Table 2.

Primary Effectiveness and Safety End Points for the SYMPLICITY HTN‐3 Trial

Effectiveness end point

Change in office SBP from baseline to 6 months postrandomization

Safety end point (MAE)

Through 1 month postrandomization, composite of:

All‐cause mortality

End‐stage renal disease (eGFR< 15 mL/min/m2 or need for renal replacement therapy)

Significant embolic event resulting in end‐organ damage (eg, kidney/bowel infarct, lower extremity ulceration or gangrene, or doubling of serum creatinine)

Renal artery perforation requiring intervention

Renal artery dissection requiring intervention

Vascular complications (eg, clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24‐hour period during the first 7 days postrandomization)

Hospitalization for hypertensive crisis not related to confirmed nonadherence with medications,

Or

New renal artery stenosis >70%, confirmed by angiography within 6 months of randomization

Abbreviations: eGFR, estimated glomerular filtration rate; MAE, major adverse events; SBP, systolic blood pressure.