High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial

Abstract

PurposePatients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES.MethodsParticipants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year.ResultsOf all 3514 patients, 1009 (28.7%) had HBR. HBR patients were older (p < 0.001) and had more co-morbidities than non-HBR patients (p < 0.001). At 1-year follow-up, HBR patients had significantly higher rates of target vessel failure (6.7 vs. 4.2%, p = 0.003), cardiac death (1.9 vs. 0.4%, p < 0.001), and major bleeding (3.3 vs. 1.5%, p = 0.001). Of all 1009 HBR patients, 673 (66.7%) received BP-DES and 336 (33.3%) had DP-DES. The primary endpoint was met by 43/673 (6.5%) patients treated with BP-DES and 24/336 (7.3%) treated with DP-DES (HR 0.88 [95%CI 0.54–1.46], p = 0.63). There were no significant between-group differences in the most global patient-oriented clinical endpoint (9.7 vs. 10.5%, HR 0.92 [95%CI 0.61–1.39], p = 0.69) and other secondary endpoints.ConclusionsAt 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES.Electronic supplementary materialThe online version of this article (10.1007/s10557-018-6823-9) contains supplementary material, which is available to authorized users.

Safety and efficacy of drug‐eluting stents for patients at high risk of bleedings: A network meta‐analysis

“…It should be noted that the SENIOR trial protocol used 1‐month DAPT in chronic coronary syndrome and 6‐months DAPT in ACS, even though the Synergy DES had better significant outcomes (especially regarding TVR and TLR) in the overall analysis and in the 1‐month regimen either with meta‐regression and with only 1‐month DAPT trials (Supporting Information: Appendix), yet the thrombotic risk in the chronic setting could be less reliable 12 . The same DES was also used in the HBR analysis of the BIO‐RESORT trial, but it wasn't the only used in more than one trial, neither it has a disproportionate number of observations that could affect our analysis 15 . In fact, 932 patient received Synergy DES in 2 trials meanwhile 2214 patient received BioFreedom in LEADERS FREE and ONYX ONE trials and 1003 patients received Onyx DES in one trial.…”

“…Finally, we considered for our analysis the following trials: ONYX-ONE, LEADERS FREE, the subanalysis of HBR patients in the BIO-RESORT and SENIOR (divided among ACS and CCS patients). [12][13][14][15] From each study we extracted the following data: author, year of publication, sample size, latest follow-up, baseline clinical features such as age, sex, the proportion of patients with history of diabetes, hypertension, hyperlipidemia, transient ischemic attack, myocardial infarction, PCI, intracerebral hemorrhage, coronary artery bypass graft, chronic kidney disease (CKD) and anemia, the indication for PCI (for example, ACS or STEMI), procedural features (type of stent, stent number, multivessel disease, bifurcation, CTO, lesion length) and medical treatment (DAPT type and duration, oral anticoagulation…”

“…Eight studies were identified but four of them were excluded due to the absence of outcomes of interest. Finally, we considered for our analysis the following trials: ONYX‐ONE, LEADERS FREE, the subanalysis of HBR patients in the BIO‐RESORT and SENIOR (divided among ACS and CCS patients) 12–15 …”

Efficacy and Safety of Shortened Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention: A Meta-analysis of Randomized Controlled Trials

“…Zocca et al demonstrated that BP-DES showed similar safety and efficacy compared with DP-DES in patients with HBR undergoing PCI. 28 Previous meta-analysis has not assessed DAPT duration at patients with HBR. In our study, further analysis showed that, in patients with HBR, # 3-month DAPT significantly reduced the risk of major bleeding and any bleeding and did not increase the risk of ischemic complications, including myocardial infarction, stent thrombosis, and stroke, compared with standard DAPT.…”

“…Zocca et al demonstrated that BP-DES showed similar safety and efficacy compared with DP-DES in patients with HBR undergoing PCI. 28…”