TABLE 3.
Percutaneous coronary intervention strategies
| Trial | Trial design | Patient population | N | Follow‐up | MACCE | All‐cause mortality | MI | Stent thrombosis | Repeat revascularization |
|---|---|---|---|---|---|---|---|---|---|
| I. Type of stent | |||||||||
| Stent Restenosis Study, 1994 45 | BMS vs. balloon angioplasty (RCT) | Symptomatic CAD and new lesion of native coronary circulation with ≥70% stenosis | 410 | 8 months | 19.5 vs. 23.8 (p = .16) | 1.5 vs. 1.5 (p = .99) | 6.3 vs. 6.9 (p = .81) | NA | 11.2 vs. 12.4 (p = .72) |
| Norwegian Coronary Stent, 2016 47 | DES vs. BMS (RCT) | All patients undergoing PCI | 9013 | 6 years | 16.6 vs. 17.1 (HR 0.98; 95% CI, 0.88–1.09, p = .66) | 8.5 vs. 8.4 (HR 1.10; 95% CI, 0.94–1.32, p = .21) | 9.8 vs. 10.5 (HR 0.89; 95% CI, 0.77–1.02, p = .10) a | 0.8 vs. 1.2 (HR 0.64; 95% CI, 0.41–1.0, p = .05) | 16.5 vs. 19.8 (HR 0.76; 95% CI, 0.69–0.85, p < .001) |
| Stone, 2007 48 | DES vs. BMS (RCT) | Single‐vessel CAD suitable for PCI | 1748 | 4 years | NA | Sirolimus: 6.7 vs. 5.3 (HR 1.27; 95% CI, 0.86–1.88, p = .23) | Sirolimus: 6.4 vs. 6.2 (HR 1.03; 95% CI, 0.71–1.51, p = .86) | Sirolimus: 1.2 vs. 0.6 (HR 2.0; 95% CI, 0.68–5.85, p = .20) | Sirolimus: 7.8 vs. 23.6 (HR 0.29; 95% CI, 0.22–0.39, p < .001) b |
| Paclitaxel: 6.1 vs. 6.6 (HR 0.94; 95% CI, 0.70–1.26, p = .68) | Paclitaxel: 7.0 vs. 6.3 (HR 1.06; 95% CI, 0.81–1.39, p = .66) | Paclitaxel: 1.3 vs. 0.9 (HR 1.44; 95% CI, 0.73–2.84, p = .30) | Paclitaxel: 10.1 vs. 20.0 (HR 0.46; 95% CI, 0.38–0.55, p < .001) | ||||||
| ABSORB III, 2015 53 | Absorb scaffold vs. DES (RCT) | Patients with ischaemia and one‐ or two‐vessel CAD undergoing PCI | 2008 | 1 year | NA | 1.1 vs. 0.4 (RR 2.58; 95% CI, 0.75–8.87, p = .12) | 6.9 vs. 5.6 (RR 1.22; 95% CI, 0.85–1.76, p = .28) | 1.4 vs. 0.7 (RR 1.87; 95% CI, 0.70–5.01, p = .21) | 1.1 vs. 0.4 (RR 2.58; 95% CI, 0.75–8.87, p = .12) |
| SYNTAX II 35 | SYNTAX II vs. SYNTAX I (PCI‐arm) | Three‐vessel CAD without LM disease | 5 years | 10.8 vs. 21.8 (HR 0.47; 95% CI, 0.32–0.68) | 8.1 vs. 13.8 (HR 0.57; 95% CI, 0.37–0.90) | 2.7 vs. 10.4 (HR 0.26; 95% CI, 0.13–0.50) | 2.3 vs. 2.7 (HR 0.83; 95% CI, 0.33–2.12) | 13.8 vs. 23.8 (HR 0.56; 95% CI, 0.39–0.78) | |
| II. FFR‐guided | |||||||||
| DEFER, 2015 54 | FFR ≥0.75 deferred PCI vs. FFR ≥0.75 perform PCI (RCT) | Referred for elective PCI stenosis >50% of native coronary artery without documented reversible ischaemia | 325 | 2 years | NA | Survival rate: 89.0 vs. 83.3 (p = .27) | NA | NA | NA |
| 5 years | NA | Survival: 79 vs. 73 (p = .52) | NA | NA | NA | ||||
| 15 years | NA | 33.0 vs. 31.1 (RR 1.06; 95% CI, 0.69–1.62, p = .79) c | 2.2 vs. 10.0 (RR 0.22; 95% CI, 0.05–0.99, p = .03) | NA | 42.9 vs. 34.4 (p = .245) | ||||
| FAME trial, 2009, 2015 37 , 55 | FFR‐guided vs. CAG‐guided PCI (RCT) | Multivessel CAD defined as ≥50% stenosis in ≥2 of the major epicardial coronary arteries | 1005 | 1 year | 13.2 vs. 18.3 (p = .02) d | 1.8 vs. 3.0 (p = .19) | 5.7 vs. 8.0 (p = .07) | NA | 6.5 vs. 9.5 (p = .08) |
| 5 years | 28.0 vs. 31.0 (p = .31) d | 9.0 vs. 10.0 (p = .50) | 9.6 vs. 12.1 (NA) | NA | 15.0 vs. 17.0 (p = .39) | ||||
Outcomes of I. different coronary stents and II. FFR‐guided PCI.
Abbreviations: AIDA, Amsterdam Investigator‐Initiated Absorb Strategy All‐Comers; ABSORB, A Bioresorbable Everolimus‐Eluting Scaffold Versus a Metallic Everolimus‐Eluting Stent; BMS, bare‐metal stent; CAD, coronary artery disease; CI, confidence interval; DEFER, Deferral versus Performance of PTCA in Patients Without Documented Ischemia; DES, drug‐eluting stent; FAME, Fractional Flow Reserve versus Angiography for Multivessel Evaluation; FFR, fractional flow reserve; HR, hazard ratio; MACCE, major adverse cardiac and cerebrovascular events; MI, myocardial infarction; OMT, optimal medical therapy; PCI, percutaneous coronary intervention; RR, relative risk.
Nonprocedural MI.
Repeat target lesion revascularization.
Composite outcome of cardiac death and MI.
Composite outcome of all‐cause death, MI and repeat revascularization. Outcomes are presented as estimated cumulative event rates, RRs, HRs with their 95% CI and p‐values.