Rationale and Design of Prospective, Multicenter, Double-Arm Clinical Trial to Investigate the Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus (TOP-HFPEF Trial).

BACKGROUND: Recent large clinical trials have revealed that sodium-glucose cotransporter 2 (SGLT2) inhibitors improve cardiovascular outcomes not only in patients with heart failure with reduced ejection fraction, but also in patients with heart failure with mildly reduced or preserved ejection fraction (HFpEF). However, the effect of SGLT2 inhibitors on left ventricular (LV) diastolic function is still controversial. METHODS AND RESULTS: The TOP-HFPEF trial (Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus) is a multicenter, double-arm, open-label, confirmatory, investigator-initiated clinical study to investigate the effect of SGLT2 inhibitor on LV diastolic function in patients with HFpEF and type 2 diabetes mellitus. The participants are randomly assigned (1:1) to the tofogliflozin group (20 mg once daily) or the control group (administration or continuation of antidiabetic drugs other than SGLT2 inhibitors). The estimated number of patients to be enrolled in this trial is 90 in total (45 in each group). The participants are followed up for 52 weeks with tofogliflozin or control drugs. The primary endpoint is the change in E/e' assessed by echocardiography from the baseline to the end of this study (52 weeks). This trial will also evaluate the effects of tofogliflozin on cardiovascular events, biomarkers, other echocardiographic parameters, the occurrence of atrial fibrillation, and renal function. CONCLUSIONS: The TOP-HFPEF trial will clarify the efficacy of an SGLT2 inhibitor, tofogliflozin, on LV diastolic function in patients with HFpEF and type 2 diabetes mellitus.

[Clipping of a Large Unruptured Basilar Artery Trunk Large Aneurysm Using Rapid Ventricular Pacing:A Case Report].

Neck clipping of basilar trunk aneurysms, particularly those of a large size, is challenging because of its location. Here, we report a case of a basilar artery aneurysm successfully treated with neck clipping using rapid ventricular pacing(RVP). A 67-year-old woman was referred to our hospital for treatment of a large basilar artery aneurysm. Although coiling was considered, we performed neck clipping of this aneurysm because of the expected radical therapeutic effect. The patient was positioned in the right park-bench position, and right suboccipital craniotomy was performed. The aneurysm was mainly approached via the right supracerebellar route. RVP softened the aneurysm for easy dissection and insertion of multiple clips. The postoperative course was uneventful, and she was discharged 1 week later without neurological deficits. RVP should be considered for the treatment of complex aneurysms as adjunctive techniques.

Vascular response to biolimus A-9 eluting stent in patients with shorter and prolonged dual antiplatelet therapy: optical coherence tomography sub-study of the NIPPON trial.

Dual antiplatelet therapy (DAPT) with thienopyridine and aspirin is the standard care for the prevention of stent thrombosis. However, the optimal duration and effect of the duration of DAPT on intra-stent thrombus (IS-Th) formation are unknown. The NIPPON study (Nobori Dual Antiplatelet Therapy as Appropriate Duration) was an open label, randomized multicenter, assessor-blinded, trial designed to demonstrate the non-inferiority of shorter (6-month) DAPT to prolonged (18-month) DAPT, after biolimus A9 eluting stent implantation in 3773 patients at 130 sites in Japan. Among them, 101 patients were randomly allocated for an optical coherence tomography (OCT) sub-study to assess the difference of local IS-Th formation between the two groups. In addition to standard OCT parameters, the number of IS-Th formed was counted in each target stent at 8 months. Baseline patient characteristics were not different between the 6- and 18-month groups. IS-Th was detected in 9.8% of the cases and the presence of IS-Th was not significantly different between the two groups (10.9% in 6-month vs. 9.1% in 12-month, P = 0.76). Furthermore, the number of IS-Th formed was not significantly different between the two groups. This OCT sub-study was in line with the main NIPPON study which demonstrated the non-inferiority of 6-month DAPT to 18-month DAPT. Shorter DAPT duration did not promote progressive IS-Th formation at the mid-term time point.

Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results.

AIMS: Optical frequency domain imaging (OFDI) is a recently developed, light-based, high-resolution intravascular imaging technique. Intravascular ultrasound (IVUS) is a widely used, conventional imaging technique for guiding percutaneous coronary intervention (PCI). We aimed to demonstrate the non-inferiority of OFDI-guided PCI compared with IVUS-guided PCI in terms of clinical outcomes. METHODS AND RESULTS: We did a prospective, multicentre, randomized (ratio 1:1), active-controlled, non-inferiority study to compare head-to-head OFDI vs. IVUS in patients undergoing PCI with a second generation drug-eluting stent. The primary endpoint was target vessel failure defined as a composite of cardiac death, target-vessel related myocardial infarction, and ischaemia-driven target vessel revascularization until 12 months after the PCI. The major secondary endpoint was angiographic binary restenosis at 8 months. We randomly allocated 829 patients to receive OFDI-guided PCI (n = 414) or IVUS-guided PCI (n = 415). Target vessel failure occurred in 21 (5.2%) of 401 patients undergoing OFDI-guided PCI, and 19 (4.9%) of 390 patients undergoing IVUS-guided PCI, demonstrating non-inferiority of OFDI-guided PCI to IVUS-guided PCI (hazard ratio 1.07, upper limit of one-sided 95% confidence interval 1.80; Pnon-inferiority = 0.042). With 89.8% angiographic follow-up, the rate of binary restenosis was comparable between OFDI-guided PCI and IVUS-guided PCI (in-stent: 1.6% vs. 1.6%, P = 1.00; and in-segment: 6.2% vs. 6.0%, P = 1.00). CONCLUSION: The 12-month clinical outcome in patients undergoing OFDI-guided PCI was non-inferior to that of patients undergoing IVUS-guided PCI. Both OFDI-guided and IVUS-guided PCI yielded excellent angiographic and clinical results, with very low rates of 8-month angiographic binary restenosis and 12-month target vessel failure. CLINICAL REGISTRATION: ClinicalTrials.gov, number NCT01873027.

Long-term prognostic impact of the attenuated plaque in patients with acute coronary syndrome.

Several intravascular ultrasound studies have reported that culprit lesion-attenuated plaque (AP) is related to slow flow/no reflow after percutaneous coronary intervention (PCI). Long-term prognostic impact of the AP is unknown. The aim of this study was to investigate acute and long-term clinical impact of the AP in patients with acute coronary syndrome (ACS). A total of 110 ACS patients who underwent successful PCI were enrolled. Acute and long-term clinical outcomes were compared between patients with AP (AP group: n = 73) and those without AP (non-AP group: n = 37). Long-term cardiac event was defined as a composite of death and ACS. Baseline characteristics in 2 groups were similar. AP was associated with higher TIMI frame count immediately after the first balloon inflation. After thrombectomy and intracoronary drug administration, final TIMI frame count became similar between AP and non-AP group. Although AP was associated with higher incidence of fatal arrhythmia during hospitalization, in-hospital mortality did not differ between the 2 groups. During follow-up (median 6.2 years), cardiac event-free survival did not differ between the 2 groups. Despite the initial unfavorable effect on coronary reflow, presence of AP did not affect acute as well as long-term clinical outcome in patients with ACS.

Serum n-3 to n-6 polyunsaturated fatty acids ratio correlates with coronary plaque vulnerability: an optical coherence tomography study.

A low ratio of eicosapentaenoic acid to arachidonic acid (EPA/AA) has been demonstrated to be associated with a higher risk of cardiovascular events. Optical coherence tomography (OCT) is useful for the assessment of coronary plaque vulnerability. The purpose of this study was to evaluate the association between EPA/AA ratio and coronary plaque vulnerability. This study involved 58 patients with stable angina pectoris undergoing percutaneous coronary intervention. OCT image acquisition was performed before the procedure in the culprit lesions. We assessed lipid-rich plaque length and arc, fibrous cap thickness, frequency of thin-cap fibroatheroma (TCFA), thrombus, ruptured plaque, macrophage infiltration, and microvessels using OCT. Patients were divided into two groups according to the median value of serum EPA/AA ratio: a low-EPA/AA group (n = 29, EPA/AA ratio <0.36) and a high-EPA/AA group (n = 29, EPA/AA ratio ≥0.36). In qualitative analyses, TCFA (35.4 vs 6.9 %, P = 0.0095), macrophage infiltration (48.3 vs 13.8 %, P = 0.0045), and microvessels (44.8 vs 10.3 %, P = 0.0033) were more frequently observed in the low-EPA/AA group. In quantitative analyses, the low-EPA/AA group had wider maximum lipid arc (114.0 ± 94.8° vs 56.4 ± 66.0°, P = 0.0097), longer lipid length (4.8 ± 4.5 vs 1.6 ± 2.6 mm, P = 0.0037), and thinner fibrous cap (69.3 ± 28.3 vs 113.3 ± 46.6 µm, P = 0.005) compared with the high-EPA/AA group. EPA/AA ratio was positively correlated with fibrous cap thickness (r = 0.46, P = 0.007). In a multivariate model, an EPA/AA ratio <0.36 was associated with the presence of TCFA (odds ratio 6.41, 95 % confidence interval 1.11-61.91, P = 0.0371). In our detailed OCT analysis, lower EPA/AA ratio was associated with higher vulnerability of coronary plaques to rupture.

Leadless Pacemaker Implantation in Severe Kyphosis: Challenging Implantation for Tortuous IVC and Narrow RA.

Leadless pacemaker implantation is recognized as safe and effective for treating bradycardia. However, there are limited descriptions of its use in patients with complex anatomical considerations. Here, we present a case detailing the successful implantation of a leadless pacemaker with a tortuous inferior vena cava and a narrow right atrium.

Unique Extraction of a Fractured Pacemaker Lead Adhered to the Spermatic Vein.

Transvenous lead extraction has been increasingly recognized as a safe and effective method of lead extraction, but there are only few references for extracting leads migrating outside the heart. We present a successful extraction of a fractured pacemaker lead from the spermatic vein using several approaches and multiple tools.

Aortic atherosclerotic plaque and long-term prognosis in patients with atrial fibrillation-a transesophageal echocardiography study.

BACKGROUND: Both left atrial spontaneous echo contrast (LASEC) and aortic atherosclerotic plaque (AoP) ≥ 4.0 mm in thickness are predictors of cardiovascular events after stroke. The aim of this study was to investigate impact of AoP ≥ 4.0 mm or LASEC on cardiovascular events in patients with atrial fibrillation (AF). METHODS AND RESULTS: One hundred and eight consecutive patients with AF were enrolled and studied. Patients were grouped according to the presence or absence of AoP ≥ 4.0 mm in the proximal aortic arch on transesophageal echocardiography (TEE). Cardiovascular events included death, myocardial infarction, ischemic stroke, systemic embolism and congestive heart failure. During a follow-up period (median, 3.9 years), cardiovascular event-free survival rate was significantly lower in patients with AoP ≥ 4.0 mm than in patients without AoP ≥ 4.0 mm (log-rank, P=0.01). In contrast, patients with LASEC showed a trend toward lower cardiovascular event-free survival than those without LASEC (log-rank, P=0.10). Univariate TEE predictors of cardiovascular events were AoP ≥ 4.0 mm, LASEC and left atrial appendage flow velocity. On multivariate Cox regression analysis, AoP ≥ 4.0 mm was the only TEE predictor of cardiovascular events during follow-up (P=0.02, hazard ratio, 2.6; 95% confidence interval: 1.1-6.0). CONCLUSIONS: In the present unselected patients with AF, AoP predicted long-term cardiovascular events.

Usefulness of functional assessment in the treatment of patients with moderate angiographic paclitaxel-eluting stent restenosis.

BACKGROUND: In recent years there has been a debate about the functional severity of restenosis of drug-eluting stents. The aim of the present study was to assess the functional severity of stenosis in patients with moderate angiographic restenosis after paclitaxel-eluting stents (PES) deployment. METHODS AND RESULTS: Forty-two patients with moderate angiographic restenosis at the in-stent segment and/or approximately 5mm from the stent edge were enrolled. For comparison, furthermore, 42 patients with de novo stenosis lesions matched for angiographic severity were assigned to the control group. Quantitative coronary angiography and functional assessment using fractional flow reserve (FFR) were performed. Although percent diameter stenosis was not significantly different between the 2 groups (PES group, 40.6±11.2%; de novo group, 40.6±9.0%, P=0.981), the functional severity of stenosis was significantly less in the PES group than in the de novo group (FFR: PES group, 0.86±0.07; de novo group, 0.79±0.10, P=0.002). CONCLUSIONS: FFR was preserved in patients with moderate angiographic restenosis after PES deployment, and the functional severity of restenosis is often limited. Therefore, revascularization should be performed with caution for patients with moderate angiographic restenosis after PES deployment.

Successful Extraction of Guidewire Entrapped in the Tricuspid Valve Leaflet Using a Laser Sheath.

Right ventriculography is a necessary step for implantation of leadless pacemaker and is considered a safe procedure. However, an inappropriate manipulation of the guidewire can lead to serious complications. We present a case where the guide-wire was entrapped in the tricuspid valve, and its successful extraction using a laser sheath. (Level of Difficulty: Advanced.).

Comparison of MECHANISM of early and late vascular responses following treatment of ST-elevation acute myocardial infarction with two different everolimus-eluting stents: a randomized controlled trial of biodegradable versus durable polymer stents.

The early and mid-term arterial healing profile of biodegradable polymer-coated everolimus-eluting stents (BP-EES) is unclear, especially in ST-segment elevation myocardial infarction (STEMI) culprit lesions. This study aimed to compare early- and mid-term arterial healing between durable polymer-coated everolimus-eluting stents (DP-EES) and BP-EES in STEMI patients. In a prospective, multicenter, non-inferiority trial, STEMI patients were randomized to receive BP-EES (n = 60) or DP-EES (n = 60). The primary endpoint of this study was the mean percentage of covered struts (%covered struts) on FD-OCT 2 weeks post-PCI. Key secondary endpoints included the percentage of uncovered struts, frequency of abnormal intra-stent tissue, and percentage of malapposed struts by FD-OCT 2 weeks and 12 months post-PCI. They underwent serial frequency-domain optical coherence tomography (FD-OCT) evaluations immediately after percutaneous coronary intervention, and at 2 weeks and at 12 months after the procedure. The primary endpoint of %covered struts at 2 weeks was 71.4% in BP-EES and 72.3% in DP-EES [risk difference - 0.94%, lower limit of one-sided 95% confidence interval (CI) - 5.6; Pnon-inferiority = 0.0756]. At 12 months, the mean percentage of uncovered struts was significantly lower [1.73% (95% CI 0.28-3.17) vs. 4.81% (95% CI 3.52-6.09); p = 0.002], and the average malapposed volume was significantly smaller in the BP-EES group than in the DP-EES group (p = 0.002). At 12 months, BP-EES had a significantly larger average neointimal area with a significantly smaller average intra-stent tissue unevenness score than DP-EES, suggesting more uniform neointimal coverage with BP-EES. Strut coverage was comparable between BP-EES and DP-EES at 2 weeks. Non-inferiority could not be proven because of an insufficient sample size. The significantly better arterial healing with BP-EES at 12 months suggests a safer profile for STEMI culprit lesions.Trial registration: jRCTs022180024 https://jrct.niph.go.jp/en-latest-detail/jRCTs022180024.

Detailed observation of arterial healing after stent implantation in swine arteries by using optical coherence tomography.

BACKGROUND: Histopathological examination is not suitable for sequential in vivo analysis of arterial healing after stenting because it can be performed only after the animals are killed. Optical coherence tomography (OCT) provides higher resolution than intravascular ultrasound (IVUS). The aim of this study was to compare arterial healing images after stenting on the basis of the findings of histopathological examination, IVUS, and OCT. METHODS: We examined 12 vessels; 12 bare-metal stents were implanted in 6 miniature swine. Histopathological examination, IVUS, and OCT imaging were performed at 1 and 4 weeks after stenting. For quantitative analysis of IVUS and OCT images, we examined cross-sectional frames at 1-mm intervals. For neointimal coverage analysis, the neointimal coverage score was classified into 1 of the 4 categories. A fully covered strut was scored as 3, a partially covered strut was scored as 1 or 2, and an uncovered strut was scored as 0. RESULTS: In IVUS and OCT analyses, the average neointimal thickness increased between 1 and 4 weeks (p < 0.0001). OCT revealed higher scores at 1 and 4 weeks than IVUS did (at week 1, p < 0.0001; at week 4, p < 0.0001). OCT analysis evaluated the neointimal coverage similarly to histopathological examination. CONCLUSIONS: On assessment of arterial healing after stenting, we found that the results of the histological examination were more similar to those of the OCT analysis than to those of the IVUS. An OCT imaging device can be used to precisely and sequentially analyze the arterial healing process after stenting.

Utility of myocardial fractional flow reserve for prediction of restenosis following sirolimus-eluting stent implantation.

Drug-eluting stents reduce restenosis due to neointimal growth suppression. Considering long-term outcomes, it is both difficult and important to predict drug-eluting stent restenosis. Thus, this study was designed to examine the utility of myocardial fractional flow reserve (FFR) as a predictor of sirolimus-eluting stent (SES) restenosis. Thirty-three patients (35 lesions) were enrolled. Upon completion of SES implantation, FFR was obtained under hyperemia. At 8 months of follow-up, coronary angiography revealed that five lesions had restenosis. Percent diameter stenosis (restenosis 68.7 ± 12.8% vs. non-restenosis 68.7 ± 12.4%, p = 0.78) and lesion length (restenosis 15.8 ± 9.4 mm vs. non-restenosis 14.4 ± 9.2 mm, p = 0.60) were similar. At post-intervention, percent diameter stenosis (restenosis 16.4 ± 6.1% vs. non-restenosis 14.0 ± 7.4%, p = 0.48) and minimum stent area (restenosis 6.01 ± 1.08 mm2 vs. non-restenosis 6.27 ± 1.85 mm2, p = 0.92) were also equivalent. However, proximal edge lumen area was smaller (restenosis 4.24 ± 1.40 mm2 vs. non-restenosis 7.73 ± 2.64 mm2, p = 0.004) and FFR was lower in the restenosis group (restenosis 0.81 ± 0.12 vs. non-restenosis 0.92 ± 0.06, p = 0.029). SES patients with restenosis had a lower FFR post stent deployment, suggesting the decreased FFR may be a useful predictor for SES restenosis.

Predictors and prognostic impact of secondary mitral regurgitation in myocardial infarction with preserved ejection fraction.

BACKGROUND: Secondary or functional mitral regurgitation (FMR) has been reported associated with poor prognosis in patients with ischemic or non-ischemic cardiomyopathy. Prognostic impact of the FMR in myocardial infarction with preserved ejection fraction (MIpEF) is unknown. The aim of this study was to investigate predictors and prognostic impact of FMR in MIpEF. METHODS: A total of 556 patients with MIpEF were selected from the Bell Land General Hospital MI (BELAMI) registry (n = 953). Patients were grouped according to the presence or absence of severe FMR. Clinical endpoint was all-cause death. RESULTS: Severe FMR was present in 26 patients (4.7%) (FMR group) and absent in 530 patients (control). FMR group was older (77.5 ± 7.2 vs. 67.3 ± 11.3 years, P < 0.01) and had more female gender (54% vs. 28%, P < 0.01). By echocardiography, FMR group had larger left atrial diameter and left ventricular end-systolic volume. E and E/e' were significantly higher and deceleration time of E was significantly shorter in FMR group. By Kaplan-Meier analysis, survival was significantly lower in FMR group than in control (log-rank, P = 0.004). CONCLUSION: Severe FMR is rare in MI patients with preserved EF but is associated with poor long-term prognosis.

An Unexpected Complication of Subcutaneous ICD Implantation and its Successful Management.

Subcutaneous implantable cardioverter-defibrillator implantation is known to be a safe procedure. However, inappropriate lead insertion can lead to serious complications. We present a case where an inappropriate lead placement resulted in puncturing the lung parenchyma, and successful management of the lead-related pneumothorax through thoracoscopic lead removal and partial lung resection. (Level of Difficulty: Intermediate.).

OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON in patients with Acute Coronary Syndrome: Study protocol for a randomized controlled trial.

BACKGROUND: A recent clinical trial demonstrated that optical frequency domain imaging (OFDI) guidance in percutaneous coronary intervention (PCI) is noninferior to intravascular ultrasound (IVUS) guidance in patients with coronary artery disease with regard to target vessel failure (composed of cardiac death, myocardial infarction attributed to the target vessel, and clinically-driven target vessel revascularization) at 12 months. The impact of OFDI guidance in PCI for patients with acute coronary syndrome (ACS) remains uncertain. METHODS: OPINION ACS is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial in Japan. Eligible patients will be randomly assigned to receive either OFDI- or IVUS-guided PCI. PCI is performed using the sirolimus-eluting stent in accordance with certain OFDI and IVUS criteria for optimal stent deployment. All patients will undergo follow-up angiography and OFDI imaging at 8 months. The primary endpoint is the minimum lumen area, as measured by OFDI at 8 months. CONCLUSION: The OPINION ACS trial outcomes will provide insights regarding the impact of OFDI-guided PCI on in-stent restenosis at 8 months in patients with ACS.

Utility of novel volumetric intravascular ultrasound analysis software for coronary artery disease.

BACKGROUND: Volumetric intravascular ultrasound (IVUS) analysis has contributed significantly to the assessment of coronary artery disease. The aim of this study is to validate the novel IVUS analysis software (NICORAS) compared to the previously validated software (EchoPlaque). METHODS: Selected from clinical cases, we used 30 IVUS images that utilized motorized pullback at 0.5 mm/sec. Judging from at least two vascular landmarks, identical coronary artery segments were selected and analyzed with two software systems (NICORAS and EchoPlaque). Lumen and external elastic membrane (EEM) borderlines were traced at every 0.5 mm interval. Plaque area was calculated as EEM minus lumen area. Then, volumetric IVUS data were calculated using interpolated frame data from which lumen, EEM, and plaque volume were computed. RESULTS: The average analyzed coronary segment was 15.4 +/- 4.3 mm. There was excellent agreement between NICORAS and EchoPlaque for lumen volume (r = 0.999, p < 0.0001), EEM volume (r= 0.999, p < 0.0001), and plaque volume (r = 0.998, p < 0.0001). CONCLUSION: The new volumetric IVUS analysis software provided IVUS data similar to previously examined software.

Early vascular responses to everolimus-eluting cobalt-chromium stent in the culprit lesions of st-elevation myocardial infarction: results from a multicenter prospective optical coherence tomography study (MECHANISM-AMI 2-week follow-up study).

The use of cobalt-chromium everolimus-eluting stents (CoCr-EES) for ST-segment elevation myocardial infarction (STEMI) reduces the incidence of stent thrombosis compared with bare metal stents, and a substantial difference is apparent in the initial 2 weeks. However, vascular behavior during this early period remains unclear. This was a prospective study (MECHANISM-AMI-2W) to investigate early vascular responses in STEMI patients immediately after CoCr-EES implantation and at 2-week follow-up using frequency domain-optical coherence tomography (FD-OCT). The study enrolled 52 patients (age 63.7 ± 11.7 years, male 85.0%), of whom 44 patients were available for complete serial FD-OCT analyses. Both % uncovered struts and % malapposed struts were improved at 2-week follow-up (63 ± 20 vs. 21 ± 14%, p < 0.0001 and 7.3 ± 9.0 vs. 4.7 ± 5.9%, p = 0.005, respectively). Thrombus was decreased, with significant changes in longitudinal length to stent (28.8 ± 27.7 vs. 18.1 ± 20.2%, p = 0.0001) and maximal area (0.93 ± 0.84 vs. 0.65 ± 0.63 mm2, p = 0.034). As a result, the average lumen area was significantly larger at 2 weeks (6.49 ± 1.82 vs. 6.71 ± 1.89 mm2, p = 0.048, respectively). The number of dissection flaps was lower (0.86 ± 1.11 vs. 0.52 ± 0.90%, p = 0.024). In conclusion, this study showed early vascular responses to CoCr-EES for STEMI lesions-including a significant reduction of thrombus-that resulted in lumen enlargement, earlier progression of strut coverage, and improvements in strut apposition and dissection. The combination of these factors may therefore be responsible for the safety of CoCr-EES within the initial 2 weeks.

Early and Mid-Term Vascular Responses to Optical Coherence Tomography-Guided Everolimus-Eluting Stent Implantation in Stable Coronary Artery Disease.

BACKGROUND: Analysis of pooled clinical data has shown the safety of 3 months of dual antiplatelet therapy with everolimus-eluting cobalt-chromium stents (Co-Cr EESs). This study evaluated early and mid-term vascular responses to Co-Cr EESs in patients with stable coronary artery disease. METHODS: The Multicenter Comparison of Early and Late Vascular Responses to Everolimus-Eluting Cobalt-Chromium Stent and Platelet Aggregation Studies in Patients With Stable Angina Managed as Elective Case (MECHANISM-Elective) study (NCT02014818) is a multicenter optical coherence tomography (OCT) registry. Enrolled patients were evaluated by OCT immediately after everolimus-eluting stent implantation were prospectively allocated to 1 month (n = 50) or 3 months (n = 50) OCT follow-up and then received a 12-month OCT evaluation. The incidences of intrastent thrombus (IS-Th) and irregular protrusion (IRP) were also assessed. RESULTS: The percentage of uncovered struts was 6.4% ± 10.3% at 1 month (P < 0.001 vs. postprocedure) and 0.5% ± 0.9% at 12 months (P < 0.001 vs. 1 month). The corresponding values in the 3-month cohort were 2.0% ± 2.5% (P < 0.001 vs. postprocedure) and 0.5% ± 1.5% (P < 0.001 vs. 3 months). The incidence of IS-Th was 32.7% at 1 month, 5.4% at 3 months, and 2.0% at 12 months. IRP was observed in 21.8% of patients post-EES but had totally resolved at 1, 3, and 12 months. CONCLUSION: Early and mid-term vascular reactions after Co-Cr EES implantation in stable patients with coronary artery disease in the MECHANISM-Elective included dynamic resolution of IS-Th and IRP and rapid decrease in uncovered struts. Thus, EES may allow shortening of dual antiplatelet therapy duration less than 3 months in this patient subset.