Transcript Document - Cardiac Catheterization

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
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
Priya Pillutla, MD
et al, JAMA, 2005
Treatment options
 Angioplasty (PTCA, cutting balloon)
 High rates of restenosis1 (39-67%)
 Mechanical debulking (rotational, laser)
 Repeat stenting (BMS, DES)
 Intracoronary radiation (brachytherapy)
1Scheller
Priya Pillutla, MD
et al, NEJM, 2006
(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
2Lemos
Priya Pillutla, MD
et al, NEJM, 2006
et al, Circulation, 2004
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 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
Uncoated
Coated
p value
1.6 mm
2.3 mm
0.004
LLL (in-segment)
0.74 mm
** primary endpoint
0.03 mm
0.002
Restenosis (%)
5
0.002
MLD (in-stent)
Priya Pillutla, MD
43
MLD = minimal lumen diameter; LLL = late lumen loss
Priya Pillutla, MD
Priya Pillutla, MD
Priya Pillutla, MD
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