Angiographic Control vs Ischemia-Driven Management of Patients Treated With PCI on Left Main With Drug-Eluting Stents - PULSE

Sep 22, 2025
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Author/Summarized by Author:
Artur Schneider, DO
Summary Reviewer:
Fred M. Kusumoto, MD, FACC; Jordan Christopher Ray, MD, FACC
Original Posted Date:
09/22/2025
References

Contribution To Literature:

In the PULSE trial, CCTA following PCI for unprotected left main disease failed to reduce the composite primary endpoint of all-cause death, spontaneous MI, unstable angina, or definite or probable stent thrombosis.

Study Design

In this multicenter, open-label, single-blinded, superiority randomized trial, 606 patients who had undergone PCI with second-generation drug-eluting stents were randomized 1:1 to coronary computed tomography angiography (CCTA) at 6 months or standard symptom- and ischemia-driven follow-up. In the experimental arm, patients with ≥50% in-stent restenosis detected on CCTA underwent confirmatory coronary angiography, and revascularization was performed if restenosis was confirmed. Patients were followed for 18 months from randomization. The trial aimed to evaluate whether routine CCTA-based follow-up improves composite clinical outcomes compared with standard care in patients undergoing left main PCI with second-generation drug-eluting stents.

  • Total number of enrollees: 606
  • Duration of follow-up: 18 months
  • Mean patient age: 69 years
  • Demographics: 18% were female, 25% had diabetes mellitus, non-ST-segment elevation acute coronary syndrome was the most frequent admission diagnosis

Inclusion criteria:

  • Age 18-85 years old
  • Glomerular filtration rate >30 mL/min/1.73 m2
  • Indication to percutaneous revascularization of unprotected left main coronary artery according to SYNTAX score (<33) or, in dubious cases after heart team evaluation

Exclusion criteria:

  • Cardiogenic shock
  • Refusal or inability to provide informed consent

Principal Findings:

Primary outcome: No reduction in the composite primary endpoint (all-cause mortality, spontaneous myocardial infarction [MI], unstable angina, or stent thrombosis) at 18 months with routine CCTA (11.9%) compared with standard care (12.5%).

Secondary outcomes: The incidence of spontaneous MI was significantly lower with routine CCTA (0.9%) compared to the control group (4.9%). Clinically driven target-lesion revascularization (TLR; revascularization of the left main) did not differ between groups, but routine CCTA led to more imaging-triggered TLR (4.9% vs. 0.3%) and non-target-lesion revascularization (4.6% vs. 0%) compared to standard care. There was no difference in cardiovascular death, unstable angina episodes and stent thrombosis among groups.

Interpretation:

The PULSE trial resulted in no reduction in the predefined composite outcome of major adverse cardiac events at 18 months. These neutral findings are in alignment with previous trials assessing ischemia-guided post-PCI surveillance strategies, for example POST-PCI, and suggest that routine follow-up with noninvasive anatomic imaging does not affect cardiovascular outcomes. The trial was powered assuming a 15% major adverse cardiovascular event rate in the control arm with power to detect a 7.5% reduction in the experimental arm; however, overall event rates were lower in the control arm than expected, which could suggest insufficient power and higher risk for type II error.

In secondary analysis, this trial showed a statistically significant reduction in spontaneous MI in patients undergoing CCTA compared to control with an absolute risk reduction of 4% at 18 months (0.9% vs. 4.9%); this important finding suggests that routine CCTA post-PCI may have a role in select patients. Note, this benefit occurred alongside an increase in imaging-triggered revascularization of both target-lesion and non-target-lesion, while clinically driven revascularization did not differ between the groups (almost 30% of the spontaneous MIs in the control group were seen in the right coronary artery). Long-term follow-up in this patient population will show whether the reduction in spontaneous MIs translates into meaningful improvements in overall cardiovascular outcomes.

References:

D'Ascenzo F, Cerrato E, De Filippo O, et al. Computed tomography angiography or standard care after left main PCI?. J Am Coll Cardiol. Published online Aug. 26, 2025. doi:10.1016/j.jacc.2025.07.060.

Presented by Dr. Ovidio De Filippo at the European Society of Cardiology Congress, Madrid, Spain, Aug. 31, 2025.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: ESC Congress, ESC25, Drug-Eluting Stents, Percutaneous Coronary Intervention, Ischemia


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