Final 5-Year Report of the Randomized BIO-RESORT Trial Comparing 3 Contemporary Drug-Eluting Stents in All-Comers

BACKGROUND: In a previous trial, higher 5‐year mortality was observed following treatment with biodegradable polymer Orsiro sirolimus‐eluting stents (SES). We assessed 5‐year safety and efficacy of all‐comers as well as patients with diabetes treated with SES or Synergy everolimus‐eluting stents (EES) versus durable polymer Resolute Integrity zotarolimus‐eluting stents (ZES). METHODS AND RESULTS: The randomized BIO‐RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug‐Eluting Stents in an All Comers Population) trial enrolled 3514 all‐comer patients at 4 Dutch cardiac centers. Patients aged ≥18 years who required percutaneous coronary intervention were eligible. Participants were stratified for diabetes and randomized to treatment with SES, EES, or ZES (1:1:1). The main end point was target vessel failure (cardiac mortality, target vessel myocardial infarction, or target vessel revascularization). Five‐year follow‐up was available in 3183 of 3514 (90.6%) patients. The main end point target vessel failure occurred in 142 of 1169 (12.7%) patients treated with SES, 130 of 1172 (11.6%) treated with EES, versus 157 of 1173 (14.1%) treated with ZES (hazard ratio [HR], 0.89 [95% CI, 0.71–1.12], P (log‐rank)=0.31; and HR, 0.82 [95% CI, 0.65–1.04], P (log‐rank)=0.10, respectively). Individual components of target vessel failure showed no significant between‐stent difference. Very late definite stent thrombosis rates were low and similar (SES, 1.1%; EES, 0.6%; ZES, 0.9%). In patients with diabetes, target vessel failure did not differ significantly between stent‐groups (SES, 19.8%; EES, 19.2%; versus ZES, 21.1% [P (log‐rank)=0.69 and P (log‐rank)=0.63]). CONCLUSIONS: Orsiro SES, Synergy EES, and Resolute Integrity ZES showed similar 5‐year outcomes of safety and efficacy, including mortality. A prespecified stent comparison in patients with diabetes also revealed no significant differences in 5‐year clinical outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01674803

Speakers' choice of frame in binary choice

A distinction is proposed between extit{recommending for} preferred choice options and extit{recommending against} non-preferred choice options. In binary choice, both recommendation modes are logically, though not psychologically, equivalent. We report empirical evidence showing that speakers recommending for preferred options predominantly select positive frames, which are less common when speakers recommend against non-preferred options. In addition, option attractiveness is shown to affect speakers' choice of frame, and adoption of recommendation mode. The results are interpreted in terms of three compatibility effects, (i) extit{recommendation mode---valence framing compatibility}: speakers' preference for positive framing is enhanced under extit{recommending for} and diminished under extit{recommending against} instructions, (ii) extit{option attractiveness---valence framing compatibility}: speakers' preference for positive framing is more pronounced for attractive than for unattractive options, and (iii) extit{recommendation mode---option attractiveness compatibility}: speakers are more likely to adopt a extit{recommending for} approach for attractive than for unattractive binary choice pairs

Speaker-listener incompatibility: Joint and separate processing in risky choice framing

Framing effects are considered in a conversational framework using the well-known Asian Disease problem [Tversky, A., & Kahneman, D. (1981). The framing of decisions and the psychology of choice. Science, 211, 453-458]. Speakers' preferred message framing is examined and its corresponding persuasiveness is assessed using listeners' responses. The results show that speakers exhibit a marked and consistent preference for positive over negative framing (Experiment 1). Judged from listeners' responses, this preference is effective for promoting riskless, but not risky options. The incompatibility between speakers and listeners may be resolved by noting that speakers can jointly (i.e., comparatively) assess the information and the persuasive qualities of alternative frames. In contrast, listeners are exposed only to one of these frames and, consequently, can only assess the information separately (i.e., non-comparatively). Experiments 2 and 3 demonstrate that no incompatibility exists when both speakers and listeners are either in separate, or in joint evaluation mode. Differences between risky choice and attribute framing [Levin, I.P., Schneider, S.L., & Gaeth, G.J. (1998). All frames are not created equal: a typology and critical analysis of framing effects. Organizational Behavior and Human Decision Processes, 76, 149-188] are briefly discussed.Joint vs. separate evaluation Framing Positivity bias Valence

Nudging for smart construction: Tackling uncertainty by changing design engineers' choice architecture

Nudging refers to the deliberate change in choice architecture (i.e., the careful design of the environments in which people make choices) with the goal of engineering a particular (benign) outcome. The core proposition of nudging is that seemingly innocuous alterations of choice architecture matter: they influence decision making. Typically, the early stages of decision making in construction projects have a long-term impact on project performance, but are at the same time often fraught with uncertainties. We experimentally examine if tweaking a trade-off matrix used to assess preliminary design options in a design competition can raise uncertainty awareness of decision makers and can nudge decision makers away from riskier, more uncertain options, towards less risky and uncertain options. First results indicate a statistically unreliable shift in the predicted direction. Based on our research results, we suggest and discuss other pertinent and potentially more effective nudges

Removing certainty from the equation: Using choice architecture to increase awareness of risk in engineering design decision making

The mediated model of determinants for risky decision making theorizes that decision making is influenced by a decision makers risk propensity and risk perception. Risk propensity is an individual's tendency to take or avoid risks. Where as risk perception is the decision makers’ assessment of how risky a situation is in terms of probabilistic estimates. Risk perception is also influenced by risk representation, which is the way risk is presented to the decision-maker. Modifications were made to the choice architecture of a trade-off matrix to test whether representing risks as embedded characteristics of design options influences engineering choice. Senior civil engineering students (n=98) were asked to consider trade-off matrices for two design options using criteria provided in a decision scenario. Half of the participants randomly received the control version of the trade-off matrix where risk was shown as an additional sixth criteria. The other half of participants received the modified tradeoff matrix where risk shown as a confidence interval. Illustrating risk as a separate criteria appears to significantly (p=0.04) influence users decision making leading participants to discount risk. Nearly 70% chose the more risky option. Yet, when risk was shown as a confidence interval participants were evenly split between the high and low risky option. The risk representation seems to meditate or counter balance those with a high propensity for risk. When controlling for risk propensity the results are even more significant (p=0.02). Meaning, those with high risk propensity more frequently choose the risky choice given the control version (as expected) but that did not hold true for the modified version, when shown as a confidence interval. Understanding how decisions are influenced by risk representation can lead to designing choice architecture that helps engineers and contractors make decisions that are in their own, or their clients’ best interests

Two-year clinical outcome of all-comers treated with three highly dissimilar contemporary coronary drug-eluting stents in the randomised BIO-RESORT trial

Aims: The aim of the study was to evaluate the two-year clinical outcome of all-comer trial participants who were treated with two very different thin-strut biodegradable polymer versus thin-strut durable polymer drug-eluting stents (DES). Prolonged clinical outcome after discontinuation of dual antiplatelet therapy is of particular interest, given the highly dissimilar polymer types, amount, distribution, and degradation speed of both biodegradable polymer DES. Methods and results: The BIO-RESORT trial (NCT01674803) randomly assigned 3,514 patients to treatment with biodegradable polymer SYNERGY everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), or durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). At two-year follow-up (available in 98.8%), the rate of the primary composite endpoint target vessel failure (TVF) was 8.3% in ZES versus 6.8% in EES (p=0.19) and 6.6% in SES (p=0.12). Landmark analyses at one year revealed differences between SES and ZES in the rates of target lesion revascularisation and target lesion failure (0.6% vs. 1.5%, p=0.04, and 1.1% vs. 2.4%, p=0.02, respectively) as well as other composite secondary endpoints that reached statistical significance. Conclusions: At two-year follow-up, there was no significant between-DES difference in the rates of the primary endpoint. Landmark analyses provided a signal that the use of SES versus ZES might reduce the risk of repeat revascularisation after one-year follow-up

Three-year clinical outcome in all-comers with “silent” diabetes, prediabetes, or normoglycemia, treated with contemporary coronary drug-eluting stents: From the BIO-RESORT Silent Diabetes study

Background: Patients with coronary disease may have unknown diabetes or prediabetes. We evaluated 3-year outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) in patients with silent diabetes, prediabetes, and normoglycemia. Methods: All BIO-RESORT trial (NCT01674803) participants without known diabetes, enrolled at our center, were invited for oral glucose tolerance testing (OGTT) and measurements of fasting plasma glucose and glycated hemoglobin (HbA1c). Results: OGTT detected silent diabetes in 68 (6.9%), prediabetes in 132 (13.4%), and normoglycemia in 788 (79.8%) of all 988 study participants. Follow-up was available in 986 (99.8%) patients. The main endpoint target vessel failure (TVF: cardiac death, target vessel-related myocardial infarction [MI], or target vessel revascularization) differed between groups (14.8, 9.9, and 5.6%; p =.002), driven by MI during the first 48 hr and by cardiac death (p <.001; p =.026). Between 48 hr and 3-years, there was no significant between-group difference in TVF, target vessel MI, and target vessel revascularization. Multivariable analysis demonstrated that silent diabetes was independently associated with TVF (adjusted HR: 2.52, 95%-CI: 1.26–5.03). An alternative diagnostic approach—HbA1c and fasting plasma glucose—detected silent diabetes and prediabetes in 33 (3.3%) and 217 (22.0%) patients, and normoglycemia in 738 (74.7%); TVF rates were 12.1, 7.9, and 6.0% (p =.23). Conclusion: In patients without known diabetes, abnormal glucose metabolism by OGTT was independently associated with higher 3-year TVF rates after PCI with contemporary DES. This difference was driven by periprocedural MI and cardiac death. After the first 48 hr, the rates of TVF, target vessel MI, and target vessel revascularization were low and did not differ significantly between metabolic groups