Coronary artery calcification is increasingly prevalent in our patient population. It significantly limits the procedural success of percutaneous coronary intervention and is associated with a higher risk of adverse cardiovascular events both in the short-term and long-term.
Study | Study Arms | Relevant Endpoint(s) | Outcomes/Results * | Conclusions |
---|---|---|---|---|
Cutting Balloon Angioplasty | ||||
GRT [10] | CBA vs. PTCA | Binary restenosis after 6 months | CBA: 31.4% PTCA: 30.4% p = NS |
No reduction in restenosis with CBA after 6 months. |
REDUCE (unpublished) | CBA vs. PTCA | Binary restenosis after 6 months | CBA: 32.7% PTCA: 25.5% p = NS |
No reduction in restenosis with CBA after 6 months. |
RESCUT [11] | CBA vs. PTCA for ISR | Binary restenosis after 7 months | CBA: 29.8% PTCA: 31.4% p = NS |
No reduction in recurrent ISR with CBA after 7 months. |
CBA before DES [12] | CBA before DES vs. BA | Minimum stent CSA (mm2), Acute lumen gain (mm2) | CBA:6.26 ± 0.4, 3.74 ± 0.38 BA:5.03 ± 0.33, 2.44 ± 0.29 p = 0.031, 0.015 |
CBA achieved larger lumen CSA and larger lumen gain compared to BA. |
Mechanisms of Acute Lumen Gain Following Cutting Balloon Angioplasty in Calcified and Noncalcified Lesions [13] | CBA vs. BA in calcified and non-calcified group | ΔEEM CSA (mm2), ΔP + M CSA (mm2), Δlumen CSA (mm2) | Calcified lesions: CBA: 1.4 ± 1.7, −2.3 ± 1.9, 3.7 ± 1.5 BA: 1.2 ± 1.2, −1.8 ± 1.9, 3.0 ± 1.5 p = NS, NS, 0.05 Non-calcified lesions: CBA: 1.0 ± 1.8, −2.9 ± 2.1, 3.9 ± 1.9 BA: 1.6 ± 1.8, −2.0 ± 1.9, 3.6 ± 1.6 p = NS(0.11), 0.03, NS |
In calcified lesions, CBA achieves a larger lumen gain vs. BA. In noncalcified lesions, there is larger plaque reduction with CBA but no difference in lumen gain vs. BA. |
Scoring Balloon Angioplasty | ||||
Intimal disruption and cobalt-chromium DES [14] | SBA vs. BA | Stent expansion, lumen eccentricity, intimal disruption frequency, extent |
SBA: 68%, 0.94, 68%, 122° BA: 62.1%, 0.80, 0.8, 65° p = 0.017, 0.18, 0.035, 0.035 |
SBA achieved increased stent expansion with similar lumen eccentricity when compared with BA. SBA had more frequent and extensive intimal disruption when compared with BA. |
Predilatation with SBA vs. NC [15] | SBA vs. NC | Stent expansion (mm), in-stent late loss after 1 year (mm) | SBA: 70.7 ± 11.2, 0.71 ± 0.63 NC: 69.1 ± 11.1, 0.23 ± 0.52 p = NS, 0.03 |
SBA achieved decreased in-stent late loss when compared to NC after 1 year. There was no difference in stent expansion between SBA and NC groups. |
Rotational Atherectomy | ||||
ERBAC [16] | RA vs. ELCA vs. PTCA | Procedural success ∑, TVR after 6 months | RA: 89%, 42.4% ELCA: 77%, 46% PTCA: 80%, 31.9% p = 0.0019, 0.013 |
RA achieved superior procedural success when compared with ELCA and PTCA, but both RA and ELCA had unfavorable late outcomes when compared with PTCA. |
COBRA [17] | RA vs. PTCA | Binary restenosis after 6 months | RA: 49% PTCA: 51% p = 0.35 |
RA did not reduce restenosis after 6 months when compared with PTCA. |
DART [18] | RA vs. PTCA in small vessels (2–3 mm) | TVF after 12 months | RA: 30.5% PTCA: 31.2% p = 0.98 |
RA did not reduce TVF after 12 months when compared with PTCA. |
STRATAS [19] | Aggressive RA (B/A 0.7–0.9) with PTCA (<1 bar) vs. routine RA (B/A < 0.7) with PTCA (4 bar) | Binary restenosis after 6 months | Aggressive: 58% Routine: 52% p = NS |
Aggressive RA debulking did not reduce restenosis after 6 months when compared with routine RA debulking. |
CARAT [20] | Aggressive RA (B/A > 0.7) vs. Routine RA (B/A = 0.7) | MACE after 6 months | Aggressive: 36.3% Routine: 32.7% p = NS |
Aggressive RA debulking did not reduce MACE after 6 months compared with routine RA debulking. |
ROOSTER [21] | RA (B/A = 0.7) vs. PTCA for diffuse ISR with IVUS guidance | TLR after 9 months | RA: 32% PTCA: 45% p = 0.04 |
RA achieved less TLR after 9 months compared with PTCA in diffuse ISR. |
ARTIST [22] | RA (B/A = 0.7) vs. PTCA for diffuse ISR with IVUS guidance in a subset | MACE after 6 months | RA: 80% PTCA: 91% p = 0.0052 |
PTCA achieved a lower MACE when compared to RA in diffuse ISR. |
ROTAXUS [23] | RA with DES vs. DES | Late lumen loss (mm) after 9 months | RA with DES: 0.31 ± 0.52 DES: 0.44 ± 0.58 p = 0.04 |
RA before DES achieved increased late lumen loss when compared to DES alone. |
Prepare-CALC [24] | RA vs. modified CSA | Successful stent delivery and expansion, late lumen loss (mm) after 9 months | RA: 98%, 0.22 ± 0.41 CSA: 81%, 0.16 ± 0.40 p = 0.001, 0.21 |
RA achieved greater success at stent delivery and expansion than CSA and had similar late lumen loss rates after 9 months. |
Orbital Atherectomy | ||||
ORBIT I [25] | OA single arm | Device success ∫ Procedural success ∬ TLR, MACE after 6 months |
Device success: 98% Procedural success: 94% TLR, MACE (6 months): 2%, 8% |
OA successfully facilitated stent delivery with a low cumulative TLR and MACE after 6 months. |
ORBIT II [26] | OA single arm | Safety endpoint Ω (95% CI) Efficacy endpoint Ψ (95% CI) |
Safety endpoint: 89.6% (86.7–92.5%) Efficacy endpoint: 88.9% (85.5–91.6%) |
OA significantly exceeded the primary safety and efficacy endpoints of 83% and 82% respectively. OA also improved in-hospital and 30-day outcomes compared to historic controls with severe CAC. |
Laser Atherectomy | ||||
LAVA [27] | ELCA vs. PTCA in native vessels or SVG | MACE after 6 months | ELCA: 28.9% PTCA: 23.5% p = 0.55 |
ELCA did not reduce MACE after 6 months compared with PTCA in native vessels or SVG. |
AMRO [28] | ELCA vs. PTCA in native vessels | MACE after 6 months | ELCA: 33.3% PTCA: 29.9% p = 0.55 |
ELCA did not reduce MACE after 6 months compared with PTCA in native vessels. |
Intravascular Lithotripsy | ||||
DISRUPT CAD I [29] | Coronary IVL single arm | Safety endpoint Ω Effectiveness endpoint Ψ | Safety endpoint: 95% Effectiveness endpoint: 98.5% |
Coronary IVL safely and effectively aided stent placement with minimal perioperative complications. |
DISRUPT CAD II [30] | Coronary IVL single arm | Safety endpoint Ω Effectiveness endpoint Ψ Calcium fractures measured by OCT Mean stent expansion |
Safety endpoint: 100% Effectiveness endpoint: 94.2% Calcium fractures: 67.4% Mean stent expansion: 101.7% |
Coronary IVL safely and effectively aided stent placement with minimal perioperative complications. OCT demonstrated that calcium fractures were an underlying mechanism for IVL. Coronary IVL allowed for excellent stent expansion. |
DISRUPT CAD III [31] | Coronary IVL single arm | Safety endpoint Ω (lower-bound of 95% CI) Effectiveness endpoint Ψ (lower-bound of 95% CI) |
Safety endpoint: 92.2% (89.9%, p = 0.0001) Effectiveness endpoint: 92.4% (90.2%, p = 0.0001) |
Coronary IVL safely and successfully assisted with stent delivery. The lower bounds of the 95% CI for the safety and effectiveness endpoints exceeded the performance goal of 84.4% and 83.4%, respectively. |
DISRUPT CAD IV [32] | Coronary IVL single arm | Safety endpoint Ω: CAD IV cohort vs. propensity matched historical IVL control group Effectiveness endpoint Ψ: CAD IV cohort vs. propensity matched historical IVL control group |
Safety endpoint: 93.8% vs. 91.2%, p = 0.008 Effectiveness endpoint: 93.8% vs. 91.6%, p = 0.007 |
Coronary IVL safely and effectively aided stent placement with minimal perioperative complications. The results from coronary IVL in the Japanese CAD IV cohort were non-inferior to those from a study of patients treated with IVL in the USA and Europe. |
Severity | OCT-Based Calcium Score
|
IVUS-Based Calcium Score
|
---|---|---|
Mild to moderate | 0–3 | 0–1 |
Severe | ≥4 | ≥2 |