番茄社区

BARCELONA -- For coronary angiography with or without percutaneous coronary intervention (PCI), radial access bested femoral access not only for reduced bleeding, but mortality as well, according to a meta-analysis by the Radial Trialists' Collaboration.

Compared with transfemoral procedures, transradial procedures were associated with reductions in both 30-day all-cause mortality (1.6% vs 2.1%, adjusted HR 0.76, 95% CI 0.61-0.94) and major bleeding (1.5% vs 2.7%, adjusted HR 0.49, 95% CI 0.39-0.60), reported Giuseppe Gargiulo, MD, PhD, of University Federico II of Naples, Italy.

His group analyzed seven higher-quality multicenter randomized trials that had data available at the individual level for 21,600 patients with suspected or confirmed coronary artery disease. This meta-analysis, presented at the European Society of Cardiology (ESC) Congress, was simultaneously published in .

European and U.S. guidelines already endorse a radial-first strategy coronary intervention because of its relative safety.

"Now we have definitive data that transradial access reduces mortality," Gargiulo emphasized.

He noted that the survival benefit associated with radial access was namely seen in people with significant anemia, not those with mild or no baseline anemia.

"Whether the absence of a statistically significant prognostic advantage of TRA [transradial access] over TFA [transfemoral access] in the subgroup of patients with milder or no anemia reflects a power issue, in a relatively low-risk study cohort, warrants further analysis," the authors wrote.

They cautioned that clinicians should not prioritize transradial access only in people with documented baseline anemia, "especially considering that this information may be unknown at the time of access site selection in urgent settings and that the reduction in major bleeding ... was remarkable regardless of baseline hemoglobin and largely consistent across analyses."

ESC session discussant Gregg Stone, MD, of the Icahn School of Medicine at Mount Sinai in New York City, also identified patients with ST-elevation myocardial infarction (STEMI) and those who had an operator with high radial experience as the groups for whom radial access had the largest survival effect.

"These data strongly support radial intervention in these settings, but provide some reassurance (to predominant femoral operators, or when TRA is difficult) that mortality may not be increased with TFA in patients without STEMI or significant anemia, and that use of bivalirudin [Angiomax] mitigates the bleeding risk," Stone said.

Notably, the most frequent complication of this approach, radial artery occlusion, may restrict future percutaneous operations and use of the artery as a conduit for coronary artery bypass grafting surgery.

For the Radial Trialists' Collaboration meta-analysis, main results were based on an intention-to-treat analysis. The findings were consistent on a per-protocol basis. Participating operators in the seven included trials were all experienced in both access approaches.

The large cohort of patients had a median age of 64 years, and 32% were women. The overwhelming majority presented with acute coronary syndrome.

Roughly three in four people underwent PCI, with the rest undergoing coronary angiography alone.

Rates of MI, stroke, and stent thrombosis were unaffected by access site selection.

The mortality difference between radial and femoral access appeared to be driven only partly by prevention of major bleeding. Ancillary access-related mechanisms, unrelated to bleeding, therefore must play a role in survival, Gargiulo said.

At a press conference, he suggested a possible link between reduced acute kidney injury after transradial procedures and better survival for patients. However, this hypothesis goes beyond the scope of the available data, he cautioned.

Stone pointed out the lack of 1-year data in these trials, noting that "it may take time for the bleeding effect to translate into a mortality benefit."

Gargiulo and colleagues also acknowledged that their meta-analysis was subject to the limitations of each trial included. Across trials, there was also some heterogeneity in antithrombotic therapies and devices used, clinical presentation, and bleeding definition and management.

Comment