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Journal of the American College of Cardiology Vol. 61, No. 15, 2013© 2013 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00

YEAR IN CARDIOLOGY SERIES

The Year in Interventional Cardiology

Simon R. Dixon, MBCHB, Robert D. Safian, MD

Royal Oak, Michigan

Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jacc.2013.01.040

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We are delighted to provide readers of the Journal with thisreview of major scientific work published or presented as alate-breaking trial in 2012. We hope that the paper willprovide a broad overview for general cardiologists, as well asa framework for more detailed study for those interested ininterventional cardiology.

Structural Heart Disease

A. Transcatheter aortic valve replacement (TAVR). Thereere excellent reviews on pathophysiology of aortic stenosis

AS) (1); quantification of AS severity (2); low-flow low-radient (LF-LG) AS (3), 10-year outcome of TAVR in0,000 patients (4,5), a current state of the art (6), andultimodality imaging for TAVR (7). Two expert docu-ents described operator and institutional requirements forAVR (8,9), and the Valve Academic Research Consor-

ium (VARC-2) developed standardized definitions (10). Aroposed AS classification based on valve area, ventricularlood flow, and transaortic pressure gradients may allowetter characterization of AS patients (11). Compared toatients with severe AS, normal left ventricular (LV) func-ion, and high gradients, those with LG have �2-foldreater 5-year mortality (12,13).

Three-dimensional angiographic reconstruction of a ro-ational aortic root angiogram can predict the ideal deploy-ent angle, and is highly correlated with computed tomog-

aphy (CT) (14). Operators should anticipate aorticovement of the Edwards SAPIEN (ES) and SAPIEN XT

ESXT) (Edwards Lifesciences Irvine, California) valveuring deployment, to optimize valve position (15). Theortic annulus is elliptical in diastole and rounded in systole;ppreciable changes in cross-sectional area but negligiblehanges in perimeter suggest that annulus perimeter isdeally suited for valve sizing (16). ES and ESXT maintainxcellent circularity, full expansion, and no stent fractures.5 years after implantation (17).Transfemoral (TF), transapical (TA), and transaortic

TAo) approaches are used for TAVR. One study demon-trated the safety of a fully percutaneous transaxillary ap-

From the Department of Cardiovascular Medicine, Beaumont Hospital, Royal Oak,Michigan. Dr. Dixon has received research grant support from Abbott Vascular Inc.,Abiomed Inc., Boston Scientific, and InfraReDx Inc. Dr. Safian has reported that he

Fhas no relationships relevant to the contents of this paper to disclose.

Manuscript received January 7, 2013; accepted January 16, 2013.

roach, relying on vascular closure or stent grafts foremostasis (18). Percutaneous TF TAVR was performed inll but 1 of 137 patients using vascular pre-closure, resultingn a dramatic decline in vascular complications (19). Aercutaneous TF approach, local anesthesia, and vascularlosure were used in 151 patients, with conversion to generalnesthesia in 3.3%, procedural success in 95.4%, and 30-dayomposite safety (death, stroke, myocardial infarction [MI],ajor bleeding, vascular complications, acute kidney injury,

epeat intervention for valve dysfunction) in 15.9% (20).here is a significant learning curve with the ES during therst 30 cases (21).A meta-analysis of 3,519 patients after ES, ESXT, andedtronic CoreValve (MCV; Medtronic, Minneapolis,innesota) reported 30-day composite safety, 30-day mor-

ality, and 1-year mortality in 32.7%, 7.8%, and 22.1%,espectively (22). Permanent pacemaker implantation (PPI)as more frequent after MCV (28.9% vs. 4.9%, p � 0.001).he Canadian ES registry reported mortality in 55.5% at 4

ears (noncardiac 59.2%, cardiac 23.0%, and unknown7.8%) (23). Predictors of late mortality were chronic pulmo-ary disease, chronic kidney disease, chronic atrial fibrillationAF), and frailty. In PARTNER (Placement of Aortic Trans-atheter Valve Trial) trial cohort A, TAVR was associatedith similar mortality and stroke at 2 years, but morearavalvular aortic regurgitation (PAR) (24); PAR wasssociated with late mortality. The FRANCE-2 registryeported mortality at 30 days and 1 year of 9.7% and 24.0%,espectively (25). Predictors of mortality included Europeanystem for Cardiac Operative Risk Evaluation (Euro-CORE), New York Heart Association functional class,A TAVR, and PAR. The Italian CoreValve registry

eported all-cause and cardiac mortality of 34.8% and3.5%, respectively (26). Pathology of transcatheter valvesxplanted at surgery or autopsy revealed a paucity of valveegeneration and fibrous ingrowth, but significant myocar-ial amyloidosis in 33% (27).TAVR outcomes have been reported in several patient

ubsets. In the Italian CoreValve registry, subclavian and TFAVR had similar procedural success, composite safety,

nd 2-year survival (28). The median survival was 2.5 to 2.7ears for patients with Society of Thoracic Surgeons mor-ality risk �10% (29). Lower surgical risk patients haveetter TAVR outcomes than higher risk patients (30).
railty was an independent predictor of 1-year mortality

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1638 Dixon and Safian JACC Vol. 61, No. 15, 2013Year in Interventional Cardiology April 16, 2013:1637–52

(hazard ratio [HR]: 3.5, 95% confidence interval: 1.4 to 8.5,p � 0.0007), but not complications (31). Female gender wasssociated with better 30-day and 1-year outcome (32,33).ompared to TAVR in patients with left ventricular ejec-

ion fraction (LVEF) �35%, those with LVEF �35% hadigher 30-day mortality (10% vs. 3%, p � 0.01), more PAR,nd lower 1-year survival (69% vs. 87%, p � 0.0001) (34).ompared to TAVR in high-gradient AS, LF-LG ASatients have more postoperative low output syndrome andigher 30-day and 1-year mortality (12.8% vs. 7.4%, p �.001; 36.9% vs. 18.1%, p � 0.0001), but similar proceduraluccess, major complications, and functional improvement35). TAVR patients with moderate or severe mitral regur-itation (MR) had higher 30-day mortality, but similarortality at 1 year; MR improved in 55% of patients (36).atients with severe AS and coronary artery disease (CAD)re candidates for TAVR, as percutaneous coronary inter-ention (PCI) can be performed without increased risk (37).

A recent review describes valve-in-valve (ViV) treatmentor bioprosthetic valve failure (38,39). The Global ViVegistry reported ES and MCV ViV procedural success in3%, 30-day mortality in 8.4%, and 1-year survival in 85.8%40). MCV ViV was performed in 27 patients with failingioprosthetic aortic valves, with 30-day mortality of 7.4%41). ViV therapy is also feasible for failed bioprostheticitral valves, using a TA approach (42). In PARTNER

ohort A, health-related quality of life (HRQOL) improvedore rapidly after TF TAVR but was similar to AVR at 1

ear (43). Male gender and operator experience were inde-endent predictors of HRQOL improvement (44). Fornoperable AS, TAVR cost per quality-adjusted life-yearas comparable to other cardiovascular procedures (45).AR after TAVR is classified as PAR, transvalvular AR

TAR), or both; PAR is an important predictor of adverseutcome after TAVR. Various methods have been proposedo reduce the incidence and severity of PAR after TAVR,nd quantitate the degree of PAR during TAVR. Cross-ectional CT annular dimensions are better than 2-dimensionalchocardiography to guide valve sizing and reduce PAR46). CT-derived annulus area and valve undersizing wereost predictive of PAR, whereas valve overexpansion re-

ulted in less PAR (47). The AR index [(diastolic bloodressure – LV end-diastolic pressure systolic blood pressure] �00) after device implantation has an inverse relationshipith PAR severity; AR index �25 had significantly higher-year mortality than AR index �25 (48,49).Some centers have adopted a zero-tolerance policy for

nything more than mild PAR (50,51). Redilation in 28%f ES TAVR patients resulted in reduction in 1 grade ofAR in 71%, and final PAR grade �2 in 54% (51).edilation is less effective in patients with heavy valve

alcification, and marked overdistension can lead to aorticnjury, leaflet injury, and stroke (51). In contrast to PAR,AR may be due to the guidewire, valve malposition, orrosthetic leaflet dysfunction. While TAR due to the
uidewire usually resolves after guidewire removal, other w
auses of TAR require definitive treatment. While trans-atheter ViV implantation is safe and decreases TAR, it mayesult in higher residual transaortic valve gradients (50,52).

TAVR is associated with a higher risk of stroke thanVR. Transcranial Doppler identified intracranial emboli-

ation in all TAVR patients; no differences were seenetween TA and TF ES. The highest intracranial signalsere observed with TF MCV (53). Myocardial injury

biomarkers �5 times the upper normal limit) was observedn 17% of MCV, and was an independent predictor of0-day mortality (54). In the PARTNER trial, majorascular complications at 30 days occurred in 15.3% due toissection (62.5%), perforation (31.3%), and hematoma22.9%) (55). Major vascular complications and baselineenal disease were independent predictors of 1-yearortality. Fortunately, most vascular complications can

e managed with stents and stent grafts, with a low riskf restenosis (56).Conduction disturbances are common after TAVR, anday impact late outcome. In 1 study of ES TAVR, 30% of

atients with normal baseline conduction developed neweft bundle branch block (LBBB); LBBB persisted in 62.3%t discharge and 42.7% at 6 to 12 months (57). PersistentBBB was associated with longer baseline QRS durationnd a more ventricular valve position. Persistent LBBB wasssociated with symptomatic heart block and PPI, but not-year mortality. In contrast, another study reported newBBB after 51.1% of MCV and 12.0% of ES; new LBBBas an independent predictor of 1-year mortality (58). In aatched study of ES and AVR, baseline right BBB was a

trong predictor of PPI, and PPI was more frequent afterAVR (7.3% vs. 3.4%, p � 0.014) (59). Compared to theriginal MCV delivery system, the new Accutrak deliveryystem had less PPI (14.3% vs. 35.1%, p � 0.003) (60). PPIfter MCV was associated with 2.37-fold higher risk of-year mortality (61).. Mitral valve disease. There were several excellent

eviews on echocardiography for percutaneous mitral valventerventions (62), quantitative assessment of MR (63–65),nd surgical approaches to MR (66). In the EVEREST IIEndovascular Valve Edge-to-Edge Repair Study) study,7% had pre-existing atrial fibrillation (AF) (67). Comparedo MitraClip (Abbott Vascular, Santa Clara, California)atients without AF, patients with AF had similar proce-ural success; freedom from death, mitral valve surgery, andR �2�; and safety at 12 months. In patients with

noperable MR, MitraClip reduced MR to �2� in 79%,nd was associated with favorable LV remodeling at 6onths (68). In a single-center study, 912 patients were

ollowed for up to 20 years after balloon mitral valvuloplastyor mitral stenosis; 30% had sustained functional improve-ent that was predicted by a scoring system relying on

mmediate residual transmitral gradient and area, age, gen-er, valve calcification, and AF (69). Asymptomatic patients
ith moderate MS, favorable valve morphology, and good

1639JACC Vol. 61, No. 15, 2013 Dixon and SafianApril 16, 2013:1637–52 Year in Interventional Cardiology

hemodynamic results had favorable long-term outcomesafter balloon mitral valvuloplasty (70).C. Paravalvular leak. Paravalvular regurgitation occurs in5% to 17% of surgically implanted prosthetic heart valves,leading to hemolysis, congestive heart failure, or both. Arecent review details the principles of paravalvular leakrepair (71).D. Patent foramen ovale. Recent reviews describe theanatomy of the foramen ovale (72), discuss strategies forsecondary stroke prevention (73), and detail the outcomes ofpatent foramen ovale (PFO) closure (74). PFO closureresulted in fewer recurrent neurological events compared tomedical therapy (11% vs. 21%; HR: 0.43; p � 0.033) during9-year follow-up (75). Three randomized trials of PFOclosure in patients with stroke/transient ischemic attack werepublished or presented. A trial with the STARFlex device(NMT Medical, Boston, Massachusetts) did not identify anadvantage for PFO closure compared to medical therapyafter 2 years (76). Two trials with the Amplatzer PFOoccluder (St. Jude Medical, St. Paul, Minnesota) reportedconflicting results, with 1 trial showing a reduction in strokerisk in a per protocol analysis (77), and the other smallertrial showing no significant benefit from closure (78).E. Left atrial appendage occlusion. In the PROTECTAF (Percutaneous Closure of the Left Atrial Appendageversus Warfarin Therapy for Prevention of Stroke in Pa-tients with Atrial Fibrillation) substudy, 32% had residualflow in the left atrial appendage (LAA) 2 months afterWatchman (Boston Scientific, Plymouth, Minnesota) im-plantation, which was not associated with increased throm-boembolism (79). There may be a relationship betweenLAA morphology and stroke: CT or magnetic resonanceimaging (MRI) of the LAA identified 4 distinct LAAmorphologic patterns, including cactus (30%), chicken wing(48%), windsock (19%), and cauliflower (3%); the preva-lence of prior stroke or transient ischemic attack was 12%,4%, 10%, and 18%, respectively (80).F. Hypertrophic cardiomyopathy. There are 2 generalreviews (81,82), a comprehensive review of pharmacologicaltreatment (83), and state-of-the-art review on the geneticsof hypertrophic cardiomyopathy (HCM) (84). Septal my-ectomy resulted in marked attenuation of outflow gradient,symptomatic improvement, and 1- and 5-year mortality of0.8% and 3.3%, respectively (85). Residual LV outflow gradi-ent was an independent predictor of late mortality after alcoholseptal ablation, but survival was similar to the general popula-tion without HCM, and to age/gender matched HCM pa-tients treated with surgical myectomy (86).

Elective PCI

A. Stable ischemic heart disease. In December 2012, anew guideline for the diagnosis and management of patientswith stable ischemic heart disease (SIHD) was published(updating the 2007 document) (87). Key elements of the
guideline include the role of testing for the initial diagnosis
of SIHD, risk assessment, guideline-directed risk factormodification, medical therapy recommendations, the role ofrevascularization, and patient follow-up. Further discussionis beyond the scope of this review, but all interventionalistsare encouraged to read this important document.B. Fractional flow reserve. Fractional flow reserve (FFR)–guided PCI plus best medical therapy was superior to astrategy of medical therapy alone in patients with stableCAD and a functionally significant stenosis (FFR �0.80)(88). The difference in clinical events was primarily drivenby a reduced need for urgent revascularization in the PCIgroup (HR with PCI: 0.13, p � 0.001) (Fig. 1).C. Multivessel revascularization. Results of an importanttrial evaluating the optimal revascularization strategy in1,900 diabetic patients with multivessel coronary diseasewas reported (89). The primary endpoint (death, nonfatalMI, or nonfatal stroke) was significantly lower in thecoronary artery bypass grafting (CABG) group (5-year rates18.7% vs. 26.6%), driven by lower rates of both death andMI. Stroke was more frequent in the CABG group. Thisstudy will have an important impact on clinical practice.D. Completeness of revascularization. There has beencontroversy regarding the benefit of complete revasculariza-tion (CR) in patients undergoing PCI or CABG. In adetailed angiographic analysis of 2,954 acute coronary syn-drome (ACS) patients, incomplete revascularization (ICR)was observed in 37% (using a threshold of �50% diameterstenosis in a vessel �2 mm diameter) (90). ICR wasstrongly associated with higher 1-year rates of MI, un-planned revascularization, and major adverse cardiac event(MACE). Similarly, 10-year follow-up of the MASS II(Second Medicine, Angioplasty, or Surgery Study) trialreported that CR was associated with lower mortalitycompared with ICR (91).E. Appropriate use criteria (AUC). In 2012, a focusedupdate of the appropriate use criteria for coronary revascu-larization was published (92). Indications for revasculariza-tion were developed based on 5 key variables: 1) clinicalpresentation; 2) severity of angina; 3) extent of ischemia onnoninvasive testing; 4) extent of medical therapy; and 5)extent of anatomic disease. These criteria are intended toassist clinicians with decision making regarding revascular-ization, but should not be a substitute for thoughtful clinicaljudgment. In 33,970 non-ACS patients in the New YorkState Registry, 14% of PCI were rated inappropriate, manyof which had minimal or no anti-ischemic therapy or diseasenot involving the proximal left anterior descending artery(93). Adherence to the AUC for revascularization wasstudied in 1,625 PCI patients with stable disease in Ontario(94). Only 14% of revascularization procedures weredeemed inappropriate, however 30% of patients with ap-propriate indications did not receive revascularization. Un-deruse of revascularization in this group was associated withan increased risk of adverse outcomes at 3 years.F. Outcomes. An analysis of 426,996 patients �65 years of
age revealed a higher periprocedural risk in women but


better long-term survival (95). Stent use and clinical out-comes was examined in 42,154 patients age �85 years ofage (96). A decline in drug-eluting stent (DES) use wasnoted in all age groups, especially in these older patients.Using data from 518,195 patients in the CathPCI Registry,Weintraub et al. developed a model for predicting survivalup to 3 years after PCI in patients age �65 years (97).G. Public reporting There has been debate about theimpact of public reporting on PCI outcomes. Utilizationand outcomes of PCI was compared in Medicare patientswith acute myocardial infarction (AMI) in states with andwithout public reporting (98). Use of PCI, especially inST-segment elevation myocardial infarction (STEMI) andcardiogenic shock, was lower in states with public reportinghowever there was no difference in overall AMI mortality.H. No on-site surgery. As the safety of contemporary PCIhas continued to improve, the need for on-site surgicalbackup has been questioned. To address this issue, 18,867patients were randomized to undergo PCI at a hospitalwithout on-site surgery or with on-site surgery (99). Pa-tients with STEMI, EF �20% and left main PCI wereexcluded. The mortality rate at 6 weeks (0.9% with on-sitesurgery; 1.0% without on-site surgery), and incidence ofMACE at 9 months (12.1% vs. 11.2%) was similar in bothgroups.I. Bleeding. Temporal trends in post PCI bleeding wereassessed in �1 million PCI patients from 2005 to 2009(100). An approximate 20% reduction in post-PCI bleedingwas observed during the study period, largely due to changesin antithrombotic strategy (bivalirudin use increased from

Figure 1 Fractional Flow Reserve–Guided PCI Versus Medical T

Kaplan-Meier curve for the cumulative incidence of the primary endpoint of death,assigned to percutaneous coronary intervention (PCI) and the best available medictherapy alone, and the group that did not undergo randomization and was enrolledpermission from De Bruyne B et al. (88).

17% to 30%; glycoprotein IIb/IIa use declined from 41% to

28%). A recent consensus report from the Bleeding Aca-demic Research Consortium (BARC) proposed a standard-ized bleeding definition for post PCI bleeding. The validityof this definition was tested in 12,459 patients undergoingPCI and demonstrated a close association between bleedingevents according to BARC and 1-year mortality after PCI(101).J. Radial. Several trials compared outcomes between radialand femoral access. In 7,021 patients, radial access wasassociated with a reduction in clinical events (includingmortality) in patients with STEMI, but no difference wasseen in patients with non–ST-segment elevation ACS(102). Two other randomized trials in STEMI reportedbetter clinical outcomes in patients treated via the radialapproach (103,104). In aggregate, these studies suggest thatthe radial approach should be the preferred strategy inprimary PCI.K. Left main. Several publications addressed PCI forunprotected left main coronary artery (ULMCA) disease.From 2004 to 2008, �5% of patients with ULMCA in theNational Cardiovascular Data Registry (NCDR) receivedPCI; this was generally reserved for patients at high risk forCABG (105). Although the SYNTAX score is an impor-tant tool to help define the optimal revascularization strat-egy in patients with ULMCA or 3-vessel disease, this doesnot include clinical factors that impact prognosis. The GlobalRisk classification, a new system that incorporates both theSYNTAX score and EuroSCORE, appears to enhance riskstratification and clinical decision making (106).

Two studies compared outcomes with DES for ULMCA

py in Stable Coronary Disease

rdial infarction, or urgent revascularization in the group that was randomlyrapy, the group that was randomly assigned to the best available medicalegistry (88). HR � hazard ratio; OMT � optimal medical therapy. Reprinted with

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disease. In a 390 patient registry, use of everolimus-eluting

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stent (EES) was associated with improved outcomes at 1year compared with first-generation paclitaxel-eluting stent(PES) (107). In a 650-patient randomized trial ofzotarolimus-eluting stent (ZES) versus EES, similar angio-graphic and clinical outcomes were observed at 8 and 12months, respectively (108).L. Chronic total occlusion. With the introduction of newdevices and techniques, there has been a resurgence ofinterest in chronic total occlusion (CTO) intervention. In150 CTO, technical success was achieved in 77% cases witha novel crossing catheter and re-entry system (BridgePointMedical System, Plymouth, Minnesota) (109). Several ex-cellent reviews described contemporary approaches to CTOintervention including retrograde recanalization and subin-timal dissection/re-entry strategies (110–112). In 3 experi-enced centers, technical success was achieved in 81.4% of462 retrograde CTO interventions (113). In a report fromthe Canadian Multicenter Chronic Total Occlusions Reg-istry, CTO was identified in 18% of patients with �50%diameter stenosis in 1 coronary artery, however CTO inter-vention was attempted in �10% lesions (114). A 208-patientandomized trial comparing 2 DES in CTO reported the EESas noninferior to sirolimus-eluting stents (SES) for angio-raphic late loss at 9 months (115).

. High-risk PCI. In high-risk patients who are deemedo require hemodynamic support during PCI, the optimalupport device has not been defined. The PROTECT IIrial randomized 452 patients with ULMCA or 3-vesselisease and severely depressed ventricular function to PCIith intra-aortic balloon pump (IABP) or the Impella 2.5

Abiomed, Danvers, Massachusetts) (116). The trial wasiscontinued early based on results of an interim analysis.he Impella 2.5 provided superior hemodynamic support,ut the primary endpoint (30-day adverse events) was notifferent between groups. At 90 days there was a trendoward improved outcomes in the Impella arm.

. Drug-eluting balloon. A paclitaxel drug-eluting bal-oon (DEB) was studied in de novo lesions in small vessels�2.8 mm) in 182 patients (117). At 6 months, angio-raphic in-stent late loss was significantly less with DEB �are-metal stents (BMS) compared with a PES. In a,095-patient registry, use of the paclitaxel-DEB was asso-iated with a low rate of target lesion revascularizationTLR) (5.2%) at 9 months (73% had restenosis) (118).

. Optical coherence tomography. A consensus docu-ent provided standards for acquisition, measurement and

eporting of optical coherence tomography (OCT) studies119). The article includes helpful tips on imaging tech-iques, lesion assessment, and imaging artifacts. In anothereport, OCT was compared with FFR to determine theptimal threshold for hemodynamically significant stenosis.CT had only a moderate diagnostic efficiency to detect a

ignificant stenosis (FFR �0.80) (area under the curve:.74) with an optimal cutoff of 1.95 mm2 (120).

P. Contrast induced nephropathy. Several strategies were
tested to prevent contrast induced nephropathy (CIN). In 1
report, LV end-diastolic pressure guided hydration (accord-ing to a sliding scale) resulted in a 59% relative reduction inCIN (121). The median hydration volume in the LVend-diastolic pressure guided arm was 1711 ml comparedwith 807 ml in the control arm. These data reaffirm theimportance of adequate hydration to prevent CIN. Inanother study, furosemide-forced diuresis and intravenoussaline infusion matched with urine output (RenalGuardSystem, PLC Medical Systems, Franklin, Massachusetts) wasassociated with a lower rate of CIN compared with standardhydration (122). In a novel approach, remote ischemic precon-ditioning using 4 cycles of inflation-deflation of a bloodpressure cuff prior to contrast administration reduced the riskof CIN in a small randomized trial (123).

Drug-Eluting Stents

A. BMS versus DES. An analysis of 76 randomized trialscomparing DES and BMS, with 117,762 patient years offollow-up, reported that DES are highly efficacious at reducingTVR without an increase in any safety outcomes includingstent thrombosis (ST) (124). The EES appeared to be thesafest stent. An 800-patient randomized trial of BMS versusEES in octogenarians reported lower rates of TVR and MIwith EES and similar rates of major bleeding (125).B. ST. Several studies evaluated the risk of late ST withDES and BMS. In a network meta-analysis of 49 trialsincluding 50,844 patients, the cobalt-chromium EES had alower rate of definite ST at 1 year compared with otherDES (126) (Fig. 2). More importantly, the EES had asignificantly lower rate of definite ST at 2 years than BMS(odds ratio: 0.35). In an observational study of 12,339patients, the EES was also found to have a lower risk of verylate ST at 4 years compared with first-generation DES(�60% risk reduction) (127). A report from the SwedishCoronary Angiography and Angioplasty Registry also sug-gested lower rates of ST with second versus first-generationDES (43% lower risk) (128). An 8,791-patient randomizedtrial comparing 2 first-generation DES (Endeavor ZES andCypher SES) found no difference in the rate of definite/probable ST at 3 years (129).C. Second-generation DES. In patients with long lesions(�25 mm), the R-ZES (Resolute, Medtronic, Minneapolis,Minnesota) was noninferior to SES for angiographic lateloss at 9 months (130). Two randomized trials comparingEES with SES reported similar clinical outcomes at 1 year(131,132). Two randomized trials compared the second-generation R-ZES and Xience EES in relatively unre-stricted patient populations and reported similar clinicaloutcomes at 1 and 3 years (133,134).D. Biodegradable polymers. DES with biodegradablepolymers have a lower risk of ST. Two randomized trialscompared 1-year clinical outcomes with the Noboriabluminal biodegradable polymer biolimus-eluting stent(BES) with a durable polymer DES. The BES was
noninferior to the EES (135), but in the other study


failed to meet noninferiority compared with a SES (136).An OCT study reported no difference in the rate of stentmalapposition with EES or BES at 6 to 8 months (137).Similar 1-year clinical outcomes were also reported in atrial comparing a SES with durable polymer and SESwith biodegradable polymer (138). A pooled analysis of 3randomized trials demonstrated a lower rate of ST andtarget lesion revascularization at 4 years with a biode-gradable polymer DES compared with durable polymerSES (139).E. New DES. A small randomized trial evaluated athin-strut platinum-chromium stent that delivers everoli-mus from an ultrathin bioabsorbable polymer appliedto the abluminal surface (140). Angiographic late lossat 6 months was similar to an EES. A polymer-freeamphilimus-eluting stent (Cre8, CIS, Salugia, Italy) hada lower in-stent late loss at 6 months than a permanentpolymer PES (141).F. DES restenosis. The optimal treatment strategy for

Figure 2 Stent Thrombosis With DES and BMS

Pooled odds ratios and 95% confidence intervals determined by network meta-anaBMS � bare-metal stent(s); CoCr-EES � cobalt-chromium everolimus-eluting stentmus-eluting stent(s); PES � paclitaxel-eluting stent(s); PtCr-EES � platinum-chromSES � sirolimus-eluting stent(s). Reprinted with permission from Palmerini T et al

DES restenosis has not been well defined. In a randomized

trial, SES and EES achieved similar angiographic outcomesat 9 months for diffuse restenosis (�10 mm), but in focalrestenosis SES implantation was more effective than cuttingballoon alone (142). Use of a paclitaxel-eluting balloon wassuperior to PTCA alone (143), and noninferior to PESimplantation (144).G. Biodegradable scaffold. A paclitaxel-eluting bioab-sorbable magnesium scaffold performed well with 12-monthlate lumen loss of 0.52 � 0.39 mm and restoration ofacetylcholine-induced vasomotor function (145). At 10years the fully biodegradable Igaki-Tamai stent was safewith intravascular ultrasound studies showing completereabsorption of most struts within 3 years (146).

Primary PCI

A. STEMI guideline. The new American College ofCardiology Foundation/American Heart Association(ACCF/AHA) guideline for STEMI was published in

or 1-year (A), 2-year (B), early (C), and late (D) definite stent thrombosis.S � drug-eluting stent(s); PC-ZES � phosphorylcholine polymer-based zotaroli-erolimus-eluting stent(s); Re-ZES � resolute zotarolimus-eluting stent(s);.

lysis f(s); DEium ev. (126)

December 2012 (147). The document provides a compre-

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hensive review of this rapidly evolving field with emphasison advances in reperfusion, organization of regional systemsof care, transfer algorithms, antithrombotic and medicaltherapies, and secondary prevention strategies.B. STEMI network. There is a growing body of evidenceto support the development of regional systems of care tofacilitate direct transfer of STEMI patients to primary PCIcenters. In a study of 1,389 STEMI patients in Ottawa,patients who were transported directly to the PCI centerhad significantly lower mortality at 180 days compared topatients who were initially transported to a non-PCI center(5.0% vs. 11.5%, p � 0.0001) (148).C. DES. In 907 patients use of SES was associated withimproved 1-year MACE compared with BMS (16.5% vs.25.8%), primarily driven by a lower rate of TVR (149).There was no difference in ST at 1 year. A meta-analysis of15 randomized trials comparing first-generation DES andBMS also reported an early benefit of DES, but increasedrisk of ST after 1 year (150). Several trials investigated useof second-generation DES in primary PCI. In 1 study, therewas no significant difference in 1-year MACE (death, MI,any revascularization) between the EES and BMS, althoughrates of TLR, TVR, and ST were lower with EES (151).Another study reported noninferiority of EES comparedwith SES in 625 AMI patients (152). A BES with abiodegradable polymer resulted in lower MACE at 1 yearcompared with BMS (153).

Dangas et al. studied clinical outcomes following defi-nite/probable ST in 3,602 AMI patients during 3-yearfollow-up (154). More than one-third of ST cases occurredduring the index hospitalization. This was associated with ahigher rate of mortality and MI, compared to ST occurringout-of-the hospital.D. New stents. Promising results were reported with use ofthe MGuard stent (InspireMD, Tel Aviv, Israel), which isnovel thin-strut stent with a polyethylene terephthalatemicronet mesh covering designed to trap debris and preventdistal embolization. In a 433-patient randomized trial, theMGuard stent was associated with improved ST-segmentresolution and Thrombolysis In Myocardial Infarction flowgrade 3 compared with noncovered stents (155). A self-expanding stent (STENTYS, Paris, France) resulted in lessstent strut malapposition at 3 days than a balloon expand-able stent (156).E. DEB. There has been interest in using a paclitaxel-eluting balloon prior to BMS as an alternative strategy toDES implantation in primary PCI. In a randomized trial of150 patients, angiographic late loss at 6 months was similarbetween BMS versus DEB plus BMS; both were inferior toDES, and use of the DEB before BMS was also associatedwith a higher rate of uncovered and malapposed struts (157).F. Thrombectomy. In prior studies, there have been con-

icting results regarding the benefit of adjunctive throm-ectomy in primary PCI. A total of 452 STEMI patientsere randomized to undergo PCI with or without aspiration

hrombectomy and/or intracoronary abciximab (158). In-

farct size by cardiac MRI, was not significantly different inpatients treated with thrombectomy compared with nothrombectomy; however, infarct size was reduced in patientswho received intracoronary abciximab compared with noabciximab (15.1% vs. 17.0%, p � 0.03). In a trial of 2,065patients, intracoronary abciximab did not improve clinicaloutcomes compared with intravenous abciximab (159). An-other trial reported that thrombectomy improved ST-segment resolution but did not impact infarct size at 3months (160).G. Adjunctive therapies. Several studies evaluated novelapproaches to enhance myocardial salvage in primary PCI.In 50 patients, post-conditioning was associated with asmaller infarct size on cardiac MR and lower peak creatinekinase (161). In contrast, a larger study of 700 patientsreported no difference in ST-segment resolution (the pri-mary endpoint), or clinical outcomes at 1 month (162).Exenatide, a glucagon-like peptide was studied in 172STEMI patients and was associated with greater myocardialsalvage index at 3 months compared with placebo (163).H. Shock. Mechanical circulatory support has been con-sidered an integral part of the management of patients withcardiogenic shock (CS). The IABP-SHOCK II (IntraaorticBalloon Pump in Cardiogenic Shock) trial randomized 600patients with CS complicating AMI to IABP or no IABP(95.8% underwent PCI) (164). There was no difference inthe primary endpoint of 30-day mortality (IABP 39.7% vs.control 41.3%), or any secondary endpoints. While thesedata call into question the routine use of IABP support inCS, critically ill patients who do not stabilize with pharma-cologic support and early revascularization, may requirecirculatory support with other novel devices.I. Cell therapy. An exciting development was reported inthe field of cellular repair using cardiosphere-derived cells(CDCs) as an alternative to autologous bone marrow cells.CDCs were cultured from endomyocardial biopsy speci-mens and administered via intracoronary injection 2 to 4weeks after AMI (165). At 6 months, patients treated withCDCs had reduced scar mass and an increase in viable heartmass compared with controls. In another report, intracoro-nary adipose tissue-derived regenerative cells (ADRCs)appeared safe and feasible in 14 patients with anterior AMI(166). An ongoing multicenter trial will evaluate the efficacyof this approach. The TIME randomized trial studied theoptimal timing for intracoronary autologous bone marrowcells after AMI (day 3 or day 7) (167). At 6 months, therewas no benefit of cell delivery on LV function or infarctvolume in either group.

Unstable Angina/NSTEMI

A focused update of the ACCF/AHA guidelines for man-agement of patients with unstable angina (UA) and non–ST-segment elevation myocardial infarction (NSTEMI)was published in 2012 (168). Key areas of change include:
1) use of ticagrelor in patients with definite UA/NSTEMI


in whom either an invasive or conservative strategy isplanned (Class 1 recommendation); 2) duration of dualantiplatelet therapy (DAPT) for UA/NSTEMI patientsmanaged with a conservative strategy modified to “up to 12months”; 3) withdrawal of ticagrelor for at least 5 days inpatients in whom CABG is planned; 4) targeting a lower INR(e.g., 2.0 to 2.5) in patients with UA/NSTEMI managed withaspirin and a P2Y12 inhibitor who also have an indication foranticoagulation (new recommendation).

A meta-analysis of 9 randomized trials (n � 9,904)evaluated the effect of invasive versus conservative manage-ment in diabetic patients (169). A routine invasive strategysignificantly reduced the 1-year incidence of nonfatal MIand rehospitalization in diabetic patients, but there was nodifference in the risk of death.

Pharmacotherapy

A. Duration of DAPT. Several studies addressed theoptimal duration of DAPT after DES implantation. In1,443 patients there was no difference in target vessel failure(death, MI, TVR) between 6 and 12 months DAPT;however, this study was underpowered for death or MI(170). In 2,117 patients, a strategy of Endeavor DES �3months DAPT was found to the noninferior to 12-monthDAPT (171). Extended use DAPT was studied in 2,013patients (75% DES) (172); 24-month DAPT did notreduce the risk of death/MI/stroke compared with 6-monthDAPT, and was associated with a higher risk of bleedingand transfusion. The risk of early DAPT discontinuationwas studied in 1,622 patients after DES implantation;10.6% patients interrupted at least 1 antiplatelet within the

Foll

EventProbability

(Primaryendpoint)

N at risks

Conven�onal 1227 835

Monitoring 1213 790

Figure 3 Platelet Function Monitoring in PCI

Proportion of patients with primary outcome events, at 1 year of follow-up, the primtransient ischemic attack, urgent coronary revascularization, and stent thrombosisthe conventional-treatment group. HR � hazard ratio. Reprinted with permission fr

first year (median 7 days) but this did not appear to beassociated with a significant increase rate of MACE (173).B. Platelet function testing. Although hyporesponsive-ness to antiplatelet therapy has been associated with adverseclinical outcomes after stenting, there has been controversyabout the role of platelet function (PF) monitoring duringPCI. In a large 11,000-patient registry, on-treatment hypo-responsiveness to clopidogrel was associated with higher1-year ST and MI, lower major bleeding, but no differencein mortality (174). Use of PF monitoring to adjust anti-platelet therapy during and after stenting was studied in2,440 patients (175). In the monitoring group, antiplatelettherapy was adjusted according to results of the VerifyNowP2Y12 (Accumetrics) and aspirin point-of-care assays.High platelet reactivity with thienopyridine (�235 plateletreaction units) was observed in 34.5% patients in the cathlab and 15.6% patients at 2 weeks. It should be noted thatonly 12% patients in the monitoring arm received prasugrel.At 1 year, there was no difference in the composite endpoint(death, MI, ST, stroke, or urgent revascularization) betweengroups (Fig. 3). Another study suggested that PF monitor-ing might be necessary in patients treated with bivalirudincompared with unfractionated heparin plus abciximab(176). In a substudy of the TRILOGY ACS trial, prasugrelresulted in lower platelet reactivity than clopidogrel amongACS patients managed without revascularization; however,there was no relationship between platelet reactivity andischemic outcomes (177).C. Genotype testing. CYP2C19 polymorphisms havebeen shown to impact the antiplatelet effect of clopidogreland clinical outcomes. A bedside point-of-care device was

(Days)

Conven onal

Monitoring

HR = 1.13 [0.98-1.29]p= 0. 096

801 767

762 730

ndpoint, a composite of death from any cause, myocardial infarction, stroke oroccurred in 34.6% of patients in the monitoring group and in 31.1% of those inllet JP et al. (175).

ow-up

ary e, hadom Co

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used in 200 patients to tailor maintenance antiplatelettherapy according to CYP2C19*2 carrier status (carriersreceived prasugrel, noncarriers received clopidogrel) leadingto a marked reduction in the proportion of CYP2C19*2carriers with high on-treatment platelet reactivity (0% onprasugrel vs. 30.4% on clopidogrel, p � 0.009) (178).D. Prasugrel. Use of prasugrel to correct high on-treatmentlatelet reactivity with clopidogrel was studied in 423 stableatients (179). At 3 months, 94.1% of patients on prasugrelad a PRU �208 compared with only 29.6% of clopidogrelatients. Prasugrel dosing was studied in low-body weightatients (�60 kg); a 5mg dose resulted in similar plateletnhibition to prasugrel 10 mg in patients �60 kg (180).

E. Ticagrelor. In 44 ACS patients with high on-treatmentplatelet reactivity, ticagrelor produced higher platelet inhi-bition at 15 days compared with prasugrel (181).F. Cangrelor. Cangrelor, an intravenous, reversible P2Y12platelet inhibitor, was evaluated as a bridging strategy inpatients with ACS or a coronary stent awaiting CABG, andresulted in consistently lower levels of platelet reactivityprior to surgery, without an increase in CABG-relatedbleeding (182).G. Elinogrel. Elinogrel is the only competitive and revers-ible P2Y12 inhibitor with both oral and intravenous formu-lations. In a randomized, dose-ranging phase 2b trial,elinogrel was found to have acceptable safety and tolerabilitycompared with clopidogrel in 652 patients undergoingnon-urgent PCI (183).H. Cilostazol. Cilostazol is a selective phosphodiesterase-3inhibitor with antiplatelet and antiproliferative properties.Triple antiplatelet therapy (aspirin, clopidogrel, and cilosta-zol) was compared with aspirin � clopidogrel 150 mg dailyn 3,755 PCI patients (184). At 1 month, the rate of clinicalvents was noninferior with triple therapy.. Vorapaxar. Platelet activation can also occur via therotease-activated receptor-1 on the platelet surface. Vora-axar was evaluated in 12,944 ACS patients (58% under-ent PCI) but did not reduce the composite endpoint

cardiovascular death, MI, stroke, hospitalization for is-hemia, or urgent revascularization) and was associated withignificantly higher risk of bleeding including intracranialemorrhage (185).. Statins. Statin pre-treatment has been shown to reduceeriprocedural myocardial injury during elective PCI, buthe efficacy of different statins has been unclear. In aandomized study, high-dose atorvastatin 80 mg or rosuv-statin 40 mg administered within 24 h of PCI in patientslready on statin therapy resulted in similar reductions inrocedural events (186).. Rivaroxaban. In 7,817 STEMI patients (71% had PCI;7% on thienopyridine) rivaroxaban (either 2.5 mg or 5 mg)educed the risk of recurrent cardiovascular events, butncreased the risk of major bleeding (187).. Concomitant anticoagulation. The optimal therapeu-

ic regimen in patients requiring concomitant antithrom-
otic and antiplatelet therapy is unclear. Bleeding risk in (
atrial fibrillation patients admitted with MI or for PCI wasstudied in 11,480 subjects in Denmark (188). Triple therapy(warfarin, aspirin, clopidogrel) was associated with a highearly and sustained risk of bleeding compared to a vitamin Kantagonist plus single antiplatelet agent (1-year HR: 1.41).There was no difference in the risk of thromboembolicevents between regimens. A randomized trial comparingtriple therapy versus warfarin � clopidogrel in DES patientsdemonstrated markedly higher bleeding events with tripletherapy and lower risk of stent thrombosis in the doubletherapy arm (189). These data suggest that triple therapyshould be avoided and only be prescribed after carefulassessment of bleeding risk.

Vascular Disease

A. Peripheral arterial disease. There are several reviews onmedical therapy (190), surgical revascularization (191), en-dovascular therapies (192), and appropriate use criteria forvascular ultrasound and physiological testing (193). In arandomized trial of aortoiliac disease, supervised exerciseresulted in greater improvement in walking time thanmedical therapy or stenting, but quality-of-life improvedmost with stenting (194). In the COBRA (Cryoplasty orConventional Balloon Post-Dilation of Nitinol Stents forRevascularization of Peripheral Arterial Segments) trial,angiographic restenosis at 12 months was significantly lowerafter cryoplasty (29.3% vs. 55.8%, p � 0.01) (195). In theItalian Registry of the paclitaxel drug-eluting balloon(PDEB) for severe femoropopliteal disease, procedural suc-cess was 100%, stenting was required in 12.3%, and TLRwas 7.6% at 1 year (196). A meta-analysis of PDEB versusangioplasty for femoropopliteal disease reported lower TLR(12.2% vs. 27.7%, p � 0.00001) at 10.3 months (197). Inpatients with femoropopliteal in-stent restenosis, patency at12 months was 92.1% after PDEB (198). Classification offemoropopliteal in-stent restenosis by length and occlusionhad significant impact on recurrent restenosis (199). In 1randomized trial, SES had lower angiographic restenosis(22.4% vs. 41.9%, p � 0.019) and higher patency (75.0% vs.7.1%, p � 0.025) than angioplasty for infrapoplitealisease (200). In another randomized trial, SES had lessLR (9.2% vs. 20%, p � 0.06) and amputation (2.6% vs.2.2%, p � 0.03) compared to BMS (201).Fibromuscular dysplasia (FMD) was reviewed (202) and

eported in a large American registry (203). Active inflam-ation (high erythrocyte sedimentation rate, C-reactive

rotein, and fibrinogen) was associated with a 7.5-foldreater risk of vascular complications after surgical andndovascular revascularization in patients with Takayasurteritis (204).. Carotid disease. The comparative effectiveness of ca-

otid revascularization was reviewed (205). Two MRI stud-es described plaque hemorrhage, lipid core, and otheromplex features in patients with carotid wall thickening
206) and minor stroke (207). The National Cardiovascular


Data Registry (NCDR) Carotid Artery Revascularizationand Endarterectomy Registry developed a simplifiedweighted score (based on impending major surgery, previousstroke, age, symptomatic status, atrial fibrillation, absence ofprior carotid endarterectomy) to predict in-hospital strokeand death after carotid stenting (208). In the randomizedPROFI (Prevention of Cerebral Embolization by ProximalBalloon Occlusion Compared to Filter Protection) study,diffusion-weighted MRI demonstrated less cerebral emboliafter proximal embolic protection device (EPD) comparedto distal EPD (209).C. Aortic aneurysm. A review detailed the pathophysiol-ogy, clinical evaluation, and treatment of acute aorticsyndromes (AAS) (210). A recent Medicare study reportedthat compared to open repair, endovascular repair (EVAR)of abdominal aortic aneurysm (AAA) was associated withshorter hospital stay (3.6 days vs. 10.4 days, p � 0.001), andlower all-cause and AAA-related mortality at 1 year (211).A recent meta-analysis showed that EVAR had lowerall-cause mortality at 30 days (relative risk: 0.35), lowerAAA-related mortality at intermediate follow-up (relativerisk: 0.46), similar AAA-related and all-cause mortality atlong-term follow-up, and more reintervention duringfollow-up (relative risk: 1.48 to 2.54) (212). In the random-ized OVER (Open versus Endovascular Repair) trial,EVAR was associated with lower mortality at 30 days and 3years, but not thereafter (213). In all AAA trials, the mostcommon cause of late mortality is cardiovascular disease, sopatients should receive medical treatment for CAD.D. Venous thromboembolism. A clinical prediction rulefor risk stratification of recurrent venous thromboembolismin cancer patients was developed (214). Although 1 studyreported that aspirin can reduce recurrent venous thromboem-bolism after therapeutic anticoagulation (215), another did not(216). Oral rivaroxaban was noninferior to enoxaparin plusvitamin K antagonists for early and late management of acutepulmonary embolism (217). Catheter-directed pulmonary em-bolectomy was recently reviewed (218).

Systemic Hypertension

Contemporary epidemiological studies differ in their assess-ment of hypertension awareness, management, and control.One study reported no improvement from 2007 to 2010compared to 1999 to 2007 (219), whereas others showedsignificant improvement resulting from performance mea-sures, automatic notifications to care providers, electronicreminders, and systematic revisits (219–222). In somesystems, only 2% of hypertension patients developed resis-tant hypertension (RH), which was strongly associated withcardiovascular events (223). Readers are referred to severalreviews on RH (224), the role of the sympathetic nervoussystem (225), and renal denervation (RDN) for RH (226).RDN resulted in significant reduction in cardiac work,diastolic dysfunction, and LV mass (227,228). A state-
transition model suggested that RDN is highly cost-
effective (229). In a randomized trial of patients with AFand refractory hypertension, pulmonary vein isolation plusRDN was more effective than pulmonary vein isolationalone in controlling blood pressure and preventing recurrentAF (230).

Reprint requests and correspondence: Dr. Simon R. Dixon,Department of Cardiovascular Medicine, Beaumont Health Sys-tem, 3601 West 13 Mile Road, Royal Oak, Michigan 48073.E-mail: [email protected].

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Key Words: aortic valve replacement y coronary artery y myocardialnfarction y percutaneous intervention y stent.

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