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Background: Radial artery access has been used for left heart catheterization (LHC) and percutaneous coronary intervention (PCI) for over 30 years. This method has gained popularity among operators due to superficial vessel anatomy, allowing for easy accessibility and compressibility, resulting in effective hemostasis., Methods: We conducted a retrospective analysis of patients who underwent PCI due to ST-elevation myocardial infarction (STEMI), non-ST-elevation acute coronary syndrome (NSTE-ACS), and chest pain (stable angina) from November 2013 to February 2023., Results: We analyzed validated registries and found 7714 PCIs. Of these, 1230 were STEMI patients, 5585 were NSTE-ACS patients, and 899 were stable angina patients, forming the basis of our final analysis. In STEMI patients, there was a trend toward a higher rate of ventriculography with femoral access compared to radial access (53.4 % vs. 47.5 %, p = 0.06), which was also observed in NSTE-ACS patients (34.2 % vs. 31.8 %, p = 0.07). The use of central venous access was more common with femoral access in all three diagnoses, with significantly higher rates seen in STEMI patients (36.2 % vs. 7.6 %, p < 0.001), NSTE-ACS patients (19.3 % vs. 2.8 %, p < 0.001), and chest pain patients (26.4 % vs. 2.7 %, p < 0.001)., Conclusions: The analysis revealed that operators may perform fewer ventriculography and RHC procedures when using radial access as compared to femoral access. While there is discrepancy in performing left ventriculography and RHC when using a radial artery, it is essential to emphasize that routinely performing ventriculography and hemodynamic assessment has not proven to impact outcomes, despite their contributions to proper decision-making and treatment., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Brian C. Case – Speaker: Asahi Intecc USA, Zoll Medical. Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Transmural Systems Inc. All other authors – None., (Copyright © 2024. Published by Elsevier Inc.)

Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Transmural Systems Inc. All other authors – None.

Background: The 12-month outcomes of BIOMAG-I - the first-in-human study investigating the third-generation drug-eluting resorbable magnesium scaffold (DREAMS 3G) - showed promising results regarding clinical outcomes and late lumen loss., Aims: The current study aimed to investigate vascular healing parameters assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS), focusing on strut visibility, vessel and scaffold areas, and neointimal growth patterns., Methods: This is a BIOMAG-I substudy including patients with available serial OCT and IVUS data. We conducted a frame-based analysis of OCT findings in conjunction with IVUS-derived vessel and scaffold areas, evaluating the qualitative and quantitative aspects of vascular healing., Results: Among the 116 patients enrolled in this trial, 56 patients treated with DREAMS 3G were included in the analysis. At 12 months, OCT imaging revealed that 99.0% of the struts were invisible, and no malapposed struts were depicted. While the vessel area showed no significant difference between the timepoints, the minimum lumen area significantly decreased from post-percutaneous coronary intervention to 6 months (6.88 mm 2 to 4.75 mm 2 ; p<0.0001), but no significant changes were observed between 6 and 12 months. Protruding neointimal tissue (PNT) - a unique neointimal presentation observed following resorbable magnesium scaffold implantation - was observed in 89.3% of the study patients at 12 months, and its area exhibited a 47.4% decrease from 6 to 12 months., Conclusions: This imaging substudy revealed that, at 12-month follow-up, virtually all struts of the DREAMS 3G scaffold became invisible, without evident malapposition. The vascular healing response to DREAMS 3G implantation also appeared favourable up to 12 months, which is indicated by advanced strut degradation and spontaneous regressing PNT between 6 and 12 months.

Spontaneous coronary artery dissection (SCAD) is a rare cause of ST-segment elevation myocardial infarction (STEMI), predominantly affecting women. Because primary percutaneous coronary intervention (PPCI) is reserved for a select group of patients, vulnerable and minority patients may experience delays in appropriate management and adverse outcomes. We examined the racial differences in the outcomes for patients with SCAD who underwent PPCI for STEMI. Records of patients aged ≥18 years who underwent PPCI for SCAD-related STEMI between 2016 and 2020 were identified from the National Inpatient Sample database. Clinical, socioeconomic, and hospital characteristics were compared between non-White and White patients. Weighted multivariate analysis assessed the association of race with inpatient mortality, length of stay (LOS), and hospitalization costs. The total weighted estimate of patients with SCAD-STEMI who underwent PPCI was 4,945, constituting 25% non-White patients. Non-White patients were younger (56 vs 60.7 years, p <0.001); had a higher prevalence of diabetes, acute renal failure, and obesity; and were more likely to be uninsured and be in the lowest income group. Inpatient mortality (7.7% vs 8.4%, p = 0.74) and hospitalization costs ($34,213 vs $31,858, p = 0.27) were similar for non-White and White patients, and the adjusted analysis did not show any association between the patients' race and inpatient mortality (odds ratio 0.60, 95% confidence interval [CI] 0.32 to 1.13, p = 0.11) or hospitalization costs (β [β coefficient]: 215, 95% CI -4,193 to 4,623, p >0.90). Similarly, there was no association between the patients' race and LOS (incident rate ratio 1.20, 95% CI 1.00 to 1.45, p = 0.054). The weighted multivariate analysis showed that age; clinical co-morbidities such as diabetes, acute renal failure, valvular dysfunction, and obesity; low-income status; and hospitalization in the western region were associated with adverse outcomes. In conclusion, our study does not show any differences in inpatient mortality, LOS, and hospitalization costs between non-White and White patients who underwent PPCI for SCAD-related STEMI., Competing Interests: Declaration of competing interest Dr. Garcia-Garcia receives institutional grant support from MedAlliance, Biotronik, Neovasc, Boston Scientific, Abbott, Shockwave, Chiesi, Philips, Spectrawave, Angiowave, InfraReDx, Medis, Pulse Medical, and MedHub; is a consultant of Biotronik and Abbott; and receives speaker's fee form Abbott, Biotronik, Boston Scientific, and InfraReDx. Dr. Chitturi is a consultant for Glass Health. Dr. Case is a speaker for Asahi Intecc USA, Zoll Medical. Dr. Waksman is on the advisory board of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; is a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receives grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; is part of the speakers bureau of AstraZeneca; and is an investor of MedAlliance and Transmural Systems Inc. The remaining authors have no competing interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

The benefit of mechanical circulatory support with Impella (Abiomed, Inc., Danvers, Massachusetts) for high-risk percutaneous coronary intervention (HR-PCI) is uncertain. PROTECT III registry data showed improved outcomes with Impella compared with historical data (PROTECT II) but lack a direct comparison with the HR-PCI cohort without Impella support. We retrospectively identified patients meeting the PROTECT III inclusion criteria for HR-PCI and compared this group (non-Impella cohort [NonIMP]) with the outcomes data from the PROTECT III registry (Impella cohort). Baseline differences were balanced using inverse propensity weighting. The coprimary outcome was major adverse cardiac events (MACE) in-hospital and at 90 days. A total of 283 patients at great risk did not receive Impella support; 200 patients had 90-day event ascertainment and were included in the inverse propensity weighting analysis and compared with 504 patients in the Impella cohort group. After calibration, few residual differences remained between groups. The primary outcome was not different in-hospital (3.0% vs 4.8%, p = 0.403) but less in NonIMP at 90 days (7.5% vs 13.8%, p = 0.033). Periprocedural vascular complications, bleeding, and transfusion rate did not differ between groups; however, acute kidney injury occurred more frequently in the NonIMP group (10.5% vs 5.4%, p = 0.023). In conclusion, under identical HR-PCI inclusion criteria for Impella use in PROTECT III, an institutional non-Impella-supported HR-PCI cohort showed similar MACE in-hospital but fewer MACE at 90 days, whereas there was no signal for periprocedural harm with Impella use. These results do not support routine usage of Impella for patients with HR-PCI., Competing Interests: Declaration of competing interest Dr. Rogers is a consultant to Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; serves on advisory boards for Medtronic and Boston Scientific; holds equity in Transmural Systems; and reports intellectual property as co-inventor on patents, assigned to National Institutes of Health. Dr. Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific (Abbott), Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems. The remaining authors have no competing interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: To date, there has been no independent core lab angiographic analysis of patients with COVID-19 and STEMI. The study characterized the angiographic parameters of patients with COVID-19 and STEMI., Methods: Angiograms of patients with COVID-19 and STEMI from the North American COVID-19 Myocardial Infarction (NACMI) Registry were sent to a Core Laboratory in Vancouver, Canada. Culprit lesion(s), Thrombolysis In Myocardial Infarction (TIMI) flow, Thrombus Grade Burden (TGB), and percutaneous coronary intervention (PCI) outcome were assessed., Results: From 234 patients, 74% had one culprit lesion, 14% had multiple culprits and 12% had no culprit identified. Multivessel thrombotic disease and multivessel CAD were found in 27% and 53% of patients, respectively. Stent thrombosis accounted for 12% of the presentations and occurred in 55% of patients with previous coronary stents. Of the 182 who underwent PCI, 60 (33%) had unsuccessful PCI due to post-PCI TIMI flow <3 (43/60), residual high thrombus burden (41/60) and/or thrombus related complications (27/60). In-hospital mortality for successful, partially successful, and unsuccessful PCI was 14%, 13%, and 27%, respectively. Unsuccessful PCI was associated with increased risk of in-hospital mortality (risk ratio [RR] 1.96; 95% CI: 1.05-3.66, P = .03); in the adjusted model this estimate was attenuated (RR: 1.24; 95% CI: 0.65-2.34, P = .51)., Conclusion: In patients with COVID-19 and STEMI, thrombus burden was pervasive with notable rates of multivessel thrombotic disease and stent thrombosis. Post-PCI, persistent thrombus and sub-optimal TIMI 3 flow rates led to one-third of the PCI's being unsuccessful, which decreased over time but remained an important predictor of in-hospital mortality., Competing Interests: Disclosures The authors have no conflicts of interest to disclose in relation to this manuscript., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: With advances in technology and technique, the expectations are that patients undergoing procedures in the cardiac catheterization laboratory will not need to return for a repeat procedure within the same day., Objectives: Report why subjects undergoing cardiac procedures return urgently to the catheterization laboratory for a repeat procedure during the same day., Methods: We retrospectively reviewed patients who were brought back to the cardiac catheterization laboratory within the same day for a repeat procedure. The reasons for index and repeat procedure were identified. Patients who were transferred from an outside center after an initial procedure at other centers were excluded., Results: Between November 2013 and January 2022, 55,942 catheterization procedures were performed at our institution, of which 140 entries were included in our analysis. Common reasons for the index procedure were diagnostic angiography (35.0%), percutaneous coronary intervention (PCI, 29.2%), and transcatheter aortic valve replacement (15.0%). The most common reason for bringing these patients back to the cardiac catheterization laboratory within the same day was vascular complications (24.2%), followed by repeat PCI (20.7%), need for hemodynamic support (15.0%), heart team discussion and PCI (10%), and pacemaker implantation (10%). Acute limb ischemia was the most commonly identified vascular complication (7.1%), followed by pseudoaneurysm (5%)., Conclusion: Our study demonstrates that a very small number of patients underwent repeat procedures within the same day. Special attention should be paid to vascular access and closure and assessment of recurrent chest pain postprocedure, as these are the main reasons for same-day repeat procedures., (© 2024 Wiley Periodicals LLC.)

Background: Recent clinical data indicate a different performance of biodegradable polymer (BP)-drug eluting stent (DES) compared to durable polymer (DP)-DES. Whether this can be explained by a beneficial impact of BP-DES stent design on the local hemodynamic forces distribution remains unclear., Objectives: To compare endothelial shear stress (ESS) distribution after implantation of ultrathin (us) BP-DES and DP-DES and examine the association between ESS and neointimal thickness (NIT) distribution in the two devices at 9 months follow up., Methods and Results: We retrospectively identified patients from the BIOFLOW II trial that had undergone OCT imaging. OCT data were utilized to reconstruct the surface of the stented segment at baseline and 9 months follow-up, simulate blood flow, and measure ESS and NIT in the stented segment. The patients were divided into 3 groups depending on whether DP-DES (N = 8, n = 56,160 sectors), BP-DES with a stent diameter of >3 mm (strut thickness of 80 μm, N = 6, n = 36,504 sectors), or BP-DES with a stent diameter of ≤3 mm (strut thickness of 60 μm, N = 8, n = 50,040 sectors) were used for treatment. The ESS, and NIT distribution and the association of these two variables were estimated and compared among the 3 groups., Results: In the DP-DES group mean NIT was 0.18 ± 0.17 mm and ESS 1.68 ± 1.66 Pa; for the BP-DES ≤3 mm group the NIT was 0.17 ± 0.11 mm and ESS 1.49 ± 1.24 Pa and for the BP-DES >3 mm group 0.20 ± 0.23 mm and 1.42 ± 1.24 Pa respectively (p < 0.001 for both NIT and ESS comparisons across groups). A negative correlation between NIT and baseline ESS was found, the correlation coefficient for all the stented segments was -0.33, p < 0.001., Conclusion: In this OCT sub-study of the BIOFLOW II trial, the NIT was statistically different between groups of patients treated with BP-DES and DP-DES. In addition, regions of low ESS were associated with increased NIT in all studied devices., Competing Interests: Declaration of competing interest Ron Waksman: Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. All other authors have no conflicts of interest to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Aims: The aim of the study is to assess the impact of the baseline plaque composition on the DREAMS 3G luminal late loss and to compare the serial plaque changes between baseline and 6 and 12 months (M) follow-up., Methods and Results: A total of 116 patients were enrolled in the BIOMAG-I trial. Patients were imaged with optical coherence tomography (OCT) pre- and post-DREAMS 3G implantation and at 6 and 12 M. OCTPlus software uses artificial intelligence to assess composition (i.e. lipid, calcium, and fibrous tissue) of the plaque. The differences between the OCT-derived minimum lumen area (MLA) post-percutaneous coronary intervention and 12 M were grouped into three terciles. Patients with larger MLA differences at 12 M (P = 0.0003) had significantly larger content of fibrous tissue at baseline. There was a reduction of 24.8% and 20.9% in lipid area, both P < 0.001, between the pre-DREAMS 3G OCT and the 6 and 12 M follow-up. Conversely, the fibrous tissue increased by 48.4% and 36.0% at 6 and 12 M follow-up, both P < 0.001., Conclusion: The larger the fibrous tissue in the lesion at baseline, the larger the luminal loss seen at 6 and 12 M. Following the implantation of DREAMS 3G, favourable healing of the vessel coronary wall occurs as shown by a decrease in the lipid area and an increase in fibrous tissue., Competing Interests: Conflict of interest: H.M.G.-G., R.W., G.D.M., M.G., S.B., A.K., and M.B.L. were core laboratory members, and the remaining authors were investigators of the trial. H.M.G.-G. has grants or contracts from Medtronic, Biotronik, Abbott, Neovasc, Corflow, Alucentbio, Philips, and Chiesi (paid to institution), received consulting fees from Boston Scientific and ACIST, and participates in DSMB/advisory board of the VIVID study. R.W. has grants or contracts from Amgen, Biotronik, Boston Scientific, Medtronic, and Philips IGT; received consulting fees from Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; received honoraria from AstraZeneca; participates in DSMB/advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; and is an investor in MedAlliance and Transmural Systems Inc. J.T. reports grants and contracts from Abbott paid to his institution, speaker honoraria and support for attending meetings from Biotronik, and is an associate editor of Cardiovascular Biologics and Regenerative Medicine and Frontiers in Cardiovascular Medicine. J.E. reports personal fees/speaker honoraria from Abbott, Boston Scientific, Philips, and Shockwave, patents from Shared, and participation in advisory boards of Abbott and Phillips. The institution of J.F.I. receives grants or contracts from Terumo Corp, Biosensors, Concept Medical, Biotronik, Abbott Vascular, and Philips Volcano. J.F.I. reports consulting fees from Biotronik, Medtronic, Cordis, Terumo Corp., and ReCor Medical; speaker fees/honoraria from Terumo Corp, Biosensors, Medalliance, OrbusNeich, Concept Medical, Bristol Myers Squibb/Pfizer, Novartis, Cordis, AstraZeneca, and Philips Volcano; and support to attend meetings from Biotronik and Amgen. The institution of J.B. receives grants or contracts from Shockwave IVLS. J.B. receives consulting fees from Biotronik AG and Boston Scientific and speaker fees/honoraria from Biotronik AG, Boston Scientific, and Abbott Vascular, participates in the DSMB of Boston Scientific, and has a leadership or fiduciary role for Biotronik. G.G.T. reports consulting fees from Biotronik, Medtronic, Abbott, and Terumo and honoraria from Biotronik, Medtronic, Abbott, and Terumo. M.J. reports grant support from Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and Infraredx; consulting fees from AlchiMedics SAS, Biotronik, TriCares, Veryan, and Shockwave; speaker fees/honoraria from Abbott Vascular, Biotronik, Boston Scientific, Edwards Lifesciences, Cardiac Dimensions, AstraZeneca, Recor Medical, and Shockwave; travel support from SIS Medical, Edwards Lifesciences, Boston Scientific, and Cardiac Dimensions; and participation in Steering Committees of Biotronik and Edwards Lifesciences. R.T. reports lecture fees from Biotronik. M.W. reports speaker honoraria and conference attendance support from Biotronik. G.O. reports lecturer honoraria from Abbott Vascular, Biotronik, and Cordis and is a DSMB member of the SCIENCE trial and a CEC-member of the BIOFREEDOM STEMI trial. M.H. reports grants/contracts from Biotronik, Cardiac Dimensions, OrbusNeich, and Philips; consulting fees from Biotronik, Cardiac Dimensions, Shockwave Medical, and OrbusNeich; honoraria/speaker fees from Biotronik, Cardiac Dimensions, Shockwave Medical, OrbusNeich, and Philips; and support to attend meetings/travel support from Biotronik, is a steering committee member of the BIOSOLVE and BIOMAG trials, and is a past president of EAPCI. All other authors have no conflict of interest to declare., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Percutaneous coronary intervention (PCI) is considered less safe in patients with reduced ejection fraction (EF), an impression based on older data. Whether the safety and durability of contemporary PCI are different in patients with reduced EF compared with normal EF patients is unknown., Methods: Patients from the BIOFLOW II, IV and V clinical trials were grouped as normal EF (≥50%) and reduced EF (30%-50%). Using multivariable logistic regression and cox proportional hazards regression, we determined relations of EF category with procedural safety (a composite of cardiac death, myocardial infarction, stroke and urgent coronary artery bypass grafting within 30 days of PCI) and target lesion failure (TLF; comprising cardiac death, target vessel myocardial infarction, target vessel revascularization within 1 year of PCI) respectively. In sensitivity analyses, we regrouped patients into EF < 45% and ≥55% and repeated the aforementioned analyses., Results: In 1685 patients with normal EF (mean age 65 years; 27% women; mean EF 61%) and 259 with low EF (mean age 64 years; 17% women; mean EF 41%), 101 safety and 148 TLF events occurred. Compared with patients in the normal EF group, those with reduced EF had neither a statistically significant higher proportion of safety events, nor a higher multivariable-adjusted risk for such events. Similarly, patients with reduced EF and normal EF did not differ in terms of TLF event proportions or multivariable-adjusted risk for TLF. The results were similar in sensitivity analyses with EF groups redefined to create a 10% between-group EF separation., Conclusion: PCI safety and durability outcomes are similar in patients with mild-moderately reduced EF and normal EF., (© 2024 Wiley Periodicals LLC.)

Competing Interests: Declaration of Competing Interest Dr. Hashim reports serving on the advisory boards of and being a speaker for Abbott Vascular, Boston Scientific, and Philips IGT. Dr. Rogers reports serving as a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; being on the advisory boards of Medtronic and Boston Scientific; holding equity in Transmural Systems; and being a co-inventor on patents, assigned to the National Institutes of Health. Dr. Garcia-Garcia reports receiving institutional grants from Medtronic, Biotronik, Neovasc, Boston Scientific, Shockwave, Chiesi, and Philips. Dr. Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems. The remaining authors have no competing interests to declare.

Background: Bleeding events are associated with higher mortality rates in patients with cardiovascular diseases, including patients presenting with acute coronary syndrome (ACS) undergoing coronary revascularization. We aimed to determine whether a reduction in hemoglobin (Hgb) from pre- to postpercutaneous coronary intervention (PCI), with or without evidence of clinical bleeding, is a correlate of in-hospital mortality for patients presenting with ACS who underwent primary PCI., Methods: We divided 33816 consecutive patients with ACS who underwent PCI into three categories: (1) target group (defined as Hgb reduction without overt bleeding [n = 112]); (2) Hgb reduction with overt bleeding (n = 48); and (3) control group (defined as no Hgb reduction and no overt bleeding [n = 3156]). Hgb reduction was defined as a drop of >3 g/dL in Hgb value from preprocedure and postprocedure during the index hospitalization. The primary outcome was in-hospital mortality. We used logistic regression to examine the relationship between Hgb reduction with and without bleeding and in-hospital mortality., Results: In crude analysis, the Hgb reduction with overt bleed group had a higher in-hospital mortality rate (16.7%) than the target (9.8%) and control groups (0.6%). Adjusted logistic regression estimates a 0.393 (95% confidence interval [CI]: 0.137, 1.869) odds ratio for in-hospital death of the target group over the Hgb reduction with bleed group, and a 54.517 (95% CI: 2.07, >1000) odds ratio of the target group over the control group., Conclusions: In patients presenting with ACS undergoing PCI, Hgb reduction with and without overt bleeding were both independently associated with in-hospital mortality., (© 2023 Wiley Periodicals LLC.)

Background: Patients with atherothrombotic risk are at high hazard of ischemic events. Preventive medicine plays a major role in modifying their outcomes. Whether the choice of a BP-SES or DP-EES can contribute to the occurrence of events remains unclear. We sought to investigate the outcomes of patients with higher atherothrombotic risk (H-ATR) versus lower atherothrombotic risk (L-ATR) undergoing percutaneous coronary intervention (PCI) with either bioresorbable-polymer sirolimus-eluting stent (BP-SES) or durable-polymer everolimus-eluting stent (DP-EES)., Methods: Patients (n = 2361) from BIOFLOW-II, -IV, and -V randomized trials were categorized into H-ATR vs. L-ATR. L-ATR patients had ≤ 1 and H-ATR ≥ 2 of the following criteria: presentation in ACS, diabetes mellitus, previous myocardial infarction, previous PCI/CABG, or previous stroke. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], target lesion revascularization [TLR]) and stent thrombosis (ST) at three years., Results: H-ATR patients (n = 1023) were more morbid than L-ATR patients (n = 1338). TLF rate was significantly higher in H-ATR patients as compared with L-ATR (11.6% vs. 7.0%; HR 1.67, 95% CI 1.27-2.20, p < 0.0001). With BP-SES TLF rates were numerically lower as compared with DP-EES in H-ATR (10.5% vs. 13.5%; HR 0.78, 95% CI 0.54-1.14, p = 0.20) and significantly lower in L-ATR (5.6% vs. 9.8%; HR 0.57, 95% CI 0.38-0.85, p = 0.006)., Conclusion: In the era of newer-generation DES, patients with H-ATR still are at hazard for ischemic events. Patients with BP-SES had lower TLF rates as compared with DP-EES, most consistent in L-ATR whereas in H-ATR patients most probably secondary preventive strategies are of higher value., Clinical Trial Registration: Clinicaltrial.gov. NCT01356888, NCT01939249, NCT02389946. https://clinicaltrials.gov/show/NCT01356888 , https://clinicaltrials.gov/show/NCT01939249 , https://clinicaltrials.gov/show/NCT02389946 ., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Background: The third-generation coronary sirolimus-eluting magnesium scaffold, DREAMS 3G, is a further development of the DREAMS 2G (commercial name Magmaris), aiming to provide performance outcomes similar to drug-eluting stents (DES)., Aims: The BIOMAG-I study aims to assess the safety and performance of this new-generation scaffold., Methods: This is a prospective, multicentre, first-in-human study with clinical and imaging follow-up scheduled at 6 and 12 months. The clinical follow-up will continue for 5 years., Results: A total of 116 patients with 117 lesions were enrolled. At 12 months, after completion of resorption, in-scaffold late lumen loss was 0.24±0.36 mm (median 0.19, interquartile range 0.06-0.36). The minimum lumen area was 4.95±2.24 mm² by intravascular ultrasound and 4.68±2.32 mm² by optical coherence tomography. Three target lesion failures were reported (2.6%, 95% confidence interval: 0.9-7.9), all clinically driven target lesion revascularisations. Cardiac death, target vessel myocardial infarction and definite or probable scaffold thrombosis were absent., Conclusions: Data at the end of the resorption period of DREAMS 3G showed that the third-generation bioresorbable magnesium scaffold is clinically safe and effective, making it a possible alternative to DES., Clinicaltrials: gov: NCT04157153.

Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems Inc. All other authors have no conflicts of interest to declare.

Background: The novel sirolimus-eluting resorbable scaffold DREAMS 3G was designed as a third-generation development of its predecessor, the Magmaris scaffold., Aims: This preclinical study aimed to examine the qualitative and temporal course of the degradation of the DREAMS 3G relative to the Magmaris scaffold., Methods: Forty-nine DREAMS 3G and 24 Magmaris scaffolds were implanted into 48 mini swine for degradation kinetics analysis. Another DREAMS 3G was implanted into one mini swine for crystallinity analysis of the degradation end product after 730 days. Degradation kinetics were determined at 28, 90, 120, 180, and 365 days., Results: Discontinuity density in DREAMS 3G was significantly lower than that in Magmaris scaffolds for the follow-up timepoints of 90 and 120 days. Planimetric analysis indicated 99.6% backbone degradation for DREAMS 3G at 12 months. Compared to the Magmaris scaffold, individual strut degradation in DREAMS 3G showed less variability and the remaining backbone core was more homogeneous. The degradation end product of DREAMS 3G manifested as calcium phosphate with a minor share of aluminium phosphate., Conclusions: DREAMS 3G showed almost complete degradation after one year, with amorphous calcium and aluminium phosphate as the end products of degradation. Despite its thinner struts, scaffold discontinuity was significantly lower in the DREAMS 3G than in the Magmaris scaffold, likely providing a longer scaffolding time.

Background: Dual-antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor is the mainstay regimen for acute coronary syndrome (ACS) patients after percutaneous coronary intervention (PCI). We aimed to investigate DAPT compliance and switching patterns in ACS patients prescribed ticagrelor and aspirin. Secondly, we evaluated the impact of a pilot strategy of close surveillance telephone calls., Methods: The study enrolled 150 consecutive ACS patients who underwent PCI and were prescribed DAPT (aspirin and ticagrelor). This cohort, the "close surveillance arm," then received telephone calls from a healthcare professional to inquire about DAPT for up to one year. These findings, and clinical outcomes, were then compared to a "historical arm" of ACS patients (n = 505) who received PCI and were prescribed DAPT before initiation of the program. Finally, healthcare providers were surveyed about their experience with prescribing DAPT., Results: The rate of ticagrelor cessation trended lower in the close surveillance arm (22.00 % versus 31.70 %, p = 0.0783). The most common reasons for ticagrelor cessation were adverse medication reaction (dyspnea), bleeding, and financial burden. Nevertheless, the adverse events were few and similar between the two groups during follow-up. Over 96 % of healthcare providers surveyed stated that they worry about their patients' DAPT compliance post-PCI., Conclusion: Noncompliance and switching medications are still common for patients who undergo PCI for ACS. A close surveillance program identified patients at risk for medication cessation or switching and could potentially mitigate this phenomenon and improve quality of care., Competing Interests: Declaration of competing interest Hayder Hashim reports being a consultant for, and receiving speaker fees from, Abbott, Cardiovascular Systems Inc., and Boston Scientific. Toby Rogers reports being a proctor and consultant for Boston Scientific, Edwards Lifesciences, and Medtronic; serving on the Advisory Board of Medtronic; and holding equity interest in Transmural Systems Inc. Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems Inc. All other authors have no competing interests to declare., (Copyright © 2022. Published by Elsevier Inc.)

Competing Interests: Funding Support and Author Disclosures Dr Weissman is the director of an academic cardiac computed tomography core lab with institutional contracts with Ancora Heart and LivaNova. Dr Rogers has been a consultant for Edwards Lifesciences, Medtronic, and Transmural Systems Inc.; has been a proctor for Edwards Lifesciences and Medtronic; has served on the advisory board of Medtronic; and is a stockholder in Transmural Systems Inc. Dr Hashim has been a consultant for, and received speaker fees from, Abbott, Cardiovascular Systems Inc., and Boston Scientific. Dr Waksman has served on advisory boards for Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; has been a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; has received institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and is an investor in MedAlliance and Transmural Systems Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

The optimal technique for bifurcation of left main coronary artery (LMCA) stenting has been a subject of controversy since the inception of drug-eluting stents. We searched PubMed, Clinical Trials Registry, and the Cochrane Central Register of Controlled Trials from January 2002 through October 2021. A total of 13 studies comparing the use of provisional versus dual stenting in patients with LMCA bifurcation lesions were included. Any major adverse cardiac event (MACE) was considered the primary composite end point. The secondary end points included individual components of MACE, including death, myocardial infarction, and target lesion revascularization. The treatment effect was defined as the log odds ratio (OR) of provisional over dual stenting for cumulative event rate at 3 years. In 12 studies with 8,377 patients included for MACE, the use of a provisional-stenting strategy was associated with a significant reduction of 3-year MACE (OR 0.64, 95% confidence interval [CI] 0.46 to 0.88) compared with a dual-stenting strategy, primarily driven by target lesion revascularization (OR 0.51, 95% CI 0.36 to 0.73). No significant difference was found regarding death (OR 0.88; 95% CI 0.65 to 1.21) or myocardial infarction (OR 0.97, 95% Cl 0.61 to 1.54). In conclusion, our meta-analysis suggests that provisional stenting should be the preferred technique over dual stenting when treating LMCA bifurcation lesions with drug-eluting stents. Further randomized controlled studies compounded with intracoronary imaging comparing the 2 strategies are warranted., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background/purpose: The PK Papyrus covered coronary stent system (Biotronik AG, Bülach, Switzerland) is intended for treatment of coronary artery perforation (CAP) and is approved for use under a Humanitarian Device Exemption (HDE) in the United States (US)., Methods/materials: The retrospective data analysis includes cases reported from the US PK Papyrus HDE post-market surveillance clinical dataset with CAP cited as the reason for PK Papyrus stent use., Results: From April 2019 to July 2021, PK Papyrus device registration forms citing CAP as the reason for use were received for 1094 cases from 335 US hospital programs. Ellis classification was assessed as: type III cavity spilling/IV, 11.0%; type III, 57.9%; type II, 23.8%; type I, 7.3%. Mechanisms of perforation included: balloon angioplasty (42.3%), stent placement (31.3%), atherectomy (13.9%), and guidewire (10.9%). The majority (72.6%) of cases involved single covered stent placement. Successful PK Papyrus delivery was reported in 97.7% of cases with successful perforation sealing in 92.1%. Emergency cardiac surgery and in-hospital death occurred in 6.3% and 12.4% of cases, respectively. Pericardiocentesis was performed in 30.2% of patients. Acute/subacute stent thrombosis occurred in 10 patients (1.1%)., Conclusion: As the largest dataset of patients treated with a covered stent for CAP, these data provide significant insight into patient characteristics, procedural outcome, and in-hospital clinical events associated with this life-threatening complication. These results demonstrate that the PK Papyrus stent is a safe and effective method to seal CAP and with the potential to reduce high morbidity and mortality associated with this event., Competing Interests: Declaration of competing interest Dr. Kandzari has received institutional research and grant support from Biotronik, Boston Scientific, Cardiovascular Systems, Medtronic, Orbus Neich, and Teleflex; and has received personal consulting honoraria from Cardiovascular Systems, Terumo, and Medtronic. Rebecca Sarao is employed by Biotronik, Inc. Dr. Waksman has received consulting fees from Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Corindus, Lifetech Medical, Medtronic, and Philips Volcano; is an advisory board member for Abbott Vascular, Amgen, Boston Scientific, Medtronic, and Philips Volcano; has received grant support from Abbott Vascular, Biosensors, Biotronik, Boston Scientific, and Edwards Lifesciences; and is a member of the Speakers Bureau for AstraZeneca., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Since optical coherence tomography (OCT) was first performed in humans two decades ago, this imaging modality has been widely adopted in research on coronary atherosclerosis and adopted clinically for the optimization of percutaneous coronary intervention. In the past 10 years, substantial advances have been made in the understanding of in vivo vascular biology using OCT. Identification by OCT of culprit plaque pathology could potentially lead to a major shift in the management of patients with acute coronary syndromes. Detection by OCT of healed coronary plaque has been important in our understanding of the mechanisms involved in plaque destabilization and healing with the rapid progression of atherosclerosis. Accurate detection by OCT of sequelae from percutaneous coronary interventions that might be missed by angiography could improve clinical outcomes. In addition, OCT has become an essential diagnostic modality for myocardial infarction with non-obstructive coronary arteries. Insight into neoatherosclerosis from OCT could improve our understanding of the mechanisms of very late stent thrombosis. The appropriate use of OCT depends on accurate interpretation and understanding of the clinical significance of OCT findings. In this Review, we summarize the state of the art in cardiac OCT and facilitate the uniform use of this modality in coronary atherosclerosis. Contributions have been made by clinicians and investigators worldwide with extensive experience in OCT, with the aim that this document will serve as a standard reference for future research and clinical application., (© 2022. Springer Nature Limited.)

Background: Randomized trials have demonstrated the superiority of ultrathin strut drug-eluting stents compared with alternative stent designs. Whether these differences persist over late-term follow-up is uncertain., Objectives: This study sought to compare late-term (5-year) clinical outcomes among patients treated with ultrathin strut (60 µm) bioresorbable polymer sirolimus-eluting stents (BP SES) and thin strut (81 µm) durable polymer everolimus-eluting stents (DP EES)., Methods: BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international, 2:1 randomized trial comparing percutaneous coronary intervention with ultrathin strut BP SES versus thin strut DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Prespecified outcomes through 5 years were assessed., Results: Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 5-year rates of TLF were 12.3% for BP SES and 15.3% for DP EES (P = 0.108). Revascularization with BP SES was associated with a significantly lower target vessel-related myocardial infarction (6.6% vs 10.3%, P = 0.015) and late/very late definite/probable stent thrombosis (0.3% vs 1.6%, P = 0.021). Ischemia-driven target lesion revascularization was numerically but not significantly lower with BP SES (5.9% vs 7.7%, P = 0.202). Cardiac death rates were 2.6% versus 1.9% (P = 0.495) for BP SES and DP EES, respectively., Conclusions: In a large, randomized trial, TLF and the individual outcomes of cardiac death and target lesion revascularization at 5 years were similar among patients treated with BP SES versus DP EES. Both target vessel-related myocardial infarction and late/very late definite/probable stent thrombosis were significantly lower with BP SES. These results confirm the durability of safety and the effectiveness of percutaneous coronary intervention with ultrathin BP SES., Competing Interests: Funding Support and Author Disclosures This study was funded by BIOTRONIK AG, Bülach, Switzerland. Dr Kandzari has received institutional research/grant support from Biotronik, Boston Scientific, Cardiovascular Systems, Inc, Medtronic, Orbus Neich, and Teleflex; and has received personal consulting honoraria from Cardiovascular Systems, Inc, Medtronic, and Terumo. Dr Koolen has received lecturer and consultant fees from Medtronic; and has been a proctor for Biotronik. Dr Doros has been a consultant for Pfizer, Sarepta, Novartis, Softworld, and Lipocine. Drs Garcia-Garcia and Bennett have received research grants from Abbott Vascular and Biotronik AG; and have received speaker fees from Abbott Vascular, Biotronik AG, Boston Scientific, and Terumo. Dr Cutlip has received salary support from Baim Institute. Dr Waksman has received consultant fees from Abbott Vascular, Biotronik, Boston Scientific, MeAlliance, SIS Medical, Medtronic, and Philips Volcano; is on the advisory board for Abbott Vascular, Boston Scientific, Medtronic, and Philips Volcano; has received grant support from Abbott Vascular, Biotronik, and Boston Scientific; and is on the Speakers Bureau for AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., Venous MedTech; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, Philips IGT; Speakers Bureau: AstraZeneca; Investor: MedAlliance, Transmural Systems Inc. All other authors – None.

Background: Patients undergoing complex percutaneous coronary intervention (PCI) are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation coronary stents., Aim: We sought to compare the clinical outcomes after complex PCI with a bioresorbable-polymer sirolimus-eluting stent (BP-SES) versus a durable-polymer everolimus-eluting stent (DP-EES)., Methods: Patients (n = 2350) from BIOFLOW-II, -IV, and -V randomized trials were categorized into non-complex PCI vs. complex PCI. Complex PCI had at least one of the following criteria: multi-vessel PCI, ≥ 3 lesions treated, ≥ 3 stents implanted, total stent length ≥ 60 mm. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], or target lesion revascularization [TLR]) and probable/definite stent thrombosis (ST) at three years., Results: Patients with complex PCI (n = 348) were older and presented more often with acute coronary syndrome than non-complex PCI patients (n = 2002). Complex PCI lesions were more often type B2/C and bifurcation lesions and required more pre- and post-dilatation. Complex PCI patients had higher rates of TLF (14.6% vs. 8.1%; aHR 1.89, 95% CI [1.31-2.73], p = 0.001), TV-MI (10.2% vs. 4.4%, aHR 2.17, 95% CI [1.40-3.37], p = 0.001), and ST (1.5% vs. 0.4%, p = 0.025) as compared with non-complex PCI. TLF was not lower with BP-SES as compared to DP-EES in complex PCI (12.6% vs 18.2%, p = 0.16)., Conclusion: Patients undergoing complex PCI with the newer-generation DES still sustain a higher risk of TLF, TV-MI and stent thrombosis as compared with non-complex PCI. This adverse outcome was not significantly modified by the stent platform (BP-SES vs. DP-EES)., Clinical Trial Registration: Clinicaltrial.gov NCT01356888, NCT01939249, NCT02389946, https://clinicaltrials.gov/show/NCT01356888 ; https://clinicaltrials.gov/show/NCT01939249 ; https://clinicaltrials.gov/show/NCT02389946 ., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Background In clinical trials, cangrelor has been shown to reduce percutaneous coronary intervention-related ischemic complications without increasing major bleeding. This study was performed to examine cangrelor use and transition to oral P2Y 12 inhibitors in routine clinical practice. Methods and Results The CAMEO (Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes) registry is a multicenter, retrospective observational study of platelet inhibition strategies for patients with myocardial infarction undergoing percutaneous coronary intervention. In phase 1, data were collected on consecutive patients with myocardial infarction (n=482) treated with any P2Y 12 inhibitor to understand cangrelor use by hospital. In phase 2, data were collected in a 2:1 (cangrelor-: non-cangrelor-treated) ratio of patients with myocardial infarction (n=873). In phase 1, cangrelor use varied across hospitals (overall, 50.4% [range, 6.0%-100%]). Of patients receiving cangrelor in both phases (n=819), 3.3% received either the bolus or infusion only. Cangrelor was infused for a median of 121 (76-196) minutes; and 38.3% received an infusion for <2 hours. Most patients transitioned from cangrelor to ticagrelor (ticagrelor, 85.3%; clopidogrel, 9.5%; prasugrel, 5.2%). Many patients (16.4%) had a >1-hour gap between cangrelor cessation and oral P2Y 12 inhibitor initiation; this was highest among those transitioned to clopidogrel (56.6% versus 34.5% prasugrel versus 10.8% ticagrelor; P <0.001). Only 27.3% were dosed with cangrelor and transitioned to an oral P2Y 12 inhibitor in a fashion consistent with the pivotal trials and US Food and Drug Administration label. Conclusions This multicenter registry demonstrated interhospital variability in how cangrelor was administered and transitioned to an oral P2Y 12 inhibitor. These findings highlight opportunities for optimization of cangrelor dosing, infusion duration, and transition of care from the catheterization laboratory to the ward setting.

Background: Polymer-free drug-coated stents aim to avoid the inflammatory potential of durable polymers, thereby improving the long-term safety profile, and allowing a shorter duration of dual antiplatelet therapy., Aims: The BIOVITESSE study was conducted to assess the safety and clinical performance of the BIOrapid polymer-free coronary stent system coated with a novel highly lipophilic sirolimus derivate., Methods: BIOVITESSE was a prospective, multicentre, first-in-man study that enrolled subjects with de novo coronary lesions in two cohorts of 33 patients each. The primary endpoint of the first cohort was strut coverage at one month as assessed by optical coherence tomography. The primary endpoint of the second cohort was late lumen loss at nine-month follow-up., Results: Patients were on average 63 years old (range: 42-87) and 12% had diabetes. The 66 patients had 70 lesions with an average lesion length of 12.5±5.4 mm. Predilatation was performed in 91.4% and post-dilatation in 87.1% lesions; device success was obtained in 97.4%. At one month, 95.2±5.6% (95% CI: 93.2-97.2) of struts were covered and at nine months, in-stent late lumen loss was 0.31±0.30 mm (95% CI: 0.20-0.42) and in-segment late lumen loss was 0.20±0.29 mm. Two target lesion failures occurred (3.1%): one at day 1 (to cover an asymptomatic stent edge dissection), and one at day 288 post-procedure for restenosis. No stent thrombosis was reported during the 12-month study duration., Conclusions: The BIOrapid stent system exhibited an excellent safety profile, high strut coverage at one-month, and moderate angiographic efficacy according to the late lumen loss at nine-month angiographic follow-up.

Background: Permanent drug-eluting stents are associated with a steady increase in late complications attributed to persistent inflammation and poor vessel remodelling. Bioresorbable scaffolds have been developed to overcome such long-term limitations by providing temporary vessel support and disappearing thereafter. We aimed to assess the long-term outcomes of an absorbable metallic scaffold at 5 years., Methods: BIOSOLVE-II is an international, multi-centre, first-in-human study assessing the safety and performance of the sirolimus-eluting absorbable metal scaffold DREAMS 2G (commercial name Magmaris) in patients with a maximum of two de novo lesions. After 3 years, follow-up was extended to 5 years with the endpoints of target lesion failure and rate of definite or probable stent thrombosis., Results: A total of 123 patients with 123 lesions were enrolled. Lesions were 12.6 ± 4.5 mm long and 2.7 ± 0.4 mm in diameter, 43.4% were class B2/C lesions, and calcification was moderate to severe in 10.6%. At 5 years, 5.4% of patients had stable angina and 94.6% had no symptoms or ischaemia. Target lesion failure rate was 8.0% [95% confidence interval:4.2;14.9], reflecting 2 cardiac deaths, 2 target-vessel myocardial infarctions, and 6 clinically driven target lesion revascularizations (TLRs). Only one target lesion failure occurred beyond 3 years: a target-vessel myocardial infarction with clinically driven TLR on post-procedure day 1157. One additional non-cardiac death beyond 3 years due to renal failure was reported on day 1777. No definite or probable scaffold thrombosis was observed., Conclusion: The Magmaris scaffold showed favourable long-term safety and clinical performance with low target lesion failure rates and absence of definite or probable scaffold thrombosis throughout 5 years., Competing Interests: Declaration of competing interest MH reports study grants and personal fees from Biotronik, Abbott Vascular, Cardiac Dimensions, Orbus Neich, and Philips, RT reports personal fees from Biotronik and Abbott Vascular, PAL reports grants from Biotronik, EHC reports grants from Biotronik, AA is a proctor for TAVR implantation for Boston Scientific, CvB reports grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic, FJN reports lectures fees paid to his institution from Amgen, Bayer Healthcare, Biotronic, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, Ferrer, Pfizer, Novartis, consultancy fees paid to his institution from Boehringer Ingelheim, and grant support from Bayer Healthcare, and Boston Scientific, WW reports institutional grants from Biotronik and MicroPort, is a co-founder of Argonauts Partners, and received speaker fees from MicroPort, JE reports speaker fee honoraria from Abbott, Biotronik, Bostoms Scientific and Philips, LST received honoraria and conference support from Terumo, Kaneka, Abbott, Medtronic, Alvimedia, Boston Scientific, Biotronik and Asahi Intecc., EE reports speaker honoraria and research grants from Biotronik. HGG reports that MedStar was the core laboratory of the study, RW reports that MedStar was the core laboratory of the study and reports grants and personal fees from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Chiesi, personal fees of Amgen, Corindus, Lifetech Medical, Medtronic, Philips Volcano, Pi-Cardia LTD, is an investor of MedAlliance, and grants from Edwards Lifesciences. All other authors have no conflict of interest to declare., (Copyright © 2021. Published by Elsevier Inc.)

Background/purpose: The Lipid Rich Plaque (LRP) study demonstrated the association between coronary plaque lipid content and outcomes. In this LRP substudy, we assessed the impact of optimal medical therapy (OMT) on the occurrence of non-culprit major adverse cardiac events (NC-MACE). Advanced intracoronary imaging modalities are able to identify patients with vulnerable coronary lesion morphology associated with future events., Methods/materials: A total of 1270 patients who underwent cardiac catheterization for suspected coronary artery disease (CAD) with evaluable maxLCBI 4mm in non-culprit vessels and known medical therapy after discharge were followed for 2 years. OMT was defined as the use of a statin and dual antiplatelet therapy (DAPT)., Results: Among the 1270 patients included in this substudy, 1110 (87.7%) had PCI for an index event, and 1014 (80%) patients received OMT. Estimated cumulative incidence functions of NC-MACE did not differ significantly between patients treated with or without OMT (log-rank p-value = 0.876). In patients labeled high risk (maxLCBI 4mm > 400), cumulative incidence function also did not differ between patients treated with vs without OMT (log-rank p-value = 0.19)., Conclusions: In the current LRP analysis, we could not identify a beneficial effect of OMT in the reduction of NC-MACE rate, even in patients with high-risk plaques, during 24-month follow-up., (Copyright © 2021. Published by Elsevier Inc.)

Despite contemporary advances in stent technology, in-stent restenosis (ISR) remains a common issue following percutaneous coronary intervention. A novel classification system based on the underlying mechanism of action of restenosis was recently introduced. The Waksman In-Stent Restenosis Classification characterizes different patterns of ISR to best delineate the type of restenosis and help guide treatment. Intravascular imaging with either intravascular ultrasound or optical coherence tomography allows for real-time evaluation of ISR. We herein provide an illustrative review of the Waksman In-Stent Restenosis Classification., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships, which may be considered as potential competing interests: Evan Shlofmitz: Consultant: Abbott Vascular; Speakers Bureau: Janssen Pharmaceuticals, Medtronic, Opsens Medical. Gary Mintz: Honoraria from Boston Scientific, Medtronic, Philips/Volcano. Ron Waksman: Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Medtronic, Philips, Pi-Cardia Ltd., Cardioset; Consultant: Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Medtronic, Philips, Pi-Cardia Ltd., Cardioset; Grant Support: Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. All other authors: No relevant disclosures., (Copyright © 2021. Published by Elsevier Inc.)

Widespread utilization of mechanical circulatory support (MCS) for high-risk percutaneous coronary intervention (PCI) remains controversial, with a lack of randomized supporting evidence and associated risk of device-related complications. We investigated whether high-risk PCI of native coronary arteries without elective MCS in patients with acute coronary syndrome (ACS) is safe and feasible. We performed a single-center, retrospective analysis for ACS patients meeting American College of Cardiology high-risk criteria: unprotected left main disease, last remaining conduit, ejection fraction <35%, 3-vessel coronary artery disease, severe aortic stenosis, or severe mitral regurgitation. Patients with cardiogenic shock and those undergoing PCI of the bypass grafts were excluded. Major in-hospital and 30-day cardiovascular outcomes were assessed. From 2003 through 2018, 499 patients (847 lesions) with unstable angina pectoris (UAP), 1218 patients (1807 lesions) with non-ST-elevation myocardial infarction (NSTEMI), and 868 patients (1260 lesions) with ST-segment elevation myocardial infarction (STEMI) underwent high-risk PCI. Procedural success was achieved in 97.2% of UAP, 98.3% of NSTEMI, and 96.6% of STEMI patients. In-hospital and 30-day all-cause mortality were as follows: UAP, 2%; NSTEMI, 2.1%; and STEMI 4.7%. Bailout intra-aortic balloon pump was required in 1.6% of UAP, 3.1% of NSTEMI, and 10.3% of STEMI patients. Major complications for UAP, NSTEMI, and STEMI were, respectively: target lesion revascularization (2.3%, 1.4%, and 1.5%), stroke or transient ischemic attack (0.8%, 0.6%, and 1.3%), acute renal failure (8.2%, 7.2%, and 10.2%), major bleeding (1.6%, 3.1%, and 8.5%). In conclusion, our results show that high-risk PCI without elective MCS is safe and feasible in most ACS patients, challenging professional societies' current recommendations. A randomized trial comparing unprotected versus protected high-risk PCI for non-shock ACS patients is warranted., (Copyright © 2021. Published by Elsevier Inc.)

Background: Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) remains common. Intravascular imaging allows for the determination of the mechanism of ISR, potentially guiding appropriate therapy. Intravascular ultrasound (IVUS)-guided stent implantation is associated with a reduction in adverse events after PCI, but its impact on treatment of ISR is not clear., Methods: All patients with 1-year follow-up after ISR treatment from 2003 through 2016 were included and stratified by IVUS use. The primary endpoint was the rate of major adverse cardiac events (MACE) at 1 year, defined as the composite of all-cause mortality, Q-wave myocardial infarction, and target vessel revascularization (TVR)., Results: The final analysis included 1522 ISR patients, 65.9% of whom were treated with IVUS guidance. The primary endpoint occurred in 18.0% of patients treated with IVUS guidance vs. 24.5% of patients treated with angiography guidance (p = 0.0014). Post-dilatation was used more often with IVUS (18.6% vs. 14.1%, p < 0.001), with a larger diameter of new stents (3.04 ± 0.35 mm vs. 2.94 ± 0.47 mm, p = 0.001). At 1 year, TVR occurred in 14.5% with IVUS guidance and 19.2% with angiography guidance (p = 0.021)., Conclusions: The use of IVUS is associated with decreased MACE at 1 year following PCI for ISR. These results support routine IVUS for the treatment of ISR lesions., (Copyright © 2021. Published by Elsevier B.V.)

Hemodynamic support is widely utilized for unprotected left main (ULM) percutaneous coronary interventions (PCI) despite lack of evidence from randomized studies and the risk of device-related complications. We aimed to compare ULMPCI with and without intra-aortic balloon pump (IABP) support. A single-center, retrospective analysis was performed for patients undergoing ULMPCI with and without IABP support. Clinical, procedural, in-hospital, and 30-day cardiovascular outcomes were compared. From 2003 through 2018, 217 patients underwent non-emergent ULMPCI, 55 with elective IABP support (IABP group), and 162 without support (No-IABP group). The study population comprised 56.4% men and 74.5% Caucasians in the IABP group and 53.7% men and 62.3% Caucasians in the No-IABP group. The mean age for IABP and No-IABP group patients was 75.75 ± 12.34 years and 73.47 ± 15.19 years, respectively (p = 0.315). Procedural success was achieved in 99% of IABP and 95.3% of No-IABP patients (p = 0.089). In-hospital and 30-day mortality was 5.5% for the IABP group and 5.6% for the No-IABP group (p = 0.977). Rates of major complications were statistically similar between the groups. Bailout IABP was required in 10% of No-IABP patients. Hospital and intensive care unit length of stay was statistically longer in the IABP group. In conclusion, ULMPCI without IABP support was not associated with increased mortality and major cardiovascular outcomes compared with supported patients and was associated with shorter hospital and intensive care unit stay. A randomized trial comparing unsupported versus supported ULMPCI is warranted to identify patients who would benefit from hemodynamic support., (Copyright © 2021. Published by Elsevier Inc.)

Background: To date, there are no real-world studies comparing cangrelor to glycoprotein IIb/IIIa inhibitors (GPI) during percutaneous coronary intervention (PCI). Thus, we performed this study to evaluate the safety and effectiveness of cangrelor compared to GPI during PCI., Methods: We identified patients who underwent PCI at our institution who received either cangrelor or GPI during PCI. Patients already on GPI or cangrelor prior to PCI or who received both cangrelor and GPI were excluded. Baseline demographics and clinical outcomes were extracted. Major bleeding is defined as a composite of major hematoma >4 cm, hematocrit drop >15, and gastrointestinal bleeding., Results: A total of 2072 patients received adjunctive antiplatelet therapy during PCI (cangrelor [n=478]; GPI [n=1594]). Patients' mean age was 61±12 years. Most (66%) presented with acute coronary syndrome. Patients who received cangrelor were older and had a higher percentage of acute coronary syndrome and lower baseline hematocrit in comparison with patients who received GPI. Procedural success was achieved in 94% of patients, with no difference between groups. Major bleeding events (1.7% vs. 5.1%, P=.001), any vascular complication rates, and hospital length of stay were significantly lower in the cangrelor group. In-hospital ischemic events did not differ between groups. On regression analysis, patients on cangrelor were noted to have significantly lower major bleeding events (OR 0.23; 95% CI, 0.09-0.59)., Conclusions: Balancing ischemic and bleeding risks with adjunctive antiplatelet drugs is of prime importance during PCI. Our real-world analysis shows that cangrelor is safe and effective when compared to GPI during PCI., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: This study sought to assess target lesion failure (TLF) and clinically driven target lesion revascularization (CD-TLR) through 1 year following second-generation drug-eluting magnesium scaffold (Magmaris) implantation using a dedicated technique (so-called "4 P's" strategy)., Methods and Results: The 4 P's strategy stands for: correct patient selection, proper scaffold sizing, pre-dilatation (<20% residual stenosis), post-dilatation. All the patient and lesion characteristics, preparation, and sizing of the device were compared in patients with TLF and CD-TLR through 1-year follow-up. We analyzed 315 patients for this study. At 1 year, there were 14 TLFs and 10 CD-TLRs. The TLF rates were 7.7%, 4.9%, and 4.1%; while the CD-TLR rates were 7.7%, 2.5%, and 3.2% in the undersized, properly sized, and oversized vessel groups, correspondingly. Diameter stenosis (DS) after pre-dilatation in patients with TLF and CD-TLR was significantly greater than in those without TLF and CD-TLR. In patients with a properly sized scaffold, DS after pre-dilatation was similar in patients with and without TLF and CD-TLR. However, in patients with non-properly sized scaffolds, greater post-balloon DS was observed in patients with TLF and CD-TLR., Conclusions: Improper sizing and poor lesion preparation before Magmaris implantation appear to be related to TLF during 1-year follow-up., Competing Interests: Declaration of competing interest Yuichi Ozaki: Grant-in-Aid for Young Scientists, Japan (No. 19 K17535). Michael Joner: Personal fees from Biotronik, Orbus Neich, Boston Scientific, Edwards, Astra Zeneca, Recor; grants from Boston Scientific, Edwards, Amgen. Stefano Galli: Speaker fees and institutional grant to registry from Biotronik. Ron Waksman: Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. Michael Haude: Grant support and personal fees: Biotronik, Abbott Vascular, Cardiac dimensions, Medtronic, Philips, and Lilly. All other authors have no conflicts of interest to declare., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background/purpose: Local hemodynamic forces such as endothelial shear stress (ESS) may have an influence on appropriate neointimal healing, vessel remodeling, and struts' absorption process following second-generation drug-eluting resorbable magnesium scaffold (RMS, Magmaris, Biotronik AG, Buelach, Switzerland) placement. The aim of this study was to investigate the impact of ESS assessed by optical coherence tomography (OCT)-based computational fluid dynamic (CFD) simulations on absorption process and coronary lumen dimension after Magmaris implantation., Methods and Results: A total of 22 patients who were enrolled in the BIOSOLVE-II trial and underwent serial OCT assessment immediately after Magmaris implantation and at 6- and 12-month follow-up were included. We evaluated qualitative OCT findings frame by frame, and CFD simulations were performed to calculate the ESS at 3-dimensional (3D) reconstructed arteries. For quantitative calculation, the average ESS within each 1-mm section was classified into three groups: low (<1.0 Pa), intermediate (1.0-2.5 Pa), or high (>2.5 Pa). A significant difference of percentage remnants of scaffold was observed among the 3 groups at 12-month follow-up (P = 0.001) but not at 6-month follow-up. Low-ESS segment at baseline resulted in a greater lumen change of -1.857 ± 1.902 mm 2 at 1 year compared to -1.277 ± 1.562 mm 2 in the intermediate-ESS segment (P = 0.017) and - 0.709 ± 1.213 mm 2 in the high-ESS segment (P = 0.001)., Conclusion: After Magmaris implantation, the presence of higher ESS might be associated with slower strut absorption process but less luminal loss., (Copyright © 2021 Elsevier Inc. All rights reserved.)

The prognosis of left circumflex (LC) versus non-LC in-stent restenosis (ISR) ostial lesions following treatment has not been assessed. We aimed to assess this prognosis. Anecdotally, treatment of ostial LC ISR has been associated with high recurrence rates. We performed a retrospective analysis of patients from our institution who underwent coronary intervention of an ostial ISR lesion between 2003 and 2018. The primary endpoint was target lesion revascularization (TLR) and major adverse cardiovascular events (MACE). Overall, 563 patients underwent ostial ISR lesion intervention, 144 for an ostial LC ISR lesion. Compared to patients with ostial ISR in non-LC lesions, patients with ostial LC ISR were older, had higher rates of diabetes mellitus and previous coronary bypass surgery. At 1-year follow-up, TLR-MACE rates were 26.6% in the LC group versus 18.4% in the non-LC group (p = 0.036). The TLR rate was also higher in the LC group compared to the non-LC group (p = 0.0498). Univariate and multivariate analyses demonstrated a higher TLR-MACE rate for LC versus non-LC ostial ISR lesions. In conclusion, our study shows increased event rates after treatment of LC versus non-LC ISR lesions. Further studies should be done to assess the optimal treatment approach for ostial LC ISR., (Copyright © 2021. Published by Elsevier Inc.)

Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None.

Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None.

Background Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare-metal and first-generation drug-eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer-generation drug-eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable-polymer sirolimus-eluting stent or a durable-polymer everolimus-eluting stent. Methods and Results Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target-lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or target-lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P =0.003) and stent thrombosis rates (2.1% versus 0.2%; P <0.0001), whereas target-lesion revascularization was not different between the groups (5.0% versus 3.9%; P =0.302). After adjustment, calcification did not emerge as an independent predictor of TLF (adjusted hazard ratio [aHR], 1.37; 95% CI, 0.89-2.08; P =0.148) but did for target-vessel myocardial infarction (aHR, 1.66; 95% CI, 1.03-2.68; P =0.037). TLF rates were similar between bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent (12.6% versus 15.4%, P =0.482) in moderate/severe calcification. In none/mild calcification, the bioresorbable-polymer sirolimus-eluting stent showed lower TLF (7.5% versus 10.3%, P =0.045). Conclusions With newer-generation drug-eluting stents, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification, whereas the rate of target-vessel myocardial infarction was higher. The bioresorbable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent were equally effective and safe in calcified lesions. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01356888, NCT01939249, NCT02389946.

Objectives: We compared access-site complications with a Micropuncture 21-gauge (G) needle to a standard 18G needle in patients undergoing femoral-access percutaneous coronary intervention (PCI)., Background: Vascular access-site complications are the most common complication after cardiac catheterization. These complications increase patient morbidity and mortality, along with healthcare costs., Methods: We retrospectively analyzed a cohort of 17,844 consecutive patients undergoing PCI. Micropuncture access was used in 2344 patients and a standard 18G needle in 15,500 patients. Primary endpoints included vascular perforation or limb ischemia requiring repair, retroperitoneal bleeding, pseudoaneurysm, arteriovenous fistula, groin hematoma (>4 cm)., Results: Patients undergoing PCI with Micropuncture were at higher risk: they were on anticoagulation (557 [23.7%] vs. 1,590 [10.2%], p < .001), used steroids more frequently (131 [5.6%] vs. 638 [4.1%], p < .001) and required the use of an intra-aortic balloon pump more often (191 [(8.1%] vs. 896 [5.7%], p < .001). Overall, the access-site complications rate was lower using Micropuncture (58 [2.5%]) versus standard needle (558 [3.6%], p = .005). The Micropuncture group had a significantly lower rate of hematoma than standard needle (32 [1.4%] vs. 309 [1.9%], p = .03). There was no significant difference in the rate of limb ischemia (1 [0.04%] vs. 12 [0.07%], p = .56), perforation (2 [0.08%] vs. 14 [0.09%], p = .93), retroperitoneal bleeding (3 [0.12%] vs. 18 [0.11%], p = .87), pseudoaneurysm (18 [0.76%] vs. 170 [1.09%], p = .14), and arteriovenous fistula (2 [0.08%] vs. 35 [0.22%], p = .16), comparing the Micropuncture group to a standard needle, respectively., Conclusions: Femoral access using a Micropuncture reduced the rate of vascular complications with significant reduction in the rate of groin hematomas., (© 2020 Wiley Periodicals LLC.)

[Figure: see text].

During a coronary intervention, the stainless-steel spring tip incorporated into the EluNIR drug-eluting stent detached from the delivery system while we were retrieving the balloon. The spring was captured., Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. Other authors – None., (Copyright © 2020. Published by Elsevier Inc.)

Background: Newest generation drug-eluting stents combine biodegradable polymers with ultrathin stent platforms in order to minimize vessel injury and inflammatory response. Evidence from randomized controlled trials suggested that differences in stent design translate into differences in clinical outcome. The aim of the present study was to evaluate the safety and efficacy of ultrathin strut, biodegradable polymer sirolimus eluting stents (BP SES) compared with thin strut, durable polymer everolimus-eluting stents (DP EES) among patients undergoing percutaneous coronary intervention (PCI)., Methods: We pooled individual participant data from 5 randomized trials (NCT01356888, NCT01939249, NCT02389946, NCT01443104, NCT02579031) including a total of 5,780 patients, and performed a one-stage meta-analysis using a mixed effects Cox regression model., Results: At a median duration of follow-up of 739 days (interquartile range 365-1,806 days), target-lesion failure occurred in 337 (10.3%) and 304 (12.2%) patients treated with BP SES and DP EES (HR 0.86, 95%CI 0.71-1.06, P = .16). There were no significant differences between BP SES and DP EES with regards to cardiac death (111 (3.4%) vs 102 (4.1%); HR 1.05, 95%CI 0.80-1.37, P = .73), target-vessel myocardial infarction (136 (4.1%) vs 126 (5.0%), HR 0.79, 95%CI 0.62-1.01, P = .061), and clinically-driven target-lesion revascularization (163 (5.0%) vs 147 (5.9%); HR 0.94, 95%CI 0.75-1.18, P = .61). The effect was consistent across major subgroups. In a landmark analysis, there was no significant interaction between treatment effect and timing of events., Conclusions: In this patient-level meta-analysis of 5 randomized controlled trials, BP SES were associated with a similar risk of target-lesion failure compared with DP EES among patients undergoing PCI., Study Registration: PROSPERO registry (CRD42018109098)., (Copyright © 2021 Elsevier Inc. All rights reserved.)