The Year in Cardiology

Coronary Interventions: The Year in Cardiology 2019

Andreas Baumbach; Christos V. Bourantas; PatrickW. Serruys; William Wijns

Disclosures

Eur Heart J. 2020;41(3):394-405. 

In This Article

Existing and Emerging Interventional Devices

Drug-eluting Stents and Bioresorbable Scaffolds

The ESC Guidelines on myocardial revascularization recommends the use of 2nd generation DES in daily clinical practice.[7] The extended follow-up of the Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction (COMFORTABLE-AMI) study and the nested intravascular imaging analysis published this year has provided further evidence about the superiority of DES over bare-metal stents in patients admitted with a STEMI. At 5-year follow-up, Biolimus stent implantation was associated with a lower incidence of target vessel MI (2.2% vs. 5.0, P = 0.02) and ischaemia driven TLR (4.4% vs. 10.4%, P < 0.001) than treatment with a bare-metal stent.[21]

The BIOSTEMI study also focused on the treatment of patients with STEMI and randomized 1300 subjects to ultrathin cobalt chromium sirolimus-eluting stent vs. durable polymer everolimus-eluting stent implantation. At 12-month follow-up, treatment with ultrathin sirolimus-eluting stents was associated with a lower incidence of target lesion failure (TLF) than everolimus-eluting stents (4% vs. 6%; rate ratio: 0.59, 95% Bayesian credibility interval: 0.37–0.94; posterior probability of superiority 0.986).[22] Conversely, the TALENT study that compared outcomes in all-comer patients randomized to ultrathin cobalt chromium sirolimus-eluting stent and durable polymer everolimus-eluting stent failed to show a difference for the incidence of the composite endpoint of cardiac death, target-vessel MI, or clinically indicated TLR between groups (4.9% vs. 5.3%, Pfor non-inferiority < 0.0001).[23]

Bioresorbable scaffolds have been introduced to overcome the limitations of DES and improve long-term outcomes. However, the increased event rate reported in these devices at short- and intermediate-term follow-up raised concerns about their safety and today are not recommended for routine clinical use. A recent meta-analysis of randomized studies comparing the Absorb bioresorbable vascular scaffold (BVS) and the everolimus-eluting stent showed a higher incidence of TLF in the Absorb BVS at 5-year follow-up (14.9% vs. 11.6%, P = 0.030) that was attributed to a higher incidence of target vessel MI and ischaemia driven TLR.[24] Landmark analysis demonstrated a higher event rate in the Absorb BVS group for the period 0–3 years of follow-up; however, for the period 3–5 years of follow-up, the incidence of cardiac death, target vessel MI, ischaemia driven TLR, and device thrombosis was similar between groups in patients who had not experienced an event in the first 3 years. These findings for the first time provide unique insights about the timing of the events in bioresobable scaffolds and indicate a low event rate at long term after their full resorption.

Adjunctive Interventional Devices

Intravascular lithotripsy (IVL) has emerged over the last years as an effective alternative for the treatment of calcified lesions that are associated with an increased risk of complications and worse prognosis.[25] It involves the advancement of a catheter with a balloon on its tip that contains multiple emitters which generate sonic pressure waves that selectively fracture vascular calcium without affecting the integrity of the fibroelastic tissue of the plaque.[26] The Shockwave Coronary Rx Lithoplasty Study (DISRUPT CAD) was the first study that systematically examined the safety and efficacy of IVL in 60 patients with heavily calcified lesions and length ≤32 mm; the procedure was successful in all the lesions resulting in an acute gain of 1.7 mm and a post-procedural percent diameter stenosis of 12.2%. The overall MACE rate at 6 months of follow-up was 8.3%; three peri-procedural MI and two cardiac deaths were reported.[27] Similar were the findings of the DISRUPT CAD II study that included 120 patients; in that study, the in-hospital MACE rate was 5.8% (7 non-Q wave MI), while at 30-day follow-up, the MACE rate was 7.6%. Optical coherence tomography (OCT) imaging was performed in 48 patients before and in 47 after stenting and demonstrated that IVL caused 3.4 ± 2.6 fractures per lesion resulting in an acute gain of 4.79 ± 2.45 mm2 and an excellent stent expansion of 102.8 ± 30.6%.[28] Recently, Wilson et al.[29] showed that IVL therapy is associated with ventricular ectopics and asynchronous pacing. In this study, no malignant arrhythmias were reported; the ongoing DISRUPT CAD III study is expected to provide further evidence about the safety and efficacy of IVL in the treatment of calcified lesions (NCT03595176).

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....