Cardiology · Medical Literature
Intravascular lithotripsy in comparison to rotational atherectomy for calcified lesions: the ICARE OFDI randomised trial.
Abstract
The management of calcified coronary lesions remains challenging. Although several devices for advanced plaque modification are available, their relative efficacy is debated. We aimed to compare intravascular lithotripsy (IVL)- and rotational atherectomy (RA)-based strategies for calcified plaque preparation during percutaneous coronary interventions (PCI). This multicentre, prospective, randomised non-inferiority trial compared IVL with RA for plaque preparation in moderate-to-severe stable calcified coronary lesions. All interventions were guided by optical frequency domain imaging. A non-inferiority margin of 0.75 mm2 was prospectively defined based on prior intracoronary imaging studies, and the sample size calculation was based on a standard deviation of 1.9 mm2, a one-sided alpha risk of 5%, and a power of 80%, under the assumption of no true difference between groups. The primary endpoint was the minimal stent area (MSA) following stent implantation. The target lesion failure (TLF) rate was analysed after 12 months. A total of 169 patients (RA: n=86, IVL: n=83; 81.1% male; mean age 71.8±8.2 years) were included in the final analysis. The baseline characteristics of each group were balanced. Calcified nodules were identified in 48% of the patients. IVL was not inferior to RA for the primary endpoint (6.0±2.3 mm2 vs 5.9±2.2 mm2, respectively; p for non-inferiority<0.05). Adequate geometrical stent expansion was similar in both groups (RA: 65.1%, IVL: 65.1%; p=0.994), whereas major strut malapposition was more frequently observed in the RA group (RA: 80.2% vs IVL: 57.8%; p=0.002). There was no difference between groups in terms of periprocedural complications. The TLF rates between groups after 12 months were equivalent (RA: 1.2%, IVL: 2.4%; p=0.61). In this trial, the IVL strategy was non-inferior to the RA strategy regarding MSA for PCI in moderate-to-severe calcified coronary lesions, with a comparable safety profile and equivalent clinical outcomes.
Clinical relevance
In patients with moderate-to-severe stable calcified coronary lesions undergoing OFDI-guided PCI, is intravascular lithotripsy (IVL) non-inferior to rotational atherectomy (RA) for achieving an adequate post-stent minimal stent area (MSA)? __SNAPSHOT__ {"studyDesign":"Prospective, multicentre, randomised non-inferiority trial (mechanistic imaging study)","setting":"14 French interventional cardiology centres","sampleSize":"n=169 (RA: n=86, IVL: n=83)","population":"Adults with moderate-to-severe stable calcified coronary lesions on OFDI; mean age 71.8 ± 8.2 years; 81.1% male; calcified nodules present in 48%; lesions had to be crossable with a 2.0 mm semi-compliant balloon prior to randomisation. Excluded: left main disease, chronic total occlusions, and very long lesions (specific length cut-off not reported in available abstract).","intervention":"Intravascular lithotripsy (IVL) using Shockwave C2 or C2+ device (Shockwave Medical/Johnson & Johnson MedTech) followed by implantation of Ultimaster Tansei drug-eluting stent (Terumo) with mandatory post-dilation, all under OFDI guidance","comparator":"Rotational atherectomy (RA) using Rotapro (Boston Scientific) followed by implantation of Ultimaster Tansei DES with mandatory post-dilation, all under OFDI guidance","primaryOutcome":"Minimal stent area (MSA) after stent implantation, assessed by optical frequency domain imaging (OFDI); pre-specified non-inferiority margin of 0.75 mm²","followUp":"12 months (for target lesion failure); MSA assessed acutely post-procedure","fundingSource":"Industry (investigator-initiated study grant from Terumo Europe); lead investigator disclosed consulting fees and honoraria from Abbott, Boston Scientific, Shockwave Medical, and Medtronic"}
Key findings
IVL met the pre-specified non-inferiority criterion for the primary endpoint of post-stent MSA: IVL 6.0 ± 2.3 mm² vs. RA 5.9 ± 2.2 mm² (p for non-inferiority < 0.05; absolute difference ~0.1 mm², well within the 0.75 mm² margin). Adequate geometrical stent expansion was identical between groups (IVL 65.1% vs. RA 65.1%; p = 0.994). A statistically significant difference in major strut malapposition was observed, occurring more frequently in the RA arm (RA 80.2% vs. IVL 57.8%; p = 0.002); the absolute risk difference is 22.4 percentage points (calculated). Periprocedural complications were similar between groups overall; however, a non-significant trend toward more periprocedural MI was observed in the RA arm (RA 5.8% vs. IVL 0%; p = 0.06). Total fluoroscopy time (median 18.9 vs. 15.9 min; p = 0.003) and contrast volume (median 190 vs. 160 mL; p = 0.024) were significantly higher with RA than with IVL. At 12 months, TLF rates were low and statistically equivalent between groups (RA 1.2% vs. IVL 2.4%; p = 0.61); NNT/NNH for TLF are not calculable from these data as the difference was non-significant and the trial was not powered for this endpoint. One patient crossed over from IVL to RA. Confidence intervals for primary and secondary outcomes were not reported in available sources.
Practice implications
This trial establishes non-inferiority of IVL versus RA for the imaging surrogate endpoint of post-stent MSA in a highly selected population with crossable moderate-to-severe calcified coronary lesions undergoing OFDI-guided PCI. The study does NOT establish clinical superiority of either strategy, nor does it demonstrate superiority of IVL for hard clinical endpoints (cardiac death, MI, TLR). The lower rate of major strut malapposition with IVL, while statistically significant, did not translate into a detectable difference in 12-month TLF, and its long-term clinical relevance is unproven. Critically, the trial enrolled only balloon-crossable lesions, explicitly excluding the most anatomically challenging cases (left main disease, CTOs, very long lesions) where RA may retain a preferential role. Findings cannot be generalised to uncrossable or wire-resistant lesions, high-risk PCI scenarios, or patients with acute coronary syndromes. The use of a single mandated DES platform (Ultimaster Tansei) limits generalisability to other stent systems. The 48% prevalence of calcified nodules—a particularly challenging substrate—reflects anatomical complexity but limits comparability with broader PCI populations. Results suggest that, for suitable crossable lesions with OFDI guidance, device choice may be driven by operator expertise, local availability, and lesion morphology rather than a mandate for one modality over the other. Practice change is not warranted at this time; the findings are best interpreted as hypothesis-generating and supportive of equipoise between these two strategies in the specific population studied. Only the abstract and secondary reporting sources were available for this review; full data tables and subgroup analyses were not accessible. __LIMITATIONS__ Small sample size (n=169), limiting statistical power to detect differences in clinical endpoints; the trial was explicitly powered only for the imaging surrogate (MSA), not for TLF or other clinical events.,Surrogate primary endpoint (MSA by OFDI): clinical significance of MSA differences at or near the 0.75 mm² non-inferiority margin is uncertain and not directly validated against hard outcomes in this study.,Highly selected population: mandatory 2.0 mm balloon crossability criterion excludes the most severely calcified, uncrossable lesions where RA has historically been preferred, limiting generalisability.,Exclusion of left main disease, CTOs, and very long lesions further restricts applicability to routine complex calcified PCI.,Single mandated stent platform (Ultimaster Tansei DES) restricts generalisability to other drug-eluting stent systems.,Industry funding (Terumo Europe) with significant conflicts of interest: lead investigator received consulting fees and honoraria from manufacturers of competing devices (Abbott, Boston Scientific, Shockwave Medical, Medtronic).,Non-inferiority margin of 0.75 mm² was prospectively defined but its clinical meaningfulness is debated; choice of margin critically affects non-inferiority conclusions.,Predominantly male cohort (81.1%) from French centres only; results may not generalise to female patients or other healthcare systems.,12-month follow-up is insufficient to detect late adverse events (e.g., late stent thrombosis, late TLF) related to the persistently high malapposition rates observed.,The clinical significance of the observed difference in major strut malapposition (80.2% RA vs. 57.8% IVL) remains uncertain without longer-term outcome data.,Confidence intervals for key outcomes were not reported in available sources, limiting precise interpretation of effect magnitude.,Single crossover from IVL to RA and the analysis approach (ITT vs. per-protocol) were not clarified in available reporting. __BOTTOM_LINE_CATEGORY__ potentially_practice_informing __BOTTOM_LINE__ In OFDI-guided PCI for crossable moderate-to-severe calcified coronary lesions, IVL achieved non-inferior post-stent MSA compared with RA, with equivalent stent expansion rates, comparable procedural safety, and similar 12-month TLF. IVL produced significantly less major strut malapposition, though the clinical relevance of this imaging finding remains unresolved at 12 months. Pending larger, clinically powered trials, device selection for crossable calcified lesions may reasonably be guided by local availability, operator expertise, and lesion morphology rather than a strict algorithmic preference for either modality.