Reply to the letter on “Intravascular lithotripsy for calcified left main coronary artery disease: procedural outcomes and two-year clinical follow-up”
1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland
Poznan University of Medical Sciences, Poznan, Poland
We would
like to thank the authors for their insightful and constructive comments
regarding our manuscript. We appreciate the opportunity to clarify several
important methodological and interpretative aspects of our study.
We fully
acknowledge the conceptual concern that direct comparison between left main
(LM) and non-LM intravascular lithotripsy (IVL) procedures may involve
inherently different anatomical, procedural, and prognostic contexts. Our
intention was not to imply procedural equivalence between these groups [1].
Although
our cohort represents one of the larger real-world datasets reported to date in
this specific setting, the study was not originally designed or powered to
assess long-term clinical endpoints or to formally compare LM versus non-LM
outcomes [1]. Rather, it reflects a prospective analysis of consecutive
patients undergoing percuntaneous coronary intervention (PCI) with Shockwave C2
and C2+ IVL in a high-volume tertiary center. The inclusion of the non-LM
cohort was intended to provide a broader clinical context and to situate
LM IVL outcomes within contemporary daily practice. At the same time, we agree
that these groups are inherently heterogeneous, as also reflected by
differences in baseline characteristics, anatomical complexity (e.g., higher SYNTAX
score), and procedural features in the LM cohort. This heterogeneity may have
influenced the observed outcomes.
We
appreciate the authors’ comment regarding the numerically higher 2-year
all-cause mortality in the LM group (14.8% vs. 6.3%). We fully agree that the
absence of statistical significance (p = 0.087) should not be
interpreted as evidence of equivalence. Importantly, our study was not designed
as a non-inferiority or equivalence trial, and the sample size – although
relatively large for this clinical niche – remains insufficient for definitive
comparisons of long-term clinical endpoints. The limited number of events
further restricts statistical power.
We...
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