Details on the effect of very short dual antiplatelet therapy after drug-eluting stent implantation in patients with high bleeding risk: insight from the STOPDAPT-2 trial.

Previously we briefly reported the effect of 1-month dual antiplatelet therapy (DAPT) for patients with high bleeding risk (HBR) receiving percutaneous coronary intervention (PCI) in the STOPDAPT-2 trial, but full analysis data have not been available. We conducted post hoc subgroup analysis regarding the effect of very short DAPT for HBR patients in STOPDAPT-2 trial. The primary endpoint was a 1-year composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) and bleeding (TIMI major/minor bleeding) outcomes. Major secondary endpoints were 1-year cardiovascular composite endpoint and bleeding endpoint. HBR was defined by the academic research consortium (ARC) HBR criteria. Among the 3009 study patients, 1054 (35.0%) were classified as HBR and 1955 (65.0%) were as non-HBR. There were no significant interactions between HBR/non-HBR subgroups and the assigned DAPT group on the primary endpoint (HBR; 3.48% vs. 5.98%, HR 0.57, 95% CI 0.32-1.03, and non-HBR; 1.81% vs. 2.36%, HR 0.78, 95% CI 0.42-1.45; P for interaction = 0.48), the major secondary cardiovascular endpoint (HBR; 3.07% vs. 4.03%, HR 0.77, 95% CI 0.40-1.48, and non-HBR; 1.41% vs. 1.61%, HR 0.89, 95% CI 0.43-1.84; P for interaction = 0.77), and the major secondary bleeding endpoint (HBR; 0.41% vs. 2.71%, HR 0.15, 95% CI 0.03-0.65, and non-HBR; 0.40% vs. 0.85%, HR 0.48, 95% CI 0.14-1.58; P for interaction = 0.22). In conclusion, the effects of 1-month DAPT for the primary and major secondary endpoints were consistent in HBR and non-HBR patients without any significant interactions. The benefit of 1-month DAPT in reducing major bleeding was numerically greater in HBR patients.Clinical trial registration Short and optimal duration of dual antiplatelet therapy after everolimus-eluting cobalt-chromium stent-2 [STOPDAPT-2]; NCT02619760.

Efficacy of drug-coated balloon angioplasty after directional coronary atherectomy for coronary bifurcation lesions (DCA/DCB registry).

OBJECTIVES: To evaluate the efficacy and safety of additional drug-coated balloon (DCB) angioplasty after directional coronary atherectomy (DCA) for coronary bifurcation lesions. BACKGROUND: The optimal therapy for bifurcation lesions has not been established, even in the drug-eluting stent era. DCA possibly prevents plaque and carina shift in bifurcation lesions by plaque debulking; however, the efficacy of combined DCA and DCB (DCA/DCB) for bifurcation lesions remains unclear. METHODS: This multicenter registry retrospectively recruited patients with bifurcation lesions who underwent DCA/DCB and follow-up angiogram at 6-15 months. The primary endpoint was the 12-month target vessel failure (TVF) rate. The secondary endpoints were procedure-related major complications, major cardiovascular events at 12 months, restenosis at 12 months, target lesion revascularization (TLR) at 12 months, and target vessel revascularization (TVR) at 12 months. RESULTS: We enrolled 129 patients from 16 Japanese centers. One hundred and four lesions (80.6%) were located around the left main trunk bifurcations. No side branch compromise was found intraoperatively. Restenosis was observed in three patients (2.3%) at 12 months. TLR occurred in four patients (3.1%): 3 (2.3%) in the main vessel and 1 (0.8%) in the ostium of the side branch at 12 months. TVF incidence at 12 months was slightly higher in 14 patients (10.9%), and only two patients (1.6%) had symptomatic TVR. One patient (0.8%) had non-target vessel-related myocardial infarction. CONCLUSIONS: Our data suggested that DCA/DCB provided good clinical outcomes and minimal side branch damage and could be an optimal non-stent percutaneous coronary intervention strategy for bifurcation lesions.

Intravascular ultrasound imaging of isolated and non aorto-ostial coronary Takayasu arteritis: a case report.

BACKGROUND: Isolated coronary Takayasu arteritis is a rare form of ischemic heart disease that typically appears as an aorto-ostial lesion. Although several vascular imaging modalities including ultrasonography, computed tomographic angiography, magnetic resonance angiography or catheter angiography, play crucial roles for diagnosing Takayasu arteritis, the intravascular ultrasound imaging of Takayasu arteritis is not well studied. CASE PRESENTATION: A 55-year-old woman who was diagnosed with heterozygous familial hypercholesterolemia underwent coronary angiography due to effort angina, which showed ostial left anterior descending coronary artery (LAD) stenosis. Although directional coronary atherectomy followed by drug-coated balloon was successfully performed, 6 months later restenosis occurred at the ostial LAD, and the ostial left circumflex coronary artery (LCx) progressed significantly. The intravascular ultrasound imaging in these lesions was noteworthy, in which the media was partly unrecognizable and an echo intensity similar to fibrotic intimal thickening traversed from the intima to the adventitia, thereby causing the whole image of the coronary artery to become unclear. Directional coronary atherectomy followed by drug-coated balloon procedures for both LAD and LCx lesions were performed again. Systemic examination of computed tomographic angiography found no other stenotic lesions except for those in the coronary arteries. Five months later, the LAD and LCx lesions progressed diffusely, therefore the coronary artery bypass graft was done. The histopathological findings of specimens of the coronary artery that were obtained during the bypass graft showed excessive fibrous thickening of the intima and adventitia, with granulomatous inflammation in the media, which led to the diagnosis of isolated coronary Takayasu arteritis. Systemic corticosteroid therapy was then started. CONCLUSIONS: We described an extremely rare case of isolated and non aorto-ostial Takayasu arteritis. The characteristic intravascular ultrasound images of diseased coronary arteries may help in the diagnosis of coronary Takayasu arteritis.

Scoring System for Identification of "Survival Advantage" after Successful Percutaneous Coronary Intervention in Patients with Chronic Total Occlusion.

BACKGROUND: Percutaneous coronary intervention (PCI) is widely used in patients with chronic total occlusion (CTO), but its benefit in improving long-term outcomes is controversial. We aimed to develop a prediction score for grading "survival advantage" conferred by successful results of CTO-PCI and a scoring system for prediction of the influence of CTO-PCI results on major adverse cardiac and cerebrovascular events (MACCEs). METHODS: Follow-up data of 2625 patients who underwent CTO-PCI at 65 Japanese centers were analyzed. An integer scoring system was developed by including statistical effect modifiers on the association between successful CTO-PCI and one-year mortality. RESULTS: Follow-up at 12 months was completed in 2034 patients. During follow-up, 76 deaths (3.7%) occurred. Patients with successful CTO-PCI had a better one-year survival than patients with failed CTO-PCI (log rank P = 0.016). Effect modifiers for the association between successful procedure and one-year mortality included diabetes (P interaction = 0.043), multivessel disease (P interaction = 0.175), Canadian Cardiovascular Society class ≥2 (P interaction = 0.088), and prior myocardial infarction (MI) (P interaction = 0.117). Each component was assigned a single point and summed to develop the scoring system. The patients were then categorized to specify the prediction of survival advantage by successful PCI: ≤2 (normal) and ≥3 (distinct). The differences in one-year mortality between patients with successful and failed treatment were -0.7% and 11.3% for normal and distinct score categories, respectively. In the scoring system for MACCE, score components were prior MI (P interaction = 0.19), left anterior descending artery (LAD)-CTO (P interaction = 0.079), and reattempt of CTO-PCI (P interaction = 0.18). The differences in one-year MACCEs between successful and failed patients for each score category (0, 1, and ≥2) were -1.7%, 7.5%, and 15.1%, respectively. CONCLUSIONS: The novel scoring system assessing the advantage of successful PCI can be easily applied in patients with CTO. It is a valid instrument for clinical decision-making while assessing the survival advantage of CTO-PCI and the influence of procedural results on MACCEs.

Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial.

Importance: Very short mandatory dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with a drug-eluting stent may be an attractive option. Objective: To test the hypothesis of noninferiority of 1 month of DAPT compared with standard 12 months of DAPT for a composite end point of cardiovascular and bleeding events. Design, Setting, and Participants: Multicenter, open-label, randomized clinical trial enrolling 3045 patients who underwent PCI at 90 hospitals in Japan from December 2015 through December 2017. Final 1-year clinical follow-up was completed in January 2019. Interventions: Patients were randomized either to 1 month of DAPT followed by clopidogrel monotherapy (n=1523) or to 12 months of DAPT with aspirin and clopidogrel (n=1522). Main Outcomes and Measures: The primary end point was a composite of cardiovascular death, myocardial infarction (MI), ischemic or hemorrhagic stroke, definite stent thrombosis, or major or minor bleeding at 12 months, with a relative noninferiority margin of 50%. The major secondary cardiovascular end point was a composite of cardiovascular death, MI, ischemic or hemorrhagic stroke, or definite stent thrombosis and the major secondary bleeding end point was major or minor bleeding. Results: Among 3045 patients randomized, 36 withdrew consent; of 3009 remaining, 2974 (99%) completed the trial. One-month DAPT was both noninferior and superior to 12-month DAPT for the primary end point, occurring in 2.36% with 1-month DAPT and 3.70% with 12-month DAPT (absolute difference, -1.34% [95% CI, -2.57% to -0.11%]; hazard ratio [HR], 0.64 [95% CI, 0.42-0.98]), meeting criteria for noninferiority (P < .001) and for superiority (P = .04). The major secondary cardiovascular end point occurred in 1.96% with 1-month DAPT and 2.51% with 12-month DAPT (absolute difference, -0.55% [95% CI, -1.62% to 0.52%]; HR, 0.79 [95% CI, 0.49-1.29]), meeting criteria for noninferiority (P = .005) but not for superiority (P = .34). The major secondary bleeding end point occurred in 0.41% with 1-month DAPT and 1.54% with 12-month DAPT (absolute difference, -1.13% [95% CI, -1.84% to -0.42%]; HR, 0.26 [95% CI, 0.11-0.64]; P = .004 for superiority). Conclusions and Relevance: Among patients undergoing PCI, 1 month of DAPT followed by clopidogrel monotherapy, compared with 12 months of DAPT with aspirin and clopidogrel, resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, meeting criteria for both noninferiority and superiority. These findings suggest that a shorter duration of DAPT may provide benefit, although given study limitations, additional research is needed in other populations. Trial Registration: ClinicalTrials.gov Identifier: NCT02619760.

Short-term outcome of percutaneous coronary intervention with directional coronary atherectomy followed by drug-coated balloon: a preliminary report.

Directional coronary atherectomy (DCA) is a unique technique used in percutaneous coronary intervention (PCI) which involves the removal of plaque from the coronary artery. Treatment with a drug-coated balloon (DCB) appears to be effective, especially when a predilatation of the lesion is performed appropriately. We hypothesize that the combination therapy of DCA with DCB is an effective strategy in PCI. PCI with DCA followed by DCB was performed for 23 patients from December 2014 to April 2017. All DCA procedures were performed under the guidance of intravascular ultrasound (IVUS) findings and all procedures were successfully performed without incurring major complications such as a coronary perforation. Plaque area (PA) was reduced from 77.3 ± 10.4% at baseline to 50.9 ± 9.2% after DCA and luminal cross-sectional area (CSA) after PCI was enlarged from 3.6 ± 1.8 to 9.3 ± 3.3 mm2. Follow-up coronary angiography (CAG) performed at 6-10 months showed no cases having incurred restenosis. Plaque area at follow-up CAG was 52.0 ± 8.5% and luminal CSA was 9.5 ± 2.1 mm2. There were no cases undergoing target vessel revascularization (TVR) and target lesion revascularization (TLR) during the follow-up periods. PCI with DCA followed by DCB might be an effective strategy for de novo lesions.

Quadricuspid pulmonary valve stenosis treated by transcatheter pulmonary valvuloplasty with inoue balloon catheter.

The quadricuspid pulmonary valve is a relatively common congenital anomaly which is rarely complicated clinically and also tends to be under-diagnosed. The following case report shows a 62-year-old man with exertional dyspnea due to quadricuspid pulmonary valve stenosis that was diagnosed by using electrocardiography-gated multiple detector computed tomography. He was then treated effectively by transcatheter balloon pulmonary valvuloplasty using an Inoue balloon catheter. .

Assessment of vascular response after drug-eluting stents implantation in patients with diabetes mellitus: an optical coherence tomography sub-study of the J-DESsERT.

Even in the drug-eluting stent era, diabetes mellitus (DM) patients have high incidences of restenosis and repeat revascularization after percutaneous coronary intervention. The aim of this study was to compare vascular response after stent implantation between sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) by using optical coherence tomography (OCT) in DM patients as well as in non-DM patients. In the Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT), the OCT sub-study enrolled 75 patients who underwent 8 months follow-up imaging after SES or PES implantation. Mean neointimal hyperplasia (NIH) thickness was significantly thinner in SES than PES in the DM group (77 ± 47 vs. 201 ± 114 µm, p < 0.001) and in the non-DM group (84 ± 37 vs. 212 ± 128 µm, p < 0.001). Unevenness of NIH thickness in longitudinal axis was significantly smaller in SES than PES in the DM group (348 ± 191 vs. 726 ± 385 µm, p < 0.001) and in the non-DM group (344 ± 174 vs. 679 ± 314 µm, p < 0.001). The percentage of uncovered struts was significantly greater in SES than PES in the DM group (24 ± 4 vs. 9 ± 14 %, p < 0.001) and in the non-DM group (16 ± 16 vs. 3 ± 4 %, p = 0.002). Compared with PES, SES showed more potent NIH inhibition in DM patients as well as in non-DM patients.

Lone aspiration thrombectomy without stenting for a patient with ST-segment elevation myocardial infarction associated with coronary ectasia.

A 57-year-old male with a previous history of inferior myocardial infarction suffered from chest pain and diagnosed as ST-segment elevation myocardial infarction (STEMI). Coronary angiography revealed a thrombus with delayed filling in the distal right coronary artery. After an aspiration thrombectomy, TIMI 3 flow was restored successfully. An intracoronary ultrasound imaging revealed coronary ectasia. Stenting and ballooning were deferred. A successful lone aspiration thrombectomy was performed for a patient with STEMI associated with coronary ectasia.

A case of massive pericardial effusion associated with hypocalcemic cardiomyopathy.

A 60-year-old woman with a 6-year history of numbness in her hands was admitted to hospital with dyspnea. Laboratory findings showed the elevation of creatine kinase (creatine kinase MB isoenzyme was less than 4 IU/l). Chest X-ray revealed cardiomegaly and pulmonary edema. Electrocardiogram showed a T wave inversion in V2-5 and a prolonged QT interval. Echocardiography demonstrated reduced left ventricular ejection fraction (LVEF) and massive pericardial effusion. The patient was diagnosed with heart failure. Further testing found hypocalcemia and idiopathic hypoparathyroidism. In addition to diuretics, calcium replacement therapy for hypocalcemia improved the LVEF and reduced pericardial effusion. Hypocalcemia rarely leads to heart failure and pericardial effusion. In our case, heart failure and the massive pericardial effusion were secondary to hypocalcemia due to idiopathic hypoparathyroidism. .

Acute myocardial infarction in Fukushima area of Japan.

Although acute myocardial infarction (AMI) is the most serious coronary disease, the background of its onset and the mortality are not fully understood, especially in Japan. From June 1999 to May 2005, we mailed an annual questionnaire to eighteen hospitals in which emergency cardiac catheterization and percutaneous coronary intervention (PCI) were available in the Fukushima area of Japan. A total of 1,590 patients were included. The onset time of AMI had two peaks, i.e., from 9:00 AM to 10:00 AM and 9:00 PM to 10:00 PM. As for reperfusion therapy, four groups were analyzed, the non-reperfusion therapy group (Group N, n = 233), thrombolysis alone group (Group T, n = 80), PCI without thrombolysis group (Group P, n = 1106), and PCI with thrombolysis group (Group TP, n = 151). The in-hospital mortality rate was significantly reduced in Group P (8.4%) compared with that in Group N (33.0%, p < 0.01) and Group T (18.8%, p < 0.01). However, the in-hospital mortality in Group P did not differ from that in Group TP (9.9%). The in-hospital mortality was analyzed by the logistic regression analysis among age, arrival time after onset, peak creatine kinase (CK) values, coronary risk factors, reperfusion therapy, PCI, and thrombolysis. There were significant differences in age (P < 0.01), peak CK values (p < 0.01), hypertension (p < 0.05), and diabetes mellitus (p < 0.01). These results suggest that the onset of AMI may be partly related to human biorhythms, and that PCI would be effective in reducing the in-hospital mortality.

Prediction of remote left ventricular volumes and functions after acute myocardial infarction with successful coronary intervention.

BACKGROUND: The scintigraphic perfusion defect size (DS) at 1 week after acute myocardial infarction (AMI) predicts remote left ventricular (LV) volumes and LV ejection fraction (LVEF). The present study examined whether LV volumes and LVEF 6 months after AMI may be better predicted by the combination of LV volumes and LVEF just after reperfusion, and DS at 1 week, after AMI in patients with Thrombolysis In Myocardial Infarction (TIMI) grade III reperfusion by percutaneous coronary intervention. METHODS AND RESULTS: In 48 patients with AMI and TIMI grade III reperfusion, quantitative gated SPECT (QGS) was performed just after reperfusion, and at 1 week and 6 months after AMI. LV end-diastolic volume index decreased (108+/-8 to 93+/-6 ml/m(2), p<0.05) and LVEF increased (44+/-3 to 50+/-2%, p<0.05) 6 months after AMI. In addition, they were better predicted by a combination of LV volumes and LVEF just after reperfusion and DS at 1 week after AMI. CONCLUSIONS: In AMI with TIMI grade III reperfusion, LV volumes and LVEF at 6 months after MI correlate with the values obtained just after reperfusion. Myocardial perfusion imaging combined with QGS at reperfusion may predict these late-phase parameters.