Table 1.
Randomized Controlled Trials With Long‐Term Follow‐Up Included in Meta‐Analysis
| Study | Nordic10 | BBK111, 12 | PERFECT13 | Nordic‐Baltic Bifurcation14 IV | BBC115, 16 | EBC217 | Smart‐Strategy18 | DK Crush II4 | DK Crush V5 |
|---|---|---|---|---|---|---|---|---|---|
| Publication year | 2013a | 2015 | 2015 | 2015 | 2016a | 2016 | 2016 | 2017a | 2017 |
| Participants (n) | 413 | 202 | 419 | 446 | 500 | 202 | 258 | 370 | 482 |
| Strategy | Provisional vs complex | Provisional vs T stent | Provisional vs crush | Provisional vs complex | Provisional vs complex | Provisional vs culotte | Conservative vs aggressive provisional | DK crush vs provisional | DK crush vs provisional |
| Primary trial end point | MACE (cardiac death, nonprocedural MI, TVR, ST) | All‐cause death, MI, or TLR | Cardiac death, MI, or TVR | MACE (cardiac death, nonprocedural MI, TLR, and definite ST) | Death | Death, MI, or TVR | TVF: cardiac death, spontaneous MI, or TVR | Cardiac death, MI, or TVR | Cardiac death, target vessel MI, or TLR |
| Enrollment period | Sep 2004 to May 2005 | Apr 2005 to Aug 2006 | Apr 2007 to Jan 2013 | N/A | Dec 2004 to Dec 2007 | Apr 2011 to Jan 2014 | Jul 2007 to Dec 2010 | Apr 2007 to Jun 2009 | Dec 2011 to Feb 2016 |
| Follow‐up duration, y | 5 | 5 | 1 | 2 | 5 | 1 | 3 | 5 | 1 |
| Mortality adjudication | Hospital records and national mortality tracking | Hospital records/treating physician | N/A | N/A | National mortality records | Outpatient review or teleconsult | National mortality registry | N/A | N/A |
| Follow‐up angiography, mo (% of patients) | 8 (88) | 9 (95) | 8 (72) | 8 (N/A) | 9 (N/A) | N/A | 9 (84.5) | 9 (92) | 13 (66) |
| Loss to follow‐up, % | 2 | 0 | <1 | <1 | 0 | 1 | 0 | <1 | 0 |
| Mean age, y | 63 | 66.8 | 61.0 | 63.5 | 63 | 64 | 62 | 64.5 | 64.5 |
| Diabetes mellitus, % | 12.5 | 22.3 | 27.4 | 15.8 | 12.3 | 28 | 27.1 | 31.5 | 27.2 |
| Smoker,% | N/A | 11.9 | 28.9 | 20.1 | 20.7 | 53 | 28 | N/A | 33.2 |
| Male, % | 77 | 78.8 | 75.2 | N/A | 77.1 | 82 | 82.5 | 77.5 | 80.3 |
| ACS presentation, % | 34.5 | 0 | 38.2 | N/A | 33.8 | 31.5 | 29.5 | 84.2 | 82.9 (includes UAP) |
| Minimum DAPT duration, mo | 6 | 6 | 12 | N/A | 9 | 12 | N/A | 12 | 12 |
| LMCA/LAD/Cx, % | 0.7 | 0 | 0 | 2 | 0 | 0 | 44.2 | 16.7 | 100 |
| LAD/Diag, % | 73.5 | 74.3 | 93.0 | 75.4 | 82 | 77.5 | 45.7 | 59.8 | 0 |
ACS indicates acute coronary syndrome; BBC1, British Bifurcation Coronary Study One; BBK1, Bifurcation Bad Krozingen trial; Cx, circumflex artery; DAPT, dual antiplatelet therapy; Diag, diagonal artery; DK Crush II, Double Kissing Crush versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions; DK crush V, Double Kissing Crush Versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions; EBC2, European Bifurcation Coronary Two; LAD, left anterior descending artery; LMCA, left main coronary artery; MACE, major adverse cardiac events; MI, myocardial infarction; N/A, not available; Nordic, The NORDIC Bifurcation Study; PERFECT, Optimal Stenting Strategy for True Bifurcation Lesions; Smart‐Strategy, Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesions; ST, stent thrombosis; TLR, target lesion revascularization; TVF, target vessel failure; TVR, target vessel revascularization; UAP, unstable angina pectoris.
5‐y follow‐up results.