Randomised clinical trials on device-based therapies for cardiovascular conditions
| Condition | Study treatment | Trial(s); sample size [ref.] | Primary end-point(s); main results |
| Acute STEMI, first hours | Primary PCI versus MT (fibrinolysis) | Multiple studies; >14 000 pts in total [6] | Death, recurrent MI, late revascularisation; PCI better |
| Heart failure, LVEF <35% | ICD versus MT | MADIT, MADIT II, COMPANION, SCD-HeFT; >5000 pts [7] | Death, sudden death; ICD better |
| Heart failure, LVEF <35%, LBBB, QRS >120 ms | CRT±ICD versus MT | CARE-HF, COMPANION | Death, heart failure hospitalisations; CRT better |
| Heart failure, LVEF <35%, LBBB, QRS >120 ms | CRT combined with ICD versus ICD | RAFT; >4000 pts [7] | CRT better |
| Refractory heart failure, ineligible for HTx | LVAD versus MT | REMATCH; 129 pts [8] | Death; LVAD better |
| Aortic stenosis, ineligible for surgery | TAVI versus MT | PARTNER B; 358 pts [9] | Death; TAVI better |
| Aortic stenosis, high surgical risk | TAVI versus surgical AVR | PARTNER A, CORE-VALVE US; ∼1500 pts [10] | Death; no significant differences |
| Degenerative/ functional mitral regurgitation, eligible for surgery | Percutaneous repair# versus surgical treatment | EVEREST II; 279 pts [11] | Death or late MV surgery; surgical treatment better (no differences for death) |
| Permanent AF | Catheter ablation versus MT | Various; ∼550 pts [12] | Recurrent AF: catheter ablation better |
| Patent PFO and prior stroke/TIA | Percutaneous PFO closure versus MT | CLOSURE, PC trial, RESPECT; ∼2300 pts [5] | Death or stroke (±TIA, peripheral embolism); no significant differences |
| Drug-resistant hypertension | Renal artery denervation versus MT, open | Symplicity HTN-2; 106 pts [13] | BP reduction; renal artery denervation better |
| Drug-resistant hypertension | Renal artery denervation versus MT, patient blinded | Simplicity HTN-3, DENERHTN; ∼2000 pts [13] | BP reduction; no significant differences |
Only some randomised, concluded and published clinical trials are reported as examples. Reference citations are to original individual trial reports, or to comments, reviews, meta-analyses or pooled data analyses. However, table 1 summarises the results of individual trials, not of meta-analysis or pooled data analyses. Synthetic reporting may imply some approximations. STEMI: ST segment elevation myocardial infarction; LVEF: left ventricular ejection fraction; LBBB: left bundle branch block; HTx: heart transplant; AF: atrial fibrillation; PFO: patent foramen ovale; TIA: transient ischaemic attack; PCI: percutaneous coronary intervention; MT: medical therapy; pt: patient; MI: myocardial infarction; ICD: implantable cardioverter–defibrillator; MADIT: Multicenter Automatic Defibrillator Implantation Trial; COMPANION: Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure; SCD-HeFT: Sudden Cardiac Death in Heart Failure Trial; CRT: cardiac resynchronisation therapy; CARE-HF: Cardiac Resynchronization – Heart Failure; RAFT: Resynchronization–Defibrillation for Ambulatory Heart Failure Trial; LVAD: left ventricular assist device; REMATCH: Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure; TAVI: transcatheter aortic valve implantation; PARTNER: Placement of Aortic Transcatheter Valves; AVR: aortic valve replacement; EVEREST: Endovascular Valve Edge-to-Edge Repair Study; MV: mitral valve; PC trial: Clinical Trial Comparing PFO Using the Amplatzer PFO Occluder with Medical Treatment in Patients with Cryptogenic Embolism; RESPECT: Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment; BP: blood pressure. #: mitral regurgitation repair with MitraClip device [3].