Native Coronary Stenosis Research Articles

Impact of intravascular ultrasound parameters on revascularization decision in grey zone fractional flow reserve: data from IRIS FFR registry

Abstract Background The optimal revascularization strategy for coronary stenosis with grey-zone fractional flow reserve (FFR) value (0.75-0.80) is still debated. This study investigated the prognostic impact of the lesion characteristics measured by intravascular ultrasound (IVUS) in grey-zone FFR. Methods A total of 734 native coronary stenoses with grey-zone FFR in 734 patients from the prospective multicenter IRIS-FFR registry were simultaneously evaluated by IVUS. The primary outcome was a composite of cardiac death, myocardial infarction and target vessel revascularization. Results Among the 734 patients, revascularization was deferred for 293 patients and performed for 441. During a median follow-up of 4.4 years, the primary outcome occurred in 31 (10.6%) patients in deferred group and 42 (9.5%) in performed group. With the best cut-off values of 2.62 mm2 (area under curve 0.64) and 75% (area under curve 0.63), respectively, the minimal lumen area (MLA) and plaque burden (PB) at the MLA site were significant predictors of the primary outcome in the deferred group, whereas they were not predictive in the performed group. Revascularization performed group showed lower incidence rate of the primary outcome than deferral group in 348 patients with smaller MLA (<2.62 mm2) and larger PB (>75%) (19.3% vs. 36.8%, hazard ratio 0.58, 95% confidence interval [CI] 0.34-0.91, P=0.017), whereas other patients showed similar incidence rate of primary outcome between two groups (15.7% vs. 19.8%, hazard ratio 0.78, 95% CI 0.47-1.31, P=0.35). Conclusions For coronary stenoses with grey-zone FFR and smaller MLA and larger PB measured by IVUS, revascularization was associated with better clinical outcomes than deferral. The incorporation of FFR and IVUS may improve the revascularization decision in native coronary stenoses with grey-zone FFR.

Changes in Internal Thoracic Artery Blood Flow According to the Degree of Stenosis of the Anterior Descending Branch of the Left Coronary Artery.

Computational fluid dynamics has enabled the evaluation of coronary flow reserve. The purpose of this study was to clarify the hemodynamic variation and reserve potential of the left internal thoracic artery (LITA). Four patients were selected on the basis of various native coronary stenosis patterns and graft design. The wall shear stress and oscillatory shear index were measured, and one patient was selected. Next, we created three hypothetical lesions with 75%, 90%, and 99% stenosis in front of the graft anastomosis, and compared the changes in LITA blood flow and coronary flow distribution. In the 75% to 90% stenosis model, blood flow was significantly higher in the native coronary flow proximal to the coronary artery bypass anastomosis regardless of time phase. In the 99% stenosis model, blood flow from the LITA was significantly dominant compared to native coronary flow at the proximal site of anastomosis. The range of LITA flow variability was the largest at 99% stenosis, with a difference of 70 ml/min. The 99% stenosis model showed the highest LITA flow. The range of LITA flow variability is large, suggesting that it may vary according to the rate of native coronary stenosis.

Computational fluid dynamic study of multiple sequential coronary artery bypass anastomoses in a native coronary stenosis model.

The objective of this study was to evaluate the hemodynamic characteristics of multiple sequential coronary artery bypass grafting using a computational fluid dynamics study. First anastomosis was configured into parallel and diamond anastomoses, and the second anastomosis was set as end-side anastomosis. The anastomosis incision lengths were fixed at 2 mm. Various combinations of the degree of first and second stenoses were studied. The diameter of both the native and graft vessels was set at 2 mm. The inlet boundary condition was set by a sample of the transient time flow measurement, which was measured intraoperatively. Both swirl and stagnation were observed at the outlets of the stenosis and the anastomosis sites. When the severity of the second stenosis was larger than that of the first, the flow at the outlet of the second stenosis was more unstable. Higher wall shear stress and larger oscillatory shear index regions were observed when the severe stenosis was bypassed by the first anastomosis, especially with diamond anastomoses. Less energy loss and higher energy efficiency were present when the vessel with more severe stenosis was bypassed as the second anastomosis. Energy loss was lower and energy efficiency was higher with parallel anastomosis than diamond anastomosis when the severity of the two stenoses was the same. It is ideal to bypass the less severe stenosis vessel first with a parallel anastomosis method when employing multiple sequential bypass grafting. This improves hemodynamic stability and energy efficiency, according to a computational fluid dynamics model.

Patency When Grafted to Coronary Stenosis More Than 50% in LIMA-RA-Y Grafts

Recent coronary surgery practice is to graft arterial conduits to more severely stenosed coronary targets than in the past. We aimed to investigate postoperative arterial graft patency with native coronary stenosis at the time of surgery, using the left internal mammary artery and radial artery (RA) as a composite Y graft (LIMA-RA-Y). In the study timeframe, it was routine clinical practice to graft coronary arteries with >50% stenosis. Of 464 patients previously reported 1996-1999, 346 who underwent LIMA-RA-Y at the Royal Melbourne Hospital, 76 had postoperative angiograms at the same institution. Each anastomosis was considered separately. For arterial grafts a "string sign" was analysed as being occluded. Predictor of patency was performed with a generalised linear mixed model (GLMM). Seventy-six (76) patients had postoperative angiograms at 5.8±5.4 years (range 0.23-19.4; interquartile range 1.7-10.0) years postoperative; with age at operation 62.5±10.7 years and 3.4±0.8 grafts per patient, 82% were male. Of 256 anastomoses, 230 were to coronary targets >50% stenosis. Overall patency was 84.0% (214/256). For coronary stenosis >50%, patency was 88% (201/230) and varied by coronary territory left anterior descending (LAD) 94% (87/93), circumflex 90% (71/79) and right coronary artery (RCA) 74% (43/58). Interaction for coronary territory was significant (p=0.022). Higher preoperative coronary stenosis predicted higher patency; with odds ratio for improved patency of 1.83 (95% CI 1.51, 2.22), p<0.001 for each 10% increase in stenosis. Late patency of composite arterial grafts is acceptable when grafted to coronary arteries of greater than 50% stenosis.

Current mechanisms of low graft flow and conduit choice for the right coronary artery based on the severity of native coronary stenosis and myocardial flow demand

ObjectivesWe investigated current mechanisms causing low graft flow (LGF) following coronary artery bypass grafting, particularly for the right coronary artery (RCA).MethodsWe retrospectively assessed 230 individual bypass grafts as the sole bypass graft for the RCA using preoperative and postoperative quantitative angiography. Overall, 155 in-situ gastroepiploic arteries (GEAs) and 75 saphenous vein grafts (SVGs) were included. The size and status of the revascularised area were examined to determine whether these factors were associated with LGF (defined as ≤ 20 mL/min with intraoperative flowmetry). A distal lesion was defined as stenosis at segment #4, whereas a proximal lesion was stenosis at #1, #2 and #3.ResultsGraft flow in the SVG and the GEA for distal lesion was significantly less compared with that for proximal lesion (34 ± 26 vs. 60 ± 46, p < 0.0001 and 22 ± 12 vs. 43 ± 28, p = 0.0004, respectively). For proximal lesion, LGF was significantly more frequent when the minimal luminal diameter was over 1.27 compared with when it was less than 1.27 (p = 0.02). Prior myocardial infarction significantly correlated with LGF in the GEA (p = 0.007) and the SVG (p = 0.03). In 55 bypass grafts with LGF, the causes were competitive flow in 20.0%, small revascularised area in 38.1% and prior myocardial infarction in 32.7%.ConclusionsAlong with the current strategy based on the severity of native coronary stenosis, the incidence of competitive flow decreased remarkably. This resulted in flow demand, myocardial status and collateral vessels more influential on graft patency.

Computational fluid dynamic study of different incision length of coronary artery bypass grafting in a native coronary stenosis model.

The objective of this study was to evaluate hemodynamic patterns in end-side coronary artery bypass grafting with different anastomosis length by computational fluid dynamic study in the native coronary stenosis model. The fluid dynamic computations were carried out using ANSYS CFX. Incision length was set to be 2, 4, 6, 8, 10 mm. The angle between the two blood vessels corresponded to the length of the incision. Native vessels were set to be 90% stenosis. The radius of both native and graft vessels was set to be 2 mm. The inlet boundary condition was set by the sample of the transient time flow which was measured intraoperatively. The energy efficiency was higher and energy loss was lower when the anastomosis length was longer until 8 mm. However, energy efficiency was lowest and energy loss was highest in the 10-mm model. In the 10-mm incision model, the streamline showed the scanty bypass flow in the bottom. Vortex showed that only 10-mm model showed the vortex just distal to the stenosis in the native inlet, and more vortex in native outlet than other length models. The oscillatory shear index (OSI) was higher in the outlet top in all models. And only 10-mm model showed high oscillatory index just distal to the stenosis. In the end-side anastomosis, an anastomosis length of 8 mm was the ideal length with less flow complexity, low OSI, and less energy loss and high energy efficiency in the native 90% stenosis model.

TCT-519 A Comprehensive Meta-analysis of Randomized Controlled Trials Comparing Drug-Eluting Stents with Bare-Metal Stents in Saphenous Vein Graft Interventions

Several large randomized controlled trials (RCTs) have proven the superiority of drug eluding stents (DESs) over bare metal stents (BMSs) for native coronary stenosis. However, RCTs comparing DESs with BMSs for saphenous vein graft (SVG) lesions have predominantly been small in size and have

A comprehensive meta-analysis of randomized controlled trials comparing drug-eluting stents with bare-metal stents in saphenous vein graft interventions.

Several large randomized controlled trials (RCTs) have proven the superiority of drug-eluting stents (DESs) over bare-metal stents (BMSs) for native coronary stenosis. However, RCTs comparing DESs with BMSs for SVG lesions have predominantly been small in size and have yielded conflicting results. Therefore, we conducted an updated comprehensive meta-analysis of RCTs comparing DESs versus BMSs for SVG interventions using the largest sample size to date. Scientific databases and websites were searched to find RCTs. Data from six RCTs involving 1,582 patients were included. Pooled risk ratios (RRs) were calculated using random-effects models. The primary outcome of this meta-analysis was target vessel revascularization (TVR). The secondary outcomes were major adverse cardiac events (MACEs), myocardial infarction (MI), stent thrombosis, all-cause mortality, and cardiac mortality. Data from six RCTs involving 1,582 patients were included. Saphenous vein graft interventions with DESs reduced TVR (RR, 0.52; 95% CI, 0.30-0.88; P = 0.017) and MACE rate (RR, 0.60; 95% CI, 0.42-0.87; P = 0.007) compared to BMSs. No difference between the stents were found in rates of MI (RR, 0.69; 95% CI, 0.43-1.10; P = 0.123), stent thrombosis (RR, 0.61; 95% CI, 0.27-1.41; P = 0.255), all-cause mortality (RR, 1.13; 95% CI, 0.74-1.71; P = 0.554), or cardiac mortality. For SVG intervention, the MACE rate was lower for DESs compared to BMSs, driven primarily by decreased non-MI-related TVR. Rates of MI, all-cause mortality, cardiac mortality, and stent thrombosis were not different between the stents.

First-in-Man Trial of SiO&lt;sub&gt;2&lt;/sub&gt; Inert-Coated Bare Metal Stent System in Native Coronary Stenosis ― The AXETIS FIM Trial ―

A novel bare metal stent with an SiO2coating was developed to prevent excessive neointimal hyperplasia by inertization of the metallic stent surface. The efficacy of the device was demonstrated in a preclinical model. The aim of this first-in-man trial was to assess the safety and feasibility of the new device.Methods and Results:This prospective non-randomized single-arm trial was designed to enroll 35 patients with a de novo coronary lesion. Quantitative coronary angiography and optical coherence tomography (OCT) were performed at the baseline procedure and at the 6-month follow-up. Stent implantation was performed with OCT guidance according to optimal stent implantation criteria. The trial was terminated upon the advice of the data safety monitoring board after enrolling 14 patients due to the high incidence of re-intervention. Optimal OCT implantation criteria were achieved in only 8.3% of lesions. At 6 months, angiographic in-stent late lumen loss as the primary endpoint was 0.77±0.44 mm, and binary restenosis occurred in 33.3% of lesions. At the 6-month OCT, neointimal volume obstruction was 32.8±15.6% with a neointimal thickness of 237±117 µm. At 12 months, the device-oriented composite endpoint (defined as cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization rate) was 33.3%. In contrast with the preclinical study, the Axetis stent did not efficiently suppress neointimal hyperplasia in humans in this trial.

TCT-375 Deferred Versus Performed Revascularization in Coronary Stenoses With Gray Zone Fractional Flow Reserve: Data From IRIS FFR Registry

The optimal cutoff of fractional flow reserve (FFR) for revascularization is in debate. We evaluated the prognosis of deferred and performed revascularization in coronary stenoses with gray zone FFR (0.75-0.80). From prospective IRIS-FFR registry, 1334 native coronary stenoses in 1334 patients with

IMPACT OF COMPETITIVE FLOW ON HEMODYNAMICS OF LIMA-LAD GRAFTING WITH DIFFERENT STENOSIS: A NUMERICAL STUDY

Background and Aims: Competitive flow exists in the native coronary artery when using artery graft in the coronary artery bypass graft (CABG), and it is a major factor affecting the long-term patency of the arterial grafts. The purpose of this study is to investigate the effects of the competitive flow on hemodynamic characteristics of left internal mammary artery (LIMA). Materials and methods: Seven three-dimensional (3D) LIMA-left anterior decending (LAD) grafting models with different diameter stenoses at the trunk of LAD were reconstructed, including 25%, 40%, 50%, 60%, 75%, 90% and 100%. The boundary conditions of these models were provided by the same lumped parameter model (LPM; 0D sub-model) of cardiovascular circulatory system, which is based on 0D/3D coupling method. Results: The simulation results show that competitive flow decreases when the stenosis rate increases and backflow exists in LIMA during systole when the degree of stenosis is below 50%; the wall shear stress (WSS) of the graft increases from 0.85[Formula: see text]Pa to 1.79[Formula: see text]Pa with the increase of the native coronary stenosis degree, while the oscillatory shear index (OSI) decreases from 0.1557 to 0.00213. Conclusions: Competitive flow may produce adverse hemodynamic effects on artery graft, especially when the stenosis degree is below 50%, competitive flow will significantly lead the long-term patency of the artery graft worse because of the backflow, low WSS and high OSI, and the effect of OSI is more obvious than WSS.

Propensity-Score Matched Comparison of Midterm Angiographic Outcomes of Sirolimus- Versus Everolimus- and Biolimus-Eluting Stents for &lt;i&gt;De Novo&lt;/i&gt; Coronary Stenosis

We conducted propensity-score matched comparisons of midterm angiographic outcomes of sirolimus (SES) versus either everolimus- (EES) or biolimus- (BES) eluting stents after placements for coronary stenosis in a daily practice environment since previous randomized trials did not demonstrate the superiority of EES and BES over SES in terms of midterm angiographic outcomes.The present study was a non-randomized, retrospective, and lesion-based study, recruiting angiographically followed-up lesions within 550 days after successful and elective SES (n = 1793), EES (n = 1303), or BES (n = 324) placement for de novo native coronary stenosis during the period from August 2004 to January 2014 at 6 institutes. The endpoint, as an angiographic surrogate marker of clinical efficacy, was the distribution of in-stent follow-up percent diameter stenosis (%DS) which comprised the percentages of 1) follow-up %DS < 20 and 2) follow-up %DS > 50. Propensityscore matched analyses were conducted to adjust 21 baselines.In 1215 baseline adjusted lesions, the endpoints in the EES group [1) 74.1%, and 2) 4.6%] were significantly different from those in the SES group [57.9%; P < 0.001, 7.2%; P = 0.006, respectively). In 307 baseline adjusted lesions, the endpoints in the BES group [1) 80.5%, 2) 2.0%] were significantly different from those in the SES group [59.3%; P < 0.001, 2) 8.1%; P = 0.001, respectively].The present study is the first to confirm the superiority of midterm angiographic outcomes after the placement of EES and BES over SES for de novo coronary stenosis in a clinical setting.

Copeptin and high-sensitivity cardiac troponin to exclude severe coronary stenosis in patients with chest pain and coronary artery disease

PurposeThe purpose was to evaluate the incremental value of copeptin associated with high-sensitivity cardiac T troponin (hs-cTnT) to exclude severe coronary stenosis in patients with coronary artery disease (CAD) and acute chest pain. MethodsThis monocentric prospective study included 96 consecutive patients with documented CAD and admitted to the intensive care unit for chest pain lasting for less than 10 hours. Acute coronary syndrome was excluded with electrocardiography and baseline hs-cTnT values <14 ng/L with dynamic changes ≤50% 3 hours later (Roche Diagnostics, COBAS 8000). Copeptin (Thermofisher, Kryptor Compact) was considered as positive when >10 pmol/L. Primary end point was severe coronary stenosis at coronary angiography or myocardial ischemia on perfusion single-photon emission computed tomography imaging. ResultsMean age of patients was 60 ± 13.8 years, and the mean time between chest pain onset and blood samples of copeptin was 4.2 ± 2.7 hours. According to clinical decision, coronary angiography was performed in 71 patients (73.9%) and severe stenosis diagnosed in 14 of them (14.6%). No ischemia was detected on single-photon emission computed tomography imaging (n = 25). Among the 69 patients with a negative kinetic of hs-cTnT and a negative baseline copeptin, 5 (7.4%) had a severe stenosis (negative predictive value, 0.93; 95% confidence interval, 0.87-0.99), 4 of them related to in-stent restenosis (negative predictive value for exclusion of native coronary stenosis, 0.98; 95% confidence interval, 0.93-1). ConclusionsFor patients with preexisting CAD and acute chest pain, and once acute coronary syndrome is excluded, copeptin provides a useful additional triage strategy to exclude severe coronary stenosis, particularly those not related to in-stent restenosis.

Long-term angiographic outcomes of sirolimus- and paclitaxel-eluting stent placement in diabetes, long lesions, and small vessels.

We conducted a lesion-based retrospective sub-analyses of diabetes mellitus (DM), diffuse long lesions (stented segment ≥40 mm; LLs), and small vessels (SVs; reference diameter ≤2.6 mm) in patients who received sirolimus- (SESs) or paclitaxel-eluting stents (PESs) for nonrandom treatment of de novo native coronary stenosis in a clinical practice setting. During the period from May 2007 to February 2009, 490 of 682 PES-treated and 293 of 386 SES-treated lesions were angiographically followed up within 1500 days of PCI, and the retrospective investigation was conducted in April 2013. The frequencies of target lesion revascularization (TLR; any recurrent PCI including both marginal stent restenosis) and binary in-stent restenosis (percentage diameter of in-stent stenosis >50%) upon follow-up angiography, evaluated by adjusting 25 baseline variables using propensity score matching analysis, after placement of SESs and PESs were the following: DM (n = 124 per arm), 14.5 vs. 15.3% (p = 0.842), and 14.5 vs. 16.1% (0.856); LLs (n = 81), 16.0 vs. 21.0% (0.433), and 12.3 vs. 22.2% (0.117); SVs (n = 107), 11.2 vs. 29.9% (<0.001), and 11.2 vs. 30.8% (<0.001), respectively. The p values of log-rank tests for the cumulative TLR-free ratios after SES and PES placement were 0.504 in DM, 0.625 in LLs, and <0.001 in SVs group, respectively. Thus, compared to PES, SES showed the equivalent efficacy for DM, the tendency to be superior for LLs due to approximately 24-45% reductions in TLR and binary restenosis rates, and the promising superiority for SVs on the angiographic outcomes during a long-term observational interval.

Mid-Term Patency in Radial Artery and Saphenous Vein After Coronary Artery Bypass Grafting in Asymptomatic Patients Using 128-Slice CT Coronary Angiography.

Background:Patency of the revascularization conduit is an essential predictor of long-standing survival after coronary artery bypass grafting.Objectives:We have conducted this study to compare the mid-term patency rates of radial artery (RA), left internal thoracic artery (LITA) and also saphenous vein (SV) grafts in asymptomatic patients following coronary artery bypass graft surgery (CABG) undergoing total IV anesthesia.Patients and Methods:In this study, 30 three-vessel disease patients with 104 RA, LITA, and SV grafts used concomitantly for primary isolated non-emergent CABG surgery were assessed. The primary end point was CT angiographic graft patency rate. After 53.5 (24-97) months’ follow-up, graft patency was assessed using 128-slice CT coronary angiography. Logistic regression analysis was used to detect the independent predictors of graft failure.Results:A total of 104 grafts, including 30 LITA, 44 SV, and 30 RA grafts, were studied. Cumulative graft patency rates were 93.3% in LITA, 83.3% in RA, and 70.5% in SV grafts. Statistically significant difference was found between the LITA and the SV graft patency rates (P = 0.019), whereas the difference between the RA conduit patency and the LITA or SV graft patency rates did not have any statistical significance (P = 0.424 and P = 0.273, respectively). Independent predictors of RA grafts occlusion were native coronary stenosis < 70% and female gender.Conclusions:In our patients, the RA grafts had an acceptable patency rate in 2 to 5 years’ follow-up. Although the SV grafts had a relatively higher patency rate than RA grafts in our asymptomatic patients, the patency rates in RA and SV grafts were close to each other. The RA graft function was poor in the patients with a higher number of risk factors and in the females.

TCTAP A-064 Midterm Clinical and Angiographic Outcomes After Placement of Paclitaxel and Everolimus-eluting Stents for De Novo Native Coronary Stenosis

TCTAP A-064 Midterm Clinical and Angiographic Outcomes After Placement of Paclitaxel and Everolimus-eluting Stents for De Novo Native Coronary Stenosis

Prevalence and predictors of nonobstructive coronary artery disease identified with coronary angiography in contemporary clinical practice

Guidelines recommend noninvasive tests (NITs) to risk stratify and identify patients with higher likelihood of coronary artery disease (CAD) prior to elective coronary angiography. However, a high percentage of patients are found to have nonobstructive CAD. We aimed to understand the relationship between patient characteristics, NIT findings, and the likelihood of nonobstructive CAD. Patients undergoing elective catheterization without history of CAD were identified from 1,128 hospitals in National Cardiovascular Data Registry's CathPCI Registry between July 2009 and December 2011. Noninvasive tests included stress electrocardiogram, stress echocardiogram, stress radionuclide, stress cardiac magnetic resonance, and computed tomographic angiography. Patient demographics, risk factors, symptoms, and NIT results were correlated with the presence of nonobstructive CAD, defined as all native coronary stenoses <50%. Of 661,063 patients undergoing elective angiography, 386,003 (58.4%) had nonobstructive CAD. Preprocedure NIT was performed in 64% of patients; 51.9% were reported to be abnormal, but only 9% had high-risk findings. Independent factors associated with nonobstructive CAD were younger age, female sex, atypical chest pain, and a low-risk NIT. Patients with high-risk findings on NIT were more likely to have obstructive CAD (adjusted odds ratio 3.03 [2.86-3.22]). Noninvasive test findings had minimal incremental value beyond clinical factors for predicting obstructive disease (C index = 0.75 for clinical factors vs 0.74 for NIT findings). In current practice, about two-thirds of patients undergo NIT prior to elective cardiac catheterization, yet most patients have nonobstructive CAD. The weak correlation between most NIT results and the likelihood of obstructive CAD provides further impetus for improving preangiography assessment of likelihood of disease.

Propensity score matched lesion-based comparison of long-term clinical and angiographic outcomes after placement of sirolimus (Cypher Bx Velocity) and paclitaxel (TAXUS Express)-eluting stents for de novo native coronary stenosis

Long-term clinical and angiographic outcomes after sirolimus (SES: Cypher Bx Velocity) and paclitaxel (PES: TAXUS Express)-eluting stent implantation were firstly compared in Japan. During PES-available period from May 2007 to February 2009, 1068 nonrandomized consecutive de novo native coronary lesions treated either with a PES (682 lesions) or SES were enrolled in this study, and a retrospective examination was conducted in April 2013. During that interval, the use ratio of drug-eluting stent (i.e. SES plus PES) was 94.2 %. By adjusting the baselines with a propensity score matching analysis produced 383 lesions in each arm, the incidence of the clinical endpoint (1500-day cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis) after placement of SES (2.1 %; mean follow-up, 1400 ± 290 days) was not significantly different from that in the PES group (2.6 %; 1394 ± 325 days, p = 0.637). SES did not relate to the clinical endpoint (hazard ratio 1.04; 95 % CI 0.29-3.76; p = 0.949). In the baseline-adjusted angiographic followed up lesions (n = 234 in each arm), the incidence of binary restenosis (percent diameter stenosis [%DS] >50 %) in the SES group (12.0 %; mean follow-up, 477 ± 281 days) was not significantly different from that in the PES group (14.5 %; 497 ± 341 days, p = 0.431). SES did not relate to binary restenosis (Odds ratio 0.73; 95 % CI 0.40-1.32; p = 0.295). In conclusion, the present propensity score matched lesion-based analysis firstly showed the statistical equivalent long-term clinical and angiographic outcomes after either SES or PES placement for de novo native coronary lesion in Japanese patients in a daily practice environment.

First report of a novel polymer‐free dual‐drug eluting stent in de novo coronary artery disease: Results of the first in human BICARE trial

Persistence of stent polymer coating has been associated with incomplete endothelialization, expansive vessel remodeling, neoatherosclerosis, and delayed healing associated with inflammation that may contribute to late adverse events. The BICARE (Lepu Medical, Beijing, China) stent is a novel polymer-free, nanotechnology-based stent eluting sirolimus and probucol. As a first in human feasibility study, patients with a single de novo native coronary stenosis <30 mm in length and with reference vessel diameter from 2.5 to 4.0 mm underwent revascularization with the BICARE stent. The primary endpoint of target lesion failure (TLF) was assessed at 30 days. Secondary endpoints included in-stent late lumen loss and proportion of uncovered or malapposed stent struts by optical coherence tomography at 4-month angiographic surveillance. Among 32 consecutive patients (age, 55.7 ± 8.7 years; men, 62.5%; diabetes, 18.8%), the average baseline reference vessel diameter and lesion length were 2.85 ± 0.48 mm and 15.0 ± 5.6 mm, respectively. At 30 days there was no occurrence of TLF. At 4 months (angiographic follow-up, N=32), angiographic in-stent late loss was 0.14 ± 0.19 mm, and the in-stent binary restenosis rate was 3.1%. Complete strut coverage was 98.2% with 0.2% malapposition among 16,751 analyzed struts. At 18 months, TLF occurred in 3 (9.4%) patients related to repeat revascularization with no adverse safety events identified. The preliminary feasibility and safety of a polymer-free, dual-drug eluting stent are demonstrated by absence of early adverse safety events and favorable angiographic suppression of neointimal hyperplasia. Stent imaging suggests favorable healing with extensive stent strut coverage and very low malapposition. These findings further inform comparison with biopermanent polymer DES.

Sirolimus-eluting stent versus bare metal stent in diabetic patients: the final five-year follow-up of the DIABETES trial

The DIABETES (DIABETes and sirolimus-Eluting Stent) trial is a prospective, multicentre, randomised, controlled trial aimed at demonstrating the efficacy of sirolimus-eluting stent (SES) as compared to bare metal stent (BMS) implantation in diabetic patients. The aim of the present analysis was to assess the five-year clinical follow-up of the patients included in this trial. One hundred and sixty patients (222 lesions) were included: 80 patients were randomised to SES and 80 patients to BMS. Patients were eligible for the study if they were identified as non-insulin-dependent diabetics (NIDDM) or insulin-dependent diabetics (IDDM), with significant native coronary stenoses in ≥1 vessel. There was a sub-randomisation according to diabetes status. Clinical follow-up was extended up to five years. Five-year clinical follow-up was obtained in 96.2%. Overall, MACE at five years was significantly lower in the SES group as compared with the BMS arm, mainly due to a significant reduction in TLR. There were no significant differences in cardiac death or myocardial infarction (MI). This was also observed in both prespecified subgroups IDDM and NIDDM. In the SES group, the incidence density of definite/probable stent thrombosis was 0.53 per 100 person-years, whereas in the BMS group it was 0.8 per 100 person-years. Independent predictors of MACE were: SES implantation (p<0.001), multivessel stent implantation (p=0.04), and creatinine levels (p=0.001). Five-year follow-up of the DIABETES trial suggests the effect of SES in reducing TLR is similar in both IDDM and NIDDM. No major safety concerns in terms of ST, MI or mortality were observed.