Patient-oriented Composite Endpoint Research Articles

External validity of the "all-comers" design: insights from the BIOSCIENCE trial.

We sought to systematically evaluate the external validity of a contemporary randomized controlled stent trial (BIOSCIENCE). Baseline characteristics and clinical outcomes of patients enrolled into the BIOSCIENCE trial at Bern University Hospital (n=1216) were compared to those of patients included in the CARDIOBASE Bern PCI Registry at the same institution (n=1045). The primary study endpoint was the rate of target lesion failure (TLF), defined as a composite of cardiac death, target vessel-myocardial infarction (MI) or target lesion revascularization (TLR), at 1year. Women were underrepresented in the RCT compared to the registry (25 vs. 29.4%, p=0.020). Non-participants were older compared to study participants (69.2±12.4 vs. 67.0±11.6, p<0.001), and had a higher prevalence of previous cerebrovascular events (10.8 vs. 5.2%, p<0.001), and chronic renal failure (35.5 vs. 15.6%, p<0.001). ST-segment elevation myocardial infarction (STEMI) and Killip class IV at presentation were more common among non-participants than participants (30.7 vs. 21.1%, p<0.001 and 7.8 vs. 0.4%, p<0.001, respectively). At 1year, non-participants experienced a significantly higher rate of TLF, (15.0 vs. 6.5%, p<0.001), and patient-oriented composite endpoint (POCE), including death, MI or any repeat revascularization (21.6 vs. 11.2%, p<0.001). There was a significant interaction between POCE and presence or absence of an acute coronary syndrome in participants versus non-participants, respectively (p=0.009). Non-participants of this all-comers trial had a higher risk profile and adverse prognosis compared to study participants. Further efforts are needed to improve the external validity of contemporary RCTs.

1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis

Compared with metallic drug-eluting stents, bioresorbable vascular scaffolds (BVS) offer the potential to improve long-term outcomes of percutaneous coronary intervention. Whether or not these devices are as safe and effective as drug-eluting stents within the first year after implantation is unknown. We did a patient-level, pooled meta-analysis of four randomised trials in which 3389 patients with stable coronary artery disease or a stabilised acute coronary syndrome were enrolled at 301 academic and medical centres in North America, Europe, and the Asia-Pacific region. These patients were randomly assigned to the everolimus-eluting Absorb BVS (n=2164) or the Xience cobalt-chromium everolimus-eluting stent (CoCr-EES; n=1225). The primary endpoints were the 1-year relative rates of the patient-oriented composite endpoint (all-cause mortality, all myocardial infarction, or all revascularisation) and the device-oriented composite endpoint of target lesion failure (cardiac mortality, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularisation). All analyses were by intention to treat. The four randomised trials included in our meta-analysis are all registered with ClinicalTrials.gov, numbers NCT01751906, NCT01844284, NCT01923740, and NCT01425281. The summary treatment effect for the 1-year relative rates of the patient-oriented composite endpoint did not differ significantly different between BVS and CoCr-EES (relative risk [RR] 1·09 [0·89-1·34], p=0·38). Similarly, the 1-year relative rates of the device-oriented composite endpoint did not differ between the groups (RR 1·22 [95% CI 0·91-1·64], p=0·17). Target vessel-related myocardial infarction was increased with BVS compared with CoCr-EES (RR 1·45 [95% CI 1·02-2·07], p=0·04), due in part to non-significant increases in peri-procedural myocardial infarction and device thrombosis with BVS (RR 2·09 [0·92-4·75], p=0·08). The relative rates of all-cause and cardiac mortality, all myocardial infarction, ischaemia-driven target lesion revascularisation, and all revascularisation did not differ between BVS and CoCr-EES. Results were similar after multivariable adjustment for baseline imbalances, and were consistent across most subgroups and in sensitivity analysis when two additional randomised trials with less than 1 year of follow-up were included. In this meta-analysis, BVS did not lead to different rates of composite patient-oriented and device-oriented adverse events at 1-year follow-up compared with CoCr-EES. Abbott Vascular.

The incidence and relevance of site-reported vs. patient-reported angina: insights from the ABSORB II randomized trial comparing Absorb everolimus-eluting bioresorbable scaffold with XIENCE everolimus-eluting metallic stent.

In the ABSORB II trial, comparing Absorb™ bioresorbable vascular scaffold with metallic XIENCE™ everolimus-eluting stent (EES), a difference was found in site-reported new or worsening angina using adverse event (AE) reporting. However, the clinical relevance of this site-reported angina is unclear. The aim of the present study was therefore to investigate the clinical relevance of site-reported angina by evaluating its relation with cardiac endpoints, cardiovascular resource utilization (including diagnostics and treatment), positive exercise stress tolerance tests (ETTs), and Seattle Angina Questionnaire (SAQ). Site-reported new or worsening angina was captured on cardiac AE forms. There was a wide variation in the total number of days with site-reported angina (overall interquartile range 35-279 days). Patients with site-reported angina showed higher rates of cardiovascular events [including the patient-oriented composite endpoint of all deaths, all myocardial infarctions (MI), or all revascularizations (21.1 vs. 4.2%, P < 0.0001), all MIs (2.3 vs. 0%, P = 0.03), and all revascularizations (21.1 vs. 0.7%, P < 0.0001)], cardiovascular resource utilization (including stress tests, anti-anginal medication, diagnostic angiographies, and hospitalization), and positive ETTs (51.9 vs. 14.9%, P < 0.001), compared with those without site-reported angina. Furthermore, an event-based analysis of the SAQ showed that patients with ongoing angina within the recall period of 4 weeks prior to the SAQ assessment have clinically and statistically significant decrements of >14 points in SAQ scores compared with those with no reported angina. We showed that the site-reported angina through AE reporting may be clinically relevant because of their relation with cardiovascular events (mostly repeat revascularizations), cardiovascular resource utilization, ETT, and SAQ. https://clinicaltrials.gov/ct2/show/NCT01425281; Unique identifier: NCT01425281.

Clinical Comparison With Short-Term Follow-Up of Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Stent in Primary Percutaneous Coronary Interventions

Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p= 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p= 0.4); death (BVS 0.8%, EES 2.0%, p= 0.4), MI (BVS 4.1%, EES 2.0%, p= 0.2), TLR (BVS 4.1%, EES 4.5%, p= 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p= 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.

Abstract 12766: Long Term Outcome of Patients With Complete Revascularization

Introduction: Complete revascularization (CR) is considered as a goal for percutaneous coronary intervention (PCI). Previous studies have proved that achieving CR is beneficial compared to incomplete CR. However there has been no research about the long term outcome within CR patients. Hypothesis: The SS has predictive value in CR patients. Methods: From patients enrolled in the Efficacy of Xience/Promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) registry, the SYNTAX score was checked before and after PCI. The primary clinical outcome was 3-year patient-oriented composite endpoint (POCE), which was a composite of all cause death, any myocardial infarction, and any revascularization. Secondary outcomes were the individual components of 3-year POCE and 3-year target lesion failure (TLF). For calculation of the clinical SS, the SS was multiplied with the value of the ‘Age, Creatinine, and Ejection Fraction’ score. Results: Among 5102 patients from the EXCELLENT registry, 2112 patients achieved CR by PCI. 3-year POCE was less common in CR patients (10.0% vs. 16.9%, p&lt;0.001) and CR was an independent predictor of adverse outcomes (Hazard ratio (HR) 1.326, 95% Confidence Interval (CI) 1.108-1.587, p=0.002). Patients who achieved CR were divided into 3 groups, according to the pre-PCI SYNTAX score (SS); 1≤low-SS&lt;6: 771 patients, 6≤mid-SS&lt;10: 692 patients, and high-SS≥10: 649 patients. 3-year POCE increased significantly along with increasing baseline SS tertiles (7.5% vs. 8.4% vs. 14.8%, p&lt;0.001) and secondary outcomes also showed similar tendency. Multivariate analysis showed that baseline SS was an independent predictor of 3-year POCE (HR 1.032, 95% CI 1.011-1.053, p=0.003 per SS point). The clinical SS was superior to baseline SS in predicting 3-year POCE (AUC: 0.595 vs. 0.649, p=0.008). In subgroup analysis, baseline SS was a predictor for POCE only in multi-vessel diseases (HR 1.027, 95% CI 1.001-1.054, p=0.042 per SS point). Conclusions: CR is an independent predictor of 3-year POCE in patients receiving PCI. However, even after CR is achieved to make the post-PCI SS zero, baseline SS still has predictive value of 3-year clinical outcomes. Moreover, the predictivity is was superior in multi-vessel diseases.

Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction

ObjectiveTo investigate clinical outcomes of coronary intervention using a biolimus-eluting stent (BES) compared with a sirolimus-eluting stent (SES) in patients with acute myocardial infarction (AMI) in the Limus Eluted from...

TCT-588 2-Year Clinical Outcome of the Randomized, Multicenter DUTCH PEERS (TWENTE II) Trial, Comparing Cobalt-Chromium Zotarolimus-Eluting Resolute Integrity Stents and Platinum-Chromium Everolimus-Eluting Promus Element Stents in “All-Comer” Patients

Background: The multicenter, prospective, randomized, single-blinded, investigator-initiated DUTCH PEERS (TWENTE II) “All Comers” Trial demonstrated at 1-year follow-up the non-inferiority of third-generation Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, CA) versus Promus Element everolimus-eluting stents (Boston Scientific, Natick, MA), based on a similar incidence of the primary endpoint target vessel failure (TVF), a composite of cardiac death, target vessel revascularization (TVR), or myocardial infarction (MI). No other follow-up data beyond 12 months have been published from a randomized head-to-head comparison of both stents. Methods: In 4 study centers in the Netherlands, 1,811 patients were 1:1 randomly assigned to treatment with one of both stents. Patients with any clinical syndrome, any lesion type, and any number of lesions or vessels to be treated were included. Study monitoring and clinical event adjudication were performed by two independent Dutch contract research organizations (Diagram, Zwolle, and Cardialysis, Rotterdam, respectively). Results: DUTCH PEERS examines an all-comer patient population that included 59% of patients with acute coronary syndromes (20% of all patients presented with an acute STEMI) and 66% of patients with complex target lesions. We will compare for both stent groups the 2-year incidence of TVF (primary endpoint) and various secondary endpoints, including individual components of the primary endpoint, the incidence of stent thrombosis, and other composite endpoints, such as target lesion failure, major adverse cardiac events, and the patient-oriented composite endpoint. In addition, we will report the outcome of patients with longitudinal stent deformation after discontinuation of dual anti-platelet therapy. Conclusions: Clinical outcome of the DUTCH PEERS trial at 2-year follow-up will be presented.

Comparison of Newer-Generation Drug-Eluting With Bare-Metal Stents in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Pooled Analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) Trials

This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI). Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES. Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year. Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p < 0.0001) and a lower risk of target-vessel infarction (RR: 0.36; 95% CI: 0.14 to 0.92; p = 0.03). Newer-generation DES also reduced the risk of definite stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS. Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up.

The impact of residual coronary lesions on clinical outcomes after percutaneous coronary intervention: Residual SYNTAX score after percutaneous coronary intervention in patients from the Efficacy of Xience/Promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) registry

The SYNTAX score (SS) is used in preprocedural evaluation for percutaneous coronary intervention (PCI); it assesses the complexity of coronary lesions and predicts PCI outcome. However, the usefulness of the residual SS (rSS), which can be calculated after PCI and may reflect the completeness of revascularization, has not been fully investigated in an enriched PCI population. The baseline SS and rSS were determined in 5,088 patients (3,046 everolimus-eluting stents and 2,042 sirolimus-eluting stents) from the EXCELLENT registry. The primary end point was 1-year patient-oriented composite end point (POCE), comprising all-cause death, myocardial infarction, and repeat revascularization. The mean baseline SS was 13.6 ± 9.1 and rSS was 4.7 ± 6.5. Residual SS tertiles were defined as rSS = 0 (42.7%), 0 < rSS < 7 (29.9%), and rSS ≥ 7 (27.4%). Increasing rSS tertiles had increasing 1-year POCE rates (5.2%, 8.1%, 12.4%; P < .001) mainly caused by the increase in repeat revascularization. Also, rSS was an independent predictor of 1-year POCE after multivariate analysis (P for trend < .001) and had better predictability in simple coronary lesions (baseline SS < 16). The clinical rSS, calculated by multiplying the rSS to a modified age, creatinine clearance, and ejection fraction score (age/ejection fraction + 1 for each 10 mL the creatinine clearance <60 mL/min), was also associated with 1-year POCE, with predictability similar to rSS (area under curve 0.610 vs 0.607, P = .634). Greater residual coronary lesions after PCI with "limus" drug-eluting stent, as quantified by the rSS and the clinical rSS, are associated with increased risk of adverse cardiac events.

TCT-188 Two-Year Clinical Outcome of Patients With Bifurcation Lesions Treated With Second-generation Zotarolimus-Eluting Resolute Stents and Everolimus-Eluting Xience V Stents in the Randomized TWENTE Trial

Background: The aim of this study was to investigate safety and efficacy of second-generation zotarolimus-eluting Resolute stents and everolimus-eluting Xience V stents in bifurcation lesions. Methods: In TWENTE - a prospective, randomized DES trial - PCI patients were randomized for treatment with contemporary Resolute or Xience V stents. Clinical endpoints were adjudicated by an external independent clinical events committee (Cardialysis CRO, Rotterdam, The Netherlands). Target vessel failure (TVF; cardiac death, target vessel-related myocardial infarction, and clinically-indicated target vessel revascularization), the primary endpoint of the TWENTE trial, was assessed after 2 years. Results: Among the 1,391 patients of the TWENTE trial, 362 (26%) patients were treated for at least one bifurcation lesion. Of these patients, 179 and 183 were randomized for treatment with Resolute and Xience V stents, respectively. At 2-year follow-up, TVF (12.8% vs. 11.5%; p=0.69) and a patient-oriented composite endpoint (17.3% vs. 16.9%; p=0.92) did not differ significantly between stent arms. In addition, rates of definite and or probable stent thrombosis were low and similar for both stent arms (0.6% vs. 0.5%; p=0.99). Within 213 (15.3%) patients, who were treated for bifurcation lesions with an additional treatment of the side-branch, there was also no significant difference in TVF between patients treated with Resolute (n=98) and Xience V (n=115) (8.2% vs. 11.3%; p=0.44). Conclusions: Treatment of bifurcation lesions with Resolute and Xience V stents resulted in favorable and similar outcomes after 2 years in the randomized TWENTE trial.

Clinical Outcome Following Stringent Discontinuation of Dual Antiplatelet Therapy After 12 Months in Real-World Patients Treated With Second-Generation Zotarolimus-Eluting Resolute and Everolimus-Eluting Xience V Stents: 2-Year Follow-Up of the Randomized TWENTE Trial

The aim of this study was to assess the safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) (Medtronic Inc., Santa Rosa, California) and Xience V everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, California) following strict discontinuation of dual antiplatelet therapy (DAPT) after 12 months.Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents.The randomized TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694).Two-year follow-up information was available on all patients. The rate of continuation of DAPT beyond 12 months was very low (5.4%). The primary endpoint of target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization, did not differ between ZES and EES (10.8% vs. 11.6, p = 0.65), despite fewer target lesion revascularizations in patients with EES (2.6% vs. 4.9%, p = 0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p = 0.75). Two-year rates of definite or probable stent thrombosis were 1.2% and 1.4%, respectively (p = 0.63). Very late definite or probable stent thrombosis occurred only in 2 patients in each study arm (0.3% vs. 0.3%, p = 1.00).After 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents. (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente [TWENTE]; NCT01066650).

Women treated with second‐generation zotarolimus‐eluting resolute stents and everolimus‐eluting xience V stents: insights from the gender‐stratified, randomized, controlled TWENTE trial

Women are underrepresented in clinical research, and few data are available from randomized head-to-head comparisons of second-generation drug-eluting stents (DES) in female patients. Aim of this study was to assess safety and efficacy of two second-generation DES in women. In TWENTE-a prospective, randomized, comparative DES trial-"real-world" patients were stratified for gender before randomization for Resolute or Xience V stents. Target vessel failure (TVF; cardiac death, target vessel-related myocardial infarction, and clinically indicated target vessel revascularization) after 1 year was the predefined endpoint. Among 1,391 patients, 382 (27.5%) women were randomized to Resolute (n = 192) and Xience V (n = 190). Baseline and procedural characteristics were similar for females in both study arms, except for smaller vessel and stent diameters in Resolute-treated lesions. After 1 year, TVF (8.9 vs. 8.4%; adjusted odds ratio [OR]: 0.95, 95% confidence interval [CI]: 0.41-2.20, P = 0.91) and a patient-oriented composite endpoint (13.0 vs. 12.1%, P = 0.79) did not differ significantly between women in both arms. Women were older than men (P < 0.01) and had more often diabetes mellitus (26.4 vs. 19.8%, P = 0.01) and hypertension (63.6 vs. 52.5%, P < 0.01), but there was no significant gender difference in TVF (adjusted OR: 1.18, 95% CI: 0.73-1.92, P = 0.50). This gender-stratified TWENTE trial analysis resulted in no significant difference in safety and efficacy outcomes between Resolute- and Xience V-treated females.

Usefulness of the SYNTAX and Clinical SYNTAX Scores in Predicting Clinical Outcome After Unrestricted Use of Sirolimus- and Everolimus-Eluting Stents

The SYNTAX score (SS) and clinical SS (cSS) can assess coronary lesion complexity and are useful indices in predicting outcomes after percutaneous coronary intervention. However, their validity has not been fully investigated in daily practice where "limus"-eluting stents are used. The SS and cSS were independently assessed from the Efficacy of Xience/Promus vs. Cypher in rEducing Late Loss after stENTing (EXCELLENT) registry, together with the 1-year patient-oriented composite endpoint (POCE; all-cause death, any myocardial infarction (MI), and any revascularization) and target-lesion failure (TLF; cardiac death, target-vessel MI, and target-lesion revascularization). Among 5,102 patients, tertiles for SS were defined as low-SS <8, 8≤mid-SS≤16, high-SS >16. Both POCE (4.2% vs. 7.7% vs. 12.2%, P<0.001) and TLF (1.6% vs. 2.4% vs. 4.5%, P<0.001) increased significantly with increasing SS tertile, and SS was an independent predictor of POCE (P<0.001 for trend) and TLF (P=0.023 for trend) in multivariate analysis. The predictability of SS and cSS was similar for POCE (area under the curve (AUC): 0.635 vs. 0.629, P=0.599), whereas SS was superior in predicting restenosis-related outcomes such as revascularization (AUC: 0.624 vs. 0.577, P<0.001) and cSS was superior in other components such as death (AUC: 0.654 vs. 0.795, P<0.001). Both SS and cSS were applicable to unrestricted use of "limus"-eluting stents in predicting the risk of 1-year clinical outcomes.

Abstract 9738: Use of the Syntax Score In Predicting Outcome After Unrestricted Use of 'limus' Stents

Background The SYNTAX score (SS) and clinical SS (cSS) are widely used to assess coronary lesion complexity, and are useful indices in predicting outcomes after percutaneous coronary intervention. However, SS was derived from a study that exclusively used paclitaxel eluting stents, and its applicability to patients receiving ‘limus’ eluting stents is unclear. Thus, we investigated the validity of the SS and cSS in predicting clinical outcomes from a cohort where ‘limus’ stents were used unrestrictedly. We also compared the predictability of the scores in everolimus eluting stents (EES) versus sirolimus eluting stents (SES). Methods Patients were from the Efficacy of Xience/Promus versus Cypher in rEducing Late Loss after stenting (EXCELLENT) registry and the SS was evaluated at an independent angiographic core lab. The 1-year patient oriented composite endpoint (POCE) (all cause death, any myocardial infarction (MI), and any revascularization) and target lesion failure (TLF) (cardiac death, target vessel MI, and target lesion revascularization) were the major analysis endpoints. The area under the curve (AUC) of a receiver operating characteristic was used as the predictability of SS and cSS. Results Among 5102 patients (7003 lesions) enrolled, 3047 patients (4235 lesions) received EES and 2055 patients (2768 lesions) received SES. Tertiles for SS were defined as low SS&lt;8, 8≤mid SS≤16, high SS&gt;16. From the whole population, both POCE (4.2% vs. 7.7% vs. 12.2%, p&lt;0.001) and TLF (1.6% vs. 2.4% vs. 4.5%, p&lt;0.001) increased significantly along with increasing SS tertiles, and SS was an independent predictor of POCE and TLF in multivariate analysis (p&lt;0.001 for all) The predictability of SS and cSS was similar for POCE (AUC: 0.635 vs. 0.629, for SS vs. cSS, p=0.599) but cSS was superior to SS in predicting TLF (AUC: 0.625 vs. 0.680, for SS vs. cSS, p=0.008). When stratified according to each stent, higher SS tertiles were significantly associated with increased risk of POCE and TLF in both EES and SES. Conclusion Both SS and cSS were applicable to unrestricted use of ‘limus’ stents to predict the risk of 1-year adverse clinical outcomes. The predictability of SS and cSS was similar for POCE but the inclusion of clinical variables improved predictability of the SS for TLF.

Acute and 16‐month outcomes of a new stent: The first‐in‐man evaluation of the medtronic S9 (integrity) stent

A first-in-man evaluation of the safety, feasibility, deliverability, and efficacy of the new Medtronic S9 (Integrity) bare metal stent (BMS) in complex coronary diseases. Excellent deliverability remains an unmet clinical need among stents especially in complex lesions. The S9 (Integrity) BMS utilizes a new, continuous sinusoidal manufacturing technology to enhance stent flexibility and deliverability, without sacrificing radial strength. This is a first-in-man, open label observational study in 15 patients treated with S9 (Integrity) BMS. Device success during implantation, clinical outcomes, 30-day and 12-month device-oriented and patient-oriented composite efficacy end-points, and 16-month angiographic restudy were evaluated (with amended protocols). Thirty-four stents were deployed to treat 30 complex lesions. Mean lesion length was 22.93 ± 11.78 mm, and mean percentage diameter stenosis was 78.59% ± 9.01%. Mean stent delivery time was 125 ± 68.3 sec. Acute device, lesion, and procedure success, as defined, were 100%. Device-oriented and patient-oriented composite end-points were zero at 30 days. Two patients had ischemic driven revascularization before 12 months. One patient had non-cardiac death at 13 months; all remaining 12 patients received 16 months angiographic restudy and only one had angiographic restenosis. The mean diameter of stenosis was 27.0% ± 18.3%, and mean late loss was 0.73 ± 0.50 mm. Total target vessel failure rate was 21.4% (3/14) at 16 months. The new S9 (Integrity) BMS exhibited excellent deliverability, flexibility, and conformability, contributing to good acute and 16 months outcomes in complex cases.

The Prognostic Utility of the SYNTAX Score on 1-Year Outcomes After Revascularization With Zotarolimus- and Everolimus-Eluting Stents: A Substudy of the RESOLUTE All Comers Trial

This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents. The SXscore can identify patients treated with PCI who are at highest risk of adverse events. The SXscore was calculated prospectively in 2,033 of the 2,292 patients enrolled in the RESOLUTE All Comers study (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). Clinical outcomes in terms of a patient-oriented composite endpoint (POCE) of all-cause death, myocardial infarction (MI), and repeat revascularization; the individual components of POCE; target lesion failure (TLF) (a composite of cardiac death, target-vessel MI, and clinically driven target lesion revascularization); and stent thrombosis were subsequently stratified according to SXscore tertiles: SXscore(LOW) ≤ 9 (n = 698), 9 <SXscore(MID) ≤ 17 (n = 676); SXscore(HIGH) >17 (n = 659). At 12-month follow-up, rates of POCE, MI, repeat revascularization, TLF, and the composite of death/MI were all significantly higher in patients in the highest SXscore tercile. Rates of stent thrombosis were all highest in the SXscore(HIGH) tertile (p > 0.05). After multivariate adjustment, the SXscore was identified as an independent predictor of POCE, MI, repeat revascularization, and TLF (p < 0.05 for all). At 12-month follow-up, the SXscore, ACEF score, and Clinical SXscore had C-statistics of 0.57, 0.78, and 0.67, respectively, for mortality and of 0.62, 0.56, 0.63, respectively, for POCE. No significant between-stent differences were observed for TLF or POCE in any of the SXscore tertiles. The SYNTAX score is able to stratify risk amongst an all-comers population treated with PCI with second-generation drug-eluting stents (DES); however, improvements can be made with the inclusion of clinical variables. (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084).

Long-Term Clinical Results Following Stenting of the Left Main Stem: Insights From RESEARCH (Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital) and T-SEARCH (Taxus-Stent Evaluated at Rotterdam Cardiology Hospital) Registries

We investigated the long-term clinical outcomes and independent predictors of major cardiac events in unprotected left main coronary artery disease (ULMCA) patients treated by percutaneous coronary intervention with drug-eluting stent (DES). There is limited information on long-term (>3 years) outcomes after DES implantation for ULMCA. Furthermore, bifurcation angle and SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score are emerging as parameters for patient risk stratification, and their prognostic implications have still to be elucidated. One hundred forty-eight patients with ULMCA treated with DES were analyzed and compared with a historical cohort of 79 patients who received bare-metal stents for the treatment of ULMCA. Patient-oriented composite end point was defined as the occurrence of all-cause death, any myocardial infarction, or any revascularization. The 4-year cumulative incidence of all-cause death, any myocardial infarction, any revascularization, and patient-oriented composite were 35.6%, 3.8%, 25.2%, and 54.4%, respectively. These end points had relatively increased from 1 year to 4 years by Delta70%, Delta5%, Delta50%, and Delta68%, respectively. When compared with a historical cohort who received bare-metal stents for ULMCA treatment, landmark analysis performed after the first 2 years of follow-up demonstrated that the DES cohort had significantly higher patient-oriented composite end point over the last 2 years of follow-up (26% vs. 8%, p = 0.02). EuroSCORE (European System for Cardiac Operative Risk Evaluation), cardiogenic shock, and SYNTAX score were identified as independent predictors for the 4-year patient-oriented composite, whereas bifurcation angle was not. Late increase in patient-oriented composite end points after DES implantation for ULMCA warrants careful and long-term follow-up. SYNTAX score and EuroSCORE appear to have a significant prognostic value in long-term patient risk.