Non-Inferiority of Resolute Integrity Drug-Eluting Stent to Benchmark Xience Drug-Eluting Stent.

BACKGROUND: The Resolute Integrity coronary drug-eluting stent (DES), the next evolution of the Resolute DES, is designed with thinner stent struts and continuous sinusoidal technology to further enhance performance. This study evaluated the performance of the Resolute Integrity DES compared with the historical performance of Xience V. Methods and Results: We assessed the safety, efficacy, and deliverability of Resolute Integrity compared with the Xience DES, the prespecified historical control, in PROPEL, a large, real-world prospective, single-arm, open-label study. A total of 1,204 subjects were enrolled in PROPEL and treated with the Resolute Integrity DES at 76 sites in Japan. Lesion and procedural success rates were 100% and 99%, respectively. Patients were equally complex in the Resolute Integrity and Xience cohorts. At 1 year in the clinical-only cohort, the primary endpoint target lesion failure was 4.3% (34/800) in the Resolute Integrity cohort compared with 8.5% (97/1,142) in the Xience historical controls (P<0.001 for non-inferiority). Target vessel failure, major adverse cardiac events, target vessel myocardial infarction, and the composite cardiac death and target vessel myocardial infarction were all lower with Resolute Integrity compared with Xience, including in "high risk" patients. CONCLUSIONS: In the large, prospective, multicenter PROPEL trial, the performance of the Resolute Integrity DES was non-inferior to that of the benchmark Xience DES used as a historical comparator.

Optical coherence tomography analysis of the stent strut and prediction of resolved strut malapposition at 3 months after 2nd-generation drug-eluting stent implantation.

Our objective was to clarify whether thrombogenic problems with stent struts are resolved at 3 months after 2nd-generation drug-eluting stent implantation. Twenty-one patients with stable angina pectoris having 28 (22 zotarolimus-eluting, 6 everolimus-eluting) stents with optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) were evaluated. Stent strut coverage and malapposition were evaluated by OCT immediately after PCI and at 3-month follow-up. Acute strut malapposition was observed in 26 out of 28 analyzed stents (92.9 %). At 3-month follow-up, 7 (26.9 %) of those 26 stents with strut malapposition were completely resolved, and the mean percentages of uncovered struts and malapposed struts were 8.3 and 2.0 % when analyzed by each individual stent. When analyzing a total of 30,060 struts, 807 struts (2.7 %) demonstrated acute strut malapposition. Among these, 219 struts (27.1 %) demonstrated persistent strut malapposition. On the basis of receiver-operating characteristic curve analysis, a strut-to-vessel (S-V) distance ≤160 µm on post-stenting OCT images was the corresponding cutoff point for resolved malapposed struts (sensitivity 78.1 %, specificity 62.8 %, area under the curve 0.758). The S-V distance of persistent malapposed struts on post-stenting OCT images was longer than that of resolved malapposed struts (235 ± 112 vs. 176 ± 93 µm, p < 0.01). At 3 months after PCI, the prevalence rates of uncovered and malapposed struts were relatively low in 2nd-generation drug-eluting stent. Our results suggest that OCT-guide PCI with an S-V distance ≤160 µm may be recommended especially in patients with planed short-term DAPT.

Effect of combination therapy of ezetimibe and rosuvastatin on regression of coronary atherosclerosis in patients with coronary artery disease.

Ezetimibe has been reported to provide significant incremental reduction in low-density-lipoprotein cholesterol (LDL-C) when added to a statin; however, its effect on coronary atherosclerosis has not yet been evaluated in detail. The aim of this study was to investigate the add-on effect of ezetimibe to a statin on coronary atherosclerosis evaluated by intravascular ultrasound (IVUS).In this prospective randomized open-label study, a total of 51 patients with stable coronary artery disease (CAD) requiring percutaneous coronary intervention (PCI) were enrolled, and assigned to a combination group (n = 26, rosuvastatin 5 mg/day + ezetimibe 10 mg/day) or a monotherapy group (n = 25, rosuvastatin 5 mg/day). Volumetric IVUS analyses were performed at baseline and 6 months after the treatment for a non-PCI site. LDL-C level was significantly reduced in the combination group (-55.8%) versus that in the monotherapy group (-36.8%; P = 0.004). The percent change in plaque volume (PV), the primary endpoint, appeared to decrease more effectively in the combination group compared with the monotherapy group (-13.2% versus -3.1%, respectively, P = 0.050). Moreover, there was a significant group × time interaction in the effects of the two treatments on PV (P = 0.021), indicating the regressive effect of the combination therapy on PV was greater than that of monotherapy for subtly different values of baseline PV in the two treatment groups. Moreover, percent change in PV showed positive correlations with percent change of LDL-C (r = 0.384, P = 0.015).Intensive lipid-lowering therapy with ezetimibe added to usual-dose statin may provide significant incremental reduction in coronary plaques compared with usual-dose statin monotherapy.

Wire bias modification with reverse orbital atherectomy for safer rotational atherectomy in calcified bifurcation.

Although debulking devices are very useful in modifying calcified plaques, their effectiveness is highly dependent on wire bias. In particular, in eccentric calcified bifurcation lesions, wire bias tends to be poor and needs to be corrected for adequate lesion preparation. A 67-year-old man was diagnosed with exertional angina pectoris. Coronary angiography showed a highly calcified eccentric lesion from the left main trunk to the left anterior descending artery. The patient refused coronary artery bypass surgery, therefore we decided to treat this complex bifurcation lesion with percutaneous coronary intervention. Initially, we performed reverse orbital atherectomy (OA) and sifted the guide wire position into the calcified plaque successfully. We continued with rotational atherectomy (RA) using a 2.0 mm burr and were able to obtain sufficient lumen without complications. Finally, the lesion was dilated with a cutting balloon and a drug-coated balloon to obtain a stent-like result. This case demonstrates that wire bias modification with reverse OA enables us to perform more aggressive and effective RA safely in eccentric calcified bifurcation lesions. This combination atherectomy can become an attractive approach in eccentric calcified bifurcation lesions. Learning objective: Atherectomy devices are helpful for lesion modification in calcified lesions but their effectiveness is highly dependent on wire bias. If the wire bias can be intentionally moved to an optimal position, it can be a very effective procedure in the treatment of calcified lesions. Wire bias modification by reverse ablation with orbital atherectomy that we have demonstrated enables subsequent aggressive rotational atherectomy and this combination atherectomy can be an attractive approach in eccentric calcified lesions.

Relationship between CYP2C19 loss-of-function polymorphism and platelet reactivities with clopidogrel treatment in Japanese patients undergoing coronary stent implantation.

BACKGROUND: CYP2C19 loss-of-function genotype (*2 and/or *3 alleles) is related to low responsiveness to clopidogrel, which is a risk factor for ischemic cardiac events. The contribution of these genotypes to platelet reactivity in Japanese patients in a steady state receiving dual antiplatelet therapy after coronary stenting was evaluated. METHODS AND RESULTS: A total of 155 Japanese patients were classified according to their CYP2C19 loss-of-function genotype. Platelet reactivity was assayed by plasma levels of soluble P-selectin and platelet-derived microparticles, light transmittance aggregometry induced by ADP (ADP-LTA), shear stress-induced platelet aggregometry, vasodilator-stimulated phosphoprotein phosphorylation (VASP) index and the VerifyNow-P2Y12 assay. Linear and logistic regression models were used to assess the associations between CYP2C19 loss-of-function genotype and high on-treatment platelet reactivity. In total, 62 patients (40.0%) were extensive metabolizers (EMs), 70 (45.2%) were intermediate metabolizers (IMs) and 23 (14.8%) were poor metabolizers (PMs). ADP-specific assays (ADP-LTA, the VASP index and VerifyNow-P2Y12) differed according to CYP2C19 genotype, with a significant gene-dose effect (PMs>IMs>EMs). CYP2C19 loss-of-function carrier status was associated with more frequent high platelet reactivity. CYP2C19 loss-of-function genotype alone could explain 12.2%, 14.3%, and 14.7% of the variability in the ADP-LTA, VASP and VerifyNow-P2Y12 assays, respectively. CONCLUSIONS: CYP2C19 loss-of-function genotype is associated with more frequent high platelet reactivity, as assessed by ADP-specific platelet function tests, in Japanese patients.

Operator experience and clinical outcomes of percutaneous coronary intervention for chronic total occlusion: insights from a pooled analysis of the Japanese CTO PCI Expert Registry and the Retrograde Summit General Registry.

There have not been enough studies to examine the association between difference in operator experience and technical success rate in contemporary percutaneous coronary intervention for chronic total occlusion (CTO-PCI). The present study sought to provide insights into the impact of operator experience on clinical outcomes of CTO-PCI through a comparison of two largest Japanese CTO-PCI registries consisting of operators with different CTO-PCI experience. After combining clinical data from the Japanese CTO-PCI Expert Registry (ER) 2014-2016 (N = 4316) including CTO-PCI performed by highly experienced operators and the Retrograde Summit General Registry (RSGR) 2014-2016 (N = 2230) including CTO-PCI performed by less experienced operators, a pooled analysis was performed to compare clinical outcomes of CTO-PCI in 2 registries. The overall technical success rate and the incidence of in-hospital major adverse events were comparable between ER and RSGR (90.1% vs 88.9%, p = 0.133, 1.7% vs 1.5%, p = 0.606, respectively). Technical success rate in ER was significantly higher among the patients treated with primary antegrade approach (91.8% vs 89.5%, p = 0.009), whereas there was no significant difference among the patients treated with the primary retrograde approach (85.7% vs 85.3%, p = 0.857). Multivariate analysis suggested ER operator could not be an independent predictor for technical success. CTO-PCI performed by less experienced but appropriately trained operators could achieve similarly high technical success rate with comparable safety compared with those performed by highly experienced specialists in contemporary Japanese context.

Diagnostic accuracy of 1.5-T unenhanced whole-heart coronary MR angiography performed with 32-channel cardiac coils: initial single-center experience.

PURPOSE: To compare the imaging time and image quality obtained with whole-heart coronary magnetic resonance (MR) angiography performed with five- and 32-channel coils in healthy subjects and determine the accuracy of MR angiography performed with 32-channel coils in the detection of obstructive coronary artery disease (CAD). MATERIALS AND METHODS: The institutional review board approved the study protocol, and all participants provided written informed consent. The authors studied 10 healthy subjects and 67 patients suspected of having CAD who were scheduled for coronary angiography. Unenhanced 1.5-T coronary MR angiography was performed with five- and 32-channel coils in healthy subjects and with 32-channel coils in patients. Clinically significant CAD was defined as a diameter reduction of at least 50% at coronary angiography. The sensitivity and specificity of coronary MR angiography were calculated. RESULTS: The mean imaging time was substantially reduced from 12.3 minutes ± 4.2 (standard deviation) with five-channel coils to 6.3 minutes ± 2.2 with 32-channel coils, with equivalent image quality scores. Acquisition of MR angiograms was completed in all 67 patients, with a mean imaging time of 6.2 minutes ± 2.8. The prevalence of CAD in the study population was 58% (39 of the 67 patients). The areas under the receiver operating characteristic curves as determined at vessel- and patient-based analyses were 0.91 and 0.90, respectively; the sensitivity and specificity at vessel-based analysis were 86% and 93%, respectively. CONCLUSION: Whole-heart coronary MR angiography performed at 1.5 T with 32-channel coils permits noninvasive detection of CAD with substantially reduced imaging time. This noninvasive approach can be an alternative to multidetector computed tomographic coronary angiography for ruling out obstructive CAD in patients who have a contraindication to contrast material and in young subjects who are at higher risk from ionizing radiation. SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11101323/-/DC1.

A case of successful percutaneous transluminal septal myocardial ablation for heart failure due to severe left ventricular outflow obstruction with Mönckeberg's arteriosclerosis, manifested after aortic valvular replacement.

Although percutaneous transluminal septal myocardial ablation (PTSMA) has been the established treatment of symptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM), the efficacy for specific HOCM is not elucidated. We report a successful case of PTSMA for heart failure with severe left ventricular outflow tract (LVOT) obstruction due to sigmoid-shaped interventricular septum and diffuse left ventricular hypertrophy with Mönckeberg's arteriosclerosis and aortic valvular stenosis. While the PTSMA relieved LVOT obstruction and symptoms in the acute phase, the modest recurrence was confirmed 6 months later, which is rare in the case of idiopathic HOCM. The possible mechanisms of LVOT obstruction and recurrence are discussed.

New coronary aneurysm formation and malapposition after zotarolimus-eluting stent implantation in Kawasaki disease.

Coronary artery involvement is the most important complication of Kawasaki disease. Coronary artery bypass surgery has been performed for ischemic heart disease caused by Kawasaki disease, however, long-term coronary graft patency is not satisfactory. Therefore, percutaneous coronary intervention (PCI) has its role in Kawasaki disease-related coronary artery disease. The incidence of new aneurysm is lower following stent implantation than balloon dilatation alone, even if a higher balloon pressure is applied. However, there are few reports about the efficacy of drug-eluting stent implantation for Kawasaki disease with coronary artery disease. Here, we describe a case of new coronary aneurysm formation and malapposition after zotarolimus-eluting stent implantation in Kawasaki disease. .

Marked improvement of renal failure and severe hypertension after renal artery stenting in the solitary functioning kidney.

Atherosclerotic renal artery stenosis (ARAS) can cause resistant hypertension, progressive renal failure and/or cardiorenal syndrome. Although no randomized study to demonstrate the superiority of renal stenting over medical treatment is available, a case-sensitive approach is required for the treatment of ARAS. Here, we describe a case report of a symptomatic ARAS patient with a solitary functioning kidney in which successful detection of ARAS by ultrasonography examination with the Doppler method and timely renal artery stenting were performed. .

A case of aortic thrombosis and embolism preceding the progression of early esophageal cancer.

Aortic thrombosis is rare, especially in non-atherosclerotic aortae. A 51-year-old woman presented with intermittent claudication in the right lower extremity. She was diagnosed as having peripheral artery disease on ultrasound. A computed tomography scan showed a large, sessile, aortic mural thrombus from the infrarenal abdominal aorta to the right common iliac artery. An arteriogram showed an abrupt occlusion of the right superficial femoral artery with collateral arteries. She had no risk factors for atherosclerosis. Interestingly, this occurred before early esophageal cancer progressed. Heparin was administered intravenously and later changed to warfarin. In the follow-up period, the thrombus disappeared, and her symptoms improved. A careful investigation for malignant disease is needed when aortic thrombus occurs in patients with no atherosclerosis risk factors. .

The impact of preprocedural hemoglobin A1c on the efficacy of sirolimus-eluting and paclitaxel-eluting stents.

Several reports have shown contrary results regarding the efficacy of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in diabetic patients. The association between hemoglobin A1c (A1c) before coronary intervention and the midterm clinical outcomes of patients treated with these stents is unclear. The enrolled population was 415 patients with diabetes or impaired glucose tolerance (IGT) who underwent follow-up angiography after being implanted with a SES (n = 282) or PES (n = 133). The enrolled population was classified into the optimal glycemic control group (n = 213) and suboptimal glycemic control group (n = 202), and the predictors of restenosis were examined in each group. In the optimal glycemic control group, the use of PES was an independent predictor of restenosis [odds ratio (OR) 9.98, 95% confidence interval (CI) 3.08-38.9, p < 0.0001]; on the other hand, the use of SES was a positive independent predictor of restenosis prevention (OR 0.10, 95% CI 0.03-0.32, p < 0.0001). In the suboptimal glycemic control group, neither stent was predictive of restenosis. In a subanalysis, preprocedural A1c (≥7.0%) was found to be an independent predictor of restenosis in the SES group (OR 3.61, 95% CI 1.14-12.8, p = 0.03), but not the PES group. Postprocedural A1c (≥7.0%) was not an independent predictor of restenosis in either stent group. This study showed that the superiority of SES compared to PES was attenuated in the suboptimal glycemic control group. Preprocedural A1c (≥7.0%) was found to be an independent predictor of restenosis in the SES group, but not in the PES group.

Efficacy of linear block at the left atrial roof in atrial fibrillation.

BACKGROUND: After extensive encircling of ipsilateral pulmonary vein isolation (EEPVI) for atrial fibrillation (AF), we sometimes observe AF recurrence, or the occurrence of atrial tachycardia originating from the left atrium. This study examined the efficacy of additional linear ablation at the left atrial (LA) roof in combination with EEPVI to prevent arrhythmia recurrences. METHODS: This study included 104 patients with drug-refractory AF (75 with paroxysmal, 29 with persistent). The patients in Group A (n=70) underwent EEPVI treatment alone, and the patients in Group B (n=34) underwent linear ablation at the LA roof in addition to EEPVI treatment. At 1, 3, 6, and 12 months after ablation, patients underwent clinical review and 24-h ambulatory electrocardiogram monitoring to identify asymptomatic arrhythmias. Follow-up included daily trans-telephonic event monitoring, transmitted irrespective of the patient's symptoms. RESULTS: At 12 months, 57% of Group A and 79% of Group B were free of arrhythmias (p<0.05). Cox regression analysis demonstrated that among the variables of age, sex, duration of AF, types of AF (paroxysmal or persistent), LA size, ejection fraction, existence of hypertension, ischemic heart disease, valvular heart disease, history of stroke, and the ablation technique, only the ablation technique of the linear block at the LA roof was the independent predictor of arrhythmia-free recovery after ablation. CONCLUSIONS: EEPVI in combination with the linear ablation at the LA roof is associated with an improved clinical outcome compared with EEPVI alone.

Biventricular pacing worsened dyssynchrony in heart failure patient with right-bundle branch block.

The use of a biventricular pacing system for patients with complete right-bundle branch block (CRBBB) is still controversial. Although cardiac resynchronization therapy-defibrillator (CRT-D) was implanted in a heart failure patient with CRBBB, dyssynchrony worsened and stroke volume decreased, and this patient was re-admitted due to exacerbated heart failure. Therefore, evaluation of dyssynchrony and cardiac function after implantation of a biventricular pacing system may be needed in patients with atypical indications for CRT.