|Year : 2021 | Volume
| Issue : 2 | Page : 128-134
One-year outcome of treating bifurcation coronary artery disease with newer generation drug-eluting stents: A single-center experience
Danny Kumar1, Sundeep Mishra2
1 Department of Cardiology, GMCH, Udaipur, Rajasthan, India
2 Department of Cardiology, AIIMS, New Delhi, India
|Date of Submission||02-May-2021|
|Date of Decision||04-Jul-2021|
|Date of Acceptance||06-Jul-2021|
|Date of Web Publication||31-Aug-2021|
AP, Geetanjali medical college, Udaipur, Rajasthan
Source of Support: None, Conflict of Interest: None
Objectives: Bifurcation percutaneous coronary interventions (PCIs) remain a challenging subset with tussle between provisional versus dedicated (i.e. two-stent) stenting. Besides technical issues, many other factors such as cost, operator skill, and availability of surgery affect the practice which is followed in a particular region. Because of paucity of data in Indian settings, as also information with later generation stents; this study was planned. Methodology: Patients with bifurcation lesion undergoing elective PCI during 1-year period were prospectively enrolled. Decision of strategy (provisional or dedicated two-stent) and drug-eluting stent type (second or third generation) were operator's choice. Patients were followed telephonically and/or clinically (on routine visits) for 1-year postprocedure for any major adverse cardiac event. Results: One hundred and seven cases (28 in dedicated and 79 in provisional group) with a mean age of 56.2 ± 10.2 years were enrolled. All cases of dedicated arm were true bifurcation compared to 63.2% in provisional group (P < 0.001). In dedicated arm, 75% of patients had stenosis ≥5 mm in side branch (SB), in provisional group, 74.7% had <5 mm stenosis in SB (P < 0.001). T-TAP was most common strategy followed by DK crush and final kissing inflation was done in 96.4% cases of dedicated arm. Nearly 84.1% of patients could be followed up till the end of year. In hospital, events were few in either arm, one patient in the dedicated arm developed acute stent thrombosis and three patients in provisional arm developed in-hospital myocardial infarction. One-year major adverse cardiovascular event (MACE) was not significantly different (9.5% provisional vs. 7.4% dedicated; P = 0.65). Conclusions: One-year MACE did not differ in either 1 or 2-stent strategy in suitable patients with bifurcation lesions.
Keywords: Bifurcation, dedicated, major adverse cardiovascular event, provisional
|How to cite this article:|
Kumar D, Mishra S. One-year outcome of treating bifurcation coronary artery disease with newer generation drug-eluting stents: A single-center experience. J Pract Cardiovasc Sci 2021;7:128-34
|How to cite this URL:|
Kumar D, Mishra S. One-year outcome of treating bifurcation coronary artery disease with newer generation drug-eluting stents: A single-center experience. J Pract Cardiovasc Sci [serial online] 2021 [cited 2021 Dec 7];7:128-34. Available from: https://www.j-pcs.org/text.asp?2021/7/2/128/325224
| Introduction|| |
Coronary bifurcations are prone to develop atherosclerotic plaque due to turbulent blood flow and high shear stress. Bifurcation lesions account for approximately 15%–20% of all percutaneous coronary interventions (PCIs). In comparison with other lesions, bifurcation PCI has lower rates of procedural success and higher rates of clinical and angiographic restenosis, higher cost, higher resource utilization, and longer hospitalization.,,
Drug-eluting stents (DESs) have resulted in a reduction of main vessel (MV) re-stenosis in comparison to historical controls. However, residual stenosis at the ostia of the side branch (SB) and long term re-stenosis remain a major problem. Stenting the MV, with SB stenting only when required (provisional stenting) is the prevailing approach currently, although in certain anatomical configurations, a desire for an optimal acute angiographic outcome, and a perception that it may lead to better long-term success often drive the use of a 2-stent strategy. In the era of third-generation DES, various 2-stent techniques are available that allow stenting of large SB in a way that ensures optimal lesion coverage and drug elution by the stent platform for both the MV and SB. Although, if one looks purely at mechanics and as confirmed by bench-testing, neither 1- nor 2-stent strategy is optimal, and here only a dedicated bifurcation stent would be ideal. On the other hand, dedicated bifurcation stents are best with their own problems and practically one has to still choose from either provisional (in the MV) or dedicated 2-stent (one in the MV and one in the SB) strategy.,,, Introduction of DES reduced re-stenosis in the MV but re-stenosis at the ostium of the SB remains a problem.,
Regarding 2-stent strategy, the most important initial question is whether the SB is large enough (>2.25 mm diameter) with a sufficient territory of distribution to justify intervention irrespective of the bifurcation pattern. If the SB is small (<1.5 mm) and supplies a small area of myocardium, stenting the MV across the SB is preferred. On the other hand, if the SB is larger, still 1-stent approach could be employed as there is usually the option of placing a second stent in the SB if there is a suboptimal result. This strategy is called provisional SB stenting as opposed to the 2-stent strategy of dedicated SB stenting.
Data on strategy of bifurcation stenting and its outcomes are not available from low-resource countries like India where often the immediate cost of additional stent has to be balanced against a long-term cost of inadequate procedure. In general, after the introduction of 2nd- and 3rd-generation DES, is it better to use “2-stent strategy” even in Indian context? We planned this study to answer few of these questions.
| Methodology|| |
The study was a prospective, observational study and patients undergoing bifurcation coronary artery stenting with DES by either strategy, provisional, or 2-stent during 1-year period at All India Institute of Medical Science, New Delhi, were included. Written informed consent was taken before inclusion. The protocol was submitted to ethics committee and approved by them. All the patients with bifurcation lesion undergoing elective PCI with DES for bifurcation lesions, with age >18 years, and undergoing either provisional or 2-stent strategies, in the year 2015 were recruited in the study. Angiographic eligibility of lesion was de novo target lesion with a visual reference vessel diameter of 2.25–4.0 mm for both the MV and SB. Patient who did not give an informed consent, patient with acute coronary syndrome (ACS) within 24 h from symptom onset, and patient with limited compliance with prolonged dual antiplatelet therapy (DAPT) were excluded (e.g. elective surgery planned, recent bleeding, significant gastro-duodenal peptic disease, etc.,). Patients with chronic kidney disease and other chronic illness were also included.
Bifurcation lesions were classified according to the Medina classification. Medina classification involves recording any narrowing in excess of 50% in each of the three arterial segments of the bifurcation in the following order: proximal MV, distal MV, and proximal SB. Such classification is the most standardized and utilized nowadays to indicate the presence of a significant stenosis (1) or the absence of stenosis (0). However, in the context of treatment strategy, a limitation of the Medina classification is that the length of the stenosis involving the SB is not specified, and this distinction is a key element to proper planning of the treatment. However, this is easiest and most utilized classification currently and therefore we used this classification in our study.
In all patients, either 2nd- or 3rd-generation stents were used. In dedicated 2-stent arm, standard techniques were utilized, for exmple, T-stenting and its variations (modified and reverse), V-stenting, simultaneous kissing stents, the crush and its variations (double, reverse and step), and the Culotte were used.
Stenting strategy, provisional or 2-stent strategy (used synonym to dedicated), and type of “dedicated strategy” were left at operator discretion. Study planned as prospective cohort, no randomization was done. Various operator experience and “ease of strategy” effect cannot be nullified and remain major limitation. Procedure was reviewed for technique; wire in SB, balloon dilatation of SB in provisional strategy, proximal optimization technique, final kissing balloon dilatation (FKBD), and type of stent strategy. Any compromise to SB and residual stenosis in SB was assessed. Assessment done by angiography, fractional flow reserve (FFR) was not used to assess same. Patients were discharged on appropriate medical treatment with proper routine counseling for DAPTs to patient and attending relative done.
Patients were followed telephonically and/or clinically on routine visit for 1-year postprocedure for any major adverse cardiovascular event (MACE). MACE included death, myocardial infarction (MI) or target vessel revascularization (TVR) (in the form of coronary artery bypass surgery or percutaneous intervention).
Event definitions were as per standard, MI was defined as any chest pain with ECG change or with cardiac enzyme elevation CPK–MB (>5 times). Periprocedural MI as occurring during procedure or within 24 h after procedure. TVR was defined as repeat attempted revascularization by PCI or CABG of the target vessel. Stent thrombosis (ST) was defined as an angiographic documented, contrast filling defect of the target lesion in the presence of an ACS. Procedural success was defined as the presence of thrombolysis in myocardial infarction (TIMI) 3 flow and ≤30% stenosis in the MV, plus TIMI 3 flow in the SB after the procedure. Statistical analysis performed with SPSS. Difference in categorical variables between two groups wasanalyzed with the Chi-square test. Continuous variables were analyzed with Mann–Whitney test. Level of significance was 5%.
| Results|| |
This prospective cohort study was conducted in All India Institute of Medical Sciences, New Delhi, from 2015 to 2017. All patients of coronary artery disease (CAD) with bifurcation lesions and SB >2.25 (visual reference) were enrolled and followed up telephonically for 1 year. All cases of bifurcation CAD who had undergone elective PCI in the year 2015 were recruited. Out of total 1028 elective PCI done, those for bifurcation lesions (with SB >2.25 mm) were 107 (10.4%). Thus, a total 107 cases were enrolled; 28 in dedicated and 79 in provisional arm. Provisional or 2-stent strategy and sub-strategy was decided by operator after analysis of bifurcation anatomy. Baseline profile of patients is as per [Table 1].
The mean age of patients was 56.2 ± 10.2 years. Overall, 44% of patients were hypertensive, 34% were diabetics, and 32% were smoker. Distribution of risk factor in either arm was uniform, and difference was not statistically significant. Male outnumbered female in either group, more in 2-stent group. Chronic stable angina Class II was most common presentation in both groups. Mean ejection fraction (EF) was 49.6% ±9.8%, only 7% patients intervened had EF <40%.
Left anterior descending artery (LAD) – D1 was most common (41.1%) bifurcation lesion intervened followed by LCX-OM1-OM2 (25%). Eight cases (7%) were left main (LM) distal bifurcation. Nearly 73% of total cases were true bifurcation having disease in both MV and SB. All cases of dedicated arm were true bifurcation, while only 63.2% in provisional group (P < 0.001) were true bifurcation. The most important deciding factor for choosing either strategy seems to be the lesion length in SB; in dedicated arm, 75% of patients had stenosis ≥5 mm in SB, whereas in provisional arm, 74.7% of patients had <5 mm stenosis in SB (P < 0.001) as shown in [Table 2] and [Figure 1].
|Figure 1: Distribution of true bifurcation and side branch length stenosis in each group.|
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In 2-stent strategy arm, T-TAP was most common strategy followed by DK crush. FKBD was done in 27 (96.4%) out 28 cases of dedicated arm. Static angiograms of few bifurcation stenting techniques performed are shown in [Figure 2],[Figure 3],[Figure 4].
|Figure 2: Left main bifurcation MEDINA 1, 1, 1 done by simultaneous kissing stent stenting.|
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|Figure 3: Left anterior descending artery – D1 bifurcation MEDINA 1, 1, 1 done by T TAP.|
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Second-/third-generation DES was used in 100% of cases, zotarolimus-eluting stent (ZES) used in 52.3% of cases, and everolimus-eluting stent (EES) in 47.7% of cases. In 2-stent arm, ZES was used in 71.4% of cases while in provisional arm in 45.6% of cases (P = 0.04).
In provisional group, SB wired only in 29% of cases which could partially explain the SB compromises which occurred in 35.4% in cases; residual significant stenosis (≥70%) occurred in 41.8% of cases. Only two cases out of 79 provisional cases had to be shifted to 2-stent strategy (both done by T TAP technique).
In-hospital, one patient in dedicated 2-stent arm developed acute ST and non-ST segment elevation myocardial infarction. This patient was treated with balloon angioplasty (plain old balloon angioplasty [POBA]). In provisional arm, three patients developed MI with raised cardiac injury marker, perhaps due to occlusion of SB but subsequent course in these patients was uneventful.
Overall, 90 patients (84.1%) could be followed up for 1 year (an attrition of 17 patients). Attrition was related to loss of contact, and these were not included in final analysis. On 1-year follow-up, in the provisional arm, one patient died suddenly (no cause could be attributed), one patient had subacute ST managed by PCI, and one patient had late ST, requiring emergency CABG, culminating in death. In the dedicated arm, one patient presented with subacute ST attributed to noncompliance of DAPT, POBA was done with good outcome. No death was reported in this arm. Overall, at the end of 1 year, MACE was no different in either arms (9.5% provisional arm vs. 7.4% dedicated arm; P = 0.65). A total of four ST episodes (4.4%) were reported, including one in hospital [Table 3].
| Discussion|| |
This study revealed bifurcation CAD profile, treatment strategies, and 1-year outcome in the Indian context. As of now, not much data are available from India regarding the burden of this disease and bifurcation strategies followed, particularly the outcome. This was a prospective, operator-based study (nonrandomized), wherein an appropriate treatment strategy was chosen by the interventionist.
The mean age of patients was at least a decade earlier than western population, in tune with other studies from this part of the world (reflecting perhaps an early onset of CAD in this part of the world).
Our study revealed that 72.9% of cases were true bifurcation, which is in tune with available randomized controlled trials (RCTs), for example, NORDIC, (72% true bifurcation), CACTUS (92%), BBC-ONE (83%), and BBK (68%) in other regions as well. However, all cases in dedicated 2-stent arm were true bifurcation lesions (while only 63.2% in provisional group, P < 0.001).
Length of lesion in SB appeared to be single most important determinant of choosing dedicated 2-stent arm (75% patients had stenosis ≥5 mm in length in SB, whereas in provisional group, 74.7% of patients had <5 mm stenosis in SB, P < 0.001). This perhaps reflects the current practice, wherein with true bifurcation having SB stenosis ≥5 mm, a dedicated 2-stent strategy is more frequently used vis-à-vis provisional stenting.
Regarding which strategy should be chosen with dedicated 2-stent technique, previous studies revealed no significant difference with either crush or Culotte technique., DK-CRUSH technique in DKCRUSH-III study revealed some advantage over Culotte. In distal LM bifurcation lesions, the difference in MACE rates at 1 year was 16.3% versus 6.2% (P = 0.001, Culotte group vs. DK group). In our study, T TAP was most common strategy used in 2-stent arm followed by DK CRUSH. While T TAP is considered best strategy to switch from 1-stent to 2-stents due to compromise of SB, in provisional strategy, but in our study, it was the most preferred approach even in the 2-stent dedicated arm, perhaps because of ease of this strategy. In our series, LAD-D1 was most common intervened bifurcation vessel and FKBD dilation was used in 96.4% of cases in dedicated arm; compared with much lower use of FKBD in the provisional arm (13.9%), in tune with current worldwide recommendations. In our series, OCT, IVUS, and FFR use was not routinely utilized again reflecting the practice in Indian sub-continent.
Regarding stents, all stents used were 2nd–3rd-generation DES, in contradistinction to prior studies available, which mainly used first-generation DES; sirolimus eluting stent (SES) or paclitaxel eluting stent (PES).
Comparison of different DES in bifurcation lesion population has been studied in previous studies. Pan et al. showed that primary end point, angiographic restenosis, was significantly lower in the SES group compared to PES (9% vs. 29%, P = 0.011), as was target lesion revascularization at 24 months after stenting (4% vs. 13%, P = 0.021). Similar outcomes were observed in the COBIS registry.
Later generation DES has performed well over first generation in various lesions and this holds true for bifurcation lesions as well., No significant difference was noted between various later generation DES. In Z-SEA-SIDE study, the ZES demonstrated improved performance compared with the SES (SB “trouble” rate was 4% vs. 16%, respectively; P = 0.014) and better SB angiographic results (minimal lumen diameter at SB ostium, 1.94 vs. 1.64 mm, P = 0.008) were obtained. However, between ZES and EESs, no difference could be observed.
In our study, ZES was used more than everolimus eluting in 2-stent dedicated arm compared to provisional (71.4% vs. 52.3%; P = 0.04). The difference could be because of greater SB access with Zotarolimus family of stents or a mere chance. However, the outcomes were not different in various stents although numbers are too small to make any comparison.
Regarding provisional or dedicated 2-stent strategy, MACE was not different in either small randomized trial by Colombo et al. and Pan et al., nor in later larger RCTs, for example, Nordic,, CACTUS, and BBK, on other hand BBC-ONE trial favored provisional strategy. In our study, 84% were followed up at 1 year, MACE was 8.8% overall and although the MACE rates were numerically lower in 2-stent arm, no statistically significant difference was found in either group (7.4% dedicated vs. 9.5% in provisional, P = 0.65). Whether this improved outcome with 2-stent strategy is due to improved technique or improved 2nd and 3rd generation stents used or a mere chance could not be determined by this study. Improved stent generations have been correlative of improved outcomes in other studies as well.,
Recent increase in LM bifurcation treatment by angioplasty leads to the evaluation of one or two stent strategy in same. In true LM bifurcation lesions, both 1- and 2-stent strategies showed no improvement in terms of periprocedural MI. DEFINATION criteria established and in complex bifurcation lesion upfront 2 stent showed better outcome at 3 years.
Recent more experience and proper technique in DK crush shown improvement of outcome. Results of DKCRUSH-V were associated with a significant reduction in both primary and secondary end points for patients with complex lesions or at high risk compare to results of previous registries., Imaging also improves outcomes if added in routine bifurcation techniques.
European cardiologist consensus suggested still provisional approach with optional SB treatment provide flexible options for the majority of case-based learning patients.
In our study, follow-up was done for symptoms and not an angiographic follow-up, and therefore target lesion failure could not be defined, revascularization was overall less with one patient in either group. Less than 1 in 10 patients (7.7%) patients had persistence or recurrence of symptoms.
Two ST occurred in dedicated arm (7.4%), one in hospital and second postdischarge due to noncompliance to DAPT. The rate was much higher than available studies worldwide, it could be a mere chance, but it could also be because of premature DAPT withdrawal. In a country like India, DAPT adherence cannot be guaranteed, perhaps because of inadequate counseling or economical barrier. This information must play a major part in decision-making, especially in context of LM bifurcation lesion where ST could be catastrophic.
In context of technique, none of the approaches is immune to ST; one patient of ST was in DK crush and other in T-TAP. Although in both of patients zotarolimbus-eluting stents were used result seems likely due to chance association only.
In provisional arm, SB compromise occurred in 35.4% of cases in the form of plaque shift culminating in pinching and 38% of SB had residual stenosis ≥70% stenosis. Intervention in SB was performed if chest pain developed or <TIMI 3 flow occurred. This happened in only two patients who were switched to 2-stent outcome (with T TAP). The fact that FKBD could be performed in >95% of cases could either speak for the excellent strategy chosen or the skill of the operators. On the other hand, SB re-crossing failed in 3.8% of cases after provisional stenting, so it is advisable to wire the SB even in provisional stent strategy. However, residual stenosis in SB was not harbinger of 1-year events and patients did equally well.
Strength of study is that it is first of its kind study from India and uses later generation stents. Good number of patients could be followed up.
Limitations are many in our study; small numbers, nonrandomized nature especially in light of presently available, large RCTs from western population. Furthermore, there are many confounding factors such as operator discretion, stent types, and different operator techniques. Follow-up was only clinical and telephonic but not angiographic and thus target lesion failure could not be determined.
| Conclusions|| |
With careful selection of cases, both provisional and dedicated 2-stent strategy had similar outcomes with later generation DES. SB stenosis length >5 mm seems to be most important deciding factor in choosing the strategy. ST represents a real danger with either of the techniques and compliance with DAPT is major factor should be considered before embarking on PCI for bifurcation lesions.
Ethical clearance was taken from ethical committee, AIIMS; New Delhi.
Patient consent was taken for each patient. Patient confidentiality was maintained.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3]