preliminary results of the inspire trial with the novel mguard™ stent system containing a...

Preliminary Results of the INSPIRE Trial With the NovelMGuardTM Stent System Containing a Protection Net

to Prevent Distal Embolization

Felipe Maia, MD, J. Ribamar Costa, Jr, MD, Alexandre Abizaid,* MD, PhD,Fausto Feres, MD, Ricardo Costa, MD, PhD, Rodolfo Staico, MD, Dimytri Siqueira, MD,

Vinicius Esteves, MD, Amanda Sousa, MD, PhD, and J. Eduardo Sousa, MD, PhD

Objective: To assess the efficacy of the MGuardTM stent combining a polymer-meshsleeve attached to the external surface of a bare-metal stent in preventing distalembolization during percutaneous coronary intervention (PCI). Background: Distalembolization of thrombus/platelet agreggates is associated with worse immediate andlong-term prognosis after PCI. Treatment of saphenous vein graft (SVG) and PCI in thesetting of acute coronary syndromes (ACS) is often related to this complication.Although protection and aspiration devices have been shown to reduce distal emboli-zation, they add time and cost to PCI. Methods: A total of 30 patients were included.Inclusion criteria were de novo lesions in SVG or native vessels with angiographic evi-dence of instability with potential to provoke flow disturbances and/or distal emboliza-tion. Primary endpoint included the incidence of major adverse cardiac events (MACE)(composite of cardiac death, non-fatal myocardial infarction and TLR) up to 30 days ofthe procedure and TIMI flow right after the PCI. Results: Mean population age was60.8 years with 36.7% of diabetes. Overall, 53.3% presented with ACS, and mostlesions were located in SVG (16 of 30). The majority of lesions had complex morphol-ogy including the presence of thrombus (30%) and ulcer (33.3%). The MGuard stentwas successfully deployed in all cases with no angiographic/clinical complicationsincluding distal embolization. Final TIMI-3/blush-3 were achieved in all cases with noMACE up to 30 days of the procedure. Conclusions: In this preliminary evaluation, theMGuard device demonstrated excellent performance in a highly complex lesion subset,including absence of angiograhpic/procedural complications, and no adverse eventsup to 30-day FU. VC 2010 Wiley-Liss, Inc.

Key words: acute coronary syndrome; bypass grafts –coronary; percutaneous coronaryintervention

INTRODUCTION

The occurrence of distal embolization of atheroma-tous and thrombotic debris after percutaneous coronaryintervention (PCI) may potentially result in microcircu-latory dysfunction, abnormal myocardial metabolism,and increased myonecrosis [1–4]. Recent studies havecorrelated these findings to worse acute and long-termclinical outcomes, including higher rates of death andmyocardial infarction (MI) [5–9].

Although relatively infrequent following electivePCI, the occurrence of distal embolization is signifi-cantly increased following PCI in saphenous vein graft(SVG) and in native coronaries with angiographicallydetected thrombus [10–12].

The use of embolic protection devices (for SVGlesions) and aspiration devices (for primary PCI innative coronaries) has been proven to reduce rates of

adverse events in recent randomized clinical trials.However, these devices may result in increased proce-dure duration and additional costs.

Instituto Dante Pazzanese de Cardiologia, Av. Dr. DantePazzanese 500, Ibirapuera, CEP, Sao Paulo, Brazil

Conflict of Interest: None of the authors report any conflict of inter-

est regarding this publication.

*Correspondence to: Alexandre Abizaid, MD, PhD, Av. Dr. Dante

Pazzanese 500, Ibirapuera, CEP 04012-909, Sao Paulo, Brazil.

E-mail: [email protected]

Received 12 January 2010; Revision accepted 15 January 2010

DOI 10.1002/ccd.22473

Published online 1 June 2010 in Wiley InterScience (www.

interscience.wiley.com)

VC 2010 Wiley-Liss, Inc.

Catheterization and Cardiovascular Interventions 76:86–92 (2010)

More recently, a dedicated system (MGuardTM

,InspireMD, Tel Aviv, Israel) comprising a bare-metalstent platform with a polymeric net attached to its sur-face has been developed as an alternative approach toprevent distal embolization and improve outcomes fol-lowing PCI in these complex scenarios [13].

The present trial was designed to assess, by meansof surrogate endpoints, the feasibility and efficacy ofthe MGuard stent in preventing distal embolizationduring PCI of either SVG or native coronary arterieswith angiographic evidence of instability.

METHODS

The INSPIRE trial is a single-center, single-arm,observational study enrolling patients with single, denovo lesions � 18 mm in length located in SVG ornative vessels of 2.5–4.5mm in diameter and with clin-ical/angiographic evidence of instability.

Patients were considered ineligible if they were olderthan 75 years and/or presented unprotected left maindisease, target lesion at bifurcation (side branch > 2mm), chronic total occlusions, recent MI (<72 hr),severe left ventricular dysfunction (EF < 30%), andchronic kidney disease (Cr > 2 mg/dl).

The protocol was approved by the ethics committeeof the institution and all patients provided writteninformed consent prior to enrollment.

Device Description

The novel MGuard stent comprises a balloon-ex-pandable, thin-strut stainless steel (316L) bare metalstent platform (strut width 100 lm) with mesh sleevefibers of polyethyleneterephtalate (fiber width of 20

lm) attached to its outer surface (Fig. 1). Of note, thesystem is 6 Fr compatible.

These fibers act like a net (aperture size 150 lm �180 lm) preventing distal embolization of the plaquedebris/thrombus placed between the vessel wall and thestent (Fig. 1, right panel).

Stenting Procedure

Final procedure strategy was left upon operators’discretion. Predilatation, when required, was recom-mended to be performed with undersized balloon-cath-eters.

MGuard stent was available in diameters rangingfrom 2.5 to 4.0 mm and lengths from 10 to 38 mm.Dual antiplatelet therapy including loading dose of as-pirin (200–325 mg) and thienopyridine (clopidogrel300 mg) was started at least 24 h before elective pro-cedures, otherwise a loading dose of 600 mg of clopi-dogrel was given immediately prior to the intervention.Postprocedural aspirin was continued indefinitely, andthienopyridine was maintained for 6 months. Duringprocedure, intravenous heparin (70–100 IU per kg) wasadministered after sheath insertion to maintain an acti-vated clotting time >250 sec. Use of additional medi-cations during the procedure, including glycoproteinIIbIIIa inhibitors, was left at operator’s discretion. Em-bolic protection devices and aspiration catheters,although not forbidden by protocol, were not used inthis population.

A 12-lead electrocardiogram was obtained: beforethe procedure, immediately afterward, and 24 hr later.Blood sample laboratory analysis included creatine ki-nase cardiac enzymes (CK and CK-MB) before

Fig. 1. MGuard stent. Left panel: a microscopic view of the mesh-sleeve fibers of polyethyle-neterephtalate attached to the outer surface of the bare-metal platform. Right panel: theschematic view of MGuard stent being deployed trapping the atheromatous and thromboticdebris against the vessel wall. [Color figure can be viewed in the online issue, which is avail-able at www.interscience.wiley.com.]

MGuardTM

Stent to Prevent Distal Embolization 87

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

procedure (<24 hr) and 6–8, 12–16, and 24 hr aftertreatment.

Study Endpoints

The primary endpoint was the occurrence of com-bined major adverse cardiac events (MACE) at 30days. Secondary endpoints included success in the de-vice deployment, angiographic and procedure success,postprocedure epicardial TIMI flow, corrected TIMIframe count, and myocardial blush and angiographicoccurrence of flow disturbance (slow/no reflow) at anytime of the procedure.

MACE was defined as cardiac death, nonfatal MI,and target vessel revascularization (TVR). All deathswere considered to be cardiac unless a noncardiac ori-gin could be clearly established by clinical and/or path-ological study. The diagnosis of MI was based on ei-ther the development of new pathological Q waves in�2 contiguous electrocardiogram leads and/or eleva-tion of CK-MB isoenzyme >3 times the upper normallimit postprocedure during index hospitalization, orcardiac enzyme elevation >2 times the upper normallimit thereafter.

Stent thrombosis was classified as definite, probable,and possible according to definitions proposed by theAcademic Research Consortium (ARC) [14], and itwas stratified as acute (<24 hr), subacute (24 hr–30days), late (1–12 months), and very late (>12 months).

Device success was defined by successful stentdeployment and retrieval of the system. Angiographicsuccess was defined as attainment of <20% residualstenosis by quantitative coronary angiography (QCA)in the treated segment post DES treatment. Proceduralsuccess was defined as angiographic success plus ab-sence of MACE during hospitalization. During theenrollment period, detailed demographic, clinical,angiographic and procedural information, includingcomplications, were gathered for each patient.

Clinical follow-ups, by office appointment, werescheduled at 1, 6, and 12 months after stent implanta-tion. At the time of the follow-up, data were collectedpertaining to current clinical status, concomitant drug-therapy, and interim occurrence of the predefinedadverse events. Individual patient data was coded toprevent the identification of study participants.

All patients signed for repeat angiographic evalua-tion at 6 months. The first 20 patients enrolled alsoagreed to undergo IVUS assessment postprocedure andat the time of the invasive follow-up. However, thepresent manuscript focuses only in the study’s primaryendpoint (30-day MACE). Six-month QCA and IVUSresults together with 1 year clinical follow-up of the

entire cohort will be presented apart following theircompletion.

Quantitative Coronary Angiography Analysis

Angiographic studies were performed at baseline andpostprocedure in two orthogonal views, after the intra-coronary administration of 100–200 lg of nitroglyc-erin. Digital angiograms were analyzed off line withthe use of an automated edge-detection system (QCA-CMS, Medis Medical Imaging Systems, Nuenen, theNetherlands).

Lesion morphology was assessed by using standardcriteria, and lesion complexity defined according to themodified American College of Cardiology/AmericanHeart Association (ACC/AHA) classification system[15]. The contrast-filled catheter tip was used for cali-bration. Qualitative assessment also included the deter-mination of final TIMI flow, corrected TIMI framecounts, and myocardial blush (after removal of allangioplasty equipment), and presence of angiographiccomplications. TIMI flows at baseline and after PCIwere graded on a scale of 0–3, and myocardial blushafter PCI was graded on a scale of 0–3 using methodspreviously described.

Quantitative angiographic parameters included: (1)reference vessel diameter; (2) minimum lumen diame-ter (MLD); (3) lesion length, and; (4) percent diameterstenosis (difference between the reference diameter andMLD divided by the reference diameter and multipliedby 100). Quantitative analysis was performed in the‘‘in-stent’’ area (inside the stented segment) and in the‘‘in-lesion’’ segment, including the stented area as wellas both the 5 mm proximally and distally to the stent.

Intravascular Ultrasound Analysis

Intravascular ultrasound (IVUS) studies were per-formed in the first 20 enrolled patients, immediatelypostprocedure, after an intracoronary administration of100–200 lg of nitroglycerin.

All IVUS were performed with a motorized auto-matic transducer pullback system (0.5 mm/sec) andcommercially available scanners (i-Lab, Boston Scien-tific Corporation) consisting of a rotating 40-MHztransducer catheter (Atlantis SR pro) with a 2.6F imag-ing sheath. The images were digitalized for off-linequantitative analysis according to the American Col-lege of Cardiology’s Clinical Expert Consensus Docu-ment on IVUS.

Quantitative IVUS analysis was made using a com-mercially available computerized planimetry program(EchoPlaque; INDEC Systems, Mountain View, CA).Plaque prolapse was defined as any tissue extrusionthrough the stent strut postprocedure.

88 Maia et al.


Quantitative parameters of lumen, stent, and vessel(external elastic membrane) cross-sectional areas weremanually determined. Stent expansion was defined asthe minimum stent CSA compared with average refer-ence (proximal þ distal) area. Lumen, stent and vesselvolumes were calculated using the Simpson’s rule.Incomplete stent apposition (ISA) was defined as �1stent strut clearly separated from the vessel wall withevidence of blood speckles behind the struts.

QCA and IVUS analyses were independently per-formed by core laboratories at Cardiovascular ResearchCenter (Sao Paulo, Brazil).

RESULTS

A total of 30 patients matched the inclusion/exclu-sion criteria and were enrolled in the INSPIRE trial.Table I shows main baseline clinical and angiographiccharacteristics of this cohort. Most patients were male(70%) with mean age of 60.8 � 10.6 years old. Ofnote, 11 patients (37%) were diabetics and 17 (56%)had previous MI. As initial clinical presentation, acutecoronary syndrome was detected in 54% of the cases,including all patients with target lesions in nativearteries. The majority of the treated lesions (53%) werelocated in SVG’s (average graft age of 9.4 � 5 years).Among the native arteries, right coronary was the mostfrequent target vessel (26%).

Preintervention lesion assessment and procedurecharacteristics are displayed in Table II. Notably, mostlesions were classified as type B2/C according to theACC/AHA classification. By preintervention qualitativeangiographic assessment, thrombus and ulcer wereobserved in 30% and 33.3% of the lesions, while hazi-ness was detected in the vast majority of the cases(73.3%). Predilatation was performed in 14 cases(47%), most of the time in native coronary arteries.MGuard stent was successfully deployed in all cases.All but one case required a single stent to treat thelesion segment.

Table III contains the main pre and postinterventionQCA data and postintervention IVUS information. Pre-intervention mean lesion length and reference vesseldiameter were 12.00 � 4.35 mm and 3.04 � 0.51 mm,respectively. Postintervention in-stent diameter of ste-nosis was 9.1% � 4.9% at the expenses of an acutegain of 1.95 � 0.49 mm. Of note, impaired preinter-vention TIMI flow and myocardial blush were detectedin 13.3% and 26.7% of the cases. Postprocedure QCAevaluation showed 100% of TIMI 3 flow and myocar-dial blush 3. Corrected TIMI frame count significantlydecreased from pre to postprocedure assessment (42.6� 56.1 vs. 17.4 � 9.3, P < 0.001).

IVUS images were obtained from the first 20patients enrolled in the study (per protocol). Average

TABLE I. Baseline Patient Characteristics

Characteristics Patients (n ¼ 30)

Mean age, years 60.8 � 10.4

Female gender, n (%) 9 (30%)

Hypertension, n (%) 27 (90%)

Dislipidemia, n (%) 24 (80%)

Diabetes, n (%) 11 (36.7%)

Smoking, n (%) 8 (26.7%)

Previous MI, n (%) 17 (56.7%)

Previous CABG, n (%) 16 (53.3%)

Target vessel

Native coronary artery, n (%) 14 (46.7%)

LAD 3 (10%)

LCX 3 (10%)

RCA 8 (26.7%)

Saphenous vein graft, n (%) 16 (53.3%)

Mean age of the treated grafts, years 9.4 � 5 years

Initial clinical presentation, n (%)

Stable angina/silent ischemiaa 14 (46.7%)

Unstable angina 4 (13.3%)

Non-ST elevation MI 10 (33.3%)

ST elevation MIb 2 (6.7%)

MI, myocardial infarction; LAD, left anterior descending artery; LCX,

left circumflex coronary artery; RCA, right coronary artery; SVG, saphe-

nous vein graft.aAll patients with SVG lesion.b>72 hr of the acute event.

TABLE II. Preintervention Lesion Assessment and ProcedureCharacteristics

Characteristics Lesions (n ¼ 30)

Lesion complexitya

Type B2/C 23 (76.7%)

Target-vessel segment treated

Ostium 3 (10%)

Proximal segment 18 (60%)

Mid segment 7 (20%)

Distal segment 2 (10%)

Special angiographic findings at lesion site, n (%)

Lesion eccentricity 28 (93.3%)

Irregularity (haziness) 22 (73.3%)

Ulcer 10 (33.3%)

Thrombus 9 (30%)

Moderate/severe calcification 3 (10%)

Use of IIb/IIIa inhibitor, n (%) 2 (6.7%)

Pre dilatation, n (%) 14 (46.7%)

Post dilatation, n (%) 21 (70%)

Number of stents per lesion 1.03

Mean stent diameter (mm) 3.39 � 0.39

Mean stent length (mm) 18.5 � 3.46

Mean final deployment pressure (atm) 14 � 3.8

Angiographic success, n (%) 30 (100%)

Procedure success, n (%) 30 (100%)

QCA, quantitative coronary angiograph; MLD, minimum lumen diame-

ter; DS, diameter of stenosis.aAccording to ACC/AHA classification.

MGuardTM



stent expansion was 82.5% � 14.1% and did not sig-nificantly differ between SVG and native vessels(83.0% �13% in the SVG cohort vs. 77.9% � 8.1% innative coronary arteries, P ¼ 0.09). Of note, there wasno case of plaque prolapse and incomplete stent appo-sition in the postprocedure IVUS evaluation.

Angiographic and procedure success were achievedin all cases. Postprocedure CKMB did not significantlyalter (3� reference value [25 U/ml]) in any of thecases (from 9.5 � 6.7 U/ml preprocedure to 12.5 �8.4 U/ml). Furthermore, up to 30 days of clinical fol-low-up, no MACE was observed.

DISCUSSION

The main findings of the INSPIRE trial include: (1)improvement of surrogate markers of distal plaqueembolization (coronary TIMI flow, corrected TIMIframe count, and myocardial blush), and; (2) attain-ment of favorable acute clinical results with this noveldevice, including no cardiac adverse events up to 30days of the procedure in both SVG and native coronarylesions.

The occurrence of coronary flow disturbance (no-reflow/slow flow) after PCI has a variable prevalence,ranging from 1% up to 40% according to the methods

used to assess the phenomenon and the populationunder evaluation [2–4]. PCI of SVG and percutaneoustreatment of patients with acute coronary syndrome areamong the most important predictors of this adversephenomenon. The occurrence of slow/no-reflow corre-lates with worse clinical outcomes, including higherrates of postprocedure MI and death.

Major recent advances in the interventional cardiol-ogy field to prevent distal lesion embolization includethe development of embolic protection and aspirationdevices.

Despite the extensive evidence pointing to the ben-efit of embolic protection devices for PCI in SVGlesions, including improvement of TIMI flow at theend of the procedure and increased survival-free ofmajor cardiac events [16,17], these devices are stillmuch underused in daily cathlab routine. Recent pub-lication by Mehta et al. [18] with 19,546 cases forPCI in SVG showed a global use of embolic protec-tion devices of < 25%. Main reasons to explain phy-sician reluctance to use such devices are related tohigh cost of the available systems and technical com-plexity to manipulate them. This situation did not sig-nificantly differ in the scenario of PCI in native coro-nary arteries. Despite the evidence of the increasedmyocardial salvage following the use aspiration cathe-ters in primary PCI [19–22], economical and technicalconstrains have prevent their wide utilization. In ourpreliminary experience, the deployment of theMGuard stent was technically equivalent to any regu-lar bare-metal stent, requiring no additional trainingand with no complication related to the device inser-tion/retrieval.

The first-in-man assessment of MGuard performancewas published by Kalunski et al. [23] and included 29patients with lesions in either native coronaries orSVG. Their device, procedure, and clinical successrates were of 100%, 96.4%, and 96.4%, respectively,with a single case of peri-procedure MI and no furtherMACE up to 30 days. More recently, in 2009, Vaknin-Assa et al. [24] published their initial experience withthis novel device for the treatment of seven vein grafts.They reported a 100% procedure success with no in-hospital and 30-day adverse events. This study supportsthe initial observations of these two experiences andrepresents the first analysis of surrogate endpoints(TIMI flow and myocardial blush), conducted by inde-pendent core laboratories, showing effectiveness of thedevice in both scenarios.

In confirming these initial enthusiastic results inlarger populations followed for longer periods, theMGuard may represent an attractive and cost-appealingalternative to treat such complex, high-risk popula-tions.

TABLE III. Pre and Postintervention Quantitative Coronary An-giography and Postintervention Intravascular Ultrasound

Variable Lesion (n ¼ 30)

Pre procedure QCA

Mean reference vessel diameter (mm) 3.04 � 0.51

Mean lesion length (mm) 12.00 � 4.35

Minimum lumen diameter (mm) 0.90 � 0.45

Diameter of stenosis (%) 71.0 � 13.0

TIMI flow < 3 (%) 4 (13.3%)

Myocardial blush < 3 (%) 8 (26.7%)

Corrected TIMI frame count, n 42.6 � 56.1

Post procedure in-stent QCA



Acute gain (mm) 1.95 � 0.49

TIMI flow < 3 (%) 0

Myocardial blush < 3 (%) 0

Corrected TIMI frame count, n 17.4 � 9.3

Post procedure in-segment QCA

Mean reference vessel diameter (mm) 3.07 � 0.44



Acute gain (mm) 1.66 � 0.46

Post procedure IVUS

Mean reference CSA (mm2) 9.6 � 4.5

In-stent minimum CSA (mm2) 7.7 � 3.0

Stent expansion (%) 82.5 � 14.1

Plaque prolapsed (%) 0

Acute incomplete stent apposition (%) 0

90 Maia et al.


LIMITATIONS

Main limitations of the present analysis are relatedto the relatively small sample size enrolled and thelack of a control group treated with standard therapy(distal filter protection and aspiration device whenproperly indicated).

CONCLUSIONS

In this preliminary evaluation, the MGuard stent im-plantation in SVG and native coronaries was shown tobe feasible and safe, with no MACE up to 30 days offollow-up, despite the nonuse of distal protection andaspiration devices.

Studies with larger cohorts must be carried on todemonstrate whether these preliminary results mighttranslate into relevant clinical benefits as compared tothe current available technologies.

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preliminary results of the inspire trial with the novel mguard™ stent system containing a...

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