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

Patient and Lesion Subset

Left Main and Three-vessel Disease

The optimal revascularization strategy in patients with advanced CAD [i.e. three-vessel disease or left main stem (LMS) disease] and in diabetic patients has been discussed in the 2018 European Society of Cardiology (ESC) Guidelines on myocardial revascularization: surgical revascularization is currently the recommended treatment strategy in diabetic patients with multivessel CAD, while PCI has a IIB indication in patients with a SYNTAX score ≤22 and is not recommended in patients with SYNTAX score >22.[7]

These recommendations are in line with the findings of the Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM) Follow-On study that included 1900 diabetic patients with multivessel disease that were randomized to surgical or percutaneous revascularization and reported a higher mortality rate at 8 years of follow-up in the PCI arm compared to the surgical revascularization group (24.3% vs. 18.3%, P = 0.010).[8] Conversely, the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) Extended Survival study that included 1689 patients with LMS or three-vessel disease did not demonstrate differences in the all-cause mortality between patients allocated to PCI and those treated surgically at 10 years of follow-up (27% vs. 24%, P = 0.092). There was, however, a treatment effect by subgroup interaction according to the presence or absence of three-vessel disease; mortality was increased in the PCI group compared to the coronary artery bypass graft (CABG) arm (HR 1.41, 95% CI 1.10–1.80), while there was no differences between the two groups in patients with LMS disease (HR 0.90, 95% CI 0.68–1.20); conversely, there was no difference in outcomes for the two treatment strategies in diabetic and non-diabetic patients (P-for interaction 0.660).[9] A limitation of both studies is the fact that the patients in the PCI arm were treated with a 1st generation drug-eluting stent (DES) that is not currently used in contemporary practice, and the fact that they both reported only all-cause mortality instead of patient-orientated cardiovascular endpoints.

The Evaluation of XIENCE vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) study overcame these limitations; in this study, 1905 patients with LMS disease and SYNTAX score ≤32 were randomized to PCI with a 2nd generation DES or CABG.[10] In the PCI arm, intravascular ultrasound (IVUS) imaging was used in 77.2% of the cases.[11] At 5-year follow-up, there were no differences between groups for the combined endpoint of all-cause death, MI, or stroke (22.0% in the PCI arm vs. 19.2% in the CABG group; P = 0.13). The event rate at 30-day follow-up was lower in the PCI arm (4.9% vs. 8.0%), there was no difference between groups for the period 30 days to 1 year (4.1% vs. 3.8%), while for the period 1–5 years of follow-up a higher event rate was reported in patients undergoing PCI (15.1% vs. 9.7%). Patients randomized to CABG were more likely to suffer a cerebrovascular event (5.2% vs. 3.3%), while those treated with PCI had increased all-cause mortality (13.0% vs. 9.9%) and more often ischaemia driven revascularization (16.9% vs. 10.0%). Similarly to what it has been reported in the SYNTAX study, there was no difference in the outcomes between the two treatment strategies in diabetic and non-diabetic patients at 3- and 5-year follow-up.[10,12]

Percutaneous Coronary Intervention of Bifurcation Stenoses

In 2019, the 3-year follow-up data of the DKCRUSH V study were published; similar to what has been reported at 1-year follow-up, double kiss-crush technique was associated with a lower incidence of target lesion revascularization (TLR, 5.0% vs. 10.3%, P = 0.029) target vessel MI (1.7% vs. 5.8%, P = 0.017), and definite or probable stent thrombosis (0.4% vs. 4.1%, P = 0.006) compared to provisional T-stenting.[13] Double kiss-crush technique, however, is a challenging procedure and requires skills and expertise; therefore, considering that the findings of the DKCRUSH V study may not be reproduced by centres with less experienced operators, the recently published 14th consensus document from the European Bifurcation Club advocates the use of provisional T-stenting technique for the treatment of bifurcations lesions and proposes a two stent strategy only in lesions with a complex anatomy, when access to the side branch is challenging, or when there is ostial disease in the side branches extending >5 mm form the carina and/or increased calcification.[14] In the case of a two stent strategy, the European Bifurcation Club recommends the use of culotte or TAP technique and when the crush technique is considered it proposes the use of the double kiss-crush.

Treatment of Chronic Total Occlusions

In 2019, the EuroCTO Club published a consensus document that summarizes the current evidence (Figure 1), discusses the indications for chronic total occlusion (CTO) revascularization, presents the advances in CTO equipment, and provides recommendations about training in CTO PCI.[15] In line with the ESC guidelines on myocardial revascularization and taking into account the findings of randomized controlled studies, the EuroCTO Club recommends CTO recanalization in the presence of symptoms despite optimal medical therapy; in asymptomatic patients, ischaemic burden assessment is recommended and CTO revascularization is advised if there is evidence of increased ischaemic burden (≥10% of the left ventricular mass). These recommendation are in line with the findings of the recently reported Drug-Eluting Stent Implantation vs. Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO) trial.[16] In this study, 815 patients with a CTO were randomized in 1:1 ratio to complete revascularization or to the treatment of the obstructive non-CTO lesions whenever these were present. Only one-fourth of the patients included in the two groups had a single-vessel disease. At 4-year follow-up, there was no difference between the two groups for the combined endpoint of death, MI, stroke, or revascularization (22.4% vs. 22.3%, P = 0.86) or patients' quality of life. These findings indicate that in case of multivessel disease revascularization of the non-CTO lesion and re-evaluation of the extent of ischaemia and patient symptoms should be considered before advocating recanalization of a CTO. Limitations of the study—the largest of its kind—included the high crossover rate (19.6%) from the non-CTO PCI group to the CTO-PCI group within the first days from randomization as well the fact that it was underpowered for the primary endpoint as patient recruitment was early terminated because of a slow enrolment rate.

Figure 1.

Summary of the findings of the three randomized control trials comparing percutaneous coronary intervention and medical therapy in patients with a total chronic occlusion. Image was Reprinted from Galassi et al.15 Percutaneous recanalization of chronic total occlusions: 2019 consensus document from the EuroCTO Club. Pages no. 198–208, Copyright 2019, with permission from Europa Digital & Publishing. CMR, cardiac magnetic resonance; CTO, chronic total occlusion; EQ-5D, EuroQol 5 dimensions questionnaire; J-CTO, Japanese chronic total occlusion; LAD, left anterior descending; LVEDV, left ventricular end-diastolic volume; LVEF, left ventricular ejection fraction; MACE, major adverse cardiovascular events; OMT, optimal medical therapy; PCI, percutaneous coronary intervention; QoL, quality of life; RCA, right coronary artery; RCT, randomized control trial; SAQ, Seattle Angina Questionnaire; SCAD, stable coronary artery disease; STEMI, ST-segment elevation myocardial infarction; ΔMIB, decrease in myocardial ischaemia burden.

Small Vessel and In-stent Restenosis

Percutaneous coronary intervention in small vessels has been associated with a higher incidence of major adverse cardiovascular events (MACE) and TLR due to in-stent restenosis. In 2019, a pre-specified sub-analysis of the Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) study was published that compared outcomes following PCI in small vessels (<2.5 mm) using ultrathin-strut cobalt chromium biodegradable polymer sirolimus-eluting stents (strut thickness 71 μm) or very thin-strut platinum chromium biodegradable polymer everolimus-eluting stents (strut thickness 78 μm) or previous-generation thin strut cobalt-chromium durable polymer zotarolimus-eluting stents (strut thickness 102 μm). A higher incidence of TLR was noted in the thicker strut zotarolimus-eluting stent than the ultrathin-strut sirolimus-eluting stent group (5.3% vs. 2.1%, P = 0.006), while there was no difference in the TLR rate between the everolimus and zotarolimus-eluting stent groups (4.0% vs. 5.1%, P = 0.31).[17] These findings convincingly highlight the prognostic implications of strut thickness in small vessels in the DES era and are in line with previous studies reporting outcomes in bare-metal stents.[18]

In-stent restenosis represents the most common cause of stent failure; its treatment is challenging and is associated with poor prognosis and a high TLR rate.[19] The two most effective treatment strategies today are drug-coated balloon angioplasty or DES implantation. In 2019, the Difference in Anti-restenotic Effectiveness of Drug-eluting stent and drug-coated balloon AngiopLasty for the occUrrence of coronary in-Stent restenosis (DAEDALUS) patient-level meta-analysis was published that included 1976 patients treated with a paclitaxel-coated balloon or a DES.[20] At 3-year follow-up, paclitaxel-coated balloon angioplasty was associated with a higher incidence of TLR comparing to DES implantation (HR 1.32, 95% CI 1.02–1.70; P = 0.035); however, there was no difference between groups for the combined endpoint of death, MI, or target lesion thrombosis (Figure 2).

Figure 2.

Summary of the efficacy of paclitaxel-coated balloon angioplasty vs. drug-eluting stent implantation for the treatment of patients with in stent restenosis. Image obtained with permission from Giacoppo et al.20 aPrimary efficacy endpoint: target lesion revascularization. bPrimary safety endpoint: the composite of death, myocardial infarction, or target lesion thrombosis. cNet composite endpoint: the composite of death, myocardial infarction, target lesion thrombosis, or target lesion revascularization. dNet composite endpoint: the composite of death, myocardial infarction, target lesion thrombosis, or target vessel revascularization.

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