Ten-Year Trends in Coronary Bifurcation Percutaneous Coronary Intervention: Prognostic Effects of Patient and Lesion Characteristics, Devices, and Techniques

Abstract

Background Despite advances in devices and techniques, coronary bifurcation lesion remains a challenging lesion subset in the field of percutaneous coronary intervention (PCI). We evaluate 10-year trends in bifurcation PCI and their effects on patient outcomes. Methods and Results We analyzed 10-year trends in patient/lesion characteristics, devices, PCI strategy, stent optimization techniques, and clinical outcomes using data from 5498 patients who underwent bifurcation PCI from 2004 to 2015. Clinical outcomes 2 years after the index procedure were evaluated in terms of target vessel failure (a composite of cardiac death, myocardial infarction, and target vessel revascularization) and a patient-oriented composite outcome (a composite of all-cause death, myocardial infarction, and any revascularization). During the 10-year study period, patient and lesion complexity, such as multivessel disease, diabetes mellitus, chronic kidney disease, and left main bifurcation, increased continuously (all P<0.001). The risk of target vessel failure or patient-oriented composite outcome decreased continuously from 2004 to 2015 (target vessel failure: from 12.3% to 6.9%, log-rank P<0.001; patient-oriented composite outcome: from 13.6% to 9.3%, log-rank P<0.001). The use of a second-generation drug-eluting stent and decreased target vessel failure risk in true bifurcation lesions were the major contributors to improved patient prognosis (interaction P values were <0.001 and 0.013, respectively). Conclusions During the past decade of bifurcation PCI, patient and lesion characteristics, devices, PCI techniques, and patient prognosis have all significantly changed. Despite increased patient and lesion complexity, clinical outcomes after bifurcation PCI have improved, mainly because of better devices and more widespread adoption of procedural optimization techniques and appropriate treatment strategies. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01642992 and NCT03068494.

Keywords: clinical outcome; coronary bifurcation lesion; drug‐eluting stent; percutaneous coronary intervention.

Conflict of interest statement

None.

Figures

Figure 1. Changes in patient and lesion characteristics.

Temporal changes in (A) patient and (B) lesion complexity in the target population for bifurcation percutaneous coronary intervention are summarized. The percentage of patients with diabetes mellitus, multivessel disease, and left main bifurcation increased, but the incidence of true bifurcation lesions decreased. The incidence of acute coronary syndrome did not significantly change.

Figure 2. Changes in treatment strategy trends from 2004 to 2015.

During the past decade, use of the simple crossover (1‐stent without side branch [SB] ballooning) strategy has continuously increased. Conversely, use of the 1‐stent with SB ballooning and 2‐stent strategy significantly decreased. The circle represents the mean proportion, and the vertical whiskers represent 95% CIs.

Figure 3. Changes in clinical outcomes 2 years after the index procedure.

A, Cumulative incidence of patient‐oriented composite outcome (red line) and target vessel failure (TVF; blue line) 2 years after the index procedure is presented. Patient‐oriented composite outcome a composite of all‐cause death, spontaneous myocardial infarction (MI), and any revascularization. TVF is a composite of cardiac death, spontaneous MI, and target vessel revascularization. B, Temporal changes in the cumulative incidence of TVF are presented according to the treatment strategy for bifurcation percutaneous coronary intervention. Cumulative incidence was estimated using Kaplan‐Meier estimates (percentages). Whiskers represent 95% CIs.

Figure 4. Changes in target vessel failure (TVF) according to stent type and lesion characteristics.

Annual changes in 2‐year TVF are presented according to (A) the use of first‐ or second‐generation drug‐eluting stent (DES) and (B) the occurrence of true or nontrue bifurcation lesion percutaneous coronary intervention (PCI). Differential prognosis was observed between first‐ and second‐generation DES and between true and nontrue bifurcation lesion PCI, and those effects showed a significant interaction with changes in the risk of TVF.

Figure 5. Prognostic implications of procedural factors in 1‐stent and 2‐stent strategies.

Annual changes in the implementation of radial access and optimization techniques and their prognostic implications for the risk of 2‐year target vessel failure (TVF) are presented. With both the 1‐ and 2‐stent strategies, the use of radial access, intravascular ultrasound (IVUS)–guided optimization, and proximal optimization technique (POT) significantly increased. A, With the 1‐stent strategy (n=4290), the use of final kissing balloon (FKB) significantly decreased. B, No variables significantly affected the risk of 2‐year TVF with the 1‐stent strategy. C, With the 2‐stent strategy (n=1208), most procedures were accompanied by FKB. D, Optimization techniques in bifurcation percutaneous coronary intervention (PCI; image‐guided PCI, FKB, and POT) effectively reduced the risk of TVF only in patients treated with the 2‐stent strategy. The multivariable analyses were complete case analysis. HRadj indicates adjusted hazard ratio.

Figure 6. Ten‐year trends in coronary bifurcation percutaneous coronary intervention (PCI).

This study evaluated the 10‐year trends in bifurcation PCI in terms of patient/lesion characteristics, devices, bifurcation PCI and stent optimization techniques, and clinical outcomes. During the past decade, patient and lesion complexity in the target population for bifurcation PCI significantly increased. Practice patterns also significantly changed: almost all procedures are now performed using second‐generation drug‐eluting stents (DES); the 1‐stent strategy has become the most commonly used strategy; procedural optimization techniques (intravascular ultrasound [IVUS] guidance, final kissing balloon [FKB], and proximal optimization technique [POT]) are increasingly used. Despite increased patient and lesion complexity, clinical outcomes after bifurcation PCI have improved as a result of enhanced devices, better patient and lesion selection, simplified procedures, and the use of advanced procedural optimization techniques. The current results from 10 years of experience support the contemporary consensus statement about bifurcation PCI and imply that practice patterns are heading in the right direction to enhance patient outcomes.