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Background: The ION Study assessed clinical outcomes for the thin-strut, ION™ (TAXUS Element) Paclitaxel-Eluting Platinum Chromium Coronary Stent System (Boston Scientific, Marlborough, MA) in unselected patients., Methods: This prospective, open-label registry enrolled the first 1,120 consenting patients treated with the ION stent without clinical or angiographic inclusion criteria at 40 clinical sites. Follow-up was at discharge, 30 days, 180 days, 1 and 2 years. The primary endpoint, the 1-year rate of cardiac death or MI (CD/MI) in PERSEUS-like patients (i.e., patients similar to those enrolled in PERSEUS, the pivotal approval trial), was tested in patients pooled from the ION study (N = 316), the European TAXUS Element post-approval registry (TE-PROVE; N = 306 PERSEUS-like patients), and the PERSEUS WH/SV populations (N = 1,166); and then compared with a prespecified performance goal. Additional outcomes were examined in the overall ION patient population., Results: A total of 1,111 (out of 1,120) enrolled patients received a study stent. Most patients were male (70%) and mean age was 64 years. At 1 year, the primary endpoint of CD/MI occurred in 2.1% (6/292) of PERSEUS-like patients in ION, and 2.3% (40/1,729) of patients in the combined analysis. The upper one-sided 95% confidence interval for the combined analysis was 2.9%, which was significantly less than the performance goal of 7.6% (P < 0.001). Within patients enrolled in the ION study (N = 1,111), the rate of CD/MI was 4.5% at 1 year and 7.5% at 2 years. Definite/probable stent thrombosis occurred in 2.1% of patients at 1 year and 2.5% at 2 years., Conclusions: The results of the ION Study confirm the mid-term safety and effectiveness of the ION stent for the treatment of coronary artery disease in everyday clinical practice., (© 2018 Wiley Periodicals, Inc.)

Aims: SYNERGY is a novel platinum chromium alloy stent that delivers abluminal everolimus from an ultrathin poly-lactide-co-glycide (PLGA) biodegradable polymer. This study evaluated the in vivo degradation of the polymer coating, everolimus release time course, and vascular compatibility of the SYNERGY stent., Methods and Results: SYNERGY stents were implanted in arteries of domestic swine. Devices were explanted at predetermined time points (up to 120 days) and the extent of PLGA coating or everolimus remaining on the stents was quantified. Everolimus levels in the arterial tissue were also evaluated. A pathological analysis on coronary arteries of single and overlapping stents was performed at time points between 5 and 270 days. PLGA bioabsorption began immediately after implantation, and drug release was essentially complete by 90 days; PLGA absorption was substantially complete by 120 days (>90% of polymer was absorbed) leaving a bare metal SYNERGY stent. Vascular response was similar among SYNERGY and control stents (bare metal, polymer-only, and 3× polymer-only). Mild increases in para-strut fibrin were seen for SYNERGY at an early time point with no significant differences in all other morphological and morphometric parameters through 270 days or endothelial function (eNOS immunostaining) at 90 or 180 days. Inflammation was predominantly minimal to mild for all device types., Conclusion: In a swine model, everolimus was released by 90 days and PLGA bioabsorption was complete shortly thereafter. The SYNERGY stent and its biodegradable polymer, even at a 3× safety margin, demonstrated vascular compatibility similar to bare metal stent controls., (© 2015 Wiley Periodicals, Inc.)

Background: The TAXUS Element (ION) platinum chromium paclitaxel-eluting stent (PtCr-PES) incorporates a thin (81 μm) strut design with a similar polymer and drug dose density as prior PES. The pivotal PERSEUS trial program consisted of two studies: PERSEUS Workhorse (WH) and PERSEUS Small Vessel (SV). The PERSEUS WH trial demonstrated the PtCr-PES to be non-inferior to the predicate TAXUS Express PES (TE-PES) for target lesion failure (TLF) at 1 year and in-segment angiographic percent diameter stenosis at 9 months. The PERSEUS SV trial demonstrated the PtCr-PES to be superior to a historical bare metal stent (BMS) for angiographic late lumen loss at 9 months. Long-term (5-year) clinical outcomes following PtCr-PES have not been previously reported., Methods: PERSEUS WH was a prospective, Bayesian, 3:1 randomized (PtCr-PES vs. TE-PES) trial in patients with lesion length ≤28 mm and vessel diameter ≥2.75 to ≤4.0 mm. PERSEUS SV was a prospective, single-arm trial in patients with lesion length ≤20 mm and vessel diameter ≥2.25 to <2.75 mm comparing PtCr-PES to a matched historical BMS control., Results: Among randomized subjects in the PERSEUS WH study, clinical event rates at 5 years were similar between treatment groups, including TLF (12.9% TE-PES vs. 12.1% PtCr-PES; P = 0.66). In the PERSEUS SV study, 5-year rates of MACE, and TLF were significantly lower for PtCr-PES (vs. BMS) following adjustment for baseline characteristics and were primarily due to lower target lesion revascularization rates (27.2% BMS vs. 14.9% PtCr-PES; P = 0.049)., Conclusions: At 5 years, the PtCr-PES provides efficacy and safety that is comparable to the TE-PES and superior efficacy with similar safety when compared with BMS in smaller caliber vessels. Cumulative stent thrombosis rates remained low and similar through 5 years for both DES platforms., (© 2015 Wiley Periodicals, Inc.)

Background: We report the 5-year results of the SYNTAX trial, which compared coronary artery bypass graft surgery (CABG) with percutaneous coronary intervention (PCI) for the treatment of patients with left main coronary disease or three-vessel disease, to confirm findings at 1 and 3 years., Methods: The randomised, clinical SYNTAX trial with nested registries took place in 85 centres in the USA and Europe. A cardiac surgeon and interventional cardiologist at each centre assessed consecutive patients with de-novo three-vessel disease or left main coronary disease to determine suitability for study treatments. Eligible patients suitable for either treatment were randomly assigned (1:1) by an interactive voice response system to either PCI with a first-generation paclitaxel-eluting stent or to CABG. Patients suitable for only one treatment option were entered into either the PCI-only or CABG-only registries. We analysed a composite rate of major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up by Kaplan-Meier analysis on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, number NCT00114972., Findings: 1800 patients were randomly assigned to CABG (n=897) or PCI (n=903). More patients who were assigned to CABG withdrew consent than did those assigned to PCI (50 vs 11). After 5 years' follow-up, Kaplan-Meier estimates of MACCE were 26·9% in the CABG group and 37·3% in the PCI group (p<0·0001). Estimates of myocardial infarction (3·8% in the CABG group vs 9·7% in the PCI group; p<0·0001) and repeat revascularisation (13·7%vs 25·9%; p<0·0001) were significantly increased with PCI versus CABG. All-cause death (11·4% in the CABG group vs 13·9% in the PCI group; p=0·10) and stroke (3·7%vs 2·4%; p=0·09) were not significantly different between groups. 28·6% of patients in the CABG group with low SYNTAX scores had MACCE versus 32·1% of patients in the PCI group (p=0·43) and 31·0% in the CABG group with left main coronary disease had MACCE versus 36·9% in the PCI group (p=0·12); however, in patients with intermediate or high SYNTAX scores, MACCE was significantly increased with PCI (intermediate score, 25·8% of the CABG group vs 36·0% of the PCI group; p=0·008; high score, 26·8%vs 44·0%; p<0·0001)., Interpretation: CABG should remain the standard of care for patients with complex lesions (high or intermediate SYNTAX scores). For patients with less complex disease (low SYNTAX scores) or left main coronary disease (low or intermediate SYNTAX scores), PCI is an acceptable alternative. All patients with complex multivessel coronary artery disease should be reviewed and discussed by both a cardiac surgeon and interventional cardiologist to reach consensus on optimum treatment., Funding: Boston Scientific., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Background: The anatomical SYNTAX score is advocated in European and US guidelines as an instrument to help clinicians decide the optimum revascularisation method in patients with complex coronary artery disease. The absence of an individualised approach and of clinical variables to guide decision making between coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) are limitations of the SYNTAX score. SYNTAX score II aimed to overcome these limitations., Methods: SYNTAX score II was developed by applying a Cox proportional hazards model to results of the randomised all comers SYNTAX trial (n=1800). Baseline features with strong associations to 4-year mortality in either the CABG or the PCI settings (interactions), or in both (predictive accuracy), were added to the anatomical SYNTAX score. Comparisons of 4-year mortality predictions between CABG and PCI were made for each patient. Discriminatory performance was quantified by concordance statistics and internally validated with bootstrap resampling. External validation was done in the multinational all comers DELTA registry (n=2891), a heterogeneous population that included patients with three-vessel disease (26%) or complex coronary artery disease (anatomical SYNTAX score ≥33, 30%) who underwent CABG or PCI. The SYNTAX trial is registered with ClinicalTrials.gov, number NCT00114972., Findings: SYNTAX score II contained eight predictors: anatomical SYNTAX score, age, creatinine clearance, left ventricular ejection fraction (LVEF), presence of unprotected left main coronary artery (ULMCA) disease, peripheral vascular disease, female sex, and chronic obstructive pulmonary disease (COPD). SYNTAX score II significantly predicted a difference in 4-year mortality between patients undergoing CABG and those undergoing PCI (p(interaction) 0·0037). To achieve similar 4-year mortality after CABG or PCI, younger patients, women, and patients with reduced LVEF required lower anatomical SYNTAX scores, whereas older patients, patients with ULMCA disease, and those with COPD, required higher anatomical SYNTAX scores. Presence of diabetes was not important for decision making between CABG and PCI (p(interaction) 0·67). SYNTAX score II discriminated well in all patients who underwent CABG or PCI, with concordance indices for internal (SYNTAX trial) validation of 0·725 and for external (DELTA registry) validation of 0·716, which were substantially higher than for the anatomical SYNTAX score alone (concordance indices of 0·567 and 0·612, respectively). A nomogram was constructed that allowed for an accurate individualised prediction of 4-year mortality in patients proposing to undergo CABG or PCI., Interpretation: Long-term (4-year) mortality in patients with complex coronary artery disease can be well predicted by a combination of anatomical and clinical factors in SYNTAX score II. SYNTAX score II can better guide decision making between CABG and PCI than the original anatomical SYNTAX score., Funding: Boston Scientific Corporation., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Objectives: The study sought to evaluate the clinical impact of angiographic complete (CR) and incomplete (ICR) revascularization and its association with the presence of total occlusions (TO), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery in the "all-comers" SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial., Background: In patients with complex coronary artery disease undergoing PCI or CABG, the long-term prognostic implications of CR versus ICR is unsettled., Methods: In this post hoc study, consisting of randomized (n = 1,800) and nested PCI (n = 198) and CABG (n = 649) registries, 4-year clinical outcomes were compared in groups, with and without angiographic CR, in the PCI and CABG arms. Clinical outcomes were analyzed with Kaplan-Meier estimates, log-rank comparisons, and Cox regression analyses. Multivariate predictors of ICR were determined. Similar analyses were undertaken in the TO and non-TO treated groups of both study arms., Results: Angiographic CR was achieved in 52.8% of the PCI arm and 66.9% of the CABG arm. Within the PCI and CABG arms, ICR (compared with CR) seemed to be a surrogate marker of a greater burden of anatomical coronary complexity and clinical comorbidity and was associated with significantly higher frequencies of 4-year mortality, all-cause revascularization, stent thrombosis (PCI arm), and major adverse cardiac and cerebrovascular events. The presence of a TO was the strongest independent predictor of ICR after PCI (hazard ratio: 2.70, 95% confidence interval: 1.98 to 3.67, p < 0.001). Eight hundred and forty patients (PCI: 26.3%, CABG: 36.4%, p < 0.001) were identified to have 1,007 TOs, with 68.1% of TOs located in the proximal-mid coronary vasculature. The findings associating ICR (compared with CR) with higher frequencies of 4-year mortality and major adverse cardiac and cerebrovascular events remained consistent in the TO-treated groups in the PCI and CABG arms., Conclusions: Within the PCI and CABG arms of the all-comers SYNTAX trial, angiographically determined ICR has a detrimental impact on long-term clinical outcomes, including mortality. This effect remained consistent in patients with and without TOs., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: To report the final, cumulative, 5-year outcomes from the TAXUS ATLAS program, which studied the use of the TAXUS Liberté paclitaxel-eluting stent in de-novo coronary artery lesions., Methods: TAXUS ATLAS Workhorse, Small Vessel, and Long Lesion are nonrandomized studies comparing TAXUS Liberté (N=871), TAXUS Liberté 2.25 mm (N=261), and TAXUS Liberté 38 mm (N=150) stents, respectively, with case-matched TAXUS Express historical controls., Results: In the unadjusted analysis, TAXUS Liberté showed comparable 5-year rates of major adverse cardiac events (27.1% TAXUS Express vs. 26.2% TAXUS Liberté, P=0.70) in workhorse lesions and greater 5-year cumulative freedom from target lesion revascularization (78.4 vs. 87.3%, P=0.03) in small vessels. In addition, a lower periprocedural myocardial infarction rate (MI, 4.1 vs. 0.0%; P=0.01) was observed in long lesions versus TAXUS Express. After propensity score adjustment, no statistically significant effect of TAXUS Liberté on the 5-year rates of TLR in small vessels (17.9 vs. 13.3%, P=0.36) or MI in long lesions (9.1 vs. 7.0%, P=0.53) was found, although the rates remained numerically lower with TAXUS Liberté., Conclusion: Cumulative 5-year results of the TAXUS ATLAS studies suggest that the TAXUS Liberté stent provides similar safety and effectiveness in workhorse lesions, and may provide lower revascularization rates in small vessels and lower periprocedural MI rates in long lesions compared with the TAXUS Express stent, although no statistically significant differences were found following propensity adjustment.

Aims: This study evaluated vascular compatibility of the novel platinum chromium alloy Element stent platform delivering abluminal everolimus from a poly-lactide-co-glycolide bioabsorbable polymer (SYNERGY stent), currently undergoing clinical trial, compared with the PROMUS (XIENCE V) and bare metal and polymer-only Element stents., Methods and Results: Stents (n=161) were implanted one per coronary artery in 72 swine at a stent-to-artery ratio of 1.1:1. Similar numbers of each device group were explanted at each of 30, 90, 180, and 360 days (except no PROMUS (XIENCE V) stent at 360 days) for pathological analysis. There was no stent thrombosis, myocardial infarction, or strut fractures in any group. Vascular response was similar between the SYNERGY and PROMUS (XIENCE V) stents, with no thrombi and complete endothelialisation on both scanning electron microscopy and histology at 30, 90 and 180 days. There were no significant differences for the morphologic parameters of luminal thrombus, endothelial cell coverage, strut tissue coverage, inflammation, internal elastic lamina (IEL) disruption, external elastic lamina (EEL) disruption and medial smooth muscle cell loss across device groups or between time points, but there was mild but greater (p<0.0001) para-strut fibrin at 30 days for both drug-eluting stents (DES) compared with the bare and polymer-only controls; this difference completely dissipated by 90 days. Inflammation was predominantly minimal to mild for all device types. No morphometric parameters, including intimal thickness, stent profile-based area stenosis, and EEL area were significantly different when comparing the SYNERGY stent with the bare metal Element and polymer-only Element control stents at 90, 180 and 360 days., Conclusions: In this non-injured porcine coronary artery model, the bioabsorbable polymer SYNERGY stent demonstrated vascular compatibility equivalent to the PROMUS (XIENCE V) stent and to the bare metal and polymer-only Element stents.

Aims: Recent reports have suggested susceptibility of novel thin-strut coronary stents to incur longitudinal stent deformation during or following deployment. This analysis assesses the incidence of longitudinal stent deformation in three stent platforms., Methods and Results: Quantitative angiographic analysis (QCA) of 2,403 stents from the PERSEUS Workhorse (WH) and PLATINUM-WH trials was performed by an independent core laboratory. The distribution of QCA measured: nominal stent length ratios was compared between platforms to evaluate longitudinal stent deformation. Stent length ratio averaged 0.95 ± 0.07 in the TAXUS Express arm and 0.94 ± 0.06 in the ION (TAXUS Element) arm of the PERSEUS-WH trial (p=0.16). In the PLATINUM-WH trial, the mean ratio in the PROMUS cohort was slightly smaller (0.92 ± 0.09) than PROMUS Element (0.94 ± 0.08; p=0.004). Manual, blinded re-examination by the core laboratory of the angiograms corresponding to the 20 lowest and highest ratios in each trial did not identify any cases of stent deformation., Conclusions: Systematic analysis by an independent angiographic core laboratory of 2,403 stents implanted in patients enrolled in two large multicentre randomised trials demonstrated no stent deformation or meaningful differences in stent length ratios between ION and TAXUS Express or between PROMUS Element and PROMUS in the patient populations studied using the methodology employed.

Objectives: The aim of this study was to assess the additional value of the Global Risk--a combination of the SYNTAX Score (SXscore) and additive EuroSCORE--in the identification of a low-risk population, who could safely and efficaciously be treated with coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI)., Background: PCI is increasingly acceptable in appropriately selected patients with left main stem or 3-vessel coronary artery disease., Methods: Within the SYNTAX Trial (Synergy between PCI with TAXUS and Cardiac Surgery Trial), all-cause death and major adverse cardiac and cerebrovascular events (MACCE) were analyzed at 36 months in low (GRC(LOW)) to high Global Risk groups, with Kaplan-Meier, log-rank, and Cox regression analyses., Results: Within the randomized left main stem population (n = 701), comparisons between GRC(LOW) groups demonstrated a significantly lower mortality with PCI compared with CABG (CABG: 7.5%, PCI: 1.2%, hazard ratio [HR]: 0.16, 95% confidence interval [CI]: 0.03 to 0.70, p = 0.0054) and a trend toward reduced MACCE (CABG: 23.1%, PCI: 15.8%, HR: 0.64, 95% CI: 0.39 to 1.07, p = 0.088). Similar analyses within the randomized 3-vessel disease population (n = 1,088) demonstrated no statistically significant differences in mortality (CABG: 5.2%, PCI: 5.8%, HR: 1.14, 95% CI: 0.57 to 2.30, p = 0.71) or MACCE (CABG: 19.0%, PCI: 24.7%, HR: 1.35, 95% CI: 0.95 to 1.92, p = 0.10). Risk-model performance and reclassification analyses demonstrated that the EuroSCORE-with the added incremental benefit of the SXscore to form the Global Risk-enhanced the risk stratification of all PCI patients., Conclusions: In comparison with the SXscore, the Global Risk, with a simple treatment algorithm, substantially enhances the identification of low-risk patients who could safely and efficaciously be treated with CABG or PCI., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to compare the safety and efficacy of 2 dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) (Boston Scientific Corp., Natick, Massachusetts) compared with the durable polymer PROMUS Element EES (Boston Scientific Corp.)., Background: Durable polymer coatings on drug-eluting stents have been associated with chronic inflammation and impaired healing. Bioabsorbable polymer-coated drug-delivery systems may reduce the risk of late adverse events, including stent thrombosis, and thus the need for prolonged dual-antiplatelet therapy., Methods: A total of 291 patients with a de novo lesion ≤28 mm in length, in a coronary artery of ≥2.25 to ≤3.5 mm diameter, were enrolled in the EVOLVE study, a prospective, randomized, single-blind, noninferiority trial. Patients were randomly assigned in a 1:1:1 ratio to PROMUS Element, SYNERGY, or SYNERGY half dose. The primary clinical endpoint was the 30-day rate of target lesion failure, defined as cardiac death or myocardial infarction related to the target vessel, or target lesion revascularization. The primary angiographic endpoint was 6-month in-stent late loss measured by quantitative coronary angiography., Results: The 30-day primary clinical endpoint of target lesion failure occurred in 0%, 1.1%, and 3.1% of patients in the PROMUS Element, SYNERGY, and SYNERGY half dose groups, respectively. The 6-month in-stent late loss was 0.15 ± 0.34 mm for PROMUS Element, 0.10 ± 0.25 mm for SYNERGY, and 0.13 ± 0.26 mm for SYNERGY half dose (SYNERGY, difference -0.06, upper 95.2% confidence limit: 0.02, p for noninferiority <0.001; SYNERGY half dose, difference -0.03, upper 95.2% confidence limit: 0.05, p for noninferiority <0.001). Clinical event rates remained low and comparable between groups, with no stent thromboses in any group at 6 months., Conclusions: The EVOLVE trial confirms the effective delivery of everolimus by a unique directional bioabsorbable polymer system utilizing the SYNERGY stent. (A Prospective Randomized Multicenter Single-Blind Noninferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System [Evolution Stent System] for the Treatment of a De Novo Atherosclerotic Lesion [EVOLVE]; NCT01135225)., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Diabetes mellitus increases adverse outcomes after coronary revascularization; however, the impact of metabolic syndrome is unclear. We examined the impact of diabetes and metabolic syndrome on coronary artery bypass graft surgery (CABG) and stenting outcomes to determine the optimal revascularization option for the treatment of complex coronary artery disease., Methods: Patients (n = 1,800) with left main or three-vessel disease or both were randomly allocated to treatment with a TAXUS Express(2) paclitaxel-eluting stent (PES) or CABG, and were included in predefined nondiabetic (n = 1,348) or diabetic subgroups (n = 452); 258 patients with diabetes also had metabolic syndrome., Results: Among diabetic patients, the 3-year major adverse cardiac and cerebrovascular event (MACCE) rate (22.9% CABG, 37.0% PES; p = 0.002) and revascularization rate (12.9% CABG, 28.0% PES; p < 0.001) were higher after PES treatment. Diabetes increased MACCE rates among PES-treated patients, but had little impact on results after CABG. Compared with CABG, PES treatment yielded comparable MACCE in diabetic patients (30.5% versus 29.8%, p =0.98) and nondiabetic patients (20.2% versus 20.3%, p =0.99) with low Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) study scores of 22 or less. For patients with SYNTAX Scores of 33 or greater, MACCE rates were lower with CABG (18.5% versus 45.9%, p < 0.001 diabetic; 19.8% versus 30.0%, p = 0.01 nondiabetic). Metabolic syndrome did not significantly predict MACCE or repeat revascularization., Conclusions: These exploratory analyses suggest that among diabetic patients with complex left main or three-vessel disease, or both, 3-year MACCE is higher after PES compared with CABG. Although PES is a potential treatment option in patients with less complex lesions, CABG should be the revascularization option of choice for patients with more complex anatomic disease, especially with concurrent diabetes. Metabolic syndrome had little impact on 3-year outcomes., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Aims: The SYNTAX-LE MANS substudy prospectively evaluated 15-month angiographic and clinical outcomes in patients with treated left main (LM) disease., Methods and Results: In the SYNTAX trial, 1,800 patients with three-vessel and/or LM disease were randomised to either CABG or PCI; of these, 271 LM patients were prospectively assigned to receive a 15-month angiogram. The primary endpoint for the CABG arm was the ratio of ≥50% to <100% obstructed/occluded grafts bypassing LM lesions to the number placed. The primary endpoint for the PCI arm was the proportion of patients with ≤50% diameter stenosis ('patent' stents) of treated LM lesions. Per protocol, no formal comparison between CABG and PCI arms was intended based on the differing primary endpoints. Available 15-month angiograms were analysed for 114 CABG and 149 PCI patients. At 15 months, 9.9% (26/263) of CABG grafts were 100% occluded and an additional 5.7% (15/263) were ≥50% to <100% occluded. Overall, 27.2% (31/114) of patients had ≥1 obstructed/occluded graft. The 15-month CABG MACCE rate was 8.8% (10/114) and MACCE at 15 months was not significantly associated with graft obstruction/occlusion (p=0.85). In the PCI arm, 92.4% (134/145) of patients had ≤50% diameter LM stenosis at 15 months (89.7% [87/97] distal LM lesions and 97.9% [47/48] non-distal LM lesions). The 15-month PCI MACCE rate was 12.8% (20/156) and this was significantly associated with lack of stent patency at 15 months (p<0.001), mainly due to repeat revascularisation., Conclusions: At 15 months, 15.6% (41/263) of grafts were at least 50% obstructed but this was not significantly associated with MACCE; 92.4% (134/145) of patients had stents that remained patent at 15 months, and stent restenosis was significantly associated with MACCE, predominantly due to revascularisation.

Aims: Long-term randomized comparisons of percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in left main coronary (LM) disease and/or three-vessel disease (3VD) patients have been limited. This analysis compares 3-year outcomes in LM and/or 3VD patients treated with CABG or PCI with TAXUS Express stents., Methods and Results: SYNTAX is an 85-centre randomized clinical trial (n= 1800). Prospectively screened, consecutive LM and/or 3VD patients were randomized if amenable to equivalent revascularization using either technique; if not, they were entered into a registry. Patients in the randomized cohort will continue to be followed for 5 years. At 3 years, major adverse cardiac and cerebrovascular events [MACCE: death, stroke, myocardial infarction (MI), and repeat revascularization; CABG 20.2% vs. PCI 28.0%, P< 0.001], repeat revascularization (10.7 vs. 19.7%, P< 0.001), and MI (3.6 vs. 7.1%, P= 0.002) were elevated in the PCI arm. Rates of the composite safety endpoint (death/stroke/MI 12.0 vs. 14.1%, P= 0.21) and stroke alone (3.4 vs. 2.0%, P= 0.07) were not significantly different between treatment groups. Major adverse cardiac and cerebrovascular event rates were not significantly different between arms in the LM subgroup (22.3 vs. 26.8%, P= 0.20) but were higher with PCI in the 3VD subgroup (18.8 vs. 28.8%, P< 0.001)., Conclusions: At 3 years, MACCE was significantly higher in PCI- compared with CABG-treated patients. In patients with less complex disease (low SYNTAX scores for 3VD or low/intermediate terciles for LM patients), PCI is an acceptable revascularization, although longer follow-up is needed to evaluate these two revascularization strategies.

Aims: Examine the incidence of clinical events after utilization of the TAXUS(®) Express(®) paclitaxel-eluting stent (PES) in multivessel and bifurcation coronary stenting in an unselected patient population., Methods and Results: The ARRIVE Program compiled data on 7,492 patients receiving ≥1 TAXUS Express PES, including patients with multivessel stenting (MVS; n = 1,208) and bifurcation stenting (n = 575). Patients were enrolled at procedure start with no mandated inclusion/exclusion criteria; all cardiac events were monitored with independent adjudication of end-points. Compared to simple use (single vessel/single stent) patients undergoing native intervention (N = 2,698), MVS patients had significantly more baseline comorbidities. Both groups had higher 2-year rates of mortality (7.3%[MVS] and 7.5%[bifurcation] vs. 4.2%[simple-use], P < 0.001), myocardial infarction (5.5% and 4.6% vs. 2.2%, P < 0.001 and P = 0.002), target vessel revascularization (15.5% and 14.8% vs. 7.7%, P < 0.001), and Academic Research Consortium definite/probable stent thrombosis (4.3% and 4.4% vs. 1.4%, P < 0.001) than the simple-use group., Conclusions: ARRIVE multivessel and bifurcation stenting patients have significantly higher clinical risk through 2 years compared to simple-use patients. In the absence of large randomized controlled trials in these populations, ARRIVE provides important insight into clinical outcomes over an extended period of time. (J Interven Cardiol 2011;24:342-350)., (©2011, Wiley Periodicals, Inc.)

Aims: 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., Methods and Results: 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., Conclusion: 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., (©2011, Wiley Periodicals, Inc.)

Aims: Assess clinical, angiographic, and intravascular ultrasound results in lesions treated with the PROMUS Element platinum chromium everolimus-eluting stent (EES)., Methods and Results: Patients (N=100) with one de novo target lesion ≤ 34 mm long and reference vessel diameter (RVD) ≥ 2.25-≤ 4.25 mm were enrolled at 14 sites. The primary endpoint was the 30-day composite of cardiac death, myocardial infarction, target lesion revascularisation (TLR), or definite/probable stent thrombosis (ST). The efficacy endpoint of 9 month in-stent late loss in workhorse lesions (defined as RVD ≥ 2.5-≤ 4.25 mm, lesion ≤ 24 mm) was compared to a performance goal based on historical results with TAXUS Express paclitaxel-eluting stents. Post-procedure incomplete stent apposition (ISA) was compared to a performance goal based on results with the PROMUS/XIENCE V EES in SPIRIT III. Mean age was 61.8 ± 9.9 years; 77.0% were male; 19% had medically treated diabetes. Baseline RVD was 2.72 ± 0.53 mm; lesion length was 15.4 ± 7.0 mm. The primary endpoint occurred in one patient (periprocedural ST with TLR) with no additional major clinical events through one year. Nine-month in-stent late loss in workhorse lesions (0.17 ± 0.25 mm, N=73) and post-procedure ISA (5.7%, 5/88) were below performance goals (p<0.001)., Conclusions: Through one year, PROMUS Element EES had an acceptable safety and efficacy profile with low in-stent late loss and post-procedure ISA.

Objectives: These studies sought to evaluate the clinical outcomes of the slow-release Taxus paclitaxel-eluting stent (PES) versus an otherwise identical bare-metal stent (BMS)., Background: Prior studies were not individually powered to generate reliable estimates of low-frequency safety endpoints or to characterize the long-term safety and efficacy profile of PES., Methods: The completed 5-year databases from the prospective, randomized, double-blind TAXUS I, II, IV, and V trials were pooled for a patient-level analysis., Results: The study population comprised 2,797 randomized patients (1,400 PES and 1,397 BMS). At the end of the 5-year study period, PES compared with BMS significantly reduced the rate of ischemia-driven target lesion revascularization (12.3% vs. 21.0%, p < 0.0001), with consistent reductions across high-risk subgroups and in patients with and without routine angiographic follow-up. There were no significant differences between the stent types in the 1-year or cumulative 5-year rates of death or myocardial infarction (MI). However, cardiac death or MI between 1 and 5 years was increased with PES (6.7% vs. 4.5%, p = 0.01), as was stent thrombosis (protocol definition: 0.9% vs. 0.2%, p = 0.007; ARC definition: 1.4% vs. 0.9%, p = 0.18)., Conclusions: In this pooled patient-level analysis from the prospective, randomized, double-blind TAXUS trials, PES compared with BMS resulted in a durable 47% reduction in the 5-year rate of ischemia-driven target lesion revascularization in simple and complex lesions, with nonsignificant differences in the cumulative 5-year rates of death or MI. Between 1 and 5 years, however, the rates of cardiac death or MI and protocol-defined stent thrombosis were increased with PES., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Small reference vessel diameter predicts adverse outcomes following coronary stenting. TAXUS Express and TAXUS Liberté paclitaxel-eluting stents (PES) reduce restenosis compared to bare metal stents (BMS) in small diameter vessels. TAXUS Element is a novel thin-strut, platinum chromium stent designed to enhance visibility, conformability, and drug delivery in small diameter vessels., Methods and Results: The PERSEUS Small Vessel (SV) prospective, single-arm, superiority trial evaluates the TAXUS Element PES in 224 subjects with target lesion length≤20 mm and vessel diameter≥2.25 to <2.75 mm, compared to 125 lesion-matched historical Express BMS control subjects from the TAXUS V trial. The primary endpoint was nine-month in-stent late loss. The secondary endpoint was 12-month target lesion failure (TLF) compared to a pre-specified performance goal (PG). Outcomes were analysed with and without propensity-score adjustment. TAXUS Element was superior to the Express BMS for late loss (0.38±0.51 versus 0.80±0.53 mm respectively; P<0.001), and TLF (7.3%) was significantly less than the 19.5% PG (P<0.001). No differences in mortality, myocardial infarction, or stent thrombosis were observed through 12 months. Results were similar after adjustment., Conclusions: PERSEUS SV supports the efficacy and safety of the platinum chromium, thin-strut TAXUS Element stent in small coronary vessels.

Aims: Very late stent thrombosis (VLST; >1 year) is an infrequent but potentially serious complication, whose risk factors have not been fully elucidated. This investigation sought to develop a clinically useful risk stratification score for VLST following drug eluting stent (DES) placement., Methods and Results: A Cox proportional hazards multivariate model of VLST was developed based on follow-up into a second year of patients enrolled in the ARRIVE registries, utilising readily available baseline clinical and angiographic characteristics. ST predictors between one and two years were identified among 7,459 consecutively enrolled patients who received a TAXUS® Express2™ (Boston Scientific, Natick, MA, USA) DES. Six significant predictors were found: presence of renal disease, prior myocardial infarction, multiple stenting, bifurcation lesions, prior CABG, and smoking at baseline. Each predictor was assigned a score, then summed for a maximum possible score of 10. Stratification into low and high risk groups revealed that VLST developed in 0.5% of 6,759 patients with scores<5, and 2.6% of 700 patients with scores≥5., Conclusions: We defined a VLST risk score for patients during the second year post DES-placement that provides a useful tool for risk stratification.

Objectives: The aim of this study was to examine the incidence of clinical events after implantation of the TAXUS Express (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent in saphenous vein graft (SVG) lesions in an unselected patient population., Background: Saphenous vein grafts have 1-year occlusion rates of 12% to 20%, with >50% failure by 7 to 10 years. Many diseased SVGs are treated by percutaneous coronary intervention to avoid higher-risk reoperation, but bare-metal stents have 35% to 40% historical SVG restenosis rates by 18 months. Reported outcomes of drug-eluting stents in SVG lesions are limited and mainly retrospective., Methods: The ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program compiled data on 7,492 patients receiving > or =1 TAXUS Express (Boston Scientific) stent, including 474 patients with SVG. All cardiac events were monitored with independent adjudication of end points. Patients enrolled at procedure start with no mandated inclusion/exclusion criteria., Results: The ARRIVE SVG patient 2-year follow-up was 96% complete (457 of 474). The SVG patients had significantly more baseline comorbidities/complex disease than simple-use patients (n = 2,698) undergoing native coronary intervention or other expanded-use patients (n = 4,320 without SVG patients). They had higher 2-year rates of mortality (10.9% vs. 4.2%, p < 0.001), myocardial infarction (5.3% vs. 2.2%, p < 0.001), and Academic Research Consortium definite/probable stent thrombosis (4.7% vs. 1.4%, p < 0.001) than the simple-use group. They also had higher 2-year adverse event rates, including significantly more mortality (10.9% vs. 7.5%, p = 0.008) than other expanded-use patients., Conclusions: The ARRIVE SVG patients have significantly different baseline risk and higher clinical risk through 2 years than simple-use and other expanded-use patients. Nonetheless, compared with historical SVG revascularization rates, treatment with paclitaxel-eluting stent seems to offer a reasonable therapeutic option in this high-risk group. (TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance Program; NCT00569491) and (TAXUS ARRIVE 2: A Multicenter Safety Surveillance Program; NCT00569751)., (Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The prospective, multinational, randomized Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial was designed to assess the optimal revascularization strategy between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), for patients with left main (LM) and/or 3-vessel coronary disease., Methods and Results: This observational hypothesis-generating analysis reports the results of a prespecified powered subgroup of 705 randomized patients who had LM disease among the 1800 patients with de novo 3-vessel disease and/or LM disease randomized to PCI with paclitaxel-eluting stents or CABG in the SYNTAX trial. Major adverse cardiac and cerebrovascular event rates at 1 year in LM patients were similar for CABG and PCI (13.7% versus 15.8%; Delta2.1% [95% confidence interval -3.2% to 7.4%]; P=0.44). At 1 year, stroke was significantly higher in the CABG arm (2.7% versus 0.3%; Delta-2.4% [95% confidence interval -4.2% to -0.1%]; P=0.009]), whereas repeat revascularization was significantly higher in the PCI arm (6.5% versus 11.8%; Delta5.3% [95% confidence interval 1.0% to 9.6%]; P=0.02); there was no observed difference between groups for other end points. When patients were scored for anatomic complexity, those with higher baseline SYNTAX scores had significantly worse outcomes with PCI than did patients with low or intermediate SYNTAX scores; outcomes for patients with CABG did not correlate with baseline SYNTAX score, but baseline EuroSCORE significantly predicted outcomes for both treatments., Conclusions: Patients with LM disease who had revascularization with PCI had safety and efficacy outcomes comparable to CABG at 1 year; longer follow-up is required to determine whether these 2 revascularization strategies offer comparable medium-term outcomes in this group of complex patients.

Aims: This first human use (FHU) study in bifurcation lesions evaluated safety and feasibility of the TAXUS Petal paclitaxel-eluting dedicated bifurcation stent., Methods and Results: This prospective, single-arm, multicentre study had a composite primary endpoint of 30-day death, myocardial infarction (MI), and target vessel revascularisation (TVR). Angiographic and intravascular ultrasound follow-up was at six months with clinical follow-up through five years. Mean age (N=28) was 60.9 + or - 9.3 years and 17.9% of patients had medically treated diabetes. Main branch (MB) lesion length was 13.8 + or - 5.9 mm with 4.4 + or - 2.5 mm in the side branch (SB). TAXUS Petal was successfully implanted in 89.3% of patients (25/28). On a per device basis, 73.5% (25/34) of Petal deployments were successful. The primary endpoint occurred in one patient (3.7%, in-hospital non-Q-wave MI). Through one year, TVR was 11.1%, target lesion revascularisation was 7.4%, and there were no deaths, Q-wave MIs, or stent thromboses. In-segment late loss (n=21) was 0.47 + or - 0.45 mm (proximal MB), 0.41 + or - 0.57 mm (distal MB), and 0.18 + or - 0.39 mm (SB)., Conclusions: The requirement for rotational alignment made delivery of this first generation TAXUS Petal stent challenging and accounted for the relatively low device delivery success. Clinical and angiographic outcomes were satisfactory when successful delivery was achieved.

Objectives: We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events., Background: The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable., Methods: We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of TAXUS IV, V, VI and TAXUS-ATLAS WH, LL, and DS trials., Results: There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) TAXUS Express patients (p = 0.28 vs. BMS), and 35 (7.3%) TAXUS Liberté patients (p = 0.21 vs. TAXUS Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for TAXUS (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with TAXUS slow-release (TAXUS Express or TAXUS Liberté), and 12 (15.4%) patients receiving TAXUS moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), TAXUS (overall, 8.3% vs. 8.1% p = 0.87), or TAXUS slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis., Conclusions: Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or TAXUS patients was associated with adverse clinical events over long-term follow-up., (Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The JACTAX HD trial ("JACTAX" Trial Drug Eluting Stent Trial) evaluated the safety and clinical performance of a novel JACTAX HD (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent (PES) in de novo coronary lesions., Background: The JACTAX HD (Boston Scientific) stent consists of a pre-crimped bare-metal Liberté (Boston Scientific) stent coated on its abluminal aspect with an ultrathin (<1 microm) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 microg each of polymer and paclitaxel per 16-mm stent)., Methods: In this prospective, single-arm, multicenter, first-human-use study (n = 103), the primary end point of 9-month major adverse cardiac events (MACE) (cardiac death, myocardial infarction, ischemia-related target vessel revascularization) was compared with an objective performance criterion (OPC) of 17% (11% MACE based on TAXUS ATLAS [TAXUS Liberté-SR Stent for the Treatment of de Novo Coronary Artery Lesions] trial results plus a pre-specified noninferiority margin of 6%)., Results: The composite primary end point occurred in 7.8% of JACTAX HD patients with an upper 1-sided 95% confidence limit of 13.6%, thus meeting the pre-specified criteria for noninferiority. There was no death, Q-wave myocardial infarction, or stent thrombosis through 9 months. In-stent late loss was 0.33 +/- 0.45 mm, with an in-stent binary restenosis of 5.2% and net volume obstruction by intravascular ultrasound of 11.4 +/- 11.2%., Conclusions: The JACTAX HD stent with an abluminal biodegradable polymer showed 9-month MACE, in-stent late loss, restenosis, and net volume obstruction comparable to that observed with the TAXUS Liberté (Boston Scientific) stent coated with a conformal durable polymer. Further studies are underway to better evaluate the potential of this new PES design, which might allow for more rapid endothelialization and improved vessel healing. ("JACTAX" Trial Drug Eluting Stent Trial; NCT00754728)., (Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: 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., Background: Although the prevalence of diabetes mellitus is increasing, the optimal coronary revascularization strategy in diabetic patients with complex multivessel disease remains controversial., Methods: 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., Results: 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)., Conclusions: 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)., (Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials., Methods/design: The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1), single-blind, non-inferiority trial in subjects with lesion length < or = 28 mm and vessel diameter > or = 2.75 mm to < or = 4.0 mm which compares TAXUS Element to the TAXUS Express2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the TAXUS Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length < or = 20 mm and vessel diameter > or = 2.25 mm to <2.75 mm that compares TAXUS Element with a matched historical bare metal Express stent control., Discussion: The TAXUS PERSEUS clinical trial program uses a novel statistical approach to evaluate whether design and metal alloy iterations in the TAXUS Element stent platform provide comparable safety and improved procedural performance compared to the previous generation Express stent. PERSEUS trial enrollment is complete and primary endpoint data are expected in 2010. PERSEUS Workhorse and Small Vessel are registered at http://www.clinicaltrials.gov, identification numbers NCT00484315 and NCT00489541.

Objectives: We explore the bifurcation angle (BA) parameters of the left main coronary artery (LM), the effect of percutaneous coronary intervention (PCI) on this angulation, and the impact of BA on clinical outcome., Background: The BA is emerging as a predictor of outcome after PCI of bifurcation lesions. Three-dimensional (3D) quantitative coronary angiography (QCA) overcomes the shortcomings of 2-dimensional analysis and provides reliable data., Methods: This is a substudy of the SYNTAX (SYNergy Between Percutaneous Coronary Intervention With TAXus and Cardiac Surgery) trial. The cineangiograms of the 354 patients who underwent PCI of their LM stem were analyzed with 3D QCA software (CardiOp-B, Paieon Medical, Ltd., Rosh Ha'ayin, Israel). The proximal BA (between LM and left circumflex [LCX]) and the distal BA (between left anterior descending and LCX) were computed in end-diastole and end-systole, both before and after PCI. The cumulative major adverse cardiac and cardiovascular event (MACCE) rates throughout the 12-month period after randomization were stratified across pre-PCI distal BA values and compared accordingly., Results: Complete analysis was feasible in 266 (75.1%) patients. Proximal and distal BA had mean pre-PCI end-diastolic values of 105.9 +/- 21.7 degrees and 95.6 +/- 23.6 degrees , respectively, and were inversely correlated (r = -0.75, p < 0.001). During systolic motion of the heart there was an enlargement of the proximal angle and a reduction of the distal angle (DeltaBA -8.2 degrees and 8.5 degrees , respectively, p < 0.001 for both). The PCI resulted in a mean decrease in the distal BA (DeltaBA 4.5 degrees , p < 0.001). The MACCE rates did not differ across distal BA values; freedom from MACCE at 12 months was 82.8%, 85.4%, and 81.1% (p = 0.74) for diastolic values (first through third tertile)., Conclusions: Left main BA analysis with 3D QCA is feasible. Both proximal and distal angles are affected by cardiac motion; PCI modifies the distal angle. There is no clear difference in event rates across pre-PCI distal BA values., (Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on 9-month follow-up paclitaxel-eluting stent (PES) patency compared with bare-metal stents (BMS)., Background: Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in PES is still unknown., Methods: From the combined TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent trials, 1,580 patients (PES 1,098, BMS 482) in IVUS substudies were analyzed. The MSA that best predicted angiographic in-stent restenosis (ISR) (% diameter stenosis > or =50%) was determined., Results: The post-intervention IVUS MSA was similar in PES and BMS (6.6 +/- 2.5 mm(2) vs. 6.7 +/- 2.3 mm(2), p = 0.92). At 9-month follow-up, ISR was lower in the PES group versus the BMS group (10% vs. 31%, p < 0.0001). Using multivariable logistic regression analysis, post-intervention IVUS MSA was the independent predictor of subsequent ISR in both the PES and BMS groups (p = 0.0002 for PES and p = 0.0002 for BMS). The ability of the post-intervention IVUS MSA to predict ISR was further assessed using receiver operating characteristic analysis. The post-intervention IVUS MSA was found to be a faithful discriminator between patients with and without ISR in both PES (c = 0.6382) and BMS (c = 0.6373). Finally, the optimal thresholds of post-intervention IVUS MSA that best predicted stent patency at 9 months were 5.7 mm(2) for PES and 6.4 mm(2) for BMS., Conclusions: Post-intervention MSA measured by IVUS can predict 9-month follow-up stent patency after both PES and BMS implantation. (Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions; NCT00301522) (Direct Stenting of TAXUS Liberté-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions; NCT00371423) (A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475) (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748).

Background: Stent thrombosis (ST) is an uncommon but serious complication of drug-eluting and bare metal stents. To assess drug-eluting stent ST in contemporary practice, we analyzed 2-year data from the 7492-patient ARRIVE registry., Methods and Results: Patients were enrolled at the initiation of percutaneous coronary intervention with no inclusion/exclusion criteria beyond use of the paclitaxel-eluting TAXUS stent. Two-year follow-up was 94% with independent adjudication of major cardiac events. A second, autonomous committee adjudicated Academic Research Consortium (ARC) definite/probable ST. Cumulative 2-year ARC-defined ST was 2.6% (1.0% early ST [<30 days], 0.7% late ST [31 to 365 days], and 0.8% very late ST [>1 year]). Simple-use (single-vessel and single-stent) cases had lower rates than expanded use (broader patient/lesion characteristics, 2-year cumulative: 1.4% versus 3.3%, P<0.001; early ST: 0.4% versus 1.4%, P<0.001; late ST: 0.5% versus 0.8%, P=0.14; very late ST: 0.4% versus 1.0%, P=0.008). Within 7 days of ST, 23% of patients died; 28% suffered Q-wave myocardial infarction. Mortality was higher with early ST (39%) than late ST (12%, P<0.001) or very late ST (13%, P<0.001). Multivariate analysis showed anatomic factors increased early ST (lesion >28 mm, lesion calcification) and late ST (vessel <3.0 mm); biological factors increased very late ST (renal disease, prior brachytherapy). Although early ST (71.4%) and very late ST (23.1%) patients had dual antiplatelet therapy at the time of ST, premature thienopyridine discontinuation was a strong independent predictor of both., Conclusions: The relative risks of early and late ST differ. Knowledge of ST risk for specific subgroups may guide revascularization options until the completion of randomized trials in these broad populations.

Background: Although drug-eluting stents have become a mainstay of percutaneous coronary intervention, information about drug-eluting stents outcomes in elderly patients is limited. Data from the paclitaxel-eluting stent (PES) trials and registries were pooled to assess PES benefits relative to advancing patient age, including comparison with bare-metal stents., Methods and Results: Data from 5 randomized trials (2271 patients with PES, 1397 patients with bare-metal stents) and from 2 postmarket registries (7492 patients with PES) were pooled separately. Each dataset was stratified into age groups: <60, 60 to 70, and >70 years. At baseline, patients aged >70 years in both datasets had significantly more adverse characteristics than younger patients. Through 5 years, trial data showed that patients aged >70 years had higher death rates, but comparable rates of myocardial infarction, stent thrombosis, and target lesion revascularization with younger patients. Compared with patients with bare-metal stents, patients with PES aged >70 years had comparable rates of death, myocardial infarction, and stent thrombosis but a significantly lower target lesion revascularization rate (22.2 versus 10.2, P<0.001). These findings were echoed in the registry data through 2 years that showed that PES patients aged >70 years had significantly higher death rates, but lower myocardial infarction, stent thrombosis, and target lesion revascularization rates, compared with younger patients. Although the mortality rates of patients aged >70 years were higher than those of younger patients, they were comparable with those of age- and gender-matched norms in the general population., Conclusions: This analysis of almost 10 000 patients demonstrated that percutaneous coronary intervention with PES is a safe and an effective treatment option that should not be withheld based on age.

Objectives: We evaluated the relative contributions of drug-eluting stent-specific and background natural history-driven causes for adverse clinical events between 1 and 5 years, in the paclitaxel-eluting stent (PES) and bare-metal stent (BMS) cohorts of the TAXUS randomized clinical trial program., Background: Prior studies have demonstrated that clinical events in the first year after BMS are predominantly stent-related but thereafter tend to be driven more by atherosclerotic activity outside the stented segment. It is not known whether the same is true for PES., Methods: Annualized hazard rates (HRs) were calculated for major adverse events in 1,400 TAXUS and 1,397 BMS patients from the randomized and blinded TAXUS I, II, IV, and V trials (median 4.8-year follow-up)., Results: Although target vessel revascularization (TVR) during the first year was driven by target lesion revascularization (TLR), TVR after 1 year involved similar numbers of TLR and non-TLR events. Moreover, the annualized HR for non-target lesion TVR and other major adverse events (including death, myocardial infarction, and stent thrombosis) were relatively constant beyond 1 year and not significantly different between PES and BMS., Conclusions: The low and similar late HR for many of the observed late events after BMS and PES suggests that many of the late events after PES reflect background disease activity outside the stented segment rather than stent-related events per se. Analyses of long-term drug-eluting stent outcomes should recognize and attempt to correct for this background event rate by using suitable BMS control subjects.

Aims: The SYNTAX score has been designed to better anticipate the risks of percutaneous or surgical revascularisation, taking into account the functional impact of the coronary circulation with all its anatomic components including the presence of bifurcations, total occlusions, thrombus, calcification, and small vessels. The purpose of this paper is to describe the baseline assessment of the SYNTAX score in the Syntax randomised trial, the corelab reproducibility, the potential difference in score assessment between the investigator and the corelab, and to ascertain the impact on one-year outcome after either percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) in patients with complex coronary artery disease., Methods and Results: To assess the reliability of Syntax scoring, 100 diagnostic angiograms from the Syntax trial were randomly selected and assessed independently by two observers. Intra-observer variability was assessed by analysing 91 sets of angiograms after an interval of at least eight weeks by one of the observers. Clinical outcomes in the randomised cohort of the Syntax trial up to one year are presented with stratification by tertile group of the SYNTAX score. The weighted kappa value for the inter-observer reproducibility on the global score was 0.45, while the intra-observer weighted kappa value was 0.59. The SYNTAX score as calculated by investigators consistently underscored the corelab score by 3.4 points. When the Syntax randomised cohort was stratified by tertiles of the SYNTAX score, there were similar or non-significantly different MACCE rates in those with low or intermediate scores; however in the top tertile the MACCE rate was greater in those receiving PCI compared to CABG., Conclusions: The SYNTAX score is a visual coronary score with an acceptable corelab reproducibility that has an impact on the one-year outcome of those having PCI, whereas it has no effect on the one-year outcome following surgical revascularisation. The SYNTAX score tool is likely to be useful in a wide range of patients with complex coronary disease.

Aims: We report 2-year outcomes in a large unselected drug-eluting stent population (N=7,492) in the TAXUS Express2 ARRIVE post-market surveillance programme (101 U.S. sites)., Methods and Results: No specific inclusion/exclusion criteria were mandated; patients enrolled at procedure initiation. Two-year follow-up was 94%, with independent adjudication of major cardiac events, monitoring of patients with cardiac events and an additional 10-20% sample by site. Most ARRIVE cases (64%, n=4,794) typified expanded use based on patient/lesion characteristics outside the simple use (single vessel/stent) pivotal trial populations. These expanded use patients had higher 2-year rates than simple use patients for mortality (7.8% vs. 4.2%, P<0.001), myocardial infarction (MI, 3.9% vs. 2.2%, P<0.001), target lesion revascularisation (TLR, 9.2% vs. 5.4%, P<0.001), and stent thrombosis (3.3% vs. 1.4%, P<0.001). Among subgroups with renal disease, chronic total occlusion (CTO), lesion >28 mm, reference vessel diameter (RVD) <2.5 mm, multivessel stenting, acute MI, bifurcation, vein graft, or in-stent restenosis, TLR ranged from 3.8% to 8.9% in year one, and from 1.3% to 6.0% during year two., Conclusions: Mortality and stent-related events were higher in expanded use than simple use patients in the pivotal trials. ARRIVE provides a detailed estimate of procedural and 2-year outcomes in such real-world patients.

Background: Percutaneous coronary intervention (PCI) involving drug-eluting stents is increasingly used to treat complex coronary artery disease, although coronary-artery bypass grafting (CABG) has been the treatment of choice historically. Our trial compared PCI and CABG for treating patients with previously untreated three-vessel or left main coronary artery disease (or both)., Methods: We randomly assigned 1800 patients with three-vessel or left main coronary artery disease to undergo CABG or PCI (in a 1:1 ratio). For all these patients, the local cardiac surgeon and interventional cardiologist determined that equivalent anatomical revascularization could be achieved with either treatment. A noninferiority comparison of the two groups was performed for the primary end point--a major adverse cardiac or cerebrovascular event (i.e., death from any cause, stroke, myocardial infarction, or repeat revascularization) during the 12-month period after randomization. Patients for whom only one of the two treatment options would be beneficial, because of anatomical features or clinical conditions, were entered into a parallel, nested CABG or PCI registry., Results: Most of the preoperative characteristics were similar in the two groups. Rates of major adverse cardiac or cerebrovascular events at 12 months were significantly higher in the PCI group (17.8%, vs. 12.4% for CABG; P=0.002), in large part because of an increased rate of repeat revascularization (13.5% vs. 5.9%, P<0.001); as a result, the criterion for noninferiority was not met. At 12 months, the rates of death and myocardial infarction were similar between the two groups; stroke was significantly more likely to occur with CABG (2.2%, vs. 0.6% with PCI; P=0.003)., Conclusions: CABG remains the standard of care for patients with three-vessel or left main coronary artery disease, since the use of CABG, as compared with PCI, resulted in lower rates of the combined end point of major adverse cardiac or cerebrovascular events at 1 year. (ClinicalTrials.gov number, NCT00114972.), (2009 Massachusetts Medical Society)

Objectives: The aim of this study was to compare, in a randomized multicenter trial, paclitaxel-eluting stents (CoStar, Conor Medsystems, Menlo Park, California) versus pimecrolimus-eluting stents (Corio, Conor Medsystems) versus stents with dual elution of both drugs (SymBio, Conor Medsystems) in native coronary arteries., Background: The CoStar cobalt-chromium reservoir-based stent platform, eluting paclitaxel in a controlled way via a bioresorbable polymer, reduces restenosis versus its respective bare-metal stent. The reservoir system allows the use of other drugs targeted to different mechanisms involved in the process of vascular restenosis and simultaneous loading of multiple, synergistic drugs., Methods: Patients with single de novo lesions were asymmetrically randomized to 1 of the 3 types of stent (1:2:2). Six-month coronary angiography was planned in all. The primary analysis was a noninferiority test for the primary end point of 6-month angiographic in-stent late lumen loss of Corio versus CoStar and SymBio versus CoStar. Secondary end points included binary angiographic restenosis and major adverse clinical events (cardiac death, myocardial infarction, target vessel revascularization)., Results: The trial was prematurely suspended after 246 patients were enrolled (planned enrollment: 375 patients): 49 patients received CoStar, 97 received SymBio, and 100 received Corio. In-stent late loss was significantly reduced with CoStar versus either SymBio or Corio (0.58 +/- 0.58 mm vs. 0.96 +/- 0.73 mm and 0.58 +/- 0.58 mm vs. 1.40 +/- 0.67 mm, p < 0.001 for both comparisons). Binary in-stent restenosis rates were, 7.1%, 20%, and 40.9%, respectively (p < 0.001 for both comparisons); 6-month major adverse cardiac event rates were, 2.0%, 14.4%, and 39.0%, respectively (p < 0.001 for both comparisons)., Conclusions: Stents eluting pimecrolimus or the dual combination of pimecrolimus and paclitaxel failed to show angiographic noninferiority when compared with paclitaxel-eluting stents. (A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems; NCT00322569).

Objectives: The TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) multicenter studies compared the performance of the thin-strut (0.0038 inch) TAXUS Liberté 2.25-mm stent (Boston Scientific; Natick, Massachusetts) and the TAXUS Liberté 38-mm long stent (Boston Scientific; Natick, Massachusetts) with the earlier paclitaxel-eluting TAXUS Express (Boston Scientific) stent that has identical polymer, drug dosage, and release kinetics but different stent geometry and thicker struts (0.0052 inch)., Background: The TAXUS Liberté stent was designed with thinner and more even strut spacing to provide more uniform drug distribution, as well as increased flexibility and conformability. Clinical benefits of the new stent design have not been evaluated., Methods: The TAXUS ATLAS SV and LL studies are nonrandomized studies comparing outcomes of the TAXUS Liberté 2.25 mm (N = 261) and TAXUS Liberté 38 mm (N = 150) stents to TAXUS Express historical control groups derived from the TAXUS IV and V trials. Inclusion/exclusion criteria for TAXUS Express and Liberté groups were similar in both studies., Results: Each study met its primary end point of noninferiority of 9-month in-segment diameter stenosis. Furthermore, TAXUS Liberté 2.25 mm, when compared with TAXUS Express, significantly reduced the rate of both 9-month angiographic restenosis (18.5% vs. 32.7%, p = 0.0219) and 12-month target lesion revascularization (6.1% vs. 16.9%, p = 0.0039). In addition, TAXUS Liberté 38 mm significantly reduced the risk of 12-month myocardial infarction compared with TAXUS Express (1.4% vs. 6.5%, p = 0.0246)., Conclusions: The thinner-strut TAXUS Liberté stent improved outcomes compared with the earlier TAXUS Express stent in both SVs and LLs (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748; A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475).

Objectives: We sought to examine the safety and efficacy of paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM)., Background: Compared with patients without DM, patients with DM undergoing percutaneous coronary intervention are at increased risk for mortality and restenosis. The safety of drug-eluting stents in diabetic patients has recently been called into question by a published meta-analysis of randomized trials., Methods: Patient-level data were pooled from 5 prospective, double-blind, randomized trials of PES versus bare-metal stents (BMS) (n = 3,513). Safety and efficacy outcomes through 4 years of follow-up were assessed among the 827 randomized patients (23.6%) with DM., Results: Patients treated with PES and BMS has similar baseline characteristics among both the diabetic and nondiabetic cohorts within these trials. At 4-year follow-up, there were no significant differences between PES and BMS among diabetic patients in the rates of death (8.4% vs. 10.3%, respectively, p = 0.61), myocardial infarction (6.9% vs. 8.9%, p = 0.17), or stent thrombosis (1.4% vs. 1.2%, p = 0.92). Treatment of diabetic patients with PES compared with treatment with BMS was associated with a significant and durable reduction in target lesion revascularization over the 4-year follow-up period (12.4% vs. 24.7%, p < 0.0001). The relative safety and efficacy of PES compared with the relative safety and efficacy of BMS in diabetic patients extended to both those requiring and not requiring insulin., Conclusions: In these 5 randomized trials in which patients with single, primarily noncomplex lesions were enrolled, treatment with PES compared with treatment with BMS was safe and effective, resulting in markedly lower rates of target lesion revascularization at 4 years, with similar rates of death, myocardial infarction, and stent thrombosis.

Background: Drug-eluting stents compared with bare metal stents (BMS) may increase late stent thrombosis (ST), although an accompanying increase in the rates of death and myocardial infarction (MI) has not been observed. We hypothesized that the prevention of restenosis-related adverse events by drug-eluting stents might offset some or all of the excess risk from ST., Methods and Results: We analyzed a pooled patient-level database from 4 prospective, double-blind trials in which 3445 patients were randomized to paclitaxel-eluting stents or BMS. The occurrence of death or MI within 7 days of ST or target lesion revascularization was assessed. With a median follow-up of 3.2 years, ST occurred in 34 patients (1.0%), 31 (91.1%) of whom sustained death or MI within 7 days. Target lesion revascularization was performed in 425 patients (12.3%), 15 (3.5%) of whom died or had MI within 7 days. ST occurred in 14 BMS and 20 paclitaxel-eluting stent patients, resulting in 12 and 19 deaths or MIs within 7 days, respectively. Target lesion revascularization was performed in 290 BMS and 135 paclitaxel-eluting stent patients, resulting in 11 and 4 deaths or MI events within 7 days, respectively. In total, 23 patients in both the BMS and paclitaxel-eluting stents groups died or had an MI event within 7 days of either ST or target lesion revascularization., Conclusions: ST, although infrequent, results in a high incident rate of death and MI, whereas the more frequent occurrence of target lesion revascularization is associated with a finite but lower rate of death and MI. The marked reduction in restenosis with drug-eluting stents compared with BMS may counterbalance the potential excess risk from late ST with drug-eluting stents.

Objectives: This study sought to study stent thrombosis with the paclitaxel-eluting Taxus stent., Background: The incidence and timing of stent thrombosis after drug-eluting stent placement compared with bare-metal stent implantation remain unsettled, with consequent uncertainty about risk stratification and long-term recommendations for antiplatelet medications., Methods: This study used a patient-based meta-analysis using the 4 principal TAXUS randomized trials (3,445 patients) with a follow-up duration of > or =1 year., Results: Cumulative stent thrombosis occurred in 1.28% +/- 0.31% in the Taxus group and 0.76% +/- 0.23% in the bare-metal stent group at 3 years (hazard ratio 1.51 [95% confidence interval 0.73 to 3.14], p = 0.26). Hazard ratios (per 100 patients per 6 months) were similar between the Taxus stent group (0.59 [95% confidence interval 0.22 to 0.95]) and the bare-metal stent group (0.64 [95% confidence interval 0.26 to 1.02]) through 6 months during the prescribed clopidogrel period. However, from 6 months to 3 years there were more stent thromboses in the Taxus group (hazard ratio 0.19 [95% confidence interval 0.06 to 0.32] vs. 0.02 [95% confidence interval 0.00 to 0.07], p = 0.049). Of 8 patients with Taxus-related thrombosis after 6 months, 0 were taking clopidogrel and 2 were not taking aspirin consistently. No Taxus-related stent thrombosis occurred after 2 years (922 patients thus far followed up for 3 years). Independent correlates of stent thrombosis were nonuse of clopidogrel, male gender, smoking, and possibly use of multiple nonoverlapping stents., Conclusions: Approximately 0.8% of Taxus patients have stent thrombosis in the first 6 months after stent implantation, similar to bare-metal stents. However, a modest increase in risk is present with Taxus stents beyond 6 months, possibly because of inadequate antiplatelet drug therapy.

Objective: Percutaneous coronary intervention with drug-eluting stents is challenging coronary artery bypass grafting (CABG) as the gold standard for treatment of three-vessel and left main coronary disease. We evaluated the current practice pattern in hospitals throughout Europe and USA., Methods: To qualify for participation in the SYNTAX (Synergy between PCI with TAXUS drug-eluting stent and Cardiac Surgery) study, a randomized trial comparing percutaneous coronary intervention with drug-eluting stent versus coronary artery bypass grafting for three-vessel and left main disease, 104 centers were asked to provide their case volume in 3 months in 2004. Anonymous procedural data were collected., Results: A total of 12,072 patients were recorded. Coronary artery bypass grafting was the most frequently performed procedure (N=8895, 74%). Three-vessel disease (3VD) predominated in this population (N=8532, 71%) versus left main (N=3540, 29%). In the 3-month period, per center a mean of 8.3 patients with left main and 22.3 patients with three-vessel disease were treated by percutaneous coronary intervention, while 26.0 patients with left main and 60.3 patients with three-vessel disease were treated by coronary artery bypass grafting. In USA, percutaneous coronary intervention for left main and/or three-vessel disease was performed in 18% of the cases while this was performed in 29% of the cases in Europe. Of all CABG procedures, only 12% were done with total arterial grafting while 7% were treated with only venous grafts., Conclusions: In patients with multivessel or left main disease, still coronary artery bypass grafting remains the dominant revascularization strategy. Percutaneous coronary intervention is performed frequently without supporting data from the literature. Percutaneous coronary intervention for this indication is performed more often in Europe than in USA. Only a minority of the patients receives total arterial grafting in case of coronary artery bypass grafting. The SYNTAX trial with randomized and registry cohorts should provide guidance for selecting the preferred form of treatment.

Background: The appropriate treatment for patients in whom reperfusion fails to occur after thrombolytic therapy for acute myocardial infarction remains unclear. There are few data comparing emergency percutaneous coronary intervention (rescue PCI) with conservative care in such patients, and none comparing rescue PCI with repeated thrombolysis., Methods: We conducted a multicenter trial in the United Kingdom involving 427 patients with ST-segment elevation myocardial infarction in whom reperfusion failed to occur (less than 50 percent ST-segment resolution) within 90 minutes after thrombolytic treatment. The patients were randomly assigned to repeated thrombolysis (142 patients), conservative treatment (141 patients), or rescue PCI (144 patients). The primary end point was a composite of death, reinfarction, stroke, or severe heart failure within six months., Results: The rate of event-free survival among patients treated with rescue PCI was 84.6 percent, as compared with 70.1 percent among those receiving conservative therapy and 68.7 percent among those undergoing repeated thrombolysis (overall P=0.004). The adjusted hazard ratio for the occurrence of the primary end point for repeated thrombolysis versus conservative therapy was 1.09 (95 percent confidence interval, 0.71 to 1.67; P=0.69), as compared with adjusted hazard ratios of 0.43 (95 percent confidence interval, 0.26 to 0.72; P=0.001) for rescue PCI versus repeated thrombolysis and 0.47 (95 percent confidence interval, 0.28 to 0.79; P=0.004) for rescue PCI versus conservative therapy. There were no significant differences in mortality from all causes. Nonfatal bleeding, mostly at the sheath-insertion site, was more common with rescue PCI. At six months, 86.2 percent of the rescue-PCI group were free from revascularization, as compared with 77.6 percent of the conservative-therapy group and 74.4 percent of the repeated-thrombolysis group (overall P=0.05)., Conclusions: Event-free survival after failed thrombolytic therapy was significantly higher with rescue PCI than with repeated thrombolysis or conservative treatment. Rescue PCI should be considered for patients in whom reperfusion fails to occur after thrombolytic therapy., (Copyright 2005 Massachusetts Medical Society.)

Background: Intracoronary polymer-based stent delivery of paclitaxel has been shown to be effective in reducing restenosis in simple coronary lesions, but the evidence base for contemporary use in longer, more complex coronary stenoses is lacking., Methods and Results: TAXUS VI is a prospective, multicenter, double-blind, randomized trial assessing clinical and angiographic outcomes of the TAXUS Moderate Release paclitaxel-eluting stent in the treatment of long, complex coronary artery lesions. Four hundred forty-eight patients at 44 sites were randomized (1:1) between a drug-eluting TAXUS Express2 and an uncoated Express2 control stent. Per protocol, the 9-month follow-up included an angiographic reevaluation in all patients. The primary end point was the rate of target-vessel revascularization 9 months after the study procedure; secondary end points included the rate of target-lesion revascularization and binary restenosis at follow-up. Mean lesion length in the study was 20.6 mm, with a mean stent-covered length of 33.4 mm. Of all lesions, 55.6% were classified as complex lesions (type C of the AHA/ACC classification). At 9 months, target-vessel revascularization was 9.1% in the TAXUS group and 19.4% in the control group (P=0.0027; relative reduction, 53%). Target-lesion revascularization was reduced from 18.9% to 6.8%, respectively (P=0.0001). The incidence of major adverse cardiac events was similar in the 2 groups, 16.4% and 22.5% in TAXUS and control, respectively (P=0.12), including comparable rates for acute myocardial infarction. Binary restenosis in the stented area was reduced from 32.9% in the control group to 9.1% in the TAXUS patients (P<0.0001)., Conclusions: The finding that the TAXUS Moderate Release stent system is safe and effective in the treatment of long, complex coronary artery lesions provides the evidence base for the more widespread use of drug-eluting stents in contemporary clinical practice.