Permanent Polymer Drug-eluting Stents Research Articles

Ten-Year Clinical Outcomes in Patients With Acute Coronary Syndrome Treated With Biodegradable, Permanent-Polymer or Polymer-Free Drug-Eluting Stents.

This study aimed to compare 10-year clinical outcomes in patients with acute coronary syndrome (ACS) treated with new-generation biodegradable-polymer (BP-DES), polymer-free (PF-DES), and permanent-polymer drug-eluting stents (PPDES). We analyzed 10-year clinical outcomes for 2042 patients with ACS enrolled in the ISAR-TEST 4 and ISAR-TEST 5 randomized controlled trials. Patients were divided into 3 groups: new-generation PP-DES, BP-DES, and PF-DES. Endpoints of interest included a device-oriented composite endpoint (DOCE) and a patient-oriented composite endpoint (POCE) at 10 years. BP-DES as compared with PP-DES demonstrated a lower DOCE frequency, but this did not meet statistical significance (BP-DES vs PP-DES, 35.4% vs 41.5%, respectively; adjusted hazard ratio (HR), 0.83; 95% confidence interval [CI], 0.68-1.00; P=.05). There was a significantly lower POCE frequency in patients treated with BP-DES compared with PP-DES (65.3% vs 69.0%, respectively; HR, 0.86; 95% CI, 0.75-0.99; P=.04). The relative frequency of the DOCE (41.4% vs 41.5%; HR, 0.97; 95% CI, 0.83-1.15; P=.76) and the POCE (66.8% vs 69.0%; HR, 0.99; 0.87-1.12; P=.82) were comparable in patients treated with PF-DES and PP-DES. In patients with ACS, BP-DES were associated with a lower relative frequency of a POCE compared with new-generation PP-DES at 10 years. The relative frequencies of both device- and patient-related outcomes were comparable in patients treated with PF-DES and PP-DES at 10 years.

Polymer free drug-eluting stents versus durable polymer drug-eluting stents in elective percutaneous coronary interventions in patients with stable coronary artery disease patients

Abstract Aim To compare the inflammatory response of polymer-free versus permanent polymer drug-eluting stents in patients with stable coronary artery disease undergoing elective PCI, and the effect of this inflammatory response on the 6 month clinical outcomes. Methods This randomized prospective comparative study was conducted on 100 patients with stable coronary artery disease planned for elective PCI divided into 50 patients with deployed permanent polymer DES (PP-DES) groups and 50 patients with polymer free DES (PF-DES). Blood samples were taken to assess serum level of hsCRP before the procedure and the first day after the procedure. The target end points were the recurrence of effort angina, incidence of target lesion revascularization (TLR) over a period of 6 months and the inflammatory response by measuring the percentage of rise in hsCRP level. Results There was no statistically significant difference in the clinical outcome in the first six months between the patients who had PP-DES and the patients who had PF-DES regarding recurrence of effort angina (p-value = 0.822) and TLR (p-value = 0.727), with no patients developing myocardial infarction or stent thrombosis. There was a statistically significant inflammatory response after stent deployment in both groups represented by a significant rise in the serum level of hsCRP on the first day after the procedure in both groups (p-value < 0.001), but there was no statistically significant difference in the inflammatory response between PP-DES and PF-DES (p-value = 0.978). The number of patients having recurrence of anginal symptoms and TLR with hsCRP rise ≥ 11.36% was higher than those having the same with hsCRP < 11.36%. However, this difference was not statistically significant regarding recurrence of anginal symptoms (p = 0.057) and TLR (p = 0.092). Conclusion The PF-DES was proved to be non-inferior to PP-DES regarding the short-term clinical outcome and the early inflammatory response. It was concluded that the presence of polymeric coating in PP-DES did not add to the magnitude of the inflammatory response and it did not significantly increase the incidence of recurrence of anginal symptoms and TLR in this group of patients.

Meta-Analysis of the Impact of Strut Thickness on Outcomes in Patients With Drug-Eluting Stents in a Coronary Artery

The aim of this network meta-analysis is to assess the impact of strut thickness on clinical outcomes in patients who underwent percutaneous coronary intervention. We searched Medline/PubMed and performed a Bayesian network meta-analysis to compare outcomes of patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) of different strut thicknesses (ultrathin 60 to 80 μm; thin 81 to 100 μm; intermediate 101 to 120 μm; thick ≥120 μm). Studies comparing DES with similar strut thickness, bare metal stents, and fully bioresorbable scaffolds were excluded. Odds ratios with credible intervals (OR [CrIs]) were generated with random-effects models to compare outcomes. Our primary end point was stent thrombosis (ST). We identified 69 RCTs including 80,885 patients (ultrathin group = 10,219; thin group = 36,575; intermediate group = 11,399; thick group = 22,692). Mean age was 64 ± 11 years and 75% were male gender. When compared with thick-strut DES, ultrathin struts had significant less ST and myocardial infarction (OR 0.43 [CrI 0.27 to 0.68]; and OR 0.73 [CrI 0.62 to 0.92], respectively). Sensitivity analysis including only studies with permanent polymer DES gave similar results. Improvement in DES technology with thinner struts is associated with significant reduction in ST and myocardial infarction compared with thicker struts.

Evolution of the SYNERGY bioresorbable polymer metallic coronary stent.

The SYNERGY stent is composed of thin, platinum-chromium metal alloy struts and an ultrathin, bioabsorbable poly-DL-lactide-co-glycolide polymer limited to the abluminal strut surface which elutes everolimus prior to complete resorption within 3-4 months. SYNERGY was designed to reduce inflammation and facilitate stent healing compared with permanent polymer drug eluting stents. This review summarizes the preclinical and clinical development of SYNERGY, its integration into clinical practice and future directions.

Long-term clinical outcomes after bioresorbable and permanent polymer drug-eluting stent implantation: final five-year results of the CENTURY II randomised clinical trial.

The aim of this study was to establish the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster) by comparison with an everolimus-eluting stent with permanent polymer (PP-EES; XIENCE). CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) is a large-scale, prospective, multicentre, randomised single-blind, controlled, non-inferiority trial conducted at 58 study sites globally, including Europe, Japan and Korea, powered to prove non-inferiority for freedom from target lesion failure (TLF: cardiac death, target vessel-related myocardial infarction [MI] and target lesion revascularisation) at nine months. Patients requiring a percutaneous coronary intervention (PCI) were randomised (1:1) to BP-SES (n=551) or PP-EES (n=550). Freedom from TLF at five years was 90.0% in the BP-SES and 91.1% in the PP-EES group (p=0.54). The patient-oriented composite endpoint (all death, any MI, any revascularisation) was 24.1 and 25.6% (p=0.57) with BP-SES and PP-EES, respectively. The very late stent thrombosis rate from one to five years was especially low at 0.2% in both arms. This randomised clinical trial showed that the BP-SES stent was non-inferior to the benchmark PP-EES stent for TLF. Safety and efficacy measures were comparable up to five-year follow-up after PCI.

A comparison of the ultrathin Orsiro Hybrid sirolimus-eluting stent with contemporary drug-eluting stents: A meta-analysis of randomized controlled trials.

Recent studies suggest the Orsiro sirolimus-eluting stent (O-SES), which has ultrathin struts with a biodegradable sirolimus-eluting polymer coating, performed better than contemporary drug-eluting stents (DES). We performed a meta-analysis to compare clinical outcomes for all randomized controlled trials (RCTs) of O-SES vs contemporary DES. PubMed, Cochrane CENTRAL, and meeting abstracts were searched for all RCTs comparing O-SES with contemporary DES. Pooled estimates of longest available clinical outcomes at a minimum of one-year follow-up, presented as odds ratios (OR) [95% confidence intervals], were generated with random-effect models. We included 8 RCTs with a total of 11,176 patients (5444 O-SES and 5732 contemporary DES [3537 EES, 1295 ZES, and 1264 BP-BES) with a mean age of 65±11, 74% were male, 40% underwent PCI for stable angina, and 56% for ACS. We assessed outcomes comparing O-SES vs. everolimus-eluting stents, vs. permanent-polymer DES, and vs. all DES including biodegradable-polymer DES. Orsiro performed comparably in all categories with a trend toward a reduction in myocardial infarction (0.83 [0.68, 1.02], p=0.07) and stent thrombosis (0.75 [0.54, 1.04], p=0.08). Overall, the Orsiro SES had similar clinical outcomes to contemporary DES with a trend toward reduction in myocardial infarction and stent thrombosis.

Efficacy and safety of polymer-free stent versus polymer-permanent drug-eluting stent in patients with acute coronary syndrome: a meta-analysis of randomized control trials

BackgroundThe efficacy and safety of polymer-free stent (PFS) versus permanent polymer drug-eluting stent (PPDES) in patients undergoing percutaneous coronary intervention (PCI) remain controversial. Our meta-analysis was undertaken to evaluate and compare the efficacy and safety of PFS with those of PPDES in patients undergoing PCI.MethodsWe searched PubMed, Cochrane Library, EMBASE, and Clinical Trials.gov databases for randomized controlled trials (RCTs). The primary endpoints were incidence of stent thrombosis (ST) and target-lesion revascularization (TLR). The secondary endpoints included the incidence of major adverse cardiovascular events (MACE), myocardial infarction (MI), cardiac death (CD), late lumen loss (LLL), and diameter stenosis (DS). Subgroup analyses were also conducted based on the follow-up time.ResultsEleven RCTs met the including criteria, and 8616 patients were included in the study. No significant differences were observed between PFS and PPDES treatments in the incidence of ST (RR 0.90; 95% CI: 0.62–1.31; P = 0.58; I2 = 0), TLR (RR 0.87; 95% CI: 0.76–1.00; P = 0.05; I2 = 37%), CD (RR 0.89; 95% CI: 0.72–1.10; P = 0.28; I2 = 0), MI (RR 0.87; 95% CI: 0.71–1.05; P = 0.15; I2 = 0), LLL (SMD 0.01; 95% CI: -0.29–0.30; P = 0.96; I2 = 90%), and DS (SMD -0.01; 95% CI: - 0.25 to 0.23; P = 0.93; I2 = 83%). Meanwhile, the patients with PFS had a lower incidence of MACE (RR 0.87; 95% CI: 0.78–0.97; P = 0.01; I2 = 0) than those with PPDES.ConclusionIn the overall analysis, patients with PFS presented a lower risk of MACE versus PPDES, but no significant difference were obtained in the risk of ST, TLR, MI, CD, DDD and DS. In the Short term follow up, patients with PSF presented a lower risk of TLR compared with PPDES.

TCT-357 Impact of Gender and Age on 3-Year Clinical Outcome and Chest Pain of Patients With Coronary Artery Disease Treated With Contemporary Drug-Eluting Stents: A Patient-Level Pooled Analysis

BACKGROUND Women report more often chest pain following percutaneous coronary intervention (PCI), yet little is known about the impact of age on these symptoms. We aimed to assess age and gender-related differences in chest pain following PCI with newergeneration drug-eluting stents (DES). METHODS A patient-level pooled analysis of the TWENTE and DUTCH PEERS randomized trials (NCT01066650; NCT01331707) was performed, in which patients were treated with newer generation permanent polymer DES. The primary endpoint of both studies was target vessel failure (TVF); secondary endpoints included MACE (composite of any death, any myocardial infarction (MI), emergent CABG or target lesion revascularization) and POCE (composite of any death, any MI and any revascularization). RESULTS Clinical follow-up was available in 3,188 patients (99.8%). Women had more risk factors including diabetes (24.2% vs. 17.8%, p65 years. Women 65 years, both women and men reported similar levels of chest pain at rest or mild exertion (8.8% and 8.7%, p=0.76); in this subgroup gender did not independently predict chest pain (adjusted OR 1.27 95%-CI:0.8-1.9, p=0.26). Nevertheless, in women and men similar 3-year rates of TVF, MACE, and POCE were found (11.6% vs. 11.3%, p=0.81; 13.6% vs. 12.5%, p=0.43; 18.8% vs. 18.0%, p=0.60, respectively). CONCLUSION While for both genders the incidence of adverse cardiovascular events was low and similar, women

Stent Polymers: Do They Make a Difference?

The necessity of polymers on drug-eluting stent (DES) platforms is dictated by the need of an adequate amount and optimal release kinetic of the antiproliferative drugs for achieving ideal DES performance. However, the chronic vessel wall inflammation related to permanent polymer persistence after the drug has been eluted might trigger late restenosis and stent thrombosis. Biodegradable polymers have the potential to avoid these adverse events. A variety of biodegradable polymer DES platforms have been clinically tested, showing equal outcomes with the standard-bearer permanent polymer DES within the first year of implantation. At longer-term follow-up, promising lower rates of stent thrombosis have been observed with the early generation biodegradable polymer DES platforms compared to first-generation DES. Whether this safety benefit still persists with newer biodegradable polymer DES generations against second-generation permanent polymer DES needs to be explored.

Biodegradable polymer stents vs second generation drug eluting stents: A meta-analysis and systematic review of randomized controlled trials.

To evaluate the premise, that biodegradable polymer drug eluting stents (BD-DES) could improve clinical outcomes compared to second generation permanent polymer drug eluting stents (PP-DES), we pooled the data from all the available randomized control trials (RCT) comparing the clinical performance of both these stents. A systematic literature search of PubMed, Cochrane, Google scholar databases, EMBASE, MEDLINE and SCOPUS was performed during time period of January 2001 to April 2015 for RCT and comparing safety and efficacy of BD-DES vs second generation PP-DES. The primary outcomes of interest were definite stent thrombosis, target lesion revascularization, myocardial infarction, cardiac deaths and total deaths during the study period. A total of 11 RCT's with a total of 12644 patients were included in the meta-analysis, with 6598 patients in BD-DES vs 6046 patients in second generation PP-DES. The mean follow up period was 16 mo. Pooled analysis showed non-inferiority of BD-DES, comparing events of stent thrombosis (OR = 1.42, 95%CI: 0.79-2.52, P = 0.24), target lesion revascularization (OR = 0.99, 95%CI: 0.84-1.17, P = 0.92), myocardial infarction (OR = 1.06, 95%CI: 0.86-1.29, P = 0.92), cardiac deaths (OR = 1.07, 95%CI 0.82-1.41, P = 0.94) and total deaths (OR = 0.96, 95%CI: 0.80-1.17, P = 0.71). BD-DES, when compared to second generation PP-DES, showed no significant advantage and the outcomes were comparable between both the groups.

Clinical performance of biodegradable versus permanent polymer drug-eluting stents: A meta-analysis of randomized clinical trials at long-term follow-up.

Several types of biodegradable polymer drug-eluting stents (BPDES) have been used for percutaneous transluminal angioplasty; however, the safety and efficiency of these BPDES have not been fully evaluated. A meta-analysis was, therefore, conducted to compare the clinical performance of BPDES with that of permanent polymer drug-eluting stents (PPDES) in unselected patients with coronary stenosis. PubMed, Web of Science, Medline and The Cochrane Library were searched for randomized clinical trials (RCTs) from January 2005 to January 2014. Trials that compared BPDES with PPDES in patients with coronary stenosis were considered. Twelve RCTs with a total of 15,938 patients with coronary stenosis were included in this meta-analysis. No significant difference was found between the two arms in the incidence of major adverse cardiac events (MACE) and definite or probable stent thrombosis (DpST) at the one-year follow-up (P>0.10). The use of BPDES, however, showed a tendency towards a lower risk of MACE (P=0.09) and a beneficial effect by reducing DpST episodes (P=0.04) at long-term follow-up, particularly when compared with the incidence of DpST at the one-year follow-up. BPDES also tended to be associated with a decreased late lumen loss in patients with coronary stenosis [instrumental variable =−0.04; 95% confidence interval =−0.08–0.00; P=0.05). In conclusion, the one-year outcomes following drug-eluting stent implantation showed BPDES were noninferior to PPDES in unselected patients with coronary stenosis. Long-term clinical outcomes, however, indicated that BPDES appeared to a present a lower risk of MACE and DpST.

GW25-e0846 Safety and Efficacy of Degradable vs. Permanent Polymer Drug-eluting stents A meta-analysis of 18, 395 Patients from randomized trials

GW25-e0846 Safety and Efficacy of Degradable vs. Permanent Polymer Drug-eluting stents A meta-analysis of 18, 395 Patients from randomized trials

Biodegradable polymer drug-eluting stents versus second-generation drug-eluting stents for patients with coronary artery disease: an update meta-analysis.

Permanent polymer drug-eluting stents (DES) are associated with a higher risk of late and very late stent thrombosis (ST); biodegradable polymer drug-eluting stents (BP-DES) were designed to reduce these risks. However, their benefits are not completely clear. We undertook a meta-analysis of randomized studies identified in systematic searches of MEDLINE, EMBASE, and the Cochrane Database. Eligible studies were those that compared BP-DES with second-generation permanent polymer DES in patients undergoing percutaneous coronary intervention. Five studies (8,740 patients) with a mean follow-up of 19.2 months were included. Overall, BP-DES were associated with a broadly equivalent risk of definite and probable ST (odds ratio [OR], 1.07; 95 % confidence interval [CI], 0.67 to 1.71; P = 0.76; I (2) = 5.0 %), target vessel revascularization (OR, 1.04; 95 % CI, 0.87 to 1.24; P = 0.68; I (2) = 38.0 %), all-cause mortality (OR, 1.10; 95 % CI, 0.87 to 1.41; P = 0.42; I (2) = 0.0 %), and major adverse cardiac events (OR, 1.03; 95 % CI, 0.88 to 1.20; P = 0.74; I (2) = 0.0 %) when compared with second-generation DES. However, BP-DES significantly decreased in-stent late luminal loss (standard mean difference [SMD], -0.01; 95 % CI, -0.12 to 0.11; P = 0.93; I (2) = 0.0 %) and in-segment late luminal loss (SMD, -0.06; 95 % CI, -0.17 to 0.05; P = 0.27; I (2) = 0.0 %) compared with second-generation DES. Compared with second-generation permanent polymer DES, biodegradable stents appear to have equivalent short- to medium-term clinical benefits, and it remains unclear whether they reduce the incidence of very late ST.

Stent infection is another safety issue that needs to be addressed

Over and above the issue of death, myocardial infarction, and the composite of definite and probable stent thrombosis [ [1] Wang Y. Liu S. Luo Y. et al. Safety and efficacy of degradable vs permanent polymer drug eluting stents a meta-analysis of 18,395 patients from randomized trials. Int J Cardiol. 2014; 173: 100-109 Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar ], safety end points should also include stent infection, the latter an increasingly recognised complication of the stent era [ 2 Elieson M. Mixon T. Carpenter J. Coronary stent infections: a case report and literature review. Tex Heart Inst J. 2012; 39: 884-889 PubMed Google Scholar , 3 Bosman W.M.P.F. Borger van der Burg B.L.S. Scuttevaer H.M. Thoma S. Joosten H.P.Ph Infections of intravascular bare metal stents: a case report and review of literature. Eur J Vasc Endovasc Surg. 2014; 47: 87-99 Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar ] since the first case (with fatal outcome) was reported in 1993 [ [4] Gunther H.U. Strupp G. Volmar J. et al. Coronary stent implantation: infection and abscess with fatal outcome. Z Kardiol. 1993; 82: 521-525 PubMed Google Scholar ]. The most up to date literature review of stent infection (including coronary artery stent infection) documented its occurrence in 29 subjects with coronary artery stents. Among those 29 subjects were 15 who had drug eluting stents (DES) only, 13 who had bare metal stents (BMS) only, and one who had both DMS and BMS [ [3] Bosman W.M.P.F. Borger van der Burg B.L.S. Scuttevaer H.M. Thoma S. Joosten H.P.Ph Infections of intravascular bare metal stents: a case report and review of literature. Eur J Vasc Endovasc Surg. 2014; 47: 87-99 Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar ]. Fourteen patients died of this complication, the fate of one other patient was unknown [ [3] Bosman W.M.P.F. Borger van der Burg B.L.S. Scuttevaer H.M. Thoma S. Joosten H.P.Ph Infections of intravascular bare metal stents: a case report and review of literature. Eur J Vasc Endovasc Surg. 2014; 47: 87-99 Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar ]. The incidence of coronary artery stent infection might, arguably, be on the increase, given the fact that, in the literature review published in 2012, only 17 cases were reported, whereas, in the literature review published in 2014, twenty nine cases were reported. Accordingly, evaluation of incidence of stent infection should be part of the safety comparison between degradable vs permanent polymer drug eluting stents.

Safety and efficacy of degradable vs. permanent polymer drug-eluting stents: A meta-analysis of 18,395 patients from randomized trials

BackgroundDegradable polymer drug-eluting stents (DP-DES) represent a promising strategy to improve the delayed healing and hypersensitive reaction in the vessel. However, the efficacy and safety of DP-DES vs. permanent polymer drug-eluting stents (PP-DES) are less well defined. The aim of this meta-analysis was to compare the total, short (<30days), mid (30days–1year) and long (>1year) term outcomes of DP-DES vs. PP-DES. MethodsPubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials to compare any of approved DP- and PP-DES. Efficacy endpoints were target-lesion revascularization (TLR) and in-stent late loss (ISLL). Safety endpoints were death, myocardial infarction (MI), and composite of definite and probable stent thrombosis (ST). ResultsThe meta-analysis included 19 RCTs (n=18,395) with interesting results. As compared with DES, there was a significantly reduced very late ST (OR [95% CI]=0.42 [0.24–0.77], p=0.852) and ISLL (OR [95% CI]=−0.07 [−0.12–0.02], p=0.000) in DP-DES patients. However, there were no differences between DP-DES and PP-DES for other safety and efficiency outcomes, except that the stratified analysis showed a significant decreased TLR with DP-DES as compared to paclitaxel-eluting stent (OR [95% CI]=0.41 [0.20–0.81], p=0.457). ConclusionsDP-DES are more effective in reducing very late ST and ISLL, as well as comparable to PP-DES with regard to death, TLR and MI. Further large RCTs with long-term follow-up are warranted to better define the relative merits of DP-DES.

A randomized, open-label clinical trial using optical coherence tomography to compare two sirolimus-eluting stents, one with a biodegradable polymer and the other with a permanent polymer

Intimal hyperplasia appears to differ after implanting a drug-eluting stent (DES) with a biodegradable or a permanent polymer. The aim of the present study was to compare biodegradable with permanent polymer DES, since the available data are limited. One hundred patients with de novo coronary artery stenosis were included in this study. The patients were classified into 2 groups: DES with a biodegradable polymer (n=50) and DES with a permanent polymer (n=50). Optical coherence tomography (OCT) examination was performed before and after stent implantation. A follow‑up OCT, performed 1 year after stent implantation, compared the morphologies of intimal hyperplasia in the 2 groups. The frequencies of uncovered stent struts (2.27 vs. 1.87%, P=0.145) and stent strut malapposition (1.9 vs. 2.02%, P=0.655) upon the first-year follow-up were not significantly different. Average neointimal thickness was lower in the biodegradable compared with the permanent polymer group (106.12±80.65 vs. 181.20±146.96 µm, P<0.001). The frequencies of neointimal thickness <100 µm were significantly higher in the biodegradable compared with the permanent polymer group (62.1 vs. 35.9%, P<0.001). The average intimal thickness was also lower in the biodegradable compared with the permanent polymer group (57.7±24.6 vs. 67.6±22.4 µm, P<0.001). In conclusion, biodegradable polymer DES resulted in significantly lower intimal hyperplasia and had well-proportioned intimal coverage compared with permanent polymer DES.

Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial

Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer-coated sirolimus-eluting stent in a population-based setting. This randomised, multicentre, all-comer, non-inferiority trial was undertaken at three sites across western Denmark. Eligible patients were aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion (>50% diameter stenosis). We randomly assigned patients (1:1) using an independently managed computer-generated allocation sequence to receive either a biolimus-eluting biodegradable polymer stent (Nobori, Terumo, Tokyo, Japan) or a sirolimus-eluting permanent polymer stent (Cypher Select Plus, Cordis, Johnson & Johnson, Warren, NJ, USA). The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation) at 9 months, analysed by intention to treat (non-inferiority margin of 0·02). This trial is registered with ClinicalTrials.gov, number NCT01254981. From July, 2009, to January, 2011, we assigned 1229 patients (1532 lesions) to receive the biolimus-eluting stent and 1239 (1555 lesions) to receive the sirolimus-eluting stent. One patient was lost to follow-up because of emigration. Intention-to-treat analysis showed that 50 (4·1%) patients who were assigned the biolimus-eluting stent and 39 (3·1%) who were assigned the sirolimus-eluting stent met the primary endpoint (risk difference 0·9% [upper limit of one-sided 95% CI 2·1%]; p(non-inferiority)=0·06). Significantly more patients in the biolimus-eluting stent group had definite stent thrombosis at 12 months than did those in the sirolimus-eluting stent group (9 [0·7%] vs 2 [0·2%], risk difference 0·6% [95% CI 0·0-1·1]; p=0·034). Per-protocol analysis showed that 45 (3·8%) of 1193 patients who received a biolimus-eluting stent and 39 (3·2%) of 1208 who received a sirolimus-eluting stent met the primary endpoint (risk difference 0·5% [upper limit of one-sided 95% CI 1·8%]; p(non-inferiority)=0·03). At 1 year follow-up, the biodegradable polymer biolimus-eluting Nobori stent did not improve clinical results compared with a first-generation sirolimus-eluting stent. We will need to obtain long-term data before we can make recommendations for the role of this biolimus-eluting stent in routine clinical practice. Terumo and Cordis (Johnson & Johnson).

TCT-579 One year clinical outcome of biodegradable and permanent polymer drug-eluting stents for multivessel disease or long lesion (≥28mm) in patients with stable and unstable angina

TCT-579 One year clinical outcome of biodegradable and permanent polymer drug-eluting stents for multivessel disease or long lesion (≥28mm) in patients with stable and unstable angina

Five‐year clinical outcomes of a polymer‐free sirolimus‐eluting stent versus a permanent polymer paclitaxel‐eluting stent: Final results of the intracoronary stenting and angiographic restenosis – test equivalence between two drug‐eluting stents (ISAR‐TEST) trial

Limited evidence exists regarding the long-term performance of polymer-free (PF) drug-eluting stents (DES) in comparison to permanent polymer DES. This study investigated the 5-year efficacy and safety of a PF sirolimus-eluting stent (PF-SES) versus a permanent polymer paclitaxel-eluting stent (PES) in the setting of the Intracoronary Stenting and Angiographic Restenosis-Test Equivalence Between Two Drug-Eluting Stents (ISAR-TEST) randomized trial. A total of 450 patients undergoing percutaneous coronary intervention were randomized to receive either PF-SES (Yukon, Translumina; n = 225) or PES (Taxus, Boston Scientific; n = 225). Clinical follow-up was performed to 5 years after enrollment. The endpoints were major adverse cardiac events (MACE), target lesion revascularization (TLR), the composite of death or any myocardial infarction (MI) and stent thrombosis (ST). The incidence of MACE at 5 years was 27.3% (57 patients) in the PF-SES group and 31.7% (65 patients) in the PES group [hazard ratio (HR) = 0.87 [95% confidence interval (95% CI) = 0.61-1.24]; P = 0.40]. The combined incidence of death or MI was 16.6% (34 patients) in the PF-SES group and 20.0% (39 patients) in the PES group (HR = 0.86 [95% CI = 0.54-1.36]; P = 0.52). The incidence of TLR was 16.5% (34 patients) in the PF-SES group and 16.4% (33 patients) in the PES group (HR = 1.03 [95% CI = 0.64-1.66]; P = 0.89). ST occurred in 0.5% (one patient) in the PF-SES group and 1.6% (three patients) in the PES group (HR = 0.33 [95% CI = 0.03-3.14]; P = 0.32). Overall there was no significant difference in clinical outcomes between PF-SES and PES to 5 years. Extended follow-up supports the durability of efficacy and safety of PF-SES.

Biodegradable polymer and permanent polymer drug-eluting stents: at the crossroads of evidence and expectation

Biodegradable polymer and permanent polymer drug-eluting stents: at the crossroads of evidence and expectation