Clinical Comparison of Drug-Coated Balloon and Drug-Eluting Stent for Femoropopliteal Lesions in Chronic Limb-Threatening Ischemia With Wounds.

BACKGROUND: Endovascular therapy (EVT) with devices such as drug-coated balloons (DCBs) and drug-eluting stents (DESs) for atherosclerotic disease in the femoropopliteal (FP) artery has been established. However, EVT using drug-based devices for chronic limb-threatening ischemia (CLTI) remains challenging. The optimal device for FP lesions in patients with CLTI remains unknown. This study compared the clinical efficacy of DCB and DES in patients with CLTI and FP lesions. METHODS AND RESULTS: This retrospective single-center study included 539 consecutive patients (562 lesions) treated with EVT between January 2018 and December 2022; 166 patients with CLTI and Rutherford Class 5 or 6 wounds underwent EVT with DCB or DES. Clinical outcomes were compared between 53 pairs after propensity score matching. There were no significant differences between the DCB and DES groups in the incidence of complete wound healing without death or major amputation (84.8% vs. 80.2%, respectively; P=0.99), primary patency (69.4% vs. 75.6%, respectively; P=0.65), and freedom from target lesion revascularization at 1 year (78.6% vs. 78.0%, respectively; P=0.92). Multivariate analysis showed that complete wound healing at 1 year is negatively associated with hemodialysis and Wound, Ischemia, and foot Infection Stage 4, but positively associated with Global Limb Anatomic Staging System FP Grade 3 or 4. CONCLUSIONS: No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.

Guideline-Directed Medical Therapy for Elderly Patients With Acute Myocardial Infarction Who Undergo Percutaneous Coronary Intervention　- Insights From a Retrospective Observational Study.

BACKGROUND: The efficacy of guideline-directed medical therapy (GDMT) in the elderly remains unclear. This study evaluated the impact of GDMT (aspirin or a P2Y12inhibitor, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, ß-blocker, and statin) at discharge on long-term mortality in elderly patients with acute myocardial infarction (AMI) who had undergone percutaneous coronary intervention (PCI). METHODS AND RESULTS: Of 2,547 consecutive patients with AMI undergoing PCI in 2009-2020, we retrospectively analyzed 573 patients aged ≥80 years. The median follow-up period was 1,140 days. GDMT was prescribed to 192 (33.5%) patients at discharge. Compared with patients without GDMT, those with GDMT were younger and had higher rates of ST-segment elevation myocardial infarction and left anterior descending artery culprit lesion, higher peak creatine phosphokinase concentration, and lower left ventricular ejection fraction (LVEF). After adjusting for confounders, GDMT was independently associated with a lower cardiovascular death rate (hazard ratio [HR] 0.35; 95% confidence interval [CI] 0.16-0.81), but not with all-cause mortality (HR 0.77; 95% CI 0.50-1.18). In the subgroup analysis, the favorable impact of GDMT on cardiovascular death was significant in patients aged 80-89 years, with LVEF <50%, or with an estimated glomerular filtration rate ≥30 mL/min/1.73 m2. CONCLUSIONS: GDMT in patients with AMI aged ≥80 years undergoing PCI was associated with a lower cardiovascular death rate but not all-cause mortality.

Calcium Fracture After Intravascular Lithotripsy as Assessed With Optical Coherence Tomography.

BACKGROUND: Plaque characteristics associated with effective intravascular lithotripsy (IVL) treatment of calcification have not been investigated. This study identified calcified plaque characteristics that favor the use of IVL.Methods and Results: Optical coherence tomography (OCT) was performed in 16 calcified lesions in 16 patients treated with IVL and coronary stenting. Cross-sectional OCT images in 262 segments matched across pre-IVL, post-IVL, and post-stenting time points were analyzed. After IVL, 66 (25%) segments had calcium fracture. In multivariable analysis, calcium arc (odds ratio [OR] 1.22; 95% confidence interval [CI] 1.13-1.32; P<0.0001), superficial calcification (OR 6.98; 95% CI 0.07-55.57; P=0.0182), minimum calcium thickness (OR 0.66; 95% CI 0.51-0.86; P=0.0013), and nodular calcification (OR 0.24; 95% CI 0.08-0.70; P=0.0056) were associated with calcium fracture. After stenting, stent area was larger for segments with fracture (8.0 [6.9-10.6] vs. 7.1 [5.2-8.9] mm2; P=0.004). CONCLUSIONS: Post-IVL calcium fracture is more likely in calcified lesions with lower thickness, a larger calcium arc, superficial calcification, and non-nodular calcification, leading to a larger stent area.

Prognostic value of comprehensive intracoronary physiology assessment early after heart transplantation.

AIMS: We evaluated the long-term prognostic value of invasively assessing coronary physiology after heart transplantation in a large multicentre registry. METHODS AND RESULTS: Comprehensive intracoronary physiology assessment measuring fractional flow reserve (FFR), the index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) was performed in 254 patients at baseline (a median of 7.2 weeks) and in 240 patients at 1 year after transplantation (199 patients had both baseline and 1-year measurement). Patients were classified into those with normal physiology, reduced FFR (FFR ≤ 0.80), and microvascular dysfunction (either IMR ≥ 25 or CFR ≤ 2.0 with FFR > 0.80). The primary outcome was the composite of death or re-transplantation at 10 years. At baseline, 5.5% had reduced FFR; 36.6% had microvascular dysfunction. Baseline reduced FFR [adjusted hazard ratio (aHR) 2.33, 95% confidence interval (CI) 0.88-6.15; P = 0.088] and microvascular dysfunction (aHR 0.88, 95% CI 0.44-1.79; P = 0.73) were not predictors of death and re-transplantation at 10 years. At 1 year, 5.0% had reduced FFR; 23.8% had microvascular dysfunction. One-year reduced FFR (aHR 2.98, 95% CI 1.13-7.87; P = 0.028) and microvascular dysfunction (aHR 2.33, 95% CI 1.19-4.59; P = 0.015) were associated with significantly increased risk of death or re-transplantation at 10 years. Invasive measures of coronary physiology improved the prognostic performance of clinical variables (χ2 improvement: 7.41, P = 0.006). However, intravascular ultrasound-derived changes in maximal intimal thickness were not predictive of outcomes. CONCLUSION: Abnormal coronary physiology 1 year after heart transplantation was common and was a significant predictor of death or re-transplantation at 10 years.

Long-term clinical outcomes with use of an angiotensin-converting enzyme inhibitor early after heart transplantation.

BACKGROUND: The safety and efficacy of angiotensin converting enzyme inhibition (ACEI) after heart transplantation (HT) is unknown. This study examined long-term clinical outcomes after ACEI in HT recipients. METHODS: The ACEI after HT study was a prospective, randomized trial that tested the efficacy of ACEI with ramipril after HT. In this study, long-term clinical outcomes were assessed in 91 patients randomized to either ramipril or placebo (median, 5.8 years). The primary endpoint was a composite of death, retransplantation, hospitalization for rejection or heart failure, and coronary revascularization. RESULTS: The primary endpoint occurred in 10 of 45 patients (22.2%) in the ramipril group and in 14 of 46 patients (30.4%) in the placebo group (Hazard ratio (HR), 0.68; 95% CI, 0.29-1.51; P = .34). When the analysis was restricted to comparing patients who remained on a renin-angiotensin system inhibitor beyond 1 year with those who did not, there was a trend to improved outcomes (HR, 0.54; 95% CI, 0.22-1.28, P = .16). There was no significant difference in creatinine, blood urea nitrogen, and potassium at 3 years after randomization. The cumulative incidence of the primary endpoint was significantly higher in patients in whom the index of microcirculatory resistance increased from baseline to 1 year compared with those in whom it did not (39.1 vs 17.4%, HR: 3.36; 95% CI, 1.07-12.7; P = .037). CONCLUSION: The use of ramipril after HT safely lowers blood pressure and is associated with favorable long-term clinical outcomes. Clinical Trial Registration-URL: https://www.clinicaltrials.gov. Unique identifier: NCT01078363.

Intravascular ultrasound radiofrequency signal analysis of blood speckles: Physiological assessment of intermediate coronary artery stenosis.

BACKGROUND: This study aimed to systematically investigate feasibility of radiofrequency intravascular ultrasound (RF-IVUS) analysis of blood signals for assessing functionally significant coronary stenosis. METHODS: First, in-vivo human study was performed to evaluate 83 intermediate coronary lesions from 75 patients, using 40-MHz RF-IVUS, fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). Average blood integrated-backscatter (IB) values within lumen were measured at proximal and distal segments to the stenosis; ΔIB values between the two sites were calculated. Second, bench-test was performed to assess relationships of blood IB values to blood flow velocity and hematocrit using 40 and 60-MHz RF-IVUS. RESULTS: In in-vivo study, ΔIB values across the stenosis significantly correlated with both FFR (r = -.85, p < .0001) and iFR (r = -.65, p < .0001), which was confirmed in small minimum lumen area (MLA) lesions (MLA <2.0 mm2 ). Receiver operating characteristic curve analyses identified the best cut-off value as 10.06 of ΔIB values for predicting FFR ≤0.8 and iFR ≤0.89 (sensitivity 76.2 and 95.5%, specificity 100 and 82.0%, positive predictive value 100 and 65.6%, negative predictive value 80.4 and 98.0%, accuracy 92.9 and 92.8% for FFR and iFR). Bench-test study also identified that blood IB values exponentially changed as a function of blood flow velocity at any given hematocrit in both 40 and 60-MHz RF-IVUS. CONCLUSIONS: This study supports the potential utility of RF-IVUS analysis of blood signals to estimate functional ischemia, demonstrating relationships of blood ΔIB values to FFR and iFR, as well as relationships between blood IB values and flow velocity.

Association between abdominal fat distribution and coronary plaque instability in patients with acute coronary syndrome.

BACKGROUND AND AIMS: This study aimed to assess possible association of detailed abdominal fat profiles with coronary plaque characteristics in patients with acute coronary syndrome (ACS). METHODS AND RESULTS: In 60 patients with ACS, culprit arteries were evaluated at 1-mm intervals (length analyzed: 66 ± 28 mm) by grayscale and integrated backscatter intravascular ultrasound (IB-IVUS) before percutaneous coronary intervention. Standard IVUS indexes (as a volume index: volume/length), plaque components (as percent tissue volume) and fibrous cap thickness (FCT) were assessed by IB-IVUS. Plain abdominal computed tomography was performed to evaluate subcutaneous adipose tissue (SAT) area, visceral adipose tissue (VAT) area, and VAT/SAT ratio. While SAT area only correlated with vessel volume (r = 0.27, p = 0.04), VAT area correlated positively with vessel (r = 0.30, p = 0.02) and plaque (r = 0.33, p = 0.01) volumes and negatively with FCT (r = -0.26, p = 0.049), but not with percent plaque volume and plaque tissue components. In contrast, higher VAT/SAT ratio significantly correlated with higher percent lipid (r = 0.34, p = 0.008) and lower percent fibrous (r = -0.34, p = 0.007) volumes with a trend toward larger percent plaque volume (r = 0.19, p = 0.15), as well as thinner FCT (r = -0.53, p < 0.0001). In the multiple regression analysis, higher VAT/SAT ratio was independently associated with higher percent lipid with lower percent fibrous volumes (p = 0.03 for both) and thinner fibrous cap thickness (p = 0.0001). CONCLUSION: Coronary plaque vulnerability, defined as increased lipid content with thinner fibrous cap thickness, appears to be more related to abnormal abdominal fat distribution, or so-called hidden obesity, compared with visceral or subcutaneous fat amount alone in patients with ACS.

Association of Endothelin-1 With Accelerated Cardiac Allograft Vasculopathy and Late Mortality Following Heart Transplantation.

BACKGROUND: Endothelin-1 (ET-1) has been implicated in the development of post-heart transplantation (HT) cardiac allograft vasculopathy (CAV), but has not been well studied in humans. METHODS AND RESULTS: In 90 HT patients, plasma ET-1 was measured within 8 weeks after HT (baseline) via a competitive enzyme-linked immunosorbent assay. Three-dimensional volumetric intravascular ultrasound of the left anterior descending artery was performed at baseline and at 1 year. Accelerated CAV (lumen volume loss) was defined with the 75th percentile as a cutoff. Patients were followed beyond the first year after HT for late death or retransplantation. A receiver operating characteristic (ROC) curve demonstrated that a baseline ET-1 concentration of 1.75 pg/mL provided the best accuracy for diagnosis of accelerated CAV at 1 year (area under the ROC curve 0.69, 95% confidence interval [CI] 0.57-0.82; P = .007). In multivariate logistic regression, a higher baseline ET-1 concentration was independently associated with accelerated CAV (odds ratio [OR] 2.13, 95% CI 1.15-3.94; P = .01); this relationship persisted when ET-1 was dichotomized at 1.75 pg/mL (OR 4.88, 95% CI 1.69-14.10; P = .003). Eighteen deaths occurred during a median follow-up period of 3.99 (interquartile range 2.51-9.95) years. Treated as a continuous variable, baseline ET-1 was not associated with late mortality in multivariate Cox regression (hazard ratio [HR] 1.22, 95% CI 0.72-2.05; P = .44). However, ET-1 >1.75 pg/mL conferred a significantly lower cumulative event-free survival on Kaplan-Meier analysis (P = .047) and was independently associated with late mortality (HR 2.94, 95% CI 1.12-7.72; P = .02). CONCLUSIONS: Elevated ET-1 early after HT is an independent predictor of accelerated CAV and late mortality, suggesting that ET-1 has durable prognostic value in the HT arena.

Comparison between instantaneous wave-free ratio versus morphometric assessments by intracoronary imaging.

Anatomical measurements obtained by intracoronary imaging devices are reported to correlate significantly with fractional flow reserve (FFR). Instantaneous wave-free ratio (iFR) is a nonhyperemic index of stenosis severity with discordant reports regarding its accuracy in relation to FFR. There is no information on the correlation of iFR with measurements derived from intracoronary imaging devices. The purpose of this study was to assess the relationship among iFR, intravascular ultrasound (IVUS), and optical frequency domain imaging (OFDI) parameters. Eighty lesions in 72 patients who underwent elective angiography and had intermediate lesions were enrolled. All lesions were assessed by iFR, FFR, IVUS, and OFDI. iFR was ≤ 0.89 in 21 (26%) lesions and FFR was ≤ 0.80 in 41 (51%) lesions. iFR correlated significantly with both IVUS-derived minimum lumen area (MLA) (r = 0.375, p = 0.003) and OFDI-derived MLA (r = 0.357, p = 0.005). FFR also correlated significantly with both IVUS-derived MLA (r = 0.472, p < 0.001) and OFDI-derived MLA (r = 0.445, p < 0.001). Among the lesions with FFR ≤ 0.80, iFR > 0.89 (mismatch) was observed in 20 lesions. There was no lesion with iFR ≤ 0.89 (reverse mismatch) among the lesions with FFR > 0.80. The lesion location among three major coronary vessels was related with the discrepancy between iFR and FFR (p = 0.007). In conclusion, iFR and FFR showed a significant correlation with IVUS and OFDI measurements. The discrepancy of iFR and FFR was associated with the lesion locations.

Assessment of bioresorbable scaffold with a novel high-definition 60 MHz IVUS imaging system: Comparison with 40-MHz IVUS referenced to optical coherence tomography.

BACKGROUND: In vivo assessment of bioresorbable scaffold (BRS) is of growing clinical interest. The novel 60MHz high-definition intravascular ultrasound (HD-IVUS) has been developed to overcome the limitations of conventional 40 MHz IVUS. This study aimed to evaluate the performance and limitations of 60 MHz HD-IVUS compared with 40 MHz IVUS with respect to polymeric-strut visualization, quantitative and qualitative analysis, and feasibility of high-speed pullback in the assessment of BRS. METHODS AND RESULTS: In a bench-test model, 361 struts were analyzed to evaluate the influence of ultrasound-beam angles and proximity of adjacent struts on IVUS visualization of BRS struts. Various settings were created by deforming the BRS and positioning the transducer offcenter. In an in vivo swine coronary model, scaffold and lumen areas, degree of visible external elastic membrane, incomplete strut apposition, and strut fracture were evaluated in 59 matched cross-sections obtained at conventional (0.5 mm/sec) and high speed (10 mm/sec) pullbacks. Both studies utilized optical coherence tomography (OCT) as reference. Overall, 60 MHz HD-IVUS demonstrated significantly improved visualization of polymeric struts compared with 40 MHz IVUS (well-visualized: 84.5% vs 62.3%, not visible: 4.4% vs 13.9%, respectively. P < 0.001), which was less affected by the beam angle and adjacent strut proximity. In the in vivo model, 60-MHz HD-IVUS showed better agreement of area measurements and strut abnormalities with OCT than 40 MHz IVUS. These findings were also confirmed on high-speed pullback images of 60 MHz HD-IVUS. CONCLUSION: As referenced to OCT, this study showed superiority of 60 MHz HD-IVUS over 40 MHz IVUS in the assessment of BRS with feasibility of high-speed pullback imaging.

Invasive Assessment of Coronary Physiology Predicts Late Mortality After Heart Transplantation.

BACKGROUND: The aim of this study is to determine the prognostic value of invasively assessing coronary physiology early after heart transplantation. METHODS AND RESULTS: Seventy-four cardiac transplant recipients had fractional flow reserve, coronary flow reserve, index of microcirculatory resistance (IMR), and intravascular ultrasound performed down the left anterior descending coronary artery soon after (baseline) and 1 year after heart transplantation. The primary end point was the cumulative survival free of death or retransplantation at a mean follow-up of 4.5±3.5 years. The cumulative event-free survival was significantly lower in patients with a fractional flow reserve <0.90 at baseline (42% versus 79%; P=0.01) or an IMR ≥20 measured 1 year after heart transplantation (39% versus 69%; P=0.03). Patients in whom IMR decreased or did not change from baseline to 1 year had higher event-free survival compared with patients with an increase in IMR (66% versus 36%; P=0.03). Fractional flow reserve <0.90 at baseline (hazard ratio, 0.13; 95% confidence interval, 0.02-0.81; P=0.03), IMR ≥20 at 1 year (hazard ratio, 3.93; 95% confidence interval, 1.08-14.27; P=0.04), and rejection during the first year (hazard ratio, 6.00; 95% confidence interval, 1.56-23.09; P=0.009) were independent predictors of death/retransplantation, whereas intravascular ultrasound parameters were not. CONCLUSIONS: Invasive measures of coronary physiology (fractional flow reserve and IMR) determined early after heart transplantation are significant predictors of late death or retransplantation.

Impact of analysis interval size on the quality of optical frequency domain imaging assessments of stent implantation for lesions of the superficial femoral artery.

OBJECTIVES: This study aimed to investigate the influence of analysis interval size on optical frequency domain imaging (OFDI) assessment of stent therapy for lesions of the superficial femoral artery (SFA). BACKGROUND: No consensus or validating data are available with respect to the methodology of intravascular imaging analysis for the peripheral arteries. METHODS: OFDI was performed for 30 SFA lesions, during endovascular therapy and at the 6-month follow-up. Initially, lumen and stent borders were traced at 1-mm axial intervals. Volumes were calculated using a PC-based software, and the volume index (VI) was defined as the volume divided by the stent length. Two additional OFDI analyses were performed using 2-mm and 5-mm intervals, thereby reducing the number of cross-sectional image frames analyzed. RESULTS: The mean stent length was 89.7 ± 35.2 mm. The mean difference in baseline minimum lumen area (MLA) was 0.4 mm2 between MLA values from the 1-mm and 2-mm interval analyses, and 2.2 mm2 between MLA values from the 1-mm and 5-mm interval analyses. In volumetric analysis, there were excellent correlations and good agreements for stent, lumen, and neointimal VI measurements obtained on the basis of different analysis intervals. CONCLUSIONS: Using large intervals in OFDI analyses of SFA lesions resulted in few differences in measurement variability of volumetric parameters. However, planar analysis for MLA assessment can be susceptible to high variability when large intervals are applied. © 2016 Wiley Periodicals, Inc.

Intravascular Ultrasound-Derived Stent Dimensions as Predictors of Angiographic Restenosis Following Nitinol Stent Implantation in the Superficial Femoral Artery.

PURPOSE: To identify intravascular ultrasound (IVUS) measurements that can predict angiographic in-stent restenosis (ISR) following nitinol stent implantation in superficial femoral artery (SFA) lesions. METHODS: A retrospective review was conducted of 97 patients (mean age 72.9±8.9 years; 63 men) who underwent IVUS examination during endovascular treatment of 112 de novo SFA lesions between July 2012 and December 2014. Self-expanding bare stents were implanted in 46 lesions and paclitaxel-eluting stents in 39 lesions. Six months after stenting, follow-up angiography was conducted to assess stent patency. The primary endpoint was angiographic ISR determined by quantitative vascular angiography analysis at the 6-month follow-up. Variables associated with restenosis were sought in multivariate analysis; the results are presented as the odds ratio (OR) and 95% confidence interval (CI). RESULTS: At follow-up, 27 (31.8%) angiographic ISR lesions were recorded. The lesions treated with uncoated stents were more prevalent in the ISR group compared with the no restenosis group (74.1% vs 44.8%, p=0.02). Lesion length was longer (154.4±79.5 vs 109.0±89.3 mm, p=0.03) and postprocedure minimum stent area (MSA) measured by IVUS was smaller (13.9±2.8 vs 16.3±1.6 mm(2), p<0.001) in the ISR group. Multivariate analysis revealed that bare stent use (OR 7.11, 95% CI 1.70 to 29.80, p<0.01) and longer lesion length (OR 1.08, 95% CI 1.01 to 1.16, p=0.04) were predictors of ISR, while increasing postprocedure MSA (OR 0.58, 95% CI 0.41 to 0.82, p<0.01) was associated with lower risk of ISR. Receiver operating characteristic analysis identified a MSA of 15.5 mm(2) as the optimal cutpoint below which the incidence of restenosis increased (area under the curve 0.769). CONCLUSION: Postprocedure MSA can predict ISR in SFA lesions, which suggests that adequate stent enlargement during angioplasty might be required for superior patency.

Association between blood glucose variability and coronary plaque instability in patients with acute coronary syndromes.

BACKGROUND: Blood glucose variability is receiving considerable attention as a new risk factor for coronary artery disease. This study aimed to investigate the association between blood glucose variability and coronary plaque tissue characteristics. METHODS: In 57 patients with acute coronary syndrome, integrated backscatter intravascular ultrasound (IB-IVUS) and gray-scale IVUS were performed before balloon dilatation or stent implantation in the culprit vessels. Standard IVUS indices were evaluated for volume index (volume/length), and plaque components were measured by IB-IVUS for percent tissue volume. In addition to conventional glucose indicators, blood glucose variability in a stable state was determined by calculating the mean amplitude of glycemic excursions (MAGE) using a continuous glucose monitoring system. RESULTS: Higher MAGE values were significantly correlated with larger percent plaque volumes (r = 0.32, p = 0.015), and increased lipid (r = 0.44, p = 0.0006) and decreased fibrous (r = -0.45, p = 0.0005) plaque components. In contrast, HbA1c or fasting plasma glucose values were not significantly correlated with plaque volumes and percent plaque components. Homeostasis model assessment of insulin resistance values were positively correlated with vessel (r = 0.35, p = 0.007) and plaque (r = 0.27, p = 0.046) volumes, but not with percent plaque components. In multiple regression analysis, higher MAGE values were independently associated with increased lipid (ß = 0.80, p = 0.0035) and decreased fibrous (ß = -0.79, p = 0.0034) contents in coronary plaques. CONCLUSIONS: Among all glucose indicators studied, only higher blood glucose variability was an independent determinant of increased lipid and decreased fibrous contents with larger plaque burden, suggesting blood glucose variability as one of the important factors related to coronary plaque vulnerability.

Baseline and 9 months IVUS analysis of the bifurcation-dedicated biolimus A9-eluting Axxess stent system: the DIVERGE IVUS substudy.

BACKGROUND: Percutaneous treatment of complex coronary bifurcation lesions remains challenging, even in the drug-eluting stent era. We sought to evaluate the baseline and 9 months intravascular ultrasound (IVUS) analysis of the Axxess™ stent, a self-expanding, Biolimus A9™-eluting, and dedicated bifurcation stent. METHODS AND RESULTS: We enrolled the first 76 patients from selected sites of the 302 patients large DIVERGE trial (a prospective, single-arm, multicenter trial evaluating the safety and efficacy of the Axxess stent). Both baseline and 9 months IVUS images were collected for serial two-dimensional (2D) and 3D analysis. A minimal amount and a low percentage of neointimal volume index were seen in the Axxess stent at 9 months (0.4 ± 0.6 mm(3) /mm and 4.3 ± 5.2%, respectively). Vessel, lumen, and stent volume indices increased significantly (respectively, 17.0 ± 3.6 to 18.9 ± 3.7 mm(3) /mm, P < 0.0001; 7.3 ± 2.0 to 9.2 ± 2.5 mm(3) /mm, P < 0.0001; and 7.4 ± 2.0 to 9.6 ± 2.6 mm(3) /mm, P < 0.0001). This resulted in minimum lumen area (MLA) enlargement (6.1 ± 1.9 to 7.2 ± 2.3 mm(2) , P < 0.0001), whereas peristent plaque area decreased (8.7 ± 2.5 to 8.5 ± 2.1 mm(3) /mm, P = 0.016). At 9 months, 16 (26%) incomplete stent apposition (ISA) persisted from baseline, while six resolved (9.7%). Only one (2%) ISA was late acquired. In the additional distal sirolimus-eluting stents, MLA decreased from 4.3 ± 1.1 to 4.1 ± 1.2 mm(2) (P = 0.04) at 9 months for the main branch, and from 3.4 ± 1.2 to 3.2 ± 1.2 mm(2) (P = 0.09) for the side branch. CONCLUSIONS: The dedicated bifurcation Axxess stent system demonstrates significant stent volume increase with minimal neointimal formation and a low incidence of late-acquired ISA at 9 months.

Intravascular ultrasound analysis of small vessel lesions treated with the Sparrow coronary stent system: results of the CARE II trial.

OBJECTIVES: The aim of this study was to evaluate the Sparrow sirolimus-eluting stent (Sparrow-SES) against the Sparrow bare-metal stent (Sparrow-BMS) and conventional balloon-expandable bare-metal stent (BMS: Driver/Micro-Driver stent, Medtronic Vascular, Santa Rosa, CA). BACKGROUND: The Sparrow stent (Biosensors International, Singapore) consists of a guide wire-based, self-expandable, ultra-thin nitinol stent. The performance of this device with sirolimus in a fully biodegradable polymer has not been determined. METHODS: A total of 74 patients were included in this intravascular ultrasound (IVUS) sub-study of the CARE II trial, which was a prospective, randomized, multicenter trial in the treatment of single de novo native coronary artery lesions in vessels ranging from 2.0 mm to 2.75 mm in diameter (Sparrow-SES: n = 31, Sparrow-BMS: n = 22, BMS: n = 21). RESULTS: Stent volume index (VI) was significantly increased 8-month later in Sparrow-SES and Sparrow-BMS, but not in BMS (4.0 ± 1.0 to 4.6 ± 1.0 mm(3) /mm, p<0.0001, 4.0 ± 0.6 to 4.4 ± 0.8 mm(3) /mm, p<0.05, and 5.2 ± 1.0 to 5.1 ± 0.9 mm(3) /mm, p=0.421, respectively). % neointimal obstruction in Sparrow-SES was significantly smaller than those in Sparrow-BMS and BMS at follow-up (17.6 ± 9.4 vs. 36.2 ± 13.8 and 39.9 ± 11.1%, p<0.001). Sparrow-SES showed a mean 15% stent expansion and good suppression of neointimal proliferation, resulting in a significantly lower percentage of change in lumen VI during follow-up period (Sparrow-SES: -6.2 ± 16.2%, Sparrow-BMS: -30.4 ± 11.6%, BMS: -40.4 ± 10.0%, p<0.001). CONCLUSIONS: The self-expanding Sparrow-SES demonstrated chronic stent expansion, good suppression of neointimal proliferation and resulted in a more preserved lumen in stented small vessels compared with the Sparrow-BMS and conventional balloon expandable BMS.

Contemporary Infrapopliteal Intervention for Limb Salvage and Wound Healing.

Infrapopliteal arterial disease is a significant cause of critical limb ischemia (CLI), whether single-segment or multisegment disease. The collaboration between the tremendous advancements in endovascular technology and the refinement of endovascular techniques has renewed the classic infrapopliteal interventions during the past decade. With this paradigm shift in the treatment of CLI, the role of a comprehensive approach of different disciplines for tissue loss is becoming greater. Given the increasing global burden of CLI, we review the cutting-edge diagnostic and endovascular approaches to infrapopliteal artery disease, and the importance of wound management in optimizing clinical outcomes.