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EuroIntervention. 2011 May;7(1):84-90. doi: 10.4244/EIJV7I1A15.

PLATINUM QCA: a prospective, multicentre study assessing clinical, angiographic, and intravascular ultrasound outcomes with the novel platinum chromium thin-strut PROMUS Element everolimus-eluting stent in de novo coronary stenoses.

Author information

1
MonashHEART, Southern Health, Monash Medical Centre, Clayton, Victoria, Australia. ian.meredith@myheart.id.au

Abstract

AIMS:

Assess clinical, angiographic, and intravascular ultrasound results in lesions treated with the PROMUS Element platinum chromium everolimus-eluting stent (EES).

METHODS AND RESULTS:

Patients (N=100) with one de novo target lesion ≤ 34 mm long and reference vessel diameter (RVD) ≥ 2.25-≤ 4.25 mm were enrolled at 14 sites. The primary endpoint was the 30-day composite of cardiac death, myocardial infarction, target lesion revascularisation (TLR), or definite/probable stent thrombosis (ST). The efficacy endpoint of 9 month in-stent late loss in workhorse lesions (defined as RVD ≥ 2.5-≤ 4.25 mm, lesion ≤ 24 mm) was compared to a performance goal based on historical results with TAXUS Express paclitaxel-eluting stents. Post-procedure incomplete stent apposition (ISA) was compared to a performance goal based on results with the PROMUS/XIENCE V EES in SPIRIT III. Mean age was 61.8 ± 9.9 years; 77.0% were male; 19% had medically treated diabetes. Baseline RVD was 2.72 ± 0.53 mm; lesion length was 15.4 ± 7.0 mm. The primary endpoint occurred in one patient (periprocedural ST with TLR) with no additional major clinical events through one year. Nine-month in-stent late loss in workhorse lesions (0.17 ± 0.25 mm, N=73) and post-procedure ISA (5.7%, 5/88) were below performance goals (p<0.001).

CONCLUSIONS:

Through one year, PROMUS Element EES had an acceptable safety and efficacy profile with low in-stent late loss and post-procedure ISA.

PMID:
21550907
DOI:
10.4244/EIJV7I1A15
[Indexed for MEDLINE]
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