Defining a new standard for IVUS optimized drug eluting stent implantation: the PRAVIO study.
OBJECTIVE
Preliminary Investigation to the Angiographic Versus IVUS Optimization Trial is a single center prospective observational intravascular ultrasound (IVUS) guided stent implantation study assessing new criteria for optimal drug eluting stent (DES) deployment.


BACKGROUND
IVUS assessment of DES often reveals underexpansion and malapposition. Optimal stent deployment is currently poorly defined and previous criteria may not be suitable in long and complex lesions.


METHODS
Optimization was defined as achieving >/or 70% of the cross-sectional area (CSA) of the postdilation balloon. This criterion was applied in 113 complex lesions. The size of this balloon was calculated according to vessel media-to-media diameters at various sites inside the stented segment. The IVUS guided treated lesions were matched according to diabetes, vessel type, reference vessel diameter, minimum lumen diameter (MLD), and lesion length with a group of angiographic treated lesions to compare final MLD achieved.


RESULTS
Mean minimum stent CSA according to the postdilation balloon utilized was 4.62 mm(2), 6.26 mm(2), 7.87 mm(2), and 9.87 mm(2) for 2.5 mm, 3.0 mm, 3.5 mm, and 4 mm balloons, respectively. Final MLD (mm) was significantly larger in the IVUS compared to the angiographic-guided group (3.09 +/- 0.50 vs. 2.67 +/- 0.54; P < 0.0001). There were no procedural complications related to IVUS use.


CONCLUSIONS
We propose new IVUS criteria based on vessel remodeling that results in an increment in the final MLD, compared to angiographic guidance, which is much larger than any previously published study. This criterion seems to be safely achievable. A proposed randomized study (angiographic vs. IVUS optimization trial) has been launched to test these concepts.
Gerber
R T
RT
Catheterisation Laboratory, San Raffaele Hospital, Milan, Italy.
Latib
A
A
Ielasi
A
A
Cosgrave
J
J
Qasim
A
A
Airoldi
F
F
Chieffo
A
A
Montorfano
M
M
Carlino
M
M
Michev
I
I
Tobis
J
J
Colombo
A
A
D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D017023:Coronary Angiography / Q000592:standards*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D006801:Humans; D010865:Pilot Projects; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D017410:Practice Guidelines as Topic; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015641:Radiography, Interventional / Q000592:standards*; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000592:standards*
D010975:Platelet Aggregation Inhibitors