Coronary artery disease is common in patients with severe aortic stenosis undergoing TAVI. Current guidelines recommend considering revascularization in significant coronary lesions, particularly in proximal segments of major vessels or the left main coronary artery, although the level of evidence remains limited. In this context, the PRO-TAVI trial was designed to evaluate whether a strategy of omitting routine pre-TAVI coronary angioplasty (i.e., treating only if clinically indicated afterward) is non-inferior to planned revascularization prior to TAVI.
This was a randomized, open-label, multicenter non-inferiority clinical trial conducted in the Netherlands, including 466 patients with an indication for TAVI and significant coronary artery disease (70–99% stenosis or 40–70% with functional evidence). Patients with unprotected left main disease and those with contraindications to dual antiplatelet therapy were excluded. The population did not present complex diffuse disease, with a low-to-intermediate SYNTAX score (median 10), and approximately 21% of lesions were located in the proximal LAD.
Patients were assigned to a strategy of no routine revascularization (n=233) or PCI prior to TAVI (n=233). The mean age was 81 years, with 35–36% women, an STS-PROM score of 3.1, and preserved left ventricular ejection fraction in 70–75% of cases.
The results showed that the strategy of not performing routine PCI before TAVI was non-inferior to prior revascularization for the composite endpoint at one year (all-cause mortality, myocardial infarction, stroke, and major bleeding), with no significant increase in major ischemic events. Individual components (mortality, MI, and stroke) were similar between groups, and no clinical benefit of routine revascularization was observed. The need for subsequent PCI in the conservative group was low and limited to patients with clinical indications during follow-up.
Conclusión: omission of routine revascularization redefines strategy in TAVI patients with stable coronary disease
In conclusion, the PRO-TAVI trial demonstrates that, in patients with severe aortic stenosis and stable coronary artery disease, omitting routine coronary angioplasty prior to TAVI is a safe strategy and non-inferior to planned revascularization in terms of major clinical events at one year. These findings challenge the practice of routine revascularization and support a more pragmatic, selective approach based on clinical indication, with potential impact on treatment simplification and bleeding risk reduction.
Original Title: Deferral of PCI in Patients Undergoing TAVI: Results from the PRO-TAVI Trial.
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