Use Of Paclitaxel-eluting Stent Research Articles

Mortality With Use of Paclitaxel-Eluting Stents Is Not Associated With Treatment Length or Drug Dosage: A Five-Year Real-World Experience

The results of a study-level meta-analysis suggested an increase in late all-cause mortality with use of paclitaxel-coated devices in femoropopliteal endovascular interventions. Subsequent review of long-term clinical trial and patient-level data has reported no mortality difference between paclitaxel-coated and uncoated devices. We have reported our real-world experience of clinical efficacy and mortality with the use of paclitaxel-eluting stents.

Increased mortality with paclitaxel-eluting stents is driven by lesion length

BackgroundEndovascular stenting has become the first-line treatment of symptomatic peripheral artery disease of the femoropopliteal axis (FPA). Several randomized clinical trials have reported that paclitaxel-eluting stents (PESs) significantly reduce the rates of restenosis. However, a meta-analysis investigating paclitaxel-coated devices in the FPA showed a significant increase in all-cause mortality after the use of PES. The aim of this study was to compare the long-term, real-world outcomes of bare-metal stents (BMSs) and PESs for treating FPA occlusive disease. MethodsA retrospective review of the medical records of 296 patients who underwent FPA stenting between January 2011 and December 2017 was performed. Patients were grouped into BMS and PES groups. The primary end point was all-cause mortality. Secondary end points included limb salvage, primary patency, primary assisted patency, and secondary patency. A comparison between the two groups within TransAtlantic Inter-Society Consensus (TASC) II subgroups was also performed. ResultsOf the study cohort, 101 patients (34%) received PES, whereas 195 patients (66%) underwent BMS placement. Median follow-up time was 23 months (interquartile range, 7-40 months). The 2-year all-cause mortality estimates were 12% for the PES group compared with 11.4% for the BMS group (P = .26). There were no differences in the 2-year limb salvage (90.7% vs 92%; P = .4), primary patency (78.8% vs 81.1%; P = .62), primary assisted patency (100% vs 96.5%; P = .4), and secondary patency (100% vs 98.6%; P = .26) between the PES and the BMS groups, respectively (all P > .05). These findings persisted when patients were stratified by TASC II lesions. Among patients with TASC C and D lesions, the use of PES was associated with significantly higher 2-year all-cause mortality (23.9% vs 5.1%; P = .05). After adjustment for age and other potential confounders, PES use was associated with significant increase in all-cause mortality (adjusted hazard ratio, 2.3; 95% confidence interval, 1.31-27 P = .02) in TASC C and D patients. ConclusionsConsistent with the meta-analysis of several randomized clinical trials, the use of PES in a real-world setting was associated with a twofold increase in the risk of death. However, these findings were seen only among patients with TASC C and D lesions, who required multiple longer stents and potentially larger paclitaxel dose. There was no advantage in terms of patency in PES vs BMS in this population with extensive disease. Further studies of larger populations are required.

Abstract 380: Comparison of 6-Year Outcomes of Bare-metal and Paclitaxel-eluting Stents: Results from New York Cardiac Registries

Background: Coronary stents are commonly used in percutaneous coronary interventions (PCI). Bare-metal stents (BMS) as the first generation stent and paclitaxel-eluting stents (PES) as a second generation stent are widely deployed in PCIs. However, the long-term comparative effectiveness of BMS vs PES in the real practice remains unclear. Our aim was to assess a comprehensive set of 6-year clinical outcomes of all patients undergoing PCI with either BMS or PES placement and to determine comparative effectiveness of BMS vs PES in “off-label” (ST Segment Elevation Myocardial , totally occluded lesions, left main disease, multiple vessels diseased, bypassed graft lesions, and ejection fraction75 years, and diabetes) patient subgroups. Methods: A 6-year longitudinal database was created by linking data from the New York State (NYS) PCI registry, the NYS Cardiac Surgery Reporting System (CSRS) registry, the Statewide Planning and Research Cooperative System (SPARCS), the National Death Index (NDI) file, and the U.S. Census data (2010) for patients undergoing PCI with BMS or PES placement from January 1, 2006 through December 31, 2007. Outcomes included all-cause mortality, acute myocardial infarction (AMI), subsequent coronary revascularizations (PCI or coronary artery bypass graft surgery) and target-vessel PCI (TVPCI). Propensity score-matched patients undergoing BMS or PES (n=13,879 pairs) were compared with respect to 6-year outcomes using Kaplan-Meier estimates and Cox proportional hazards regression models applied to propensity-matched patients. Results: There were no significant differences in demographics, comorbidities, clinical profile, vessel/lesion related risk factors, and hospital/physician level characteristics between BMS and PES after propensity score matching. Kaplan-Meier estimates indicated that there were significant differences between BMS and PES for 6-year all-cause mortality (BMS: 26.87%, PES: 22.0%, Log-rank P<0.001), AMI (BMS: 8.91%, PES: 8.89%, P=0.045), repeat revascularization (BMS: 34.14%, PES: 36.27%, P=0.004), and TVPCI (BMS: 15.43%, PES: 15.28%, P=0.01). After further adjustment with Cox models, PES use was associated with significantly lower occurrence of 6-year all-cause mortality (adjusted hazard ratio : 0.74, P<0.001), AMI (AHR: 0.91, P=0.04), and TVPCI (AHR: 0.92, P=0.02) but higher occurrence of 6-year repeat revascularization (AHR: 1.08, P=0.001). The reason why BMS had lower repeat revascularization rate was because of its lower rate of repeat PCI in non-target vessels. For “off-label” and “high-risk” subgroups, PES had superior or non-inferior outcomes relative to BMS. Conclusion: Overall, PES improved clinical outcomes compared to BMS at 6 years. For each “off-label” or “high-risk” subgroup, the comparative effectiveness of PES vs BMS varied by the outcome assessed.

Comparación de stents de paclitaxel y stents de everolimus en el infarto agudo de miocardio con elevación del segmento ST e influencia de la trombectomía en los resultados. Estudio ESTROFA-IM

Introduction and objectivesWe sought to compare the long-term clinical outcome of patients with ST-segment elevation myocardial infarction treated with paclitaxel-eluting stents or everolimus-eluting stents and the influence of thrombectomy on outcomes. MethodsThe ESTROFA-IM is a multicenter retrospective registry collecting consecutive patients with infarction treated with these stents in 16 centers. Propensity-score matching was performed to select comparable stent groups and comparable groups with and without thrombectomy. ResultsAfter matching patients, 350 treated with everolimus-eluting stents and 350 with paclitaxel-eluting stents were included in the analysis. The clinical and angiographic characteristics were comparable in both groups. The 2-year incidence of death, infarction, and target lesion revascularization was 14.9% for paclitaxel-eluting stents and 11.5% for everolimus-eluting stents (P = .04) and the incidence of definite/probable thrombosis 4.3% and 1.4%, respectively (P = .01). The use of paclitaxel-eluting stents was an independent predictor for events (hazard ratio = 2.44, 95% confidence interval, 1.28-4.65; P = .006). The benefit of everolimus-eluting stents over paclitaxel-eluting stents regarding stent thrombosis was more evident in the nonthrombectomy subgroup (5.4% vs 1.4%; P = .01). A significant interaction was found in the subgroups with and without thombectomy in the comparison between paclitaxel-eluting stents and everolimus-eluting stents for the end-point of stent thrombosis (P = .039). ConclusionsThe results of this multicenter registry suggest better clinical outcomes with the everolimus-eluting stents in ST-segment elevation myocardial infarction. The lower risk of thrombosis with these stents could be more relevant in the absence of thrombectomy.Full English text available from:www.revespcardiol.org/en

Drug-eluting stents in patients on chronic hemodialysis: Paclitaxel-eluting stents vs. limus-eluting stents

Patients requiring chronic hemodialysis (HD) are at high risk for restenosis after percutaneous coronary intervention (PCI) with bare metal stents. Outcome data on drug-eluting stent (DES) implantation in HD patients are limited and suggest superiority of paclitaxel-eluting stents (PES) over limus-eluting stents (LES). In total, 218 consecutive patients were prospectively enrolled. A comparison of post-PCI outcomes up to 2 years was carried out between patients receiving PES (n=62) and LES (n=156; SES n=112, EES n=44). The primary end point was 2-year major adverse cardiac events [MACE; death, Q-wave myocardial infarction and target lesion revascularization (TLR)]. Baseline characteristics were comparable. The overall prevalence of diabetes mellitus was 71%. On clinical follow-up to 2 years, MACE rates were similar [PES 32/51 (62.7%) vs. LES 77/132 (58.3%), p=0.59]; however, clinically-driven revascularization occurred more than twice as frequently in LES patients: TLR [PES 4/36 (11.1%) vs. LES 24/93 (25.8%), p=0.07] and target vessel revascularization [5/37 (13.5%) vs. 33/96 (34.4%), p=0.02]. Given that overall mortality was nominally higher for PES patients [31/50 (62.0%) vs. 61/127 (48.0%), p=0.09], a competing outcome analysis was implemented for TLR against mortality, which demonstrated that the trend for increased TLR with LES was no longer apparent (p=0.282). On multivariable adjustment, only diabetes mellitus was independently associated with TLR (use of PES was not). Patients on chronic HD experience high rates of clinically driven TLR despite DES implantation. Use of PES does not demonstrate a significant advantage over LES in this population.

Dynamic Observation of Artery Endothelial Cell Layers in Response to Bare Metal Stent and Paclitaxel‐Eluting Stent In Vitro

We aimed to investigate the mechanism of paclitaxel-eluting stent (PES) induced thrombosis by real-time dynamic monitoring of live endothelial cells. PES is widely used in clinics to inhibit restenosis effectively. However, late stent thrombosis is a major concern with the use of PES. We established an in vitro cell culture system to mimic the close contact of endothelial cells with PES struts. The dynamic response of porcine innominate artery endothelial cells (PIECs) to stents was observed using a bright field microscope and a high-resolution charge-coupled device PES changed elongated PIECs to round PIECs within 24 hours. Paracellular gaps were readily observed in a PIEC monolayer exposed to PES. By contrast, paracellular gaps were almost undetectable in an endothelial monolayer incubated with bare metal stent (BMS). As incubation time was prolonged (days 5-9), round PIECs returned to their elongated shape, but paracellular gaps were retained at lower frequencies and smaller sizes than those on days 1 and 2. In addition, the PIEC monolayer in the PES group retained an uneven surface topology during incubation, whereas PIECs in the BMS group developed a smooth surface of epithelial cell sheets on days 5-7. Our findings showed that the shift of cell shape causes impaired integrity of the monolayer characteristic with enlarged paracellular gaps and uneven surface topology in exposure to PES. The results might serve as structural information for understanding the mechanism of PES-induced early and late thrombosis.

Impact of advanced age on the safety and effectiveness of paclitaxel‐eluting stent implantation in patients with ST‐segment elevation myocardial infarction undergoing primary angioplasty

To assess the impact of age on safety and efficacy of paclitaxel-eluting stent (PES) implantation during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). The benefits of paclitaxel-eluting stent (PES) implantation during primary PCI were confirmed by the long-term results of the HORIZONS-AMI trial. Whether the effects of PES are independent of age has not been reported. Data on 3,006 patients from the HORIZONS-AMI study randomized in a 3:1 ratio to PES or bare-metal stent (BMS) in whom at least one stent was implanted were assessed. There were 2,302 (76.6%) patients <70, and 704 patients ≥70 years of age. At 3 years, among older patients a trend toward lower risk of major adverse cardiac events (MACE; death from any cause, stroke, reinfarction and unplanned revascularization for ischemia) related to PES use was observed (PES vs. BMS: 18.0% vs. 21.3%; P = 0.07). There was also a trend for reduction of MACE related to PES in older patients (26.4% vs. 33.1%; P = 0.09). Both, patients <70 and ≥70 years of age treated with PES were at lower risk for ischemic target vessel revascularization. However, a higher risk of major bleeding in elderly patients treated with PES was observed (P = 0.02 for interaction between age group and PES effects). No interaction between age and stent type in terms of the risk of other clinical end points, including all-cause death, was confirmed. For STEMI patients undergoing primary PCI, the implantation of PES as compared with BMS reduced ischemic TVR, and this effect was independent of age.

Impact of Drug-Eluting Stents on Distal Vessels

Previous studies have not addressed vessel response >5 mm distal to the stent edge. Therefore, we investigated the impact of paclitaxel-eluting stents (PES) versus bare metal stents (BMS) on distal vessels in the serial intravascular ultrasound substudies of TAXUS IV, V, and VI. TAXUS IV, V, and VI were double-blind, randomized, multicenter, controlled trials comparing PES with BMS. In their intravascular ultrasound substudies, 103 patients (54 BMS, 49 PES) had intravascular ultrasound data ≥10 mm distal to the stent both postprocedure and at 9 months follow-up. Baseline characteristics were similar between the 2 groups. Multilevel modeling was used to account for the variation between patients and within patients among distal segments. Effect of stent type, time, and their interaction was tested using a mixed effect model controlling for distal segments. Postprocedure lumen and vessel were not significantly different between PES versus BMS; however, lumen (P=0.006) and vessel (P=0.0001) were significantly reduced for BMS at 9-month follow-up but not for PES. Conversely, there was a significant plaque increase from postprocedure to 9-month follow-up for PES (P=0.0008) but not for BMS. These vessel responses were statistically consistent among 0- to 5-mm versus 5- to 10-mm versus 10- to 15-mm segments distal to the stent in both groups. PES use was associated with plaque increase from baseline to 9-month follow-up >5 mm distal to the stent along with positive remodeling, whereas BMS use was associated with negative remodeling and no plaque increase. These vessel responses were consistent in 5-mm long subsegments: 0 to 5 mm versus 5 to 10 mm versus 10 to 15 mm distal to the stent. URL: HTTP://WWW.CLINICALTRIAL.GOV. Unique identifiers: TAXUS IV: NCT00292474; TAXUS V: NCT00301522; TAXUS VI: NCT00297804.

The impact of preprocedural hemoglobin A1c on the efficacy of sirolimus-eluting and paclitaxel-eluting stents

Several reports have shown contrary results regarding the efficacy of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in diabetic patients. The association between hemoglobin A1c (A1c) before coronary intervention and the midterm clinical outcomes of patients treated with these stents is unclear. The enrolled population was 415 patients with diabetes or impaired glucose tolerance (IGT) who underwent follow-up angiography after being implanted with a SES (n = 282) or PES (n = 133). The enrolled population was classified into the optimal glycemic control group (n = 213) and suboptimal glycemic control group (n = 202), and the predictors of restenosis were examined in each group. In the optimal glycemic control group, the use of PES was an independent predictor of restenosis [odds ratio (OR) 9.98, 95% confidence interval (CI) 3.08-38.9, p < 0.0001]; on the other hand, the use of SES was a positive independent predictor of restenosis prevention (OR 0.10, 95% CI 0.03-0.32, p < 0.0001). In the suboptimal glycemic control group, neither stent was predictive of restenosis. In a subanalysis, preprocedural A1c (≥7.0%) was found to be an independent predictor of restenosis in the SES group (OR 3.61, 95% CI 1.14-12.8, p = 0.03), but not the PES group. Postprocedural A1c (≥7.0%) was not an independent predictor of restenosis in either stent group. This study showed that the superiority of SES compared to PES was attenuated in the suboptimal glycemic control group. Preprocedural A1c (≥7.0%) was found to be an independent predictor of restenosis in the SES group, but not in the PES group.

Lack of long‐term clinical benefit of thrombus aspiration during primary percutaneous coronary intervention with paclitaxel‐eluting stents or bare‐metal stents: Post‐hoc analysis of the PASSION‐trial

Although current clinical guidelines recommend the use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI), previous studies evaluating TA demonstrated contradictory results. The aim of this study was to evaluate long-term clinical outcome after TA in adjunct to PPCI for acute ST-segment myocardial infarction (STEMI), as compared with conventional treatment, with the use of paclitaxel-eluting stents or bare-metal stents. We analyzed data of the PASSION trial, in which 619 patients with STEMI were randomly assigned to a paclitaxel-eluting stent or a bare-metal stent. TA was performed in 311 patients (50.2%). Clinical endpoints at 2 years were compared between patients who received TA during PPCI with patients who underwent conventional PPCI. The primary outcome of interest was a composite of cardiac death, recurrent myocardial infarction (MI), or target-lesion revascularization (TLR). A propensity score model was made to account for baseline differences that could have affected the probability of performing TA. Complete follow-up was available for 598 patients (96.6%). The cumulative incidence of the combined outcome measure of cardiac death, recurrent MI, or TLR was 40 (13.0%) in the TA group and 41 (13.5%) in the conventional PPCI group (HR 0.96; 95% CI 0.62-1.47; P = 0.84). Also after adjusting for propensity score, no significant difference in event rate was observed between both treatment groups. In this post-hoc analysis of the PASSION trial, TA in adjunct to PPCI did not affect rates of major adverse cardiac events at 2 years follow-up, as compared with conventional PPCI.

Paclitaxel-eluting stents reduce neointimal hyperplasia compared to bare metal stents in saphenous vein grafts: intravascular ultrasonography analysis of the SOS (Stenting of Saphenous Vein Grafts) trial

To compare the intravascular ultrasonography (IVUS) findings between saphenous vein grafts (SVG) treated with paclitaxel-eluting stents (PES) vs. bare metal stents (BMS) in the Stenting Of Saphenous Vein Grafts (SOS) trial. Of the 80 SOS trial patients, 38 had both baseline and follow-up IVUS examination and were included in this substudy: 17 patients received 28 BMS in 26 lesions and 21 patients received 30 PES in 28 lesions. Quantitative IVUS analysis was performed to determine the volume of in-stent neointimal hyperplasia (NIH) - defined as the difference between stent volume and lumen volume in the stented segments. Baseline characteristics were similar between patients who did and did not undergo baseline and follow-up IVUS. Patients receiving BMS and PES had similar stent and lumen volumes immediately after stenting. At 12-month follow-up, compared to BMS, PES-treated lesions had significantly less NIH volume (3.4 vs. 21.9 mm³, p<0.001) and neointima hyperplasia progression (1.6 vs. 17.1 mm³, p<0.001). No significant differences were seen in the 5 mm segment proximal and distal to the stent. Compared to BMS, use of PES in SVG lesions is associated with significantly lower NIH formation, which may help explain the improved clinical outcomes with PES in these lesions.

Risk of in-stent thrombus formation at one year after drug-eluting stent implantation

Introduction Although very late stent thrombosis is an important problem with drug-eluting stents, risks for in-stent thrombus formation have not been clarified. Therefore, we examined the risks among patient and lesion characteristics by direct visualization of the stented lesion by angioscopy. Materials and methods Consecutive patients (n = 118) who received successful angioscopic examination of drug-eluting (sirolimus- or paclitaxel-eluting) stents at 1-year after implantation were included. Presence or absence of thrombus directly on the area of each condition determined by the combination of lesion color (white or yellow) and neointima coverage (grade 0 − 2) was evaluated for each stent; and the factors associated with the presence of thrombus were analyzed. Results Multivariate logistic regression analysis revealed lesion color (= yellow; odds ratio [OR] 5.5, 95% confidence interval [CI] 3.0-10, p < 0.001), neointima coverage (= grade 0 or 1; OR 5.5, 95% CI 2.4-13, p < 0.001), and stent type (= paclitaxel-eluting stent; OR 7.6, 95% CI 3.9-15, p < 0.001) as independent contributors for in-stent thrombus formation. Conclusion Yellow color of the lesion, poor neointima coverage, and use of paclitaxel-eluting stent were the risks of in-stent thrombus formation at 1 year after DES implantation.

Two‐Year Clinical Outcomes with Paclitaxel‐Eluting Coronary Stents in Patients with Chronic Total Occlusions: Analysis from the TAXUS ARRIVE Program

To examine the incidence of clinical events after implantation of the TAXUS Express paclitaxel-eluting stent (PES) in chronic total occlusions (CTO) in an unselected patient population. The TAXUS ARRIVE registries compiled data on 7,492 patients, including 113 patients with CTO (TIMI flow 0). Patients enrolled at procedure start with no mandated inclusion/exclusion criteria; all cardiac events were monitored with independent end-point adjudication. Two-year follow-up was 89% (101/113) for CTO patients who had significantly more baseline comorbidities/complex disease than simple-use patients undergoing native coronary intervention (N = 2,698) and significantly longer lesions/smaller vessels than other expanded-use patients (N = 4,681 without CTO). Among CTO patients the rate of 2-year major cardiac events (MCE, including cardiac death, myocardial infarction, and target vessel revascularization) was 22.3%, significantly higher than in simple-use patients (10.3%, P < 0.001). CTO MCE was similar to that for other expanded-use patients (16.5%, P = 0.14) but target lesion revascularization was significantly higher in year 2 (6.9% vs. 2.7%, P = 0.02). Academic Research Consortium definite/probable stent thrombosis through 2 years was 5.7%, significantly higher than simple-use patients but similar to other expanded-use cases. In a "real-world" setting, PES use in CTO was associated with increased MCE compared to simple- use patients, but achieved long-term outcomes similar to that observed in other complex patient/lesion cases.

Continued Benefit From Paclitaxel-Eluting Compared With Bare-Metal Stent Implantation in Saphenous Vein Graft Lesions During Long-Term Follow-Up of the SOS (Stenting of Saphenous Vein Grafts) Trial

This study sought to report the long-term outcomes after drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions in the SOS (Stenting of Saphenous Vein Grafts) trial. The long-term outcomes after DES implantation in SVGs are poorly studied. Apart from the SOS trial, the only other randomized trial comparing DES with bare-metal stents (BMS) in SVGs reported higher mortality in the DES group at 32 months. In the SOS trial, 80 patients with 112 lesions in 88 SVGs were randomized to a BMS or paclitaxel-eluting stent (PES) and demonstrated improved short-term angiographic and clinical outcomes with PES. Extended clinical follow-up was subsequently obtained. Mean age was 67 ± 9 years, and all patients were men. The indications for stenting included acute coronary syndrome in 60% and stable angina in 31% of patients. The mean SVG age was 12 ± 6 years. The baseline characteristics of the patients in the 2 study groups were similar. Procedural success was achieved in 77 patients (96%). During a median follow-up of 35 months, compared with patients randomized to BMS, those receiving PES had a lower incidence of myocardial infarction (hazard ratio [HR]: 0.32, p = 0.01), target lesion revascularization (HR: 0.20, p = 0.004), target vessel revascularization (HR: 0.41, p = 0.03), and target vessel failure (HR: 0.34, p = 0.001) as well as a trend toward less definite or probable stent thrombosis (HR: 0.15, p = 0.08). All-cause mortality (HR: 2.04, p = 0.19) and cardiac mortality (HR: 0.62, p = 0.51) did not differ between groups. During long-term follow-up, use of PES was associated with significantly better clinical outcomes than BMS in SVG lesions. (Stenting of Saphenous Vein Grafts Trial [SOS]; NCT00247208).

022 Paclitaxel Eluting Stent use in everyday practice and impact of diabetes mellitus on safety and efficacy at 3 years

We sought to assess the efficacy and safety of the PES used in everyday practice in diabetic patients (DP) with single or multiple vessel disease compared to non-diabetic patients (NDP) over at least 3 years. Safety concerns about PES have been raised, particularly when used in less highly selected patients than those included in randomized trials and especially among DP. The EVASTENT-Tax study is a multicenter matched cohort registry of 502 patients (pts) revascularised exclusively with paclitaxel stents (Taxus ® ). For each DP included a NDP patient was subsequently included. Patients were followed for at least 3 years (follow-up at 1 yr 98%, at ≥3 yrs 92%). The safety primary end point was a composite of cardiac death and nonfatal myocardial infarction (with or without stent thrombosis, according to Academic Research Consortium definitions), and for efficacy target lesion revascularisation (TLR). Target vessel revascularisation excluding TLR (TVR) and non TVR were also assessed. We included 502 patients (mean age 70 years) presenting with ACS (52%) or a stable condition (48%), but not acute MI, of who 233 were diabetic and 381 (76%) were male. During follow-up 30 pts (6%) died, with cardiac death in 12 pts (2.4%). Nonfatal myocardial infarction occurred in 12 pts (2%). Stent thrombosis was noted in 15 pts (3%): 4 definite (3 acute), 6 probable (1 sub-acute), and 5 possible; 4 acute or sub acute, 4 late and 7 very late ST. At 3-years, the safety endpoint rate was significantly higher in diabetic than in non-diabetic patients (8% vs.1%, p ≤ 0.001), whereas TLR was not significantly different. In everyday practice the PES has a good efficacy with comparable clinical parameters for restenosis in DP and NDP at 3 years. PES are clinically safe, however the risk of paclitaxel stent thrombosis, including very late ST, is higher for DP.

5-Year Follow-Up After Primary Percutaneous Coronary Intervention With a Paclitaxel-Eluting Stent Versus a Bare-Metal Stent in Acute ST-Segment Elevation Myocardial Infarction: A Follow-Up Study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction With ST-Segment Elevation) Trial

The purpose of this study was to evaluate the long-term outcomes of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial. In primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction (STEMI), the use of drug-eluting stents (DES) is still controversial. Several randomized controlled trials of DES, compared with bare-metal stents (BMS), with short-term follow-up showed a reduction in target lesion revascularization (TLR), but no differences in rates of cardiac death or recurrent myocardial infarction. Moreover, the occurrence of (very) late stent thrombosis (ST) continues to be of major concern, and, therefore, long-term follow-up results are needed. We randomly assigned 619 patients presenting with STEMI to a paclitaxel-eluting stent (PES) or the similar BMS. The primary end point was the composite of cardiac death, recurrent myocardial infarction, or TLR. We performed clinical follow-up at 5 years. At 5 years, the occurrence of the composite of cardiac death, recurrent myocardial infarction, or TLR was comparable at 18.6% versus 21.8% in PES and BMS, respectively (hazard ratio [HR]: 0.82, 95% confidence interval [CI]: 0.58 to 1.18, p = 0.28). The incidence of definite or probable ST was 12 (4.2%) in the PES group and 10 (3.4%) in the BMS group (HR: 1.19, 95% CI: 0.51 to 276, p = 0.68). In the present analysis of PES compared with BMS in primary percutaneous coronary intervention for STEMI, no significant difference in major adverse cardiac events was observed. In addition, no difference in the incidence of definite or probable ST was seen, although very late ST was almost exclusively seen after the use of PES. (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation [PASSION]; ISRCTN65027270).

Incidence, Mechanisms, Predictors, and Clinical Impact of Acute and Late Stent Malapposition After Primary Intervention in Patients With Acute Myocardial Infarction

The incidence and mechanisms of acute and late stent malapposition after primary stent implantation in ST-segment elevation myocardial infarction remain unclear. The Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial was a dual-arm, factorial, randomized trial comparing paclitaxel-eluting stents (PES) and otherwise equivalent bare metal stents (BMS) in ST-segment elevation myocardial infarction patients. The intravascular ultrasound substudy enrolled 241 patients with 263 native coronary lesions (201 PES, 62 BMS) with baseline and 13-month follow-up imaging. Postintervention acute stent malapposition (ASM) occurred in 34.3% PES- and 40.3% BMS-treated lesions. Of these, 39.1% PES- and 40.0% BMS-treated lesions resolved at follow-up, especially within the stent body (66.7%); complete resolution was accompanied by a reduction in external elastic membrane area. An ASM area >1.2 mm(2) best separated persistent from resolved ASM. At follow-up, a higher frequency of late stent malapposition was detected in PES-treated lesions (46.8%) mainly because of more late acquired stent malapposition (30.8%) compared with BMS-treated lesions. Late acquired stent malapposition area correlated to the decrease of peri-stent plaque in the subset of lesions without positive remodeling and only to change in external elastic membrane in the group with positive remodeling. Independent predictors of late acquired stent malapposition were plaque/thrombus protrusion (odds ratio, 5.60; 95% confidence interval [CI], 2.32 to 13.54) and PES use (odds ratio, 6.32; 95% CI, 2.15 to 18.62). The incidence of ASM was similar in PES- and BMS-treated lesions, but late acquired stent malapposition was more common in PES-treated lesions. The reason for resolved ASM was negative remodeling, with larger ASM areas separating persistent from resolved ASM. Late acquired stent malapposition was due mainly to positive remodeling and plaque/thrombus resolution. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.

Long-Term Vascular Changes After Drug-Eluting Stent Implantation Assessed by Serial Volumetric Intravascular Ultrasound Analysis

Using serial volumetric intravascular ultrasonography, we evaluated the predictors of late intimal hyperplasia (IH) increases after drug-eluting stent implantation. All eligible patients who underwent 6-month angiography without visual restenosis were requested to undergo a 2-year follow-up examination. Complete serial (after stenting and early [6-month], and late [2-year] follow-up) angiographic and intravascular ultrasound data were available for 135 patients with 143 lesions: 99 sirolimus-eluting stents and 44 paclitaxel-eluting stents. The external elastic membrane, stent, lumen, and peri-stent plaque volumes (external elastic membrane minus stent) were normalized by stent length. The percentage of IH volume was calculated as IH volume/stent volume x 100. The early reduction in the minimum lumen area was greater than the late reduction in the minimum lumen area (-0.8 +/- 0.8 vs -0.2 +/- 0.5 mm(2), p <0.001). A progressive increase occurred in the percentage of IH volume: 8.1 +/- 7.1% from baseline to 6 months and 2.4 +/- 3.9% from 6 months to 2 years (p <0.001, between the early and late increases in the percentage of IH). The use of paclitaxel-eluting stents was the only independent predictor for the percentage of IH volume at 6 months (beta = 0.419, p <0.001). The use of paclitaxel-eluting stents (beta = 0.365, p <0.001, 95% confidence interval 3.7 to 9.7) and the post-stenting normalized plaque and media volume (beta = 0.195, p = 0.020, 95% confidence interval 0.1 to 1.6) were the only independent predictors for the percentage of IH volume at 2 years. However, when the percentage of IH at 6 months was forced into the model, the percentage of IH at 6 months and the post-stenting normalized plaque and media volume, not paclitaxel-eluting stent use, predicted the 2-year percentage of IH. In conclusion, although IH continued to increase beyond 6 months, the growth rate of intima and luminal loss attenuated with time.

Sirolimus- Versus Paclitaxel-Eluting Stents for the Treatment of Coronary Bifurcations: Results From the COBIS (Coronary Bifurcation Stenting) Registry

We aimed to compare the long-term clinical outcomes of patients treated with sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) for coronary bifurcation lesions. There are limited data regarding comparisons of SES and PES for the treatment of bifurcation lesions. Patients who received percutaneous coronary intervention for non-left main bifurcation lesions were enrolled from 16 centers in Korea between January 2004 and June 2006. We compared major adverse cardiac events (MACE [cardiac death, myocardial infarction, or target lesion revascularization]) between the SES and PES groups in patients overall and in 407 patient pairs generated by propensity-score matching. We evaluated 1,033 patients with bifurcation lesions treated with SES and 562 patients treated with PES. The median follow-up duration was 22 months. Treatment with SES was associated with a lower incidence of MACE (hazard ratio [HR]: 0.53, 95% confidence interval [CI]: 0.32 to 0.89, p < 0.01) and target lesion revascularization (HR: 0.55, 95% CI: 0.31 to 0.97, p = 0.02), but not of cardiac death (HR: 2.77, 95% CI: 0.40 to 18.99, p = 0.62) and cardiac death or myocardial infarction (HR: 0.97, 95% CI: 0.38 to 2.49, p = 0.94). After propensity-score matching, patients with SES still had fewer MACE and target lesion revascularization incidences than did patients with PES (HR: 0.52, 95% CI: 0.30 to 0.91, p = 0.02, and HR: 0.48, 95% CI: 0.25 to 0.91, p = 0.02, respectively). There was no significant difference in the occurrences of stent thrombosis between the groups (0.7% vs. 0.7%, p = 0.94). In patients with bifurcation lesions, the use of SES resulted in better long-term outcomes than did the use of PES, primarily by decreasing the rate of repeat revascularization. (Coronary Bifurcation Stenting Registry in South Korea [COBIS]; NCT00851526)

Diabetic and Nondiabetic Patients With Left Main and/or 3-Vessel Coronary Artery Disease: Comparison of Outcomes With Cardiac Surgery and Paclitaxel-Eluting Stents

This study was designed to compare contemporary surgical revascularization (coronary artery bypass graft surgery [CABG]) versus TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stents (PES) in diabetic and nondiabetic patients with left main and/or 3-vessel disease. Although the prevalence of diabetes mellitus is increasing, the optimal coronary revascularization strategy in diabetic patients with complex multivessel disease remains controversial. The SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) study randomly assigned 1,800 patients (452 with medically treated diabetes) to receive PES or CABG. The overall 1-year major adverse cardiac and cerebrovascular event rate was higher among diabetic patients treated with PES compared with CABG, but the revascularization method did not impact the death/stroke/myocardial infarction rate for nondiabetic patients (6.8% CABG vs. 6.8% PES, p = 0.97) or for diabetic patients (10.3% CABG vs. 10.1% PES, p = 0.96). The presence of diabetes was associated with significantly increased mortality after either revascularization treatment. The incidence of stroke was higher among nondiabetic patients after CABG (2.2% vs. PES 0.5%, p = 0.006). Compared with CABG, mortality was higher after PES use for diabetic patients with highly complex lesions (4.1% vs. 13.5%, p = 0.04). Revascularization with PES resulted in higher repeat revascularization for nondiabetic patients (5.7% vs. 11.1%, p < 0.001) and diabetic patients (6.4% vs. 20.3%, p < 0.001). Subgroup analyses suggest that the 1-year major adverse cardiac and cerebrovascular event rate is higher among diabetic patients with left main and/or 3-vessel disease treated with PES compared with CABG, driven by an increase in repeat revascularization. However, the composite safety end point (death/stroke/myocardial infarction) is comparable between the 2 treatment options for diabetic and nondiabetic patients. Although further study is needed, these exploratory results may extend the evidence for PES use in selected patients with less complex left main and/or 3-vessel lesions. (SYNergy Between PCI With TAXus and Cardiac Surgery [SYNTAX]; NCT00114972).