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The optimal duration of dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with implantation of the Orsiro Mission stent remains unclear. The BIOFLOW-DAPT (clinicaltrials.gov, NCT04137510) trial is a prospective, multi-center, randomized controlled study designed to assess the safety of the Orsiro Mission versus the Resolute Onyx stent in HBR patients. Patients are treated with DAPT (aspirin and a P2Y 12 inhibitor) for 1 month, followed by a single antiplatelet therapy (SAPT). The primary endpoint is the composite of cardiac death, myocardial infarction, and definite or probable stent thrombosis at 1 year. With a final sample size of 1948 HBR patients, this study is powered to assess the noninferiority of the Orsiro Mission stent with respect to the primary study endpoint. The BIOFLOW-DAPT is the first randomized clinical trial investigating 1-month DAPT duration in HBR patients after implantation of the Orsiro Mission stent.Trial Registration: ClinicalTrials.gov number, NCT04137510 Study design and key features. Patient selection starts before the index PCI, when consented patients will be randomized to the Orsiro Mission or the Resolute Onyx stent with mandated 1-month DAPT. At 1 month, eligibility is reassessed and if met, patients will discontinue DAPT and continue with P2Y 12 inhibitor or aspirin monotherapy. PCI, percutaneous coronary intervention; DAPT, dual antiplatelet therapy; DES, drug-eluting stent; HBR, high bleeding risk; P2Y12i, P2Y12 inhibitor; ST, stent thrombosis., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI., Methods: The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha., Results: A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P <0.0001 for noninferiority for both tests)., Conclusions: Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT04137510., Competing Interests: Disclosures Dr Valgimigli reports grants and personal fees from Terumo and personal fees from AstraZeneca, Alvimedica/CID, Abbott Vascular, Daiichi Sankyo, Bayer, CoreFLOW, IDORSIA Pharmaceuticals Ltd, Universität Basel, Department Klinische Forschung, Vifor, Bristol Myers Squibb SA, Biotronik, Boston Scientific, Medtronic, Vesalio, Novartis, Chiesi, and PhaseBio. Dr Wlodarczak has no conflicts of interest to report. Dr Tölg reports personal fees for lectures from Biotronik. Dr Merkely reports personal fees from Abbott, AstraZeneca, Biotronik, Boehringer Ingelheim, CSL Behring, Daiichi Sankyo, Duke Clinical Research Institute, Medtronic, and Novartis, and institutional grants from Abbott, AstraZeneca, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, CSL Behring, Daiichi Sankyo, Duke Clinical Institute, Eli Lilly, Medtronic, Novartis, Terumo, and VIFOR Pharma. Dr Kelbæk has no conflicts of interest to report. Dr Legutko reports lecture fees from Abiomed, AstraZeneca, Berlin Chemie-Menarini, Abbott, Bayer AG, Ely Lilly, Medtronic, MSD, Philips-Volcano, Procardia, Sanofi, and Novartis; meeting or travel fees from Abbott, Boston, Medtronic, and Abiomed; and data safety monitoring board or advisory board fees from AstraZeneca, Berlin Chemie-Menarini, Abbott, Sanofi, Gedeon Richte, Hemolens Diagnostics, Novartis, and Ferrer. Dr Galli reports consulting fees from BIOACADEMY and lecture fees from PCR. Dr Godin reports lecture fees from B. Braun, Medtronic, and Edwards, and data safety monitoring board or advisory board fees from Terumo and Microport. Dr Toth reports grants and personal fees from Terumo, Abbott Vascular, Biotronik, and Medtronic. Dr Lhermusier reports consulting fees from Abbott and meeting or travel fees from Medtronic. Dr Honton reports consulting fees from Medtronic, Shockwave, Terumo, and Microport; lecture fees from Shockwave, Medtronic, and Boston; and data safety monitoring board or advisory board fees from Microport, Terumo, and Medtronic. Dr Dietrich reports educational event fees to his institution from Cordis. Drs. Stammen and Ferdinande have no conflicts of interest to report. Dr Silvain reports consulting fees from AstraZeneca, Bayer Health Care SAS, CSL Behring SA, Sanofi-Aventis France, and Zoll, and stock options without payment at 4P-Pharma. Dr Capodanno reports honoraria fees from Biotronik and honoraria fees to his institution from Medtronic. Dr Cayla reports personal consulting fees from Edwards, Medtronic, and Microport CRM, and personal honoraria fees from Amgen, AstraZeneca, Abbott, Bayer, Biotronik, Bristol-Myers Squibb, Edwards, Microport, Medtronic, Pfizer, and Sanofi-Aventis.

Background: To chart the evolution of the CTO-PCI landscape in Belgium and Luxembourg, the Belgian Working Group on Chronic Total Occlusions (BWGCTO) was established in 2016., Methods: Between May 2016 and December 2019, patients undergoing a CTO-PCI treatment were prospectively and consecutively enrolled. Twenty-one centres in Belgium and one in Luxembourg participated. Individual operators had mixed levels of expertise in treating CTO lesions. Demographic, angiographic, procedural parameters and incidence of major adverse cardiac and cerebrovascular events (MACCE) were systematically registered., Results: Over a four-year enrolment period, 1832 procedures were performed in 1733 patients achieving technical success in 1474 cases (80%), with an in-hospital MACCE rate of 2.3%. Fifty-nine (3%) cases were re-attempt procedures of which 41 (69%) were successful. High-volume centres treated more complex lesions (mean J-CTO score: 2.15 ± 1.21) as compared to intermediate (mean J-CTO score: 1.72 ± 1.23; p  < 0.001) and low-volume centres (mean J-CTO score: 0.99 ± 1.21; p  = 0.002). Despite this, success rates did not differ between centres ( p  = 0.461). Overall success rates did not differ over time ( p  = 0.810). High-volume centres progressively tackled more complex CTOs while keeping success rates stable. In all centres, the most applied strategy was antegrade wire escalation (83%). High-volume centres more often successfully applied antegrade dissection and re-entry and retrograde techniques in lesions with higher complexity., Conclusion: With variable experience levels, operators treated CTOs with high success and relatively few complications. Although AWE remains the most used technique, it is paramount for operators to be skilled in all contemporary techniques in order to be successful in more complex CTOs.

Aims: The current study assessed the impact of COVID-19-related public containment measures (i.e. lockdown) on the ST elevation myocardial infarction (STEMI) epidemic in Belgium., Methods and Results: Clinical characteristics, reperfusion therapy modalities, COVID-19 status and in-hospital mortality of consecutive STEMI patients who were admitted to Belgian hospitals for percutaneous coronary intervention (PCI) were recorded during a three-week period starting at the beginning of the lockdown period on 13 March 2020. Similar data were collected for the same time period for 2017-2019. An evaluation of air quality revealed a 32% decrease in ambient NO 2 concentrations during lockdown (19.5 µg/m³ versus 13.2 µg/m³, p  < .001). During the three-week period, there were 188 STEMI patients admitted for PCI during the lockdown versus an average 254 STEMI patients before the lockdown period (incidence rate ratio = 0.74, p  = .001). Reperfusion strategy was predominantly primary PCI in both time periods (96% versus 95%). However, there was a significant delay in treatment during the lockdown period, with more late presentations (>12 h after onset of pain) (14% versus 7.6%, p  = .04) and with longer door-to-balloon times (median of 45 versus 39 min, p  = .02). Although the in-hospital mortality between the two periods was comparable (5.9% versus 6.7%), 5 of the 7 (71%) COVID-19-positive STEMI patients died., Conclusion: The present study revealed a 26% reduction in STEMI admissions and a delay in treatment of STEMI patients. Less exposure to external STEMI triggers (such as ambient air pollution) and/or reluctance to seek medical care are possible explanations of this observation.

Background: Important developments in materials, devices, and techniques have improved outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI), and resulted in a growing interest in CTO-PCI. The Belgian Working Group on Chronic Total Occlusions ( BWGCTO) working group aims to assess the evolution within the CTO-PCI landscape over the next years. Methods: From May 2016 onwards, patients undergoing CTO-PCI were included in the BWGCTO registry by 15 centres in Belgium and Luxemburg. Baseline, angiographic, and procedural data were collected. Here, we report on the one-year in-hospital outcomes. Results : Over the course of one year, 411 procedures in 388 patients were included with a mean age of 64 ± 11 years. The majority were male (81%). Relatively complex CTOs were treated (Japanese CTO score =2.2 ± 1.2) with a high procedure success rate (82%). Patient- and lesion-wise success rates were 83 and 85%, respectively. Major adverse in-hospital events were acceptably low (3.4%). Antegrade wire escalation technique was applied most frequently (82%). On the other hand, antegrade dissection and re-entry and retrograde strategies were more frequently applied in higher volume centres and successful for lesions with higher complexity. Conclusion: Satisfactory procedural outcomes and a low rate of adverse events were obtained in a complex CTO population, treated by operators with variable experience levels. Antegrade wire escalation was the preferred strategy, regardless of operator volume.

Objectives: The long-term clinical outcome of covered stents in the percutaneous treatment of diseased saphenous vein graft (SVG) has been disappointing. The single self-expanding polytetrafluoroethylene (PTFE)-covered Symbiot stent with a unique profile may present advantages that translate into superior long-term clinical outcomes. This study evaluated the safety, effectiveness and clinical outcome of the Symbiot covered stent system (Boston Scientific, Natick, Mass.) and FilterWire EX (Boston Scientific, Natick, Mass.) versus bare metal stents (BMS) in SVG intervention., Methods and Results: Between January 2003 and August 2005, 90 patients with degenerative SVG lesions were prospectively randomized at 6 study sites to Symbiot implantation (n = 30), BMS with FilterWire as embolic protection device (EPD, n = 30), or BMS without EPD (control group, n = 30). The primary end point was reduction in peri-procedural cardiac enzyme rise. The major secondary end points were in-hospital, 6-month and long-term target vessel failure rates, defined as the cumulative of death, myocardial infarction and clinically driven target lesion revascularization. There was no significant reduction in median [IQR] post-procedural troponin-I rise in the Symbiot group compared to the FilterWire or the control group (0.08 [0-1.40] microg/l; 0.06 [0-0.28] microg/l; and 0.04 [0-0.31] microg/l, P = 0.58). At 7.4 +/- 1.3 (mean +/- SD) years, there were numerically less deaths in the Symbiot group, although this did not reach statistical significance (P = 0.20). There was no significant difference in TVF-free survival between the treatment groups (P = 0.98)., Conclusion: This study failed to show a procedural or long-term clinical advantage for the Symbiot PTFE-covered stent in the treatment of degenerated SVG.