|Year : 2021 | Volume
| Issue : 1 | Page : 31-35
Clinical and angiographic outcomes of coronary bifurcation lesions treated by TAP- stenting as an initial two stent strategy
Krishna Malakonda Reddy Parvathareddy, Naga Chaitanya Karella, Srinivas Ravi, Praveen Nagula, Jagadeesh Reddy Kolli, Syed Imamuddin
Department of Cardiology, Osmania General Hospital, Hyderabad, Telangana, India
|Date of Submission||05-Feb-2021|
|Date of Decision||15-Mar-2021|
|Date of Acceptance||17-Mar-2021|
|Date of Web Publication||24-Apr-2021|
Department of Cardiology, Osmania General Hospital, Hyderabad, Telangana
Source of Support: None, Conflict of Interest: None
Context: The T-stenting with small protrusion (TAP) technique is a relatively new strategy among the bifurcation lesion interventions. Apart from being technically easy, there is complete coverage of the side-branch ostium and minimal overlap of the stent struts. Aims: We sought to report the outcomes of TAP technique in the management of the bifurcation lesions. Settings and Design: Prospective observational study between December 2017 and December 2019. Subjects and Methods: Patients with a diagnosis of coronary artery disease and bifurcation lesion on angiography were included in the study. Patients who underwent intervention with TAP technique were analyzed at baseline and followed up for a period of 1 year. The measured endpoints include major adverse cardiac events (MACE), target vessel revascularization (TVR), stent thrombosis (ST), and binary restenosis at 1-year follow-up. Results: During the study period, 152 bifurcation lesions in 148 patients were treated by percutaneous coronary intervention using drug-eluting stents. Of these, 15 patients (10.13%) underwent TAP stenting. The median age was 60 years. The procedural success was 100% in all the patients. At 1-year follow-up, MACE was seen in 13.3%, TVR in 6.66%, and binary stenosis in 6.66%. Conclusion: The TAP stenting as an initial two-stent strategy is associated with acceptable clinical outcomes (MACE and in-stent restenosis). There was no case of definite ST.
Keywords: Bifurcation lesions, major adverse cardiac events, target vessel revascularization, T-stenting with small protrusion
|How to cite this article:|
Parvathareddy KM, Karella NC, Ravi S, Nagula P, Kolli JR, Imamuddin S. Clinical and angiographic outcomes of coronary bifurcation lesions treated by TAP- stenting as an initial two stent strategy. J Pract Cardiovasc Sci 2021;7:31-5
|How to cite this URL:|
Parvathareddy KM, Karella NC, Ravi S, Nagula P, Kolli JR, Imamuddin S. Clinical and angiographic outcomes of coronary bifurcation lesions treated by TAP- stenting as an initial two stent strategy. J Pract Cardiovasc Sci [serial online] 2021 [cited 2021 Sep 25];7:31-5. Available from: https://www.j-pcs.org/text.asp?2021/7/1/31/314472
| Introduction|| |
A bifurcation coronary lesion is a lesion occurring at, or adjacent to, a significant division of a major epicardial coronary artery. Despite the interventional advancements, the optimal management of such lesions is still of considerable debate. The major concerns being risk of late stent thrombosis (ST) and complexity. Several strategies have been proposed, each with its own merits and technical challenges. The T-stenting with small protrusion (TAP) technique, a relatively new one is technically less challenging, ensures complete coverage of the ostium of side branch (SB) with minimal deformation and overlap of the stent struts. Compared to the data for other bifurcation strategies, the long-term clinical outcomes for the TAP technique are limited globally. The study has been taken up to assess the outcomes of the TAP technique with follow-up of 1 year.
| Subjects and Methods|| |
The present study is a prospective observational study between December 2017 and December 2019 in the Department of Cardiology. Patients with a diagnosis of coronary artery disease and bifurcation lesion on coronary angiography were included in the study. The presence of chronic renal disease, valvular heart disease, cardiomyopathy, congenital heart disease, significant peripheral artery disease, and patients with a history of intervention of the artery involved in the bifurcation lesion were excluded from the study. The Institutional Ethical Committee approved the study.
The baseline demographic data were collected and routine laboratory investigations, chest X-ray, electrocardiogram, and two-dimensional Echocardiogram were done for all the patients included in the study. All the patients provided the informed consent for the procedure. The classification of Coronary Artery Bifurcation Disease (CABD) was sorted by the Medina classification system and the true bifurcation disease was defined as Medina classification 1, 1, 1, 1,0, 1, or 0, 1, 1. The standard technique of TAP stenting for CABD was employed. The steps of the TAP technique are, respectively, wiring of the main vessel (MV) and SB, predilation of MV and/or SB at the operator's discretion, stenting of the MV by jailing the wire in SB, angiographic evaluation poststenting of MV, rewiring the SB through the struts of the MV stent, followed by balloon dilation to open the stent struts and MV balloon dilation, A stent will be positioned in the SB with portrusion as minimally as possible, ensuring complete coverage of the ostium of SB; deployment of the SB stent while the uninflated balloon will remain parked in the MV at the bifurcation. The SB stent balloon will be pulled backward slightly, ensuring it to be within the MV stent. Subsequently, simultaneous final kissing balloon inflation will be performed using the SB balloon and the previously positioned MB balloon at high pressure; check angiogram to confirm there is no dissection and vessel compromise [Figure 1].
|Figure 1: “Provisional” T-stenting with small protrusion technique step by step in a bench model. (a) The stent for the side branch is placed with a minimal protrusion in the main vessel and an uninflated balloon is prepared for final kissing in the main vessel. (b) The side branch stent is deployed with the main vessel balloon uninflated. (c) The balloon of the side branch stent is pulled back to achieve perfect alignment with the main vessel balloon. (d) Kissing balloon inflation is performed with the side branch stent's balloon and the main vessel balloon. (e) Final result with T-stenting with small protrusion stenting.|
Click here to view
Dual antiplatelets (i.e., aspirin 150 mg and clopidogrel 75 mg daily) for 12 months after percutaneous coronary intervention (PCI) were given for all patients. The in-hospital mortality, as well as 1-year mortality, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and ST were noted during follow-up. Angiography was performed 1 year after the procedure unless indicated earlier by the clinical suspicion or positive functional imaging test.
Quantitative coronary angiographic measurements
Matched orthogonal views were used for the quantitative analysis before and after the treatment. Angiography was performed after the intracoronary injection of nitroglycerine (100–200 μg). Angiograms were analyzed using the Quantitative coronary analysis (QCA) Clinical Measurements Solutions system. The SYNergy between PCI with TAXus and cardiac surgery (SYNTAX) score was used to define the severity of coronary artery disease. QCA measurements at baseline and after stent implantation on both MV and SB were assessed. Minimal lumen diameter (MLD), diameter stenosis (DS), and reference vessel diameters (RVD) were measured. The percentage stenosis was calculated as 100 (1-MLD/normal RVD). Angiographic success was defined as a final residual stenosis <20% with the thrombolysis in MI (TIMI) flow grade 3 in either the MV or the SB. The presence of binary angiographic restenosis at the end of 12 months was noted.
The measured endpoints were major adverse cardiac events (MACE) during the follow-up period.
- MACE was defined as a composite of cardiac death, MI, and TVR
- Death was considered cardiac in origin unless obvious noncardiac causes could be identified
- MI was diagnosed by the criteria of universal definition during the follow-up period
- TLR was defined as repeat PCI or coronary artery bypass graft for the lesion in the previously stented segment or in the adjacent 5 mm
- TVR was defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel
- The occurrence of ST was defined based on the Academic Research Consortium definitions
- Procedural success was defined as completion of the procedure with no in-lab complications, final TIMI flow grade 3 with residual stenosis <20% in MB and SB
- Binary angiographic restenosis was defined as a 50% DS of the target lesion.
SPSS (Statistical Package for the Social Sciences for Windows, version 21.0, Chicago, IL, USA) was used for all statistical calculations. Data were expressed as mean ± standard deviation for the continuous variables and as a percentage for the categorical variables. Time to event curve was generated using the Kaplan–Meier method.
| Results|| |
During the study period, 152 bifurcation lesions in 148 patients were treated by PCI using DES. Of these, 15 patients with a mean age of 60.86 years underwent TAP stenting. There was an equal distribution of the genders (males constitute 53.3%). The baseline clinical characteristics are shown in [Table 1].
Angiographic and procedural characteristics
Angiographic and procedural characteristics are shown in [Table 2]. The mean SYNTAX score of the participants was 20.6 ± 5.57. Bifurcation lesions were located predominantly in the left anterior descending artery/diagonal artery in 10 (66.66%) followed by distal left main coronary artery in 5 (33.33%). All the lesions were true bifurcation lesions with Medina 1, 1, 1 as the predominant one in 12 (80%), followed by 0, 1, 1 in 2 (13.3%) and 1,0,1 in 1 (6.6%) patient. Sirolimus-eluting stents were used in all the patients. Procedural success was achieved in all patients with no procedure-related deaths or complications. QCA measurements at baseline and the end of the procedure are shown in [Table 3].
Clinical follow up
All the patients were followed up clinically every month till 12 months and coronary angiography was performed at the end of 1 year. During this period, 2 (13.33%) MACE occurred: 1 (6.66%) patient had target vessel MI and died, 8 months after implantation of a DES. Consequently, probable ST was adjudicated in this patient. There were no cases of definite ST.
One patient (6.66%) required TLR in the form of repeat PCI, 9 months after stent implantation. He had focal restenosis involving the SB ostium (bifurcation type 1, 1, 1).
| Discussion|| |
A total of 152 bifurcation lesions in 148 patients were treated by PCI using DES. Of these, 15 patients underwent TAP stenting. The main findings were 100% procedural success with a MACE rate of 13.33% during the follow-up of 1 year.
Historically, two independent groups (from Italy and the Republic of Korea) developed the TAP stenting technique in the early years of the drug-eluting stent era. The two-stent strategy is usually taken as bailout procedure. The initial two-stent strategy techniques needs elective cases, most of the techniques are laborious and may not achieve complete success due to technical difficulties. TAP technique has some advantages such as there is a minimal protrusion of the SB stent into the MB, leading to minimal stent overlap and more importantly, ensuring ostial coverage. These advantages may theoretically reduce the rates of restenosis and ST.
Although this technique has been adopted worldwide, there are no large randomized trials with long-term outcome data to reference. Most of the data in the literature regarding the TAP technique is from the bailout procedures. Like, in our study, systematic TAP technique was evaluated by Al Rashad et al.
Burzotta et al. have evaluated TAP stenting as a bailout procedure in 73 patients with procedural success in all. At 9 months, the clinically driven TVR was 6.8%. The rate of definite ST was 1.4%. Al Rashdan and Amin, did TAP stenting in 156 patients with 99% procedural success and the TVR rate was 5.3%. The rate of definite ST was 0.06%. In a study by Burzotta et al., out of 19 patients with TAP stenting as a bailout procedure, the 1 year MACE rate was 8.2% and the rate of TVR was 4.5%. There were two cases of probable ST.
Naganuma et al. retrospectively analyzed the data of 95 patients who underwent TAP stenting. Procedural success was achieved in all. The 3-year MACE rate was 12.9%, and the rate of TVR was 9.7%. No ST was observed in this cohort.
The angiographic result of TAP using drug-eluting stents in the management of ischemic SB-ARTEMIS study was published in 2014 which evaluated the midterm angiographic results of TAP as the bailout strategy in 71 patients. At 9 months, the rate of restenosis was 12.5% and the rate of TVR was 8.5%. None of them had definite ST.
Cheng et al. made a randomized study on TAP stenting versus simple stenting in which TAP stenting was done in 69 patients. The rate of MACE was 13% at the end of 1 year. At 8 months, the rate of restenosis was 3.8% in the TAP group.
In the Bifurcations Bad Krozingen trial, Culotte and TAP techniques were compared. One hundred and fifty patients underwent TAP stenting and the rate of TLR at the end of 1 year was 12%. The rate of binary restenosis was 17%. From [Table 4] and [Table 5], it is evident that the rates of MACE and TLR are comparable to the results of the previous studies. There are no cases of definite ST. The rates of in-stent restenosis are acceptable and comparable to the rest of the studies. It is the first study in India to see the outcomes of TAP technique as an initial two-stent strategy rather than using as bailout procedure.
|Table 4: Comparison of clinical outcomes of T-stenting with small protrusion|
Click here to view
|Table 5: Comparison of clinical and angiographic outcomes of the present study with previous randomized trials|
Click here to view
The sample size is less. We did not compare the TAP technique with other 2-stent strategies to claim a technical and clinical advantage. Although the TAP technique ensures complete ostial coverage with minimal overlap, we were not able to confirm this with intravascular imaging.
Further randomized studies should compare the systematic TAP technique with other 2-stent strategies in a larger population.
| Conclusions|| |
Procedural success was achieved in all patients with no procedure-related deaths or complications. There are no cases of definite ST. The TAP technique is associated with acceptable clinical outcomes.
The ethical committee has provided the clearance for the conduct of study.
The authors would like to thank the Staff of the Department of Cardiology, OGH
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Thomas M, Hildick-Smith D, Louvard Y, Albiero R, Darremont O, Stankovic G, et al
. Percutaneous coronary intervention for bifurcation disease. A consensus view from the first meeting of the European Bifurcation Club. EuroIntervention 2006;2:149-53.
Burzotta F, Gwon HC, Hahn JY, Romagnoli E, Choi JH, Trani C, et al
. Modified T-stenting with intentional protrusion of the side-branch stent within the main vessel stent to ensure ostial coverage and facilitate final kissing balloon: The T-stenting and small protrusion technique (TAP-stenting). Report of bench testing and first clinical Italian-Korean two-centre experience. Catheter Cardiovasc Interv 2007;70:75-82.
Medina A, Suárezde Lezo J, Pan M. A new classification of coronary bifurcation lesions. Rev Esp Cardiol 2006;59:183-4.
Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A, Dawkins K, et al
. The SYNTAX Score: An angiographic tool grading the complexity of coronary artery disease. EuroIntervention 2005;1:219-27.
Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, et al
. Fourth universal definition of myocardial infarction (2018). J Am Coll Cardiol 2018;72:2231-64.
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al
. Clinical end points in coronary stent trials: A case for standardized definitions. Circulation 2007;115:2344-51.
Al Rashdan I, Amin H. Carina modification T stenting, a new bifurcation stenting technique: Clinical and angiographic data from the first 156 consecutive patients. Catheter Cardiovasc Interv 2009;74:683-90.
Burzotta F, Sgueglia GA, Trani C, Talarico GP, Coroleu SF, Giubilato S, et al
. Provisional TAP-stenting strategy to treat bifurcated lesions with drug-eluting stents: One-year clinical results of a prospective registry. J Invasive Cardiol 2009;21:532-7.
Naganuma T, Latib A, Basavarajaiah S, Chieffo A, Figini F, Carlino M, et al
. The long-term clinical outcome of T-stenting and small protrusion technique for coronary bifurcation lesions. JACC Cardiovasc Interv 2013;6:554-61.
Jim MH, Wu EB, Fung RC, Ng AK, Yiu KH, Siu CW, et al
. Angiographic result of T-stenting with small protrusion using drug-eluting stents in the management of ischemic side branch: The ARTEMIS study. Heart Vessels 2015;30:427-31.
Cheng WJ, Zhou YJ, Zhao YX, Nie B, Guo YH, Wang ZJ, et al
. Randomized study on T stenting and small protrusion technique versus simple stenting for patients with coronary artery bifurcation lesions and with big size side branch. Zhonghua Xin Xue Guan Bing Za Zhi 2010;38:131-4.
Ferenc M, Gick M, Comberg T, Rothe J, Valina C, Toma A, et al
. Culotte stenting vs. TAP stenting for treatment of de-novo coronary bifurcation lesions with the need for side-branch stenting: The Bifurcations Bad Krozingen (BBK) II angiographic trial. Eur Heart J 2016;37:3399-405.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]