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

Cath Conference

History

Priya Pillutla, MD

• HPI – 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 rest– Cath planned but patient eloped; referred

back from clinic for persistent chest pain• PMH – CAD, DJD

– NSTEMI 11/07. Cath showed R dominant system, 90% proximal LAD stenosis s/p PCI (3.5x12mm taxus and 4x18mm driver)

History

Priya Pillutla, MD

• Meds – 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

Physical Exam

Priya Pillutla, MD

VS – 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

Laboratory Data

Priya Pillutla, MD

Electrolytes - K 4.5, Cr 0.8Hematocrit - 40.8Platelets - 230KINR - 1Cardiac biomarkers - Troponin neg, CKMB

normal x 3

Priya Pillutla, MD

Cardiac Catheterization

Priya Pillutla, MD

Summary

Priya Pillutla, MD

• High-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

+utox

• Excellent angiographic result with TIMI 3 flow and resolution of chest pain

• Patient observed overnight and discharged the following day without complications

• Missed cath f/u appointment

In-stent restenosis

Priya Pillutla, MD

Can be seen in 5-35%1 of patients after PCI Somewhat lower after DES

Mechanisms include:Negative remodelingElastic recoilNeointimal hyperplasia

1Stone et al, JAMA, 2005

Treatment options

Priya Pillutla, MD

Angioplasty (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 Dauerman, JACC, 2006

(Not shown - TAXUS V, showing that PES is better than brachytherapy)

Current effective treatments

BrachytherapyWorks well but considerable safety, logistical

and technical issuesRisk of stent-edge restenosis and thrombosis

DESRecurrence rates 13-22%1

DES + DES = higher rate of restenosis2 (43%)Very small but serious risk of stent

thrombosis1Scheller et al, NEJM, 2006

2Lemos et al, Circulation, 2004

Priya Pillutla, MD

What’s special about DES?Drug-elution is key

Can 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

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

Study designDouble-blind, randomized pilot study Inclusion

Angina or +functional studySingle restenotic lesion

ExclusionRecent MI, CKD, allergySick or noncompliantLong (>30mm) or small (<2.5mm) lesions<70% stenosisSignificant calcificationThrombus

Priya Pillutla, MD

Study DesignPatients randomized to

Conventional 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 aloneEndpoints

Primary – late luminal loss (lumen at 6 months vs after PTCA)

Secondary – restenosis, combined clinical events

Priya Pillutla, MD

Results52 patients

26 patients in each groupSimilar baseline and procedural

characteristicsMean age 64 years71% menMost patients had multi-vessel disease with

diffuse ISR

Priya Pillutla, MD

Angiographic findings – 6 months

Uncoated Coated p value

MLD (in-stent) 1.6 mm 2.3 mm 0.004

LLL (in-segment)

** primary endpoint

0.74 mm 0.03 mm 0.002

Restenosis (%) 43 5 0.002

MLD = minimal lumen diameter; LLL = late lumen lossPriya Pillutla, MD

Priya Pillutla, MD

Priya Pillutla, MD

Priya Pillutla, MD

Adverse events – related or possibly related to procedureUncoated group

2 small groin hematomas 6 revascularizations, 1 unstable angina

Coated 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

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 restenosis

Nevertheless results are encouraging

Priya Pillutla, MD

SummaryIn-stent restenosis continues to complicate

PCIsNeoproliferation, negative remodeling and

elastic recoil are causative factorsTherapy

Data most strongly supports DES at this timeDrug-coated balloon PTCA is likely to be an

emerging modality

Priya Pillutla, MD