Randomized Comparison of the Nobori Biolimus A9-Eluting Coronary Stent With the Taxus Liberté Paclitaxel-Eluting Coronary Stent in Patients With Stenosis in Native Coronary Arteries

Abstract

for the NOBORI 1 Clinical InvestigatorsBackground-The newly developed Nobori coronary stent coated with a bioresorbable polymer, polylactic acid, and the antiproliferative 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 Liberté, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia, and Australia. Patients with previously untreated lesions in up to 2 native coronary arteries were considered for enrollment. The primary end point was in-stent late loss at 9 months, whereas secondary end points included other quantitative coronary angiography parameters, such as in-segment late loss and the rate of restenosis as well as key intravascular ultrasound parameters. Clinical secondary end points were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction, and target vessel revascularization. At 9 months, the in-stent late loss was significantly lower in the Nobori group compared with the Taxus group (0.11Ϯ0.30 mm versus 0.32Ϯ0.50 mm) reaching both the primary hypothesis of noninferiority of Nobori stent versus Taxus Liberté stent (PϽ0.001) and the secondary hypothesis of superiority (Pϭ0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (Pϭ0.02) and neointimal volume obstruction, detected by intravascular ultrasound, from 5.5Ϯ7.2% in Taxus to 1.8Ϯ5.2% in Nobori (Pϭ0.01). The major adverse cardiac events rate was 4.6% in the Nobori and 5.6% in the 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-noninferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberté stent in reducing neointimal proliferation. Both stents showed a low major adverse cardiac events rate in the studied population. (Circ Cardiovasc Intervent. 2009;2:188-195.)

Advantages and disadvantages of biodegradable platforms in drug eluting stents

“…In the following paragraphs we will review and summarize the main findings from published randomized data of the Limus Eluted from a Durable vs Erodable Stent Coating (LEADERS) [28] , NOBORI [33,34] , Individualized Drug Eluting Stent System to Abrogate Restenosis (ISAR)-TEST-3 [35] and TEST-4 [36,37] with sirolimus (rapamycin), PAINT (percutaneous intervention with BIO-polymer based paclitaxel-eluting or sirolimus-eluting vs bare stents for de novo coronary lesions) [38] and EUCATAX [39] trials. Study and stent design of each trial is described in Table 1.…”

“…In this trial [33,34] , 243 patients were randomized in a 2:1 ratio between Biolimus with BIO polymer stents (Nobori) and paclitaxel with durable polymer stents (Taxus).…”

Real world experience of GenXSync and trade; sirolimus eluting coronary stent system in patients with long coronary lesions: outcome of the GEL registry

“…2,3 These techniques have effectively enhanced efficacy and safety of the DES as reported in the SPIRIT group of studies LEADERS, STEALTH, NOBORI 1 trial and Meri T-I studies. [4][5][6][7][8][9][10] Late lumen loss is considered as the surrogate of neo-intimal hyperplasia; the latter being an indicator of DES efficacy. 11 Whereas drug and its dose on the stent remains an important factor influencing neo-endothelial growth, the most important among mechanical factors is the strut thickness of the stent.…”

Biocompatibility Assessment of Biosorbable Polymer Coated Nitinol Alloys

“…In-vivo studies conducted by Joner M. et al [91], demonstrated an improved reendothelialization in rabbits iliofemoral artery by the usage of DES. However, an excess of late loss (reduction in vessel diameter after stent implantation) [90], lack of reduction in stent thrombosis [92,93], and a high inflammatory reaction due to major particle debris (coating degradation),were some of the limitations of DES with biodegradable polymers. Consequently, the complex process of designing and developing a DES with biodegradable polymer coating remains a challenge.…”

“…Figure 6.23 (a) and (b) show the modulus and hardness calculated by using the Oliver Pharr approach (depths above 1000 nm and peak loads above 25 mN). The modulus of NiTi alloys (79)(80)(81)(82)(83)(84)(85)(86)(87)(88)(89)(90)(91)(92)(93)(94)(95)(96)(97)(98) increased with the addition of alloying elements as did the hardness (3-7.4 GPa) (see Table 6.4 and Figure 6.23). The significance of each peak observed in the aforementioned FTIR spectra is tabulated in Table 6.5.…”