Registry Finds Overall Decrease in Post-PCI Bleeding but Not in STEMI

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Bleeding rates are steadily dropping after both elective and emergent percutaneous coronary intervention (PCI), according to registry data published in the May 22, 2012, issue of the Journal of the American College of Cardiology. But the decrease—nearly half of which can be traced to changing antithrombotic strategies—was absent in patients with ST-segment elevation myocardial infarction (STEMI).

Sumeet Subherwal, MD, MBA, of Duke Clinical Research Institute (Durham, NC), and colleagues investigated temporal trends in post-PCI bleeding documented by the National Cardiovascular Data CathPCI registry from 2005 to 2009. Patients undergoing elective PCI (n = 599,524) were included, as were those being treated for unstable angina/NSTEMI (n = 836,103) or STEMI (n = 267,632).

Over the study period, radial access remained low at less than 3%, while closure device use increased slightly (from 44% to 49%). Bivalirudin use became more common (from 17% to 30%), while the use of heparin plus glycoprotein IIb/IIIa inhibitors (GPIs) became less frequent (from 41% to 28%).

Overall, patients treated in 2009 experienced approximately 20% less post-PCI bleeding compared with those treated in 2005 (2.0% vs. 2.4%). But the shift was apparent only in elective PCI and unstable angina/NSTEMI cases; after adjustment for clinical characteristics, these groups had annual reductions in bleeding risk that ranged from 6% to 8%, whereas STEMI patients showed no significant improvement (table 1).

Table 1. Changes in Post-PCI Bleeding

Notably, all 3 groups saw reductions in access site bleeding (P < 0.001), while non-access site bleeding held steady for elective PCI and unstable/NSTEMI but increased for STEMI (from 2.6% in 2005 to 3.1% in 2009; P < 0.001).

Adjustment for various factors including baseline patient characteristics, vascular strategies (access route and closure device), and anticoagulation strategy (heparin or bivalirudin, with or without GPI use) showed that differences in anticoagulation were responsible for half of the annual reduction.

Anticoagulation Key but Not Alone

The investigators characterize the decrease in bleeding as “modest, but significant,” noting that while vascular strategies remained fairly constant over the course of the study, changes in anticoagulant strategy were “marked.”

“[I]t must be emphasized that changes in anticoagulation strategy only partly explain the decrease in bleeding,” they stress. “Unmeasured variables such as clinician bias in selecting patients for intervention with lower complication risk, bias in choice of vascular access strategy, bias in selection of antithrombotic choice, improvements in antithrombotic dosing, and greater physician awareness of bleeding risk may also contribute to [the change].” In addition, the study did not account for sheath size, the timing of sheath removal, duration of manual compression, or specific anticoagulant doses.

According to Dr. Subherwal and colleagues, STEMI patients may have been hindered by more aggressive anticoagulation with thrombolytics (11.8%) and higher use of intra-aortic balloon pump (10%). They also were less likely to receive radial PCI and closure devices. Moreover, “[t]he increase in non-access site bleeding seen with the STEMI group might have offset the benefit in access site bleeding reduction over time,” the researchers add.

Improved Awareness Has Impact

In a telephone interview, Deepak L. Bhatt, MD, MPH, of Brigham and Women's Hospital (Boston, MA), told TCTMD that the findings “are important, and they’re believable. I think because of the focus that we collectively as an interventional community have had on bleeding these past few years—and the fact that we’re measuring it and reporting it—has led to decreased rates of bleeding.

“It’s been an appropriate focus, because there are enough data now suggesting that bleeding might be associated with other bad events including ischemic events,” he continued. “Regardless of how robust [you think that link is,] no patient wants to bleed. So trying to prevent bleeding for its own sake is a good enough reason.”

Changes are still occurring, he said, with radial access seeing more uptake over the past 6 months. “Eventually that will contribute to less bleeding,” Dr. Bhatt said, noting that femoral access is also becoming more refined. Techniques include using smaller sheaths in the femoral arteries and avoiding routine right heart catheterization, which requires an additional venous sheath. “Also, just taking care in terms of femoral artery access [may help reduce bleeding]. A lot of people now use fluoroscopy to find the femoral head, some use ultrasound, and some use micropuncture kits,” he added.

In short, “there has been a lot of progress made, but there’s still room for improvement, particularly in high-risk patients like [those with] STEMI,” Dr. Bhatt concluded.

 

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Source:
Subherwal S, Peterson ED, Dai D, et al. Temporal trends in and factors associated with bleeding complications among patients undergoing percutaneous coronary intervention: A report from the National Cardiovascular Data CathPCI Registry. J Am Coll Cardiol. 2012;59:1861-1869.

 

 

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