STEMI Protocol Reduces Disparity Between Sexes, Improves Outcomes

While full parity may be impossible, a 4-step protocol did decrease discrepancies in clinical outcomes and mortality between men and women.

Umesh Khot, MD

The implementation of a 4-step protocol for ST-elevation myocardial infarction (STEMI) not only improved clinical outcomes and reduced mortality in both male and female patients but also eliminated the disparities often seen in care and outcomes that typically occur between the sexes.

Presented at the 67th American College of Cardiology Scientific Sessions in Orlando, Florida, the Cleveland Clinic study investigated STEMI outcomes and care in 1272 patients (68% male, n = 868; 32% female, n = 404) by implementing a protocol consisting of 4-steps:

  1. Emergency department catheterization lab activation.
  2. STEMI Safe Handoff Checklist.
  3. Immediate transfer to an immediately available catheterization lab.
  4. Radial artery as the first-approach to percutaneous coronary intervention (PCI).

Prospectively, the team examined the use of guideline-directed medical therapy (GDMT) prior to PCI, the median door to balloon time (D2BT), in-hospital adverse events (AEs), and 30-mortality with stratification by sex before—from January 1, 2011, to July 14, 2014 (control)—and after—from July 15, 2014, to December 31, 2016—implementation of the STEMI protocol.

"It's long been known that the gender gap for these types of critical heart attacks is a real issue. However, there is very little data demonstrating successful strategies and no formal recommendation on how a system should be designed to provide the best possible care for women," Umesh Khot, MD, the vice chairman of Cardiovascular Medicine at Cleveland Clinic and senior author of the study, said in a statement. "Our research shows that putting into place a system that minimizes care variability raises the level of care for everyone and could be the first step to resolving the long-standing gender disparities."

The results showed improvements in reductions in 30-day mortality for both men (6.5%) and women (3.3%), with the differences post-protocol no longer being statistically significant between the sexes. Prior to the protocol, the absolute difference in 30-day mortality was 6.1% higher in women (P = .002), whereas post-protocol it was only 3.2% higher (P = .090).

The rate of GDMT in the pre-protocol control time was 69% in women compared to 77% in men (P = .019) and D2BT was 112 minutes in women compared to 104 minutes in men (P = .023). Women also had higher rates of in-hospital AEs such as stroke, vascular complications, bleeding, transfusion, and death. After implementation of the 4-step protocol, gender disparities were resolved in GDMT (84% vs. 80%; P = .320), D2BT (89 mins [range, 68—106] vs. 91 mins [range, 68–114]; P = .250), as well as in-hospital AEs. In-hospital death in women was reduced by an estimated 50% with the STEMI protocol.

Cardiovascular disease is the leading cause of death in women and STEMI is experienced by an estimated 1 million women annually, underscoring the need to improve care and reduce gender disparities in treatment.

Despite this, some studies have suggested that these discrepancies between genders in relation to care and outcomes may be due to women with STEMI tending to be older and at higher risk than their male counterparts—women in this study were older and more comorbid—leading many physicians to believe that the ability to increase parity may be limited.

The study, “Four-Step Protocol for Disparities in STEMI Care and Outcomes in Women,” was simultaneously published in the Journal of the American College of Cardiology.

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