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Randomized comparison of a novel, ultrathin strut biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent for percutaneous coronary revascularization

ESC Congress 2014 - Hot Line report



 

Presentation

Thomas Pilgrim, By Thomas Pilgrim, (Bern, Switzerland)
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List of Authors:
Thomas Pilgrim, MD 1; Dik Heg, PhD 2; Marco Roffi, MD 3; David Tüller, MD 4; Olivier Muller, MD 5; André Vuilliomenet, MD 6; Stéphane Cook, MD 7; Daniel Weilenmann, MD 8; Christoph Kaiser, MD 9; Peiman Jamshidi, MD 10; Bernhard Meier, MD 1; Peter Jüni, MD 2; Stephan Windecker, MD 1

1 Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern;
2 Institute of Social and Preventive Medicine and Clinical Trials Unit, Bern University Hospital,  Bern;
3 Department of Cardiology, University Hospital, Geneva;
4 Department of Cardiology, Triemlispital, Zurich;
5 Department of Cardiology, University Hospital, Lausanne;
6 Department of Cardiology, Kantonsspital, Aarau;
7 Department of Cardiology, University Hospital, Fribourg;
8 Department of Cardiology, Kantonsspital, St. Gallen;
9 Department of Cardiology, University Hospital, Basel;
10 Department of Cardiology, Kantonsspital, Luzern; Switzerland

Abstract

Background
Although new generation drug-eluting stents have markedly improved outcomes, refinements in stent design including strut thickness, surface polymer and drug release aim to further improve upon these results. We compared a novel ultrathin strut (60 μm), cobalt chromium DES with amorphous silicon-carbide coating releasing sirolimus (1.4 μg/mm2) from PLLA (poly-L-lactic acid) biodegradable polymer (ORSIRO, BP-SES) with the current gold standard, a thin strut (81 μm), cobalt chromium DES releasing everolimus from a durable polymer stent (XIENCE prime/xpedition, DP-EES) in a randomized controlled trial.
Methods
The BIOSCIENCE trial was a randomized non-inferiority trial comparing BP-SES with DP-EES in a patient population with minimal exclusion criteria undergoing PCI at nine sites in Switzerland (NCT01443104). Patients with stable coronary artery disease or acute coronary syndromes (NSTE-ACS or STEMI) with at least one lesion of >50% diameter stenosis suitable for stent implantation qualified for enrolment. Randomisation was performed by means of an electronic web-database. The primary endpoint target lesion failure (TLF) was a composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization at 12 months. Anticipating a TLF rate of 8% at 12 months in both treatment arms and accepting a non-inferiority margin of 3.5%, inclusion of 2,060 patients was estimated to provide more than 80% power to detect non-inferiority of BP-SES compared with DP-EES at an one-sided type I error of 0.05. All events were independently adjudicated by a blinded clinical event committee. Clinical outcomes were analyzed according to the intention-to-treat principle.
Results
Between February 2012 and May 2013, 2119 patients with 3139 lesions were randomly assigned to treatment with BP-SES (1063 patients, 1594 lesions) or DP-EES (1056 patients, 1545 lesions). A total of 407 (19%) patients presented with ST-segment elevation myocardial infarction (Table 1). BP-SES were non-inferior to DP-EES for the primary endpoint target lesion failure (69 [6.5%] versus 70 [6.6%] absolute risk difference −0.14%, upper limit of one-sided 95% CI 1.97%, p for non-inferiority = 0.0004) at 12 months (Table 2, Figure 1). There were no significant between-group differences in rates of definite stent thrombosis (9 [0.9%] versus 4 [0.4%], RR 2.26, 95% CI 0.70-7.33, p=0.16) (Table 2). In pre-specified stratified analyses of the primary endpoint, BP-SES were associated with improved outcome compared with DP-EES in the subgroup of patients with ST-segment elevation myocardial infarction (7 [3.3%] versus 17 [8.7%], RR 0.38, 95% CI 0.16-0.91, p=0.024, p for interaction = 0.014).
Conclusion
In a patient population with minimal exclusion criteria, BP-SES were found non-inferior to DP-EES for the primary endpoint target lesion failure. The observed benefit in the subgroup of patients with ST-segment elevation myocardial infarction requires further study.  

Funding: Clinical Trials Unit, University of Bern and Biotronik, Bülach, Switzerland

Table 2 legend:

Percentages are Kaplan Meier estimates of the cumulative incidence. Rate ratios RR (95% CI) are estimated using the Mantel-Cox method with two-sided p-values from log-rank test. All events were censored beyond 365 days. Continuity corrected RR with Fisher's exact test for zero outcomes. MI = myocardial infarction; TLR = target lesion revascularisation; TVR = target vessel revascularisation ; BARC = Bleeding Academic Research Consortium
* Primary endpoint, defined as the composite of Cardiac death, Target vessel Q-wave or non-Q wave MI, clinically indicated TLR
** Defined as the composite of Cardiac death, Q-wave or non-Q wave MI, and TVR.
*** Patient oriented composite endpoint.
†Cerebrovascular events is defined as transient ischemic attacks and strokes.
‡ischemic and hemorrhagic stroke
Possible stent thrombosis cannot occur by definition within 30 days. Landmark used at 30 days for >30 days to 12 months analyses.

 

Discussion

By Patrick Serruys, FESC (Rotterdam, Netherlands)
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References


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SessionTitle:

Hot Line: Heart failure: devices and interventions

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.