Element Everolimus-eluting Stent Research Articles

5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents: Final Report of the DUTCH PEERS (TWENTE II) Trial

ObjectivesThe study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts). BackgroundThe DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices. MethodsIn total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated. ResultsFive-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83). ConclusionsAt 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.

One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study.

The PROMUS™ Element™ European Post-Approval Surveillance Study (PE-Prove) is a prospective, open-label, multicentre observational study designed to assess outcomes following PROMUS Element everolimus-eluting stent implantation in an unselected patient population. A total of 1,010 patients were enrolled at 40 clinical sites in Europe, including 24.9% with medically treated diabetes, 50.0% with Type B2/C lesions, 6.1% with chronic total occlusion, 17.8% with acute myocardial infarction (MI ≤24 hours pre-procedure), and 20.1% with unstable angina. The target lesion was the culprit for ST-segment elevation MI in 7.3% of patients. The one-year, per patient target vessel failure rate was 6.2% (60/975), 3.4% (33) being related to the PROMUS Element stent. Rates of cardiac death, MI, and Academic Research Consortium (ARC) definite/probable stent thrombosis were 1.7%, 3.5%, and 0.6%, respectively. The target vessel revascularisation rate was 3.2% (31/975), 2.1% (20) being related to the PROMUS Element stent. In a large and relatively complex group of "real-world" patients, coronary artery revascularisation with the PROMUS Element everolimus-eluting stent provides favourable results with low event rates consistent with those reported for other contemporary drug-eluting stents.

TCT-27 Comparison of Novel Zotarolimus-Eluting Cobalt-Chromium Stents and Everolimus-Eluting Platinum-Chromium Stents in Patients of the Randomized DUTCH PEERS Trial Presenting with Acute Myocardial Infarction

Background: Biocompatible durable polymer coatings for drug-eluting stents (DES) were developed to reduce the risk of stent thrombosis, which is generally increased in the setting of acute myocardial infarction (MI). These coatings are used on novel, flexible, and highly deliverable third-generation DES, investigated in the randomized, multicenter, all-comer DUTCH PEERS (TWENTE II) trial. Of the 1,811 eligible all-comer patients of DUTCH PEERS, 817 (45%) were treated in the setting of acute MI. Methods: We assessed the one-year safety and efficacy of the Resolute Integrity zotarolimus-eluting stent (ZES) (Medtronic, Santa Rosa, CA, USA) and Promus Element everolimus-eluting stent (EES) (Boston Scientific, Natick, MA, USA) in 817 DUTCH PEERS patients who were treated for acute MI. One-year follow-up data of all patients were obtained; adverse events were externally adjudicated by an independent committee. The primary endpoint was target vessel failure (TVF) at 1-year, a composite of cardiac death, target vessel related MI, and clinically indicated target vessel revascularization. Secondary endpoints included all the individual components of the primary endpoint, the incidence of stent thrombosis (ST), and the patient-oriented clinical endpoint (POCE). Results: Patient and lesion characteristics did not differ between groups with the only exception being higher proportions of severely calcified lesions (87/548(16%) vs. 108/500(22%), p=0.02) and stent postdilatation in EES (402/548 (73%) vs. 400/500 (80%), p=0.01). At one year, TVF did not differ significantly between the two stent arms (20/421(5%) vs. 15/396 (4%, p=0.50). In addition, POCE was 8% (32/421) for ZES and 6% (23/396) for EES (p=0.31). Definite-or-probable ST rates were very low and similar in both groups (2/421 (0.5%) vs. 1/396 (0.3%), p=1.00). Conclusions: One-year follow-up of DUTCH PEERS patients, who were treated for acute MI, demonstrated excellent clinical results with a similar and sustained safety and efficacy of the Resolute Integrity ZES and the Promus Element EES.

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.

Japanese and non-Japanese patient outcomes in the PLATINUM randomized trial comparing the PROMUS Element and XIENCE V everolimus-eluting stents

BackgroundThe 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. MethodsPatients with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter ≥2.50mm to ≤4.25mm and length ≤24mm) were randomized 1:1 to PtCr-EES (N=63 patients in Japan) versus CoCr-EES (N=61 patients in Japan). ResultsSeveral 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). ConclusionsThis PLATINUM study subanalysis suggests that the PtCr-EES and CoCr-EES provide comparable safety and efficacy in both Japanese and non-Japanese patients.

CRT-47 Two-Year Outcomes Following Platinum Chromium Everolimus-Eluting Stent Implantation in Small Vessel Lesions in Japan

Small vessel diameter is associated with increased restenosis rates and adverse outcomes following coronary stenting. The PLATINUM Japan Small Vessel multicenter study specifically assessed small vessel stenting in Japanese patients treated with the PROMUS Element everolimus-eluting stent (Boston

PLATINUM QCA: a prospective, multicentre study assessing clinical, angiographic, and intravascular ultrasound outcomes with the novel platinum chromium thin-strut PROMUS Element everolimus-eluting stent in de novo coronary stenoses

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