elective stenting versus balloon angioplasty with bail-out stenting for small vessel coronary artery...
TRANSCRIPT
Elective Stenting versus Balloon
Angioplasty with Bail-out Stenting for
Small Vessel Coronary Artery Disease:
Evidence from a Meta-analysis of
Randomized Trials
TCT, Washington, 30 September 2004
There are no conflicts of interest nor funding to declare
Pierfrancesco Agostoni
on behalf of all co-authors
INTRODUCTION
Bare-metal stents have been shown to reduce angiographic restenosis and repeat revascularization in discrete lesions in large vessels.1,2
1.Serruys PW, et al. BENESTENT Trial. NEJM,19942. Fishman DL, et al. STRESS Trial. NEJM,1994
The use of stents has increased radically also for “non-STRESS/BENESTENT” lesions, despite the lack of evidence of benefit.
INTRODUCTION
Small vessels (with RVD < 3 mm) account for 40-50% of all coronary stenoses.3
3. Wong P, et al. Catheter Cardiovasc Interv, 2000
Several recent randomized trials have compared bare-metal stenting vs. PTCA in small vessels, with conflicting and overall inconclusive results.
INTRODUCTION
As systematic overviews and meta-analytic techniques may provide more precise effect estimates with greater statistical power, leading to more robust and generalized conclusions...
AIM OF OUR REVIEW* Research
* Retrieve
* Evaluate
* Combine
in a systematic way
all the randomized trials comparing bare-metal stenting vs. PTCA for the treatment of atherosclerotic lesions in small coronary vessels.
METHODS
Systematic Research MEDLINE, CENTRAL
AHA, ACC, ESC, TCT 2000-2004 abstracts
Inclusion criteria Prospective comparison
Randomized allocation
Intention-to-treat
Follow-up 6 months Exclusion criteria
Non-mandatory angiographic follow-up Use of DES or other devices stents
Antithrombotic drugs ASA and thienopyridines
METHODS
Death
Myocardial infarction
Repeat revascularization (TVR/TLR)
MACE
Secondary end-points Restenosis, RVD, MLD pre-, post-PCI and at follow-up,
DS pre-, post-PCI and at follow-up, acute gain, late loss
Primary End-points
METHODS
Binary outcomes
Odds Ratios (95% Confidence Intervals)
Random effect model
Heterogeneity
Cochran Q 2 test
METHODS
Trials with mean DS post-PTCA < 20% (optimal)
and
Trials with mean DS post-PTCA > 20% (sub-optimal)
1. ACC Expert consensus Document JACC, 19982. Kastrati et al. JACC, 2001
Pre-specified sub-group analysis1,2
Included Studies
Death
Heterogeneity: p = 0.76Overall effect: p = 0.42
Myocardial Infarction
Heterogeneity: p = 0.92Overall effect: p = 0.18
Repeat Revascularization
Heterogeneity: p = 0.04Overall effect: p = 0.02
Heterogeneity: p = 0.62Overall effect: p = 0.54
MACE
Heterogeneity: p = 0.01Overall effect: p = 0.004
Heterogeneity: p = 0.27Overall effect: p = 0.24
CONCLUSIONS
Bare-metal stenting is clinically superior to PTCA for the treatment of small vessels, in particular when compared to a sub-optimal PTCA result.
The finding of significant heterogeneity casts a light of caution on the comprehensive pooled effect estimates.
A strategy based on “optimal” PTCA with provisional stenting may be a valid alternative to systematic stenting.
CONCLUSIONS
In any case, the rates of MACE (17%) and repeat revascularization (15%) remain high after stenting, unfavorably comparing with the MACE and revascularization rates in vessels with RVD > 3 mm ( 10%).4,5
4. Weaver WD, et al. OPUS-1 Trial. Lancet, 20015. Serruys PW, et al. JACC, 1999
Future Strategies
As drug-eluting stents have been proved to be effective both in randomized trials6-8 and in observational registries8…
6. Schofer J, et al. E-SIRIUS Trial. Lancet, 2003 7. Schampaert E, et al. C-SIRIUS Trial. JACC, 20048. Ardissino D. SES-SMART Trial. ACC meeting, 20038. Lemos PA, et al. RESEARCH Registry. AJC, 2004
The use of DES should be considered the
first-line therapy
for the treatment of vessels with RVD < 3 mm.
Angiographic Restenosis
Heterogeneity: p = 0.002Overall effect: p < 0.001
Heterogeneity: p = 0.11Overall effect: p = 0.25
High quality trials: Park et al., ISAR-SMART, SISCA
Quality AssessmentJadad’s Score (0-5 points)
• Study defined as randomized(1 point)– if randomization was correct 1 point more
– if not correct 1 point less
– if not mentioned no points
• Study defined as blinded(1 point)– it is impossible in “interventional” trials! Stent is visible!
• Clear description of drop-outs and withdrawals (1 point)
For further slides on these topics For further slides on these topics please feel free to visit the please feel free to visit the
metcardio.org website:metcardio.org website:
http://www.metcardio.org/slides.html