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BACKGROUND Biodegradable polymer biolimus-eluting stents (BP-BES) may be associated with better outcomes in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) compared to other current-generation limus-eluting stents (LES). AIMS To compare BP-BES with other current-generation LES in ACS patients undergoing PCI. METHODS We pooled individual data of Non-ST-segment elevation (NSTE)-ACS patients from two large randomized controlled trials (GLASSY and TWILIGHT). The BP-BES groups consisted mostly of GLASSY patients, while the control group (other current-generation LES) included exclusively TWILIGHT patients. The primary outcome was major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, or stent thrombosis; the key secondary outcome was target-vessel failure (TVF). To account for trial design differences, outcomes were assessed at 3 months (short-term) and between 3 and 12 months (long-term) after PCI and subsequently pooled to estimate the 12-month hazards. RESULTS Of 7107 and 6053 NSTE-ACS patients included in the short- and long-term analysis, 32.7% and 36.5% received a BP-BES, respectively. Risk of MACE associated with BP-BES versus other LES was similar at short-term (1.1% vs 1.4%, adjusted HR 0.81, 95%CI 0.51-1.29), lower at long-term (1.7% vs 3.1%, adjusted HR 0.46, 95%CI 0.32-0.67), and lower in the entire 12-month period (pooled adjusted HR 0.58, 95%CI 0.43-0.77). The cumulative 12-month risk of TVF was reduced with BP-BES (adjusted HR 0.52, 95%CI 0.38-0.70). CONCLUSION BP-BES was associated with lower 12-month risks of MACE and TVF compared to other current generation LES among NSTE-ACS patients treated with abbreviated or standard ticagrelor-based DAPT. These non-randomized findings are hypothesis-generating. CONDENSED ABSTRACT Differences in clinical outcomes may exist between biodegradable polymer biolimus-eluting stents (BP-BES) and other current-generation limus-eluting stent (LES) in patients with acute coronary syndrome (ACS). We pooled individual data of about 7000 Non-ST-segment elevation ACS patients undergoing PCI and treated with ticagrelor with or without aspirin from two large randomized controlled trials (GLASSY and TWILIGHT). BP-BES patients derived very largely from GLASSY and other LES patients from TWILIGHT. In this population, BP-BES compared to other current generation LES, were associated with a lower 12-month risk of major adverse cardiovascular events and target-vessel failure.

Background: The risk/benefit tradeoff of dual antiplatelet therapy after percutaneous coronary intervention may vary in East Asian patients as compared with their non-East Asian counterparts. Methods: The double-blind, placebo-controlled, randomized TWILIGHT trial (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) enrolled patients undergoing high-risk percutaneous coronary intervention. After 3 months of treatment with ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding; the key secondary end point was the first occurrence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke. Results: Of 9006 enrolled and 7119 randomized patients in TWILIGHT, 1169 patients (13.0%) were enrolled at 27 Chinese sites in this prespecified substudy, of whom 1028 (14.4%) patients were randomized after 3 months. The incidence of the primary end point was 6.2% in the ticagrelor+aspirin group versus 3.5% in the ticagrelor+placebo group between randomization and 1 year (hazard ratio, 0.56 [95% CI, 0.31–0.99]; P =0.048). The key secondary end point occurred in 3.4% of patients in the ticagrelor+aspirin group versus 2.4% in the ticagrelor+placebo group (hazard ratio, 0.70 [95% CI, 0.33–1.46]; P =0.34). There was no interaction between the region of randomization (China versus the rest of the world) and randomized treatment assignment in terms of the primary or key secondary end points. Conclusions: Ticagrelor monotherapy significantly reduced clinically relevant bleeding without increasing ischemic events as compared with ticagrelor plus aspirin in Chinese patients undergoing high-risk percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02270242.

Background: Medicare administrative data has been proposed as an efficient alternative for long-term event detection. The accuracy of these data relative to investigator reported and event adjudicated results are unknown. Methods: We linked 3217 older patients (65+ years) with acute coronary syndromes (ACS) from 4 ACS clinical trials to Medicare inpatient standard analytic files (SAFs) using a deterministic linkage and indirect patient identifiers (e.g., sex, date of birth, date of index hospitalization). We compared event ascertainment for death, all-cause rehospitalization, myocardial infarction (MI), heart failure and revascularization to 180 days after hospital discharge. Up to four Medicare ICD-9-CM coding algorithms were evaluated for each outcome. Sensitivity, specificity and positive and negative predictive values were assessed for Medicare events considering trial records as the ‘gold standard’. Results: The 180 day incidences of adverse events following discharge were: death 4.6%, all-cause rehospitalization 50.9%, MI 5.6%, heart failure 15.1%, and any revascularization 13.2%. For most outcomes, Medicare claims displayed similar or higher event rates as those reported for trials. In general, Medicare claims had high sensitivity, specificity, and positive and negative predictive value when compared to trial outcomes; however, these differed depending on the Medicare coding algorithm used (Table). Conclusions: Medicare claims detect similar or greater numbers of events as those identified by existing clinical trial mechanisms. These data demonstrate the potential utility of administrative claims for efficient long-term follow-up of older patients enrolled in clinical trials or post-market surveillance efforts. Further investigation is needed to both optimize Medicare coding algorithms and determine which mechanism is most accurate among discordant reported events.

Absrac Caegor: 7. CI - Adjuc harmacologyreseao Number: 2536-628Auhors: Usman Baber, Antonio Colombo, Giora Weisz, Alaide Chieffo, C. Michael Gibson, Maria Alu, Pushpam Barathi, Ziad Sergie, David Cohen, David Moliterno, Bernhard Witzenbichler, Mitchell Krucoff, Philippe Steg, Roxana Mehran, Mount Sinai Medical Center, New York, NY, USABackground: ual a-laele hera (AT: Asr + Theorde) s a corersoe of reame for aes ho rese h acue coroar sdromes (AC), ad aes udergog ercuaeous coroar ereo (CI). Curre gudeles call for rologed AT for all s udergog CI h a drug-elug se (E), ad shorer durao (≥ 1 moh) for all s receg a bare meal se ( BM). hle remaure dscouao of AT has bee assocaed h a creased rs of se hromboss reous sudes, real-orld aers of adherece o DAT rescro hae o bee characerzed deal, or has relaosh of AT o-adherece o oher clcal oucomes bee esablshed.Methods: The ARI (aers of No-Adherece o A-laele Regmes eed aes) regsr s a mul-ceer, mulaoal, rosece obseraoal sud ha ll follo subjecs for 24 mohs afer se mlaao, ad ll exame he feaures of o-adherece o AT follog seg.Results: Amog 5033 subjecs, he mea age as 64 ears, 74.5% ere male, 40.9% reseed h AC, ad 82% receed a drug-elug se.37.6% of subjecs ere o AT re-rocedure, ad 99.6% ere o AT a he me of dscharge. A 30 das, he oerall cdece of o-adherece as 2.1% (104 subjecs, 147 esodes): dsruo 69%, erruo 19%, ad dscouao 12%. e hromboss (robable ad deie er ARC deios) as rare a 0.46%. Of he 26 s h T, 17 ere deie T, ad 9 ere robable T. The rae of T adhere oulao as 0.46% (23/4929), comared o 2.9% (3/104) amogs he o-adhere grou (OR: 6.3; 95% CI [1.9-21.4). To dae all s hae comleed 6 moh follo-u ad all resuls cludg adjudcaed aderse ees ll be reseed.Conclusion: I hs real-orld oulao of aes udergog CI h se mlaao, o-adherece o AT as lo a 30 das. hle he rae of T a 30 das as lo (0.46%), here as a srog assocao beee o-adherece ad T. Comlee 6 moh daa ll be reseed.