TE-PROVE: European Postapproval Study of PES Shows Safety in All-Comers

Safety and performance outcomes are good 1 year after implantation of a thin-strut paclitaxel-eluting stent (PES), according to a European postapproval study published online January 7, 2015, ahead of print in EuroIntervention. 

The Taxus Element stent (Boston Scientific) is composed of a platinum-chromium alloy, with a nominal strut thickness of 81 µm, coated with a paclitaxel-eluting polymer. It received CE mark approval in May 2010 following the positive results of the PERSEUS trial.

“The introduction of [this] platform with increased radiopacity is intended to address multiple technical conundrums of stent-based percutaneous coronary intervention, including stent deliverability, radial strength, and visibility,” the authors write.

For TE-PROVE, Davide Capodanno, MD, PhD, of Ferrarotto Hospital (Catania, Italy), and colleagues looked at 1,014 all-comer patients (median age 65.1 years; 75% male) who underwent PCI with the Taxus Element stent at 37 European sites from November 2010 to October 2011. One in 10 had STEMI and a quarter had diabetes. Among 1,299 treated lesions, baseline mean lesion length was 19.8 ± 12.0 mm and mean reference diameter was 3.1 ± 0.5 mm.

Clinical procedural success was achieved in 98.3%, and follow-up at 1 year was available in 97.3%. Dual antiplatelet therapy (DAPT) was prescribed in 96.9% of patients at discharge and maintained in 84.3% at 12 months.

Low Event Rate With PES

The primary endpoint of target vessel failure (TVF; cardiac death, MI related to the target vessel, and TVR) was present in 6.0% of patients at 12 months; failure was stent-related in 3.7%. The findings were consistent across multiple subgroups. MACE and death at 12 months occurred in 6.2% and 1.2% of patients, respectively. The incidence of ARC-defined definite and probable stent thrombosis was 0.5% overall, with 0.4% occurring within 30 days.

In a secondary analysis comparing the all-comers results with those of 13 other stent studies, the overall weighted means for TVF, MACE, and death at 12 months were 8.1%, 7.4%, and 2.1%, respectively.

With regard to this comparison, Dr. Capodanno and colleagues write that it “is intended for descriptive purposes only,” even though it gives perspective to the overall TE-PROVE results.

Additionally, the 69.8% of TE-PROVE patients who matched PERSEUS inclusion criteria were compared with the rest. At 12 months, the former reported less MACE (3.6% vs 7.2%; P = .03) and TVF (3.6% vs 6.9%; P = .048) compared with the latter.

Paclitaxel of Limited Preference

The stent thrombosis rates are “reassuring for a PES, and may suggest a role of the [platinum-chromium] platform in reducing thrombogenicity and promoting vascular healing,” the authors write. “Additionally, increased radiopacity of [platinum-chromium] platforms may help to identify underexpanded stents and, potentially, aid in reducing the rate of [stent thrombosis].”

However, optimal length of DAPT remains unknown with this stent type and “is a matter of ongoing investigation,” they note.

They acknowledge a lack of comparator in TE-PROVE, “but the objectives were to extend the results of the PERSEUS trials in a broader patient population and more precise detection of low-frequency events.”

In an email with TCTMD, Antonio Colombo, MD, of San Raffaele Hospital (Milan, Italy), said he does not see a future for PES use, except for diabetic patients. “Since the limus-eluting stents became available, I stopped using [PES],” he said, explaining that PES have been associated with less healthy endothelialization and more late stent thrombosis.

Source:
Tamburino C, Capodanno D, Erglis A, et al. One-year outcomes in unselected patients treated with a thin-strut, platinum-chromium, paclitaxel-eluting stent: primary endpoint results from the TAXUS Element European post-approval surveillance study (TE-PROVE). EuroIntervention. 2015;Epub ahead of print.

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