clinical outcomes are lacking. OBJECTIVES: The aim of this study was to test the long-term safety and efficacy of conversion from CNI to SRL as maintenance therapy on CAV progression and outcomes after HT. METHODS: A cohort of 402 patients who underwent HT and were either treated with CNI alone (n = 134) or converted from CNI to SRL (n = 268) as primary immunosuppression was analyzed. CAV progression was assessed using serial coronary intravascular ultrasound during treatment with CNI (n = 99) and after conversion to SRL (n = 235) in patients who underwent at least 2 intravascular ultrasound studies. RESULTS: The progression in plaque volume (2.8 ± 2.3 mm3/mm vs. 0.46 ± 1.8 mm3/mm; p < 0.0001) and plaque index (plaque volume-to-vessel volume ratio) (12.2 ± 9.6% vs. 1.1 ± 7.9%; p < 0.0001) were significantly attenuated when treated with SRL compared with CNI. Over a mean follow-up period of 8.9 years from time of HT, all-cause mortality occurred in 25.6% of the patients and was lower during treatment with SRL compared with CNI (adjusted hazard ratio: 0.47; 95% confidence interval: 0.31 to 0.70; p = 0.0002), and CAV-related events were also less frequent during treatment with SRL (adjusted hazard ratio: 0.35; 95% confidence interval: 0.21 to 0.59; p < 0.0001). Further analyses suggested more attenuation of CAV and more favorable clinical outcomes with earlier conversion to SRL (≤2 years) compared with late conversion (>2 years) after HT. CONCLUSIONS: Early conversion to SRL is associated with attenuated CAV progression and with lower long-term mortality and fewer CAV-related events compared with continued CNI use.

Effects of genetic variants on platelet reactivity and one-year clinical outcomes after percutaneous coronary intervention: A prospective multicentre registry study.

Clopidogrel is the mainstay for antiplatelet treatment after percutaneous coronary intervention (PCI). The relationship of platelet reactivity and genetic polymorphism with clinical outcomes with newer-generation drug-eluting stents is unclear. We analysed 4,587 patients for the most powerful single-nucleotide polymorphisms (CYP2C19, CYP2C9, ABCB1, PON1, and P2Y12) related to on-treatment platelet reactivity (OPR). The optimal cut-off value of high OPR for major adverse thrombotic events was 266. CYP2C19 was significantly associated with high OPR and the number of CYP2C19*R (*2 or *3) alleles was proportional to the increased risk of high OPR. Death, myocardial infarction (MI), stroke, stent thrombosis, and bleeding events were assessed during a 1-year follow-up period. Primary endpoints were death and non-fatal MI. The cumulative 1-year incidence of death and stent thrombosis was significantly higher in patients with CYP2C19*2/*2, CYP2C19*2/*3, and CYP2C19*3/*3 (Group 3) than in patients with CYP2C19*1/*1 (Group 1). Multivariate Cox proportional hazard model showed that cardiac death risk was significantly higher in Group 3 than in Group 1 (hazard ratio 2.69, 95% confidence interval 1.154-6.263, p = 0.022). No association was reported between bleeding and OPR. Thus, CYP2C19 may exert a significant impact on the prognosis of PCI patients even in the era of newer-generation drug-eluting stents.

Thrombus aspiration during primary percutaneous coronary intervention for preserving the index of microcirculatory resistance: a randomised study.

AIMS: We aimed to investigate whether thrombus aspiration could preserve the index of microcirculatory resistance (IMR) after primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: Sixty-three patients with STEMI were randomised into two groups: primary PCI after thrombus aspiration (aspiration group, n=33) and primary PCI without thrombus aspiration (non-aspiration group, n=30). IMR was measured using a pressure-temperature sensor-tipped coronary wire. Echocardiography was performed at baseline and at six-month follow-up. No significant differences in baseline ejection fraction (EF, 47.3±8.5% vs. 49.5±7.8%, p=0.281) and baseline wall motion score index (WMSI, 1.45±0.31 vs. 1.37±0.27, p=0.299) were observed between the two groups. However, significant differences in IMR (23.5±10.2 U vs. 34.2±21.7 U, p=0.018), %E2%88%86EF (follow-up EF - baseline EF; 3.33±4.6% vs. 0.73±1.9%, p=0.005), and %E2%88%86WMSI (follow-up WMSI - baseline WMSI; -0.121±0.16 vs. -0.004±0.07, p=0.001) were observed between the two groups. CONCLUSIONS: Thrombus aspiration as an adjunctive method to primary PCI for STEMI may preserve microvascular integrity and have beneficial effects on myocardial microcirculation.

Pulmonary Alveolar Hemorrhage after Clopidogrel Use for ST Elevation Myocardial Infarction.

Combination treatment of antiplatelet drugs containing aspirin and clopidogrel reduces systemic ischemic events after percutaneous coronary intervention (PCI) in high risk patients. However, this combination treatment of antiplatelet drugs is associated with increased risk of nonfatal and fatal bleeding. Diffuse alveolar hemorrhage after PCI is a rare complication that has been mostly reported in association with glycoprotein IIb/IIIa inhibitors. We report the case of a 62-year-old man who presented with ST elevation myocardial infarction and suffered a diffuse alveolar hemorrhage after clopidogrel use following primary PCI.

Comparison of antiplatelet efficacy and tolerability of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients after percutaneous coronary intervention: a prospective, multicenter, randomized, open-label, phase IV, noninferiority trial.

BACKGROUND: Clopidogrel bisulfate, a potent antiplatelet agent, has a pivotal role in the prevention and treatment of atherothrombotic disease. Clopidogrel napadisilate, a different salt preparation of clopidogrel, has been developed and approved in Korea and several European countries. Recent studies have suggested that clopidogrel napadisilate might have improved stability and comparable bioequivalence to clopidogrel bisulfate. However, these 2 clopidogrel preparations have not been compared in terms of efficacy and tolerability in patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI). OBJECTIVE: We sought to investigate the antiplatelet efficacy and safety profile of clopidogrel napadisilate compared with clopidogrel bisulfate in CAD patients after PCI. METHODS: This was a randomized, multicenter, open-label, Phase IV, noninferiority clinical trial. We prospectively recruited CAD patient in 6 institutions in Korea between October 2010 and November 2011. Patients who underwent PCI were randomly assigned to the test group (clopidogrel napadisilate plus aspirin) or control group (clopidogrel bisulfate plus aspirin). Antiplatelet efficacy and safety profile were assessed after 4 weeks of maintenance treatment. The primary end point was noninferiority of the percentage of P2Y(12) inhibition, measured by point-of-care assay. The rate of major adverse cardiovascular events (MACE), as a secondary end point, was compared between the 2 clopidogrel preparations. To assess tolerability, we evaluated the incidence, severity, and causal relation of adverse events (AEs) of 2 groups. RESULTS: A total of 169 patients were screened, and 127 patients completed the study (64 in the test group and 63 in the control group; P = 0.296). The baseline characteristics of patients did not differ significantly between the treatment groups. The between-group difference in percentage of P2Y(12) inhibition did not exceed the prespecified limit for noninferiority (P for noninferiority = 0.032; 95% CI, -8.33 to 5.53). With respect to the risk of MACE, no significant difference was found in the incidence of myocardial infarction or stroke between the groups (1 in the test group and 2 in the control group; P > 0.99); no mortality was reported in either group. The tolerability of clopidogrel napadisilate was comparable with that of clopidogrel bisulfate in terms of all AEs, drug-related AEs, and serious AEs (all AEs: test group, 33.3%; control group, 32.9% [P > 0.99]; drug-related AEs: test group, 4.17%; control group, 0% [P = 0.113]; serious AEs: test group, 1.39%; control group, 5.26% [P=0.367]). CONCLUSIONS: In this study of CAD Korean patients who have undergone PCI, the antiplatelet efficacy of clopidogrel napadisilate was noninferior to that of clopidogrel bisulfate after 4 weeks of maintenance treatment. No statistically significant difference was found in tolerability between the 2 treatment groups.

Postcardiac injury syndrome after percutaneous coronary intervention.

The post cardiac injury syndrome is characterized by the development of a fever, pleuropericarditis, and parenchymal pulmonary infiltrates in the weeks following trauma to the pericardium or myocardium. According to previous reports, almost all cases develop after major cardiac surgery or a myocardial infarction. Recently, a few reports have described post cardiac injury syndrome as a complication of endovascular procedures such as percutaneous cardiac intervention. Here we describe an unusual case of post cardiac injury syndrome after a percutaneous coronary intervention.

A case of acute myocardial infarction with the anomalous origin of the right coronary artery from the ascending aorta above the left sinus of Valsalva and left coronary artery from the posterior sinus of Valsalva.

Coronary anomalies are rare angiographic findings. Moreover, there are few reports of cases of an anomalous origin of the right coronary artery from the left sinus of Valsalva and of the left coronary artery from the posterior sinus of Valsalva. Here, we report a case with an anomalous origin of the right coronary artery from the ascending aorta above the left sinus of Valsalva and the left coronary artery from the posterior sinus of Valsalva. This was observed in a patient who was treated for a myocardial infarction of the inferior wall caused by a thrombus in the proximal right coronary artery. The patient was treated successfully with the implantation of a stent in the anomalous origin of the right coronary artery using a 6Fr Amplatz left 1 catheter.

Effects of early losartan therapy on ventricular late potentials in acute myocardial infarction.

BACKGROUND: Ventricular late potentials (LPs) obtained by the signal-averaged electrocardiogram (SAECG) have prognostic significance as independent predictors of arrhythmic events after an acute myocardial infarction (AMI). Angiotensin receptor blockers reduce the overall mortality and risk of sudden cardiac death in postinfarction patients. The aim of this study was to investigate the effect of early losartan therapy on ventricular LPs, a noninvasive method for the evaluation of arrhythmogenic substrates in AMI patients. METHODS: The study included 97 patients with their first AMI. Forty-eight patients (39 men and 9 women, aged 58.8 +/- 13.19 years), received early losartan therapy. The control group consisted of 49 patients (38 men and 11 women, aged 59.55 +/- 11.0 years), did not received early losartan therapy. The SAECG was performed at admission and day 14. RESULTS: The baseline clinical, angiographic characteristics, and reperfusion methods were similar in both groups. The baseline SAECG findings were also similar in the two groups. There was a significant decrease in the rate of LP, between the first and last SAECG recordings, after reperfusion therapy in the losartan group. All of the parameters of LPs were significantly improved in the losartan group on the last SAECG recordings. CONCLUSION: The results of this study showed that losartan treatment, early after an AMI, reduced the incidence of LP and may thus favorably affect arrhythmia substrates.

The relationship between the left atrial volume and the maximum P-wave and P-wave dispersion in patients with congestive heart failure.

PURPOSE: A maximum P-wave duration (Pmax) of > or = 110 msec and a P-wave dispersion (PWD) > or = 40 msec are accepted indicators of a disturbance in interatrial conduction and an inhomogeneous propagation of the sinus impulse, respectively. The left atrial (LA) volume has been reported to be strongly associated with a systolic and diastolic dysfunction and is considered to be an index of atrial remodeling. We aimed to investigate the relationship between LA volume and Pmax or PWD in patients with congestive heart failure (CHF). PATIENTS AND METHODS: Sixty-one patients with CHF were enrolled in this study. The study population was classified into four groups: two groups were divided according to the Pmax (> or = 110 msec or < 110 ms), and the other two groups were formed based on the PWD (> or = 40 msec or < 40 msec). The left atrial volume index (LAVi) was measured by three-dimensional (3-D) transthoracic echocardiography. The Pmax and PWD were measured from a 12-lead electrocardiogram. RESULTS: There were significant differences in the ejection fraction (EF), diastolic function, and LAVi between patients with a Pmax > or = 110 ms or a PWD > or = 40 ms and those with a Pmax < 110 ms or a PWD < 40 ms. The LAVi was independently associated with a disturbance in interatrial conduction and an inhomogeneous propagation of the sinus impulse. The LAVi can be used to identify patients with a disturbance in interatrial conduction and an inhomogeneous propagation of the sinus impulse with reasonably good accuracy. CONCLUSION: We concluded that a disturbance in interatrial conduction and an inhomogeneous propagation of the sinus impulse in patients with CHF is associated with an increase in the LA volume and a deleterious systolic and diastolic dysfunction.