Final 5-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial (A Trial of Everolimus-Eluting Stents and Paclitaxel Stents for Coronary Revascularization in Daily Practice).

OBJECTIVES: This study sought to report the 5-year outcomes of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an all-comers population undergoing percutaneous coronary intervention (PCI). BACKGROUND: The medium-term 1 and 2-year results of the prospective randomized COMPARE trial (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) showed superior clinical outcomes with EES compared with PES in an all-comers PCI population. Whether this benefit is sustained over longer-term follow-up is unknown. Furthermore, systematic long-term follow-up data on these metallic drug eluting stents with durable polymers are scarce. METHODS: We randomly assigned 1,800 patients undergoing PCI to EES or PES. The pre-specified composite primary endpoint was death, myocardial infarction (MI), or target vessel revascularization (TVR). RESULTS: Follow-up at 5 years was completed in 1,791 (99.5%) patients. Treatment with EES compared with PES led to a relative risk reduction of the primary endpoint by 27% (18.4% vs. 25.1%, p = 0.0005), driven by lower rates of MI (7.0% vs. 11.5%, p = 0.001) and TVR (7.4% vs. 11.4%, p = 0.003), but not with mortality (9.0% vs. 10.3%, relative risk 0.88, p = 0.36). Moreover, patients treated with EES compared with PES had lower rates of definite/probable stent thrombosis at 5 years (3.1% vs. 5.9%, p = 0.005). The hazard curves for TVR, MI, and stent thrombosis diverge over the first 3 years and, subsequently, progress in parallel. CONCLUSIONS: The early- and medium-term superiority of EES over PES measured both by safety and efficacy endpoints is sustained at 5 years in this all-comer population. (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice [COMPARE]; NCT01016041).

Everolimus-eluting stents and paclitaxel-eluting stents in patients presenting with myocardial infarction: insights from the two-year results of the COMPARE prospective randomised controlled trial.

AIMS: Although large clinical trials have shown that everolimus-eluting stents (EES) significantly reduce target vessel revascularisation (TVR), myocardial infarction (MI) and stent thrombosis (ST) compared to paclitaxel-eluting stents (PES) in diverse populations, there is a paucity of data comparing EES and PES in patients presenting with MI. METHODS AND RESULTS: We performed a post hoc subgroup analysis on COMPARE, an all-comer trial comparing EES to PES. We identified 863 patients (EES=434, PES=429 treated for MI: 452 ST-elevation MI (STEMI) and 411 non ST-elevation MI (NSTEMI). EES was associated with a significant reduction in the primary endpoint, a composite of all-cause mortality, MI, and TVR, at two years (RR=0.57; 95% CI: 0.40-0.83, p=0.002). While the effect was more marked in the STEMI (RR=0.51; 95% CI: 0.30-0.87, p=0.01) than the NSTEMI subgroup (RR=0.65; 95% CI: 0.39-1.08, p=0.09), the interaction p-value (0.5) suggests that a difference in treatment effect between presentations is unlikely. ST rates were significantly lower with EES (RR=0.30; 95% CI: 0.12-0.73, p=0.005). CONCLUSIONS: At two years, EES results are superior to PES in terms of safety and efficacy endpoints in treatment of MI.

2-year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice. COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTÉ stent in all-comers: a randomized open label trial).

OBJECTIVES: The purpose of this study was to compare the safety and efficacy of the Xience V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) with the Taxus Liberté (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) at 2-year follow-up. BACKGROUND: COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTÉ stent in all-comers: a randomized open label trial) demonstrated a superior clinical outcome of EES over PES at 1 year in all comers. Whether this superiority is maintained after discontinuation, at 12 months, of dual antiplatelet therapy is unclear. METHODS: Patients undergoing percutaneous coronary intervention with limited exclusion criteria were randomly allocated to EES or PES. The 2-year pre-specified endpoints are composites of safety and efficacy and stent thrombosis. RESULTS: Follow-up was completed in 1,795 of 1,800 patients (99.7%). The groups had similar baseline characteristics. At 2 years, significantly fewer EES patients took dual antiplatelet therapy (11.4% vs. 15.4%, p = 0.02). The primary composite of all death, nonfatal myocardial infarction, and target vessel revascularization occurred in 9.0% of EES patients and 13.7% of PES patients (relative risk [RR]: 0.66; 95% confidence interval [CI]: 0.50 to 0.86) driven by a lower rate of myocardial infarction (3.9% vs. 7.5%; RR: 0.52; 95% CI: 0.35 to 0.77) and target vessel revascularization (3.2% vs. 8.0%; RR: 0.41; 95% CI: 0.27 to 0.62), in parallel with a lower rate of definite or probable stent thrombosis (0.9% vs. 3.9%; RR: 0.23; 95% CI: 0.11 to 0.49). Differences significantly increased between 1- and 2-year follow-up for the primary composite endpoint (p = 0.04), target vessel revascularization (p = 0.02), and definite or probable stent thrombosis (p = 0.02). CONCLUSIONS: The substantial clinical benefit of the EES over the PES with regard to measures of both safety and efficacy is maintained at 2 years in real-life practice with an increasing benefit in terms of safety and efficacy between 1 year and 2 years.

Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial.

BACKGROUND: Everolimus-eluting and paclitaxel-eluting stents, compared with bare metal stents, reduced the risk of restenosis in clinical trials with strict inclusion and exclusion criteria. We compared the safety and efficacy of the second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice. METHODS: We randomly assigned 1800 consecutive patients (aged 18-85 years) undergoing percutaneous coronary intervention at one centre to treatment with everolimus-eluting or paclitaxel-eluting stents. The primary endpoint was a composite of safety and efficacy (all-cause mortality, myocardial infarction, and target vessel revascularisation) within 12 months. Patients were not told which stent they had been allocated. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01016041. FINDINGS: Follow-up was completed in 1797 patients. The primary endpoint occurred in 56 (6%) of 897 patients in the everolimus-eluting stent group versus 82 (9%) of 903 in the paclitaxel-eluting stent group (relative risk 0.69 [95% CI 0.50-0.95], p value for superiority=0.02). The difference was attributable to a lower rate of stent thrombosis (6 [<1%] vs 23 [3%], 0.26 [0.11-0-64], p=0.002), myocardial infarction (25 [3%] vs 48 [5%], 0.52 [0.33-0.84], p=0.007), and target vessel revascularisation (21 [2%] vs 54 [6%], 0.39 [0.24-0.64], p=0.0001). Cardiac death, non-fatal myocardial infarction, or target lesion revascularisation occurred in 44 [5%] patients in the everolimus-eluting stent group versus 74 [8%] patients in the paclitaxel-eluting stent group, p value for superiority was 0.005. INTERPRETATION: The everolimus-eluting stent is better than the second generation paclitaxel-eluting stent in unselected patients in terms of safety and efficacy. On the basis of our results, we suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice. FUNDING: Unrestricted grants from Abbott Vascular and Boston Scientific.

MAHOROBA, first-in-man study: 6-month results of a biodegradable polymer sustained release tacrolimus-eluting stent in de novo coronary stenoses.

AIMS: To report the 4-month angiographic and 6-month clinical follow-up in first-in-man study using the tacrolimus-eluting bioabsorbable polymer-coated cobalt-chromium MAHOROBA stent. METHODS AND RESULTS: A total of 47 patients with either stable angina or unstable angina, or silent myocardial ischaemia, based on a de novo coronary stenosis that could be covered by a single 18 mm stent in a native coronary artery with a diameter between 3.0 and 3.5 mm were enrolled at three sites. The primary endpoint was in-stent late loss at 4 months. The secondary endpoints include %volume obstruction of the stents assessed by intravascular ultrasound (IVUS) at 4 months and major adverse cardiac events (MACE) at 6 months. Forty-seven patients were enrolled. Procedural success was achieved in 97.9%. At 4-month follow-up, in-stent late loss was 0.99 +/- 0.46 mm, whereas in-stent %volume obstruction in IVUS was 34.8 +/- 15.8%. At 6 months, there were no deaths, but 2 patients suffered from a myocardial infarction and 11 patients required ischaemia-driven repeat revascularization. The composite MACE rate was 23.4%. CONCLUSION: This tacrolimus-eluting stent failed to prevent neointimal hyperplasia, despite the theoretical advantages of the tacrolimus, which has less inhibitory effects on endothelial cells than smooth muscle cells.