Propensity-Score Matched Comparison of Midterm Angiographic Outcomes of Sirolimus- Versus Everolimus- and Biolimus-Eluting Stents for De Novo 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.

Comparison of percutaneous coronary intervention for chronic total occlusion outcome according to operator experience from the Japanese retrograde summit registry.

OBJECTIVES: This study was performed to evaluate the acute outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) based on operator experience. BACKGROUND: Despite developments in both technology and techniques, PCI procedures for CTO's remain challenging. METHODS: A total of 3,229 eligible subjects who underwent CTO-PCI were enrolled from 56 centers by a retrograde summit using a web registry system. To compare the acute outcomes of the CTO data, 18 centers were classified as higher volume centers (HC) and 38 centers as lower volume centers (LC) depending on the CTO-PCI experience of the operator. RESULTS: The mean procedural success rate of all centers was 88.4%. The overall procedural success rate was significantly higher in HC than LC (90.6% vs. 85.6%, respectively; P < 0.0001). In addition, overall antegrade success rate was also higher in HC than LC (91.0% vs. 83.9%, respectively; P < 0.0001). Although the overall retrograde approach success rate was significantly higher in HC than LC (85.0% vs. 77.6%, respectively; P < 0.0001), there was no significant difference in that of the retrograde alone (89.0% vs. 93.7%, respectively; P = 0.051). Major in-hospital adverse events were observed in 0.53% of cases, and the rates were similar between the two groups (0.45% vs. 0.62%, respectively; P = 0.25). CONCLUSIONS: Although CTO-PCI was safe in both groups, the procedural success rate was significantly higher in HC than LC, even in this new era of CTO-PCI. This difference was attributed to the difference in the antegrade procedural success rate. © 2015 Wiley Periodicals, Inc.

Japanese multicenter registry evaluating the retrograde approach for chronic coronary total occlusion.

OBJECTIVES: This registry evaluated the current trends and outcomes associated with retrograde percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). BACKGROUND: Since its introduction, several techniques and technologies have been introduced for retrograde PCI for CTO. METHODS: Eight hundred and one patients who underwent retrograde PCI for CTO in 28 Japanese centers between January 2009 and December 2010 were enrolled in this registry. RESULTS: Overall procedural and clinical success rates were 84.8 and 83.8%, respectively, of which, retrograde procedures accounted for 71.2 and 70.3%, respectively. The use of channel dilators increased in 2010 compared to that in 2009 (36 vs. 95.3%, P < 0.0001), attributed improving collateral channel crossing using a wire and catheter (70.6% vs. 81.1%, P = 0.0005) and increased availability of epicardial channels (27.6% vs. 36.9%). The use of the reverse controlled antegrade and retrograde tracking technique also increased (41.9 vs. 66.5%). Although these changes decreased procedure time (203.3 min vs. 187.9 min, P = 0.024), they did not significantly improve overall procedural success rate (84.1% vs. 85.3%, P = 0.63). Multivariate analysis identified age 65 years or more and lesion calcification as unfavorable factors and the use of a channel dilator as a favorable factor for retrograde procedural success. CONCLUSIONS: Increased availability of channel dilators has altered strategies for retrograde PCI for CTO. However, retrograde PCI for CTO could be improved by overcoming its main obstacle of severe calcification.

Operator experience and clinical outcomes of percutaneous coronary intervention for chronic total occlusion: insights from a pooled analysis of the Japanese CTO PCI Expert Registry and the Retrograde Summit General Registry.

There have not been enough studies to examine the association between difference in operator experience and technical success rate in contemporary percutaneous coronary intervention for chronic total occlusion (CTO-PCI). The present study sought to provide insights into the impact of operator experience on clinical outcomes of CTO-PCI through a comparison of two largest Japanese CTO-PCI registries consisting of operators with different CTO-PCI experience. After combining clinical data from the Japanese CTO-PCI Expert Registry (ER) 2014-2016 (N = 4316) including CTO-PCI performed by highly experienced operators and the Retrograde Summit General Registry (RSGR) 2014-2016 (N = 2230) including CTO-PCI performed by less experienced operators, a pooled analysis was performed to compare clinical outcomes of CTO-PCI in 2 registries. The overall technical success rate and the incidence of in-hospital major adverse events were comparable between ER and RSGR (90.1% vs 88.9%, p = 0.133, 1.7% vs 1.5%, p = 0.606, respectively). Technical success rate in ER was significantly higher among the patients treated with primary antegrade approach (91.8% vs 89.5%, p = 0.009), whereas there was no significant difference among the patients treated with the primary retrograde approach (85.7% vs 85.3%, p = 0.857). Multivariate analysis suggested ER operator could not be an independent predictor for technical success. CTO-PCI performed by less experienced but appropriately trained operators could achieve similarly high technical success rate with comparable safety compared with those performed by highly experienced specialists in contemporary Japanese context.

Direct microscopic observation of striations in a fractured section of a sirolimus-eluting stent (Cypher Bx Velocity®) indicates induction of stent fracture by continuous shear stress.

A 73-year-old woman with severe congestive heart failure was treated by implantation with a sirolimus-eluting stent (SES; Cypher Bx Velocity(®)) in the left main coronary artery (LMCA) using the staged T-stent, kissing balloon, and hugging balloon techniques. Follow-up coronary multislice computed tomography after 10 months revealed that SES was completely fractured in 2 directions; the fractured stent appeared in the shape of the letter "L" and had migrated into the aorta. An SES fragment was surgically removed and subsequent electron microscopy revealed striations (striped patterns in fractured sections) on the fracture plane, indicating continuous shear stress after SES implantation in the LMCA. This case provides direct evidence of continuous shear stress on the SES and indicates the necessity of improving the structure of the stent such that it can withstand shear stress.

Retrospective comparison of clinical and angiographic outcomes after sirolimus-eluting and bare-metal stent implantation in 312 consecutive, nonrandomized severely calcified lesions using a rotablator.

In order to compare the long-term clinical and angiographic outcomes after sirolimus-eluting stent (SES) and bare-metal stent (BMS) placement in severely calcified lesions using a rotablator under the widespread indication of SES, a nonrandomized examination of 312 consecutive lesions after successful implantation of a BMS (99 lesions in 84 patients; from January 2003) or SES (213 in 167; from September 2004) using a rotablator was conducted. The lesion-based primary endpoints (cardiac death and nonfatal recurrent myocardial infarction) and the secondary endpoint [binary restenosis (BR) (diameter stenosis > 50%) at follow-up angiography] were retrospectively determined in August 2010. The incidence of primary endpoint in the SES group (2.3%; mean follow-up period of 1289 ± 526 days) was significantly lower than that in the BMS group (7.1%; P = 0.043; 1803 ± 887 days), although the several variables related to the endpoints were present in the SES group. Cox proportional hazard model analysis revealed that SES was not significantly related to a primary endpoint [hazard ratio of 0.42 (95% CI, 0.073-2.42; P = 0.33)]. The incidence of BR in the SES group (21.3%) was not significantly different from that in the BMS group (27.1%) (P = 0.33). Multivariate logistic regression analysis revealed that SES was not a significant predictor of BR [Odds ratio of 0.78 (95% CI, 0.41-1.51; P = 0.47)]. Thus, although the results of the present retrospective nonrandomized study demonstrate the long-term safety of SES for calcified lesions using a rotablator in daily practice, SES did not show a benefit for the angiographic outcomes compared to BMS.

High-Density Lipoprotein Cholesterol Efflux Capacity as a Novel Prognostic Surrogate for Coronary Artery Disease.

AIM: We examined the impact of baseline high-density lipoprotein cholesterol efflux capacity (CEC) on major cardiac adverse events (MACE) in patients with coronary artery disease (CAD) during a long-term secondary prevention. METHOD: CEC was measured using a cell-based efflux system in (3)[H]-cholesterol-labeled J774 macrophages in apolipoprotein B-depleted plasma between January 2011 and January 2013. Patients with CAD were divided into 2 groups as a boundary CEC value of 1: 0.19 ≤ CEC ＜1 (impaired CEC group, mean CEC of 0.76±0.16, n=136), and 1 ≤ CEC ≤ 2.08 (enhanced CEC group, 1.20±0.19, n=44). MACE, comprised the incidence of cardiac death, non-fatal myocardial infarction, and any revascularizations (RV) without restenosis approximately 1 year after vascularization, was retrospectively investigated at September 2019. Impact of enhanced CEC on MACE among 22 variables was examined by applying a Cox proportional hazard model. RESULT: The frequency of MACE in impaired CEC group (16.9%, mean observational interval of 2111±888 days) was significantly higher than that in enhanced CEC group (2.3%, 2,252±685, p=0.013), largely driven by the significantly higher RV incidence (14.0 % versus 2.3 %, p=0.032). Enhancement of CEC was the significant predictor of MACE (hazard ratio: 0.11; 95% CI: 0.013-0.879; p=0.038). CONCLUSION: A baseline CEC level of more than 1 in patients with CAD brought favorable long-term clinical outcomes, suggesting that CEC is a useful prognostic and therapeutic surrogate for secondary prevention of CAD.

Midterm angiographic outcomes with sirolimus- and everolimus-eluting stents for small vessels in diabetic patients: propensity-score-matched comparisons in three different vessel diameters.

We conducted propensity-score-matched comparisons of midterm angiographic follow-up outcomes of sirolimus- versus everolimus-eluting stents (SES, EES) after elective placements for de novo coronary stenosis in small vessels (SV) in patients with diabetes mellitus (DM), because the angiographic efficacy of EES over SES for those cohorts remained unclear. The study was a non-randomized, retrospective, lesion-based, multicenter study, examining lesions followed up angiographically within 550 days, extracted from the unified database of 6 institutes. The endpoint (binary restenosis) was defined as the percentage of subjects having >50% diameter stenosis at follow-up. Propensity-score-matched analyses were conducted in 3 different vessel-size cohorts, defined by a preprocedural reference diameter (RD) <2.10, <2.35, and <2.60 mm, yielding group sizes of n = 107, 183, and 312 baseline-adjusted lesions in each of the 2 stent arms. The frequency of binary restenosis decreased significantly with increasing vessel size, at 16.8, 12.6, and 12.2%, in the SES group. However, it remained almost the same across vessel-size groups in the EES group (8.0, 6.0, and 7.5%). The p values for the significance of the differences in binary restenosis between EES and SES in each vessel size increased with the decrease in vessel size [p = 0.002, 0.040, and 0.063 (the last still nearly significant)]. Thus, in patients with DM, EES showed increasingly superior efficacy over SES for SV stenosis as the vessel size became smaller, i.e., the risk for binary restenosis became greater.

Very long-term clinical and angiographic outcomes after sirolimus- and paclitaxel-eluting stent placement for ST-elevation myocardial infarction: a propensity score-matched comparison.

We conducted a retrospective examination of the very long-term outcomes of placing sirolimus (SES) and paclitaxel (PES)-eluting stents in patients with ST-elevation myocardial infarction (STEMI). This was a nonrandomized, retrospective, single-center study that included 872 first STEMI patients who underwent successful placement of either SES (n = 547) or PES from November 2004 to April 2012. The primary end point was the incidence of severe cardiac events comprising cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis (ST). The frequency of target lesion revascularization (TLR) was also compared. A propensity score-matched analysis was used to adjust the 29 baseline variables. In the baseline-adjusted cohorts in 231 STEMI patients in each arm, the frequency of the primary end point in the SES group (5.6 %) during the follow-up duration of 2583 ± 806 days was not significantly different from that in the PES group (6.1 %, follow-up: 1866 ± 699 days). The cumulative primary end point-free ratio in the SES group was not significantly different from that in the PES group (p = 0.503). The frequency of TLR in the SES group (7.5 %) was significantly lower than that in the PES group (16.9 %, p = 0.005), with and the significantly higher cumulative TLR-free ratio in the SES group than that in the PES group (p < 0.001). The very long-term clinical outcomes after SES or PES placement for STEMI patients were statistically equivalent. SES showed the better angiographic outcomes for STEMI compared to PES.

Case Series of Pulmonary Tumor Embolism and Intravascular Lymphoma: Evaluation of the Usefulness of Pulmonary Microvascular Cytology.

Pulmonary tumor embolism (PTE) and intravascular lymphoma cause rapidly progressive deterioration and an antemortem diagnosis is difficult. The usefulness of pulmonary microvascular cytology (PMC) in the diagnosis of these disorders has been reported in sporadic case reports. We retrospectively evaluated the records of 7 patients with tumor cells in the pulmonary microvasculature (4 with PTE and 3 with malignant lymphoma) who underwent pulmonary microvascular cytology. Two of the 4 patients with PTE and 2 of the 3 patients with malignant lymphoma (all 3 had intravascular metastasis) had positive PMC results. These findings suggested that PMC may be useful in the diagnosis of these disorders.

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.

Long-term clinical and angiographic outcomes after sirolimus- and paclitaxel-eluting stent placement following rotablation for severely calcified lesions: a retrospective nonrandomized study.

We conducted a retrospective comparison of the long-term clinical and angiographic outcomes of 281 consecutive nonrandomized severely calcified lesions in 221 patients treated with a sirolimus-eluting stent (SES; CYPHER Bx VELOCITY) or a paclitaxel-eluting stent (PES; TAXUS Express) placed after rotablation between August 2004 and February 2009. The clinical safety endpoint, comprising the incidence of cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis, in 164 patients after exclusive SES placement (4.9 % with a mean clinical follow-up period of 1396 ± 763 days) was not significantly different from that after exclusive PES placement in 51 patients (2.0 %, 1011 ± 605 days; p = 0.364 and p < 0.001, respectively). The cumulative clinical safety endpoint-free ratio after exclusive SES placement was not significantly different from that after PES placement (p = 0.61, by log-rank test). The angiographic efficacy endpoint (binary restenosis: diameter stenosis >50 % at follow-up angiography) in the 169 lesions placed using SES (20.1 % with a mean angiographic follow-up period of 669 ± 605 days) was not significantly different from that in the 40 lesions using PES (17.5 %; 498 ± 320 days) (p = 0.707). In univariate analysis, SES use did not relate to the efficacy endpoint (p = 0.707). Thus, our small single-center study showed that the long-term clinical and angiographic outcomes after SES placements for severely calcified lesions after rotablation were not significantly different from those after PES placement.

Midterm outcomes of bare-metal stenting after primary stenting for ST-segment elevated myocardial infarctions in the drug-eluting stent era: a propensity score-matched comparison with sirolimus-eluting stent.

We performed a propensity score-matching comparison of the midterm clinical and angiographic outcomes after primary stenting between using bare-metal stents (BMSs) and sirolimus-eluting stent (SES; Cypher Bx Velocity) for ST-segment elevated myocardial infarction (STEMI), because, in the drug-eluting stent era, the indication of the BMSs when a large balloon diameter is required remained to be controversial. This was a single-center, nonrandomized, retrospective study investigated in October 2013 by enrolling STEMI patients treated with primary stenting using either SES (n = 468) or BMS (n = 171) between September 2004 and December 2011. In 204 patients, the baseline-adjusted values produced similar mean maximum balloon sizes (BMS 3.67 ± 0.47 mm; SES 3.70 ± 0.56 mm; p = 0.477), and the incidence rates of binary in-stent restenosis (% diameter stenosis >50 % on secondary angiography) after SES placement (7.8 %) was significantly lower than that after BMS placement (23.5 %; p = 0.002). In baseline-adjusted 300 patients, the incidence of the clinical endpoints comprising cardiac death, nonfatal recurrent MI, and definite stent thrombosis after SES placement (11.3 %; 1241 ± 786 days; p = 0.557) was not significantly different from after BMS placement (8.7 %; mean follow-up period, 549 ± 486 days; p = 0.557). SES was not significantly related to the clinical endpoint [hazard ratio 2.31; 95 % confidence interval (CI) 0.88-6.08; p = 0.089). BMS did not offset the SES's angiographic efficacy for primary stenting for STEMI patients, despite placed using a large-sized balloon.

High-density lipoprotein cholesterol efflux capacity as a relevant predictor of atherosclerotic coronary disease.

BACKGROUND: We examined the clinical relevance of high-density lipoprotein cholesterol (HDL-C) efflux capacity from macrophage (cholesterol efflux capacity) as a predictor of atherosclerotic coronary artery disease (CAD) in comparison with that of conventional coronary and lipid risk variables in Japanese daily practice. METHODS AND RESULTS: Fasting blood sampling, including 6 routinely measured dyslipidemia-related variables, was performed at the time of coronary angiography (CAG) or multi-slice coronary computed tomography (MSCT) between January 2011 and January 2013. CAD, defined as native coronary atherosclerosis stenosis >50% by CAG or MSCT, was identified in 182 patients (CAD group), but not in 72 patients (non-CAD group). Cholesterol efflux capacity, measured using a cell-based efflux system in (3)[H]-cholesterol-labeled J774 macrophages in apolipoprotein B-depleted plasma, was significantly impaired in the CAD group compared with the non-CAD group (0.86 ± 0.26 vs. 1.02 ± 0.38; p = 0.001). After adjusting 15 patient and dyslipidemia-related variables using a propensity score matching analysis produced 55 patients in each arm, cholesterol efflux capacity in the CAD group remained to be significant compared with the non-CAD group (0.83 ± 0.24 vs. 0.97 ± 0.36; p = 0.019). Stepwise logistic regression analysis using a backward method after the baseline adjustment showed that cholesterol efflux capacity (odds ratio [OR]: 0.23; 95% confidence interval [CI]: 0.056-0.91; p = 0.037) was the single predictor of CAD, while other variables including HDL-C (p = 0.088) and apolipoprotein (apo) A-I (p = 0.681) were removed owing to those insignificance. The area under the receiver operating characteristic curve after the baseline adjustment was 0.67 (95% CI: 0.51-0.73, p = 0.048 by Hosmer-Lemeshow goodness-of-fit statistics). CONCLUSIONS: The present observational study conducted under daily clinical practice confirmed that cholesterol efflux capacity is a clinically relevant predictor of CAD among the conventional coronary risk factors and dyslipidemia-related variables.

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.

Propensity score-matched lesion-based comparison of mid-term angiographic outcomes of TAXUS Liberté with Cypher Bx Velocity stents for de novo native coronary stenosis and in patients with diabetes.

OBJECTIVE: We sought to perform a propensity score-matched lesion-based comparison of mid-term angiographic outcomes of sirolimus- (SES, Cypher Bx Velocity) and paclitaxel- (PES, TAXUS Liberté, the 2nd-generation TAXUS) eluting stents to treat de novo coronary stenosis and, particularly, in patients with diabetes mellitus (DM) in a daily practice environment. METHODS: The present study was a non-randomized, retrospective, lesion-based, single center study that included 1,287 de novo native coronary stenosis cases after successful SES or PES placement between February 2007 and April 2011. The primary endpoint was angiographic-based binary in-stent restenosis (% diameter stenosis >50 at secondary angiogram) within 550 days of placement. A propensity score-matched analysis was used to adjust the baselines. RESULTS: Among 360 baseline-adjusted angiographic lesions followed up in each arm, the incidence of the primary endpoint in the PES group (11.7%, follow-up period: 350±76 days) was not significantly different from that in the SES group (10.3%, p=0.645, 354±81 days, p=0.912). PES was not associated with the primary endpoint by logistic regression analysis (odds ratio: 1.15, 95% confidence interval: 0.68-1.93, p=0.605). In the DM specific sub-analysis, the primary endpoint in the PES group (19.6%) was not significantly different from that in the SES group (12.8%, p=0.105) in 148 baseline-adjusted lesions in each arm. CONCLUSION: The mid-term angiographic outcomes after TAXUS Liberté placement for all-comer de novo native coronary stenosis and in patients with DM were not significantly different from those of SES in a Japanese daily practice environment.

Comparison of long-term clinical and 1-year angiographic outcomes after primary stenting (-12 hours) and late reperfusion (12 hours-) using sirolimus-eluting stents for ST-segment elevated myocardial infarctions: a propensity score matching analysis.

OBJECTIVE: We compared the long-term clinical and 1-year angiographic outcomes in ST-segment elevation myocardial infarction (STEMI) patients who presented between 12 to 48 hours after symptom onset and underwent emergent procedures (late reperfusion) using sirolimus-eluting stents (SES; Cypher Bx Velocity) with those of primary stenting patients who presented within 12 hours. METHODS: The study design was a retrospective, nonrandomized single-center study in which the investigations were conducted in October 2012 following the enrollment of consecutive STEMI patients treated with late reperfusion (n=75) and primary stenting using SES (n=386) between September 2004 and May 2007. The incidence of the primary end points (cardiac death, nonfatal recurrent MI and definite stent thrombosis) after late reperfusion (6.7%; mean follow-up, 2,176±742 days) was not significantly different from that observed after primary stenting (8.5%; 2,237±722 days) (p=0.59). The incidence of the secondary end point (binary in-stent restenosis: % diameter stenosis greater than 50% on secondary angiography at approximately one year) after late reperfusion (11.1%, n=54) was not statistically different from that observed after primary stenting (8.0%, n=276) (p=0.45). Using a propensity score matching analysis, the incidences of the primary (6.7%, n=75) and secondary (11.3%, n=53) end points after late reperfusion were not found to be significantly different from those observed after primary stenting (8.0% and 9.4%) (p=0.75 and 0.75, respectively). CONCLUSION: The present small study showed the long-term clinical and 1-year angiographic outcomes after late reperfusion using SES for STEMI patients in emergent procedures in daily practice to be statistically equivalent to those observed after primary stenting using SES for STEMI patients.

Propensity-matched lesion-based comparison of midterm outcomes of TAXUS Express and TAXUS Liberté stents for de novo native coronary stenosis.

BACKGROUND: We examined the implication of the revised platform of TAXUS Liberté (TAXUS-Lib; Boston Scientific, Natick, MA, USA) from TAXUS Express (TAXUS-Exp; Boston Scientific) stents, after stent placements in a daily practice environment, on midterm clinical and angiographic outcomes. METHODS AND RESULTS: By adjusting historically different baselines with propensity score matching analysis in 1358 de novo native coronary stenoses, the incidence of the clinical safety endpoint (700-day cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis) after placement of TAXUS-Lib (0.60%; mean follow-up, 683±64 days) was not significantly different from that in the TAXUS-Exp group (1.20%; 677±96 days, p=0.182). Cardiac dysfunction (ejection fraction of left ventricle less than 40%) was the predictor of primary endpoint [odds ratio (OR), 17.8; 95% CI, 4.39-71.9; p<0.001]. In the baseline-adjusted angiographic followed-up lesions (n=443 in each arm), the incidence of secondary endpoint [binary in-stent restenosis: percent diameter stenosis (%DS) >50% at the follow-up angiography] in the TAXUS-Lib group (11.3%) was not significantly different from that in the TAXUS-Exp group (13.5%, p=0.368). TAXUS-Exp was not the predictor of secondary endpoint (OR, 1.20; 95% CI, 0.77-1.85; p=0.424). CONCLUSIONS: The midterm clinical and angiographic outcomes after placement of the new TAXUS-Lib stent for de novo coronary stenosis in a daily practice environment were statistically equivalent compared to the former TAXUS-Exp.

Retrospective comparison of midterm clinical and angiographic outcomes after the implantation of paclitaxel- and sirolimus-eluting stents for de novo coronary complex lesions in nonrandomized Japanese patients.

OBJECTIVE: We retrospectively analyzed the midterm clinical and angiographic outcomes after the implantation of paclitaxel- (PES, TAXUS Express) and sirolimus- (SES, Cypher Bx Velocity) eluting stents in Japanese patients with complex coronary lesions. METHODS: From August 2004 to May 2009, 1,335 nonrandomized de novo native complex coronary lesions treated with either a PES (357 cases) or SES were included. The inclusion criteria for patients with complex lesions were those with diabetes, those undergoing hemodialysis, and those with a low ejection fraction, as well as subjects who had lesions with severe calcification, ostiums of the right coronary and left circumflex arteries, and who underwent the side-branch bifurcation 2-stent technique. The subjects were evaluated for consistent predictors of cardiac events, binary restenosis and target lesion vascularization of the SES. The composite primary endpoint percentage (900-day cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis) after PES placement was 0.6%, which was not significantly different from that after SES placement (0.12%; p=0.290). The incidence of the secondary endpoint (binary restenosis; stenosis >50% of the diameter at the secondary angiographic examination performed within 550 days after the procedure) after PES placement (15.0%) was also not significantly different than that after SES placement (13.3%; p=0.498). There was no relationship between PES placement and binary restenosis upon angiographic follow-up of 989 lesions (odds ratio of 1.14; 95% confidence interval, 0.73-1.77; p=0.57). CONCLUSION: For de novo native complex coronary stenosis, the midterm safety and efficacy of PES placement was statistically equivalent to that of SES placement in a clinical setting in Japan.

Post-discharge clinical and angiographic outcomes of patients presenting within 48h of STEMI treated with paclitaxel- or sirolimus-eluting stents.

BACKGROUND AND PURPOSE: The purpose of the present study was to examine the mid-term clinical and angiographic outcomes of patients with ST-segment elevation myocardial infarction (STEMI) who presented within 48 h and received paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES). METHODS AND RESULTS: This study was a retrospective, non-randomized, single-center study. The post-discharge clinical outcomes of 357 consecutive patients who presented within 48 h of their first STEMI and received PES (n=163) or SES (n=194) between February 2007 and February 2009 were analyzed in May 2011. The incidence of post-discharge events (i.e. cardiac death and non-fatal recurrent MI) after PES placement (0.6%) did not significantly differ from that after SES placement (1.5%). Treatment with PES was not related to the risk of adverse events post-discharge (mean follow-up period for PES placement, 1170±243 days; hazard ratio, 0.346; 95% CI, 0.036-3.371; p=0.361). No definite stent thromboses developed after treatment with PES or SES. The incidence of binary in-stent restenosis (stenosis of more than 50% of the diameter at secondary angiography performed 10-18 months after the initial procedure) after PES placement (17.1%) was significantly higher than that after SES placement (4.8%; p<0.001). PES placement was an independent predictor of binary in-stent restenosis (odds ratio, 3.892; 95% CI, 1.470-10.30; p=0.006). CONCLUSIONS: Retrospective examination of the post-discharge clinical course after placement of PES and SES showed favorable midterm clinical outcomes among Japanese STEMI patients treated within 48h of onset. However, SES treatment resulted in superior angiographic outcomes compared to PES.