The DKCRUSH V (Randomized Study on Double Kissing Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions) trial, reported at Transcatheter Cardiovascular Therapeutics 2017 and published in the Journal of the American College of Cardiology,¹ compared outcomes of stenting the main vessel (MV) with provisional side branch (SB) stenting to the two-stent double kissing crush technique for the distal left main (LM) true bifurcation. The primary endpoint was 1-year target lesion failure.

A total of 240 patients were randomized to double kissing, and 242 patients were randomized in the provisional stenting strategy. Baseline characteristics were well-matched, and diabetes was present in 27.2% of patients; 70% of patients presented with unstable angina. The mean SYNTAX score was 30.6. Multivessel disease was present in 88.2% of patients. Medina class was 1,1,1 in 81.7% of cases and 0,1,1 in 18.3% of cases.

Clinical follow-up was obtained in all patients at 1 year, and angiographic follow-up was obtained at 13 months in 158 patients (65.3%) in the provisional stenting group and 159 patients (66.3%) in the double kissing group.

At 1 year, mortality was low: 1.2% in the double kissing arm versus 2.1% in the provisional stenting arm (p = 0.42). Target lesion failure occurred in 10.7% assigned to provisional stenting and 5.0% assigned to double kissing crush (hazard ratio 0.42; 95% confidence interval, 0.21-0.85; p = 0.02). Compared with provisional stenting, double kissing crush also resulted in lower rates of target vessel myocardial infarction (2.9 vs. 0.4%, p = 0.03) and definite or probable stent thrombosis (3.3 vs. 0.4%, p = 0.02). Clinically driven target lesion failure (7.9 vs. 3.8%, p = 0.06) and angiographic restenosis within the LM complex (14.6 vs. 7.1%, p = 0.10) also tended to be less frequent with double kissing crush compared with provisional stenting. Rates of angiographic success and complete revascularization were similar in the two groups, although procedural time and contrast use were greater with double kissing crush stenting than provisional stenting.

The important aspects of the trial were the outcomes of the two strategies based on lesion complexity (Figure 1). Involvement of the SB determines lesion complexity. A simple lesion has an SB ostial stenosis of ≤70% and lesion length ≤10 mm; in a complex lesion, SB ostial stenosis is ≥70% with a lesion length ≥10 mm. Added criteria for increasing lesion complexity based on the DEFINITION (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents)² study were any 2 of 6 minor criteria: distal bifurcation angle <45° or ≥70°, MV reference vessel diameter ≤2.5 mm, MV lesion length ≥25 mm, multiple bifurcations, thrombus-containing lesion, and severe calcification.

Figure 1: Simple Versus Complex Lesion and Outcomes of Stenting Strategies

SB pre-dilatation was performed in 39.7% of patients in the provisional stenting group due to severe SB compromise after MV treatment. A total of 114 (47.1%) patients in the provisional stenting group required an additional SB stent for suboptimal results after MV stenting, including 64 of 165 (38.8%) patients with simple LM bifurcation lesions and 50 of 77 (64.9%) patients with complex lesions (p = 0.001). An SB stent was successfully implanted in all double kissing crush patients. The proximal optimization technique and final kissing balloon inflation were more frequently used in the double kissing crush group than in the provisional stenting group. In the 114 patients in the provisional stenting group who required an SB stent versus the 128 patients who did not, the 1-year rates of target lesion failure were 13.2% and 8.6%, respectively (p = 0.30), and the 1-year rates of stent thrombosis were 6.1% and 0.8%, respectively. Angiographic restenosis primarily at the left circumflex ostium occurred in 14.6% patients treated with provisional stenting versus 7.1% patients treated with double kissing crush (p = 0.10). Interestingly, left circumflex ostial restenosis was similar at 12% with a single stent provisional approach in the EXCEL (Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease)³ and NOBLE (Percutaneous Coronary Angioplasty Versus Coronary Artery Bypass Grafting in Treatment of Unprotected Left Main Stenosis)⁴ trials.

As demonstrated in the central illustration (Figure 1), in a simple LM bifurcation, there were comparable outcomes with single stent provisional stenting with a 1-year target lesion failure of 8.3% versus 5.0% with double kissing techniques (p = 0.45). With a more complex LM bifurcation lesion, target lesion failure was 18.0% with provisional stenting and 4.8% with double kissing (p = 0.018).

Results of the DKCRUSH V trial support our treatment algorithm⁵ for LM bifurcation stenting strategies (Figure 2). A suggested approach to LM intervention is to first assess whether the lesion is simple or complex (Figure 1) and then proceed with a stenting approach as described in the algorithm.

Figure 2: Algorithm for LM Bifurcation Intervention

The evolution of treatment strategies suggest that two stent double kissing crush technique is the best treatment strategy for the complex LM bifurcation lesion (Figure 3). For the simple lesion, an MV single stent technique has good outcomes. However, adding an SB stent increases target lesion failure, target lesion revascularization, stent thrombosis, and restenosis rates.

Figure 3: Evolution of LM Bifurcation Techniques^6,7,1

References

1. Chen SL, Zhang JJ, Han Y, et al. Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial. J Am Coll Cardiol 2017;Oct 30:[Epub ahead of print].
2. Chen SL, Sheiban I, Xu B, et al. Impact of the complexity of bifurcation lesions treated with drug-eluting stents: the DEFINITION study (Definitions and impact of complEx biFurcation lesIons on clinical outcomes after percutaNeous coronary IntervenTIOn using drug-eluting steNts). JACC Cardiovasc Interv 2014;7:1266-76.
3. Stone GW, Sabik JF, Serruys PW, et al. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med 2016;375:2223-35.
4. Mäkikallio T, Holm NR, Lindsay M, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet 2016;388:2743-52.
5. Rab T, Sheiban I, Louvard Y, Sawaya FJ, Zhang JJ, Chen SL. Current Interventions for the Left Main Bifurcation. JACC Cardiovasc Interv 2017;10:849-65.
6. Chen SL, Xu B, Han YL, et al. Comparison of double kissing crush versus Culotte stenting for unprotected distal left main bifurcation lesions: results from a multicenter, randomized, prospective DKCRUSH-III study. J Am Coll Cardiol 2013;61:1482-8.
7. Ferenc M, Gick M, Comberg T, 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.

Keywords: Transcatheter Cardiovascular Therapeutics, TCT17, Drug-Eluting Stents, Coronary Artery Disease, Tomography, Optical Coherence, Constriction, Pathologic, Confidence Intervals, Dilatation, Angioplasty, Balloon, Coronary, Percutaneous Coronary Intervention, Angina, Unstable, Stents, Coronary Artery Bypass, Myocardial Infarction, Thrombosis, Diabetes Mellitus, Algorithms

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