Two-Year PLATINUM SV and LL Data Published for Boston Scientific's Promus Element PtCr-EES

February 2, 2015—In Catheterization and Cardiovascular Interventions, Paul S. Teirstein, MD, et al published 1- and 2-year clinical outcomes of patients who underwent treatment with the Promus Element platinum chromium everolimus-eluting stent (PtCr-EES; Boston Scientific Corporation) in the prospective, single-arm PLATINUM long lesion (LL) and small vessel (SV) studies (2015;85:207–215).

The PLATINUM LL study enrolled 102 patients with lesions > 24 to ≤ 34 mm long in vessels ≥ 2.5 to ≤ 4.25 mm in diameter. Dr. Teirstein, who serves as Coprincipal Investigator of the PLATINUM LL trial, first presented the 2-year clinical endpoint data on the Promus Element PtCr stent system (Boston Scientific Corporation) in October 2012 at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida. Dr. Teirstein is with the Scripps Clinic in La Jolla, California.

The PLATINUM SV study enrolled 94 patients with coronary artery lesions in vessels ≥ 2.25 to < 2.5 mm in diameter and ≤ 28 mm in length. The PLATINUM clinical program’s Coprincipal Investigator, Prof. Ian Meredith, MD, first presented the 2-year PLATINUM SV data in May 2012 at the EuroPCR 2012 conference in Paris, France. Dr. Meredith is Director of MonashHeart at Monash Medical Centre in Melbourne, Australia.
 
As summarized in Catheterization and Cardiovascular Interventions, the primary endpoint for both studies was target lesion failure (TLF) at 1 year compared to a prespecified performance goal based on outcomes with the Taxus Express paclitaxel-eluting stent (Boston Scientific) in small vessels and long lesions.

The investigators reported that 1-year TLF rates with the PtCr-EES were significantly lower (P < .001) than the predetermined performance goals: 2.4% versus 21.1% in the SV cohort and 3.2% versus 19.4% in the LL cohort. Cumulative rates of TLF to 2 years were 4.7% in the SV cohort and 8.8% in the LL cohort. No myocardial infarction or Academic Research Consortium definite/probable stent thromboses occurred in either cohort through 2-year follow-up.

The clinical efficacy and safety outcomes observed in these small vessel and long lesion cohorts support the use of the PtCr-EES for the treatment of small diameter vessels and long lesions, concluded the PLATINUM investigators in Catheterization and Cardiovascular Interventions.