The Experts below are selected from a list of 1974 Experts worldwide ranked by ideXlab platform

Laura Mauri - One of the best experts on this subject based on the ideXlab platform.

  • rationale of a novel study design for the bioflow v study a prospective randomized multicenter study to assess the safety and efficacy of the orsiro sirolimus eluting coronary stent system using a bayesian approach
    American Heart Journal, 2017
    Co-Authors: Gheorghe Doros, Jacques J Koolen, David E Kandzari, Laura Mauri, Joseph M Massaro, Donald E Cutlip, Ron Waksman
    Abstract:

    Background Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with Bioresorbable Polymer compared with DES most commonly in use today that use durable Polymers for drug elution. Study design and objectives This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro Bioresorbable Polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable Polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N = 452 and BIOFLOW IV, N = 579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization. Conclusions The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the comparison.

  • ultrathin Bioresorbable Polymer sirolimus eluting stents versus thin durable Polymer everolimus eluting stents in patients undergoing coronary revascularisation bioflow v a randomised trial
    The Lancet, 2017
    Co-Authors: David E Kandzari, Jacques J Koolen, Laura Mauri, Joseph M Massaro, Gheorghe Doros, Hector M Garciagarcia, Johan Bennett, Ariel Roguin, Elie Gharib, Donald E Cutlip
    Abstract:

    Summary Background The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of Bioresorbable Polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a Bioresorbable Polymer sirolimus-eluting stent compared with a durable Polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention. Methods BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) Bioresorbable Polymer sirolimus-eluting stent or to a durable Polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of Bioresorbable Polymer sirolimus-eluting stent and durable Polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946. Findings Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with Bioresorbable Polymer sirolimus-eluting stents (n=884) or durable Polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the Bioresorbable Polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable Polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI −6·84 to −0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the Bioresorbable Polymer sirolimus-eluting stent is non-inferior to the durable Polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency −2·6% [95% credible interval −5·5 to 0·1], non-inferiority margin 3·85%, n=2208). Interpretation The outperformance of the ultrathin, Bioresorbable Polymer sirolimus-eluting stent over the durable Polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology. Funding BIOTRONIK.

Adel Aminian - One of the best experts on this subject based on the ideXlab platform.

  • thin composite wire strut zotarolimus eluting stents versus ultrathin strut sirolimus eluting stents in bionyx at 2 years
    Jacc-cardiovascular Interventions, 2020
    Co-Authors: Rosaly A Buiten, Paolo Zocca, Ariel Roguin, Eline H Ploumen, Carine J M Doggen, Gillian A J Jessurun, Carl E Schotborgh, Peter W Danse, Edouard Benit, Adel Aminian
    Abstract:

    Abstract Objectives The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-Polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-Polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis. Background The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates. Methods A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel–related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods. Results Two-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% [log-rank p = 0.75], target lesion revascularization 4.0% vs. 4.4% [log-rank p = 0.77]). Conclusions At 2-year follow-up, the novel thin composite-wire-strut durable-Polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-Polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.

  • thin composite wire strut durable Polymer coated resolute onyx versus ultrathin cobalt chromium strut Bioresorbable Polymer coated orsiro drug eluting stents in allcomers with coronary artery disease bionyx an international single blind randomised non inferiority trial
    The Lancet, 2018
    Co-Authors: Paolo Zocca, Ariel Roguin, Rosaly A Buiten, Gillian A J Jessurun, Carl E Schotborgh, Peter W Danse, Edouard Benit, Clemens Von Birgelen, Adel Aminian
    Abstract:

    Summary Background During the past decade, many patients had zotarolimus-eluting stents implanted, which had circular shape cobalt–chromium struts with limited radiographic visibility. The Resolute Onyx stent was developed to improve visibility while reducing strut thickness, which was achieved by using a novel composite wire with a dense platinum–iridium core and an outer cobalt–chromium layer. We did the first randomised clinical trial to assess the safety and efficacy of this often-used stent compared with the Orsiro stent, which consists of ultrathin cobalt–chromium struts. Methods We did an investigator-initiated, assessor-blinded and patient-blinded, randomised non-inferiority trial in an allcomers population at seven independently monitored centres in Belgium, Israel, and the Netherlands. Eligible participants were aged 18 years or older and required percutaneous coronary intervention with drug-eluting stents. After guide wire passage with or without predilation, members of the catheterisation laboratory team used web-based computer-generated allocation sequences to randomly assign patients (1:1) to either the Resolute Onyx or the Orsiro stent. Randomisation was stratified by sex and diabetes status. Patients and assessors were masked to allocated stents, but treating clinicians were not. The primary endpoint was target vessel failure at 1 year, a composite of cardiac death, target-vessel-related myocardial infarction, and target vessel revascularisation, and was assessed by intention to treat (non-inferiority margin 2·5%) on the basis of outcomes adjudicated by an independent event committee. This trial is registered with ClinicalTrials.gov , number NCT02508714 . Findings Between Oct 7, 2015, and Dec 23, 2016, 2516 patients were enrolled, 2488 of whom were included in the intention-to-treat analysis (28 withdrawals or screening failures). 1243 participants were assigned to the Resolute Onyx group, and 1245 to the Orsiro group. Overall, 1765 (70·9%) participants presented with acute coronary syndromes and 1275 (51·2%) had myocardial infarctions. 1-year follow-up was available for 2478 (99·6%) patients. The primary endpoint was met by 55 (4·5%) patients in the Resolute Onyx group and 58 (4·7%) in the Orsiro group. Non-inferiority of Resolute Onyx to Orsiro was thus established (absolute risk difference −0·2% [95% CI −1·9 to 1·4]; upper limit of the one-sided 95% CI 1·1%; p non-inferiority =0·0005). Definite or probable stent thrombosis occurred in one (0·1%) participant in the Resolute Onyx group and nine (0·7%) in the Orsiro group (hazard ratio 0·11 [95% CI 0·01–0·87]; p=0·0112). Interpretation The Resolute Onyx stent was non-inferior to Orsiro for a combined safety and efficacy endpoint at 1-year follow-up in allcomers. The low event rate in both groups suggests that both stents are safe, and the very low rate of stent thrombosis in the Resolute Onyx group warrants further clinical investigation. Funding Biotronik and Medtronic.

  • functional comparison between the buma supreme biodegradable Polymer sirolimus eluting stent and a durable Polymer zotarolimus eluting coronary stent using quantitative flow ratio pioneer qfr substudy
    Eurointervention, 2018
    Co-Authors: Taku Asano, Salvatore Brugaletta, Giovanni Amoroso, Yuki Katagiri, Carlos Collet, Erhan Tenekecioglu, Yosuke Miyazaki, Yohei Sotomi, Adel Aminian, Mathias Vrolix
    Abstract:

    AIMS: Quantitative Flow Ratio (QFR) based on 3-dimensional quantitative coronary angiography (3D-QCA) is a novel method to assess the physiological functionality after treatment with stents. The current study aimed to evaluate the difference in physiological functionality 9 months after implantation of a Bioresorbable Polymer-based sirolimus-eluting stent with an electrografting base layer (BuMA Supreme: B-SES) versus a durable Polymer-based zotarolimus-eluting stent (Resolute: R-ZES). METHODS AND RESULTS: The current post-hoc analysis was performed in the PIONEER randomized trial (1:1 randomization to B-SES [83 patients/95 lesions] and R-ZES [87 patients/101 lesions]). QFR was measured in stented vessels in both arms at pre-procedural, post-procedural and 9-month angiography without pharmacologically induced hyperemia (contrast QFR). At 9 months, both the values of QFR distal to the stent (B-SES: 0.89 +/- 0.10 vs. R-ZES: 0.89 +/- 0.11, p=0.97) and the numbers of the vessels with QFR =0.8 were not significantly different between the two groups (11.0% vs. 12.8%, p=0.72), while the in-stent binary restenosis rate was also comparable (3.7% versus 3.5%, P=1.00). QFR gradient across the device (?QFR) at 9 months was also similar between both groups (B-SES: 0.03 +/- 0.04 vs. R-ZES: 0.03 +/- 0.07, p=0.95). CONCLUSIONS: Quantitative flow assessment 9 months after stenting did not differ between B-SES and R-ZES, despite of a significant difference in in-stent late lumen loss.

Olivier Varenne - One of the best experts on this subject based on the ideXlab platform.

  • comparison of the biodegradable Polymer everolimus eluting stent with contemporary drug eluting stents a systematic review and meta analysis
    International Journal of Cardiology, 2019
    Co-Authors: Fabien Picard, Michele Pighi, Quentin De Hemptinne, Juhani Airaksinen, Giulia Vinco, Aurelien De Pommereau, Fausto Biancari, Olivier Varenne
    Abstract:

    Abstract Aims Despite similar efficacy and safety profile in pilot studies, Bioresorbable Polymer drug-eluting stents (BP-DES) could have potential benefit over latest generation durable Polymer (DP)-DES by facilitating vessel healing, therefore reducing inflammation and neoatherosclerosis leading to enhanced clinical safety. Therefore, we sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of everolimus-eluting BP-DES (BP-EES) to second-generation DP-DES. Methods and results We conducted a systematic review and meta-analysis to examine the safety and efficacy of BP-EES in patients treated for coronary artery disease. We searched PubMed, Scopus, and the Cochrane Library through February 2018 for RCTs that included outcome data on BP-EES. We identified four eligible studies, which included a total of 4631 patients. Three studies reported a follow-up of one year and one study of five years. The BP-EES group, included 2315 patients and the DP-DES group included 2316 patients (1143 treated with DP-EES and 1173 treated with zotarolimus eluting DP-DES). Patient's characteristics were comparable between the two groups except for higher prevalence of prior MI in the DP-DES group (25.7 vs 22.5%, respectively, p = 0.001). Procedural characteristics were comparable among groups except for slightly longer lesions in the BP-EES group compared to the DP-DES group (mean 15.1 vs 14.9 mm, p = 0.04). No significant differences were observed for cardiac mortality (p = 0.72), occurrence of MI (p = 0.64), any TLR (p = 0.93), ST (p = 0.85) or major adverse cardiac events (p = 0.43). Conclusion Overall, based on the available data BP-EES had similar one-year outcomes to contemporary DP-DES. Whether these devices could enhance clinical safety remains to be evaluated at longer follow-up.

  • Bioresorbable Polymer sirolimus-eluting coronary stent compared with permanent Polymer everolimus-eluting coronary stent implantation for treatment of small vessel coronary artery disease: CENTURY II trial.
    Eurointervention, 2016
    Co-Authors: Jochen Wöhrle, Antonio Serra, David Antoniucci, Toshiya Muramatsu, Kazushige Kadota, Sinisa Markovic, Wolfgang Rottbauer, Nicolás Vázquez-gonzález, Jacob Odenstedt, Olivier Varenne
    Abstract:

    AIMS CENTURY II is a prospective, multicentre, randomised, single-blind trial comparing the Bioresorbable Polymer sirolimus-eluting Ultimaster® stent (BP-SES) with the permanent Polymer everolimus-eluting XIENCE stent (PP-EES). Here we present a pre-specified analysis of safety and efficacy outcomes in a subgroup of patients with small vessel coronary artery disease. METHODS AND RESULTS CENTURY II included 525 patients with lesions of reference diameter ≤2.5 mm. Treatment was randomly assigned: 277 patients received BP-SES (399 lesions) and 248 patients received PP-EES (377 lesions). The primary outcome was target lesion failure (TLF), which is a composite of cardiac death, target vessel-related myocardial infarction (MI) and target lesion revascularisation (TLR). There was no significant difference between treatment groups in baseline or procedural data. Mean pre-procedural reference diameter was similar (BP-SES 2.30±0.40 mm, PP-EES 2.31±0.42 mm, p=0.59). Stented length was 24.0±11.7 mm for BP-SES and 23.5±11.5 mm for PP-EES (p=0.45). At 12 months, there was no significant difference between the BP-SES and PP-EES groups in TLF (6.9% vs. 7.7%; p=0.72), cardiac death (1.1% vs. 1.2%; p=0.90), target vessel MI (1.8% vs. 3.2%; p=0.30), TLR (4.0% vs. 5.7%; p=0.37), or definite or probable stent thrombosis (0.7% vs. 1.2%; p=0.57). CONCLUSIONS In the large-scale, randomised CENTURY II trial, use of BP-SES and PP-EES for the treatment of small vessel coronary artery disease resulted in similar outcomes at 12 months.

Ran Kornowski - One of the best experts on this subject based on the ideXlab platform.

Jacques J Koolen - One of the best experts on this subject based on the ideXlab platform.

  • rationale of a novel study design for the bioflow v study a prospective randomized multicenter study to assess the safety and efficacy of the orsiro sirolimus eluting coronary stent system using a bayesian approach
    American Heart Journal, 2017
    Co-Authors: Gheorghe Doros, Jacques J Koolen, David E Kandzari, Laura Mauri, Joseph M Massaro, Donald E Cutlip, Ron Waksman
    Abstract:

    Background Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with Bioresorbable Polymer compared with DES most commonly in use today that use durable Polymers for drug elution. Study design and objectives This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro Bioresorbable Polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable Polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N = 452 and BIOFLOW IV, N = 579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization. Conclusions The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the comparison.

  • ultrathin Bioresorbable Polymer sirolimus eluting stents versus thin durable Polymer everolimus eluting stents in patients undergoing coronary revascularisation bioflow v a randomised trial
    The Lancet, 2017
    Co-Authors: David E Kandzari, Jacques J Koolen, Laura Mauri, Joseph M Massaro, Gheorghe Doros, Hector M Garciagarcia, Johan Bennett, Ariel Roguin, Elie Gharib, Donald E Cutlip
    Abstract:

    Summary Background The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of Bioresorbable Polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a Bioresorbable Polymer sirolimus-eluting stent compared with a durable Polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention. Methods BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) Bioresorbable Polymer sirolimus-eluting stent or to a durable Polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of Bioresorbable Polymer sirolimus-eluting stent and durable Polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946. Findings Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with Bioresorbable Polymer sirolimus-eluting stents (n=884) or durable Polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the Bioresorbable Polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable Polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI −6·84 to −0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the Bioresorbable Polymer sirolimus-eluting stent is non-inferior to the durable Polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency −2·6% [95% credible interval −5·5 to 0·1], non-inferiority margin 3·85%, n=2208). Interpretation The outperformance of the ultrathin, Bioresorbable Polymer sirolimus-eluting stent over the durable Polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology. Funding BIOTRONIK.

  • randomized comparison of the nobori biolimus a9 eluting coronary stent with the taxus liberte paclitaxel eluting coronary stent in patients with stenosis in native coronary arteries the nobori 1 trial phase 2
    Circulation-cardiovascular Interventions, 2009
    Co-Authors: Bernard Chevalier, Karl Eugen Hauptmann, Harry Suryapranata, Jacques J Koolen, Seungjung Park, Sigmund Silber, Gerhard Schuler, William Wijns, Eulogio Garcia, Marie-claude Morice
    Abstract:

    Background —The newly developed Nobori coronary stent coated with a Bioresorbable Polymer, poly-lactic acid, and the anti-proliferative agent Biolimus A9 has the potential to reduce restenosis by suppressing neointima formation. Methods and Results —We conducted a randomized (2:1), controlled trial comparing the Biolimus A9-eluting stent Nobori and the paclitaxel-eluting stent Taxus Liberte, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia and Australia. Patients with previously untreated lesions in up to two native coronary arteries were considered for enrolment. The primary endpoint was in-stent late loss at 9 months, while secondary endpoints included other QCA parameters, such as in-segment late loss and the rate of restenosis as well as key IVUS parameters. Clinical secondary endpoints were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction and target vessel revascularization. At nine months the in-stent late loss was significantly lower in the Nobori group as compared to the Taxus group (0.11±0.30 mm versus 0.32±0.50 mm) reaching both the primary hypothesis of non-inferiority of Nobori stent versus Taxus Liberte stent (p<0.001), and the secondary hypothesis of superiority (p=0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (p=0.02) and neointimal volume obstruction, detected by IVUS, from 5.5±7.2% in Taxus to 1.8±5.2% in Nobori (p=0.01). Major adverse cardiac events rate was 4.6% in Nobori and 5.6% in Taxus cohort of patients. The stent thrombosis rate was 0% in the Nobori arm and 4.4% in the Taxus arm. Conclusions —The NOBORI 1 clinical trial confirmed its primary hypothesis - non-inferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberte stent in reducing neointimal proliferation. Both stents showed low major adverse cardiac events rate in the studied population.