Background:Overlapping first generation drug eluting stents (DES) have been demonstrated in preclinical models to show evidence of a persistent inflammatory response, fibrin deposition and delayed endothelialisation. The SIRTAX (Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization) Trial (nϭ1012) associated the implantation of overlapping first generation DES with impaired angiographic and adverse 3-year clinical outcomes, including death or myocardial infarction (MI). Methods: Patient level data from 5 controlled studies of the RESOLUTE Global Clinical Program evaluating the RESOLUTE zotarolimus-eluting stent (R-ZES) were pooled (nϭ5130). Enrolment criteria encompassed more complex patients, including acute MI, long lesions, unprotected left main, bifurcations, total occlusions, bypass grafts & visible thrombus. The position of the R-ZES in relation to the previous implanted stents during the index or staged procedures were reported by the study site as either 'separate,' 'abutting' or 'overlapping.' Comparisons of clinical outcomes -using propensity score adjustment of baseline anatomical and clinical characteristics -were undertaken between patients implanted with at least one overlapping DES against patients with no overlapping DES (Kaplan Meier analyses). Results: 644 of 5130 study patients (12.6%) underwent overlapping DES implantation. Baseline characteristics indicated that the implantation of overlapping DES compared to non-overlapping DES (nϭ4486) were performed more frequently in the RCA and in more complex coronary lesions. Thirty day, 1 & 2 year clinical outcomes indicated comparable all-cause death (2 year overlap vs. non overlap: 5.1% vs. 3.5%, pϭ0.13), cardiac death (3.0% vs. 2.1%, pϭ0.36), MACE (13.3% vs. 10.7%, pϭ0.19), target lesion (10.9% vs. 9.0%, pϭ0.41) & target vessel (12.8% vs. 10.6%, pϭ0.25) failure, and stent thrombosis (ARC definite/probable 1.4% vs. 0.9%, pϭ0.16). Conclusions: The adverse clinical outcomes associated with 1st generation DES were not apparent with 2nd generation DES. Overlapping second generation DES (compared to the non overlap) is safe & effective with comparable 2 year clinical outcomes, including repeat revascularisation.
was 2.67Ϯ0.41 (948 lesions) versus 2.66Ϯ0.45 (500 lesions) , respectively in the BES and EES arm (pϭ0.60). At 12 months follow-up, the primary endpoint was 7.0% in the BES arm vs 7.9% in the EES arm (pϭ0.66). In the BES and EES arm, 1.6% vs 1.6% patients suffered cardiac death (pϭ1.0), 3.3% vs 3.6% MI (pϭ0.83), 4.3% vs 4.4% TVR (pϭ1.0), and 2.5% vs 2.0 TLR (pϭ0.80), respectively. Definite and probable stent thrombosis rate was 0.8% in BES and 1.6% in EES (pϭ0.45), despite similar DAPT regimens. Conclusions:In an all-comer population, treatment of small vessels with the biodegradable polymer Nobori DES showed similar outcomes compared to the everolimus eluting Xience/Promus stent. Background:The newer generation drug eluting stents (DES) have shown advantages over first generation DES, particularly relating to long term safety. However, comparative data for contemporary DES are still insufficient. We aim to compare safety and efficacy between Nobori DES, eluting Biolimus A9 from an abluminal biodegradable polymer (BES) and Xience/Promus DES eluting everolimus from a permanent polymer (EES). Methods: COMPARE II, a prospective, randomized (2:1), controlled, multi-centre study, enrolled 2707 patients (1795 BES arm, 912 EES arm) with limited exclusion criteria. The primary endpoint was a composite of safety (cardiac death, non fatal myocardial infarction-MI) and efficacy (target vessel revascularization-TVR) at 1 year. Dual antiplatelet therapy was 12 months for both arms. The primary hypothesis was non-inferiority of BES vs EES. Data were independently monitored and adverse events were adjudicated by an independent clinical event committee. Results: No significant differences were detected for any of the baseline characteristics. The patients (74% male) were ϳ63 years old, 22% had diabetes mellitus, 20% history of MI, 18% and 6% respectively had prior PCI or CABG. In both groups 58% of patients were treated for acute coronary syndrome (21% for STEMI). Lesions complexity was similar (B2/C: 63%), 14% ostial, 6% bifurcated, 20% thrombosed. Lesions were longer in EES (17.7mm vs. 16.4mm in BES, pϭ0.02), while mean number of stents per lesions was similar (1.4Ϯ0.8). The 1 year primary endpoint was 5.2% in BES arm vs 4.8% in EES arm, confirming the hypothesis of non-inferiority hypothesis (pϽ0.0001). There were no significant differences in any of the secondary endpoints: 0.8% vs 0.8% patients suffered cardiac death, 2.8% vs 2.5% had a MI, 2.9% vs 2.2% underwent TVR, and 2.7% vs 2.2% TLR in the BES and EES arm respectively. Definite and probable stent thrombosis rate was 0.8% in BES and 1.0% in EES. Conclusions: In the largest prospective randomised all-comer trial, the Nobori BES is non-inferior compared to the Xience/Promus EES. Primary and secondary endpoints in this real-life population were not significantly different between both stent groups, with similar, low cardiac death and ST rates.
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