Table 1 Open in new tab Key...

Table 1

Key characteristics of trials included

Author (year) Journal	Trial	Condition	Intervention (active vs. placebo)	Number of patients randomized (active/placebo)	Primary outcome
Author (year) Journal	Trial	Condition	Intervention (active vs. placebo)	Number of patients randomized (active/placebo)	Definition (follow-up)	Statistical superiority of active treatment over placebo
Raizner et al. (2000)¹³ Circulation	PREVENT	De novo/restenotic lesions	PTCA/stenting and intracoronary radiation vs. PTCA/stenting only	80/25	Incidence of MACE between baseline and 12 months	No
Stone et al. (2002)¹⁴ J Am Coll Cardiol		Refractory angina (unsuccessful percutaneous coronary intervention)	PMLR vs. coronary catheterization	71/70	Change in exercise duration at 6 months	No
Connolly et al. (2003)¹⁵ JAMA	VPS-II	Vasovagal syncope	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	48/52	Time to first recurrence of syncope	No
Raviele et al. (2004)¹⁶ Eur Heart J	SYNPACE	Vasovagal syncope	Dual-chamber pacemaker turned on (DDD) with rate-drop response vs. pacemaker not turned on (OOO)	16/13	Recurrence of syncope	No
Raviele et al. (2004)¹⁶ Eur Heart J	SYNPACE	Vasovagal syncope		16/13	Time to first recurrence of syncope	No
Serruys et al. (2004)¹⁷ Int J Cardiovasc Intervent	EUROSPAH	Stable/unstable angina or silent ischaemia	Intravascular ultrasound after stenting vs. stenting only	202/201	In-stent late lumen loss at 6 months	No
Salem et al. (2004)¹⁸ Am J Cardiol	BELIEF	Stable angina	PMLR vs. laser turned on, but no procedure	40/42	Improvement of ≥1 CCS angina classes at 12 months	Yes
Leon et al. (2005)¹⁹ J Am Coll Cardiol	DIRECT	Refractory angina	PMLR vs. laser turned on, but no procedure	98/102	Change in exercise duration at 6 months	No
Geiger et al. (2006)²⁰ Strahlenther Onkol	EVEREST	Coronary artery disease	PTCA/BMS and intracoronary radiation vs. PTCA/BMS	21/11	Composite clinical outcome^a at 16 months	No
Syeda et al. (2006)²¹ Radiother Oncol	REGARD	Coronary artery disease in diabetic patients	PTCA/stenting and intracoronary radiation vs. PCTA/stenting	45/44	Incidence of thrombosis/MACE at 9 months	No
					Late lumen loss at 9 months	Yes
					Restenosis >50% at 9 months	Yes
Reynen et al. (2006)²² Coron Artery Dis		Coronary in-stent restenosis	PTCA and intracoronary radiation vs. PTCA	78/78	Diameter of stenosis at 6 months	No
Reynen et al. (2006)²² Coron Artery Dis		Coronary in-stent restenosis	PTCA and intracoronary radiation vs. PTCA	78/78	Re-restenosis rate at 6 months	Yes
Misra et al. (2006)²³ Kidney Int	BRAVO I	Dysfunctional dialysis access graft	PTA and endovascular radiation vs. PTA only	14/11	Angiographic target lesion primary patency at 6 months	Yes
Dowson et al. (2008)²⁴ Circulation	MIST	PFO and migraine with aura	Percutaneous PFO occlusion vs. skin incision	74/73	Cessation of migraine headache 3 through 6 months after randomization	No
Parry et al. (2008)²⁵ Heart		Falls attributed to carotid sinus hypersensitivity	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	34 (crossover)	Number of falls at 6 months	No
Bisognano et al. (2011)²⁶ J Am Coll Cardiol	Rheos Pivotal Trial	Resistant hypertension	BAT device implantation and turned on vs. BAT device not turned on	181/84	Composite efficacy outcome^b	No
Brignole et al. (2012)²⁷ Circulation	ISSUE-3	Neurally mediated syncope	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	38/39	Recurrence of syncope between baseline and 24 months	Yes
Bhatt et al. (2014)²⁸ N Engl J Med	SYMPLICITY HTN-3	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. renal angiography only	364/171	Change in office SBP at 6 months	No
Zannad et al. (2015)²⁹ Eur Heart J	NECTAR-HF	HFrEF	Implantation and vagal nerve stimulator system turned on vs. implantation only	59/28	Change in left ventricular systolic diameter at 6 months	No
Verheye et al. (2015)³⁰ N Engl J Med	COSIRA	Refractory angina	Coronary sinus reducer vs. coronary angiography	52/52	Improvement of ≥2 CCS angina classes at 6 months	Yes
Desch et al. (2015)³¹ Hypertension	Leipzig RSD	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. renal angiography only	32/35	Change in 24 h-ambulatory SBP at 6 months	No
Mathiassen et al. (2016)³² J Hypertens	ReSET	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. catheter in situ and radiograph scan	36/33	Change in ambulatory daytime SBP at 3 months	No
Beige et al. (2017)³³ J Hypertens		Resistant hypertension	BAT device turned on vs. BAT device turned off	17 (crossover)	Intraindividual increase in office SBP ≥35 mmHg while BAT device turned off	No
Al-Lamee et al. (2018)³⁴ Lancet	ORBITA	Symptomatic angiographically significant (≥70%) non-occluded lesion in a single vessel	PTCA/DES vs. coronary angiography	105/91	Change in exercise duration at 6 weeks	No
Tobis et al. (2017)³⁵ J Am Coll Cardiol	PREMIUM Migraine	PFO and migraine with/without aura	Percutaneous PFO closure vs. right heart catheterization	123/107	50% reduction of monthly number of migraine attacks during months 10 through 12 compared with baseline	No
Baron-Esquivias et al. (2017)³⁶ J Am Coll Cardiol	SPAIN	Vasovagal syncope	Dual-chamber pacing (DDD) with CLS vs. placebo pacing (DDI)	46 (crossover)	Reduction of syncopal episodes ≥50% at 12 months	Yes
Baron-Esquivias et al. (2017)³⁶ J Am Coll Cardiol	SPAIN	Vasovagal syncope	Dual-chamber pacing (DDD) with CLS vs. placebo pacing (DDI)	46 (crossover)	Time to first recurrence of syncope	Yes
Feldman et al. (2018)³⁷ Circulation	REDUCE-LAP HF I	HFpEF (EF ≥40%) and elevated left atrial pressure	Transcatheter interatrial shunt device vs. intracardiac echocardiography	22/22	Difference in exercise PCWP at 1 month	Yes
Kandzari et al. (2018)³⁸ Lancet	SPYRAL HTN-ON MED	Mild-to-moderate hypertension	Catheter-based RDN (multi-electrode radiofrequency catheter) vs. renal angiography only	38/42	Change in 24 h-ambulatory blood pressure at 6 months	Yes
Azizi et al. (2018)³⁹ Lancet	RADIANCE HTN SOLO	Mild-to-moderate uncontrolled or controlled (≤2 drugs) hypertension	Catheter-based RDN (ultrasound-based catheter) vs. renal angiography only	74/72	Change in daytime SBP at 2 months	Yes
Witte et al. (2019)⁴⁰ JACC Heart Fail	REDUCE FMR	Functional mitral regurgitation	Catheter-based mitral annuloplasty vs. coronary sinus angiography only	87/33	Change in mitral regurgitant volume at 12 months	Yes
Weber et al. (2020)⁴¹ JACC Cardiovasc Interv	REDUCE HTN: REINFORCE	Mild-to-moderate hypertension in the absence of antihypertensive medication	Catheter-based RDN (bipolar radiofrequency catheter) vs. renal angiography only	34/17	Change in 24 h-ambulatory blood pressure at 2 months	No
Böhm et al. (2020)⁴² Lancet	SPYRAL HTN-OFF MED Pivotal (including pilot phase)	Mild-to-moderate hypertension in the absence of antihypertensive medication	Catheter-based RDN (multi-electrode radiofrequency catheter) vs. renal angiography only	166/165	Change in 24 h-ambulatory blood pressure at 3 months	Yes

Author (year) Journal	Trial	Condition	Intervention (active vs. placebo)	Number of patients randomized (active/placebo)	Primary outcome
Author (year) Journal	Trial	Condition	Intervention (active vs. placebo)	Number of patients randomized (active/placebo)	Definition (follow-up)	Statistical superiority of active treatment over placebo
Raizner et al. (2000)¹³ Circulation	PREVENT	De novo/restenotic lesions	PTCA/stenting and intracoronary radiation vs. PTCA/stenting only	80/25	Incidence of MACE between baseline and 12 months	No
Stone et al. (2002)¹⁴ J Am Coll Cardiol		Refractory angina (unsuccessful percutaneous coronary intervention)	PMLR vs. coronary catheterization	71/70	Change in exercise duration at 6 months	No
Connolly et al. (2003)¹⁵ JAMA	VPS-II	Vasovagal syncope	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	48/52	Time to first recurrence of syncope	No
Raviele et al. (2004)¹⁶ Eur Heart J	SYNPACE	Vasovagal syncope	Dual-chamber pacemaker turned on (DDD) with rate-drop response vs. pacemaker not turned on (OOO)	16/13	Recurrence of syncope	No
Raviele et al. (2004)¹⁶ Eur Heart J	SYNPACE	Vasovagal syncope		16/13	Time to first recurrence of syncope	No
Serruys et al. (2004)¹⁷ Int J Cardiovasc Intervent	EUROSPAH	Stable/unstable angina or silent ischaemia	Intravascular ultrasound after stenting vs. stenting only	202/201	In-stent late lumen loss at 6 months	No
Salem et al. (2004)¹⁸ Am J Cardiol	BELIEF	Stable angina	PMLR vs. laser turned on, but no procedure	40/42	Improvement of ≥1 CCS angina classes at 12 months	Yes
Leon et al. (2005)¹⁹ J Am Coll Cardiol	DIRECT	Refractory angina	PMLR vs. laser turned on, but no procedure	98/102	Change in exercise duration at 6 months	No
Geiger et al. (2006)²⁰ Strahlenther Onkol	EVEREST	Coronary artery disease	PTCA/BMS and intracoronary radiation vs. PTCA/BMS	21/11	Composite clinical outcome^a at 16 months	No
Syeda et al. (2006)²¹ Radiother Oncol	REGARD	Coronary artery disease in diabetic patients	PTCA/stenting and intracoronary radiation vs. PCTA/stenting	45/44	Incidence of thrombosis/MACE at 9 months	No
					Late lumen loss at 9 months	Yes
					Restenosis >50% at 9 months	Yes
Reynen et al. (2006)²² Coron Artery Dis		Coronary in-stent restenosis	PTCA and intracoronary radiation vs. PTCA	78/78	Diameter of stenosis at 6 months	No
Reynen et al. (2006)²² Coron Artery Dis		Coronary in-stent restenosis	PTCA and intracoronary radiation vs. PTCA	78/78	Re-restenosis rate at 6 months	Yes
Misra et al. (2006)²³ Kidney Int	BRAVO I	Dysfunctional dialysis access graft	PTA and endovascular radiation vs. PTA only	14/11	Angiographic target lesion primary patency at 6 months	Yes
Dowson et al. (2008)²⁴ Circulation	MIST	PFO and migraine with aura	Percutaneous PFO occlusion vs. skin incision	74/73	Cessation of migraine headache 3 through 6 months after randomization	No
Parry et al. (2008)²⁵ Heart		Falls attributed to carotid sinus hypersensitivity	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	34 (crossover)	Number of falls at 6 months	No
Bisognano et al. (2011)²⁶ J Am Coll Cardiol	Rheos Pivotal Trial	Resistant hypertension	BAT device implantation and turned on vs. BAT device not turned on	181/84	Composite efficacy outcome^b	No
Brignole et al. (2012)²⁷ Circulation	ISSUE-3	Neurally mediated syncope	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	38/39	Recurrence of syncope between baseline and 24 months	Yes
Bhatt et al. (2014)²⁸ N Engl J Med	SYMPLICITY HTN-3	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. renal angiography only	364/171	Change in office SBP at 6 months	No
Zannad et al. (2015)²⁹ Eur Heart J	NECTAR-HF	HFrEF	Implantation and vagal nerve stimulator system turned on vs. implantation only	59/28	Change in left ventricular systolic diameter at 6 months	No
Verheye et al. (2015)³⁰ N Engl J Med	COSIRA	Refractory angina	Coronary sinus reducer vs. coronary angiography	52/52	Improvement of ≥2 CCS angina classes at 6 months	Yes
Desch et al. (2015)³¹ Hypertension	Leipzig RSD	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. renal angiography only	32/35	Change in 24 h-ambulatory SBP at 6 months	No
Mathiassen et al. (2016)³² J Hypertens	ReSET	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. catheter in situ and radiograph scan	36/33	Change in ambulatory daytime SBP at 3 months	No
Beige et al. (2017)³³ J Hypertens		Resistant hypertension	BAT device turned on vs. BAT device turned off	17 (crossover)	Intraindividual increase in office SBP ≥35 mmHg while BAT device turned off	No
Al-Lamee et al. (2018)³⁴ Lancet	ORBITA	Symptomatic angiographically significant (≥70%) non-occluded lesion in a single vessel	PTCA/DES vs. coronary angiography	105/91	Change in exercise duration at 6 weeks	No
Tobis et al. (2017)³⁵ J Am Coll Cardiol	PREMIUM Migraine	PFO and migraine with/without aura	Percutaneous PFO closure vs. right heart catheterization	123/107	50% reduction of monthly number of migraine attacks during months 10 through 12 compared with baseline	No
Baron-Esquivias et al. (2017)³⁶ J Am Coll Cardiol	SPAIN	Vasovagal syncope	Dual-chamber pacing (DDD) with CLS vs. placebo pacing (DDI)	46 (crossover)	Reduction of syncopal episodes ≥50% at 12 months	Yes
Baron-Esquivias et al. (2017)³⁶ J Am Coll Cardiol	SPAIN	Vasovagal syncope	Dual-chamber pacing (DDD) with CLS vs. placebo pacing (DDI)	46 (crossover)	Time to first recurrence of syncope	Yes
Feldman et al. (2018)³⁷ Circulation	REDUCE-LAP HF I	HFpEF (EF ≥40%) and elevated left atrial pressure	Transcatheter interatrial shunt device vs. intracardiac echocardiography	22/22	Difference in exercise PCWP at 1 month	Yes
Kandzari et al. (2018)³⁸ Lancet	SPYRAL HTN-ON MED	Mild-to-moderate hypertension	Catheter-based RDN (multi-electrode radiofrequency catheter) vs. renal angiography only	38/42	Change in 24 h-ambulatory blood pressure at 6 months	Yes
Azizi et al. (2018)³⁹ Lancet	RADIANCE HTN SOLO	Mild-to-moderate uncontrolled or controlled (≤2 drugs) hypertension	Catheter-based RDN (ultrasound-based catheter) vs. renal angiography only	74/72	Change in daytime SBP at 2 months	Yes
Witte et al. (2019)⁴⁰ JACC Heart Fail	REDUCE FMR	Functional mitral regurgitation	Catheter-based mitral annuloplasty vs. coronary sinus angiography only	87/33	Change in mitral regurgitant volume at 12 months	Yes
Weber et al. (2020)⁴¹ JACC Cardiovasc Interv	REDUCE HTN: REINFORCE	Mild-to-moderate hypertension in the absence of antihypertensive medication	Catheter-based RDN (bipolar radiofrequency catheter) vs. renal angiography only	34/17	Change in 24 h-ambulatory blood pressure at 2 months	No
Böhm et al. (2020)⁴² Lancet	SPYRAL HTN-OFF MED Pivotal (including pilot phase)	Mild-to-moderate hypertension in the absence of antihypertensive medication	Catheter-based RDN (multi-electrode radiofrequency catheter) vs. renal angiography only	166/165	Change in 24 h-ambulatory blood pressure at 3 months	Yes

BAT, baroreceptor activation therapy; BMS, bare metal stent; CCS, Canadian Cardiovascular Society; CLS, closed-loop-stimulation; DES, drug-eluting stent; EF, ejection fraction; HFpEF/HFrEF, heart failure with preserved/reduced ejection fraction; MACE, major adverse cardiovascular events; PCWP, pulmonary capillary pressure; PFO, patent foramen oval; PMLR, percutaneous myocardial laser revascularization; PTA, percutaneous transluminal angioplasty; PTCA, percutaneous transluminal coronary angioplasty; RDN, renal denervation; SBP, systolic blood pressure.

Composite of death, myocardial infarction, repeat target lesion or percutaneous revascularization, and coronary artery bypass surgery.

Composite of (i) blood pressure responder rate at 6 months, (ii) sustained blood pressure-lowering response at 12 months, (iii) procedure, (iv) BAT, and (v) device safety.

Table 1

Open in new tab

Key characteristics of trials included

Author (year) Journal	Trial	Condition	Intervention (active vs. placebo)	Number of patients randomized (active/placebo)	Primary outcome
Author (year) Journal	Trial	Condition	Intervention (active vs. placebo)	Number of patients randomized (active/placebo)	Definition (follow-up)	Statistical superiority of active treatment over placebo
Raizner et al. (2000)¹³ Circulation	PREVENT	De novo/restenotic lesions	PTCA/stenting and intracoronary radiation vs. PTCA/stenting only	80/25	Incidence of MACE between baseline and 12 months	No
Stone et al. (2002)¹⁴ J Am Coll Cardiol		Refractory angina (unsuccessful percutaneous coronary intervention)	PMLR vs. coronary catheterization	71/70	Change in exercise duration at 6 months	No
Connolly et al. (2003)¹⁵ JAMA	VPS-II	Vasovagal syncope	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	48/52	Time to first recurrence of syncope	No
Raviele et al. (2004)¹⁶ Eur Heart J	SYNPACE	Vasovagal syncope	Dual-chamber pacemaker turned on (DDD) with rate-drop response vs. pacemaker not turned on (OOO)	16/13	Recurrence of syncope	No
Raviele et al. (2004)¹⁶ Eur Heart J	SYNPACE	Vasovagal syncope		16/13	Time to first recurrence of syncope	No
Serruys et al. (2004)¹⁷ Int J Cardiovasc Intervent	EUROSPAH	Stable/unstable angina or silent ischaemia	Intravascular ultrasound after stenting vs. stenting only	202/201	In-stent late lumen loss at 6 months	No
Salem et al. (2004)¹⁸ Am J Cardiol	BELIEF	Stable angina	PMLR vs. laser turned on, but no procedure	40/42	Improvement of ≥1 CCS angina classes at 12 months	Yes
Leon et al. (2005)¹⁹ J Am Coll Cardiol	DIRECT	Refractory angina	PMLR vs. laser turned on, but no procedure	98/102	Change in exercise duration at 6 months	No
Geiger et al. (2006)²⁰ Strahlenther Onkol	EVEREST	Coronary artery disease	PTCA/BMS and intracoronary radiation vs. PTCA/BMS	21/11	Composite clinical outcome^a at 16 months	No
Syeda et al. (2006)²¹ Radiother Oncol	REGARD	Coronary artery disease in diabetic patients	PTCA/stenting and intracoronary radiation vs. PCTA/stenting	45/44	Incidence of thrombosis/MACE at 9 months	No
					Late lumen loss at 9 months	Yes
					Restenosis >50% at 9 months	Yes
Reynen et al. (2006)²² Coron Artery Dis		Coronary in-stent restenosis	PTCA and intracoronary radiation vs. PTCA	78/78	Diameter of stenosis at 6 months	No
Reynen et al. (2006)²² Coron Artery Dis		Coronary in-stent restenosis	PTCA and intracoronary radiation vs. PTCA	78/78	Re-restenosis rate at 6 months	Yes
Misra et al. (2006)²³ Kidney Int	BRAVO I	Dysfunctional dialysis access graft	PTA and endovascular radiation vs. PTA only	14/11	Angiographic target lesion primary patency at 6 months	Yes
Dowson et al. (2008)²⁴ Circulation	MIST	PFO and migraine with aura	Percutaneous PFO occlusion vs. skin incision	74/73	Cessation of migraine headache 3 through 6 months after randomization	No
Parry et al. (2008)²⁵ Heart		Falls attributed to carotid sinus hypersensitivity	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	34 (crossover)	Number of falls at 6 months	No
Bisognano et al. (2011)²⁶ J Am Coll Cardiol	Rheos Pivotal Trial	Resistant hypertension	BAT device implantation and turned on vs. BAT device not turned on	181/84	Composite efficacy outcome^b	No
Brignole et al. (2012)²⁷ Circulation	ISSUE-3	Neurally mediated syncope	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	38/39	Recurrence of syncope between baseline and 24 months	Yes
Bhatt et al. (2014)²⁸ N Engl J Med	SYMPLICITY HTN-3	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. renal angiography only	364/171	Change in office SBP at 6 months	No
Zannad et al. (2015)²⁹ Eur Heart J	NECTAR-HF	HFrEF	Implantation and vagal nerve stimulator system turned on vs. implantation only	59/28	Change in left ventricular systolic diameter at 6 months	No
Verheye et al. (2015)³⁰ N Engl J Med	COSIRA	Refractory angina	Coronary sinus reducer vs. coronary angiography	52/52	Improvement of ≥2 CCS angina classes at 6 months	Yes
Desch et al. (2015)³¹ Hypertension	Leipzig RSD	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. renal angiography only	32/35	Change in 24 h-ambulatory SBP at 6 months	No
Mathiassen et al. (2016)³² J Hypertens	ReSET	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. catheter in situ and radiograph scan	36/33	Change in ambulatory daytime SBP at 3 months	No
Beige et al. (2017)³³ J Hypertens		Resistant hypertension	BAT device turned on vs. BAT device turned off	17 (crossover)	Intraindividual increase in office SBP ≥35 mmHg while BAT device turned off	No
Al-Lamee et al. (2018)³⁴ Lancet	ORBITA	Symptomatic angiographically significant (≥70%) non-occluded lesion in a single vessel	PTCA/DES vs. coronary angiography	105/91	Change in exercise duration at 6 weeks	No
Tobis et al. (2017)³⁵ J Am Coll Cardiol	PREMIUM Migraine	PFO and migraine with/without aura	Percutaneous PFO closure vs. right heart catheterization	123/107	50% reduction of monthly number of migraine attacks during months 10 through 12 compared with baseline	No
Baron-Esquivias et al. (2017)³⁶ J Am Coll Cardiol	SPAIN	Vasovagal syncope	Dual-chamber pacing (DDD) with CLS vs. placebo pacing (DDI)	46 (crossover)	Reduction of syncopal episodes ≥50% at 12 months	Yes
Baron-Esquivias et al. (2017)³⁶ J Am Coll Cardiol	SPAIN	Vasovagal syncope	Dual-chamber pacing (DDD) with CLS vs. placebo pacing (DDI)	46 (crossover)	Time to first recurrence of syncope	Yes
Feldman et al. (2018)³⁷ Circulation	REDUCE-LAP HF I	HFpEF (EF ≥40%) and elevated left atrial pressure	Transcatheter interatrial shunt device vs. intracardiac echocardiography	22/22	Difference in exercise PCWP at 1 month	Yes
Kandzari et al. (2018)³⁸ Lancet	SPYRAL HTN-ON MED	Mild-to-moderate hypertension	Catheter-based RDN (multi-electrode radiofrequency catheter) vs. renal angiography only	38/42	Change in 24 h-ambulatory blood pressure at 6 months	Yes
Azizi et al. (2018)³⁹ Lancet	RADIANCE HTN SOLO	Mild-to-moderate uncontrolled or controlled (≤2 drugs) hypertension	Catheter-based RDN (ultrasound-based catheter) vs. renal angiography only	74/72	Change in daytime SBP at 2 months	Yes
Witte et al. (2019)⁴⁰ JACC Heart Fail	REDUCE FMR	Functional mitral regurgitation	Catheter-based mitral annuloplasty vs. coronary sinus angiography only	87/33	Change in mitral regurgitant volume at 12 months	Yes
Weber et al. (2020)⁴¹ JACC Cardiovasc Interv	REDUCE HTN: REINFORCE	Mild-to-moderate hypertension in the absence of antihypertensive medication	Catheter-based RDN (bipolar radiofrequency catheter) vs. renal angiography only	34/17	Change in 24 h-ambulatory blood pressure at 2 months	No
Böhm et al. (2020)⁴² Lancet	SPYRAL HTN-OFF MED Pivotal (including pilot phase)	Mild-to-moderate hypertension in the absence of antihypertensive medication	Catheter-based RDN (multi-electrode radiofrequency catheter) vs. renal angiography only	166/165	Change in 24 h-ambulatory blood pressure at 3 months	Yes

Author (year) Journal	Trial	Condition	Intervention (active vs. placebo)	Number of patients randomized (active/placebo)	Primary outcome
Author (year) Journal	Trial	Condition	Intervention (active vs. placebo)	Number of patients randomized (active/placebo)	Definition (follow-up)	Statistical superiority of active treatment over placebo
Raizner et al. (2000)¹³ Circulation	PREVENT	De novo/restenotic lesions	PTCA/stenting and intracoronary radiation vs. PTCA/stenting only	80/25	Incidence of MACE between baseline and 12 months	No
Stone et al. (2002)¹⁴ J Am Coll Cardiol		Refractory angina (unsuccessful percutaneous coronary intervention)	PMLR vs. coronary catheterization	71/70	Change in exercise duration at 6 months	No
Connolly et al. (2003)¹⁵ JAMA	VPS-II	Vasovagal syncope	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	48/52	Time to first recurrence of syncope	No
Raviele et al. (2004)¹⁶ Eur Heart J	SYNPACE	Vasovagal syncope	Dual-chamber pacemaker turned on (DDD) with rate-drop response vs. pacemaker not turned on (OOO)	16/13	Recurrence of syncope	No
Raviele et al. (2004)¹⁶ Eur Heart J	SYNPACE	Vasovagal syncope		16/13	Time to first recurrence of syncope	No
Serruys et al. (2004)¹⁷ Int J Cardiovasc Intervent	EUROSPAH	Stable/unstable angina or silent ischaemia	Intravascular ultrasound after stenting vs. stenting only	202/201	In-stent late lumen loss at 6 months	No
Salem et al. (2004)¹⁸ Am J Cardiol	BELIEF	Stable angina	PMLR vs. laser turned on, but no procedure	40/42	Improvement of ≥1 CCS angina classes at 12 months	Yes
Leon et al. (2005)¹⁹ J Am Coll Cardiol	DIRECT	Refractory angina	PMLR vs. laser turned on, but no procedure	98/102	Change in exercise duration at 6 months	No
Geiger et al. (2006)²⁰ Strahlenther Onkol	EVEREST	Coronary artery disease	PTCA/BMS and intracoronary radiation vs. PTCA/BMS	21/11	Composite clinical outcome^a at 16 months	No
Syeda et al. (2006)²¹ Radiother Oncol	REGARD	Coronary artery disease in diabetic patients	PTCA/stenting and intracoronary radiation vs. PCTA/stenting	45/44	Incidence of thrombosis/MACE at 9 months	No
					Late lumen loss at 9 months	Yes
					Restenosis >50% at 9 months	Yes
Reynen et al. (2006)²² Coron Artery Dis		Coronary in-stent restenosis	PTCA and intracoronary radiation vs. PTCA	78/78	Diameter of stenosis at 6 months	No
Reynen et al. (2006)²² Coron Artery Dis		Coronary in-stent restenosis	PTCA and intracoronary radiation vs. PTCA	78/78	Re-restenosis rate at 6 months	Yes
Misra et al. (2006)²³ Kidney Int	BRAVO I	Dysfunctional dialysis access graft	PTA and endovascular radiation vs. PTA only	14/11	Angiographic target lesion primary patency at 6 months	Yes
Dowson et al. (2008)²⁴ Circulation	MIST	PFO and migraine with aura	Percutaneous PFO occlusion vs. skin incision	74/73	Cessation of migraine headache 3 through 6 months after randomization	No
Parry et al. (2008)²⁵ Heart		Falls attributed to carotid sinus hypersensitivity	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	34 (crossover)	Number of falls at 6 months	No
Bisognano et al. (2011)²⁶ J Am Coll Cardiol	Rheos Pivotal Trial	Resistant hypertension	BAT device implantation and turned on vs. BAT device not turned on	181/84	Composite efficacy outcome^b	No
Brignole et al. (2012)²⁷ Circulation	ISSUE-3	Neurally mediated syncope	Dual-chamber pacing (DDD) with rate-drop response vs. sensing only (ODO)	38/39	Recurrence of syncope between baseline and 24 months	Yes
Bhatt et al. (2014)²⁸ N Engl J Med	SYMPLICITY HTN-3	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. renal angiography only	364/171	Change in office SBP at 6 months	No
Zannad et al. (2015)²⁹ Eur Heart J	NECTAR-HF	HFrEF	Implantation and vagal nerve stimulator system turned on vs. implantation only	59/28	Change in left ventricular systolic diameter at 6 months	No
Verheye et al. (2015)³⁰ N Engl J Med	COSIRA	Refractory angina	Coronary sinus reducer vs. coronary angiography	52/52	Improvement of ≥2 CCS angina classes at 6 months	Yes
Desch et al. (2015)³¹ Hypertension	Leipzig RSD	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. renal angiography only	32/35	Change in 24 h-ambulatory SBP at 6 months	No
Mathiassen et al. (2016)³² J Hypertens	ReSET	Resistant hypertension	Catheter-based RDN (monoelectrode radiofrequency catheter) vs. catheter in situ and radiograph scan	36/33	Change in ambulatory daytime SBP at 3 months	No
Beige et al. (2017)³³ J Hypertens		Resistant hypertension	BAT device turned on vs. BAT device turned off	17 (crossover)	Intraindividual increase in office SBP ≥35 mmHg while BAT device turned off	No
Al-Lamee et al. (2018)³⁴ Lancet	ORBITA	Symptomatic angiographically significant (≥70%) non-occluded lesion in a single vessel	PTCA/DES vs. coronary angiography	105/91	Change in exercise duration at 6 weeks	No
Tobis et al. (2017)³⁵ J Am Coll Cardiol	PREMIUM Migraine	PFO and migraine with/without aura	Percutaneous PFO closure vs. right heart catheterization	123/107	50% reduction of monthly number of migraine attacks during months 10 through 12 compared with baseline	No
Baron-Esquivias et al. (2017)³⁶ J Am Coll Cardiol	SPAIN	Vasovagal syncope	Dual-chamber pacing (DDD) with CLS vs. placebo pacing (DDI)	46 (crossover)	Reduction of syncopal episodes ≥50% at 12 months	Yes
Baron-Esquivias et al. (2017)³⁶ J Am Coll Cardiol	SPAIN	Vasovagal syncope	Dual-chamber pacing (DDD) with CLS vs. placebo pacing (DDI)	46 (crossover)	Time to first recurrence of syncope	Yes
Feldman et al. (2018)³⁷ Circulation	REDUCE-LAP HF I	HFpEF (EF ≥40%) and elevated left atrial pressure	Transcatheter interatrial shunt device vs. intracardiac echocardiography	22/22	Difference in exercise PCWP at 1 month	Yes
Kandzari et al. (2018)³⁸ Lancet	SPYRAL HTN-ON MED	Mild-to-moderate hypertension	Catheter-based RDN (multi-electrode radiofrequency catheter) vs. renal angiography only	38/42	Change in 24 h-ambulatory blood pressure at 6 months	Yes
Azizi et al. (2018)³⁹ Lancet	RADIANCE HTN SOLO	Mild-to-moderate uncontrolled or controlled (≤2 drugs) hypertension	Catheter-based RDN (ultrasound-based catheter) vs. renal angiography only	74/72	Change in daytime SBP at 2 months	Yes
Witte et al. (2019)⁴⁰ JACC Heart Fail	REDUCE FMR	Functional mitral regurgitation	Catheter-based mitral annuloplasty vs. coronary sinus angiography only	87/33	Change in mitral regurgitant volume at 12 months	Yes
Weber et al. (2020)⁴¹ JACC Cardiovasc Interv	REDUCE HTN: REINFORCE	Mild-to-moderate hypertension in the absence of antihypertensive medication	Catheter-based RDN (bipolar radiofrequency catheter) vs. renal angiography only	34/17	Change in 24 h-ambulatory blood pressure at 2 months	No
Böhm et al. (2020)⁴² Lancet	SPYRAL HTN-OFF MED Pivotal (including pilot phase)	Mild-to-moderate hypertension in the absence of antihypertensive medication	Catheter-based RDN (multi-electrode radiofrequency catheter) vs. renal angiography only	166/165	Change in 24 h-ambulatory blood pressure at 3 months	Yes

Composite of death, myocardial infarction, repeat target lesion or percutaneous revascularization, and coronary artery bypass surgery.

Composite of (i) blood pressure responder rate at 6 months, (ii) sustained blood pressure-lowering response at 12 months, (iii) procedure, (iv) BAT, and (v) device safety.

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