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BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

Few data are available on procedural complications of percutaneous coronary intervention (PCI) in the setting of acute coronary syndrome in the contemporary era.We sought to describe the prevalence of procedural complications of PCI in a non-ST-segment elevation acute coronary syndrome (NSTE ACS) cohort, and to identify their clinical characteristics and association with clinical outcomes.Patients randomized in TAO (Treatment of Acute coronary syndrome with Otamixaban), an international randomized controlled trial (ClinicalTrials.gov Identifier: NCT01076764) that compared otamixaban with unfractionated heparin plus eptifibatide in patients with NSTE ACS who underwent PCI, were included in the analysis. Procedural complications were collected prospectively, categorized and adjudicated by a blinded Clinical Events Committee, with review of angiograms. A multivariable model was constructed to identify independent clinical characteristics associated with procedural complications.A total of 8656 patients with NSTE ACS who were enrolled in the TAO trial underwent PCI, and 451 (5.2%) experienced at least one complication. The most frequent complications were no/slow reflow (1.5%) and dissection with decreased flow (1.2%). Procedural complications were associated with the 7-day ischaemic outcome of death, myocardial infarction or stroke (24.2% vs. 6.0%, odds ratio 5.01, 95% confidence interval 3.96-6.33; P0.0001) and with Thrombolysis In Myocardial Infarction major and minor bleeding (6.2% vs. 2.3%, odds ratio 2.79, 95% confidence interval 1.86-4.2; P0.0001). Except for previous coronary artery bypass grafting, multivariable analysis did not identify preprocedural clinical predictors of complications.In a contemporary NSTE ACS population, procedural complications with PCI remain frequent, are difficult to predict based on clinical characteristics, and are associated with worse ischaemic and haemorrhagic outcomes.

A growing number of patients undergoing percutaneous coronary intervention (PCI) with stent implantation also have atrial fibrillation. This poses challenges for their optimal antithrombotic management because patients with atrial fibrillation undergoing PCI require oral anticoagulation for the prevention of cardiac thromboembolism and dual antiplatelet therapy for the prevention of coronary thrombotic complications. The combination of oral anticoagulation and dual antiplatelet therapy substantially increases the risk of bleeding. Over the last decade, a series of North American Consensus Statements on the Management of Antithrombotic Therapy in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention have been reported. Since the last update in 2018, several pivotal clinical trials in the field have been published. This document provides a focused updated of the 2018 recommendations. The group recommends that in patients with atrial fibrillation undergoing PCI, a non–vitamin K antagonist oral anticoagulant is the oral anticoagulation of choice. Dual antiplatelet therapy with aspirin and a P2Y12inhibitor should be given to all patients during the peri-PCI period (during inpatient stay, until time of discharge, up to 1 week after PCI, at the discretion of the treating physician), after which the default strategy is to stop aspirin and continue treatment with a P2Y12inhibitor, preferably clopidogrel, in combination with a non–vitamin K antagonist oral anticoagulant (ie, double therapy). In patients at increased thrombotic risk who have an acceptable risk of bleeding, it is reasonable to continue aspirin (ie, triple therapy) for up to 1 month. Double therapy should be given for 6 to 12 months with the actual duration depending on the ischemic and bleeding risk profile of the patient, after which patients should discontinue antiplatelet therapy and receive oral anticoagulation alone.

The feasibility of rapid genetic testing in patients undergoing percutaneous coronary intervention (PCI) and the comparison of the pharmacodynamic effects of prasugrel versus ticagrelor among carriers of cytochrome P450 2C19 loss-of-function alleles treated with PCI has been poorly explored. Rapid genetic testing using the Spartan assay was shown to be feasible and provides results in a timely fashion in a real-world setting of patients undergoing coronary angiography (n = 781). Among patients (n = 223, 28.5%), carriers of at least 1 loss-of-function allele treated with PCI (n = 65), prasugrel, and ticagrelor achieve similar levels of platelet inhibition. (A Pharmacodynamic Study Comparing Prasugrel Versus Ticagrelor in Patients Undergoing PCI With CYP2C19 Loss-of-function [NCT02065479]).

From the aDivision of Cardiology, A.O.U. "Policlinico-Vittorio Emanuele," University of Catania, Catania, Italy; b3rd Medical Department, Cardiology and Intensive Care Medicine and Sigmund Freud University, Medical Faculty, Vienna, Austria; cCardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; dLiverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; eAalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; fBrigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts; gDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina; hDepartment of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and faculty of Medicine and Life Sciences at the University of Hasselt, Hasselt, Belgium; iCardiology Department, Nimes University Hospital, ACTION Study Group, Montpellier University, Nimes, France; jDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands; kMayo Clinic College of Medicine, Rochester, Minnesota; and the lDivision of Cardiology, University of Florida College of Medicine, Jacksonville, Florida. Dr. Capodanno has received speakers honoraria from Bayer, AstraZeneca, Daiichi-Sankyo, Pfizer, and Boehringer Ingelheim; and has received consulting fees from Abbott Vascular, Bayer, and Daiichi-Sankyo. Dr. Huber has received lecture fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Pfizer, Portola, Sanofi, and The Medicines Company. Dr. Mehran has received institutional research funding from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi-Sankyo, Medtronic, Novartis, and OrbusNeich; has served as a consultant to Boston Scientific, Abbott Vascular, Medscape, Siemens Medical Solutions, Regeneron Pharmaceuticals (no fees), Roivant Sciences, and Sanofi; has served as an institutional consultant (payment to institution) for Abbott Vascular and Spectranetics/Phillips/Volcano Corporation; has served on the Executive Committee for Janssen Pharmaceuticals and Bristol-Myers Squibb; has received institutional (payment to institution) Advisory Board funding from Bristol-Myers Squibb and Novartis; has received Data and Safety Monitoring Board membership funding to his institution from Watermark Research; and has < 1% equity with Claret Medical and Elixir Medical. Dr. Lip has served as a consultant for Bayer/Janssen, Bristol-Myers Squibb/Pfizer, Medtronic, Boehringer Ingelheim, Novartis, Verseon, and Daiichi-Sankyo; and has received speaker's honoraria from Bayer, Bristol-Myers Squibb/Pfizer, Medtronic, Boehringer Ingelheim, and Daiichi-Sankyo. Dr. Faxon has received personal fees from Boston Scientific, Medtronic, and Baim. Dr. Granger has received personal fees from Janssen, Boston Scientific, and Medtronic; has received research grant support from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Daiichi-Sankyo, Janssen Pharmaceuticals, Bayer, Pfizer, Novartis, Population Health Research Institute, the U.S. Food and Drug Administration, and the National Heart, Lung, and Blood Institute; and has received consulting fees from Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Medtronic, Merck & Co., Novartis, Pfizer, Daiichi-Sankyo, Rho Pharmaceuticals, Verseon, and Janssen Pharmaceuticals. Dr. Vranckx has received personal fees from AstraZeneca, Bayer Health Care, CLS Behring, and Daiichi-Sankyo. Dr. Lopes has received consulting fees from Amgen, Bayer, Boehringer Ingelheim, BristolMyers Squibb, GlaxoSmithKline, Medtronic, Pfizer, and Sanofi; and has received institutional grants from Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer, and Sanofi. Dr. Montalescot has received research grants to the institution or consulting/lecture fees from Abbott, Amgen, Actelion, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Beth Israel Deaconess Medical, Brigham Women's Hospital, Cardiovascular Research Foundation, Daiichi-Sankyo, Idorsia, Lilly, Europa, Elsevier, Federation Francaise de Cardiologie, ICAN, Medtronic, Journal of the American College of Cardiology, Lead-Up, Menarini, Merck Sharp & Dohme, Novo Nordisk, Pfizer, Sanofi, Servier, The Mount Sinai School, TIMI Study Group, and WebMD. Dr. Cannon has received institutional grants and personal fees from Boehringer Ingelheim and Bristol-Myers Squibb; institutional grants from Daiichi-Sankyo and Janssen; and honoraria from Amgen, Amarin, Merck, Alnylam, Kowa, Pfizer, Eisai Co., Ltd., Sanofi, and Regeneron. Dr. Ten Berg has received grant support, Advisory Board fees, consulting fees, and lecture fees from AstraZeneca; has received Advisory Board fees, consulting fees, and lectures fees from Eli Lilly, Daiichi-Sankyo, The Medicines Company, Accumetrics, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Bayer; and has received grant support from ZonMw and AstraZeneca. Dr. Gersh has received research contracts with Apple, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Janssen, Novartis, GlaxoSmithKline, Medtronic Foundation, Pfizer, the U.S. Food and Drug Administration, and the National Institutes of Health; and has a consulting relationship with Abbvie, AstraZeneca, Bayer, BristolMyers Squibb, Boehringer Ingelheim, Boston Scientific, Gilead, Pfizer, Daiichi-Sankyo, Novartis, Medtronic, Merck, Novo Nordisk, and Roche Diagnostics. Dr. Bhatt has served on the Advisory Board of Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, PhaseBio, and Regado Biosciences; has served on the Board of Directors of Boston VA Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; has served as Chair of the American Heart Association Quality Oversight Committee, NCDR-ACTION Registry Steering Committee, and the VA CART Research and Publications Committee; has served on the Data Monitoring Committees of 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), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi-Sankyo), and the Population Health Research Institute; has received honoraria from 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), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), HMP Global (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Medtelligence/ReachMD (CME steering committees), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national coleader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), and WebMD (CME Steering Committees); has served as Deputy Editor of Clinical Cardiology; has received research funding from Abbott, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Idorsia, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, Regeneron, Roche, Sanofi, Synaptic, and The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); has served as site coinvestigator for Biotronik, Boston Scientific, St. Jude Medical (now Abbott), and Svelte; has served as a Trustee of the American College of Cardiology; and has performed unfunded research for FlowCo, Fractyl, Merck, Novo Nordisk, PLx Pharma, and Takeda. Dr. Angiolillo has received consulting fees or honoraria as an individual from 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; has participated in review activities for CeloNova and St. Jude Medical; and has received institutional 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, and Renal Guard Solutions. Stefan Hohnloser, MD, served as Guest Associate Editor for this paper.

Background Premature discontinuation of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention is related to higher short‐term risks of adverse outcomes. Whether these risks persist in the long‐term is uncertain. Methods and Results We assessed all patients having percutaneous coronary intervention with coronary second‐ or first‐generation drug‐eluting stents in the Veterans Affairs healthcare system between 2006 and 2012 who were free of major ischemic or bleeding events in the first 12 months. The characteristics of patients who stopped DAPT prematurely (1–9 months duration), compared with >9 to 12 months, or extended duration (>12 months) were assessed by odds ratios (ORs) from multivariable logistic models. The risk of adverse clinical outcomes over a mean 5.1 years in patients who stopped DAPT prematurely was assessed by hazard ratios (HRs) and 95% CIs from Cox regression models. A total of 14 239 had second‐generation drug‐eluting stents, and 8583 had first‐generation drug‐eluting stents. Premature discontinuation of DAPT was more likely in Black patients (OR, 1.54; 95% CI, 1.40–1.68), patients with greater frailty (OR, 1.04; 95% CI, 1.03–1.05), and patients with higher low‐density lipoprotein cholesterol, and less likely in patients on statins (OR, 0.87; 95% CI, 0.80–0.95). Patients who stopped DAPT prematurely had higher long‐term risks of death (second‐generation drug‐eluting stents: HR, 1.35; 95% CI, 1.19–1.56), myocardial infarction (second‐generation drug‐eluting stents: HR, 1.46; 95% CI, 1.22–1.74), and repeated coronary revascularization (second‐generation drug‐eluting stents: HR, 1.24; 95% CI, 1.08–1.41). Conclusions Patients who stop DAPT prematurely have features that reflect greater frailty, poorer medication use, and other social factors. They continue to have higher risks of major adverse outcomes over the long‐term and may require more intensive surveillance many years after percutaneous coronary intervention.

ObjectiveApproximately 10% of patients with myocardial infarction (MI) have no obstructive coronary artery disease. The prognosis and role of intensified antiplatelet therapy in those patients were evaluated.MethodsWe analysed data from the Clopidogrel and Aspirin Optimal Dose Usage to Reduce Recurrent Events–Seventh Organisation to Assess Strategies in Ischaemic Symptoms trial randomising patients with ACS referred for early intervention to receive either double-dose (600 mg, day 1; 150 mg, days 2–7; then 75 mg/day) or standard-dose (300 mg, day 1; then 75 mg/day) clopidogrel. Outcomes in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA) versus those with obstructive coronary artery disease (CAD) and their relation to standard-dose versus double-dose clopidogrel were evaluated. The primary outcome was cardiovascular (CV) death, MI or stroke at 30 days.ResultsWe included 23 783 patients with MI and 1599 (6.7%) with MINOCA. Patients with MINOCA were younger, presented more frequently with non-ST-segment elevation MI and had fewer comorbidities. All-cause mortality (0.6% vs 2.3%, p=0.005), CV mortality (0.6% vs 2.2%, p=0.006), repeat MI (0.5% vs 2.3%, p=0.001) and major bleeding (0.6% vs 2.4%, pConclusionsPatients with MINOCA are at lower risk of recurrent CV events compared with patients with MI with obstructive CAD. Compared with a standard clopidogrel-based dual antiplatelet therapy (DAPT) regimen, an intensified dosing strategy appears to offer no additional benefit with a signal of possible harm. Further randomised trials evaluating the effects of potent DAPT in patients with MINOCA are warranted.Trial registration numberNCT00335452.

Purpose The utility of a transitions-of-care (TOC) pharmacist intervention focused on improving the quality and safety of the medication process for high-risk cardiovascular patients was evaluated. Methods A quality-improvement initiative was developed for patients with heart failure or acute coronary syndrome followed longitudinally at a hospital’s outpatient cardiovascular clinic. The TOC pharmacist intervention occurred either before a patient’s outpatient cardiovascular clinic appointment or during a hospitalization. The major outcome analyzed was the number of unplanned hospital readmissions within 30 days. Additional endpoints evaluated included the time to healthcare utilization, number of medication discrepancies identified, percentage of therapeutic recommendations accepted by a provider, number of medication access issues resolved, patient cost savings, patient satisfaction, and mean time spent on an intervention by the pharmacist per patient encounter. Results A total of 118 patients received the TOC pharmacist intervention. A total of 516 medication discrepancies were identified and corrected, with 55.6% of discrepancies involving cardiovascular medications. A total of 244 recommendations for therapeutic optimization were provided, with an 81% provider acceptance rate and a 100% patient satisfaction rate. Fifty-five patients were provided with medication cost savings, and medication-access issues were resolved for 8 patients. A TOC pharmacist spent means of 98 and 73 minutes on patient education and coordination of care during inpatient and ambulatory encounters, respectively. The 30-day hospital readmission rate for patients with heart failure was reduced by 20%. Conclusion A TOC pharmacist intervention improved the quality and safety of care across both inpatient and ambulatory settings for high-risk cardiovascular patients at our institution.

The optimal antithrombotic treatment regimen for patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation represents a challenge in clinical practice. In 2016, an updated opinion of selected experts from the United States and Canada on the treatment of patients with atrial fibrillation undergoing percutaneous coronary intervention was reported. After the 2016 North American consensus statement on the management of antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention, results of pivotal clinical trials assessing the type of oral anticoagulant agent and the duration of antiplatelet treatment have been published. On the basis of these results, this focused update on the antithrombotic management of patients with atrial fibrillation undergoing percutaneous coronary intervention recommends that a non–vitamin K antagonist oral anticoagulant be preferred over a vitamin K antagonist as the oral anticoagulant of choice. Moreover, a double-therapy regimen (oral anticoagulant plus single antiplatelet therapy with a P2Y 12 inhibitor) by the time of hospital discharge should be considered for most patients, whereas extending the use of aspirin beyond hospital discharge (ie, triple therapy) should be considered only for selected patients at high ischemic/thrombotic and low bleeding risks and for a limited period of time. The present document provides a focused updated on the rationale for the new expert consensus–derived recommendations on the antithrombotic management of patients with atrial fibrillation treated with oral anticoagulation undergoing percutaneous coronary intervention.

Approximately half of patients presenting to the hospital with an acutely occluded coronary artery that is causing ST segment elevation myocardial infarction (STEMI) have significant stenosis of other coronary arteries.1 Observational studies have shown that patients with STEMI along with multivessel disease (MVD) fare worse than those with single vessel disease. Timely revascularisation of the culprit coronary artery is considered crucial for the treatment of STEMI. However, the management of other diseased, non-culprit coronary vascular territories has been an area of considerable debate. Recently published randomised clinical trials (RCTs) suggesting a beneficial effect from complete revascularisation have led to changes in guidelines, now supporting intervention of non-culprit vessels (class IIa or IIb recommendation).2 3 The goal of this Cochrane systematic review was to compare efficacy and safety of the culprit-only versus complete revascularisation strategies in patients with STEMI and MVD. Importantly, we also analysed comprehensively the quality of the evidence using the Cochrane standards. We searched for RCTs comparing complete revascularisation versus culprit-only percutaneous coronary intervention (PCI) in adult patients (≥18 years old) with STEMI and MVD in the Cochrane Central Register, MEDLINE, EMBASE, WHO ICTRP Portal and ClinicalTrials.gov since their inception up to January 2017.4 We extracted data on all-cause mortality, cardiovascular mortality, myocardial infarction, revascularisation and adverse events that included stroke, acute kidney injury and bleeding. The data were extracted on short-term (within the first 30 days after the index procedure) and long-term (1 year or greater after the index procedure) outcomes. Data were analysed as risk ratio (RR) with 95% CI, and we conducted analyses according to the statistical guidelines contained in the Cochrane Handbook for Systematic Reviews of Interventions.5 Furthermore, for trial sequential analysis (TSA),6 the required information size was calculated based on a 20% relative risk reduction (RRR) in the intervention group, a type …

Background Approximately 10% of patients presenting with myocardial infarction (MI) do not have obstructive coronary artery disease (MINOCA). The role of antiplatelet therapy and outcomes in this group remain unclear. We assessed prognosis and the effect of an intensified clopidogrel regimen in MINOCA patients. Methods We analyzed data from the CURRENT-OASIS 7 trial, which randomized 25,086 patients with acute coronary syndromes (ACS) referred for early intervention to receive either double-dose (600mg day 1; 150mg days 2–7; then 75mg daily) or standard-dose (300mg day 1; then 75mg daily) clopidogrel. We evaluated clinical outcomes at 30-days in patients with versus without obstructive CAD and in relation to standard versus double-dose clopidogrel. Results Overall, 23,783 MI patients were included, of which 1,599 (6.7%) had MINOCA. MINOCA patients were younger, more frequently presented with non-ST-segment elevation MI and had fewer comorbidities. Rates of all-cause mortality (0.7% versus 2.4%, p=0.0046), cardiovascular mortality (0.6 versus 2.2%, p=0.0056), repeat MI (0.5% versus 2.3%, p=0.0009) and major bleedings (0.7% versus 2.5%, p=0.0001) were significantly lower among patients with MINOCA versus those with obstructive CAD. Compared with the standard-dose clopidogrel regimen, the double-dose regimen appeared to increase the risk of cardiovascular death, MI or stroke in MINOCA patients (0.8% versus 2.1%, hazard ratio (HR) 2.74, P=0.033). There was no difference in those with obstructive CAD (4.7% versus 4.4%, HR 0.93, P=0.226; P-for-interaction=0.023) (see Figure 1A). Major bleeding did not occur more frequently in MINOCA patients with double- versus standard-dose clopidogrel regimen (0.7% versus 0.6%, (HR 1.16 (95% CI 0.35–3.80), p=0.805), but their rate was higher In MI patients with obstructive CAD (2.7% versus 2.2% (HR 1.26 (95% CI 1.06–1.49), p=0.008) (Figure 1B). Figure 1A & B Conclusions Compared to MI patients with obstructive CAD, patients presenting with MINOCA represent a distinct cohort, which is generally younger, has a higher NSTEMI prevalence and fewer comorbidities. Their risk for adverse events, especially repeat MI, stroke, death, and bleeding, is low ( Acknowledgement/Funding The CURRENT-OASIS 7 trial was sponsored by Sanofi-Aventis and Bristol-Myers Squibb.

Objectives To assess the impact of stent type on the risk of death or myocardial infarction (MI) related to dual antiplatelet therapy (DAPT) more than 12 months (prolonged DAPT) versus 12 or less months after PCI for an acute coronary syndrome (ACS). Background The recent DAPT study reported lower recurrent ischemic events from prolonged DAPT in patients treated with PCI for an ACS, but was underpowered to determine the impact of stent type. Methods We determined clinical outcomes after PCI for an ACS (median follow-up: DES = 26 months, BMS = 46 months) in 18,484 patients in the Veterans Affairs system treated with first generation drug-eluting stents (DES) or bare-metal stents (BMS). We used landmark analyses starting 1 year after the index PCI to assess the risk of prolonged DAPT on the primary endpoint of death or MI. Multivariable and propensity models adjusted for confounding. Results There was a significant interaction between stent type and prolonged DAPT for death and MI (P = 0.0036), death (P = 0.054), and major bleeding (P = 0.0013). Patients treated with prolonged DAPT had lower risks of death or MI (HR = 0.71, 95% CI = 0.61, 0.82) and death (HR = 0.74, 95%CI = 0.62, 0.89) with DES, but not BMS, and higher risks of major bleeding, particularly with BMS (HR = 1.67, P

Percutaneous cardiac interventions were introduced in the 1960s, and, with the introduction of percutaneous coronary interventions by Gruentzig in 1978, the field has had an astounding growth. Percutaneous coronary intervention (PCI) is the most commonly preformed revascularization technique in the United States today with an estimated 492 000 procedures done in 20101 (Figure 1). This exceeds the number of coronary bypass operations estimated to be 397 000. Likewise, the growth of structural heart disease, in particular, valvular heart disease, has been remarkable with >10 000 procedures in 2013 in the United States 2 years after approval and 38 000 over the first 5 years of approval in Europe.2 It is estimated that > 200 000 transcatheter aortic valve replacement (TAVR) procedures have been done worldwide to date. Growth in TAVR has increased the volume of surgical aortic valve replacement as well3 (Figure 2). Invasive pediatric interventions have accelerated over the past decade with better devices and improved success. Peripheral vascular interventions have also grown, expanding into venous in addition to arterial interventions. The field of interventional cardiology is now much broader and more complex than ever before and specialization within interventional cardiology is increasing.4 This review will discuss 2 areas where change has been most dramatic: coronary and valvular interventions. Figure 1. Trends in cardiovascular procedures, United States: 1979 to 2010; inpatient procedures only.1 PCI indicates percutaneous coronary intervention. Original Source: National Hospital Discharge Survey, National Center for Health Statistics, and National Heart, Lung, and Blood Institute. Figure 2. Growth of TAVR in Germany 2007 to 2013.3 Number of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) procedures performed, according to type of procedure and age group, 2007 to 2013. TA indicates transapical; and TF, transfemoral. ### The Current Status of Coronary Interventions Studies over the past decade have shown that the procedure is effective in relieving …

Cardiogenic shock complicates approximately 5% of contemporary cases of acute coronary syndrome and is associated with an adverse prognosis, especially early after percutaneous coronary intervention (PCI) [(1)][1]. Perturbations in hemodynamics, together with impaired gut absorption of oral

> Success is the journey, not a destination . > > —Arthur Ash Circulation: Cardiovascular Interventions published its first issue in August of 2008. It was 1 of 6 new journals started by the American Heart Association to address the needs of the major subspecialty areas in Cardiology. It joined the established journals of the American Heart Association: Circulation ; Circulation Research ; Arteriosclerosis, Thrombosis, and Vascular Biology; Hypertension ; and Stroke . The 6 daughter journals were initially under the umbrella of Circulation , and there was a natural close relationship between the subspecialty journals and Circulation because nearly all the initial subspecialty editors were members of the Editorial Board of Circulation . Under the guidance of Circulation , this remarkable experiment exceeded expectations and quieted skeptics. All the daughter journals have grown to be among the top 25 Cardiology journals in the world as measured by impact factor. Before 2008, there were only 4 dedicated interventional cardiology journals: Catheterization and Cardiovascular Intervention (formerly Catheterization and Cardiovascular Diagnosis published from 1975 to 1998), Journal of Invasive Cardiology (1990–), Journal of Interventional Cardiology (1991–), and EuroIntervention (2005–). Today, there are a total of 9 interventional journals listed on PubMed and many others online. Circulation: Cardiovascular Interventions and JACC: Cardiovascular Interventions are leading in metrics, and both rank within the top 10 Cardiovascular Journals overall. We set out to publish original experimental …

This editorial refers to ‘Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial’†, by M. Haude et al ., on page 2701. Bioresorbable scaffolds have captured the imagination of the medical community and patients as well. It is no wonder; the idea of a temporary stent that is in place as long as it needs to be, and then is reabsorbed, is an attractive idea that has many potential advantages. By removing the rigid metallic cage imposed by the permanent metal stent, vascular function could return toward normal, long-term complications such as stent fracture, late stent thrombosis, and in-stent restenosis could be reduced, and in turn obviate the need for prolonged dual antiplatelet therapy; and recurrent in-tent restenosis, often a difficult problem, could be more effectively treated. The early prototypes of a bioresorbable scaffold were introduced in the early 1990s, and the Igaki–Tamai stent was the first to be clinically tested in early 2000.1,2 The most studied bioresorbable stent, the ABSORB BVS scaffold (Abbott Vascular), is an everolimus-eluting scaffold with 150 μm struts made of poly-l-lactic acid (PLLA). The early observational studies have shown a good initial success rate, with improvements in outcomes as refinements in the device were introduced.3–8 ( Table 1 ) As hoped, vascular reactivity was restored in 6–12 months at a point when the scaffold was significantly degraded and partially resorbed.9 The 5-year results of initial ABSORB cohort A and B trials have shown excellent long-term outcomes.10 Randomized …

Background Prior Studies have suggested better outcomes in smokers compared with nonsmokers receiving clopidogrel (“smoker's paradox”). The impact of a more intensive clopidogrel regimen on ischemic and bleeding risks in smokers with acute coronary syndromes requiring percutaneous coronary interventions remains unclear. Methods and Results We analyzed 17 263 acute coronary syndrome patients undergoing percutaneous coronary intervention from the CURRENT ‐ OASIS 7 (Clopidogrel and Aspirin Optimal Dose Usage to Reduce Recurrent Events—Seventh Organization to Assess Strategies in Ischemic Symptoms) trial, which compared double‐dose (600 mg day 1;150 mg days 2–7; then 75 mg daily) versus standard‐dose (300 mg day 1; then 75 mg daily) clopidogrel in acute coronary syndrome patients. The primary outcome was cardiovascular death, myocardial infarction, or stroke at 30 days. Interactions between treatment allocation and smoking status (current smokers versus nonsmokers) were evaluated. Overall, 6394 patients (37.0%) were current smokers. For the comparison of double‐ versus standard‐dose clopidogrel, there were significant interactions in smokers and nonsmokers for the primary outcome ( P =0.031) and major bleeding ( P =0.002). Double‐ versus standard‐dose clopidogrel reduced the primary outcome among smokers by 34% (hazard ratio [ HR ] 0.66, 95% confidence interval [ CI ], 0.50–0.87, P =0.003), whereas in nonsmokers, there was no apparent benefit ( HR 0.96, 95% CI , 0.80–1.14, P =0.61). For major bleeding, there was no difference between the groups in smokers ( HR 0.77, 95% CI , 0.48–1.24, P =0.28), whereas in nonsmokers, the double‐dose clopidogrel regimen increased bleeding ( HR 1.89, 95% CI , 1.37–2.60, P HR 0.41, 95% CI , 0.24–0.71) and nonsmokers ( HR 0.63, 95% CI , 0.42–0.93; P for interaction=0.19). Conclusions In smokers, a double‐dose clopidogrel regimen reduced major cardiovascular events and stent thrombosis after percutaneous coronary intervention, with no increase in major bleeding. This suggests that clopidogrel dosing in patients with acute coronary syndromes should be personalized, taking into consideration both ischemic and bleeding risk. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT 00335452.

Background Multi-vessel coronary disease in people with ST elevation myocardial infarction (STEMI) is common and is associated with worse prognosis after STEMI. Based on limited evidence, international guidelines recommend intervention on only the culprit vessel during STEMI. This, in turn, leaves other significantly stenosed coronary arteries for medical therapy or revascularisation based on inducible ischaemia on provocative testing. Newer data suggest that intervention on both the culprit and non-culprit stenotic coronary arteries (complete intervention) may yield better results compared with culprit-only intervention. Objectives To assess the effects of early complete revascularisation compared with culprit vessel only intervention strategy in people with STEMI and multi-vessel coronary disease. Search methods We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, World Health Organization International Clinical Trials Registry Platform Search Portal, and ClinicalTrials.gov. The date of the last search was 4 January 2017. We applied no language restrictions. We handsearched conference proceedings to December 2016, and contacted authors and companies related to the field. Selection criteria We included only randomised controlled trials (RCTs), wherein complete revascularisation strategy was compared with a culprit-only percutaneous coronary intervention (PCI) for the treatment of people with STEMI and multi-vessel coronary disease. Data collection and analysis We assessed the methodological quality of each trial using the Cochrane 'Risk of bias' tool. We resolved the disagreements by discussion among review authors. We followed standard methodological approaches recommended by Cochrane. The primary outcomes were long-term (one year or greater after the index intervention) all-cause mortality, long-term cardiovascular mortality, long-term non-fatal myocardial infarction, and adverse events. The secondary outcomes were short-term (within the first 30 days after the index intervention) all-cause mortality, short-term cardiovascular mortality, short-term non-fatal myocardial infarction, revascularisation, health-related quality of life, and cost. We analysed data using fixed-effect models, and expressed results as risk ratios (RR) with 95% confidence intervals (CI). We used GRADE criteria to assess the quality of evidence and we conducted Trial Sequential Analysis (TSA) to control risks of random errors. Main results We included nine RCTs, that involved 2633 people with STEMI and multi-vessel coronary disease randomly assigned to either a complete (n = 1381) versus culprit-only (n = 1252) revascularisation strategy. The complete and the culprit-only revascularisation strategies did not differ for long-term all-cause mortality (65/1274 (5.1%) in complete group versus 72/1143 (6.3%) in culprit-only group; RR 0.80, 95% CI 0.58 to 1.11; participants = 2417; studies = 8; I2 = 0%; very low quality evidence). Compared with culprit-only intervention, the complete revascularisation strategy was associated with a lower proportion of long-term cardiovascular mortality (28/1143 (2.4%) in complete group versus 51/1086 (4.7%) in culprit-only group; RR 0.50, 95% CI 0.32 to 0.79; participants = 2229; studies = 6; I2 = 0%; very low quality evidence) and long-term non-fatal myocardial infarction (47/1095 (4.3%) in complete group versus 70/1004 (7.0%) in culprit-only group; RR 0.62, 95% CI 0.44 to 0.89; participants = 2099; studies = 6; I2 = 0%; very low quality evidence). The complete and the culprit-only revascularisation strategies did not differ in combined adverse events (51/2096 (2.4%) in complete group versus 57/1990 (2.9%) in culprit-only group; RR 0.84, 95% CI 0.58 to 1.21; participants = 4086; I2 = 0%; very low quality evidence). Complete revascularisation was associated with lower proportion of long-term revascularisation (145/1374 (10.6%) in complete group versus 258/1242 (20.8%) in culprit-only group; RR 0.47, 95% CI 0.39 to 0.57; participants = 2616; studies = 9; I2 = 31%; very low quality evidence). TSA of long-term all-cause mortality, long-term cardiovascular mortality, and long-term non-fatal myocardial infarction showed that more RCTs are needed to reach more conclusive results on these outcomes. Regarding long-term repeat revascularisation more RCTs may not change our present result. The quality of the evidence was judged to be very low for all primary and the majority of the secondary outcomes mainly due to risk of bias, imprecision, and indirectness. Authors' conclusions Compared with culprit-only intervention, the complete revascularisation strategy may be superior due to lower proportions of long-term cardiovascular mortality, long-term revascularisation, and long-term non-fatal myocardial infarction, but these findings are based on evidence of very low quality. TSA also supports the need for more RCTs in order to draw stronger conclusions regarding the effects of complete revascularisation on long-term all-cause mortality, long-term cardiovascular mortality, and long-term non-fatal myocardial infarction.

> The best preparation for tomorrow is to do today’s work superbly well. > > —William Osler The last decade has witnessed several groundbreaking innovations in medical and interventional therapies for cardiovascular diseases.1 The field of interventional cardiology, which began with percutaneous transluminal coronary angioplasty in the 1980s with no formal training programs, now encompasses coronary stent technology with various platforms—metallic scaffolds, bioresorbable polymers, and bioabsorbable vascular scaffolds and percutaneous treatment of complex chronic total occlusions. Furthermore, the field of interventional cardiology has expanded to include peripheral vascular interventions, involving superficial femoral, iliac, and renal artery interventions, to the more complex carotid, subclavian, below-the-knee interventions and endovascular repair of abdominal and thoracic aortic aneurysms. The interventional subspecialty that has exploded and caught the attention of many over the past 5 years is the field of structural heart interventions. Transcatheter aortic valve replacement (TAVR), which is now the standard therapy for patients with intermediate- and high-risk aortic stenosis, has been recognized among the top 10 innovations of the decade.2,3 Currently, TAVR is growing at a rate of >16% per year, and further growth is expected as new valves become available for widening indications. If TAVR is shown to be as effective as surgical aortic valve replacement in low-risk patients, the volume of cases is expected to significantly increase rapidly. In addition, percutaneous mitral and several tricuspid valve therapies are on the horizon that are expected to expand the gamut of structural heart procedures.4 Similar growth is expected in …

In-stent restenosis (ISR) remains a concern even in the drug-eluting stent (DES) era and carries a high risk of recurrence. Brachytherapy is being used as an alternative treatment for resistant ISR, yet the safety and efficacy of this approach has not been well studied. We analyzed the outcomes of 101 patients who underwent coronary brachytherapy for resistant DES ISR. Baseline demographic, clinical, procedural, and outcome data were collected by phone and from electronic records. Comorbidities and overt cardiovascular disease were highly prevalent. Median previous stent layers were 2 with a maximum of 5 layers. Procedural angiographic success rate was 97% and median time to discharge was 1 day after brachytherapy. The primary outcome of target vessel revascularization was 24% at 1 year, 32% at 2 years, and 42% at 3 years. The rate of nonfatal myocardial infarction was 0% at 1 year, 3.5% at 2 years, and 6% at 3 years. The rate of all-cause mortality was 8.5% at 1 year, 12% at 2 years, and 16% at 3 years. We observed only 1 case of late stent thrombosis. After multivariable adjustment, female gender (hazard ratio 2.37, 95% confidence interval 1.02 to 5.52, p = 0.04) and diffuse ISR pattern (hazard ratio 2.95, 95% confidence interval 1.21 to 7.17, p = 0.01) were independently associated with the primary outcome. In conclusion, brachytherapy is feasible for the treatment of resistant DES ISR and is associated with high immediate procedural success and reasonable efficacy in a complex patient population. This approach might be used as an alternative for these patients.

A patient referred from an outside hospital for cardiothoracic surgery transferred to the general cardiology floor. An 83-year-old female presented with syncope after multiple days of diarrhea. A transthoracic echocardiogram revealed concern for a left atrial mass that was also visualized on

Cardiogenic shock is characterized by abnormal hemodynamics, impaired gut absorption, and multiorgan system dysfunction, which collectively complicate traditional oral antiplatelet management after percutaneous coronary intervention (PCI). Potent, parenteral antiplatelet strategies are thus

Objectives The purpose of this analysis was to assess in patients with type 2 diabetes and stable coronary artery disease (CAD) whether the risk of all-cause mortality and cardiovascular events varied according to the presence or absence of angina and angina equivalent symptoms. Background Data on the prognostic value of symptoms in these patients are limited. Methods Post-hoc analysis was performed in 2,364 patients with type 2 diabetes and documented CAD enrolled in the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial to determine the occurrence of death and composite of death, myocardial infarction, and stroke during a 5-year follow-up according to cardiac symptoms at baseline. Results There were 1,434 patients with angina (A), 506 with angina equivalents (E), and 424 with neither of these (N). The cumulative death rates (total 316) were 12% in A, 14% in E, and 10% in N (p = 0.3), and cardiovascular composite rates (total 548) were 24% in A, 24% in E, and 21% in N (p = 0.5). Compared with N, the hazard ratios adjusted for confounders were not different for death in A (1.11; 99% CI: 0.81 to 1.53) and E (1.17; 99% CI: 0.81 to 1.68) or for cardiovascular events in A (1.17; 99% CI: 0.92 to 1.50) and E (1.11; 99% CI: 0.84 to 1.48). Conclusions Whatever their symptom status, patients with type 2 diabetes and stable CAD were at similar risk of cardiovascular events and death. These findings suggest that these patients may be similarly managed in terms of risk stratification and preventive therapies. (Bypass Angioplasty Revascularization Investigation 2 Diabetes [BARI 2D]; NCT00006305)

The optimal antithrombotic treatment regimen for patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation is an emerging clinical problem. Currently, there is limited evidenced-based data on the optimal antithrombotic treatment regimen, including antiplatelet and anticoagulant therapies, for these high-risk patients with practice guidelines, thus, providing limited recommendations. Over the past years, expert consensus documents have provided guidance to clinicians on how to manage patients with atrial fibrillation undergoing percutaneous coronary intervention. Given the recent advancements in the field, the current document provides an updated opinion of selected North American experts from the United States and Canada on the treatment of patients with atrial fibrillation undergoing percutaneous coronary intervention. In particular, this document provides the current views on (1) embolic/stroke risk, (2) ischemic/thrombotic cardiac risk, and (3) bleeding risk, which are pivotal for discerning the choice of antithrombotic therapy. In addition, we describe the recent advances in pharmacology, stent designs, and clinical trials relevant to the field. Ultimately, we provide expert consensus–derived recommendations, using a pragmatic approach, on the management of patients with atrial fibrillation undergoing percutaneous coronary intervention.

The explosion of cardiovascular registries during the past 2 decades has been remarkable but not surprising. Registries have become an important component of current quality initiatives that were started after the Institute of Medicine’s call in 1999 for the United States to better address the quality of care. Three important publications ensued, including the report “Crossing the Quality Chasm” in 2001.1 Several national efforts—including establishment of standards of care through guideline development, performance measures, public reporting, and appropriate use criteria—have been initiated as a result and now are part of our daily lives. Prospective registries gained in popularity when they were components of randomized trials. Their intent was to determine the relevance of randomized trials in relation to real-world practice. In the case of the Coronary Artery Surgery Study (CASS), a randomized trial of bypass surgery versus medical therapy done in the 1980s, the registry component demonstrated that the findings of the randomized trial were generalizable and provided additional insights into subgroups not treated in the randomized trial.2 Local databases, such as the Duke database, were early pioneers in the field, which were followed by regional and national registries, such as the NHLBI PTCA Registry in 1980. It was the Cooperative Cardiovascular Project started by the Health Care Finance Administration (Centers for Medicare & Medicaid Services [CMS]) in the early 1990s that was the first to measure quality in large patient populations with acute myocardial infarction (AMI).3 In 1987, the American College of Cardiology (ACC) established the National Cardiovascular Data Registry (NCDR) to define the clinical characteristics and outcomes of patients undergoing cardiac catheterization and coronary interventions.4 The New York State Cardiac Registry started in 1988 to assess quality and outcomes in percutaneous coronary intervention (PCI) and coronary artery bypass graft.5 The largest and most …

The optimal antiplatelet regimen for patients on oral anticoagulants undergoing coronary stenting continues to be controversial. It is not an insignificant problem, as 5-7 % of patients undergoing stenting are on oral anticoagulation for atrial fibrillation, a prosthetic valve, a recent left ventricular thrombus and recent pulmonary embolus. When given in combination with dual antiplatelet therapy, major bleeding is significantly increased, which is associated with an increased mortality. The balance between a reduction in stroke, stent thrombosis and myocardial infarction without a significant increase in major bleeding requires choosing therapy based upon the estimation of the risks of each adverse event. In patients with a low risk of stroke, such as those with atrial fibrillation and a CHADS(2) score of 0-1, dual antiplatelet therapy alone is sufficient. In those at moderate to high risk of stroke, dose-adjusted oral anticoagulation is needed. In those with the highest bleeding risk, use of a bare metal stent is strongly advised. In addition to bare metal stent use, the use of proton pump inhibitors, tight control of the international normalized ratio (INR) and only one month of dual antiplatelet therapy can reduce the bleeding risk without an increase in stroke or stent thrombosis. When a drug eluting stent (DES) is needed, a second generation DES should be used and triple therapy continued for 6 months (12 months if stent thrombosis risk is very high), followed by a single antiplatelet therapy and an oral anticoagulant. Since the newer antiplatelet agents and anticoagulants have not been studied in this setting, clopidogrel and warfarin should be used. Recently, the WOEST trial suggested that clopidogrel alone plus an oral anticoagulant resulted in an equal outcome with a significantly lower bleeding risk when compared to triple therapy. If confirmed, this regimen may become the standard of care. Presently, however, limiting the duration of triple therapy followed by clopidogrel and an oral anticoagulant seems the best option for the majority of patients to minimize bleeding risk without an increase in other adverse events.

Drug-eluting stents (DES) are effective in reducing neointimal proliferation and in-stent restenosis. However, the procedure is complicated by early and late stent thrombosis that is related to incomplete healing, leading to stent malapposition and incomplete reendothelialization. Stent restenosis results in significant mortality and morbidity and portends a poor long-term outcome. In this article, we review recent findings regarding the prevalence of late and very late stent thrombosis (VLST) and the mechanisms that may be at play.Long-term follow-up from large registry studies and randomized controlled trials of DES implantation have recently created an awareness of the persistence of VLST (0.26%/year) for up to at least 5 years. Recent findings utilizing intravascular ultrasound and optical coherence tomography have also provided important insights into the mechanism of VLST and suggest that delayed healing and neoatherosclerosis are important. Finally, the development of novel stent scaffolds and antiplatelet agents holds much promise for reducing the risk of VLST.DES implantation continues to be complicated by the risk of VLST. Recent insights into the mechanisms of this significant clinical problem have important implications in preventing VLST.

In patients who have multivessel but stable coronary artery disease (CAD), the perceived advantages of complete revascularization (CR) over incomplete revascularization (IR) are intuitively logical and have been the impetus to perform CR whenever feasible. These advantages were suggested by early studies in patients with 3-vessel CAD who underwent coronary artery bypass graft (CABG) demonstrating a survival benefit of patients with CR compared with those with IR.1–4 Nonetheless, in practice, the variations in severity of the coronary anatomy as well as the patient’s clinical status often precludes CR resulting in a higher frequency of IR in patients with multivessel disease. For example, in the SYNTAX (SYNergy between PCI with TAXus and Cardiac Surgery) trial, patients randomized to percutaneous intervention (PCI)5 had CR in only 56.7% even when CR was intended and in Bypass Angioplasty Revascularization Investigation (BARI) this was 56%.6 A critical review of the literature demonstrates the complexity of the issues and poses several unanswered questions (Table 1). View this table: Table 1. Unanswered Questions In the current era of significantly improved medical therapy (primary and secondary prevention) of CAD as well as the increasing use of sophisticated invasive and noninvasive testing of the physiological significance of coronary artery stenoses, both surgeons and cardiologists have an arsenal of diagnostic tools at hand that may guide decisions in selecting revascularization strategies. This review provides a contemporary overview of the currently available literature in the field and proposes an evidence-based approach for patients with severe CAD and stable angina undergoing revascularization. ### The Missing Universal Definition The dilemma of comparing outcomes after CR and IR begins with the lack of universal definitions. There are considerable differences between complete/incomplete anatomic and functional/physiological revascularization. Ong and Serruys8 reviewed comprehensively past definitions of CR used in different trials (Table 2). View this table: Table 2. Summary of Definitions for Complete Revascularization …

Background— Current guidelines recommend combining clopidogrel with aspirin for up to 1 year after coronary stenting, but the value of clopidogrel beyond this time is uncertain. Methods and Results— We evaluated all patients in the Veterans Administration healthcare system receiving either drug-eluting or bare metal stents from 2002 to 2006. The Veterans Administration National Patient Care and Pharmacy databases were used to extract patient characteristics, duration of clopidogrel use, and outcomes for up to 4 years after the index procedure. We used Cox proportional hazards to estimate hazard ratios for death, myocardial infarction, revascularization, and bleeding from a 12-month landmark after stenting that excluded patients with events within the first 12 months. Of 42 254 patients, 29 175 met the study inclusion criteria. Compared with ≤12 months of clopidogrel, prolonged clopidogrel (>12 months) was associated with a lower adjusted risk of death for both drug-eluting stents (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.61, 0.82; P P =0.01) as well as for death and myocardial infarction but was unrelated to stroke or major bleeding. The effect of prolonged clopidogrel on death or myocardial infarction was significantly greater among patients receiving drug-eluting (HR, 0.70; 95% CI, 0.64, 0.84) compared with bare metal stents (HR, 0.88; 95% CI, 0.79, 0.98; interaction P =0.024). Conclusions— Patients receiving clopidogrel beyond 12 months had a lower risk of death or myocardial infarction compared patients receiving clopidogrel ≤12 months. The risk reduction was greater for drug-eluting stents. These data support longer durations of dual antiplatelet therapy for patients receiving a stent, particularly for those receiving a drug-eluting stent.

Cangrelor, a rapidly acting, intravenous P2Y12 inhibitor, has been approved for use during percutaneous coronary intervention (PCI). The 3 phase 3 CHAMPION (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition) trials collectively provided robust randomized data in

Objectives The purpose of this study was to determine the extent to which effectiveness of cardiac and diabetes treatment strategies varies by patient age. Background The impact of age on the effectiveness of revascularization and hyperglycemia treatments has not been thoroughly investigated. Methods In the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) trial, 2,368 patients with documented stable heart disease and type 2 diabetes were randomized to receive prompt revascularization versus initial medical therapy with deferred revascularization and insulin sensitization versus insulin provision for hyperglycemia treatment. Patients were followed for an average of 5.3 years. Cox regression and mixed models were used to investigate the effect of age and randomized treatment assignment on clinical and health status outcomes. Results The effect of prompt revascularization versus medical therapy did not differ by age for death (interaction p = 0.99), major cardiovascular events (interaction p = 0.081), angina (interaction p = 0.98), or health status outcomes. After intervention, participants of all ages had significant angina and health status improvement. Younger participants experienced a smaller decline in health status during follow-up than older participants (age by time interaction p Conclusions Among patients with stable heart disease and type 2 diabetes, the relative beneficial effects of a strategy of prompt revascularization versus initial medical therapy and insulin-sensitizing versus insulin-providing therapy on clinical endpoints, symptom relief, and perceived health status outcomes do not vary by age. Health status improved significantly after treatment for all ages, and this improvement was sustained longer among younger patients. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes [BARI 2D]; NCT00006305 )

Coronary artery disease with left main stenosis is associated with the highest mortality of any coronary lesion. Studies in the 1970s and 1980s comparing coronary artery bypass grafting (CABG) and medical therapy showed a significant survival benefit with revascularization. In the angio- plasty era, initial experience with percutaneous intervention was associated with poor clinical outcomes. As a result, percutaneous coronary intervention (PCI) was restricted to patients who were considered inoperable, or those with prior CABG with a functional graft to the left anterior descending or circumflex artery ("protected left main disease"). With the introduction of drug-eluting stents, there are new studies demonstrating comparable survival in patients who were revascularized using PCI and CABG, although percu- taneous revascularization is associated with a higher rate of repeat revascu- larization. In the SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) trial, the combined incidence of death, myocardial infarction, and stroke was similar between the CABG and PCI groups; however, the stroke rate was higher in the CABG group. The degree and extent of disease as defined by the SYNTAX scoring system has allowed for stratification of risk and improved assignment of patients with left main stenosis to either PCI or CABG. tration Cooperative Study, which randomized 686 patients with stable angina to initial CABG or initial medical therapy. 4 Overall, there was a survival benefit for patients assigned to initial CABG. There was a subgroup of 91 patients with left main CAD, and among these patients, survival at 42 months was 88% in the surgical arm and 65% in the medical arm (P 0.016) 5 (Fig. 1A). The benefit was greatest in those patients with left main stenosis 75%, where survival was 83% in the surgical arm versus 48% in the medical arm (P 0.036). A substantial benefit was also seen in patients with abnormal left ventricular function, where survival was 89% in the surgical group and 62% if treated medically (P 0.012). During the same period, there were 7 randomized trials that compared early CABG to initial medical therapy. The 3 largest trials were the Veterans Administration Cooperative study, 6 the European study, 7 and the Coronary Artery Surgery study. 8 There were 4 smaller trials also. 9-11 An important meta-analysis that included all 7 trials showed that the mortality of the CABG group was signifi- cantly lower than that in the medical group—5-year mortality was 10.2% in the CABG group and 15.8% in the medical group (P 0.0001). 12 This mortality benefit persisted over time, with the 10-year mortality being 26.4% in the CABG group and 30.5% in the medical group (P 0.03). Analysis of the left main cohort, which included 175 patients, showed a 68% reduction in mortality at 5 years and a 33% reduction in mortality at 10 years. It was believed that the less-pronounced mortality reduction at 10 years was par- tially attributable to crossover, as 45% of patients crossed over from the medical group to the CABG group. Interestingly, an analysis of factors associated with extension of survival by revascularization showed that left main CAD was the strongest predictor of increasing life expectancy by revascularization. At 10 years, patients with left main CAD were estimated to have a 20-month increase in survival with revascularization. This is in comparison with the 6-month increase in survival seen in patients with 3-vessel disease and the 11-month increase in survival in patients with abnormal left ven- tricular dysfunction.

AIMS The aim of the present study was to examine the impact of the transradial approach (TRA), in comparison to the transfemoral approach (TFA), on PCI-related bleeding and patient outcomes in acute coronary syndrome patients who underwent PCI in the OASIS-5 trial. METHODS AND RESULTS The primary outcome (death, myocardial infarction, refractory ischaemia) at nine days was similar in both groups (7.1% in 872 TRA and 7.7% in 7,013 TFA). Major bleeding was significantly lower in patients who underwent PCI with TRA by comparison to TFA (1.6% vs 3.5%, p

Patients with peripheral arterial disease (PAD) undergoing percutaneous coronary intervention (PCI) are at high risk for adverse cardiovascular events. Trends over time in outcomes with advances in PCI and medical therapy are unknown. We evaluated 866 patients with PAD in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry undergoing PCI according to treatment eras: the early bare metal stent (BMS) era (wave 1, 1997 to 1998, n = 180), the BMS era (waves 2 and 3, 1999 and 2001 to 2002, n = 339), and the drug-eluting stent (DES) era (waves 4 and 5, 2004 and 2006, n = 347). We compared in-hospital and 1-year outcomes by recruitment era. In-hospital coronary artery bypass graft surgery rates were significantly lower in the later eras (3.9%, 0.9%, and 0.6% for the early BMS, BMS, and DES eras, respectively, p for trend = 0.005), and an increasing percentage of patients were discharged on aspirin, β blockers, statins, and thienopyridines (p for trend

> Variability is the law of life,…and no two individuals react alike and behave alike under the abnormal conditions which we know as disease. > > —William Osler National efforts to improve the quality of care were greatly enhanced by the Institute of Medicine’s landmark publication, Crossing the Quality Chasm .1 The report concludes that a fundamental redesign of the healthcare system is needed to achieve the core needs of health care to be safe, effective, patient-centric, timely, efficient, and equitable. One goal has been to reduce inequity in care by reducing sex, race, and socioeconomic and geographic variability because inequality was felt to represent lack of adherence to optimal standard of care. The Dartmouth Healthcare Atlas project was the first to demonstrate significant regional differences in Medicare spending in the United States without an improvement in quality.2 This group and others have also shown wide geographic variations in the use of procedures such as coronary angiography and percutaneous coronary angioplasty (PCI).2–4 The causes for this large difference in practice are unclear, but it has been speculated that it is because of both underuse and overuse of these procedures.5,6 Several factors have been shown to relate to the variation in practice, including the operator, hospital, sex, race, the availability of a cardiac catheterization laboratory, the type of hospital, rural location, the type of health insurance, and socioeconomic class.3,7–9 Efforts to reduce the variability in care have focused on overuse through adoption of appropriate use criteria (AUC), performance measures, public reporting, and pay for performance. The Rand Corporation first developed AUC in 1986 using a modified Delphi process. Based on guidelines, registry studies, and expert opinion, a panel of experts developed a consensus on several indications for common procedures including angioplasty. …

In patients presenting with acute coronary syndromes, 30-60% of patients have multiple significant coronary lesions. Patients presenting with acute coronary syndrome and multivessel disease have a significant increase in the incidence of major cardiovascular morbidity and mortality when compared with patients who have single-vessel disease. Although great progress has been made to reduce the extent of infarction through effective and rapid reperfusion due to faster time to reperfusion, potent antiplatelets, and antithrombotics, there is not much consensus as to how best to treat multivessel disease in patients presenting with acute coronary syndromes. We present a review of the current body of evidence for safety and efficacy of multivessel revascularization in patients presenting with acute coronary syndromes.

Early reperfusion in ST-segment elevation myocardial infarction (STEMI) is imperative. Acute reperfusion may be achieved with fibrinolytic agents and/or percutaneous coronary intervention (PCI); however, PCI is associated with lower rates of death and myocardial infarction compared with fibrinolysis. As treatment delays are associated with worse outcomes, current guidelines recommend minimizing time from symptom onset to treatment initiation. Regardless of the reperfusion strategy, patients with STEMI are at increased risk of early recurrent ischemic events and death. These risks can be significantly reduced by promptly initiating a combination of pharmacotherapies that includes antiplatelet and anticoagulant agents, β-blockers, and inhibitors of the renin-angiotensin-aldosterone system. This manuscript reviews the evidence supporting the most recent guidelines for STEMI management published jointly by the American College of Cardiology and American Heart Association. More recent evidence and its potential impact on future evidence-based guidelines are also addressed.

Rapid reestablishment of infarct vessel patency and microvascular flow provides the best opportunity for minimizing mortality in the patient post myocardial infarction (MI). Early infarct artery patency can be restored by thrombolysis, primary angioplasty, or facilitated percutaneous coronary intervention (PCI). In comparative studies, primary angioplasty offers a greater mortality benefit than thrombolysis in patients with acute MI. Short‐term rates of mortality and stroke were significantly lower in patients receiving primary angioplasty compared with thrombolysis, as was the risk of nonfatal reinfarction. The timing of reperfusion therapy after symptom onset affects outcomes. Patients presenting >3 h after symptom onset are likely to benefit more from PCI than from thrombolysis. Nevertheless, PCI should be performed as soon as possible for optimal results. If PCI is to be delayed, then immediate thrombolysis is likely to be as effective as PCI. Registry data indicate that reperfusion for acute MI is currently underused, with different techniques frequently misapplied. Outcomes tend to be better at centers that perform a high volume of reperfusion procedures, partly due to shorter treatment delays. Facilitated PCI combines fibrinolytic therapy with angioplasty. It is designed to promote very early patency in those who respond to drug therapy, with very high final patency rates assured by angioplasty. Clinical trials have generally found facilitated PCI to be more efficacious than thrombolysis alone. Rescue PCI in cases of failed fibrinolysis is associated with a modest mortality benefit compared with conservative treatment. Myocardial injury following reperfusion after ischemia can limit the benefits of PCI and fibrinolysis; however, strategies for minimizing reperfusion injury have not yet shown clinical efficacy.

Because of the central role of platelets in mediating ischemic events, antiplatelet agents are critical components of atherothrombosis prevention. Given their robust safety and efficacy profiles, aspirin and clopidogrel are consistently recommended by evidence-based treatment guidelines. Despite these recommendations, controversies surrounding the appropriate application of aspirin and clopidogrel remain. Questions of appropriate dosing, length of therapy, and use of combination therapy are most pressing, and considerable debate exists regarding the variability of response to antiplatelet therapy, including the definition, measurement, and clinical relevance of responsiveness. This review discusses the facts and controversies surrounding the use of aspirin and clopidogrel. Overall, despite the existing controversies, antiplatelet therapy with aspirin and/or clopidogrel remains a proven and essential therapeutic tool for safe and effective management of atherothrombotic risk in specific clinical settings.