October 14, 2020

Meta-Analysis Examines Mortality and Bleeding Rates for Bivalirudin Versus Heparin in Patients With MI

October 14, 2020—In a presentation at TCT Connect, an individual patient-data pooled analysis comparing the use of bivalirudin versus heparin in heart attack patients undergoing percutaneous coronary intervention (PCI) found that bivalirudin use was associated with similar overall rates of 30-day mortality across all heart attack patients, but lower rates of serious bleeding events. Moreover, mortality was reduced in patients with ST-segment elevation myocardial infarction (STEMI) who were treated with a post-PCI bivalirudin infusion.

TCT Connect is the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14–18, 2020.

According to the TCT press release, numerous randomized trials examining the outcomes of anticoagulation with bivalirudin versus heparin in patients undergoing PCI have reported conflicting results given varying patient populations, study designs, sample size, endpoints, and follow-up durations. Study-level meta-analyses have been unable to address these limitations, nor can they evaluate events over time, perform multivariable adjustment, or examine outcomes in important subgroups.

In this analysis, the investigators pooled the individual patient data from all eight randomized clinical trials of bivalirudin versus heparin in patients with MI (STEMI or non-STEMI [NSTEMI]) undergoing PCI that enrolled 1,000 or more patients: MATRIX, VALIDATE-SWEDEHEART, EUROMAX, BRIGHT, HEAT-PPCI, ISAR-REACT 4, ACUITY, and HORIZONS-AMI.

The final study cohort included 27,409 patients (13,346 randomized to bivalirudin and 14,063 randomized to heparin). Of these, 15,254 patients had STEMI and 12,155 had NSTEMI.

The prespecified primary effectiveness endpoint was the 30-day risk of all-cause mortality and the primary safety endpoint was the 30-day risk of serious bleeding (TIMI major or minor if available; alternatively, BARC type 3 or 5).

As summarized in the TCT press release, overall, bivalirudin was associated with similar rates of 30-day mortality (1.9% vs 2.1%; hazard ratio [HR] 0.91; 95% CI, 0.75-1.10) and lower rates of serious bleeding (3.4% vs 5.7%; HR, 0.6; 95% CI, 0.52-0.68). Further analyses were stratified by presentation (STEMI or NSTEMI).

In STEMI patients, all-cause mortality was lower with use of bivalirudin compared to heparin (2.5% vs 2.9%; HR, 0.80; 95% CI, 0.64, 1.01).

The mortality rates were substantially reduced with bivalirudin when a post-PCI bivalirudin infusion was used (HR 0.67; 95% CI, 0.50, 0.89). Serious bleeding was also lower with bivalirudin use (3.5% vs 6.0%, HR 0.57; 95% CI, 0.47, 0.68).

In NSTEMI patients, bivalirudin use and heparin use had similar rates of mortality (1.2% vs 1.1%; HR, 1.21; 95% CI, 0.84, 1.73), although bivalirudin use was also associated with lower rates of serious bleeding (3.3% vs 5.3%; HR, 0.63; 95% CI, 0.52, 0.76).

“This individual patient data pooled analysis aimed to determine the optimal anticoagulant to be used during PCI in patients with acute MI,” commented Gregg W. Stone, MD, in the TCT announcement. “In patients with STEMI undergoing primary PCI, bivalirudin use was associated with reductions in the 30-day rates of mortality, serious bleeding, and net adverse clinical events, despite increased rates of MI and stent thrombosis compared with heparin. The mortality benefit of bivalirudin in STEMI was pronounced in patients treated with a post-PCI bivalirudin infusion (low-dose or high-dose); a high-dose infusion mitigated the MI and stent thrombosis risk.”

Dr. Stone added, “In patients with NSTEMI undergoing PCI, bivalirudin use was associated with a reduction in the 30-day rate of serious bleeding but similar rates of mortality, MI, and stent thrombosis compared with heparin.”


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