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Cath Conference. 7/9/08 Priya Pillutla, M.D. History . 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
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Cath Conference 7/9/08 Priya Pillutla, M.D.
History • 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) Priya Pillutla, MD
History • 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 Priya Pillutla, MD
Physical Exam VS – BP 128/65, HR 60, RR 13, 98% RA Disheveled JVP 7 cm H20. Neck supple, normal carotid upstrokes PMI nonsustained, nondisplaced. RRR nl s1/s2. No s3/s4. No murmurs. Lungs clear Abdomen soft, nontender No edema 2+ radial, femoral and dorsalis pedis pulses Priya Pillutla, MD
Laboratory Data • Electrolytes - K 4.5, Cr 0.8 • Hematocrit - 40.8 • Platelets - 230K • INR - 1 • Cardiac biomarkers - Troponin neg, CKMB normal x 3 Priya Pillutla, MD
Cardiac Catheterization Priya Pillutla, MD
Summary • 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 Priya Pillutla, MD
In-stent restenosis • Can be seen in 5-35%1 of patients after PCI • Somewhat lower after DES • Mechanisms include: • Negative remodeling • Elastic recoil • Neointimal hyperplasia 1Stone et al, JAMA, 2005 Priya Pillutla, MD
Treatment options • 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
(Not shown - TAXUS V, showing that PES is better than brachytherapy) Priya Pillutla, MD Dauerman, JACC, 2006
Current effective treatments • Brachytherapy • Works well but considerable safety, logistical and technical issues • Risk of stent-edge restenosis and thrombosis • DES • Recurrence rates 13-22%1 • DES + DES = higher rate of restenosis2 (43%) • Very small but serious risk of stent thrombosis 1Scheller 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 – PACCOCATHISR • NEJM, 2006 (Scheller et al) • Hypothesis - Angioplasty using paclitaxel-coated balloons will prevent in-stent restenosis • Balloon delivers all of the drug at once and is then withdrawn Priya Pillutla, MD
Study design • Double-blind, randomized pilot study • Inclusion • Angina or +functional study • Single restenotic lesion • Exclusion • Recent MI, CKD, allergy • Sick or noncompliant • Long (>30mm) or small (<2.5mm) lesions • <70% stenosis • Significant calcification • Thrombus Priya Pillutla, MD
Study Design • Patients 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 alone • Endpoints • Primary – late luminal loss (lumen at 6 months vs after PTCA) • Secondary – restenosis, combined clinical events Priya Pillutla, MD
Results • 52 patients • 26 patients in each group • Similar baseline and procedural characteristics • Mean age 64 years • 71% men • Most patients had multi-vessel disease with diffuse ISR Priya Pillutla, MD
Angiographic findings – 6 months Priya Pillutla, MD MLD = minimal lumen diameter; LLL = late lumen loss
Adverse events – related or possibly related to procedure • Uncoated group • 2 small groin hematomas • 6 revascularizations, 1 unstable angina • Coated group • 3 small groin hematomas • 1 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
Limitations • Extremely small • Not truly blinded – coated balloons had distinct appearance • Should be studied in comparison with standard of care (DES) • Anti-platelet agents only given for 1 month • Was LLL an appropriate parameter? • DES trials show that early LLL may not correlate well with restenosis • Nevertheless results are encouraging Priya Pillutla, MD
Summary • In-stent restenosis continues to complicate PCIs • Neoproliferation, negative remodeling and elastic recoil are causative factors • Therapy • Data most strongly supports DES at this time • Drug-coated balloon PTCA is likely to be an emerging modality Priya Pillutla, MD