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Aims: Bioabsorbable polymer drug-eluting stents (DES) may reduce the inflammation and delayed healing associated with some permanent polymer-coated DES. Whether late clinical outcomes are improved, particularly among patients with medically treated diabetes, is unknown. Therefore, we analysed outcomes from a pre-specified substudy of the EVOLVE II trial to evaluate the safety and effectiveness of the SYNERGY stent in patients with diabetes mellitus. Methods and Results: SYNERGY is a thin-strut, platinum-chromium everolimus-eluting stent with an ultra-thin bioabsorbable poly(DL-lactide-co-glycolide) abluminal polymer. The EVOLVE II randomised, controlled trial proved the non-inferiority of the SYNERGY versus the PROMUS Element Plus stent for one-year target lesion failure (TLF: ischaemia-driven target lesion revascularisation [ID-TLR], target vessel myocardial infarction [TVMI], or cardiac death). The pre-specified EVOLVE II diabetes substudy prospectively pooled randomised patients with diabetes (N=263) with a sequential single-arm diabetic cohort (n=203). The substudy primary endpoint was one-year TLF compared with a pre-specified performance goal (14.5%). The primary endpoint occurred in 7.5% of SYNERGY-treated patients with diabetes, significantly less than the performance goal (p<0.0001). The two-year rate of TLF was 11.2% (cardiac death 1.5%, TVMI 6.4%, ID-TLR 6.8%) and definite/probable stent thrombosis occurred in 1.1% of patients. Conclusion(s): The EVOLVE II diabetes substudy demonstrates the efficacy and safety of the SYNERGY stent in patients with medically treated diabetes. Clinical Trial Registration Information: NCT01665053 (http://clinicaltrials.gov/).Copyright © Europa Digital & Publishing 2017. All rights reserved.

Item does not contain fulltext, BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1.17 [95% CI 0.97-1.41], p=0.092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1.41 [95% CI 1.10-1.80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0.90 [0.68

Aims: This analysis aimed to evaluate the incidence and predictors of the need for permanent pacemaker (PPM) implantation following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System. Methods and Results: The prospective, single-arm, multicentre REPRISE II study with extended cohort enrolled 250 symptomatic, high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation (TAVI) with a 23 mm or 27 mm LOTUS valve. Echocardiography, computed tomography, and electrocardiography data were evaluated by independent core labs. Post TAVI, 32.0% (72/225) of pacemaker-naive patients underwent new PPM implantation at 30 days. Most (59/72, 82%) patients were implanted for third-degree atrioventricular block, and >10% overstretch of the LVOT by area was observed in 59.7% (43/72) of PPM patients. Significant independent predictors of PPM at 30 days included baseline RBBB (odds ratio [OR] 12.7, 95% CI: 4.5, 36.2; p<0.001) and LVOT overstretch >10% (OR 3.4, 95% CI: 1.7, 6.7; p<0.001). There was a trend towards a lower 30-day PPM rate in patients with a shallower (<=5 mm) implant depth (23.9% <=5 mm vs. 36.9% >5 mm depth from LCS; p=0.06). Conclusion(s): Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve.Copyright © Europa Digital & Publishing 2017. All rights reserved.

Aims: The REPRISE IIE trial aimed to evaluate outcomes following transcatheter aortic valve implantation of the fully repositionable and retrievable LOTUS valve with a unique seal designed to minimise paravalvular leak (PVL). Methods and Results: This prospective, multicentre study enrolled 250 patients with severe aortic stenosis considered high-risk for surgery by a multidisciplinary Heart Team. An independent clinical events committee adjudicated events per Valve Academic Research Consortium criteria. Mean age was 84 years; 77% were in NYHA Class III/IV. LOTUS valve implantation produced significant haemodynamic improvements at one year without valve embolisation, ectopic valve deployment, or additional valve implantation. Primary endpoints were met as the 30-day mortality rate in the extended cohort (4.4%, N=250), and mean valve gradient in the main cohort (11.5+/-5.2 mmHg, N=120) were below (p<0.001) their predefined performance objectives. At 30 days, disabling stroke was 2.8% and new pacemaker implantation was 28.9% in all patients and 32.0% in pacemaker-naive patients. By one year, all-cause mortality was 11.6%, disabling stroke was 3.6%, 95% of patients alive were in NYHA Class I/II, and there was no core laboratory-adjudicated moderate/severe PVL. Conclusion(s): LOTUS valve implantation produced good valve haemodynamics, minimal PVL, sustained significant improvement in functional status, and good clinical outcomes one year post implant.Copyright © Europa Digital & Publishing 2017. All rights reserved.

Paravalvular leak (PVL) after transcatheter aortic valve replacement is associated with worse long-term outcomes. The Lotus Valve incorporates an innovative Adaptive Seal designed to minimize PVL. This analysis evaluated the incidence and predictors of PVL after implantation of the Lotus transcatheter aortic valve. The REPRISE II (REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Performance) Study With Extended Cohort enrolled 250 high-surgical risk patients with severe symptomatic aortic stenosis. Aortic regurgitation was assessed by echocardiography pre-procedure, at discharge and 30 days, by an independent core laboratory. Baseline and procedural predictors of mild or greater PVL at 30 days (or at discharge if 30-day data were not available) were determined using a multivariate regression model (n = 229). Of the 229 patients, 197 (86%) had no/trace PVL, 30 had mild, and 2 had moderate PVL; no patient had severe PVL. Significant predictors of mild/moderate PVL included device:annulus area ratio (odds ratio [OR] 0.87; 95% CI 0.83 to 0.92; p <0.001), left ventricular outflow tract calcium volume (OR 2.85; 95% CI 1.44 to 5.63; p = 0.003), and annulus area (OR 0.89; 95% CI 0.82 to 0.96; p = 0.002). When the device:annulus area ratio was <1, the rate of mild/moderate PVL was 53.1% (17 of 32). The rates of mild/moderate PVL with 0% to 5%, 5% to 10%, and >10% annular oversizing by area were 17.5% (11 of 63), 2.9% (2 of 70), and 3.2% (2 of 63), respectively. Significant independent predictors of PVL included device:annulus area ratio and left ventricular outflow tract calcium volume. When the prosthetic valve was oversized by >=5%, the rate of mild or greater PVL was only 3%. In conclusion, the overall rates of PVL with the Lotus Valve are low and predominantly related to device/annulus areas and calcium; these findings have implications for optimal device sizing.Copyright © 2017 Elsevie

BACKGROUND The repositionable and fully retrievable Lotus Valve is designed to facilitate controlled, precise positioning and minimize paravalvular aortic regurgitation. Here we report 4-year outcomes from the original cohort of the REPRISE I first-in-human feasibility study, representing the longest follow-up to date for the current iteration of the Lotus Valve. METHODS REPRISE I is a prospective, single-arm study designed to assess acute safety and performance of the 23mm Lotus Valve for TAVR in symptomatic patients with calcified aortic stenosis considered at high surgical risk by the Heart Team. RESULTS The Lotus Valve was implanted in 11 female patients (mean age, 83.0+/-3.6 years; mean STS score, 4.9+/-2.5%). All (11/11) patients were successfully implanted with a Lotus Valve with no procedural mortality. The survival rate was 100%up to 2 years, 90.9% at 3 years, and 72.7% at 4 years (3/11 patients died, including cardiovascular death in 1 patient); 7/8 patients (87.5%) completed 4-year clinical follow-up. The cumulative major stroke rate at 4 years was 9.1% (major stroke occurred in 1 patient on day 3). Conduction disturbance requiring new permanent pacemaker implantation remained at 4 patients. There were no repeat hospitalizations for valve-related symptoms or cardiac decompensation. Mean aortic gradient at 4 years was 15.6+/-4.6mmHg (vs 53.9+/-20.9 mmHg at baseline, P<0.001; vs 13.7+/-3.7mmHg at discharge, P=0.469). Mean effective aortic orifice area at 4 years was 1.55+/-0.2cm2 (vs 0.68+/-0.2 cm2at baseline, P<0.001; vs 1.53+/-0.2 cm2 at discharge, P=0.773). Four years after TAVR, 5/7 patients (71.4%) were New York Heart Association (NYHA) Class I or II, 2 patients (28.6%) were NYHA Class III. Core laboratory-adjudicated paravalvular aortic regurgitation was absent in 7/7 patients (100%) at 4 years. CONCLUSION Data from the REPRISE I feasibility study demonstrate sustained favorable clinical outcomes 4 years post-TAVR with the Lotus Valve.

Objectives The authors sought to evaluate the final 5-year safety and effectiveness of the platinum-chromium everolimus-eluting stent (PtCr-EES) in the randomized trial, as well as in 2 single-arm substudies that evaluated PtCr-EES in small vessels (diameter <2.5 mm; n = 94) and long lesions (24 to 34 mm; n = 102). Background In the multicenter, randomized PLATINUM (PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions), the PtCr-EES was noninferior to the cobalt-chromium everolimus-eluting stent (CoCr-EES) at 1 year in 1,530 patients undergoing percutaneous coronary intervention. Methods Patients with 1 or 2 de novo coronary artery lesions (reference vessel diameter 2.50 to 4.25 mm, length <=24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. All patients in the substudies received PtCr-EES. The primary endpoint was target lesion failure (TLF), a composite of target vessel-related cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. Results In the randomized trial, the 5-year TLF rate was 9.1% for PtCr-EES and 9.3% for CoCr-EES (hazard ratio [HR]: 0.97; p = 0.87). Landmark analysis demonstrated similar TLF rates from discharge to 1 year (HR: 1.12; p = 0.70) and from 1 to 5 years (HR: 0.90; p = 0.63). There were no significant differences in the rates of cardiac death, myocardial infarction, target lesion or vessel revascularization, or stent thrombosis. PtCr-EES had 5-year TLF rates of 7.0% in small vessels and 13.6% in long lesions. Conclusions PtCr-EES demonstrated comparable safety and effectiveness to CoCr-EES through 5 years of follow-up, with low rates of stent thrombosis and other adverse events. The 5-year event rates were also acceptable in patients with small vessels and long lesions treated with PtCr-EES. (The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions [PLATINUM

Aims: The SYNERGY stent has a unique design to enhance optimal intravascular healing. The EVOLVE study compared the performance of the bioabsorbable polymer SYNERGY everolimus-eluting stent (EES at 2 doses) to the permanent polymer PROMUS Element EES. Methods and Results: The EVOLVE trial was a prospective,multicentre, randomised, controlled first human use trial enrolling patients with a de novo lesion <=28 mm in length in a coronary artery >=2.25 and <=3.5 mm in diameter. Patients were randomised 1:1:1 to treatment with one of three stents: PROMUS Element (N=98), SYNERGY stents releasing everolimus at an equivalent dose to PROMUS Element ("SYNERGY" group; N=94) and SYNERGY stents releasing half-dose everolimus ("SYNERGY 1/2 Dose" group; N=99). The primary clinical endpoint was 30-day target lesion failure (defined as target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularisation). At 30 days, the rate of TLF was not significantly different among groups; 0% in the PROMUS Element arm, 1.1% with SYNERGY, and 3.1% in the SYNERGY 1/2 Dose group (PROMUS Element: vs SYNERGYP=0.49; vs SYNERGY 1/2 Dose P=0.25). The primary angiographic endpoint of 6-month in-stent late loss was non-inferior between the control and SYNERGY groups (0.15+/-0.34 mm for PROMUS Element, 0.10+/-0.25 mm for SYNERGY, and 0.13+/-0.26 mm for SYNERGY 1/2 Dose; PROMUS Element: vs SYNERGY P=0.19; vs SYNERGY 1/2 Dose P=0.56). Four-year clinical event rates including TLF, TVF, death, MI and revascularisation were low and not significantly different between groups. At 4 years, the rate of TLF was 8.4% in the PROMUS Element group, 5.5% in the SYNERGY group and 5.2% in the SYNERGY 1/2 Dose group (PROMUS Element: vs SYNERGY P=0.64; vs SYNERGY 1/2 Dose, P=0.59). No TLF events were reported between 2 to 4 years of follow-up in either SYNERGY cohort. TVF at 4 years was 12.4% in the PROMUS Element group, 7.7% in the SYNERGY group and 8.3% in the SYNERGY 1

Aims: First-generation transcatheter aortic valve implantation (TAVI) devices may be associated with an increased risk for stroke, vascular complications, and paravalvular leak, which can be associated with higher early and late mortality. The second-generation, fully repositionable and retrievable LotusTM Valve (Boston Scientific, Marlborough, MA, USA) was designed to allow precise positioning of the valve during implantation, provide early valve function for haemodynamic stability, and with an Adaptive Seal to mitigate paravalvular leak. Methods and Results: The prospective, single-arm, multi-centre REPRISE II study with extended cohort enrolled 250 patients at 20 sites in Europe and Australia. Patients at high surgical risk, defined as Society of Thoracic Surgeons risk score >8% and/or documented Heart Team agreement of high risk due to frailty or other comorbidities, who had symptomatic, calcific native aortic valve stenosis (annulus size 1927 mm) received a 23 mm or 27 mm transfemoral Lotus Valve. Patients were 52.4% female, mean age was 84.0 years, mean STS Score (v2.73) was 6.5%, and 77.2% (193/25) were New York Heart Association functional class III or IV. The primary device performance endpoint of 30 day mean pressure gradient, as assessed by an independent echocardiographic core laboratory, was 11.5 mmHg, which was significantly (P<0.001) below the pre-specified performance goal of 18.0 mmHg. Similarly, the primary safety endpoint of 30 day all-cause mortality was 4.4%, which was also significantly (P<0.001) less than the performance goal of 16%. The rate of disabling stroke at 30 days was 3.2% and 28.9% (72/249) patients required a newly implanted pacemaker. By independent core lab adjudication, at 30 days, 80.2% of patients had no paravalvular regurgitation, 5.6% had trace, 13.6% had mild, and 1 (0.6%) patient had moderate; no patients had severe paravalvular regurgitation. Conclusion(s): In the REPRISE II extended cohort, the Lotus Valve met the primary

Objectives This analysis presents the first report of 1-year outcomes of the 120 patients enrolled in the REPRISE II (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance) study. Background The fully repositionable and retrievable Lotus Valve (Boston Scientific, Marlborough, Massachusetts) was designed to facilitate accurate positioning, early valve function, and hemodynamic stability during deployment and to minimize paravalvular regurgitation in patients undergoing transcatheter aortic valve replacement. Methods The study enrolled 120 symptomatic patients 70 years of age or older at 14 centers in Australia and Europe. Patients had severe calcific aortic stenosis and were deemed to be at high or extreme risk of surgery based on assessment by the heart team. Results The mean age was 84.4 +/- 5.3 years, 57% (68 of 120) of patients were women, and the mean Society of Thoracic Surgeons score was 7.1 +/- 4.6. The mean baseline aortic valve area was 0.7 +/- 0.2 cm2, and the mean transvalvular pressure gradient was 46.4 +/- 15.0 mm Hg. All patients were successfully implanted with a Lotus Valve, and 1-year clinical follow-up was available for 99.2% (119 of 120 of patients). The mean 1-year transvalvular aortic pressure gradient was 12.6 +/- 5.7 mm Hg, and the mean valve area was 1.7 +/- 0.5 cm2. A total of 88.6% patients had no or trivial paravalvular aortic regurgitation at 1 year by independent core lab adjudication, and 97.1% of patients were New York Heart Association functional class I or II. At 1 year, the all-cause mortality rate was 10.9% (13 of 119 patients), disabling stroke rate was 3.4% (4 of 119 patients), disabling bleeding rate was 5.9% (7 of 119 patients), with no repeat procedures for valve-related dysfunction. A total of 31.9% (38 of 119 patients) underwent new permanent pacemaker implantation at 1 year. Conclusions At 1 year of follow-up, the Lotus Valve demonstrat

Aims: Bioabsorbable-polymer DES may reduce inflammation and delayed healing associated with some permanent polymer-coated DES. Whether late clinical outcomes are improved, particularly among patients with diabetes mellitus, is unknown. Methods and Results: We report the prespecified analysis of patients with medically-treated diabetes enrolled in the EVOLVE II trial at 2 years following SYNERGY stent deployment. SYNERGY is a novel, thin-strut, platinum chromium stent eluting everolimus from an ultrathin 4mum bioabsorbable poly(DL-lactide-co-glycolide) polymer applied to the abluminal side of the stent. The polymer resorbs shortly after everolimus elution is complete at 3 months. SYNERGY was found to be noninferior to the permanent polymer coated PROMUS Element Plus stent for the primary endpoint of 12-month target lesion failure (TLF: composite occurrence of ischaemia-driven target lesion revascularisation, target-vessel myocardial infarction, or cardiac death) in the EVOLVE II pivotal, randomised controlled trial (RCT). The EVOLVE II Diabetes substudy pooled: 1) patients with diabetes randomised to the SYNERGY arm of the EVOLVE II RCT (N=263) and, 2) patients with diabetes enrolled in the non-randomised Diabetes single-arm study (N=203) following EVOLVE II RCT completion for a total of 466 patients with diabetes treated with SYNERGY stent. Enrolled patients could have up to 3 native coronary artery lesions in up to 2 major epicardial vessels with reference vessel diameter >=2.25 mm to <=4.00 mm, and lesion length <=34 mm. Exclusion criteria included recent (<72 hours) STEMI, left main, vein graft or ostial stenosis, in stent restenosis, chronic total occlusion, or thrombus. The prespecified Diabetes substudy primary endpoint was 12-month TLF tested against a prespecified performance goal based on TLF rates derived from cohorts of patients with diabetes treated with permanent polymer everolimus-eluting stents in prior studies (PLATINUM, SPIRIT IV, COMPARE, EVOLVE).

Aims: The Lotus Valve Next Generation Delivery System (Lotus NGDS) incorporates the same innovative performance and safety features from the currently available Lotus Valve, but uses a new delivery system to provide enhanced deliverability. Key changes to the Lotus NGDS include: 1) removal of the pre-formed J-curve to increase catheter flexibility; 2) reduced proximal shaft profile to improve deliverability; and 3) reduced overall multi-lumen catheter diameter to further enhance deliverability. The goal of the first human use REPRISE NGDS study is to evaluate the safety and performance of the Lotus NGDS. Methods and Results: This prospective, single-arm study has enrolled 10 surgical-high-risk patients with symptomatic aortic valve stenosis (defined as an initial aortic valve area <=1.0 cm or aortic valve area index of <=0.6 cm/m and either a mean pressure gradient >=40 mm Hg or a jet velocity >=4 m/s, as measured by echocardiography), and New York Heart Association Functional Class >=II at 2 Australian sites. The primary endpoint of the study was technical success (defined as successful vascular access, delivery, positioning, and deployment of one Lotus NGDS with uncomplicated delivery system retrieval). Secondary endpoints included device performance endpoints (successful repositioning/retrieval if attempted), paravalvular regurgitation at discharge/7 days, mean aortic valve pressure gradient and effective orifice area, and VARC safety and efficacy endpoints (including mortality, stroke, myocardial infarction, bleeding, and vascular complications). Patient follow-up was at baseline, peri- and post-procedure, discharge/7 days, and 30 days, and will continue through six months and one year. Independent core laboratories assessed echocardiography, angiography, and histopathology, and an independent clinical events committee has adjudicated clinical events. Conclusion(s): The REPRISE NGDS is a first human use study designed to evaluate outcomes with LOTUS NGDS. Primar

Background - Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent. Methods and Results - Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively. Conclusions - In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.Copyright © © 2015 American Hea

Aims: We report the results of apre-specified analysis of all medically treated diabetic subjects enrolled into the EVOLVE II randomised trial (RCT) and the diabetes substudy who received treatment with the SYNERGY stent. Methods and Results: Enrolled diabetic subjects could have up to 3 native coronary artery lesions in up to 2 major epicardial vessels with reference vessel diameter >=2.25 mm to <=4.00 mm, and lesion length <=34 mm. Exclusion criteria included recent (<72 hours) STEMI, left main, vein graft or ostial stenosis, in stent restenosis, chronic total occlusion, or thrombus. The trial primary endpoint is TLF (composite occurrence of ischaemia-driven target lesion revascularisation, target-vessel myocardial infarction, or cardiac death) to 12 months among diabetic patients treated with the SYNERGY stent. The primary endpoint was tested against a pre-specified performance goal based on TLF rates derived from diabetic patient cohorts treated with durable polymer everolimus-eluting stents in prior studies (PLATINUM, SPIRIT IV, COMPARE, EVOLVE). Enrolled diabetic subjects were either randomised to SYNERGY in the EVOLVE II RCT (263 patients from 125 centres in 11 countries between November, 2012 and August, 2013) or following EVOLVE II RCT completion were enrolled in the diabetes substudy (203 patients from 48 sites from August to December, 2013) for a total of 466 diabetic patients treated with SYNERGY stent. All endpoint component events were independently adjudicated. Dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) was recommended for >=6 months or longer, as tolerated and aspirin was prescribed indefinitely. Patients will be followed for 5 years. Primary endpoint and component events to 1 year will be presented and compared with the performance goal to determine the relative safety and efficacy of SYNERGY stent in patients with diabetes. Conclusion(s): The EVOLVE II Diabetes substudy will establish the relative safety and efficacy of the novel SY

Aims: This analysis evaluated the incidence and predictors of paravalvular regurgitation at 30 days following implantation of the Lotus Valve in the extended REPRISE II cohort of 250 patients. Methods and Results: The prospective, single arm, multicentre REPRISE II and REPRISE II Extension studies enrolled 250 symptomatic, high-surgical-risk patients with calcific aortic stenosis and an annulus of 19-27 mm. Two valve sizes of 23 mm or 27 mm were available in these studies. Paravalvular regurgitation was assessed by echocardiography at discharge and 30 days according to VARC-2 criteria, and aortic valve dimensions and calcification by CT in end-systole; both were analysed and reported by an independent corelab. At 30 days, 80.2% (142/177) of patients had no paravalvular regurgitation, 5.6% (10/177) had trace/trivial regurgitation, 13.6% (24/177) had mild regurgitation, 0.6% (1/177) had moderate regurgitation, and no patients had severe paravalvular regurgitation. Baseline and procedural predictors of mild or moderate paravalvular regurgitation at 30 days (or at discharge if 30-day data were not available) were determined by using a multivariate regression model (n=229). Significant independent predictors of mild/moderate paravalvular regurgitation included the ratio of device area to annulus area (odds ratio 0.87; 95% CI: 0.83, 0.92; p<0.001), calcium volume in the left ventricular outflow tract (odds ratio: 2.85 per 100 mm increase; 95% CI: 1.44, 5.63; p=0.003), and annulus area (odds ratio per 10 mm increase: 0.89; 95% CI: 0.82, 0.96; p=0.002). Calcium volume in the leaflet and annulus was a borderline-significant predictor (odds ratio: 1.07 per 100 mm increase; 95% CI: 1.00, 1.16; p=0.06). When the nominal valve area was smaller than the annulus, i.e., device:annulus area ratio <1, the rate of mild or moderate paravalvular regurgitation was 53.1% (17/32). The rates of mild/moderate paravalvular regurgitation with 0-5%, 5-10%, and >10% annular oversizing by area we

Objectives: To report 1- and 2-year clinical outcomes of patients receiving platinum chromium everolimus-eluting stents (PtCr-EES) in the prospective, single-arm PLATINUM small vessel (SV) and long lesion (LL) studies. Background(s): Small vessel diameter and long lesion length are independently associated with increased risk of adverse cardiac events after drug-eluting stent implantation. Method(s): The PLATINUM SV study enrolled 94 patients with coronary artery lesions in vessels <=2.25 mm to <2.50 mm in diameter and & <=28 mm in length. The PLATINUM LL study enrolled 102 patients with lesions >24 to & <=34 mm long in vessels <=2.50 to & <=4.25 mm in diameter. The primary endpoint for both studies was target lesion failure (TLF) at 1 year compared to a prespecified performance goal based on outcomes with the TAXUS Express paclitaxel-eluting stent in small vessels and long lesions. Result(s): One-year TLF rates with the PtCr-EES were significantly (P < 0.001) lower than the predetermined performance goals: 2.4% versus 21.1% in the SV cohort and 3.2% versus 19.4% in the LL cohort. Cumulative rates of TLF to 2 years were 4.7% in the SV cohort and 8.8% in the LL cohort. No myocardial infarction or ARC definite/probable stent thromboses occurred in either cohort through 2-year follow-up. Conclusion(s): The clinical efficacy and safety outcomes observed in these small vessel and long lesion cohorts support the use of the PtCr-EES in the treatment of small diameter vessels and long lesions.Copyright © 2014 Wiley Periodicals Inc.

Aims Recent cost-effectiveness analyses of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) have been limited by a short time horizon or were restricted to the US healthcare perspective. We, therefore, used individual patient-level data from the SYNTAX trial to evaluate the cost-effectiveness of PCI versus CABG from a European (Dutch) perspective. Methods and results Between 2005 and 2007, 1800 patients with three-vessel or left main coronary artery disease were randomised to either CABG (n=897) or PCI with drug-eluting stents (DES; n=903). Costs were estimated for all patients based on observed healthcare resource usage over 5 years of follow-up. Health state utilities were evaluated with the EuroQOL questionnaire. A patient-level microsimulation model based on Dutch life-tables was used to extrapolate the 5-year in-trial data to a lifetime horizon. Although initial procedural costs were lower for CABG, total initial hospitalisation costs per patient were higher (.17 506 vs .14 037, p >0.001). PCI was more costly during the next 5 years of follow-up, due to more frequent hospitalisations, repeat revascularisation procedures and higher medication costs. Nevertheless, total 5-year costs remained .2465/patient higher with CABG. When the in-trial results were extrapolated to a lifetime horizon, CABG was projected to be economically attractive relative to DES-PCI, with gains in both life expectancy and quality-adjusted life expectancy. The incremental cost-effectiveness ratio (ICER) (.5390/quality-adjusted life year (QALY) gained) was favourable and remained >.80 000/QALY in <90% of the bootstrap replicates. Outcomes were similar when incorporating the prognostic impact of non-fatal myocardial infarction and stroke, as well as across a broad range of assumptions regarding the effect of CABG on post-trial survival and costs. However, DES-PCI was economically dominant compared with CABG in patients with a SYNTAX Score .22 or in those

Results Mean age was 84.4 years, 57% of the patients were female, and 76% were New York Heart Association functional class III/IV. Mean aortic valve area was 0.7 +/- 0.2 cm2. The valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n = 26) and retrieval (n = 6) attempts were successful; 34 patients (28.6%) received a permanent pacemaker. The primary device performance endpoint was met, because the mean gradient improved from 46.4 +/- 15.0 mm Hg to 11.5 +/- 5.2 mm Hg. At 30 days, the mortality rate was 4.2%, and the rate of disabling stroke was 1.7%; 1 (1.0%) patient had moderate PVR, whereas none had severe PVR. Conclusions REPRISE II demonstrates the safety and effectiveness of the Lotus valve in patients with severe aortic stenosis who are at high surgical risk. The valve could be positioned successfully with minimal PVR. (REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotusTM Valve System - Evaluation of Safety and Performance; NCT01627691). Background Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR). Objectives The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis. Methods Patients (n = 120; aortic annulus 19 to 27 mm) considered by a multidisciplinary heart team to be at high surgical risk received the valve transfemorally. The primary device performance endpoin

In the randomized PLATINUM trial, the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES; Boston Scientific, Natick, Massachusetts) was noninferior to the XIENCE V cobalt-chromium everolimus-eluting stent (CoCr-EES; Boston Scientific and Abbott Vascular, Santa Clara, California) for the primary end point of 1-year target lesion failure. This study reports the 3-year outcomes. Patients (n = 1,530) with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter >=2.50 mm to <=4.25 mm and length <=24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. Three-year follow-up was available in 93.9% (703 of 749) of patients with CoCr-EES and 96.7% (733 of 758) of patients with PtCr-EES. Comparing CoCr-EES with PtCr-EES, 3-year rates of death (4.3% vs 3.7%, hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.52 to 1.48, p = 0.62), cardiac death (1.9% vs 1.2%, HR 0.63, 95% CI 0.27 to 1.45, p = 0.27), myocardial infarction (2.5% vs 2.3%, HR 0.92, 95% CI 0.48 to 1.79, p = 0.81), ischemia-driven target lesion revascularization (4.9% vs 3.5%, HR 0.72, 95% CI 0.43 to 1.20, p = 0.21), and Academic Research Consortium definite or probable stent thrombosis (0.5% vs 0.7%, HR 1.23, 95% CI 0.33 to 4.57, p = 0.76) were not significantly different. In conclusion, 3-year results of the PLATINUM randomized, controlled, clinical trial demonstrate comparable safety and efficacy outcomes of the PROMUS Element PtCr-EES and the XIENCE V CoCr-EES. © 2014 Elsevier Inc. All rights reserved.

As a result of recent randomised controlled trials and registry observations, transcatheter aortic valve replacement (TAVR) enjoys growing appeal for the treatment of patients at high or extreme risk from surgical aortic valve replacement. However, the current technologies and techniques have important limitations, including risk of stroke, vascular complications and paravalvular aortic regurgitation, which may in turn influence survival. While careful patient selection and screening may improve outcomes, new valve designs and iterations are required. The Lotus aortic valve replacement system is a new fully repositionable device designed to facilitate more precise delivery and minimise paravalvular regurgitation. The safety and efficacy of the Lotus valve are being studied systematically in the REPRISE clinical trial programme.

Aims: To assess outcomes with a new fully repositionable and retrievable valve for transcatheter aortic valve replacement (TAVR). Methods and Results: The Lotus Aortic Valve System is designed to facilitate precise positioning and minimise paravalvular regurgitation. REPRISE I enrolled symptomatic, high-surgical-risk patients with severe aortic stenosis. The primary endpoint (clinical procedural success) included successful implantation without major adverse cardiovascular or cerebrovascular events (MACCE). In all patients (N=11) the first Lotus Valve was successfully deployed. Partial resheathing to facilitate accurate placement was attempted and successfully performed in four patients; none required full retrieval. The primary endpoint was achieved in 9/11 with no in-hospital MACCE in 10/11. There was one major stroke; in another patient, discharge mean aortic gradient was 22 mmHg (above the primary endpoint threshold of 20 mmHg), but improved to 15 mmHg at 30 days. The cohort's mean aortic gradient decreased from 53.9+/-20.9 mmHg at baseline to 15.4+/-4.6 mmHg (p<0.001) at one year; valve area increased from 0.7+/-0.2 cm2 to 1.5+/-0.2 cm2 (p<0.001). Discharge paravalvular aortic regurgitation, adjudicated by an independent core laboratory, was mild (n=2), trivial (n=1), or absent (n=8). Four patients required a permanent pacemaker post-procedure. There were no deaths, myocardial infarctions or new strokes through one year. Conclusion(s): Initial results support proof-of-concept with the Lotus Valve for TAVR. © Europa Digital & Publishing 2014. All rights reserved.

Aims: Early transcatheter aortic valve implantation (TAVI) devices have established the feasibility of TAVI in patients who are unsuitable for surgical valve replacement, but these devices may face challenges with precise valve positioning, paravalvular leakage, and undesirable rates of stroke, bleeding, or vascular complications. The repositionable and fully retrievable LotusTM Valve was designed to facilitate accurate positioning and minimise paravalvular leakage in patients with severe aortic stenosis who are at high or extreme risk for surgery. The device demonstrated favourable efficacy and safety primary outcomes at 30 days in the REPRISE II CE-Mark trial. This analysis will present the first report of 6-month outcomes in the full cohort of patients in REPRISE II. Methods and Results: The prospective, single-arm, multicentre REPRISE II study was designed to assess the safety and performance of the Lotus Valve System in symptomatic patients aged >=70 years with severe calcific aortic stenosis who are at high or extreme surgical risk. The primary device performance endpoint was the mean aortic valve pressure gradient at 30 days post-procedure, as assessed by an independent core laboratory. The primary safety endpoint was 30-day all-cause mortality. Among 120 enrolled patients, the mean age of 84.4+/-5.3 years, 57% (68/120) were female, mean STS Score was 7.1+/-4.6, mean euroSCORE II was 6.9+/-5.8, and 26% had medically treated diabetes. The mean baseline aortic valve area was 0.7+/-0.2 cm, and the mean aortic valve pressure gradient was 46.4+/-15.0 mmHg. All patients (100%) were successfully implanted with a Lotus valve. A total of 28.6% (34/119) patients had a permanent pacemaker implanted within 30 days post-procedure. The primary device performance endpoint of 30-day mean aortic valve pressure gradient was 11.5+/-5.2 mmHg, which was significantly less than the performance goal of 18 mmHg (P<0.001). All-cause mortality at 30 days was 4.2% and disabling stroke

Background The results of SYNTAX trial have been reported based on "corelab" calculated SS (cSS). It has been shown that reproducibility of SS is better among the core laboratory technicians than interventional cardiologists. Thus, the prognostic value and clinical implication of the "site" SYNTAX SS (sSS) remain unknown. Objectives The study sought to evaluate the prognostic value and clinical implication of the sSS after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery in the randomized SYNTAX trial. Methods The sSS was calculated by the site investigators before randomization in the SYNTAX trial. New tertiles based on the sSS were defined with low (0 to 19), intermediate (20 to 27), and high (≥28) scores. The clinical endpoints were compared between PCI and CABG by Kaplan-Meier estimates, log-rank comparison, and Cox regression analyses using the new tertiles. The sSS-based SS II was calculated and its predictive performance was evaluated. Results The mean difference in cSS and sSS is 3.8 ± 11.2, with a mean absolute difference of 8.9 ± 7.8. In the overall cohort, using sSS there was a higher incidence of major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up in the PCI group for low (31.9% vs. 24.5%; p = 0.054), intermediate (39.5% vs. 29.5%; p = 0.019), and high (43.0% vs. 31.4%; p = 0.003) tertiles, compared with the CABG group. Similarly, in the 3-vessel disease subgroup, 5-year MACCE rates were higher in PCI group in all tertiles. Conversely, in the left main subgroup, MACCE rates were similar for PCI and CABG groups in all tertiles. The sSS-based SS II (c-index: 0.736) had predictive performance similar to the cSS-based SS II (c-index: 0.744), with net reclassification index of -0.0062 (p = 0.79). Conclusions Appropriate training and unbiased assessment are needed when using SS in clinical decision making. sSS and tertiles based on sSS showed poor discrimination among low, intermediate, and high-r

Background: The PLATINUM randomized trial enrolled 1530 patients treated with either the platinum chromium PROMUS Element everolimus-eluting stent (PtCr-EES; Boston Scientific, Natick, MA, USA) or the predicate cobalt chromium PROMUS/XIENCE V EES (CoCr-EES; manufactured as XIENCE V by Abbott Vascular, Santa Clara, CA, USA also distributed as PROMUS by Boston Scientific), including 124 patients from Japanese sites. This substudy examines 2-year outcomes in the Japanese and non-Japanese cohorts. Method(s): Patients with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter >=2.50. mm to <=4.25. mm and length <=24. mm) were randomized 1:1 to PtCr-EES (N=63 patients in Japan) versus CoCr-EES (N=61 patients in Japan). Result(s): Several significant differences were noted in baseline demographics, lesion characteristics, and procedural technique between Japanese and non-Japanese patients, including longer fluoroscopy time, less use of contrast, and greater post-dilatation usage and maximum pressure in Japan. Dual antiplatelet usage at 2 years was also higher in Japan. Despite these differences, the 2-year rates of target lesion failure were comparable in patients treated with PtCr-EES and CoCr-EES both in Japan (3.2% vs 5.0% respectively, p=. 0.68) and outside Japan (4.7% vs 5.9% respectively, p=. 0.33; p for interaction. =. 0.82). Conclusion(s): This PLATINUM study subanalysis suggests that the PtCr-EES and CoCr-EES provide comparable safety and efficacy in both Japanese and non-Japanese patients. © 2013 Japanese College of Cardiology.

Aims: The EVOLVE FHU trial demonstrated non-inferiority of six-month late loss with two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) compared with the durable polymer PROMUS Element (PE) EES. The current analysis describes the six-month IVUS and clinical results through two years from the EVOLVE FHU trial. Methods and Results: EVOLVE recruited 291 patients from 29 centres. At six months, IVUS-assessed in-stent net volume obstruction was 3.40+/-5.06% for PROMUS Element (PE) vs. 2.68+/-4.60% for SYNERGY (p=0.34) and 3.09+/-4.29% for SYNERGY 1/2 dose (p=0.68 vs. PE). There were no significant differences between groups for any other measured IVUS parameter including resolved, persistent, and late-acquired incomplete stent apposition (ISA). At two years, target lesion failure (TLF) was 6.1% for PE vs. 5.5% for SYNERGY (p=0.87) and 5.2% for SYNERGY 1/2 dose (p=0.81). There were no significant differences between groups for cardiac death, repeat revascularisation, MI or stent thrombosis through two years. Conclusion(s): At six months, everolimus delivered from an ultrathin bioabsorbable abluminal polymer resulted in equivalent net volume obstruction and ISA compared with a permanent polymer EES. There were no significant differences between PE and either SYNERGY stent for any major cardiac endpoint through two years. Clinical trials number: NCT01135225. © Europa Digital and Publishing 2013. All rights reserved.

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. Conclusion(s): 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. © Europa Edition 2012. All rights reserved.

Objectives: We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). Background(s): Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. Method(s): A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received <1 assigned study stent), powered for noninferiority. Result(s): The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, pnoninferiority = 0.001, psuperiority = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). Conclusion(s): In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. (A Prospective, Randomi

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 l ate 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). Conclusion(s): Through one year, PROMUS Element EES had an acceptable safety and efficacy profile with low in-stent late loss and post-procedure ISA. © Europa Edition 2011. All rights reserved.

Background: Long coronary lesions are associated with high restenosis rates and adverse clinical outcomes. The platinum chromium PROMUS Element everolimus-eluting stent (EES, Boston Scientific, Natick, MA) demonstrated noninferior clinical outcomes compared to the XIENCE V EES (Abbott, Santa Clara, CA) in lesions <=24mm. The PLATINUM Long Lesion (LL) study assessed results in lesions >24mm. Method(s): Patients had angina pectoris or documented silent ischemia. One de novo target lesion >24 to <=34mm long with reference diameter >=2.50 to <=4.25mm could be treated with a 32 or 38mm stent. A lesion in a different epicardial vessel could be treated with a non-study treatment before the target lesion. The primary endpoint, 12-month target lesion failure (composite of target vessel related cardiac death/MI and ischemia-driven target lesion revascularization) in the per-protocol population, was compared to a performance goal (PG) of 19.4% based on historical outcomes with 32mm paclitaxel-eluting stents (the only long drug-eluting stent approved in the US when PLATINUM LL was initiated) in the TAXUS V DN trial. Clinical follow-up is at 1, 6, 12, 18M and annually to 5 years. Result(s): 102 patients enrolled at 30 international sites. Table 1 shows baseline characteristics and outcomes. TLF in the per-protocol population was 3.2% with a onesided upper confidence bound of 7.96%, significantly less than the PG (p<0.0001). (Table Presented) Conclusion(s): The PLATINUM LL results support the safety and efficacy of the 32 and 38mm PROMUS Element stent.

BACKGROUND: Previous studies have shown that among patients undergoing multivessel revascularization, coronary-artery bypass grafting (CABG), as compared with percutaneous coronary intervention (PCI) either by means of balloon angioplasty or with the use of bare-metal stents, results in greater relief from angina and improved quality of life. The effect of PCI with the use of drug-eluting stents on these outcomes is unknown. METHODS: In a large, randomized trial, we assigned 1800 patients with three-vessel or left main coronary artery disease to undergo either CABG (897 patients) or PCI with paclitaxeleluting stents (903 patients). Health-related quality of life was assessed at baseline and at 1, 6, and 12 months with the use of the Seattle Angina Questionnaire (SAQ) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The primary end point was the score on the angina-frequency subscale of the SAQ (on which scores range from 0 to 100, with higher scores indicating better health status). RESULTS: The scores on each of the SAQ and SF-36 subscales were significantly higher at 6 and 12 months than at baseline in both groups. The score on the angina-frequency subscale of the SAQ increased to a greater extent with CABG than with PCI at both 6 and 12 months (P = 0.04 and P = 0.03, respectively), but the between-group differences were small (mean treatment effect of 1.7 points at both time points). The proportion of patients who were free from angina was similar in the two groups at 1 month and 6 months and was higher in the CABG group than in the PCI group at 12 months (76.3% vs. 71.6%, P = 0.05). Scores on all the other SAQ and SF-36 subscales were either higher in the PCI group (mainly at 1 month) or were similar in the two groups throughout the follow-up period. CONCLUSIONS: Among patients with three-vessel or left main coronary artery disease, there was greater relief from angina after CABG than after PCI at 6 and 12 months, although the extent of t

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.

Background: Everolimus-eluting stents (EES) reduce restenosis following percutaneous coronary intervention as compared to earlier generation paclitaxel-eluting stents (PES). The next generation PROMUS Element EES (Boston Scientific Corporation, Natick, MA, USA) consists of a novel platinum-chromium alloy thin-strut radiopaque stent with improved radial strength and low recoil. We report for the first time results of the PLATINUM QCA trial which collected clinical outcomes, quantitative coronary angiography (QCA) data, and intravascular ultrasound (IVUS) data in lesions treated with PROMUS Element. Method(s): Subjects with a de novo target lesion length <=34 mm in a vessel of >2.25 mm to <4.25 mm diameter were treated in this prospective, single-arm, multicenter trial. The primary endpoint was the 30-day composite rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and definite or probable stent thrombosis (ST). The efficacy endpoint of 9-month in-stent late loss by QCA was compared to a prespecified performance goal based on historical results with TAXUS Express PES. Additional endpoints include 9-month percent diameter stenosis and binary restenosis (QCA); 9-month percent net volume obstruction and incomplete apposition (IVUS); and clinical endpoints of all-cause death, cardiac death, MI, revascularization, and ST at 9 and 12 months. Result(s): Subjects (n=100) were enrolled at 14 clinical sites in Australia, New Zealand, Malaysia, and Singapore. Mean age was 62 years, 23%) of patients were female, and 19%) of patients had medically treated diabetes mellitus. Lesions treated were in the left anterior descending (35%), the left circumflex (30%), and the right coronary (35%) arteries. Technical success (successful study stent delivery and deployment to the target lesion without balloon rupture or embolization) was 100%) (108/108). Clinical procedural success (mean lesion diameter stenosis <30% with TIMI3 flow and no in-hospital c

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 even