Single-Session Versus Staged Multivessel Optimal IVUS-Guided PCI in Patients With CCS or NSTE-ACS.

Background: There are no studies comparing single-session vs staged multivessel intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) in patients with chronic coronary syndrome (CCS) or non-ST-segment-elevation acute coronary syndrome (NSTE-ACS). Objectives: The authors aimed to compare single-session vs staged multivessel IVUS-guided PCI in patients with CCS or NSTE-ACS. Methods: The OPTIVUS-Complex PCI study multivessel cohort was a prospective multicenter single-arm trial enrolling 1,021 patients with CCS or NSTE-ACS undergoing multivessel PCI including left anterior descending coronary artery using IVUS aiming to meet the prespecified OPTIVUS criteria for optimal stent expansion. We compared single-session vs staged multivessel PCI. The primary endpoint was a composite of death, myocardial infarction, stroke, or any coronary revascularization. Results: There were 246 patients (24.1%) undergoing single-session multivessel PCI, and 775 patients (75.9%) undergoing staged multivessel PCI. There was a wide variation in the prevalence of single-session multivessel PCI across the participating centers. The staged multivessel PCI group more often had complex coronary anatomy such as 3-vessel disease, chronic total occlusion, and calcified lesions requiring an atherectomy device compared with the single-session multivessel PCI group. The rates of PCI success, procedural complications, and meeting OPTIVUS criteria were not different between groups. The cumulative 1-year incidence of the primary endpoint was not different between single-session and staged multivessel PCI groups (9.0% vs 10.8%, log-rank P = 0.42). After adjusting confounders, the effect of single-session multivessel PCI relative to staged multivessel PCI was not significant for the primary endpoint (HR: 0.95; 95% CI: 0.58-1.55; P = 0.84). Conclusions: Single-session and staged multivessel IVUS-guided PCI had similar 1-year outcomes.

Dual Antiplatelet Therapy Duration After Multivessel Optimal Intravascular Ultrasound-Guided Percutaneous Coronary Intervention.

BACKGROUND: There is a scarcity of data evaluating contemporary real-world dual antiplatelet therapy (DAPT) strategies after percutaneous coronary intervention (PCI).Methods and Results: In the OPTIVUS-Complex PCI study multivessel cohort enrolling 982 patients undergoing multivessel PCI, including left anterior descending coronary artery using intravascular ultrasound (IVUS), we conducted 90-day landmark analyses to compare shorter and longer DAPT. DAPT discontinuation was defined as withdrawal of P2Y12inhibitors or aspirin for at least 2 months. The prevalence of acute coronary syndrome and high bleeding risk by the Bleeding Academic Research Consortium were 14.2% and 52.5%, respectively. The cumulative incidence of DAPT discontinuation was 22.6% at 90 days, and 68.8% at 1 year. In the 90-day landmark analyses, there were no differences in the incidences of a composite of death, myocardial infarction, stroke, or any coronary revascularization (5.9% vs. 9.2%, log-rank P=0.12; adjusted hazard ratio, 0.59; 95% confidence interval, 0.32-1.08; P=0.09) and BARC type 3 or 5 bleeding (1.4% vs. 1.9%, log-rank P=0.62) between the off- and on-DAPT groups at 90 days. CONCLUSIONS: The adoption of short DAPT duration was still low in this trial conducted after the release of the STOPDAPT-2 trial results. The 1-year incidence of cardiovascular events was not different between the shorter and longer DAPT groups, suggesting no apparent benefit of prolonged DAPT in reducing cardiovascular events even in patients who undergo multivessel PCI.

Target Lesion Revascularization After Intravascular Ultrasound-Guided Percutaneous Coronary Intervention.

BACKGROUND: Several stent expansion criteria derived from the intravascular ultrasound (IVUS) evaluation have been proposed to predict future clinical outcomes, but optimal stent expansion criteria as a guide during percutaneous coronary intervention (PCI) are still controversial. There are no studies evaluating the utility of stent expansion criteria along with the clinical and procedural factors in predicting target lesion revascularization (TLR) after contemporary IVUS-guided PCI. METHODS: OPTIVUS-Complex PCI study (Optimal Intravascular Ultrasound Guided Complex Percutaneous Coronary Intervention) multivessel cohort was a prospective multicenter study enrolling 961 patients undergoing multivessel PCI including left anterior descending coronary artery using IVUS with an intention to meet the prespecified criteria for optimal stent expansion. We compared several stent expansion criteria (minimum stent area [MSA], MSA/distal or average reference lumen area, MSA/distal or average reference vessel area, OPTIVUS criteria, IVUS-XPL [Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions] criteria, ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-Comers" Coronary Lesions] criteria, and modified MUSIC [Multicenter Ultrasound Stenting in Coronaries Study] criteria) as well as clinical, angiographic, and procedural characteristics between lesions with and without TLR. RESULTS: Among 1957 lesions, the cumulative 1-year incidence of lesion-based TLR was 1.6% (30 lesions). Hemodialysis, treatment of proximal left anterior descending coronary artery lesions, calcified lesions, small proximal reference lumen area, and small MSA had univariate associations with TLR, while all of the stent expansion criteria except for MSA were not associated with TLR. The independent risk factors of TLR were calcified lesions (hazard ratio, 2.34 [95% CI, 1.03-5.32]; P=0.04) and small proximal reference lumen area (Tertile 1: hazard ratio, 7.01 [95% CI, 1.45-33.93]; P=0.02; and Tertile 2: hazard ratio, 5.40 [95% CI, 1.17-24.90]; P=0.03). CONCLUSIONS: In contemporary IVUS-guided PCI practice, the 1-year incidence of TLR was very low. MSA, but not other stent expansion criteria, had univariate association with TLR. Independent risk factors of TLR were calcified lesions and small proximal reference lumen area, although the findings should be interpreted with caution due to small number of TLR events, limited lesion complexity, and short duration of follow-up.

Optimal Intravascular Ultrasound-Guided Percutaneous Coronary Intervention in Patients With Multivessel Disease.

Background: Intravascular ultrasound (IVUS) was only rarely used in landmark trials comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel disease. Objectives: The authors aimed to evaluate clinical outcomes after optimal IVUS-guided PCI in patients undergoing multivessel PCI. Methods: The OPTIVUS (OPTimal IntraVascular UltraSound)-Complex PCI study multivessel cohort was a prospective multicenter single-arm study enrolling 1,021 patients undergoing multivessel PCI, including left anterior descending coronary artery using IVUS, aiming to meet the prespecified criteria (OPTIVUS criteria: minimum stent area > distal reference lumen area [stent length ≥28mm], and minimum stent area >0.8 × average reference lumen area [stent length <28mm]) for optimal stent expansion. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) (death/myocardial infarction/stroke/any coronary revascularization). The predefined performance goals were derived from the CREDO-Kyoto (Coronary REvascularization Demonstrating Outcome study in Kyoto) PCI/CABG registry cohort-2 fulfilling the inclusion criteria in this study. Results: In this study, 40.1% of the patients met OPTIVUS criteria in all stented lesions. The cumulative 1-year incidence of the primary endpoint was 10.3% (95% CI: 8.4%-12.2%), which was significantly lower than the predefined PCI performance goal of 27.5% (P < 0.001), and which was numerically lower than the predefined CABG performance goal of 13.8%. The cumulative 1-year incidence of the primary endpoint was not significantly different regardless of meeting or not meeting OPTIVUS criteria. Conclusions: Contemporary PCI practice conducted in the OPTIVUS-Complex PCI study multivessel cohort was associated with a significantly lower MACCE rate than the predefined PCI performance goal, and with a numerically lower MACCE rate than the predefined CABG performance goal at 1 year.

[Very Late Stent Thrombosis during Perioperative Period of Aortic Valve Replacement:Report of a Case].

A 73-year-old man underwent drug eluting stent (DES) implantation in the left anterior descending artery (LAD) 11 years ago and in the right coronary artery (RCA) 8 years ago. He suffered from chest tightness and was diagnosed with severe aortic valve stenosis. Perioperative coronary angiography revealed no significant stenosis and thrombotic occlusion of the DES. Five days before operation, antiplatelet therapy was discontinued. Aortic valve replacement was performed uneventfully. But he developed chest pain and transient loss of consciousness, electrocardiographic changes were observed on the 8th postoperative day. Emergency coronary angiography revealed thrombotic occlusion of the drug eluting stent in the RCA, despite the postoperative oral adoministration of warfarin and aspirin. Percutaneous catheter intervention (PCI) restored the stent patency. Dual antiplatelet therapy (DAPT) was initiated immediately after the PCI, and anticoagulation therapy with warfarin was continued. Clinical symptons of stent thrombosis disappeared immediately after the PCI. He was discharged 7 days after the PCI.

Efficacy of Add-on Therapy with Carvedilol and the Direct Renin Inhibitor Aliskiren for Improving Cardiac Sympathetic Nerve Activity, Cardiac Function, Symptoms, Exercise Capacity and Brain Natriuretic Peptide in Patients with Dilated Cardiomyopathy.

Purpose/Method: Aliskiren is a direct renin inhibitor that has been reported to be effective for CHF, but the usefulness of combined therapy with carvedilol and aliskiren has not been reported. Forty-four patients with dilated cardiomyopathy (DCM) were randomized into a group receiving add-on therapy with carvedilol plus aliskiren and another group receiving carvedilol alone for 6 months. Nuclear imagings with 123I-Metaiodobenzylguanidine (MIBG) and 99mTc-Sestamibi were performed. Exercise capacity using a specific activity scale (SAS) and the New York Heart Association (NYHA) class were evaluated. Cardiac sympathetic nerve activity was evaluated by 123I-MIBG imaging, with the delayed heart-to-mediastinum activity ratio (H/M), delayed total defect score (TDS), and washout rate (WR). Results: Combined add-on therapy with carvedilol and aliskiren improved several parameters much more than carvedilol alone (p<0.05) with respect to TDS, ejection fraction (EF), NYHA, SAS on 6 months and the changes in TDS, EF, end-diastolic volume and brain natriuretic peptide (BNP). Conclusion: Add-on therapy with carvedilol and aliskiren is more effective than carvedilol alone for improving cardiac sympathetic nerve activity, cardiac function, symptoms, exercise capacity, and brain natriuretic peptide in patients with DCM.

Ventilatory Efficacy After Transcatheter Aortic Valve Replacement Predicts Mortality and Heart Failure Events in Elderly Patients.

BACKGROUND: We aimed to clarify the predictors of death or heart failure (HF) in elderly patients who undergo transcatheter aortic valve replacement (TAVR).Methods and Results:We prospectively enrolled 83 patients (age, 83±5 years) who underwent transthoracic echocardiography (TTE) and cardiopulmonary exercise testing (CPET) with impedance cardiography post-TAVR. We investigated the association of TTE and CPET parameters with death and the combined outcome of death and HF hospitalization. Over a follow-up of 19±9 months, peak oxygen uptake (V̇O2) was not associated with death or the combined outcome. The minimum ratio of minute ventilation (V̇E) to carbon dioxide production (V̇CO2) and the V̇E vs. V̇CO2slope were higher in patients with the combined outcome. After adjusting for age, sex, Society of Thoracic Surgeons score and peak V̇O2, ventilatory efficacy parameters remained independent predictors of the combined outcome (minimum V̇E/V̇O2: hazard ratio, 1.108; 95% confidence interval, 1.010-1.215; P=0.031; V̇E vs. V̇CO2slope: hazard ratio, 1.035; 95% confidence interval, 1.001-1.071; P=0.044), and had a greater area under the receiver-operating characteristic curve. The V̇E vs. V̇CO2slope ≥34.6 was associated with higher rates of the combined outcome, as well as lower cardiac output at peak work rate during CPET. CONCLUSIONS: In elderly patients, lower ventilatory efficacy post-TAVR is a predictor of death and HF hospitalization, reflecting lower cardiac output at peak exercise.

Diastolic Stunning as a Marker of Severe Coronary Artery Stenosis: Analysis by Speckle Tracking Radial Strain in the Resting Echocardiogram.

BACKGROUND: Two-dimensional speckle tracking (2DST) stress echocardiography detects postischemic myocardial diastolic stunning. However, the use of 2DST at rest for detecting diastolic stunning in ischemia is unclear. RESULTS: Thirty-nine patients (age = 65 ± 12 years; male/female = 34/5) with effort angina pectoris that was confirmed by stress myocardial perfusion scintigraphy were enrolled. Ischemic area (I) was determined in the middle LV short axial view using stress myocardial scintigraphy. The area opposite to it was defined as nonischemic area (non-I). Midventricular parasternal short-axis (SAX) radial strains were estimated using 2DST at rest on the following day. LV diastolic function was evaluated using diastolic index (DI, changes in the regional LV radial strain during diastole) and radial strain rate (SR) during early diastolic period. These parameters were compared between I and non-I before and 1 month after percutaneous coronary intervention (PCI) in the I of 3 coronary vessels. For the I, the DI was lower (38 ± 27 vs. 55 ± 27; P = 0.003) and SR was higher (-1.6 ± 0.6 vs. -1.9 ± 0.8; P = 0.007) than in non-I before PCI. One month after PCI, the DI and SR recovered to 53 ± 27 (P = 0.008) and -2.1 ± 0.8 (P = 0.006), respectively. Furthermore, the DI of the LAD and LCX significantly improved (P = 0.0004 and 0.002, respectively); the RCA area showed tendency to improve (P = 0.092), and the SR also improved (P < 0.05) in all areas after PCI. CONCLUSION: Diastolic stunning in ischemic areas can be detected using 2DST at rest and recover 1 month after PCI.

Two-year clinical outcome in patients with small coronary artery disease treated with everolimus- versus paclitaxel-eluting stenting.

BACKGROUND: Percutaneous coronary interventions involving small coronary vessels represent a true challenge because of the increased risk of restenosis and adverse outcomes. We evaluated the 2-year clinical outcomes between single everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in small coronary artery disease. METHODS: From the data of SACRA (SmAll CoronaRy Artery treated by TAXUS Liberté) and PLUM (PROMUS/Xience V Everolimus-ELUting Coronary Stent for sMall coronary artery disease) registries, 245 patients with 258 lesions and 264 patients with 279 lesions, respectively, were enrolled in this study. RESULTS: The 2-year clinical driven target lesion revascularization (4.5% vs. 10.6%, p=0.01) and target vessel revascularization (8.0% vs. 13.9%, p=0.03) rates were significantly lower in the EES group compared with the PES group. Major adverse cardiac events in the EES group tended to be lower than those in the PES group (8.7% vs. 14.3%, p=0.05). On the other hand, all new lesions for remote target vessel revascularization were observed at the proximal site of target lesions in both groups and those rates were not different between the two groups (3.4% vs. 3.3%, p>0.99). CONCLUSION: EES showed better clinical results at 2-year follow-up compared with PES in small coronary artery diseases, however, new lesions at the proximal remote site of the target lesion remain problematic.

Coronary artery calcification as a new predictor of non-target lesion revascularization during the chronic phase after successful percutaneous coronary intervention.

In the drug-eluting stent era, the outcome of patients undergoing percutaneous coronary intervention (PCI) has remarkably improved. Nevertheless, non-target lesion revascularization (non-TLR) is often performed even after successful PCI and optimized medical therapy. This study aimed to determine the predictor of non-TLR. In all, 125 consecutive patients with stable angina pectoris underwent intravascular ultrasound (IVUS)-guided PCI and were followed up for 3.3 ± 0.5 years. We performed oral glucose-tolerance tests in patients with no history of known diabetes mellitus (DM) to investigate glucose tolerance. To evaluate the severity of coronary artery calcification (CAC), we calculated CAC score by multiplying the arc (degree) with the length (mm) of the superficial calcium deposit detected by IVUS. Fourteen patients underwent non-TLR (non-TLR group); the remaining 111 did not (reference group). Glycosylated hemoglobin (HbA1c; %) and prevalence of known DM were similar in both groups, but the non-TLR group had higher fasting blood glucose (103 ± 16 vs. 94 ± 11 mg/dl, p = 0.04) and blood glucose (196 ± 60 vs. 149 ± 48 µU/ml, p = 0.01) and insulin at 2 h (184 ± 241 vs. 67 ± 49 µU/ml, p < 0.01) than did the reference group. CAC score was significantly higher in the non-TLR group (788 ± 585 vs. 403 ± 466, p = 0.01). Multiple logistic analysis indicated that CAC score is an independent predictor of non-TLR (p = 0.008). Non-TLR-free rate was significantly higher for patients with CAC score ≥400 than for those with CAC score <400 (p = 0.01). Non-TLR is associated with abnormal glucose tolerance and CAC score; CAC score is an independent predictor of non-TLR. Secondary prevention is especially important in patients with high CAC scores.

Combination of ¹²³I-metaiodobenzylguanidine scintigraphy and flow-mediated dilation for the detection of patients with coronary spastic angina.

BACKGROUND: This study evaluated the usefulness of cardiac sympathetic nerve activity, estimated by (123)I-MIBG scintigraphy, and endothelial function, estimated by flow-mediated dilation (FMD), in the detection of coronary spastic angina (CSA). METHODS AND RESULTS: We compared 78 consecutive patients suspected of CSA with ten age-matched controls. On the basis of a spasm provocation test with acetylcholine, 53 patients were diagnosed as CSA and 25 patients were considered to have chest-pain syndrome (CPS). The total defect score (TDS) by delayed (123)I-MIBG scintigraphy was significantly higher in both patient groups than in controls (P < 0.05), and was significantly higher in CSA than in CPS patients (P = 0.02). The heart/mediastinum activity (H/M) ratio by delayed (123)I-MIBG scintigraphy and FMD were significantly lower in both patient groups than in controls (P < 0.05), and were lower in CSA than in CPS patients (P = 0.04). In receiver-operating curve analysis, the areas under the curve for TDS, H/M, and FMD were 0.78, 0.72, and 0.70, respectively. The combination of delayed (123)I-MIBG scintigraphy and FMD showed a higher diagnostic value than either method alone. CONCLUSIONS: (123)I-MIBG scintigraphy and FMD can distinguish CSA patients among patients complaining of chest pain at rest, with good sensitivity and specificity.

Impact of angiographic peri-stent contrast staining (PSS) on late adverse events after sirolimus-eluting stent implantation: an observation from the multicenter j-Cypher registry PSS substudy.

This study sought to assess clinical significance of angiographic peri-stent contrast staining (PSS) after sirolimus-eluting stent (SES) implantation in a large multicenter study with 5-year follow-up. The j-Cypher PSS substudy is a multicenter study including 5712 patients (7838 lesions) who underwent follow-up angiographic study within 12 months after SES implantation. Late acquired PSS was observed in 184 patients (3.2 %) or 194 lesions (2.5 %). Independent risk factors of PSS were chronic total occlusion and left anterior descending artery lesion, while negative risk factors were in-stent restenosis, diabetes mellitus, ≥70 years of age, and left circumflex coronary artery lesion. Cumulative incidence of definite very late stent thrombosis (VLST) at 4 years after the index follow-up angiography in lesions with PSS was significantly higher than that in lesions without PSS (5.3 versus 0.7 %, P < 0.0001). Late target-lesion revascularization (TLR) was also more frequently observed in the PSS group (13 versus 6.9 %, P = 0.01), while late TLR for restenosis excluding those TLR procedures for VLST tended to be higher in the PSS group (9.9 versus 6.3 %; P = 0.15). PSS found in 2.5 % of lesions within 12 months after SES implantation was associated with higher risk for subsequent VLST.

Long-term clinical outcome of a single stent approach with and without a final kissing balloon technique for coronary bifurcation.

BACKGROUND: The advantages of the final kissing balloon technique (FKB) in a provisional 1-stent approach are under debate. Long-term clinical outcomes remain unclear due to limited data. METHODS AND RESULTS: Of 2,132 patients (2,502 lesions) enrolled in the TAXUS Japan Postmarket Surveillance Study at 56 centers between July 2007 and December 2008, patients having coronary bifurcation treated with a single cross-over stenting with FKB (FKB-group: 132 patients/137 lesions) were compared to those treated without FKB (no-FKB-group: 121 patients/124 lesions). The no-FKB-group was also compared with non-bifurcation patients who had a single-stent implantation (814 patients/937 lesions). The primary outcome was MACE (major adverse clinical events), defined as cardiac death, myocardial infarction and target vessel revascularization (TVR) at 3 years. Higher late loss and binary restenosis were found in the main vessel (MV) of the FKB-group at the 9-month angiogram compared to the no-FKB-group. At 3 years, MACE was numerically higher (14.6% vs. 6.9%, P=0.07) and TVR was significantly higher (14.6% vs. 5.9%, P<0.05) in the FKB-group compared with the no-FKB-group. The rate of MACE (6.9% vs. 10.4%, P=0.34) and TVR (5.9% vs. 7.7%, P=0.57) were similar between the no-FKB and non-bifurcation patients. CONCLUSIONS: In a 1-stent approach, FKB was associated with worse angiographic outcomes in the MV, and did not demonstrate any clinical benefit over the long-term follow-up period. Cross-over stenting without FKB showed similar clinical outcomes to patients without bifurcation.

A randomized comparison of sirolimus- vs. paclitaxel-eluting stents for treatment of bifurcation lesions by single stent and kissing balloon: results of the SINGLE KISS trial.

BACKGROUND: In the treatment of bifurcation lesions, routine stenting of both branches has thus far failed to demonstrate a clear clinical advantage over a provisional one-stent strategy. On the other hand, large scale data evaluating different stent types for clinical outcomes after one-stent treatment with final kissing inflation (FKI) of bifurcation lesions is also limited. This prospective study evaluated the clinical and angiographic outcomes of paclitaxel-eluting stents (PES) vs. sirolimus-eluting stents (SES) in single crossover main branch stenting followed by FKI in patients with bifurcation lesions. METHODS: We randomized 800 patients with single bifurcation lesions to PES (n=400) and SES (n=400) groups. RESULTS: Crossover rates to the two-stent strategy were low in both groups (PES 1.5%, SES 2.8%; p=0.23). At 1 year, there was no significant difference in the primary endpoint of this study, target lesion revascularization rate (PES 3.8%, SES 3.2%, hazard ratio 0.83; 95% confidence interval 0.39 to 1.76; p=0.62). Stent thrombosis occurred in only 1 case in the SES group after 282 days. At 9 months, a total of 593 patients underwent quantitative coronary measurement. The main branch restenosis rate in the PES group was significantly higher than that of the SES group (PES 12.2%, SES 5.5%; p=0.004), however both groups exhibited similar high side branch restenosis rates (PES 17.2%, SES 19.3%; p=0.6). CONCLUSIONS: In patients with bifurcation lesions, a single stent strategy using PES and SES with FKI indicated similar 1 year clinical outcomes and safety profiles.

Olmesartan improves coronary flow reserve of hypertensive patients using coronary magnetic resonance imaging compared with amlodipine.

OBJECTIVES: Hypertension impairs coronary endothelial cell function, coronary microvascular function and the coronary flow (CF) reserve (CFR). Angiotensin II receptor blockers (ARBs) have been reported to possibly improve coronary endothelial function and coronary microvascular function. The purpose of this study was to determine whether treatment with the ARB olmesartan was more effective for improving CFR than the calcium channel blocker amlodipine. METHODS: Twenty patients with untreated essential hypertension (M/F = 13/7, aged 55.6 ± 11.6 years) were randomly assigned to treatment with either olmesartan (n = 10) or amlodipine (n = 10) for 6 months. CF was measured in the proximal left anterior descending artery by magnetic resonance imaging before and during intravenous infusion of adenosine. CFR was calculated as the ratio of the hyperemic to baseline diastolic peak flow before and after 6 months of treatment. RESULTS: The extent of systolic blood pressure reduction was similar in both groups (-40.0 ± 19.1 vs. -48.8 ± 14.7 mm Hg, p = 0.26). The olmesartan group showed significant improvement of CFR (from 1.9 ± 1.0 to 3.1 ± 1.1, p = 0.005), but this did not occur in the amlodipine group. CONCLUSION: Olmesartan, but not amlodipine, improves CFR in hypertensive patients.

Low-dose and long-term G-CSF treatment can improve severe myocardial ischemia in patients with severe coronary artery disease.

BACKGROUND: It has been reported that granulocyte colony-stimulating factor (G-CSF) can promote angiogenesis by mobilizing bone marrow stem cells to blood vessels. The purpose of this study is to clarify whether low-dose and long-term G-CSF treatment can improve severe myocardial ischemia. METHODS: We studied 40 patients (M/F = 29/11, age = 68 ± 9 years) who had severe coronary artery disease (7 with and 5 without old myocardial infarction; 3VD/2VD/1VD = 17/17/6) and severe myocardial ischemia with no indication for revascularization. G-CSF (1.5 µg/kg) was injected for 14 consecutive days. All patients were evaluated using stress myocardial scintigraphy, the Canadian Cardiovascular Society (CCVS) score, and cardiopulmonary exercise testing before and after 3 months of treatment. On 17 SPECT segments, the total defect score (TDS) and delta TDS (TDS (stress) minus TDS (resting)) were evaluated to assess the severity of myocardial ischemia. RESULTS: The changes in stress TDS, delta TDS, and regional wall motion score were significantly greater in the G-CSF group than the control group (P < .0001). The CCVS score improved significantly from baseline to the 3-month follow-up assessment in the G-CSF group (P < .0001). The increase of peak VO2 was significantly larger in the G-CSF group than the control group (P = .015). CONCLUSION: Low-dose and long-term G-CSF treatment can improve severe ischemia in patients with severe coronary artery disease.

Safety and efficacy of sirolimus-eluting stent implantation in patients with acute coronary syndrome in the real world.

The use of drug-eluting stents in patients with acute coronary syndrome (ACS), particularly those with acute myocardial infarction (AMI), is controversial owing to concerns about late adverse events. We evaluated the long-term safety of sirolimus-eluting stent implantation in patients with ACS. Of 10,778 patients treated exclusively with a sirolimus-eluting stent in the j-Cypher registry, the 3-year outcomes of 2,308 patients with ACS (953 patients with AMI) were compared to those of 8,470 patients without ACS. Compared to patients without ACS, the patients with ACS had a significantly greater adjusted risk of death or myocardial infarction (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.12 to 1.37, p <0.0001) and definite or probable stent thrombosis (HR 1.43, 95% CI 1.11 to 1.82, p = 0.006) within the first year after sirolimus-eluting stent implantation. However, after 1 year, patients with ACS no longer had a greater risk of death or myocardial infarction (HR 1.01, 95% CI 0.90 to 1.13, p = 0.87) and stent thrombosis (HR 1.32, 95% CI 0.92 to 1.86, p = 0.13). Of the patients with ACS, those with AMI had a greater risk of death or myocardial infarction (HR 1.33, 95% CI 1.12 to 1.6, p = 0.001) and stent thrombosis (HR 1.57, 95% CI 1.05 to 2.39, p = 0.03) than those with unstable angina pectoris within the first year. However, they had a similar risk of death or myocardial infarction (HR 1.00, 95% CI 0.78 to 1.22, p = 0.83) and stent thrombosis (HR 0.83, 95% CI 0.38 to 1.6, p = 0.59) after 1 year. The risk of late adverse events >1 year after sirolimus-eluting stent implantation was similar between those with and without ACS and between those with AMI and those with unstable angina pectoris.

Sirolimus-eluting stent versus balloon angioplasty for sirolimus-eluting stent restenosis: Insights from the j-Cypher Registry.

BACKGROUND: Optimal treatment strategies for restenosis of sirolimus-eluting stents (SES) have not been adequately addressed yet. METHODS AND RESULTS: During the 3-year follow-up of 12 824 patients enrolled in the j-Cypher registry, 1456 lesions in 1298 patients underwent target-lesion revascularization (TLR). Excluding 362 lesions undergoing TLR for stent thrombosis or TLR using treatment modalities other than SES or balloon angioplasty (BA), 1094 lesions with SES-associated restenosis in 990 patients treated with either SES (537 lesions) or BA (557 lesions) constituted the study population for the analysis of recurrent TLR and stent thrombosis after the first TLR. Excluding 24 patients with both SES- and BA-treated lesions, 966 patients constituted the analysis set for the mortality outcome. Cumulative incidence of recurrent TLR in the SES-treated restenosis lesions was significantly lower than that in the BA-treated restenosis lesions (23.8% versus 37.7% at 2 years after the first TLR; P<0.0001). Among 33 baseline variables evaluated, only hemodialysis was identified to be the independent risk factor for recurrent TLR by a multivariable logistic regression analysis. After adjusting for confounders, repeated SES implantation was associated with a strong treatment effect in preventing recurrent TLR over BA (odds ratio, 0.44; 95% confidence interval, 0.32 to 0.61; P<0.0001). The 2-year mortality and stent thrombosis rates between the SES- and the BA-treated groups were 10.4% versus 10.8% (P=0.4) and 0.6% versus 0.6%, respectively. CONCLUSIONS: Repeated implantation of SES for SES-associated restenosis is more effective in preventing recurrent TLR than treatment with BA, without evidence of safety concerns.