Sex, Race Do Indeed Negatively Influence PCI Outcomes: PLATINUM Diversity

Patrice Wendling

November 03, 2016

WASHINGTON, DC — The first prospective PCI study to shut out white men shows women and minorities do worse 1 year after PCI with second-generation     drug-eluting stents when compared with historical white male controls[1].

At 12 months, the risk for death and MI was nearly twofold higher in women (odds ratio [OR] 1.9, P=0.01) and female and male minorities (OR 1.9, P=0.004)     than in white men after adjustment for clinical and angiographic factors.

The adjusted risk for MI was also higher in minorities (OR 2.6, P=0.002) and trended so in women (OR 2.6, P=0.09) compared with white     men.

These difference are not thought to be due to stent failure since stent thrombosis and target vessel revascularization (TVR) were comparable among the     three groups, all implanted with an everolimus-eluting platinum chromium stent, co–principal investigator Dr Wayne Batchelor (Tallahassee Memorial Healthcare, FL) noted in presenting the Platinum Diversity trial at a first-report session at    TCT 2016.

                                                               

Dr Wayne Batchelor

                       

He concluded, "These results suggest there is significant heterogeneity conferred by sex and race, and we need further study of the biological underpinnings     as well as social, behavior, and economic factors that might impact risk."

Commenting to heartwire from Medscape, Dr Bonnie Weiner (St Vincent     Hospital, Worcester, MA) said, "It's a great start to try to look at the differences in outcomes for women and men that's powered sufficiently to have a     large-enough population. As pointed out, there are still lots of questions to answer."

She added, "It's also important to recognize that the comparison of men with women may not be the right comparison ultimately. What we really need to be     interested in is not whether men do better than women but whether women get the same incremental benefit from our interventions that men do."

                                                               

Dr Roxana Mehran

                       

Co–principal investigator Dr Roxana Mehran (Mount Sinai Medical Center, NY, NY) told heartwire , "For me, this is one of the most     monumental times—to actually have a trial that is dedicated to the diverse patient population, the underrepresented patient population who are previously     at 10% [enrollment] for African Americans, 20% to 25% for females, and Latinas even less.

"To have so few data on these important patients who make up a very, very large portion of our population to me is unconscionable."

Study Details

The investigators prospectively enrolled 1501 women and minorities (blacks, Hispanic/Latino, Asian, Native American, Pacific Islander; 30% male) who received at     least one Promus Premier stent (Boston Scientific) and pooled their data with 2687 patients  (70% male; 14% minority) implanted with the Promus Element Plus stent     (Boston Scientific) in the prospective all-comers observational PROMUS Element PAS (US Postapproval Study).

At baseline, women were slightly older and both women and minorities  tended to have a higher prevalence of diabetes, hypertension, and renal disease,     whereas white men had slightly higher reference vessel diameter and were more likely to present with acute coronary syndrome.

Despite these differences, the primary composite end point of death, MI, and TVR was similar at 12 months, occurring in 7.6% of white men vs 8.6% of women     (P=0.33) and 9.6% of minorities (P=0.08 vs white men).

Components of the primary end point were more common in minorities and women, as was the secondary composite end point of death and MI.

Clinical End Point

                                                                                                                                                                                                                                                                                                                                                                                                                                                               
End point White men (%) Women (%) Minority (%) P, white men vs women P, white men vs minority
Death 2.23.43.70.040.03
MI 1.11.93.10.060.0002
TVR 5.54.65.40.270.97
Death and MI 3.05.16.50.0060.0002

"I suspect if you looked at other stents you'd find very similar findings," Batchelor told heartwire , noting that they previously     reported a three- to fivefold difference in stent thrombosis and MI between African Americans and whites.

During a discussion of the results, panelist Dr Nabil Dib (University of Arizona Medical College, Phoenix) commented that "when they introduced gender into     the SYNTAX II trial, they found that women had a higher risk with a     worse outcome, so I do think there is some consistency when it comes to gender."

Session moderator Dr Howard Hermann (University of Pennsylvania, Philadelphia) noted that about 30% of the women were also minorities, "which then raises     the question of whether women are more like white men, or is it that the minorities are not like white men?"

Batchelor responded that this will be the focus of future analyses along with socioeconomic factors, but that this was the first cut of the data.

To heartwire , Hermann said the data "were not that surprising, because we've always felt there were a combination of factors for     why women and minorities don't do as well as white men. Maybe they don't have as much access on socioeconomic grounds beforehand and present later in the     disease and then there are the atypical presentations in women and the smaller vessels.

"But it would be interesting to tease out the 31% of patients who are in the women category but are actually minorities to see whether this is a double     whammy."

The investigators did track medication use during follow-up and found that men were significantly more likely to remain on aspirin and dual antiplatelet     therapy over the 12 months.

Dr David Holmes Jr (Mayo Clinic, Rochester, MN) told heartwire , "I was really surprised at his finding that compliance rates were     higher in men; I would have said just the reverse, that women were much more compliant with everything, clearly medication use."

Mehran said one clear takeaway from the study is that the time for underenrollment of minority and female patients is past.

"This trial shows you no more excuses, no more 'What can we do? We can't get a diverse population in our trial.' The 1500 patients were done in 6 months.     So hello, you better be doing these really focused trials to make sure that the women, the Latinas, the African Americans are there. Just get them in your     trial."

Commenting to heartwire , Dr Vivek Reddy (Mount Sinai Medical Center) agreed that clinical-trial diversity is a problem even when     diversity mandates are in place.

But, he added, there also "are differences in how men look at randomized trials compared with men, meaning the amount of risk. There are also differences     probably in the trial enrollment materials; there haven't been any that are specifically geared toward women."

 

        The study was sponsored by Boston Scientific. Batchelor reported grant/research support from Boston Scientific and consulting fees/honoraria from         Abbott, Boston Scientific, and Medtronic. Mehran reported grant support from/research contracts with Daiichi Sankyo/Eli Lilly, Bristol-Myers Squibb,         AstraZeneca, the Medicines Company, OrbusNeich, Bayer, and CSL Behring; consultant fees/honoraria from or being on a speaker's bureau for Janssen Pharmaceuticals, Osprey         Medical, Watermark Research Partners, and Medscape; equity in Claret Medical and Elixir Medical; and other financial support from Abbott Vascular.         Weiner and Holmes reported no financial relationships. Dib reported consultant fees/honoraria from or being on a speaker's bureau for Cephalon/TEVA,         Cardiovascular Systems, and Biologics Delivery Systems. Hermann reported grants from/research contracts with WL Gore, Abbott, Boston Scientific, Edwards         Lifesciences, and Medtronic; and consultant fees/honoraria from or being on a speaker's bureau for Edwards Lifesciences. Reddy reported grant         support/research contracts and consultant fees/honoraria from or being on a speaker's bureau for Medtronic, St Jude Medical, and Coherex Medical.    

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