7/9/08Priya Pillutla, M.D.Cath Conference

Priya Pillutla, MD

HistoryPriya Pillutla, MDHPI 58 y/o M presented in May 08 w/escalating chest pressure at rest and with exertion Symptoms relieved with NTG; exertional chest pain better with restCath planned but patient eloped; referred back from clinic for persistent chest painPMH CAD, DJDNSTEMI 11/07. Cath showed R dominant system, 90% proximal LAD stenosis s/p PCI (3.5x12mm taxus and 4x18mm driver)

Priya Pillutla, MD

HistoryPriya Pillutla, MDMeds Metoprolol, clopidigrel, simvastatin, lisinopril, NTG as needed, adderal

Allergies - ?iodine (no complications 11/07)

Social hx - Marginally housed, denies substance abuse Utox + meth, cannabis

Family hx - noncontributory

Priya Pillutla, MD

Physical ExamPriya Pillutla, MDVS BP 128/65, HR 60, RR 13, 98% RADisheveled JVP 7 cm H20. Neck supple, normal carotid upstrokesPMI nonsustained, nondisplaced. RRR nl s1/s2. No s3/s4. No murmurs.Lungs clearAbdomen soft, nontenderNo edema2+ radial, femoral and dorsalis pedis pulses

Priya Pillutla, MD

Laboratory DataPriya Pillutla, MDElectrolytes - K 4.5, Cr 0.8Hematocrit - 40.8Platelets - 230KINR - 1Cardiac biomarkers - Troponin neg, CKMB normal x 3

Priya Pillutla, MD

Priya Pillutla, MD

Priya Pillutla, MD

Cardiac CatheterizationPriya Pillutla, MD

Priya Pillutla, MD

SummaryPriya Pillutla, MDHigh-grade (95-99%) in-stent restenosis of the proximal LAD and proximal stent 40% stenosis PCI of proximal LAD using cutting balloon (4x10mm)Probable compliance issues given living situation and +utoxExcellent angiographic result with TIMI 3 flow and resolution of chest painPatient observed overnight and discharged the following day without complicationsMissed cath f/u appointment

Priya Pillutla, MD

In-stent restenosisPriya Pillutla, MDCan be seen in 5-35%1 of patients after PCI Somewhat lower after DESMechanisms include:Negative remodelingElastic recoilNeointimal hyperplasia

1Stone et al, JAMA, 2005

Priya Pillutla, MD

Treatment optionsPriya Pillutla, MDAngioplasty (PTCA, cutting balloon)High rates of restenosis1 (39-67%)Mechanical debulking (rotational, laser)Repeat stenting (BMS, DES)Intracoronary radiation (brachytherapy)

1Scheller et al, NEJM, 2006

Priya Pillutla, MD

Priya Pillutla, MDDauerman, JACC, 2006(Not shown - TAXUS V, showing that PES is better than brachytherapy)

Priya Pillutla, MD

Current effective treatments BrachytherapyWorks well but considerable safety, logistical and technical issuesRisk of stent-edge restenosis and thrombosisDESRecurrence rates 13-22%1DES + DES = higher rate of restenosis2 (43%)Very small but serious risk of stent thrombosis

1Scheller et al, NEJM, 20062Lemos et al, Circulation, 2004Priya Pillutla, MD

Priya Pillutla, MD

Whats special about DES?Drug-elution is keyCan drug be delivered for a shorter time?Can lower levels of drug still attain antiproliferative effects?Data (cell-culture and swine experiments) suggest that both of the above are true!

Priya Pillutla, MD

Priya Pillutla, MD

Paclitaxel-Coated Balloon Angioplasty PACCOCATH ISR NEJM, 2006 (Scheller et al)Hypothesis - Angioplasty using paclitaxel-coated balloons will prevent in-stent restenosisBalloon delivers all of the drug at once and is then withdrawn

Priya Pillutla, MD

Priya Pillutla, MD

Study designDouble-blind, randomized pilot studyInclusionAngina or +functional studySingle restenotic lesion

ExclusionRecent MI, CKD, allergySick or noncompliantLong (>30mm) or small (

Study DesignPatients randomized toConventional PTCA PTCA with paclitaxel-coated balloon (3 ug/mm2)Angiography before, after and at 6 months using QCA (quantitative coronary angiography)ASA, plavix x 1 month then ASA aloneEndpointsPrimary late luminal loss (lumen at 6 months vs after PTCA)Secondary restenosis, combined clinical events Priya Pillutla, MD

Priya Pillutla, MD

Results52 patients26 patients in each groupSimilar baseline and procedural characteristicsMean age 64 years71% menMost patients had multi-vessel disease with diffuse ISRPriya Pillutla, MD

Priya Pillutla, MD

Angiographic findings 6 monthsMLD = minimal lumen diameter; LLL = late lumen lossPriya Pillutla, MD

UncoatedCoatedp valueMLD (in-stent)1.6 mm2.3 mm0.004LLL (in-segment)** primary endpoint0.74 mm0.03 mm0.002Restenosis (%)4350.002

Priya Pillutla, MD

Priya Pillutla, MD

Priya Pillutla, MD

Priya Pillutla, MD

Priya Pillutla, MD

Priya Pillutla, MD

Priya Pillutla, MD

Adverse events related or possibly related to procedureUncoated group2 small groin hematomas 6 revascularizations, 1 unstable anginaCoated group3 small groin hematomas1 MI (possibly related)** Second MI noted in a patient randomized to uncoated balloon who erroneously received coated balloon, possibly related to balloon

Priya Pillutla, MD

Priya Pillutla, MD

LimitationsExtremely smallNot truly blinded coated balloons had distinct appearanceShould be studied in comparison with standard of care (DES)Anti-platelet agents only given for 1 monthWas LLL an appropriate parameter?DES trials show that early LLL may not correlate well with restenosisNevertheless results are encouragingPriya Pillutla, MD

Priya Pillutla, MD

SummaryIn-stent restenosis continues to complicate PCIsNeoproliferation, negative remodeling and elastic recoil are causative factorsTherapyData most strongly supports DES at this timeDrug-coated balloon PTCA is likely to be an emerging modalityPriya Pillutla, MD

Priya Pillutla, MD

NSR 57 bpm with APCsNormal axisNormal intervalsBorderline R wave progressionNo ST-T changes

Suggests reduction in neointimal proliferation. For comparison, LLL for conventional drug-eluting stents is around 0.32 mm.?lose this slide*