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Dual antiplatelet therapy (DAPT) is key for the prevention of recurrent ischemic events after percutaneous coronary intervention (PCI); however, it increases the risk of bleeding complications. While new generation drug-eluting stents have been shown superior to bare-metal stents after a short DAPT course, the optimal DAPT duration in patients at high bleeding risk (HBR) remains to be determined. TRIAL DESIGN: The XIENCE Short DAPT program consists of three prospective, single-arm studies (XIENCE 90, XIENCE 28 Global and XIENCE 28 USA) investigating 3- or 1-month DAPT durations in HBR patients undergoing PCI with the XIENCE stent. The XIENCE 90 study is being conducted in the US and enrolled 2047 subjects who discontinued DAPT at 3 months if they were free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis. The XIENCE 28 program includes the USA study, enrolling 642 patients in US and Canada, and the Global study, enrolling 963 patients in Europe and Asia. In XIENCE 28, patients were to discontinue DAPT at 1 month post-PCI if event-free. The primary hypothesis for both XIENCE 90 and XIENCE 28 is that a short DAPT regimen will be non-inferior to a conventional DAPT duration with respect to the composite of all-cause death or MI. Patients enrolled in the prospective multicenter post-market XIENCE V USA study will be used as historical control group in a stratified propensity-adjusted analysis. CONCLUSIONS: The XIENCE Short DAPT Program will provide insights into the safety and efficacy of 2 abbreviated DAPT regimens of 3- and 1-month duration in a large cohort of HBR patients undergoing PCI with the XIENCE stent., Competing Interests: Disclosures Dr Valgimigli has received grants and/or personal fees from AstraZeneca, Terumo, Alvimedica/CID, Abbott Vascular, Daiichi-Sankyo, Opsens, Bayer, CoreFLOW, Idorsia Pharmaceuticals Ltd, Universität Basel Department Klinische Forschung, Vifor, Bristol-Myers Squibb SA, iVascular, and Medscape. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has served as national Principal Investigator for Portico (Abbott) and Acurate (Boston Scientific) US investigation device exemption trials; has received personal proctoring fees from Edwards Lifesciences; and has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Bangalore reports consultant/speaker fees from Abbott Vascular, Biotronik, Meril, Pfizer, Reata, and Amgen, and has received research grants from Abbott Vascular and NHLBI. Dr Bhatt discloses the following relationships—Advisory Board: Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, PhaseBio, PLx Pharma, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, Novo Nordisk, Takeda. Dr Angiolillo has received payment as an individual for: reports receiving payments as an individual for: a) Consulting fee or honorarium from Abbott, Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company; b) Participation in review activities from CeloNova and St. Jude Medical. Institutional payments for grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli-Lilly, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, Renal Guard Solutions and the Scott R. MacKenzie Foundation. Dr Neumann reports that his institution has received research grants, consultancy fees, and speaker honoraria to from Daiichi Sankyo, Astra Zeneca, Sanofi-Aventis, Bayer, The Medicines Company, Bristol, Novartis, Roche, Boston Scientific, Biotronik, Medtronic, Edwards. Dr Hermiller reports consulting fees from Abbott. Dr Toelg reports speaker honoraria from Boston Scientific, Abbott Vascular, and Biotronik. Dr Maksoud has received speaker honoraria and/or personal fees from Bristol Myers Squib, Pfizer and Abbott Vascular. Dr Chehab has received research grants from Edwards Lifescience and Abbott, speaker honoraria and/or personal fees from Edwards and Abbott and Biotronics. Dr Mehran reports institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich; consultant fees from Abbott Laboratories, Boston Scientific, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, Siemens Medical Solutions; consultant fees paid to the institution from Abbott Laboratories, Bristol-Myers Squibb; advisory board, funding paid to the institution from Spectranetics/Philips/Volcano Corp; consultant (spouse) from Abiomed, The Medicines Company, Merck; Equity <1% from Claret Medical, Elixir Medical; DSMB Membership fees paid to the institution from Watermark Research Partners; consulting (no fee) from Idorsia Pharmaceuticals Ltd., Regeneron Pharmaceuticals. Associate Editor for ACC, AMA. The other authors have nothing to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Complete revascularization with routine percutaneous coronary intervention of nonculprit lesions after primary percutaneous coronary intervention improves outcomes in ST-segment-elevation myocardial infarction. Whether this benefit is associated with nonculprit lesion vulnerability is unknown., Methods: In a prospective substudy of the COMPLETEs trial (Complete vs Culprit-Only Revascularization to Treat Multi-Vessel Disease After Early PCI for STEMI), we performed optical coherence tomography of at least 2 coronary arteries before nonculprit lesion percutaneous coronary intervention in 93 patients with ST-segment-elevation myocardial infarction and multivessel disease; and the ST-segment-elevation myocardial infarction culprit vessel if there was unstented segment amenable to imaging. Nonculprit lesions were categorized as obstructive (≥70% stenosis by visual angiographic assessment) or nonobstructive, and as thin-cap fibroatheroma (TCFA) or non-TCFA by optical coherence tomography criteria. TCFA was defined as a lesion with mean fibrous cap thickness <65 μm overlying a lipid arc >90°., Results: On a patient level, at least one obstructive TCFA was observed in 44/93 (47%) of patients. On a lesion level, there were 58 TCFAs among 150 obstructive nonculprit lesions compared with 74 TCFAs among 275 nonculprit lesions (adjusted TCFA prevalence: 35.4% versus 23.2%, P =0.022). Compared with obstructive non-TCFAs, obstructive TCFAs had similar lesion length (23.1 versus 20.8 mm, P =0.16) but higher lipid quadrants (55.2 versus 19.2, P <0.001), greater mean lipid arc (203.8° versus 84.5°, P <0.001), and more macrophages (97.1% versus 54.4%, P <0.001) and cholesterol crystals (85.8% versus 44.3%, P <0.001). For nonobstructive lesions, TCFA lesions had similar lesion length (16.7 versus 14.6 mm, P =0.11), but more lipid quadrants (36.4 versus 13.5, P <0.001), and greater mean lipid arc (191.8° versus 84.2°, P <0.001) compared with non-TCFA., Conclusions: Among patients who underwent optical coherence tomography imaging in the COMPLETE trial, nearly 50% had at least one obstructive nonculprit lesion containing complex vulnerable plaque. Obstructive lesions more commonly harbored vulnerable plaque morphology than nonobstructive lesions. This may help explain the benefit of routine percutaneous coronary intervention of obstructive nonculprit lesions in patients with ST-segment-elevation myocardial infarction and multivessel disease. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01740479s.

Background: Protection against acute kidney injury (AKI) has been reported with the use of Impella during high-risk percutaneous coronary intervention (HR-PCI). We sought to evaluate this finding by determining the occurrence of AKI during Impella-supported HR-PCI in patients from the Global cVAD Study and compare this incidence with their calculated AKI risk at baseline., Methods and Results: In this prospective, multicenter study, we enrolled 314 consecutive patients. We included 223 patients that underwent nonemergent HR-PCI supported with Impella 2.5 or Impella CP and excluded those requiring hemodialysis prior to HR-PCI (19) and those with insufficient data (72). The primary outcome was AKI postprocedurally at 48 hr versus the predicted risk of AKI according to Mehran risk score. Logistic regression analysis determined predictors of AKI. Overall, 4.9% (11) of Impella-supported patients developed AKI (exclusively stage 1) at 48 hr versus a predicted rate of 21.9%, representing a 77.6% lower AKI rate (p < .0001). In this study, no Impella-supported patients required renal replacement therapy. Estimated glomerular filtration rate (ml/min/1.73 m 2 ) alone predicted AKI (adjusted odds ratio [AOR]: 4.915; 95% confidence intervals [CI]: 1.02-23.53, p = .046), and increasing contrast had insignificant effects on AKI during high-risk PCI (AOR: 1.15; 95% CI: 0.87-1.51, p = .332). In patients not protected from AKI, the postprocedure incidence of AKI was not significantly greater and did not correlate with chronic kidney disease severity., Conclusion: The incidence of AKI was lower during HR-PCI than expected from current risk models. Although further exploration of this finding is warranted, these data support a new protective strategy against AKI during HR-PCI., (© 2019 Wiley Periodicals, Inc.)

Background/objective: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear., Methods: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke)., Results: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death., Conclusions: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR., (© 2019 Wiley Periodicals, Inc.)

Objectives: This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial., Background: Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear., Methods: Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population., Results: The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access., Conclusions: In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Atrial fibrillation (AF) has been associated with worse outcomes after primary percutaneous coronary intervention (PCI) for acute myocardial infarction. The aim of this study was to evaluate the incidence and impact of new-onset AF after primary PCI in patients with ST-segment elevation myocardial infarctions from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. HORIZONS-AMI was a large-scale, multicenter, international, randomized trial comparing different antithrombotic regimens and stents during primary PCI in patients with ST-segment elevation myocardial infarctions. Three-year ischemic and bleeding end points were compared between patients with and without new-onset AF after PCI. Of the 3,602 patients included in the HORIZONS-AMI study, 3,281 (91.1%) with sinus rhythm at initial presentation had primary PCI as their primary management strategy. Of these, new-onset AF developed in 147 (4.5%). Compared with patients without AF after PCI, patients with new-onset AF had higher 3-year rates of net adverse clinical events (46.5% vs 25.7%, p <0.0001), mortality (11.9% vs 6.3%, p = 0.01), reinfarction (16.4% vs 7.0%, p <0.0001), stroke (5.8% vs 1.5%, p <0.0001), and major bleeding (20.9% vs 8.2%, p <0.0001). By multivariate analysis, new-onset AF after PCI was a powerful independent predictor of net adverse clinical events (hazard ratio 1.74, 95% confidence interval 1.30 to 2.34, p = 0.0002) and major adverse cardiac events (hazard ratio 1.73, 95% confidence interval 1.27 to 2.36) at 3 years. In conclusion, new-onset AF after PCI for ST-segment elevation myocardial infarction was associated with markedly higher rates of adverse events and mortality., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Thrombus and soft, friable atheromatous plaque are present in the majority of patients with acute myocardial infarction (AMI), and may result in distal embolization and no reflow during primary angioplasty. Thrombectomy prior to intervention may decrease thromboembolic complications and improve outcomes., Methods: The X-TRACT AMI registry was a prospective, multicenter study evaluating the safety and feasibility of the X-Sizer thrombectomy system prior to primary angioplasty in native coronary arteries and saphenous vein grafts (SVGs) in patients presenting within 24 hours AMI onset., Results: A total of 216 patients (220 target lesions) with AMI were enrolled at 28 U.S. sites, with approximately 90% of lesions in native coronary arteries and 10% in SVGs. Preprocedural TIMI 0/1 flow was present in 56% of patients, with thrombus in 76%. Glycoprotein IIb/IIIa inhibitors were used in 86% of patients, and bare metal stents were implanted in 94% (mean stent length 26 mm). TIMI-3 flow was present in 27% of patients at baseline, in 81% after thrombectomy, and in 92% following PCI. Normal myocardial blush grade 3 was present in 6% of patients at baseline, and in 52% postprocedure. At 30 and 360 days, 93.1% and 80.8% of patients were free from major cardiovascular events., Conclusion: In this broad multicenter experience, use of the X-Sizer device prior to stent implantation in thrombus containing native coronary arteries and diseased SVGs was feasible and associated with high rates of normalized postprocedural epicardial blood flow and myocardial blush, warranting further study as an adjunct during primary angioplasty.

A Canadian field surgical hospital was deployed in the former Yugoslavia to support the medical needs of Canadian and other United Nations troops. Over a 6-month period, 5661 patients were seen and 50 surgical procedures performed. Gunshot, shrapnel and other blast injuries were responsible for the injury in only 10 patients seen at the hospital. Strict adherence to the concepts of hygiene, safety and trauma prevention is essential for the proper health care of large groups of peacekeepers abroad. Civilian involvement was limited by political restrictions, but a few civilians were helped. The ability to provide modern medicine in the field of battle boosted the morale of the Canadian troops.

In the first of two papers on the experience of a Canadian military surgical team in the former Yugoslavia, the authors describe the deployment of the field surgical hospital, the medical structure that supported the Canadian battle group. The hospital was made up of tent sections erected within an unfinished concrete factory building. The hospital comprised a treatment area for sick parades and reception, a pharmacy, a resuscitation area for nonambulatory casualties, a laboratory, an x-ray section, an operating room and sterilization section and a ward. The hospital could be mobilized if necessary. The setup proved to be functional for the treatment of injured soldiers. Although long delays were expected because of difficulties in transporting the injured, the patients reached the hospital in a reasonable time after injury and could be treated satisfactorily. During the period of its deployment, this hospital was used more than any other Canadian hospital in the United Nations mission. This experience allowed the authors to identify deficiencies and to correct them quickly.