Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials.
OBJECTIVE
We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on 9-month follow-up paclitaxel-eluting stent (PES) patency compared with bare-metal stents (BMS).


BACKGROUND
Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in PES is still unknown.


METHODS
From the combined TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent trials, 1,580 patients (PES 1,098, BMS 482) in IVUS substudies were analyzed. The MSA that best predicted angiographic in-stent restenosis (ISR) (% diameter stenosis > or =50%) was determined.


RESULTS
The post-intervention IVUS MSA was similar in PES and BMS (6.6 +/- 2.5 mm(2) vs. 6.7 +/- 2.3 mm(2), p = 0.92). At 9-month follow-up, ISR was lower in the PES group versus the BMS group (10% vs. 31%, p < 0.0001). Using multivariable logistic regression analysis, post-intervention IVUS MSA was the independent predictor of subsequent ISR in both the PES and BMS groups (p = 0.0002 for PES and p = 0.0002 for BMS). The ability of the post-intervention IVUS MSA to predict ISR was further assessed using receiver operating characteristic analysis. The post-intervention IVUS MSA was found to be a faithful discriminator between patients with and without ISR in both PES (c = 0.6382) and BMS (c = 0.6373). Finally, the optimal thresholds of post-intervention IVUS MSA that best predicted stent patency at 9 months were 5.7 mm(2) for PES and 6.4 mm(2) for BMS.


CONCLUSIONS
Post-intervention MSA measured by IVUS can predict 9-month follow-up stent patency after both PES and BMS implantation. (Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions; NCT00301522) (Direct Stenting of TAXUS Liberté-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions; NCT00371423) (A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475) (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748).
Doi
Hiroshi
H
Cardiovascular Research Foundation and Columbia University Medical Center, New York, New York 10022, USA.
Maehara
Akiko
A
Mintz
Gary S
GS
Yu
Alan
A
Wang
Hong
H
Mandinov
Lazar
L
Popma
Jeffrey J
JJ
Ellis
Stephen G
SG
Grube
Eberhard
E
Dawkins
Keith D
KD
Weissman
Neil J
NJ
Turco
Mark A
MA
Ormiston
John A
JA
Stone
Gregg W
GW
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000209:etiology / Q000503:physiopathology; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D016017:Odds Ratio; D017239:Paclitaxel / Q000008:administration & dosage*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012372:ROC Curve; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D013927:Thrombosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014654:Vascular Patency
D002317:Cardiovascular Agents; D008670:Metals; D017239:Paclitaxel