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REDUCE (unpublished) |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. |