An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial.

BACKGROUND: Bleeding rates on dual antiplatelet therapy (DAPT) within 1 month after percutaneous coronary intervention (PCI) remain high in clinical practice, particularly in patients with acute coronary syndrome or high bleeding risk. Aspirin-free strategy might result in lower bleeding early after PCI without increasing cardiovascular events, but its efficacy and safety have not yet been proven in randomized trials. METHODS: We randomly assigned 6002 patients with acute coronary syndrome or high bleeding risk just before PCI either to prasugrel (3.75 mg/day) monotherapy or to DAPT with aspirin (81-100 mg/day) and prasugrel (3.75 mg/day) after loading of 20 mg of prasugrel in both groups. The coprimary end points were major bleeding (Bleeding Academic Research Consortium 3 or 5) for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) for noninferiority with a relative 50% margin. RESULTS: The full analysis set population consisted of 5966 patients (no-aspirin group, 2984 patients; DAPT group, 2982 patients; age, 71.6±11.7 years; men, 76.6%; acute coronary syndrome, 75.0%). Within 7 days before randomization, aspirin alone, aspirin with P2Y12 inhibitor, oral anticoagulants, and intravenous heparin infusion were given in 21.3%, 6.4%, 8.9%, and 24.5%, respectively. Adherence to the protocol-specified antiplatelet therapy was 88% in both groups at 1 month. At 1 month, the no-aspirin group was not superior to the DAPT group for the coprimary bleeding end point (4.47% and 4.71%; hazard ratio, 0.95 [95% CI, 0.75-1.20]; Psuperiority=0.66). The no-aspirin group was noninferior to the DAPT group for the coprimary cardiovascular end point (4.12% and 3.69%; hazard ratio, 1.12 [95% CI, 0.87-1.45]; Pnoninferiority=0.01). There was no difference in net adverse clinical outcomes and each component of coprimary cardiovascular end point. There was an excess of any unplanned coronary revascularization (1.05% and 0.57%; hazard ratio, 1.83 [95%CI, 1.01-3.30]) and subacute definite or probable stent thrombosis (0.58% and 0.17%; hazard ratio, 3.40 [95% CI, 1.26-9.23]) in the no-aspirin group compared with the DAPT group. CONCLUSIONS: The aspirin-free strategy using low-dose prasugrel compared with the DAPT strategy failed to attest superiority for major bleeding within 1 month after PCI but was noninferior for cardiovascular events within 1 month after PCI. However, the aspirin-free strategy was associated with a signal suggesting an excess of coronary events. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111.

Pulmonary hypertension secondary to interstitial fibrosis with pulmonary venous lesions masquerading pulmonary veno-occlusive disease.

We present a 41-year-old man with idiopathic interstitial pneumonia and pulmonary hypertension (PH) in the setting of a non-autoimmune background whose clinical presentation masqueraded pulmonary veno-occlusive disease (PVOD). Because of no histological evidence of venous occlusion in his previous lung biopsy, phosphodiesterase type-5 inhibitor was given, resulting in sudden onset of pulmonary edema. At autopsy, there were histological features of interstitial fibrosis with occlusion of the lobular septal veins and venules. Clinical presentations of PH due to interstitial fibrosis with pulmonary venous lesions may simulate those of PVOD and careful diagnostic and therapeutic approaches are required.

Intracardiac Thrombosis and Systemic Embolism in a Patient with Cardiac Amyloidosis in Sinus Rhythm.

Intracardiac thrombosis formation in patients in sinus rhythm is a rare phenomenon. An 84-year-old woman was admitted because of worsening dyspnea on exertion. An electrocardiogram showed sinus rhythm, left atrial overload, marked left axis deviation, low voltage, and poor r-wave progression in leads V1-4. An echocardiogram showed relatively preserved left ventricular ejection fraction with minimal wall thickening. Her serum level of B-type natriuretic peptide (931 pg/mL) was markedly elevated and a diagnosis of worsening heart failure was made. During the course of treatment for heart failure, she was complicated by acute abdominal aortic thromboembolism together with left atrial thrombus. An emergency abdominal aortic thrombectomy was followed by the removal of a left atrial thrombus 2 days later. Left ventricular biopsy performed during the surgery revealed amyloid deposits in the myocardial interstitium. Immunohistochemical study confirmed the diagnosis of transthyretin cardiac amyloidosis. It is postulated that the risk of intracardiac thrombosis and systemic embolism is increased even in sinus rhythm in patients with cardiac amyloidosis.

Fulminant lymphocytic myocarditis: Prediction of successful weaning from Impella support for cardiogenic shock.

We present a series of four patients with biopsy-proven fulminant lymphocytic myocarditis with cardiogenic shock and discuss whether it is possible to predict recovery of left ventricular function and successful weaning at the time of initial placement of mechanical circulatory support. Impella CP (Abiomed, Danvers, MA, USA) was placed in these patients on admission. Patients 1 and 2 made complete recovery. Patient 3 proceeded to bi-ventricular assist device and is currently waiting for transplantation. Patient 4 proceeded to Impella 5 but died from multiple organ failure. Although the Impella provides excellent hemodynamic support, outcomes of the patients with fulminant myocarditis with Impella support may depend upon the severity of myocarditis and myocardial failure. In addition to the previously reported predictors such as the level of elevated biomarkers, the severity of ventricular wall edema, and the development of rhythm disturbances, the absence of right ventricular dysfunction seems important to predict successful weaning from Impella support. .

Dual-Chamber pacing for postoperative residual left ventricular gradient after aortic valve replacement and concomitant septal myectomy for severe aortic stenosis and subvalvular obstruction.

BACKGROUND: Aortic stenosis is occasionally associated with subvalvular obstruction and remaining obstruction may at times be found after aortic valve replacement. CASE REPORT: A 69-year-old woman with a history of several episodes of unconsciousness was admitted because of exertional chest oppression. The echocardiography revealed severe aortic stenosis (flow velocity 6.2 m/sec, maximum / mean pressure gradient 152 / 99 mmHg, valve area 0.59 cm2) as well as gradient within the left ventricular cavity from the mid ventricular level (flow velocity 4.5 m/sec, maximum gradient 82 mmHg). Despite aortic valve replacement and concomitant septal myectomy which was thought adequate in reducing subvalvular pressure gradient during surgery, postoperative echocardiography revealed significant residual mid ventricular gradient (flow velocity 4.9 m/sec, maximum gradient 95 mmHg). It was decided to implant dual-chamber pacemaker, which resulted in significant reduction of residual mid ventricular gradient (flow velocity 1.4 m/sec, maximum gradient 8 mmHg). CONCLUSION: Dual-chamber pacing was extremely effective in reducing residual mid ventricular gradient in a patient who underwent aortic valve replacement and concomitant septal myectomy for severe aortic stenosis and subvalvular obstruction..

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.

Primary Cardiac Lymphoma: A Lesson Learned from an Unsuccessful Experience.

A 79-year-old man was admitted because of complete heart block. Echocardiograms showed an abnormal mass adjacent to the sinus of Valsalva. Subsequent surgical resection was not successful. Despite chemotherapy, the patient died from multiple organ failure. It is important to recognize that approximately 80% of cases of cardiac lymphoma are diffuse large B-cell lymphoma, which is the only malignant neoplasm that may respond well to chemotherapy with rituximab. In order to save patients' lives, the early implementation of chemotherapy with rituximab is critical and should be considered as a therapeutic diagnostic option in select patients.

Second-Generation vs. First-Generation Drug-Eluting Stents in Patients With Calcified Coronary Lesions　- Pooled Analysis From the RESET and NEXT Trials.

BACKGROUND: The comparative efficacy of second-generation (G2) vs. first-generation (G1) drug-eluting stents (DES) for calcified coronary lesions is unknown.Methods and Results:We compared the 3-year clinical outcomes of patients with G1- or G2-DES according to the presence or absence of calcified coronary lesions as assessed in an angiographic core laboratory using data from 2 large-scale prospective multicenter randomized trials, RESET and NEXT. G1-DES and G2-DES were implanted in 299 and 1,033 patients, respectively, in the Calc stratum (≥1 lesion with moderate/severe calcification), and 1,208 and 3,550 patients, respectively, in the Non-calc stratum (no/mild calcification). The patients in the Calc stratum had a significantly higher adjusted risk for the primary outcome measure (any target-lesion revascularization (TLR)) than those in the Non-calc stratum (HR: 1.38, 95% CI: 1.11-1.71, P=0.004). The cumulative 3-year incidence of any TLR was not significantly different between the G1-DES and G2-DES groups in both the Calc and Non-calc strata (12.1% vs. 9.7%, P=0.22, and 6.8% vs. 6.1%, P=0.44, respectively). After adjusting for confounders, the effect of G2DES relative to G1-DES for any TLR remained insignificant in both the Calc and Non-calc strata (HR: 0.78, 95% CI: 0.48-1.25, P=0.3, and HR: 0.84, 95% CI: 0.61-1.17, P=0.31, respectively, P interaction=0.55). CONCLUSIONS: The effect of G2-DES relative to G1-DES for TLR was not significantly different regardless of the presence or absence of lesion calcification.

Comprehensive arrhythmic surgery for sustained ventricular tachycardia revisited.

A 68-year-old woman with a history of old inferior myocardial infarction was admitted because of sustained ventricular tachycardia. Double vessel coronary disease was found with subtotal obstruction of the right coronary artery (#1) and severe stenosis of the left circumflex coronary artery (#13). Dilated left ventricle with a large ventricular aneurysm at the inferior wall and severely reduced systolic function were also present. A comprehensive surgical ablation using subendocardial resection and cryoablation was performed in combination with aneurysmectomy, left ventricular reconstruction, and coronary bypass grafting to the circumflex coronary artery. An implantable cardioverter-defibrillator was also implanted. She has remained well without recurrence of sustained ventricular tachycardia for one year. Although radiofrequency catheter ablation is nowadays considered a first-line therapy for patients with sustained ventricular tachycardia, surgical ablation remains a valuable option for selected patients, particularly for those requiring left ventricular aneurysmectomy and coronary artery bypass grafting, in order to gain a better long-term prognosis through total cure of ventricular tachycardia. .

Subacute effusive-constrictive pericarditis: Echocardiography-guided diagnosis and management.

A 49-year-old man presented with flu-like symptoms of two weeks. Electrocardiogram showed diffuse ST elevation. Blood samples revealed severe renal failure and moderate inflammatory results. Echocardiogram showed large pericardial effusion, dilated inferior vena cava, but no right ventricular collapse. The patient underwent hemodialysis, after which he developed clinical signs of cardiac tamponade with echocardiographic features of collapse of the right ventricle. Pericardial drainage was then performed revealing purulent fluid of 800 ml. Streptococcus agalactiae was found in the cultures of urine, blood, and pericardial fluid. Despite removal of the pericardial fluid, echocardiogram failed to show any improvement in dilated inferior vena cava and estimated right atrial pressure remained elevated. Thus, a diagnosis of subacute effusive-constrictive pericarditis was made. Following antibiotic treatment for purulent pericarditis, early pericardiectomy was performed under transesophageal echocardiographic monitoring which successfully guided surgeons to careful removal of thick and adhesive visceral pericardium as well as an additional Waffle procedure resulting in significant clinical and hemodynamic improvement. Echo-guided approach is most practical in establishing the diagnosis of effusive-constrictive pericarditis and also most helpful in obtaining successful surgical results. .

Late rupture of artificial neochordae associated with hemolytic anemia.

A 63-year-old man, status post-mitral valve repair for severe mitral regurgitation secondary to ruptured chordae of the anterior leaflet, was admitted seven years after surgery because of a recent history of hematuria. A new apical pansystolic murmur was audible. Hemoglobin level was 5.7 g/dL. Results of other hematologic studies and a peripheral blood smear were indicative of mechanical hemolysis. Transesophageal echocardiography showed a high-velocity jet of mitral regurgitation that directly collided with the annuloplasty ring. At re-operation, one of the artificial neochordae to A2 and A3 segments was found to be disrupted. The mitral valve was replaced with a 33/31 mm On-X valve. Hemolytic anemia disappeared immediately after surgery. Although mitral valve repair with artificial neochodae has been shown to have long-term durability, it should be recognized that artificial neochordae may rupture a long time after mitral valve repair. Also, although hemolytic anemia is known as an early complication after mitral valve repair, it is worth knowing that hemolytic anemia may occur as a late complication after mitral valve repair. Continuous long-term monitoring of the patients after mitral valve repair is recommended. .

Effect of Optimal Medical Therapy Before Procedures on Outcomes in Coronary Patients Treated With Drug-Eluting Stents.

It has not been established whether the achievement of optimal medical therapy (OMT) before implantation of a drug-eluting stent has a clinical benefit for patients with stable coronary artery disease (CAD). This study included 3,004 patients with CAD treated with drug-eluting stent from 123 Japanese participating centers. The achievement of OMT was defined as control of blood pressure <130/80 mm Hg, hemoglobin A1c <7.0%, and low-density lipoprotein cholesterol <100 mg/dl. The primary end point was target vessel failure, a composite of death related to the target vessel, myocardial infarction, or clinically driven revascularization at 24 months after stent implantation. Immediately before the procedure, only 548 patients (18.2%) had achieved all 3 target criteria (the achieved OMT group), whereas the remaining 2,456 patients failed to achieve one or more criteria (the non-OMT group). At 24 months, the incidence of target vessel failure was 7.0% in the achieved OMT group versus 10.0% in the non-OMT group (hazard ratio 0.68, 95% CI 0.48 to 0.96, p = 0.03). The incidence of non-Q-wave myocardial infarction was also lower in the achieved OMT group than in the non-OMT group (0.5% vs 1.5%, p = 0.08). Multivariate logistic regression analysis identified that hemoglobin A1c <7.0% was the only protective predictor of 24-month target vessel failure (odds ratio 0.56, 95% CI 0.43 to 0.73, p <0.01). In conclusion, this study demonstrated that in patients with stable CAD scheduled for stent implantation, achievement of OMT before percutaneous coronary intervention significantly reduced subsequent cardiac events. Achievement of OMT is still insufficient in modern clinical practice.

Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry.

BACKGROUND: There is a scarcity of long-term data from large-scale drug-eluting stent registries with a large enough sample to evaluate low-frequency events such as stent thrombosis (ST). METHODS AND RESULTS: Five-year outcomes were evaluated in 12 812 consecutive patients undergoing sirolimus-eluting stent (SES) implantation in the j-Cypher registry. Cumulative incidence of definite ST was low (30 day, 0.3%; 1 year, 0.6%; and 5 years, 1.6%). However, late and very late ST continued to occur without attenuation up to 5 years after sirolimus-eluting stent implantation (0.26%/y). Cumulative incidence of target lesion revascularization within the first year was low (7.3%). However, late target lesion revascularization beyond 1 year also continued to occur without attenuation up to 5 years (2.2%/y). Independent risk factors of ST were completely different according to the timing of ST onset, suggesting the presence of different pathophysiological mechanisms of ST according to the timing of ST onset: acute coronary syndrome and target of proximal left anterior descending coronary artery for early ST; side-branch stenting, diabetes mellitus, and end-stage renal disease with or without hemodialysis for late ST; and current smoking and total stent length >28 mm for very late ST. Independent risk factors of late target lesion revascularization beyond 1 year were generally similar to those risk factors identified for early target lesion revascularization. CONCLUSION: Late adverse events such as very late ST and late target lesion revascularization are continuous hazards, lasting at least up to 5 years after implantation of the first-generation drug-eluting stents (sirolimus-eluting stents), which should be the targets for developing improved coronary stents.

Incidence and outcome of surgical procedures after sirolimus-eluting stent implantation: a report from the j-Cypher registry.

The incidence of surgical procedures after sirolimus-eluting stent (SES) implantation and, more importantly, the rate of perioperative stent thrombosis (ST) and/or other adverse events have not yet been adequately addressed. The incidence and outcome of the surgical procedures after SES implantation were prospectively evaluated in a large-scale multicenter registry of patients undergoing SES implantation. Among 12,824 patients enrolled in the registry, cumulative incidences of surgical procedures were 0.7% at 60 days, 5.1% at 1 year and 14.7% at 3 years. Surgical procedures were performed in 1,430 patients including non-coronary artery bypass graft (CABG) surgery in 1,275 patients and CABG in 189 patients. The incidences of death/myocardial infarction/ST (definite or probable) and ST (definite or probable) at 30 days after surgical procedures were 2.7 and 0.35%, respectively. Surgery performed within 60 days after SES implantation as compared with that performed beyond 60 days was associated with significantly higher incidences of death/myocardial infarction/ST (definite or probable) and ST (definite or probable) at 30 days after surgical procedures (6.4 vs. 2.5%: P = 0.02 and 2.2 vs. 0.23%: P = 0.002, respectively). Surgery within 60 days as well as hemodialysis and small body mass index were independent risk factors of death/myocardial infarction/ST (definite or probable) identified by multivariable analysis. Surgical procedures were required fairly often after SES implantation. The incidences of adverse cardiac events including ST after surgical procedures were acceptably low. Surgery within 60 days after SES implantation carried significantly higher risks as compared with those beyond 60 days.

Smoking cessation after discharge among Japanese patients with established ischemic heart disease: a prospective cohort study.

In this prospective cohort study for Japanese patients with established ischemic heart disease (IHD), the authors investigated the rate of success of smoking cessation 3 months after hospital discharge and its related factors. The subjects included 90 current smokers admitted for IHD. A total of 58 subjects (64%) had quit smoking for 3 months after being discharged. In comparison with subjects with acute myocardial infarction, those with stable angina (SA) showed a significantly lower frequency of smoking cessation (relative risk of resuming smoking (95% confidence interval):2.06 (1.09, 3.92), p=0.036). This relationship remained significant even after controlling for sex, age, and scores of the Fagerstrom Test for Nicotine Dependence (adjusted odds ratio:3.39 (1.01, 11.37), p=0.048). However, it became insignificant when hospital admission followed by emergency medical service (EMS) care was additionally adjusted (adjusted odds ratio:2.48 (0.36, 16.97), p=0.356). The smoking cessation rate in this study was identical to that observed in studies conducted in Japan prior to the recent social changes with regard to tobacco use. SA still appears to be a risk factor for smoking resumption after discharge. Experiencing EMS care would be an intermediate variable in this relationship.