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PCI Reduces MACE in Nonfrail Patients With CAD and Severe Aortic Stenosis Undergoing TAVRPCI reduces heart events in nonfrail patients but increases bleeding risk for frail patients

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Key Takeaway
Consider PCI for nonfrail undergoing TAVR, but monitor bleeding risk in frail patients given post hoc.

This international randomized controlled trial included 407 patients with coronary artery disease and severe aortic stenosis undergoing transcatheter aortic valve replacement. The setting was international. Participants were assigned to percutaneous coronary intervention or conservative treatment. The primary outcome was a composite of all-cause mortality, myocardial infarction, and urgent coronary revascularization. Follow-up duration was 24.0 months.

In nonfrail patients, percutaneous coronary intervention reduced the primary composite outcome compared to conservative treatment. HR: 0.42 with 95% CI: 0.25-0.69. The absolute event rates were 15% vs 33%. Statistical significance was observed with P < 0.001. All-cause death showed a reduced rate with P = 0.019. Myocardial infarction incidence was reduced with P = 0.004. Urgent coronary revascularization was also reduced with P = 0.005.

Outcomes differed significantly based on frailty status. In frail patients, there was no difference in the composite outcome. However, bleeding adverse events increased in this subgroup. HR: 2.51 with 95% CI: 1.23-5.11. P = 0.011. Serious adverse events and discontinuations were not reported.

Key limitations include that frailty was assessed post hoc. Findings require confirmation in larger prospective studies. While the intervention showed benefit in nonfrail individuals, clinicians must weigh the increased bleeding risk in frail patients. The evidence supports selective use but requires further validation before broad implementation. Clinical decisions should account for these factors.

This study looked at 407 patients who had both coronary artery disease and severe aortic stenosis. These patients were getting a heart valve procedure called TAVR. Researchers compared using a stent to open blocked arteries against a conservative approach without stents. The goal was to see if opening the arteries improved heart health over two years.

The results depended heavily on how frail the patients were. For patients who were not frail, using stents reduced major heart events like death, heart attacks, and the need for urgent procedures. About 15% of nonfrail patients had these events compared to 33% in the conservative group. However, for frail patients, there was no benefit.

Safety concerns were noted, particularly regarding bleeding. Frail patients who received stents had a higher risk of bleeding compared to those who did not. The study authors note that frailty was assessed after the study started, which limits the strength of this finding. They say these results need confirmation in larger studies before changing standard care.

Readers should understand this is one study with specific conditions. It suggests a potential benefit for some patients but highlights risks for others. Patients should discuss their individual health status with their doctor before making decisions about heart procedures.

What this means for you:
Stents helped nonfrail patients avoid heart events but raised bleeding risks for frail ones; results need confirmation.

Study Details

Study typeRct
Sample sizen = 407
EvidenceLevel 2
Follow-up24.0 mo
PublishedApr 2026
View Original Abstract ↓
BACKGROUND: Frailty is an important predictor of outcomes in patients with coronary artery disease (CAD) and following transcatheter aortic valve replacement (TAVR). The NOTION-3 (Third Nordic Aortic Valve Intervention) trial demonstrated that performing percutaneous coronary intervention (PCI) in addition to TAVR reduced the risk for major adverse cardiac events (MACE). Whether this benefit applies to frail patients remains uncertain. OBJECTIVES: The aim of this study was to evaluate efficacy and safety of PCI in frail TAVR patients with CAD. METHODS: NOTION-3 was an international, open-label, randomized superiority trial enrolling patients with CAD and severe aortic stenosis undergoing TAVR. Patients were randomized 1:1 to PCI or conservative treatment. Frailty was assessed post hoc using a calculated frailty score derived from baseline data on symptom-related limitations, daily function, and quality of life. Primary endpoint was a composite of all-cause mortality, myocardial infarction (MI), and urgent coronary revascularization. Safety endpoints included bleeding and acute kidney injury. RESULTS: Frailty data were available for 407 patients (90%), of whom 130 (32%) were frail. During median follow-up of 2 years (Q1-Q3: 1-4 years), PCI reduced MACE in nonfrail patients (15% vs 33%; HR: 0.42; 95% CI: 0.25-0.69; P < 0.001), as well as death of any cause (P = 0.019), MI (P = 0.004), and urgent revascularization (P = 0.005). No differences were observed in frail patients. In contrast, frail patients undergoing PCI had more bleeding events (HR: 2.51; 95% CI: 1.23-5.11; P = 0.011). CONCLUSIONS: In nonfrail patients with CAD undergoing TAVR, PCI lowered the risk for MACE, all-cause mortality, and MI compared to conservative treatment. In frail patients, PCI increased bleeding without clinical benefit. These findings require confirmation in larger prospective studies.
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