Drug-coated balloon-only strategy for percutaneous coronary intervention of de novo left main coronary artery disease: the importance of proper lesion preparation

Abstract

This retrospective single-center registry study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using drug coated-balloon (DCB)-only strategy between August 2011 and December 2018. To best of our knowledge, no previous studies of DCB-only strategy of treating de novo left main coronary artery disease, exist. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups depending on weather the lesion preparation was done according to the international consensus group guidelines. Sixty-six patients (mean age 75±8.6, 72% male), 52% of whom had acute coronary syndrome, underwent left main PCI with the DCB-only strategy. No procedural mortality and no acute closures of the treated left main occurred. At 12 months, MACE and TLR occurred in 24% and 6% of the whole cohort, respectively. If the lesion preparation was done according to the guidelines, the MACE and TLR rates were 21.2% and 1.9%. Left main PCI with the DCB only-strategy is safe leading to acceptable MACE and low TLR rates at one year, if the lesion preparation is done according to the guidelines.

Keywords

drug-coated balloon / left main / high bleeding risk / predilatation / calcifield lesion / percutaneous coronary intervention

1 Introduction

The implantation of a stent is the standard approach of percutaneous coronary intervention (PCI) with proven durable results in the left main (LM) [1]. However, long-term complications can follow stenting, even with the latest generation of drug-eluting stents (DESs) [2,3]. Noticeably, dual antiplatelet therapy (DAPT) is required to prevent stent thrombosis on the cost of increasing bleeding risk. Bleeding post-PCI increases 1-year mortality by seven times, and it also increases the risk of other adverse outcomes, such as non-fatal myocardial infarction [4,5].

Recent trials have demonstrated the non-inferiority of drug-coated balloon (DCB) angioplasty as compared with stenting in selected patient groups. These groups include those with atherosclerotic lesions in small-diameter coronary arteries, in-stent restenosis (ISR), and patients at high bleeding risk (HBR) even with proximal coronary artery disease (CAD) [6–8]. Patients with LM lesions were excluded in these studies. Nowadays, increasingly complex cases, including LM disease, are treated with PCI. Many of these patients have HBR; examples are those on anticoagulants and elderly patients with comorbidities, who previously tended to be managed conservatively [9,10]. HBR patients have been excluded from randomized clinical trials investigating the efficacy and safety of the LM PCI [11–13]. Moreover, the mean age of the patients in the randomized controlled trials is quite low, ranging from 63 to 68 years. Optimal management of elderly patients or patients with HBR presenting with LM lesion remains unknown.

To best of our knowledge, this is the first published study of PCI using a DCB-only strategy on de novo LM disease. This retrospective single-center registry study investigated the safety and efficacy of the PCI of de novo LM lesion performed with a DCB-only strategy without stenting.

2 Methods

2.1 Study design

Our study included consecutive patients between August 2011 and December 2018, who underwent PCI for a de novo lesion of the LM coronary artery performed with the DCB-only strategy. The only exclusion criteria was ISR. Both protected and unprotected LM lesions, as well as stable and unstable CAD, were included. The selection process of the patients is illustrated in Fig.1. The patients were followed for adverse events from the day of PCI to the occurrence of death, or to the end of year 2019, whichever came first. All patients in the present registry had their PCI before the end of year 2018. Thus, all patients had a chance to complete 12 months of follow-up. Five patients had their PCI during year 2018 and therefore could not complete 24 months of follow-up. These five patients were excluded from the analyses of the occurrence of adverse events within 24 months from PCI. Mortality data were obtained from the Population Registry of Finland. Data of other adverse events were obtained from local healthcare records.

We studied all-cause mortality and the occurrence of major adverse cardiac events (MACEs), defined as a composite of cardiovascular death, non-fatal myocardial infarction, and ischemia-driven target lesion revascularization (TLR), at 12 months and at 24 months. Myocardial infarction was defined according to the fourth universal definition of myocardial infarction. BARC type 2‒5 bleeding events were analyzed according to the Bleeding Academic Research Consortium (BARC) criteria [14]. Two experienced interventional cardiologists evaluated whether DCB-only PCI was performed according to the International Consensus Statement [15]. According to the recommendation, no recoil more than 30% or no flow-limiting dissection (TIMI flow < 3) after predilatation is allowed for DCB-only PCI. Bleeding risk factors were assessed according to DEBUT (randomized trial on DCB-only PCI in HBR patients) trial criteria and are shown in Tab.1 [8].

2.2 DCB-only PCI for de novo left main disease

All patients received a loading dose (250‒500 mg) of aspirin perorally or intravenously before PCI, if not already in use, or contraindicated. Enoxaparin, unfractionated heparin or bivalirudin was used as a procedural anticoagulant with doses according to the guidelines of European Society of Cardiology [16]. P2Y12 inhibitors were given orally or intravenously according to the clinical setting. The duration of DAPT after the procedure was planned individually according to the operator’s discretion. PCI procedures were performed according to the standard techniques. The decision to treat the LM lesion with DCB was based on operator’s discretion, which was contributed by the vast experience of DCB use in other lesion types in our institution. Predilatation of the lesion was done with the use of a semi-compliant, non-compliant, or cutting balloon according to the choice of the operator. Rotational atherectomy was used for debulking of excess calcium.

The postoperative care of the patients and the clinical follow-up was done according to the normal local practices. Most of the patients had the follow-up visit in a community health center. No routine control angiograms were obtained. Our center serves a local population of approximately 170 000 inhabitants. All patients in the area in need for coronary angiography are referred to our institution. The Central Hospital and all community health care centers in the region use the common electronic medical record allowing access to all patient data during the follow-up. No patient was lost on the follow-up. This study was approved by a regional institutional review board.

2.3 Statistical analyses

Continuous data are presented as mean, and categorical data are given as the number of patients (%). Statistical significance of between-group differences was assessed with the t-test, Mann–Whitney U test, and Chi-square test, as appropriate. Kaplan–Meier plots are used to illustrate patient survival free of MACE. P < 0.05 is considered statistically significant and all reported P values are two-sided. All statistical analyses were conducted using IBM SPSS Statistics version 25 (IBM Corp., Armonk, NY).

The funders and sponsors had no role in study design, patient recruitment or monitoring, data collection, data analysis, data interpretation, or writing of the report. The corresponding author (SU) and the last author (TTR) had full access to all the data in the study. The corresponding author had final responsibility for the decision to submit for publication.

3 Results

3.1 Baseline patient characteristics and procedural data

The mean follow-up time was 39 months. The inclusion criteria of the study fulfilled 66 patients (mean age 75, 72% male). Tab.1 shows the baseline demographics of the patients. 52% had acute coronary syndrome. At least one bleeding risk factor had 77% of the patients. 30% were on anticoagulation; most of the patients were on warfarin, one patient on dabigatran, two on apixaban. The predilatation result was acceptable and DCB-only PCI was done according to the consensus statement in 79% of the cases. The subgroups were otherwise similar but the group with suboptimal predilatation result had significantly more prior myocardial infarctions (17% vs. 50%, P= 0.03). 77% of the LM PCIs were unprotected. 64% of the lesions were bifurcations. Multivessel PCI was done in 65% of the cases. Cutting balloon and rotational atherectomy was used in 50% and 48% of the cases, respectively. All DCBs used had a paclitaxel-coating. The median diameter for the DCB used was 3.5 mm. The pressure used for DCB was available only in 14 cases. The mean pressure for DCB was 10 ATM. The time for DCB dilatation was available in 13 cases. In 10 cases, the time for DCB dilatation was 30 s, 20 s in 2 cases and 60 s in 1 case. All procedural data are shown in Tab.2.

3.2 Reason for DCB-only strategy in the left main PCI

No specific reason for DCB-only strategy could be derived from medical records in most of the patients (39%) (Tab.2). The most common reason that could be identified, was HBR in 27% of the cases. The DCB-only strategy was chosen in 26% of the cases due to anatomical reasons (e.g., trifurcation lesion or the size difference between LM and left anterior descending or aneurysmatic LM). For two patients (3%) an urgent upcoming elective non-cardiac surgery was the reason for DCB-only PCI. In two cases, the predilatation result was unsatisfactory due to excess calcium possibly resulting in an underexpanded stent. In one case the operator planned to continue the procedure in a second session, stenting was not done, and the LM was treated with DCB.

3.3 Procedural medication and DAPT

Procedural medication is shown in Tab.3. All patients, except one allergic, received aspirin prior to PCI. As the procedural anticoagulant, majority received enoxaparin (97%), one PCI was done using bivalirudin and one using unfractioned heparin. P2Y12 inhibitor was given to 89% of the patients before or after PCI. In two patients (3%) cangrelor was used. 11% did not receive P2Y12 inhibitors at all during or after the procedure. Tab.4 presents the duration of DAPT after PCI. Median duration of DAPT was 1 month (mean 2.6 months). 14 patients (21%) were discharged without DAPT of whom 8 (57%) were on oral anticoagulation.

3.4 MACE rates and bleeding

There was no procedural mortality and no acute closures of the treated LM occurred. Tab.5 shows the adverse events at 12 and 24 months. In the whole cohort, MACE had occurred in 24% of the patients and the rate of TLR was 6% by 12 months. In the subgroup with acceptable predilatation result, the rate for TLR was significantly lower than in the subgroup with suboptimal predilatation result (1.9% vs. 21.4%, P = 0.028). There was a trend toward less 24-month total mortality in the subgroup of acceptable predilatation as compared to the subgroup of suboptimal predilatation followed by DCB-only treatment (P = 0.087). No difference was detected in chronological enrollment distribution between subjects having acceptable or suboptimal predilatation result (P = 0.745). Survival from MACE in all patients, and in subjects with and without acceptable predilatation result, are illustrated in Fig.2. BARC type 2 bleeding had 10 (15%) patients and 4 (6%) patients had BARC type 3a bleeding over 12 months follow up. None of the bleedings was fatal.

4 Discussion

Significant stenosis of the left main (LM) coronary artery is associated with poor outcomes and is a strong indication for revascularization [16]. LM stenosis may be treated with equal long-term results both with coronary artery bypass grafting (CABG) or PCI with DESs, especially in the case of a lesion in the ostium or the shaft of the LM [16]. Moreover, CABG is not an option for patients with unacceptably high surgical risk due to comorbidities and some patients decline surgery. Currently, the use of DCB is recommended only for the treatment of ISR by the European guidelines (1A recommendation) [16]. Recent randomized trials have demonstrated the non-inferiority of DCB angioplasty compared with stenting in selected patient groups, such as those with small coronary artery disease and in patients with HBR [7,8]. Some other emerging indications for DCB are bifurcations, diffuse disease, chronic total occlusions, and calcified complex lesions [17–20]. A few case reports have been published to demonstrate the DCB-only strategy PCI of de novo LM CAD [21,22].

The MACE rate was clearly higher in this study as compared to randomized trials addressing the efficacy of LM PCI with DES [11,12]. The 12-month MACE rate was also higher in this study compared to other DCB registries [23–26]. The patient population in this study was very different than in RCTs and all-comers registries including younger patients with less complex CAD. In our study, the mean age was high, and the patients had several comorbidities as shown by the fact that 77% of patients had HBR. Many patients had poor life expectancy and for some patients the left main PCI was mainly a palliative treatment. In our study and in a registry study on PCI with DES in high surgical risk LM patients, both the outcomes and patient characteristics were similar [27]. In the aforementioned registry, all-cause death at 12 months was 28% among patients with non-ST-elevation myocardial infarction or unstable angina, and 11% among patients with stable CAD. In our study, all-cause death at 12 months was 12%. 12 months rate for TLR and myocardial infarction were also similar. A small registry study (38 patients) that included de novo lesions and ISR, investigated DCB-only strategy in LM bifurcation lesions after rotational atherectomy [28]. Also in that study, the TLR rate at 12 months (3.2%), among patients with de novo LM lesion, was similar to our study.

A matched cohort treated with LM stenting would have been valuable in assessing the clinical utility of the DCB-only strategy. However, most of the patients in our study were at severely increased risk of bleeding. Thus, a major contributor in the choice of the DCB only strategy was the fear that the patient would not tolerate a DAPT regimen mandatory after stenting. Indeed, the DAPT duration was ≤ 1 month in over half of the patients treated in the present study, and still, > 20% of the patients had BARC2 + bleeding during the follow-up. Therefore, we believe that despite the use of modern statistical methods, such as propensity score matching, no truly matching cohort of patients treated with LM stenting would be available.

Three patients died shortly after the DCB PCI. The deaths were likely not LM PCI related. One patient died because of a septic shock due to an abdominal infection. One died to ischemic heart failure and the PCI was mainly a last attempt to improve the patient’s condition. One elective patient died two days after the PCI. The autopsy revealed dilated cardiomyopathy with heavily scarred myocardium. The LM was open without any thrombus, and a ventricular arrythmia was suspected to be the cause of death. Besides these three cases, no other deaths occurred in 30 days. Despite of the short median duration of DAPT, and the fact that 21% of patients were discharged without DAPT, 21% of the patients had BARC2-5 bleeding event during the first year, highlighting the high bleeding risk of this patient population. High risk of bleeding is also a surrogate marker of increased mortality after PCI [29]. In the current guidelines, the recommendation for DAPT duration after DES implantation is 3–6 months in stable CAD in patients at HBR [30,31]. No randomized studies exist on the optimal duration of DAPT in the patients at HBR having PCI of the LM. Moreover, the optimal antithrombotic regimen after DCB-only PCI in patients at HBR, is not known. In the previously published registry studies on DCB-only approach, 4% of patients were safely discharged with single antiplatelet therapy (SAPT) [23,32]. After DCB angioplasty, acute target lesion thrombosis is a rare phenomenon (0‒0.2%) [7,8,23,32]. Importantly, after DCB-only PCI, in the case of an acute life-threatening bleeding, all antithrombotic can be immediately stopped, according to our clinical experience.

To assure a sufficient amount of the antiproliferative drug to be transferred to the vessel wall, the recommendation dilatation time for paclitaxel-coated DCBs is 30 s. Occasionally, the occlusion of the LM with DCB for 30 s, leads to a blood pressure drop. In our study, the DCB dilatation time was recorded in the medical file only in the small number of the cases. In some of them, the time was less than 30 s, which could compromise the transfer and lead to an increased risk of restenosis. One option could be to inflate the DCB for multiple times for a short time, to prevent the drop of the blood pressure. This method should be studied in the future and could be helpful in the setting of the DCB-only PCI of the LM.

In the Rotaxus-study [33], which compared rotational atherectomy and standard approach lesion preparation in calcified lesions before DES implantation, the TLR rates were 11.7% and 12.5% and the MACE rates 24.2% and 28.3%, at 9 months. This emphasizes the fact that after a PCI of a complex, such as heavily calcified lesions, higher event rates are observed compared with simple lesions [34]. In our study, half of the treated LMs were significantly calcified. For lesion preparation, cutting balloon was used in half, and rotational atherectomy in nearly half of the cases. If the DCB-only PCI was done according to the International Consensus Group recommendations [15], the TLR rate was low (1.9%) at 12 months. In contrast, the TLR rate was very high (21%), if the predilatation result was suboptimal and more than 30% recoil was accepted before DCB angioplasty. This highlights the importance of a proper lesion preparation and a good predilatation result, if DCB-only strategy is the method of choice for de novo lesions. In our study, the MACE rate for the whole study population, was 24% at 12 months, which is in line with the results of the DES studies in calcified lesions and in elderly population [32].

Safety of paclitaxel-coated devices has been questionable since a meta-analysis, published in December 2018, reported an increased mortality in trials with 2 or more years of follow-up after combining treatments with paclitaxel-coated stents or balloons in peripheral artery disease [35]. In a meta-analysis, the use of paclitaxel DCB for treatment of CAD was associated with lower risk of death at longer-term follow-up when compared with control subjects including DESs, bare metal stents, and plain old balloon angioplasties [36]. In a recent RCT on the use of paclitaxel-coated DCBs in peripheral arterial disease, all-cause mortality was not increased between the groups in the incidence of death during 1 to 4 years of follow-up [37]. In conclusion, the use of paclitaxel-DCB in CAD is safe.

Compared to stenting, DCB-only angioplasty has some proven and some potential advantages in addition to short DAPT or even SAPT. Without a metallic cage left behind, positive vessel remodeling is possible [38,39]. In bifurcation PCI, DCB angioplasty is faster to perform, and technically less complex, than done with stenting, especially in the case of two stent techniques. If the result of DCB-only angioplasty is unsatisfactory due to excess recoil or flow-limiting dissection, bail-out (drug-eluting) stenting appears safe [40].

The evaluation of the predilatation result and the decision whether it is appropriate to proceed with DCB-only PCI requires experience, especially in the case of the LM. Since 2009 approximately 3000 DCB-only PCIs, including CTOs and complex calcified lesions, have been performed in our center [17,32]. However, DCB-only PCI in the LM main has been performed less frequently. Between 2015 and 2018, 13% of LM PCIs were done with DCB-only strategy in our center. According to our clinical experience, the option of DCB-only PCI with short DAPT or even SAPT may change conservative treatment strategy to intervention in a patient at HBR such as elderly, frail, anticoagulated one with comorbidities and short life-expectancy.

5 Limitations

The major limitation of this study is that it is a retrospective single-center registry. The number of the patients treated with this new strategy is relatively low. A selection bias, regarding what kind of patients were treated with DCB-only strategy, is likely. HBR patients, elderly patients and those with calcified complex left main lesion are overrepresented in this cohort, leading to higher MACE rate than in the randomized LM PCI studies using DES. Intravascular imaging was not used routinely. No matching cohort of patients treated with LM stenting was available. Finally, the duration of the DAPT was at the discretion of the operator.

6 Conclusions

The population in the Western world is aging and increasing number of patients at HBR are treated with PCI. After PCI, bleeding is a major predictor for adverse events in this population. DCB-only strategy enables short duration of DAPT, or even no DAPT at all, in patients with extreme HBR. In our study, the TLR rate was low, when DCB-only PCI was done according to the guidelines of the International Consensus Group. We conclude, that after proper lesion preparation, DCB-only strategy for de novo LM lesions could be a novel potential approach especially for HBR patients. Future randomized trials comparing DCB angioplasty to stenting with DES are needed to confirm these results.

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