Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial.

BACKGROUND: Intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation is associated with fewer major adverse cardiovascular events compared with angiography guidance for patients with individual lesion subset. However, the beneficial effect on major adverse cardiovascular event outcome of IVUS guidance over angiography guidance in all-comers who undergo DES implantation still remains understudied. OBJECTIVES: This study aimed to determine the benefits of IVUS guidance over angiography guidance during DES implantation in all-comer patients. METHODS: A total of 1,448 all-comer patients who required DES implantation were randomly assigned (1:1 ratio) to either an IVUS guidance or angiography guidance group. The primary endpoint was target-vessel failure (TVF) at 12 months, including cardiac death, target-vessel myocardial infarction, and clinically driven target-vessel revascularization (TVR). The procedure was defined as a success if all IVUS-defined optimal criteria were met. RESULTS: At 12 months follow-up, 60 TVFs (4.2%) occurred, with 21 (2.9%) in the IVUS group and 39 (5.4%) in the angiography group (hazard ratio [HR]: 0.530; 95% confidence interval [CI]: 0.312 to 0.901; p = 0.019). In the IVUS group, TVF was recorded in 1.6% of patients with successful procedures, compared with 4.4% in patients who failed to achieve all optimal criteria (HR: 0.349; 95% CI: 0.135 to 0.898; p = 0.029). The significant reduction of clinically driven target-lesion revascularization or definite stent thrombosis (HR: 0.407; 95% CI: 0.188 to 0.880; p = 0.018) based on lesion-level analysis by IVUS guidance was not achieved when the patient-level analysis was performed. CONCLUSIONS: The present study demonstrates that IVUS-guided DES implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance. (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-Comers" Coronary Lesions [ULTIMATE]; NCT02215915).

Efficacy of one- vs. two-stent implantation for coronary bifurcation lesions in diabetic patients utilizing AIR2 as an endpoint.

OBJECTIVE: This study aimed to assess the long term outcomes (all-cause death, myocardial infarction, target vessel revascularization, and silent restenosis at 12 months) of one-stent vs. two-stent implantation due to coronary bifurcation lesionsin diabetic patients using AIR2 as a new endpoint. METHODS AND RESULTS: A total of 178 diabetic patients with true coronary bifurcation lesions underwent percutaneous coronary intervention in the DK-Crush trials. All patients were stratified based on the stent placement strategy: one-stent group (n=76) and two-stent group (n=102). Results showed the primary endpoint, AIR2, in one-stent group was twice that in two-stent group (32.9% vs. 16.7%, P=0.013). The incidence of silent restenosis at 12 months was also significantly higher in one-stent group (19.7% versus 4.9%, P=0.003). Moreover, Kaplan-Meier analysis revealed the cumulative AIR2-free survival rate after a 12-month follow-up was markedly lower in one-stent group than in two-stent group. Interestingly, MACEs, including death, myocardial infarction and repeat revascularization, were not comparable between 2 groups (13.2% vs. 12.7%, P=0.935). Likewise, the incidence of definite or probable ST in one-stent group was also similar to that in two-stent group (2.6% vs. 4.9%, P=0.761). CONCLUSION: Our study indicates that, in terms of the AIR2 as a combined clinical and angiographic endpoint, two-stent implantation is superior to one-stent implantation for the treatment of coronary bifurcation intervention in diabetic patients.

Analysis of Serum MicroRNAs as Potential Biomarker in Coronary Bifurcation Lesion.

Recent evidence suggests that cell-derived circulating miRNAs may serve as the biomarkers of cardiovascular diseases. However, no study has investigated the potential of circulating miRNAs as biomarker for coronary bifurcation lesion. In this study, we aimed to characterize the miRNA profiles that could distinguish coronary bifurcation lesion and identify potential miRNAs as biomarkers of coronary bifurcation lesion. We employed miRNA microarray to screen serum miRNAs profiles of patients with coronary bifurcation lesion and coronary nonbifurcation lesions. We identified 197 miRNAs differentially expressed, including 150 miRNAs upregulated and 47 miRNAs downregulated. We chose 3 miRNAs with significant differences for further testing in 200 patients. RT-PCR analysis of serum samples confirmed that miR30d was upregulated and miR1246 was downregulated in the serum of coronary bifurcation lesion patients compared with nonbifurcation lesion patients. Our findings suggest that these miRNAs may have a role in the pathogenesis of coronary bifurcation lesion and may represent novel biomarkers for the diagnosis and prognosis of coronary bifurcation lesion.

Angiographic and clinical comparisons of intravascular ultrasound- versus angiography-guided drug-eluting stent implantation for patients with chronic total occlusion lesions: two-year results from a randomised AIR-CTO study.

AIMS: This study sought to compare angiographic endpoints at one-year follow-up after a drug-eluting stent implantation guided by either intravascular ultrasound (IVUS) or angiography in patients with chronic total occlusion (CTO) lesions. METHODS AND RESULTS: Patients with at least one CTO lesion recanalised successfully were randomly assigned to the IVUS-guided or the angiography-guided group. The use of IVUS for penetration of the true lumen and optimisation of stent expansion was only done in the IVUS-guided group. The primary endpoint was in-stent late lumen loss (LLL) at one-year follow-up. A total of 230 patients with CTO lesions after successful recanalisation were enrolled and followed with office visits or telephone contact up to 24 months. In-stent LLL in the IVUS-guided group was significantly lower compared to the angiography-guided group at one-year follow-up (0.28±0.48 mm vs. 0.46±0.68 mm, p=0.025), with a significant difference in restenosis of the "in-true-lumen" stent between the two groups (3.9% vs.13.7%, p=0.021). The minimal lumen diameter and minimal stent cross-section area significantly and negatively correlated with LLL (all p<0.001). The rates of adverse clinical events were comparable between the IVUS- and angiography-guided groups at two-year follow-up (21.7% vs. 25.2%, p=0.641). CONCLUSIONS: The IVUS-guided stenting of the CTO lesion was associated with less LLL and a lower incidence of "in-true-lumen" stent restenosis. Additional study is required to identify the clinical benefit of the IVUS-guided procedure for CTO lesions. [ChiCTR-TRC-10000996].

Randomized Comparison of FFR-Guided and Angiography-Guided Provisional Stenting of True Coronary Bifurcation Lesions: The DKCRUSH-VI Trial (Double Kissing Crush Versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions VI).

OBJECTIVES: This study sought to compare the outcomes of fractional flow reserve (FFR)-guided and angiography (Angio)-guided provisional side-branch (SB) stenting for true coronary bifurcation lesions. BACKGROUND: Angio-guided provisional SB stenting after stenting of the main vessel provides favorable outcomes for the majority of coronary bifurcation lesions. Whether an FFR-guided provisional stenting approach is superior has not been studied. METHODS: A total of 320 patients with single Medina 1,1,1 and 0,1,1 coronary bifurcation lesions undergoing stenting with a provisional SB approach were randomly assigned 1:1 to Angio-guided and FFR-guided groups. SB stenting was performed for Thrombolysis In Myocardial Infarction flow grade<3, ostial SB stenosis>70%, or greater than type A dissection after main vessel stenting in the Angio-guided group and for SB-FFR<0.80 in the FFR-guided group. The primary endpoint was the 1-year composite rate of major adverse cardiac events (cardiac death, myocardial infarction, and clinically driven target vessel revascularization). RESULTS: Comparing the Angio-guided and FFR-guided groups, treatment of the SB (balloon or stenting) was performed in 63.1% and 56.3% of lesions respectively (p=0.07); stenting of the SB was attempted in 38.1% and 25.9%, respectively (p=0.01); and, when attempted, stenting was successful in 83.6% and 73.3% of SBs, respectively (p=0.01). The 1-year composite major adverse cardiac event rate was 18.1% in both groups (hazard ratio: 0.91, 95% confidence interval: 0.48 to 1.88; p=1.00). The 1-year target vessel revascularization and stent thrombosis rates were 6.9% and 5.6% (p=0.82) and 1.3% and 0.6% (p=0.56) in the Angio-guided and FFR-guided groups, respectively. CONCLUSIONS: In this multicenter, randomized trial, angiographic and FFR guidance of provisional SB stenting of true coronary bifurcation lesions provided similar 1-year clinical outcomes. (Randomized Study on DK Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions; ChiCTR-TRC-07000015).

[Risk factors and clinical outcome of coronary artery aneurysms developed after drug-eluting stent implantation].

OBJECTIVE: To evaluate risk factors and clinical outcome of coronary artery aneurysms (CAA) developed after drug-eluting stent implantation evidenced by coronary angiographic follow-up. METHODS: This study analyzed 4500 consecutive patient with de novo coronary artery stenosis receiving drug-eluting stent (DES) implantation from January 2004 to May 2009. Seven hundred and sixty patients with angiographic follow-ups at 6 - 8 months and 28 - 48 months after the index procedure were enrolled. CAA was defined as a localized dilatation exceeding 1.5 times the diameter of the adjacent artery. The independent risk factors and major adverse cardiac events (MACE) including cardiac death, myocardial infarction, target-vessel revascularization (TVR) and in-stent thrombosis were analyzed. RESULTS: CAA was detected in 70 patients with 70 lesions (9.2%, 70/760). Logistic analysis showed that lesion in an infarct-related artery (OR: 5.9, P < 0.01), lesion in the left anterior descending artery (OR: 4.5, P < 0.01), lesion with chronic total occlusion (OR: 3.4, P < 0.05), and lesion length > 33 mm (OR: 2.9, P < 0.05) were independent risk factors for CAA. Follow-up duration was (1131 ± 478) days. MACE was found in 19 patients and all received TVR. There were 11 patients with myocardial infarction and 8 patients with evidence of in-stent thrombosis. Mortality was zero during follow-up. CONCLUSIONS: The risk factors for the development of CAA after DES are lesions in an infarct-related artery, in the left anterior descending artery, with chronic total occlusion, and with lesion length > 33 mm. MACE is not uncommon in patients with CAA and long-ferm clinical follow-up is warranted for patients with CAA.

Coronary bifurcation lesions treated with double kissing crush technique compared to classical crush technique: serial intravascular ultrasound analysis.

BACKGROUND: The double kissing (DK) crush technique is a modified version of the crush technique. It is specifically designed to increase the success rate of the final kissing balloon post-dilatation, but its efficacy and safety remain unclear. METHODS: Data were obtained from the DKCRUSH-I trial, a prospective, randomized, multi-center study to evaluate safety and efficacy. Post-procedural and eight-month follow-up intravascular ultrasound (IVUS) analysis was available in 61 cases. Volumetric analysis using Simpson's method within the Taxus stent, and cross-sectional analysis at the five sites of the main vessel (MV) and three sites of the side branch (SB) were performed. Impact of the bifurcation angle on stent expansion at the carina was also evaluated. RESULTS: Stent expansion in the SB ostium was significantly less in the classical crush group ((53.81 ± 13.51)%) than in the DK crush group ((72.27 ± 11.46)%) (P = 0.04). For the MV, the incidence of incomplete crush was 41.9% in the DK group and 70.0% in the classical group (P = 0.03). The percentage of neointimal area at the ostium had a tendency to be smaller in the DK group compared with the classical group ((16.4 ± 19.2)% vs. (22.8 ± 27.1)%, P = 0.06). The optimal threshold of post-procedural minimum stent area (MSA) to predict follow-up minimum lumen area (MLA) < 4.0 mm(2) at the SB ostium was 4.55 mm(2), yielding an area under the curve of 0.80 (95% confidence interval: 0.61 to 0.92). CONCLUSION: Our data suggest that the DK crush technique is associated with improved quality of the final kissing balloon inflation (FKBI) and had smaller optimal cutoff value of post-procedural MSA at the SB ostium.

Real polymer-free sirolimus- and probucol-eluting versus biodegradable polymer sirolimus-eluting stents for obstructive coronary artery disease: DKPLUS-Wave 1, a multicenter, randomized, prospective trial.

BACKGROUND: Polymer-free sirolimus- and probucol-eluting stents (Real Dual drug-eluting stents [DES]) is as effective as first-generation DES in treating coronary artery stenosis. It is unknown whether sirolimus-eluting stents containing biodegradable polymer (Excel) would be superior to real Dual DES. This study aimed to investigate the difference in target vessel revascularization (TVR) at 12 months in patients with coronary artery disease treated by the implantation of Dual DES or Excel stents. METHODS: Three hundred and forty-six patients with de novo coronary artery disease were recruited from six centers in China and randomly assigned to either the Dual DES or the Excel group. The primary endpoint was the occurrence of TVR at 12 months. The secondary endpoint was angiographic in-stent restenosis and late lumen loss at 13 months. Stent thrombosis (ST) served as the safety endpoint. Dual anti-platelet therapy (DAPT) was prescribed for 6 months. RESULTS: Clinical follow-up for 12 months and repeat angiography at 13 months were available in 100% and >90% of patients, respectively. The ISR and in-stent late loss were significantly different between the Excel (3.1%, 0.09 ± 0.11 mm) and the Dual DES (19.5%, 0.36 ± 0.32 mm, P < 0.001, P < 0.001, respectively) groups. The TVR (3.5%) in the Excel group was significantly less than in the Dual DES group (13.9%, P = 0.001). The ST rate beyond 12 months in the Dual DES group was 0%, and this was 1.2% in the Excel group (P = 0.499). CONCLUSIONS: The Excel stent was statistically superior to the Dual DES in terms of restenosis, late loss, and TVR for long lesions.

Crush stenting with drug-eluting stents: relevance of coronary bifurcation lesion location on angiographic and clinical outcomes.

BACKGROUND: Data on the relevance of the location of coronary bifurcation lesions treated by crush stenting with outcomes were limited. HYPOTHESIS: We hypothesized that the location of the bifurcation lesion correlated with clinical outcome. METHOD: A total of 212 patients with 230 true bifurcation lesions treated by crush stenting with drug-eluting stents (DES) were assessed prospectively. Surveillance quantitative angiographies were indexed at 8 months after procedure. Primary endpoint was major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR). RESULTS: Patients in the distal right coronary artery (RCAd) group were characterized by higher proportions of prior myocardial infarction and very tortuous lesions. However, lesions in the RCAd group, compared to those of other groups, had the lowest late lumen loss, with resultant lowest incidence of MACE at a mean follow-up of 268±35 days. Independent predictors of MACE included unsatisfied kissing (KUS; hazard ratio [HR]: 12.14, 95% confidence interval [CI]: 4.01-12.10, P = .001) and non-RCA lesion (HR: 20.69, 95% CI: 5.05-22.38, P = .001), while those of TLR were KUS (HR: 10.21, 95% CI: 0.01-0.34, P = .002), bifurcation angle (HR: 4.728, 95% CI: 2.541-4.109, P = .001), and non-RCA lesion (HR: 16.05, 95%CI: 1.01-4.83, P = .001). CONCLUSIONS: Classical crush stenting with drug-eluting stents is associated with significantly better outcomes in RCAd. Quality of kissing inflation is mandatory to improve outcome.

Contradictory shear stress distribution prevents restenosis after provisional stenting for bifurcation lesions.

BACKGROUND: Endothelial shear stress is one of the local hemodynamic factors suspected in the development of coronary atherosclerosis in bifurcation lesions. In patients with provisional stenting, the endothelial shear stress (SS) distribution is unknown. OBJECTIVE: The aim of this study was to investigate the magnitude and distribution of the SS of coronary bifurcation lesions stenting by the provisional approach. METHODS: Ten consecutive patients were included in this study. Quantitative coronary analysis, flow study, and three-dimensional computational analysis with the aid of the commercial software CD STAR-CCM+ were done before and after the provisional stenting procedure and also 8 months later. RESULTS: Clinical and angiographic follow-up were available in all patients. No patient had a side branch (SB) stent. At the 8-month follow-up, no major adverse cardiac event (MACE) occurred. There was also no clinical and angiographic restenosis. Before PCI, the distal main vessel (MV)-lateral, and the SB-lateral subsegments had relative nonsignificant lower SS value (4.08 +/- 2.78 Pa and 4.35 +/- 5.04 Pa, respectively) when compared to other segments. After 8-month follow-up, sustained decreased SS value was shown in the distal MV-lateral segment (4.08 +/- 2.78-1.68 +/- 1.65 Pa), when compared with significantly increased SS value in the SB-lateral subsegment 4.35 +/- 5.04-16.50 +/- 40.45 Pa). The explanation is that after stenting in the MV, the flow was redistributed immediately after percutaneous coronary intervention (PCI) and reversed back to its original 8 months later. However, the growth of the fibrous tissue causing in-stent restenosis (ISR) is prohibited by sirolimus on the stent struts. In contrast, in a branch opened up by plain old balloon angioplasty (POBA), the flow did not change much, the flow could even be worse because it is shifted to the MV after the cross-sectional area of the MV improved by stenting. However, thanks to POBA, there is increased fibrous tissue formation, enough to increase the SS and prevent further accumulation of cell and cholesterol needed for more restenosis. CONCLUSION: In the provisional approach, low endothelial SS correlated with no restenosis for patients who underwent stenting of the MV, while a contradictory combination of high SS and no restenosis was seen in the SB after only POBA. The mechanism of prevention of restenosis in the SB is by increasing the SS while in the MV, the mechanism of prevention of ISR is secondary to sirolimus on the stents struts.

Distribution and magnitude of shear stress after coronary bifurcation lesions stenting with the classical crush technique: a new predictor for in-stent restenosis.

BACKGROUND: Wall shear stress (SS) plays an important role in the initiation and proliferation of coronary atherosclerosis, especially for bifurcations. Stenting in the coronary artery will cause many different changes in velocity, flow, cross-sectional area, and especially the wall SS. However, it is still unknown how much wall SS distribution varies with stenting in coronary bifurcation. OBJECTIVE: The purpose of this study was to investigate the magnitude and distribution of wall SS after the classical crush stenting for bifurcation lesions. METHODS: Eleven patients with true coronary bifurcation stenting by the classical crush technique were included. We studied the difference of wall SS between restenosis and nonrestenosis groups in these patients. The differences in SS between preprocedure and postprocedure, as well as between immediately postprocedure and after an 8-month follow-up, were also analyzed. Diameter stenosis or minimal lumen diameter were measured by quantitative coronary analysis. The commercial CD STAR-CCM+ was used to calculate the SS. RESULTS: At baseline, the SS in all the segments of all patients was high. The baseline SS of the restenosis group was 50% lower than the nonrestenosis group. Immediately after percutaneous coronary intervention (PCI), the SS in both areas decreased; however, the SS of the nonrestenosis group decreased to its lowest level possible while the SS of the restenosis group decreased moderately. Eight months later, the SS of all the segments of the nonrestenosis group remained persistently low at the same level of right after PCI. In contrary, the SS in the restenosis group returned to near its baseline level. CONCLUSION: From our study, after a 2-stent crush technique using drug-eluting stents (DES), the degree of SS reduction appears to predict in-stent restenosis (ISR). A SS decrease to its lowest level and remaining homogenously low is a prime condition to prevent ISR. A baseline low SS, which decreases minimally after PCI and recovers to around its baseline level, appears to be the setting for restenosis. These conditions can be evaluated as predictors of lesions that may need surveillance angiography and proper IVUS evaluation to prevent future in-stent restenosis.

Different edge effects of paclitaxel- and sirolimus-eluting stents on proximal and distal edges in patients with unstable angina: serial intravascular ultrasound analysis.

BACKGROUND: It is unclear whether edge segments have different responses to paclitaxel eluting stent (PES) and sirolimus eluting stent (SES) implantation in patients with unstable angina. This study aimed to compare the different vascular edge responses in patients with unstable angina and single de novo coronary lesion treated with SES and PES. METHODS: Two hundred and fifty-five patients with unstable angina and single de novo lesion were randomly assigned to PES and SES groups. Serial volumetric intravascular ultrasound (IVUS) images were taken immediately after stenting and at an eight-month follow-up. Five-mm edge segments proximal and distal to the stents were analyzed. RESULTS: Baseline characteristics were comparable between the two groups. At proximal-edge segment, the vessel area decreased and the plaque area increased significantly in the PES group as compared with the SES group. A significant net loss of lumen area was found in the PES group (from (11.10 +/- 3.12) mm(2) at baseline to (9.92 +/- 3.59) mm(2) at the follow-up, P < 0.001). At the distal-edge segment, the net loss of lumen area in the PES group (from (7.71 +/- 2.81) mm(2) at baseline to (6.66 +/- 2.29) mm(2) at the follow-up, P < 0.001) was attributed to a significant increase of plaque area. Proximal-edge stenosis was commonly seen in the PES group (20.0%) as compared with the SES group (5.0%, P = 0.001). This correlated with the higher incidence of target lesion revascularization in the PES group (P = 0.03). Subsegmentally, the smallest Delta lumen area was located at 2 mm proximally in both groups, at 0 mm distally in the PES group, and at 1 mm distally in the SES group. CONCLUSIONS: The two groups demonstrated negative remodeling of edge segments. PES was less effective than SES in inhibiting the growth of plaque within the first 1-mm length proximal to the stent.

Effect of coronary bifurcation angle on clinical outcomes in Chinese patients treated with crush stenting: a subgroup analysis from DKCRUSH-1 bifurcation study.

BACKGROUND: Bifurcation angles may have an impact on the clinical outcomes of crush stenting. We sought to compare high (> or = 60 degrees ) with low (< 60 degrees ) bifurcation angle in patients who underwent either classical or double kissing (DK) crush stenting for bifurcation lesions from the DKCRUSH-1 data base. METHODS: There were 212 patients with 220 lesions, some with low-angle (n = 138) and some with high-angle (n = 74). Angiography was indexed at 8-month after procedure. Primary endpoint was the occurrence of major adverse cardiac events (MACEs), defined as cardiac death, myocardial infarction and target lesion revascularization (TLR). Secondary endpoint included late lumen loss, the rate of restenosis, and final kissing balloon inflation (FKBI). RESULTS: At 8 months, clinical follow-up was 100%; angiographic follow-up was 75% in the low-angle group and 83.3% in the high-angle group. There were no significant differences in the FKBI between the high-angle group (91.43%) and the low-angle group (82.39%). In the high angle group, there was a significant difference in contrast volume used (P = 0.005) but no significant difference in acute gain, minimum lumen diameter (MLD), late loss and diameter stenosis in the pre-bifurcation segment, post-bifurcation segment or side branch. When lesions were assigned into with-(n = 133) and without-FKBI (n = 42), significant side-branch late loss was seen in the group without-FKBI ((0.65 +/- 0.49) mm vs (0.47 +/- 0.62) mm, P = 0.02), with a resultant greater restenosis rate (37.68% vs 18.32%, P = 0.001). No difference was detected in the MACE free survival rate between the high and low angle groups (82.39% vs 82.36%, P = 0.84). The rate of stent thrombosis tended to be higher in the lower-angle group although there was no significant difference (P = 0.38). The TLR free survival rate was 87.2% in the with-FKBI group vs 73.5% in the without-FKBI group (P = 0.001). Cox regression analysis showed that the independent predictors for target vessel revascularization were the side branch stent MLD post stenting (hazard ratios (HR) 1.028, 95% CI 2.357 - 16.233, P = 0.002), lack of FKBI (HR 4.910, 95% CI 4.706 - 8.459, P = 0.001) and unsatisfactory kissing (HR 3.120, 95% CI 2.975 - 5.431, P = 0.001). CONCLUSIONS: Bifurcation angles do not influence the clinical outcome of crush stenting. Successful final kissing balloon inflation, regardless of bifurcation angles, can predict TLR.

[Comparison of DK crush with classical crush technique with drug-eluting stents for the treatment of coronary bifurcation lesions from DKCRUSH-1 study].

OBJECTIVE: To determine independent factors correlated with clinical effects of DK crush and classical crush technique with drug-eluting stents on bifurcation lesions. METHODS: 311 patients with bifurcation lesions were randomized to classical (C, n = 156) or double kissing (DK) crush (n = 155) stent implantation group. The primary endpoints included major adverse cardiac events (MACE). RESULTS: Final kissing balloon inflation (FKBI) success rate was 76% in C and 100% in DK groups (P < 0.001). DK crush procedure was characterized by lower unsatisfactory FKBI rate (27.6% vs.6.3%, P < 0.01). Clinical follow-up was available in 100% and angiographic follow-up in 82% patients. The overall restenosis rate was 32.3% in C and 20.3% in DK groups (P = 0.01), respectively. Cumulative 8-month MACE was 35.9% in without-FKBI and 19.7% in with-FKBI sub-groups, and 11.4% in DK group (P = 0.02). The incidence of stent thrombosis was 3.2% in C group (5.1% without vs. 1.7% with FKBI) and 1.3% in DK group (P > 0.05). The predictive factors of MACE included minimal side branch stent lumen diameter and lack of DK crush technique. CONCLUSION: DK crush technique is an alternative of double stenting techniques in terms of improvement of restenosis and clinical outcomes.

In vivo virtual histology intravascular ultrasound correlates of risk factors for sudden coronary death in men: results from the prospective, multi-centre virtual histology intravascular ultrasound registry.

AIMS: We hypothesized a relationship between virtual histology intravascular ultrasound (VH-IVUS) findings and risk factors histopathologically associated with sudden coronary death (SCD) in men: cigarette smoking and an increased total cholesterol-to-high-density lipoprotein cholesterol (HDL-C) ratio (TC/HDL > 5). METHODS AND RESULTS: We assessed volumetric VH-IVUS parameters in a consecutive series of 473 male patients: fibrous, fibro-fatty, dense calcium (DC), necrotic core (NC), and a calculated NC/DC ratio. Patients' age was 61 ± 11 years, with 27% smokers and 69% having a lipid disorder. The NC/DC ratio was the only VH-IVUS parameter related to both TC/HDL ratio (r = 0.18, P= 0.0008) and low-density lipoprotein cholesterol levels (r = 0.17, P= 0.002); had a negative correlation with HDL-C levels (r = -0.11, P= 0.03); and was higher for smokers [median 1.98 (1.35-3.18)] vs. non-smokers [median 1.70 (1.23-2.53), P= 0.006]. An NC/DC value >3 was the threshold that best identified smokers and/or patients presenting TC/HDL >5 (odds ratio 3.0, 95% CI 1.7-4.9, P= 0.0001), and receiver-operator curves showed the superiority of the NC/DC ratio [area under curve (AUC) 0.64, P < 0.0001] over %DC (AUC 0.58, P= 0.006) or %NC (AUC 0.51, P= 0.43) to identify these patients. CONCLUSION: The ratio of NC to calcification detected by VH-IVUS in diseased coronary segments is related to known risk factors for SCD and, thus, may be associated with a worse prognosis.

Treatment of restenotic drug-eluting stents: an intravascular ultrasound analysis.

BACKGROUND: The intravascular ultrasound (IVUS) findings during repeat intervention for drug-eluting stent (DES) restenosis have not been well described. METHODS: We identified 62 consecutive DES restenosis lesions (45 sirolimus-eluting stents and 17 paclitaxel-eluting stents) undergoing repeat intervention with pre and postintervention IVUS. Lumen, stent and intimal hyperplasia (stent minus lumen) areas were measured at the minimal lumen area (MLA) site and minimal stent area (MSA) site. RESULTS: Repeat stent implantation was performed in 55 lesions (88.7%). Overall, MLA increased from 2.3 +/- 0.7 mm(2) preintervention to 4.6 +/- 1.6 mm(2) postintervention. Preintervention MLA was seen at exactly the preintervention MSA site in 42%, while 73% of postintervention MLAs were located at the preintervention MSA site. There was a strong correlation between the preintervention MSA and the postintervention MLA (r = 0.79; p < 0.001). Preintervention MSA was the strongest independent predictor of a larger postintervention MLA (coefficient 0.72; p < 0.001). CONCLUSIONS: The preintervention MSA was a major predictor of larger lumen area after repeat intervention for DES restenosis. Several IVUS studies have shown that stent dimensions do not change over time. Therefore, the MSA of the original stent implantation procedure still has the greatest impact on subsequent interventions to treat DES restenosis.

Assessing intermediate left main coronary lesions using intravascular ultrasound.

BACKGROUND: Angiographic assessment of a left main coronary artery stenosis (LMCS) is often difficult and unreliable. We aimed to evaluate the severity of ambiguous LMCSs by intravascular ultrasound (IVUS) and to clarify how frequently significant stenosis occurs in the "real world". METHODS: We retrospectively found 115 consecutive patients in our clinical IVUS database with a de novo, angiographically ambiguous, intermediate LMCS who underwent IVUS evaluation. Quantitative coronary angiography (QCA) and IVUS analyses were performed. We define a significant LMCS as a diameter stenosis >50% by QCA and a minimal lumen area <6.0 mm2 by IVUS. RESULTS: Ostial, mid, and distal LMCSs were seen in 44 (38.3%), 6 (5.2%), and 65 (56.5%) lesions. Overall, IVUS minimal lumen area and plaque burden measured 6.8 +/- 2.6 mm2 and 63% +/- 14%. A significant LMCS was seen in 51 (44.3%) lesions by IVUS but in only 15 (13.0%) lesions by QCA. In particular, only 36.4% of ostial lesions had a significant IVUS stenosis, and minimal lumen diameter by QCA was less well correlated with IVUS in ostial lesions than in other lesion locations. CONCLUSIONS: This real-world IVUS analysis showed that less than half of intermediate LMCSs had significant stenoses by IVUS assessment, especially for lesions located at the left main ostium. Such patients deserve IVUS assessment or physiologic assessment before blindly proceeding to revascularization.

DK crush (double-kissing and double-crush) technique for treatment of true coronary bifurcation lesions: illustration and comparison with classic crush.

BACKGROUND: Classic crush has a lower success rate compared to final kissing balloon inflation (FKBI). We previously reported the double-kissing (DK) crush technique that involves double-kissing along with double-crushing for the treatment of true bifurcation coronary lesions in 2005. METHODS AND RESULTS: This is a consecutive, nonrandomized, open-label study. Eighty-eight consecutive patients with single, true coronary bifurcation lesions according to Lefevre Classification2 and side branch diameter >2.0 mm were enrolled. The first 44 patients (from October 2004 to January 2005) were assigned to the classic crush treatment arm and the next 44 patients (from February 2005 to June 2005) were assigned to the DK crush technique arm, respectively. Data within 30 days were analyzed. Patients in the DK crush group, compared to those in classic crush group, were characterized by longer lesion length in the side branch (13.5 +/- 3.4 mm vs 7.8 +/- 3.1 mm; p <0.05), shorter procedural time (44 +/- 12 minutes vs 68 +/- 17 minutes; p <0.05 ), higher success rate of FKBI (100% vs 70%; p <0.01), and lower contrast volume required (102 +/- 38 mm vs 176 +/- 46 mm; p <0.05). There was a trend toward a larger distal angle between the main vessel and the side branch (57 +/- 180 vs 47 +/- 150) in the DK crush group, as well as longer lesion length in the main vessel (24.3 +/- 8.6 mm vs 21.1 +/- 7.3 mm), though without significant differences (p >0.05). Subacute stent thrombosis was detected in 2 patients with failure of FKBI in the classic crush group (4.3%). In addition, patients in the classic crush group were characterized by a smaller minimum lumen diameter (MLD) at the side branch ostium (2.74 +/- 0.12 mm vs 3.01 +/- 0.13 mm; p <0.01) and had a higher degree of residual stenosis at the ostial side branch (17.4 +/- 11.2% vs 7.3 +/- 8.6%; p <0.05). CONCLUSIONS: Compared with classic crush, DK crush has the potential to improve the clinical outcome in patients with coronary bifurcation lesions. Further randomized, prospective, multicenter studies are required to confirm these differences between the classic crush and DK crush techniques.