Long-Term Clinical Outcomes After Filter Protection During Percutaneous Coronary Intervention in Patients With Attenuated Plaque　- 1-Year Follow up of the VAMPIRE 3 (Vacuum Aspiration Thrombus Reemoval 3) Trial.

BACKGROUND: Selective use of distal filter protection during percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) decreased the incidence of no-reflow phenomena and in-hospital serious adverse cardiac events compared with conventional PCI in patients with attenuated plaque ≥5 mm; however, its long-term clinical outcome remains unknown.Methods and Results:Patients who had ACS with attenuated plaque ≥5 mm were assigned to receive distal protection (DP) (n=98) or conventional treatment (CT) (n=96). The rate of major adverse cardiovascular events (MACE), a composite of death from any cause, non-fatal myocardial infarction, or target vessel revascularization (TVR) at 1 year, was the pre-specified secondary endpoint of the trial. MACE at 1 year occurred in 12 patients (12.2%) in the DP group and 3 patients (3.1%) in the CT group (P=0.029), which was driven by a higher risk of TVR (11 [11.2%] vs. 2 [2.1%], P=0.018). In patients treated with bare-metal stents (n=42), MACE occurred in 25.0% of the patients in the DP group and in none of the patients in the CT group (P=0.029), whereas in patients treated with drug-eluting stents (n=151), rates of MACE were similar in the groups (8.1% vs. 3.9%, P=0.32). CONCLUSIONS: In ACS patients with attenuated plaque ≥5 mm, the 1-year rates of MACE were higher in the DP group than in the CT group. This effect might be mitigated by the use of drug-eluting stents.

Diagnostic performance of coronary angiography utilizing intraprocedural 320-row computed tomography with minimal contrast medium.

Recently developed coronary angiography with intraprocedural 320-row computed tomography can be performed in a catheterization laboratory (XACT) by injecting contrast medium from a place close to the coronary arteries, thereby requiring a minimal amount of contrast medium. However, its clinical application has not yet been established. This study aimed to evaluate the diagnostic accuracy of XACT angiography with a minimal volume of contrast medium in patients with suspected coronary artery disease (CAD). A total of 167 coronary segments were analyzed in 14 patients (9 males, median age 70 years) with suspected CAD by XACT angiography with 7.5 ml of contrast medium and invasive coronary angiography (ICA) with standard techniques. The segmental-based diagnostic accuracy of XACT angiography in detecting stenosis of ≥ 50% and ≥ 75% and visualized by ICA was good (sensitivity: 74% and 62%, specificity: 99% and 99%, positive predictive value: 93% and 80%, and negative predictive value: 97% and 97%, respectively). These results suggest that XACT angiography with a very low amount of contrast medium may have strong clinical utility for screening coronary arteries in patients with renal dysfunction or undergoing clinical procedures such as pacemaker implantation.

Impact of Residual Stenosis on the Angiographic Edge Restenosis of a Second-Generation Drug-Eluting Stent.

Edge restenosis has gained attention as a main cause of restenosis after first-generation drug-eluting stent (DES) implantation. The aim of this study was to assess the incidence of edge restenosis and identify the predictors of edge restenosis after second-generation DES implantation. Data were obtained from several postmarketing surveillance (PMS) studies on a cobalt-chromium everolimus-eluting stent (CoCr-EES; Xience V/PROMUS, Xience Prime, Xience Prime SV, and Xience Expedition SV), a second-generation DES, in Japan. Angiographic analysis was conducted at the baseline and after eight months on the following subsegments: in-stent region, proximal edge, and distal edge. Restenosis was defined as ≥ 50% diameter stenosis (DS) at follow-up. We used multivariate logistic regression (with lesions as a random effect) to compare the instances of restenosis between the proximal and the distal edges. Univariate and multivariate analyses of the risk factors for restenosis were performed for each subsegment. We analyzed 1,966 lesions in 1,687 patients. The restenosis rates at the in-stent region, proximal edge, and distal edge were 4.4%, 3.0%, and 1.1%, respectively. The risk of restenosis at the distal edge was significantly lower than that at the proximal edge, when adjusted for 13 variables. The predictors of restenosis were postprocedural % diameter stenosis (%DS), postprocedural reference diameter, ≥ 45° bending, stent overlap at the proximal edge, and postprocedural %DS at the distal edge. Our analysis of eight-month angiographic outcomes from CoCr-EES PMS demonstrated that postprocedural %DS is a major predictor of edge restenosis. Edge restenosis is more likely attributable to postprocedural angiographic results than to the patient's background.

Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan.

BACKGROUND: The Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) Post-marketing Surveillance (PMS) is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. METHODS AND RESULTS: We enrolled 2,010 consecutive patients (2,649 lesions) who underwent PCI using CoCr-EES. Clinical outcomes were evaluated for up to 3 years. Clinical follow-up was available in 1,930 patients (96%) at 3 years. Major adverse cardiovascular events (MACE) occurred in 6.8% of patients, including cardiac death (1.7%), myocardial infarction (1.5%), and clinically driven target lesion revascularization (CD-TLR, 4.2%). Late CD-TLR rate was 0.8% from 1 to 2 years, and 0.5% from 2 to 3 years. Definite or probable stent thrombosis occurred in 7 patients (0.3%) up to 1 year. There was no very late definite or probable stent thrombosis from 1 to 3 years. Significant independent predictors for MACE were hemodialysis, prior coronary intervention, triple-vessel coronary artery disease, and age >70 years. CONCLUSIONS: Three-year clinical outcomes from the CoCr-EES PMS demonstrated a low incidence of clinical events. There was no major concern about very late stent thrombosis or late catch-up phenomenon in patients treated with EES in routine clinical practice in Japan.

Angioscopic assessment of peri-stent contrast staining following drug-eluting stent implantation.

BACKGROUND: Peri-stent contrast staining (PSS) has been recognized as a predictor of late stent thrombosis following drug-eluting stent (DES) implantation. However, the intravascular conditions at PSS sites remain unclear. METHODS AND RESULTS: We evaluated 10 patients (median age 72 years, 80% male) with stable angina pectoris by coronary angioscopy. The patients had a total of 11 DES implantations (5 sirolimus-eluting stents; 4 paclitaxel-eluting stents; 2 everolimus-eluting stents) that showed PSS. Neointimal coverage (NIC), presence of thrombus, and yellow plaques underneath the stent were compared between PSS and non-PSS sites for each stent. NIC was graded as: grade 0, struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded by neointima, but translucent; grade 3, struts fully embedded and invisible. Mean follow-up was 394±206 days (median: 289). NIC grade was lower at PSS sites (P=0.021) with 8 out of 11 stents (73%) having grade 0. Angioscopy detected a thrombus more frequently at PSS sites than at non-PSS sites (64% vs. 9%, P=0.012). Yellow plaques tended to be more significant at PSS sites than at non-PSS sites (82% vs. 45%, P=0.091). CONCLUSIONS: The angioscopic findings suggest high thrombogenicity at PSS sites.

Angioscopic assessment of early phase arterial repair after paclitaxel-coated nitinol drug-eluting stent implantation in the superficial femoral artery.

BACKGROUND: Although durable clinical outcomes have been reported, arterial repair after paclitaxel-coated nitinol drug-eluting stent (Zilver PTX) implantation in the superficial femoral artery (SFA) remains unclear. METHODS AND RESULTS: Angioscopic evaluation was performed in SFA intra-stent surfaces 80±29 (range, 49-135) days or 84±18 (range, 52-112) days following Zilver PTX (20 stents in 10 patients; mean age, 72±8 years; 40% men) or bare metal stent (BMS; 14 stents in 9 patients; mean age, 70±7 years; 67% men) implantation, respectively. Neointimal coverage (NIC) was graded as 0, stent struts exposed; grade 1, struts bulging into the lumen, but still transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous when the NIC grade variation was ≥1. Presence of yellow plaque and thrombus were investigated. Dominant NIC was significantly different between Zilver PTX (grade 0, 35%; grade 1, 20%; grade 2, 25%; grade 3, 20%) and BMS (grade 0, 7%; grade 1, 0%; grade 2, 14%; grade 3, 79%; P=0.001). NIC heterogeneity was less frequently observed in Zilver PTX (40% vs. 86%, P=0.009). Prevalence of yellow plaque or thrombus (75% vs. 79%, P=0.57) or thrombus (75% vs. 79%, P=0.57) were similar between Zilver PTX and BMS. CONCLUSIONS: Early phase arterial repair was different between Zilver PTX and BMS.

Arterial repair 4 months after zotarolimus-eluting stent implantation observed on angioscopy.

BACKGROUND: Arterial repair in the early phase following implantation of a zotarolimus-eluting stent (ZES) remains unknown. METHODS AND RESULTS: Following implantation of 49 Endeavor ZES in 33 patients, follow-up angioscopy was performed in 13 patients (26 ZES) in the early phase (EP; 123±24 days) and in 20 patients (23 ZES) in the middle phase (MP; 247±17 days). Neointimal coverage (NIC) was graded as follows: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts were embedded by the neointima but were seen translucently; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous for NIC grade variation≥1. The presence of thrombus and yellow plaque was also investigated. Although NIC heterogeneity tended to be more frequent in EP than in MP (50% vs. 22%, P=0.070), and yellow plaque significantly more frequent (58% vs. 13%, P=0.0025), the majority of stents were dominant NIC grade 3 at both follow-up periods (73% in EP vs. 78% in MP, P=0.75). There was no significant difference in thrombus (23% in EP vs. 4% in MP, P=0.10) between the follow-ups. CONCLUSIONS: Sufficient arterial repair may have occurred by 4 months after ZES implantation.

Angioscopic assessment of arterial repair following biodegradable polymer-coated biolimus A9-eluting stent implantation. - Comparison with durable polymer-coated sirolimus-eluting stent-.

BACKGROUND: Second-generation drug-eluting stents (DES) are expected to show better arterial repair than older DES. We angioscopically compared the biodegradable polymer-coated biolimus A9-eluting stent (BES) and durable polymer-coated sirolimus-eluting stent (SES) to explore differences in arterial repair. METHODS AND RESULTS: Angioscopy was performed 9 ± 1 months after 15 BES and 16 SES were implanted initially in the native coronary artery. Heterogeneity of neointimal coverage (NIC) as well as the dominant NIC grade was examined. NIC was defined as: grade 0 = fully visible struts; grade 1 = struts bulging into the lumen, but covered; grade 2 = embedded, but translucent struts; grade 3 = invisible struts. Heterogeneity was judged when the NIC grade varied ≥ 1. In-stent late loss (0.06 ± 0.23 vs. 0.07 ± 0.18 mm, P = 0.80), and dominant NIC grade (1.5 ± 0.8 vs. 1.3 ± 0.7, P = 0.45) were similar for BES and SES. Within the stents, NIC was more heterogeneous in SES than in BES (P = 0.035). 80% of BES showed homogeneous NIC, while 56% of SES had heterogeneous NIC. CONCLUSIONS: BES showed limited late loss similar to that for SES. Nonetheless, the NIC with BES was more homogeneous than that with SES. Biodegradable polymer-coated BES may have an advantage in homogeneous NIC.

Prognostic impact of nutritional status and physical capacity in elderly patients with acute decompensated heart failure.

AIMS: Nutritional status as well as physical capacity is related to prognosis in patients with heart failure. The purpose of this study was to explore a simple prognostic indicator in patients with acute decompensated heart failure (ADHF) by including both nutritional status and physical capacity. METHODS AND RESULTS: Patients hospitalized with ADHF (N = 203; mean age, 81 years) were enrolled. We evaluated the geriatric nutritional risk index (GNRI) on hospital admission and at discharge. A GNRI score < 92 was defined as malnutrition. Physical capacity was evaluated by simple walking test to determine if patients could walk 200 m, with a Borg scale score ≤ 13, without critical changes in vital signs. Primary endpoints were mortality and heart failure rehospitalization within 2 years. A total of 49% and 48% of patients showed malnutrition on admission and at discharge, respectively. Malnutrition at discharge was more strongly related to mortality [hazard ratio (HR) 3.382, 95% confidence interval (CI) 1.900-6.020, P < 0.0001)] than that on admission (HR 2.448, 95% CI 1.442-4.157, P = 0.001) by univariable analysis. Malnutrition at discharge was related to mortality (HR 2.370, 95% CI 1.166-4.814, P = 0.02), but malnutrition on admission was not related (HR 1.538, 95% CI 0.823-2.875, P = 0.18) by multivariable analysis. Almost half of patients (45%) could not walk 200 m, which was significantly related to mortality by univariable analysis (HR 3.303, 95% CI 1.905-5.727, P < 0.0001), but was not by multivariable analysis (HR 1.990, 95% CI 0.999-3.962, P = 0.05). The combined index including both GNRI and simple walking test was an independent and stronger predictor of mortality than either index alone by multivariable analysis (HR 2.249, 95% CI 1.362-3.716, P < 0.01). Neither malnutrition nor low physical capacity was related to heart failure rehospitalization by univariable analysis (HR 0.702, 95% CI 0.483-1.020, P = 0.06; HR 1.047, 95% CI 0.724-1.515, P = 0.81, respectively). Malnutrition at discharge significantly reduced heart failure rehospitalization by multivariable analysis (HR 0.431, 95% CI 0.266-0.698, P < 0.01). When patients were classified into Group G (both nutritional status and physical capacity at discharge were good), Group E (either was good), and Group B (both were bad), mortality rates were significantly different among the groups (log rank P < 0.0001). CONCLUSION: A simple indicator including both nutritional status and physical capacity may predict 2 year mortality in elderly patients with ADHF.

Five-year clinical outcomes of everolimus-eluting stents from the post marketing study of CoCr-EES (XIENCE V/PROMUS) in Japan.

The Cobalt Chromium Everolimus-Eluting Stent (CoCr-EES) Post Marketing Surveillance (PMS) Japan study is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. We enrolled 2010 consecutive patients (2649 lesions) who underwent percutaneous coronary intervention using CoCr-EES. Clinical outcomes were evaluated through 5 years. Mean age was 68.8 years, 41.9% had diabetes, 4.9% received hemodialysis. Five-year clinical follow up was available for 1704 (84.8%) patients. Major adverse cardiovascular events (MACE) occurred in 10.7% of patients, including cardiac death (3.8%), myocardial infarction (1.8%), and clinically driven target lesion revascularization (TLR) (6.0%). Beyond 1 year, annual incidence of clinically driven TLR was 0.5-0.8%. Definite or probable stent thrombosis occurred in 9 (0.5%) patients at 5 years. After 1 year, definite stent thrombosis occurred in only 1 patient. Significant predictors for MACE were dialysis (ODDs ratio 4.58, 95% CI 2.75-7.64), prior cardiac intervention (ODDs ratio 2.47, 95% CI 1.75-3.49), total stent length (ODDs ratio 1.01, 95% CI 1.01-1.02), and number of diseased vessels (ODDs ratio 1.66, 95% CI 1.08-2.55). Five-year clinical outcomes from the CoCr-EES PMS Japan study demonstrated a low incidence of clinical events in the daily practice up to 5 years.Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT01086228 .

Satisfactory arterial repair 1 year after ultrathin strut biodegradable polymer sirolimus-eluting stent implantation: an angioscopic observation.

The ultrathin strut biodegradable polymer sirolimus-eluting stent (Orsiro, O-SES) exhibits satisfactory clinical outcomes. However, no report to date has documented the intravascular status of artery repair after O-SES implantation. We examined 5 O-SES placed in 4 patients (age 65 ± 12 years, male 75%) presenting with stable angina pectoris due to de novo lesions in native coronary arteries. Coronary angioscopy was performed immediately after percutaneous coronary intervention and 1 year later. Angioscopic images were analyzed to determine the following: (1) dominant grade of neointimal coverage (NIC) over the stent; (2) maximum yellow plaque grade; and (3) existence of thrombus. Yellow plaque grade was evaluated both immediately after stent implantation and at the time of follow-up observation. The other parameters were evaluated at the time of follow-up examination. NIC was graded as: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. Yellow plaque severity was graded as: grade 0, white; grade 1, light yellow; grade 2, yellow; and grade 3, intensive yellow. Angioscopic findings at 1 year demonstrated the following: dominant NIC grade 1, grade 2, and grade 3 in 1, 2, and 2 stents, respectively; all stents were covered to some extent; focal thrombus adhesion was observed in only 1 stent. Yellow plaque grade did not change from immediately after stent implantation to follow-up. O-SES demonstrated satisfactory arterial repair 1 year after implantation.

Relation of Chronic Total Occlusion to In-Hospital Mortality in the Patients With Sudden Cardiac Arrest Due to Acute Coronary Syndrome.

Although the presence of chronic total occlusion (CTO) has been associated with long-term mortality in the patients with ST-segment elevation myocardial infarction, the influence of having CTO on in-hospital mortality in sudden cardiac arrest (SCA)-acute coronary syndrome (ACS) patients has not been reported. Therefore, we examined the association between the presence of CTO and in-hospital mortality in those patients. Consecutive 106 SCA-ACS patients who received coronary angiography were retrospectively included. The factors associated with in-hospital mortality were analyzed. Among 106 patients, 40 (38%) patients died during hospitalization. Multivariate analysis revealed presence of CTO dependent on infarct-related artery (IRA-dependent-CTO) (hazard ratio [HR] = 2.88, p = 0.004), diabetes mellitus (HR = 2.04, p = 0.044), percutaneous cardiopulmonary support use (HR = 2.22, p = 0.045), successful recanalization (HR = 0.31, p = 0.004), and peak creatine kinase muscle-brain fraction (HR = 1.11, p < 0.001) were significantly associated with mortality. In conclusion, presence of IRA-dependent-CTO was significantly associated with in-hospital mortality in SCA-ACS patients.

Serial angioscopic evidence of incomplete neointimal coverage after sirolimus-eluting stent implantation: comparison with bare-metal stents.

BACKGROUND: The time course of neointimal formation after stent implantation has not been studied extensively by angioscopy in the drug-eluting stent era. METHODS AND RESULTS: Serial angioscopic findings at first follow-up (3.6+/-1.1 months), second follow-up (10.5+/-1.6 months), and third follow-up (21.2+/-2.2 months) after stent implantation were compared between sirolimus-eluting stents (SES, n=17) and bare-metal stents (BMS, n=11). Neointimal coverage, thrombus, and presence of yellow plaques underneath the stents were assessed. Neointimal coverage was graded as follows: grade 0, stent struts were fully visible; grade 1, struts bulged into the lumen, although they were covered; grade 2, struts were embedded by the neointima but were seen translucently; or grade 3, struts were fully embedded and invisible. Neointimal coverage was remarkably different between SES and BMS at each follow-up point. Neointimal coverage grade was 1.1+/-0.5 in SES versus 2.9+/-0.3 in BMS at the first follow-up (P<0.0001), 1.1+/-0.5 in SES versus 3.0+/-0.0 in BMS (P<0.0001) at the second follow-up, and 1.3+/-0.5 in SES versus 3.0+/-0.0 in BMS at the third follow-up (P=0.0009). No significant serial changes in coverage grade were noted in the BMS group, whereas coverage grade slightly but significantly increased at the third follow-up in the SES group (P<0.05). Thrombi were detected in 4 SES: a red thrombus was seen from the first to the third follow-up in 2; another was detected only at the third follow-up; and the fourth was seen at the first follow-up but disappeared at the second follow-up, associated with a new white thrombus despite dual antiplatelet therapy. Yellow plaques had disappeared by the time of the second follow-up in BMS. In contrast, yellow plaques were exposed in 71% of SES at the first follow-up and remained exposed until the third follow-up. Neointimal coverage grades correlated with thrombi (P=0.002) and with yellow plaques (P<0.0001). CONCLUSIONS: Serial angioscopic findings up to 2 years after SES implantation were markedly different from those after BMS. Neointimal coverage was completed by 3 to 6 months in BMS. In contrast, SES demonstrated the presence of thrombi and yellow plaques even as much as 2 years after implantation.

The impact of coronary calcification on angiographic and 3-year clinical outcomes of everolimus-eluting stents: results of a XIENCE V/PROMUS post-marketing surveillance study.

Coronary calcification (CCA) is one of the independent predictors for major adverse cardiac events (MACEs) in coronary intervention. Post-marketing surveillance study Japan is a prospective registry designed to evaluate the safety and efficacy of the everolimus-eluting stent (EES, XIENCE V/PROMUS Stent) in routine clinical practice at 47 centers. In this study, 1848 lesions (1546 patients) were assessed using quantitative coronary angiography. In these 1546 patients, renal function data were unknown in 26 patients. Three patients in 70 patients with dialysis and 56 patients in 1450 patients with no dialysis were excluded, because they had multiple lesions with mixed calcification lesions. We evaluated the effects of CCA on 8-month angiographic and 3-year clinical outcomes in dialysis and non-dialysis patients. Moderate-to-severe (Ca group) and none-to-mild CCA (non-Ca group) were observed in 33 lesions (30 patients) and 48 lesions (37 patients) in dialysis patients, and these were observed in 306 lesions (286 patients) and 1303 lesions (1108 patients) in non-dialysis patients, respectively. In non-dialysis patients, the ischemic-driven target lesion revascularization (ID-TLR) and MACE rate over the 3 years were significantly higher in the Ca group than in the non-Ca group (5.8 vs. 3.1%, p = 0.025 and 10.0 vs. 5.0%, p = 0.0011). In dialysis patients, ID-TLR and MACE rates were high in both groups (14.3 vs. 17.9%, p = 0.85 and 17.5 vs. 36.1%, p = 0.16). In non-dialysis patients, 8-month angiographic and 3-year clinical outcomes were worse in the Ca group. However, in dialysis patients, both outcomes were worse regardless of CCA.Clinical Trial registration https://clinicaltrials.gov/ct2/show/NCT01086228 .

Comparison of early-phase arterial repair following cobalt-chrome everolimus-eluting stent and slow-release zotarolimus-eluting stent: an angioscopic study.

Whether arterial repair following implantation of drug-eluting stents (DES) of the second generation differs among stent types remains unknown. We examined 41 DES placed in 28 patients (age 72 ± 7 years, male 89%) presenting with stable angina pectoris due to de novo lesions in native coronary arteries. Coronary angioscopy was performed 4 ± 1 months after stent implantation. Patients were divided into two groups based on the DES types: 22 cobalt-chrome everolimus-eluting stents (CoCr-EES) in 13 patients and 19 slow-release zotarolimus-eluting stents (R-ZES) in 15 patients. Neointimal coverage (NIC) was graded as: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous when the NIC grade variation was ≥1. Presence of thrombus was also investigated. Distribution of dominant NIC grade (CoCr-EES: grade 0, 9%; grade 1, 77%; grade 2, 9%; grade 3, 5%; R-ZES: grade 0, 16%; grade 1: 47%; grade 2, 37%; grade 3, 0%, P = 0.38) and heterogeneity of NIC (P = 0.43) were similar between CoCr-EES and R-ZES groups. Existence of thrombus was not significantly different in CoCr-EES and R-ZES (18 versus 42%, P = 0.17). Arterial repair occurred without significant differences between CoCr-EES and R-ZES 4 months after implantation.

A Randomized Study of Distal Filter Protection Versus Conventional Treatment During Percutaneous Coronary Intervention in Patients With Attenuated Plaque Identified by Intravascular Ultrasound.

OBJECTIVES: The aim of this study was to evaluate the utility of distal protection during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes at high risk for distal embolization. BACKGROUND: The results of previous clinical trials indicated that the routine use of distal protection in patients with ST-segment elevation myocardial infarction did not improve clinical outcomes. However, selective use of distal protection by means of a filter-based distal protection system has not been evaluated. METHODS: Two hundred patients with acute coronary syndromes who had native coronary artery lesions and attenuated plaque with longitudinal length ≥5 mm on pre-PCI intravascular ultrasound were randomly assigned to undergo PCI with distal protection or conventional treatment. RESULTS: The primary endpoint (no-reflow phenomenon) occurred in 26 patients (26.5%) in the distal protection group and 39 patients (41.7%) in the conventional treatment group (p = 0.026), and the corrected TIMI (Thrombolysis In Myocardial Infarction) frame count after revascularization was significantly lower in the distal protection group (23 vs. 30.5; p = 0.0003). The incidence of cardiac death, cardiac arrest, cardiogenic shock after revascularization requiring defibrillation, cardiopulmonary resuscitation, or extracorporeal membrane oxygenation was significantly lower in the distal protection group than in the conventional treatment group (0% vs. 5.2%; p = 0.028). CONCLUSIONS: The use of distal embolic protection applied with a filter device decreased the incidence of the no-reflow phenomenon and was associated with fewer serious adverse cardiac events after revascularization than conventional PCI in patients with acute coronary syndromes with attenuated plaque ≥5 mm in length. (Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome [ACS] [VAMPIRE3]; NCT01460966).

Ideal Guiding Catheter Position During Bilaterally Engaged Percutaneous Coronary Intervention.

Using a novel combined angiography computed tomography (CT) system, we evaluated the impact of the intra-aortic root position of a right coronary artery (RCA) catheter on its coaxiality. We retrospectively enrolled 19 patients who underwent CT scans during bilaterally engaged percutaneous coronary intervention. Coaxiality was defined as the angle between the RCA and the RCA catheter. The coaxiality was better when the RCA catheter was placed anterior to the left main coronary artery catheter (median 27.0° vs 53.7°, p = 0.02). The position of the RCA catheter had a significant impact on the coaxiality of it, with a coaxiality improvement ratio of 0.506 (95% confidence interval 0.294 to 0.871, p = 0.017). Three-dimensional reconstructed CT images of the right anterior oblique projection could determine the position of catheters in all cases. In conclusion, the RCA catheter should be placed anterior, rather than posterior, to the left main coronary artery catheter for better coaxiality during bilaterally engaged percutaneous coronary intervention. The right anterior oblique projection is useful for determining the catheter position.

Efficient distal tip size of primary guidewire for antegrade percutaneous coronary intervention in chronic total occlusion: The G-FORCE study.

BACKGROUND: Although several new techniques have been introduced for CTO such as the retrograde approach, the fundamental question of what type of guidewire is the most appropriate as a primary guidewire in the antegrade approach has not been answered. METHODS: The G-FORCE study was designed as a prospective multicenter randomized controlled trial to determine the efficient primary guidewire in antegrade approach for chronic total occlusion (CTO). The first guidewire was randomly assigned to a regular size distal tip group (0.014in. size) or tapered tip group (0.010in. or less). The primary endpoint was defined as successful lesion penetration by the first guidewire into distal true lumen. This study was registered at ClinicalTrials.gov with identifier NCT00987610. RESULTS: A total of 260 patients were enrolled, with an average age of 66±11years and 16% were female. The average J-CTO score was 1.8±1.1. The primary endpoint was achieved in 38% and 32% of patients using tapered and regular distal tip guidewires, respectively (P=0.80). The final PCI success rate was 81% vs. 85%, respectively (P=0.57). Easy CTO lesions with a J-CTO score=0 exhibited a primary endpoint significantly different between tapered and regular distal tip primary guidewires (79% vs. 40%; P=0.046). Guidewire distal coating or distal tip load did not relate with primary guidewire success rate. CONCLUSION: Tapered and regular distal tip guidewires are equivalent as a first choice for CTO. Tapered guidewires are superior for CTO lesions with a J-CTO score=0.

Effect of exercise on frequency of stent fracture in the superficial femoral artery.

Stent fracture has emerged as a new problem in the percutaneous transluminal angioplasty of the superficial femoral artery (SFA). The aim of our study was to delineate the factors influencing nitinol stent fracture in the SFA. Forty consecutive patients with peripheral artery disease who underwent rescue stenting with a nitinol stent (Luminexx, Bard) in the SFA were enrolled between May 2004 and January 2005. Follow-up angiography was performed 13.6+/-1.0 months later to detect stent fracture. Stent fracture occurred in 11 patients (28%). Lesion length>100 mm, the number of stents used, the lesion involving the distal SFA, chronic total occlusion, and walking>5,000 steps per day were more frequently observed in those with stent fracture than in those without fracture. Of these variables, walking>5,000 steps per day was the strongest independent determinant associated with stent fracture by discriminant analysis (p=0.0027). Vigorous exercise adversely affects stent fracture in patients implanted with a nitinol stent in the SFA.