(Circulation. 2000;102:2938.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
Randomized Comparison of Elective Stent Implantation and Coronary Balloon Angioplasty Guided by Online Quantitative Angiography and Intracoronary Doppler
Correspondence to Carlo Di Mario, MD, PhD, FESC, FACC, Cardiac Catheterization Laboratory, Centro Cuore Columbus, Via M. Buonarroti 48, 20145 Milano, Italy. E-mail dimario{at}micronet.it
Background—The purpose of this study was to compare long-term outcomes of coronary stenting in all lesions (elective stenting) or only in lesions with inadequate morphological and functional results after balloon angioplasty (guided PTCA).
Methods and
Results—Treatment of multivessel disease, with
any lesion length and vessel size, was allowed provided that all
lesions were suitable for stent implantation. Patients were randomized
to elective stent implantation (n=370) or guided PTCA (n=365). An
optimal PTCA result (residual diameter stenosis 
35%,
coronary flow reserve measured with a Doppler guidewire
>2.0, absence of threatening dissections) was achieved in 166 lesions
(43%). The remaining 218 lesions underwent stent implantation
(provisional stenting). Final residual diameter stenosis was
lower in the elective and provisional stent groups (9.3% and 10.2%)
than in the optimal PTCA group (24.8%,
P<0.00001). On an
intention-to-treat analysis, the probability of 
1 major
adverse cardiac event at 12 months was 17.8% in the elective stenting
group and 18.9% in the guided PTCA group (20.1% for optimal PTCA and
18.0% for the provisional stenting subgroup,
P=NS). The incidence of repeat
target lesion revascularization at 1 year was
14.9% in the elective stent group and 15.6% in the guided PTCA group
(17.6% for optimal PTCA and 14.1% for the provisional stenting
subgroup,
P=NS).
Conclusions—When balloon angioplasty is guided by online quantitative angiography and Doppler-derived coronary flow reserve, with provisional stenting reserved for suboptimal results, early and late clinical outcomes are comparable to those achieved by elective stenting of all patients.
Key Words: angioplasty • stents • angiography
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