Abbott IVL Posts 97% Success But Durability Proof Will Decide Approval

Abbott's SonicForce IVL System Achieves Strong 30-Day Outcomes in TECTONIC Trial

Abbott announced strong 30-day results from the TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) Investigational Device Exemption (IDE) Study for its investigational SonicForce™ Coronary IVL System. The study, which enrolled 335 patients with severe coronary calcification across 40 U.S. sites, met its primary safety and effectiveness endpoints. Key findings include a low 30-day target lesion failure rate of 0.3% and a high procedural success rate of 97%. These positive early clinical outcomes for the device, designed to crack calcium buildup in coronary arteries, were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference and simultaneously published in the Journal of the American College of Cardiology: Cardiovascular Interventions.

• The TECTONIC study successfully met its primary safety endpoint, demonstrating a remarkably low 30-day target lesion failure rate of 0.3%. Concurrently, the primary effectiveness endpoint was achieved with high procedural success in 97% of patients. These robust early clinical outcomes highlight the potential of Abbott's investigational SonicForce Coronary IVL System as a safe and effective approach for treating severe coronary calcification.
• Key secondary endpoints were also met, including successful post-IVL stent delivery with remaining vessel blockage dropping to less than 50% for all patients, and a low major adverse cardiovascular events (MACE) rate of 0.3%. Furthermore, a prespecified imaging sub-study using optical coherence tomography (OCT) in 106 patients confirmed calcium fractures within lesions post-treatment, indicating improved post-stent expansion.
• Experts like Dr. Eric A. Secemsky emphasized that coronary calcium poses significant challenges to optimal percutaneous coronary intervention outcomes. The TECTONIC data suggest that the SonicForce System could provide physicians with a crucial tool to modify severe coronary calcification before stenting, potentially improving procedural success and patient care for increasingly complex coronary disease. This would strengthen Abbott's leadership in treating calcified coronary arteries.

Addressing the Challenges of Severe Coronary Calcification

Severe coronary calcification compromises percutaneous coronary intervention by limiting optimal stent delivery, deployment, apposition and expansion. Heavily calcified lesions are difficult to dilate appropriately with conventional balloons and interfere with catheter passage, increasing the risk of restenosis, thrombosis and poor clinical outcomes.

• Suboptimal stent results and stent failure: Heavily calcified lesions may limit optimal stent deployment resulting in stent underexpansion, suboptimal stent delivery, deployment, apposition and expansion which can lead to in-stent restenosis and/or thrombosis, target lesion failure, stent thrombosis, and cardiac mortality.

• Persistent long-term hazard despite new devices: Severe coronary calcification is associated with incremental hazard for adverse clinical events, including death, during 5-10 years following PCI despite the use of new generation drug-eluting stents, with major adverse cardiac event rates as high as 30% historically reported.

• Difficult assessment and lesion preparation: Severe calcified lesions are difficult to assess using conventional coronary computed tomography angiography, and treating stent underexpansion or restenosis due to calcified tissue is a great challenge, with deployed stents remaining underexpanded despite extensive lesion preparation and no consensus on how to treat stent underexpansion in this scenario.

• Limited comparative evidence: Large scale randomized comparative trials of calcium modifying technologies are limited and the relative safety and effectiveness of these modalities is poorly defined, with few head-to-head trials and limited data on clinical outcomes.

• Procedural safety trade-offs: Atherectomy-based strategies carried a higher risk of severe adverse events versus a conventional strategy, driven by slow-flow/no-reflow phenomenon, with rotational atherectomy associated with more coronary perforation and slow flow/no-reflow.

• Cost and standardization barrier: The higher costs incurred by intravascular lithotripsy represent a major drawback that limits the use and the standardization of such a technique in clinical practice, and cost-effectiveness of such advanced technology will need to be considered.

TECTONIC Study Reveals Strong SonicForce Outcomes

Disrupt CAD III (NCT03595176) evaluated Shockwave coronary intravascular lithotripsy (IVL) as an adjunct to coronary stenting in de novo, severely calcified coronary lesions. In the prospective, single-arm multicenter study in 431 patients enrolled at 47 sites in 4 countries, the primary safety endpoint of 30-day freedom from major adverse cardiovascular events was 92.2%, with lower bound of the 95% confidence interval was 89.9%, which exceeded the PG of 84.4% (p < 0.0001), while the primary effectiveness endpoint of procedural success was 92.4%, with lower bound of the 95% confidence interval was 90.2%, which exceeded the PG of 83.4% (p < 0.0001). At 1 year, MACE occurred in 13.8% of patients (cardiac death: 1.1%, MI: 10.5%, ischemia-driven target vessel revascularization: 6.0%) and target lesion failure occurred in 11.9% (ID-TLR: 4.3%), both driven by non-Q-wave MI (9.2%), with stent thrombosis (definite or probable) in 1.1% of patients (including 1 event [0.3%] beyond 30 days).

The BASIL study randomized 60 patients with severely calcified coronary disease undergoing PCI in a 1:1 ratio to conventional balloon angioplasty (BA) or IVL pretreatment prior to drug-eluting stent (DES) implantation. Procedural success, defined as successful stent implantation without bailout calcium modification devices, no major angiographic complications, and residual stenosis less than 20%, was achieved in 15 (55.6%) patients in the BA group and 24 (72.7%) patients in the IVL group (P = .165), with requirement for bailout calcium modification higher in the BA group (22.2% vs 0.0%; P = .004). The primary safety endpoint of freedom from in-hospital major adverse cardiovascular events was achieved in 26 (96.3%) patients in the BA group and 30 (90.9%) patients in the IVL group (P = .405).

The ROLLER COASTR-EPIC22 Trial randomized 171 patients with moderate to severe calcified coronary lesions, 57 in each treatment arm, to percutaneous coronary intervention with rotational atherectomy (RA), IVL, or excimer laser coronary angioplasty (ELCA). Severe angiographic calcification was observed in 82.5% of lesions (n = 141), with final minimum stent area (RA, 5.5 ± 2.1 mm; IVL, 5.4 ± 1.8 mm; ELCA, 5.1 ± 1.8 mm) and procedural success rate similar among the 3 arms. IVL proved to be noninferior to RA, with no differences in stent expansion (RA, 86.4% ± 14.1%; IVL, 85.6% ± 13.3%; P = 0.77), while ELCA did not reach noninferiority in the intention-to-treat analysis, and the rate of complications was low, with no significant differences in the 3 arms but numerically lower with IVL.

SonicForce's Role in the Evolving IVL Landscape

Severely calcified lesions require lesion preparation to achieve a larger minimal stent area (MSA), the strongest predictor of long-term outcomes, and randomized comparisons show improved mechanical performance with dedicated calcium-modification strategies over conventional noncompliant balloons. In a network meta-analysis of 22 trials enrolling 4855 patients, cutting/scoring balloon (mean difference: 0.81 mm2, 95% confidence interval: [0.36, 1.27]; p = 0.001), super high-pressure balloon (SHPB, 0.95 mm2 [0.18, 1.72]; p = 0.016), intravascular lithotripsy (IVL, 0.87 mm2 [0.40, 1.34]; p < 0.001), rotational atherectomy (RA, 0.90 mm2 [0.30, 1.50]; p = 0.003), and RA plus cutting balloon (1.24 mm2 [0.46, 2.02]; p = 0.002) led to larger MSA, with RA, SHPB, and IVL ranked as possibly the best options. In the prospective, multicenter ECLIPSE trial in 2005 patients randomized to orbital atherectomy (OA) versus balloon angioplasty (BA), calcium modification was greater in the OA group with greater number, total length, and maximal depth of calcium fractures, especially in lesions with thicker calcium, yet MSA at the site of maximal calcification (median [interquartile range], 7.44 [6.03-8.94] mm versus 7.05 [5.78-8.66] mm; P=0.08) and MSA across the entire stent (5.86 [4.60-7.38] mm versus 5.57 [4.50-6.97] mm; P=0.10) were large in both groups and not different.

Procedural success and acute safety have been comparable between IVL and conventional approaches, with less need for bailout devices after IVL. In the BASIL study of 60 patients randomized 1:1 to BA or IVL pretreatment, procedural success was achieved in 15 (55.6%) patients in the BA group and 24 (72.7%) patients in the IVL group (P = .165), requirement for bailout calcium modification was higher in the BA group (22.2% vs 0.0%; P = .004), and freedom from in-hospital major adverse cardiovascular events was achieved in 26 (96.3%) patients in the BA group and 30 (90.9%) patients in the IVL group (P = .405). In the CCS-Coronary Calcification Study randomizing 50 patients with 52 lesions to IVL or RA, procedural success was achieved in 21 patients (84.0%) in the IVL group and in 24 patients (96%) in the RA group (p = 0.349). Single-arm and first-in-center experiences report high acute performance for IVL, including Disrupt CAD III (n = 431) with procedural success of 92.4% and 30-day freedom from major adverse cardiovascular events of 92.2%, and the prospective Shunmei ShockFast IVL system case series of 16 patients with acute procedural success of 100%, no intraprocedural complications, abrupt closure, or in-hospital MACE, calcium fractures in all OCT-imaged lesions with ≥2 fractures in 63% of cases, median stent expansion of 90% [IQR 9], and median acute lumen gain of 1.86 mm [0.62].

Despite differences in mechanism and acute mechanical effects, long-term clinical outcomes have not differed significantly between strategies. The network meta-analysis found no significant differences in all-cause death and stent thrombosis between calcium-modification strategies, and the ECLIPSE OCT substudy reported 1-year target-vessel failure rates of 7.8% with OA and 6.6% with BA (P=0.61). In ROLLER COASTR-EPIC22 randomizing 171 patients to RA (n = 57), IVL (n = 57), or excimer laser coronary angioplasty (ELCA) (n = 57), at one year there were no significant differences in MACE (RA 5.3%, IVL 5.3%, ELCA 3.5%; p = 0.88), all-cause death (RA 5.3%, IVL 0%, ELCA 5.3%), TV-MI (RA 1.7, IVL 1.7, ELCA 0%; p = 0.61), TVR (RA 3.5%, IVL 5.3%, ELCA 1.7%; p = 0.59), TLR (RA 1.7%, IVL 1.7%, ELCA 1.7%; p = 1.00), or stent thrombosis (RA 1.7%, IVL 0%, ELCA 1.7; p = 0.61). Similarly, 12-month late lumen loss (0.12 mm [IQR: - 0.06; 0.68] vs. 0.61 mm [IQR: 0.22; 0.72]; p = 0.084), binary ISR (11.1% vs. 8.0%; p >0.999), MACE (18.5% vs. 8.0%; p = 0.422), TLR (14.8% vs. 8.0%; p = 0.670) and TLF (18.5% vs. 8.0%; p = 0.422) did not show significant differences between IVL and RA groups in the CCS study.