AIMS
Severe coronary artery calcification remains a major challenge during percutaneous coronary intervention (PCI), frequently resulting in inadequate lesion preparation, stent under-expansion, and adverse clinical outcomes. Intravascular lithotripsy (IVL) has emerged as a novel calcium-modifying technology; however, real-world data in complex lesion subsets and South Asian populations are limited.
Objectives:
This study sought to evaluate the short- and long-term safety and effectiveness of IVL-facilitated PCI in patients with severely calcified coronary lesions in a real-world Indian cohort.
METHODS AND RESULTS
Severely Calcified Coronary Artery Lesions Treated with High-Pressure Intravascular Lithotripsy – A Real-World Single-Center Indian Experience: SHINE-IVL Study was a single-center, single-arm, observational study including 150 consecutive patients (180 lesions) undergoing IVL-assisted PCI between February 2020 and March 2025. Angiographic or imaging evidence of severe calcification was present in all treated lesions. All-comer calcified lesions, including in stent-restenosis and total occlusions, were included. The primary effectiveness endpoint was procedural success, defined as residual stenosis <30% with final TIMI III flow. The primary safety endpoint was major adverse cardiovascular events (MACE), defined as a composite of cardiac death, myocardial infarction (MI), stroke, and target lesion or target vessel revascularization (TLR/TVR) at 1 month, 6 months, and 1 year.
Results:
The mean age was 69.1±9.8 years, with 52% aged ≥70 years; 80.7% were male. Cardiovascular risk burden was high, with diabetes in 72%, hypertension in 76.7%, renal insufficiency in 16%, and dyslipidemia in 26.7%. Acute coronary syndromes accounted for 62% of presentations. Left ventricular (LV) function is normal in 55% of the cohort, and severe systolic dysfunction in 13%. A total of 180 severely calcified lesions were treated, including left main disease (21.2%), multi-vessel PCI (20.6%), in-stent restenosis (11.3%), and total occlusions (30.7%), Bifurcation lesions (30%). Intravascular imaging was used in 94.7% of cases (IVUS 62%, OCT 32.7%).
Overall procedural success was achieved in 99.3% of the study cohort with TIMI III flow. IVL achieved high effectiveness across complex subsets, with procedural success of 94.2% in ISR lesions and 91.3% in total occlusions. Adjunctive calcium-modifying devices were required in selected lesions, including rotational atherectomy (8.7%), orbital atherectomy (2.7%), excimer laser (1.3%) in balloon uncrossable lesions followed by IVL, and cutting balloons (12%). Overall complication rate was 15.3%, including dissections (5.3%), transient slow-flow/no-reflow (7.3%), perforations (1.3%), and subacute stent thrombosis (1.3%), all managed successfully. MACE rates were 8% at 30 days, 10.6% at 6 months, and 12% at 1 year (n=133: cardiac death: 8.7%, MI: 1.3%, TVR/TLR: 4.0%, without any bleeding and stroke).
CONCLUSIONS
In a high-risk, elderly, real-world Indian population with complex and severely calcified coronary lesions, IVL-facilitated PCI demonstrated excellent procedural success, high stent deliverability with acceptable complication and mid-term MACE rates. These findings support IVL as a safe and effective calcium-modifying strategy for complex coronary interventions in routine clinical practice.